menu

Publications by
Quintiles Authors



Psychiatry

Clinical pharmacology of ponesimod, a selective S1P₁ receptor modulator, after uptitration to supratherapeutic doses in healthy subjects.
Eur J Pharm Sci. 2014 Oct 15;63:147-53.
The moral imperative of improving patient adherence to pharmacotherapy for cardiodiabesity, Part I: A focus on type 2 diabetes mellitus.
Journal for Patient Compliance. 2012;2(1):32-6.
Who will benefit from antidepressants in the acute treatment of bipolar depression? A reanalysis of the STEP-BD study by Sachs et al. 2007, using Q-learning.
Int J Bipolar Disord. 2015 Apr 3;3:7. doi: 10.1186/s40345-014-0018-5. eCollection 2015.
The moral imperative of improving patient adherence to pharmacotherapy for cardiodiabesity, Part II: A focus on cardiovascular disease.
Journal for Patient Compliance. 2012;2(2):36-41. 
Optimising patient centric services: a tailored solution. 
Journal for Patient Compliance. 2011;1(3):36-40.
Behavioral Health Outcomes Among Adults: Associations With Individual and Community-Level Economic Conditions.
Psychiatr Serv. 2016 Jan;67(1):71-7. doi: 10.1176/appi.ps.201400016. Epub 2015 Sep 1.
Translational toxicology: a developmental focus for integrated research strategies.
BMC Pharmacol Toxicol. 2013 Sep 30;14:51.
Encyclopedia of Behavioral Medicine.
New York: Springer. 2013. 

Biostatistics

Combining analysis results from multiply imputed categorical data. 
PharmaSUG 2013. 2013;Web. 05 Jun. 2013. 
Tradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs.
J Biopharm Stat. 2015 Sep 21.
Missing data in clinical trials: from clinical assumptions to statistical analysis using pattern mixture models.
Pharm Stat. 2013;12(6):337-47.
Tutorial in biostatistics: data-driven subgroup identification and analysis in clinical trials.
Stat Med. 2016 Aug 3. doi: 10.1002/sim.7064. [Epub ahead of print]
Traditional multiplicity adjustment methods in clinical trials.
Stat Med. 2013;32(29):5172-218.
General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials.
J Biopharm Stat. 2016;26(1):71-98. doi: 10.1080/10543406.2015.1092033.
Optimal dose-finding designs with correlated continuous and discrete responses.
Stat Med. 2012;31(3):217-34.
Practical designs for phase I combination studies in oncology.
J Biopharm Stat. 2015 Sep 17.
Nine-Year Change in Statistical Design, Profile, and Success Rates of Phase II Oncology Trials.
J Biopharm Stat. 2015 Sep 14.
Superchain procedures in clinical trials with multiple objectives.
Stat Med. 2013;32(3):486-508. 
Methods for identification and confirmation of targeted subgroups in clinical trials: a systematic review.
J Biopharm Stat. 2015 Sep 17.
Special Issue of Journal of Biopharmaceutical Statistics: Trends and Innovations in Clinical Trial Statistics.
J Biopharm Stat. 2015 Sep 23.
Cardiac Structure and Function and CHADS2 Risk Score in Patients with Atrial Fibrillation: The Effects Anticoagulation with Factor XA Next Generation in Afthrombolysis in Myocardial Infarction 48 (Engage AF - TIMI 48) Echocardiographic Study
J Am Coll Cardiol. 2013;61
Optimal design for nonlinear response models.
Chapman & Hall/CRC Biostatistics Series. July 15, 2013
Lasagna plots made in different (statistical) ovens.
Epidemiology. 2012;23(6):934.
Bayesian assessment of the influence and interaction conditions in multipopulation tailoring clinical trials.
J Biopharma Stat. 2014;24(1):94-109.
Achieving a culture of quality in pharmaceutical biostatistics.
Therapeutic Innovation & Regulatory Science. 2013;47(3):301-305.
A Bayesian Nonlinear Mixed-Effects Regression Model for the Characterization of Early Bactericidal Activity of Tuberculosis Drugs.
J Biopharm Stat. 2015;25(6):1247-71. doi: 10.1080/10543406.2014.971170. Epub 2014 Oct 16.
Pharmacodynamic models: parameterizing the Hill equation, Michaelis-Menten, the logistic curve, and relationships among these models.
J Biopharm Stat. 2013;23(3):648-61.
Advances in Statistical Approaches Oncology Drug Development
Therapeutic Innovation & Regulatory Science 2014;48(1):81-89.
Randomized discontinuation trials with binary outcomes.
Journal of Statistical Theory and Practice. 2014.
Strategies for identifying predictive biomarkers and subgroups with enhanced treatment effect in clinical trials using SIDES.
J Biopharm Stat. 2014;24(1):130-53.
Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial.
Ann Rheum Dis. 2012;71(8):1289-96.
Meta-methodology: conducting and reporting meta-analyses.
J Clin Hypertens (Greenwich). 2014;16(2):91-3.
Key multiplicity issues in clinical drug development.
Stat Med. 2013;32(7):1079-111.
A Macro to Batch Submit a List of Programs with Real Time Feedback. 
PharmaSUG 2013. May 12-15, 2013.
Elemental information matrices and optimal experimental design for generalized regression models
Journal of Statistical Planning and Inference. 2014;144:81–91.
A statistical framework for decision making in confirmatory multipopulation tailoring clinical trials. 
Drug Information Journal. 2012;46(6):647-56.

Cardiovascular

Prognostic impact of metabolic syndrome in patients with chronic heart failure: data from GISSI-HF trial.
Int J Cardiol. 2015 Jan 15;178:85-90.
Lessons Learned in Developing Cardiovascular and Metabolic Drugs
International Pharmaceutical Industry
Prevalence of morphologic abnormalities in baseline ECGs in healthy normal volunteers participating in phase I studies. 
Indian J Med Res. 2012;135:322-30. 
Estrogen therapy, independent of timing, improves cardiac structure and function in oophorectomized mRen2.Lewis rats.
Menopause. 2013;20(8):860-8.
Left arm - left leg reversal in a case of inferior wall myocardial infarction mimics as high lateral wall infarction.
J Cardiovasc Dis Res. 2013;4(3):201-3.
Reader variability in QT measurement due to measurement error and variability in leads selection: a simulation study comparing 2-way vs. 3-way interaction ANOVA model.
J Electrocardiol. 2014 Mar-Apr;47(2):140-3.
Morphological abnormalities in baseline ECGs in healthy normal volunteers participating in phase I studies.
Indian J Med Res. 2012 Mar;135:322-30.
Diagnosis and treatment of resistant hypertension: the critical role of ambulatory blood pressure monitoring.
J Clin Hypertens (Greenwich). 2013 Dec;15(12):868-73.
Cerebrovascular events in 21,105 patients with atrial fibrillation randomized to edoxaban versus warfarin: effective anticoagulation with factor Xa next generation in atrial fibrillation-Thrombolysis in Myocardial Infarction 48.
Stroke. 2014 Jun 19. [Epub ahead of print]
Intradialytic blood pressure variability is associated with increased all-cause and cardiovascular mortality
Am J Kidney Dis. 2013;61(6):966-74.
Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial.
JAMA. 2012;308(19):2001-11.
Single coronary artery: anomalous origin of right coronary artery from the left anterior descending artery.
BMJ Case Rep. 2013;2013. pii: bcr2013200548.
QTc interval and its variability in patients with schizophrenia and healthy subjects: implications for a Thorough QT study.
Int J Neuropsychopharmacol. 2012;15(10):1535-40.
Effect of a monoclonal antibody to PCSK9 on LDL cholesterol.
N Engl J Med. 2012;366(12):1108-18. 
Percutaneous coronary intervention in patients with anomalous origin of coronary artery presenting with acute coronary syndrome: a case series.
J Cardiovasc Dis Res. 2013;4(3):204-8.
Comparison of two methods of estimating reader variability in QT interval measurements in Thorough QT/QTc studies.
Ann Noninvasive Electrocardiol. 2014;19(2):182-9.
Role of estrogen in diastolic dysfunction.
Am J Physiol Heart Circ Physiol. 2014;306(5):H628-40.
Renal denervation therapy for hypertension: pathways for moving development forward.
J Am Soc Hypertens. 2015 May;9(5):341-50. doi: 10.1016/j.jash.2015.02.012.
American Society of Hypertension Scientific Statements Addressing Resistant Hypertension.
J Clin Hypertens (Greenwich). 2015 Jul 14
Drug-induced QT prolongation when QT interval is measured in each of the 12 ECG leads in men and women in a thorough QT study.
J Electrocardiol. 2014;47(2):155-7.
Blood Pressure Measurement Modalities: A Primer for Busy Practitioners.
J Clin Hypertens (Greenwich). 2016 Apr;18(4):262-6. doi: 10.1111/jch.12709. Epub 2015 Nov 12.
Ambulatory blood pressure monitoring in clinical practice: a review.
Am J Med. 2015 Jan;128(1):14-20.
An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis.
Int J Antimicrob Agents. 2015 Oct 22. pii: S0924-8579(15)00330-1.
Semiautomated QT interval measurement in electrocardiograms from a Thorough QT study: comparison of the grouped and ungrouped superimposed median beat methods. 
J Electrocardiol. 2012;45(3):225-30.
An Update on Surgical versus Expectant Management of Ovarian Endometriomas in Infertile Women.
Biomed Res Int. 2015;2015:204792.
Hemodynamic and hormonal patterns of untreated essential hypertension in men and women.
Ther Adv Cardiovasc Dis. 2013;7(6):293-305.
Cost-consequence analysis of long-term prophylaxis in the treatment of von Willebrand disease in the Italian context.
Clinicoecon Outcomes Res. 2014 Dec 17;7:17-25.
n-3 fatty acids in patients with multiple cardiovascular risk factors.
N Engl J Med. 2013;368(19):1800-8.
Blood Pressure Measurement Modalities: A Primer for Busy Practitioners.
J Clin Hypertens (Greenwich). 2015 Nov 12.
Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder.
Neurourol Urodyn. 2015 Jul 14. doi: 10.1002/nau.22800. [Epub ahead of print]
Routine health check-ups: A boon or a burden?
Natl Med J India. 2016 Jan-Feb;29(1):18-21. Review.
ffect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study.
Am J Kidney Dis. 2015 Mar;65(3):464-73.
The Cardiac Safety Research Consortium enters its second decade: An invitation to participate.
Am Heart J. 2016 Jul;177:96-101. doi: 10.1016/j.ahj.2016.04.009. Epub 2016 Apr 23. Review.
Choice of an alternative lead for QT interval measurement in serial ECGs when Lead II is not suitable for analysis. 
Indian Heart J. 2012;64(6):535-40. 
Cardiovascular risk of oral antidiabetic drugs: current evidence and regulatory requirements for new drugs. 
J Assoc Physicians of India. 2012;60:56-61. 
CHADS2 and CHA2DS2 -VASc risk factors to predict first cardiovascular hospitalization among atrial fibrillation/atrial flutter patients.
Am J Cardiol. 2012;109(10):1526-33.
Baseline and New-Onset Morphologic ECG Abnormalities in Healthy Volunteers in Phase I Studies Receiving Placebo: Changes Over a 6-Week Follow-Up Period.
J Clin Pharmacol. 2014 Mar 11.
Cardiovascular safety monitoring during oncology drug development and therapy.
Am J Ther. 2014 Jan 21 [Epub ahead of print]
Diagnosis and treatment of resistant hypertension: the critical role of ambulatory blood pressure monitoring.
J Clin Hypertens (Greenwich). 2013;15(12):868-73.
Patient and physician adherence in hypertension management.
J Clin Hypertens (Greenwich). 2013;15(7):447-52.
Arrhythmias Seen in Baseline 24-Hour Holter ECG Recordings in Healthy Normal Volunteers During Phase I Clinical Trials.
J Clin Pharmacol. 2015 Dec 2.
Characterization of the cardiac renin angiotensin system in oophorectomized and estrogen-replete mRen2.Lewis rats.
PLoS One. 2013;8(10):e76992.
Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.
Am Heart J. 2015 Feb;169(2):197-204.
Moral Imperative of Improving Patient Adherence to Pharmacotherapy for Cardiodiabesity.  Part 2:  A Focus on Cardiovascular Disease.
Journal for Patient Compliance
Fifteen years of cardiac safety: history, state-of-the-art research, and glimpses into the future.
International Pharmaceutical Industry. 2013;5(1):110-9.
Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol.
Br J Clin Pharmacol. 2014;77(3):522-31.
Raising the Bar in Renal Sympathetic Denervation Research and Reporting.
J Clin Hypertens (Greenwich). 2016 Feb;18(2):89-94. doi: 10.1111/jch.12666. Epub 2015 Sep 15. No abstract available.
Transjugular percutaneous transvenous mitral commissurotomy (PTMC) using conventional PTMC equipment in rheumatic mitral stenosis with interruption of inferior vena cava.
J Invasive Cardiol. 2012;24(12):675-8.
Semiautomated QT interval measurement in electrocardiograms from a thorough QT study: comparison of the grouped and ungrouped superimposed median beat methods.
J Electrocardiol. 2012;45:225-30.
Study of Vitamin D deficiency prevalence in acute myocardial infarction
IJC Heart & Vessels, Available online 19 March 2014
Cardiac imaging approaches to evaluate drug-induced myocardial dysfunction. 
Am Heart J. 2012;164:846-55.
Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A.
Blood. 2015 Jul 8. pii: blood-2015-03-630897. [Epub ahead of print]
Assessing blood pressure responses to noncardiovascular drugs: the beneficial role of ambulatory blood pressure monitoring.
J Clin Hypertens (Greenwich). 2012;15(1):55-62. 
Reader variability in QT measurement due to measurement error and variability in leads selection: a simulation study comparing 2-way vs. 3-way interaction ANOVA model.
J Electrocardiol. 2014;47(2):140-3.
European Bioanalysis Forum: recommendation on dealing with hemolyzed and hyperlipidemic matrices.
Bioanalysis. 2014;6(23):3113-20. doi: 10.4155/bio.14.252. Erratum in: Bioanalysis. 2015 Feb;7(3):402.
Comparison of the spatial QRS-T angle derived from digital ECGs recorded using conventional electrode placement with that derived from Mason-Likar electrode position.
J Electrocardiol. 2016 Jun 21. pii: S0022-0736(16)30071-1. doi: 10.1016/j.jelectrocard.2016.06.006. [Epub ahead of print]
Dection, evaluation, and treatment of severe and resistant hypertension.
J Am Soc Hypertens. In press.
Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.
Am Heart J. 2013;165(4):477-88.
Translational cardiovascular safety: a primer of nonclinical investigations for clinical scientists. 
Journal for Clinical Studies. 2012;4(1):50-61.
Kidney function changes with aging in adults: comparison between cross-sectional and longitudinal data analyses in renal function assessment.
Biopharm Drug Dispos. 2015 Aug 24.
Macrophage autophagy in atherosclerosis.
Mediators Inflamm. 2013;2013:584715.
Detecting moxifloxacin-induced QTc prolongation in thorough QT and early clinical phase studies using a highly automated ECG analysis approach.
Br J Pharmacol. 2016 Jan 19. doi: 10.1111/bph.13436. [Epub ahead of print]
Cholesterol-lowering interventions and stroke: Insights from IMPROVE-IT.
Atherosclerosis. 2016 May;248:216-8. doi: 10.1016/j.atherosclerosis.2016.03.024. Epub 2016 Mar 18.
Therapeutic Clearance of Amyloid by Antibodies to Serum Amyloid P Component.
N Engl J Med. 2015 Jul 15. [Epub ahead of print]
Early repolarization and short QT interval in healthy subjects. 
Heart Rhythm. 2012;9(8):1265-71. 

Neurology

Abl Kinases are required for vascular function, Tie2 expression, and angiopoietin-1-mediated survival
Proc Natl Acad Sci U S A. 2013;110(30):12432-7.
Development of a sensitive and fast UHPLC-MS/MS method for determination of clopidogrel, clopidogrel acid and clopidogrel active metabolite H4 in human plasma.
Bioanalysis. 2015 Jul;7(12):1471-82. doi: 10.4155/bio.15.82.
Incidences of extrapyramidal symptoms in patients with schizophrenia after treatment with long-acting injection (depot) or oral formulations of olanzapine.
Clin Schizophr Relat Psychoses. 2014;7(4):216-22.
Glucocorticoid-dependent mechanisms in photoreceptor survival.
Adv Exp Med Biol. 2012;723:101-6.
Efficacy and safety of lurasidone 80mg/day and 160mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial. 
Schizophr Res. 2013;145(1-3):101-9
Modification of the SF-36 for a headache population changes patient-reported health status.
Headache. 2012;52(6):993-1004.
Neurotherapeutics to inhibit exocytosis from sensory neurons for the control of chronic pain.
Curr Opin Pharmacol. 2012;12(1):100–8.
The development and activity-dependent expression of aggrecan in the cat visual cortex
Cereb Cortex. 2013;23(2):349-60.
Edoxaban versus warfarin in patients with atrial fibrillation.
N Engl J Med. 2013;369(22):2093-104.
Who will benefit from antidepressants in the acute treatment of bipolar depression? A reanalysis of the STEP-BD study by Sachs et al. 2007, using Q-learning.
Int J Bipolar Disord. 2015 Apr 3;3:7. doi: 10.1186/s40345-014-0018-5. eCollection 2015.
Integrated safety of levodopa-carbidopa intestinal gel from prospective clinical trials
Mov Disord. 2015 Dec 23. doi: 10.1002/mds.26485. [Epub ahead of print]
Experience-dependent, layer-specific development of divergent thalamocortical connectivity. 
Cereb Cortex. 2014 Mar 7. [Epub ahead of print]
Anitpsychotic medication adherence in outpatients with schizophrenia: focusing interventions for adherence improvement.
Meditsinski Pregled / Medical Review. 2012;48:27-31
Evidence of an association between bipolar disorder and rs16917237 in the BDNF gene in a Bulgarian sample.
Psychiatr Genet. 2013;23(3):141-2.
Transmission disequilibrium of DISC1 haplotypes in Bulgarian families with affective disorder.
Psychiatry Res. 2013;210(3):1320-1.
The Influence of Ultrasound Measurement Techniques on the Age-Related Differences in Achilles Tendon Size.
Exp Gerontol. 2016 Jan 28. pii: S0531-5565(16)30015-8. doi: 10.1016/j.exger.2016.01.015. [Epub ahead of print]
Amyloid-related imaging abnormalities from trials of solanezumab for Alzheimer's disease.
Alzheimers Dement (Amst). 2016 Mar 2;2:75-85. doi: 10.1016/j.dadm.2016.02.004. eCollection 2016.
Premotor cortex is sensitive to auditory-visual congruence for biological motion.
J Cogn Neurosci. 2012;24(3):575-87.
Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial. 
CNS Spectr. 2013;18(1):43-54.
Evidence for auditory-visual processing specific to biological motion.
Seeing Perceiving. 2012;25(1):15-28.
Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial.
Lancet. 2015 Jun 6;385(9984):2288-95.
Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial.
J Am Coll Cardiol. 2014 Aug 12;64(6):576-84.

Product Marketing and Sales - Commercialization

Development of targeted agents and companion diagnostics.
Drug Information Journal

Early Clinical Development

A novel role for C3 in antibody-induced red blood cell clearance and antigen modulation.
Blood. 2013;122(10):1793-801.
A phase 1 study of prasugrel in patients with sickle cell disease: pharmacokinetics and effects on ex vivo platelet reactivity. 
Br J Clin Pharmacol. 2013;75(6):1433-44.
Effect of hepatic or renal impairment on the pharmacokinetics of casopitant, a neurokinin-1 receptor antagonist.
Invest New Drugs. 2012;30(2):662-71.
Erythropoietin and erythropoiesis stimulating agents.
Drug Test Anal. 2012;4(11):805-12.
Participation of Hypertension Patients in Early-Phase Clinical Trials.
J Clin Hypertens (Greenwich). 2014 Apr 22. doi: 10.1111/jch.12296. [Epub ahead of print]
Accelerated mammary tumor onset in a HER2/Neu mouse model exposed to DDT metabolites locally delivered to the mammary gland.
Environ Health Perspect. 2012;120(8):1170-6.
First-time-in-human study of GSK923295, a novel anti-mitotic inhibitor of centromere-associated protein E (CENP-E), in patients with refractory cancer.
Cancer Chemother Pharmacol. 2012;69(3):733-41.
Transfusion of murine red blood cells expressing the human KEL glycoprotein induces clinically significant alloantibodies.
Transfusion. 2014;54(1):179-89.
Alloantibodies to a paternally derived RBC KEL antigen lead to hemolytic disease of the fetus/newborn in a murine model.
Blood. 2013;122(8):1494-504.
Pharmacokinetics of fostamatinib, a SYK Inhibitor, in healthy human subjects following single and multiple oral dosing in three phase I studies. 
Br J Clin Pharmacol. 2013;76(1):78-88. 
Inhibition of Neu-induced mammary carcinogenesis in trangenic mice expressing ER delta 3, a dominant negative estrogen receptor variant.
Horm Cancer. 2012;3(5-6):227-39.
Human erythropoietin increases the pro-angiogenic potential of A2780 ovarian adenocarcinoma cells under hypoxic conditions
Oncol Rep. 2013;30(3):1455-62. 
Translational toxicology: a developmental focus for integrated research strategies.
BMC Pharmacol Toxicol. 2013;14:51.

Endocrinology - Diabetes

Structural and functional screening in human induced-pluripotent stem cell-derived cardiomyocytes accurately identifies cardiotoxicity of multiple drug types.
Toxicol Appl Pharmacol. 2015 May 15;285(1):51-60. doi: 10.1016/j.taap.2015.03.008. Epub 2015 Apr 2.
EDA-containing fibronectin increases proliferation of embryonic stem cells
PLoS One. 2013;8(11):e80681.
Cytomics: Managing biocomplexity in drug development, clinical diagnostics, and clinical medicine. 
International Pharmaceutical Industry. 2012;4(4):46-53. 
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
AAPS J. 2015 Sep 16.
Pharmaceutical interventions for obesity: a public health perspective. 
Diabetes Obes Metab. 2011;13:490-497. 
The role of replicates for error mitigation in next-generation sequencing.
Nat Rev Genet. 2014;15(1):56-62
Development of a sensitive and fast UHPLC-MS/MS method for determination of clopidogrel, clopidogrel acid and clopidogrel active metabolite H4 in human plasma.
Bioanalysis. 2015 Jul;7(12):1471-82. doi: 10.4155/bio.15.82.
Addressing unmet medical needs in type 2 diabetes: a narrative review of drugs under development.
Curr Diabetes Rev. 2015;11(1):17-31.
Determination of cobimetinib in human plasma using protein precipitation extraction and high-performance liquid chromatography coupled to mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Dec 1;972:117-23.
A botulinum toxin-derived targeted secretion inhibitor downregulates the GH/IGF1 axis.
J Clin Invest. 2012;122(9):3295-306. 
Development and validation of a HILIC-MS/MS method for quantification of decitabine in human plasma by using lithium adduct detection.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Oct 15;969:117-22.
Impact of nocturnal hypoglycemia on T1DM and T2DM patients
Diabetes Educator.  2014 [in press]
Accurate whole-genome sequencing and haplotyping from 10 to 20 human cells.
Nature. 2012;487(7406):190-5.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZP-531, a First-in-class Analogue of Unacylated Ghrelin (UAG), in Healthy, Overweight/Obese, and Type 2 Diabetes Subjects.
Diabetes Obes Metab. 2016 Apr 10. doi: 10.1111/dom.12675. [Epub ahead of print]
FDA and EMA actions regarding the cardiovascular safety of drugs for type 2 diabetes mellitus, 2007-2012: An overview of respective regulatory landscapes. 
Journal of Clinical Studies. 4(3):50-57.
The patient care pathway for type 2 diabetes mellitus in Asian countries: implications on target physician group for diabetes clinical trials.
J Diabetes Metab 2014 5: 331
CD34+ gene expression profiling of individual children with very severe aplastic anemia indicates a pathogenic role of integrin receptors and the proapoptotic death ligand TRAIL.
Haematologica. 2012;97(9):1304-11.
Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs under Development.
Curr Diabetes Rev. 2016 Apr 13. [Epub ahead of print]
Epigenomes as therapeutic targets.
Pharmacol Ther. 2015 Jul;151:72-86. doi: 10.1016/j.pharmthera.2015.03.003. Epub 2015 Mar 20.
Imaging biomarkers in oncology drug development.
Journal for Clinical Studies. 2012;4(3):22-5. 
Building value through biomarkers: the ''Smarter Development'' initiative. 
Drug Information Journal. 2012;46(4):397-403.
Alternate Approaches for Pediatric Type 1 Diabetes Drug Development and Potential Regulatory Approval: A Perspective.
Diabetes Care. 2015 Oct;38(10):1986-91.
HMG-coenzyme A reductase inhibition, type 2 diabetes, and bodyweight: evidence from genetic analysis and randomised trials.
Lancet. 2015 Jan 24;385(9965):351-61.
Assessing cardiovascular safety in the development of new drugs for type 2 diabetes mellitus. 
The Physician. 2012;1(1):34-37.
Automated high-capacity on-line extraction and bioanalysis of dried blood spot samples using liquid chromatography/high-resolution accurate mass spectrometry.
Rapid Commun Mass Spectrom. 2014 Nov 30;28(22):2415-26.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules.
Bioanalysis. 2012;4(19):2343-56.
Low-Turnover Drug Molecules: A Current Challenge for Drug Metabolism Scientists.
Drug Metab Dispos. 2015 Sep 11. pii: dmd.115.066431.
A rat RNA-Seq transcriptomic BodyMap across 11 organs and 4 developmental stages.
Nat Commun. 2014;5:3230.
A public resource facilitating clinical use of genomes.
Proc Natl Acad Sci U S A. 2012;109(30):11920-7.
Genomic analysis identifies unique signatures predictive of brain, lung, and liver relapse. 
Breast Cancer Res Treat. 2012;132(2):523-35. 
On the design of clone-based haplotyping.
Genome Biol. 2013;14(9):R100.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Expression profile of COL2A1 and the pseudogene SLC6A10P predicts tumor recurrence in high-grade serous ovarian cancer.
Int J Cancer. 2015 Aug 27.
GLYCATED ALBUMIN AT 4 WEEKS CORRELATES WITH A1C LEVELS AT 12 WEEKS AND REFLECTS SHORT-TERM GLUCOSE FLUCTUATIONS.
Endocr Pract. 2015 Jul 27.

Gastroenterology

Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials.
Gastroenterol Rep (Oxf). 2015 May;3(2):91-102.
Central Reading of Endoscopy Endpoints in Inflammatory Bowel Disease Trials.
Inflamm Bowel Dis. 2015 Oct;21(10):2475-82. doi: 10.1097/MIB.0000000000000470. Review.
An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis.
Int J Antimicrob Agents. 2015 Oct 22. pii: S0924-8579(15)00330-1.
An Update on Surgical versus Expectant Management of Ovarian Endometriomas in Infertile Women.
Biomed Res Int. 2015;2015:204792.
Cost-consequence analysis of long-term prophylaxis in the treatment of von Willebrand disease in the Italian context.
Clinicoecon Outcomes Res. 2014 Dec 17;7:17-25.
Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder.
Neurourol Urodyn. 2015 Jul 14. doi: 10.1002/nau.22800. [Epub ahead of print]
ffect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study.
Am J Kidney Dis. 2015 Mar;65(3):464-73.
Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A.
Blood. 2015 Jul 8. pii: blood-2015-03-630897. [Epub ahead of print]
Effects of CYP3A4 Inhibitors Ketoconazole and Verapamil and the CYP3A4 Inducer Rifampicin on the Pharmacokinetic Parameters of Fostamatinib: Results from In Vitro and Phase I Clinical Studies.
Drugs R D. 2016 Jan 6. [Epub ahead of print]
Kidney function changes with aging in adults: comparison between cross-sectional and longitudinal data analyses in renal function assessment.
Biopharm Drug Dispos. 2015 Aug 24.
Therapeutic Clearance of Amyloid by Antibodies to Serum Amyloid P Component.
N Engl J Med. 2015 Jul 15. [Epub ahead of print]

Nephrology

A transient improvement in renal function occurs after ischemic stroke.
Ren Fail. 2012;34(1):7-12.
Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.
J Am Soc Nephrol. 2016 Jul;27(7):1902-10. doi: 10.1681/ASN.2015090976. Epub 2016 Apr 28.
Effect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study.
Am J Kidney Dis. 2015 Mar;65(3):464-73. doi: 10.1053/j.ajkd.2014.10.021. Epub 2014 Dec 17.
The landscape of clinical trials in nephrology: a systematic review of clinicaltrials.gov.
Am J Kidney Dis. 2013; pii: S0272-6386(13)01426-1.
Comparing mandated health care reforms: the Affordable Care Act, accountable care organizations, and the Medicare ESRD program.
Clin J Am Soc Nephrol. 2012;7(9):1535-43.
New perspectives on blood pressure variability in hemodialysis patients.
Am J Kidney Dis. 2012;59(3): 333-5.
Cardiovascular toxicity of epoetin-alfa in patients with chronic kidney disease.
Am J Nephrol. 2013;37(6):549-58.
Addressing Peritoneal Dialysis: In Vitro PD Models, In Vivo Rodent PD Model, Clinical Biobanks, and Underutilization of PD.
Biomed Res Int. 2016;2016:4964316. doi: 10.1155/2016/4964316. Epub 2016 Jan 3. No abstract available.
Effect of hemoglobin target on progression of kidney disease: a secondary analysis of the CHOIR trial. 
Am J Kidney Dis. 2012;60(3):390-401.
Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction.
Clin J Am Soc Nephrol. 2012;7(8):1300-9.
Peri-dialytic hypertension and hypotension: another U-shaped BP-outcome association.
Kidney Int. 2013;84(4):641-4.
Peritoneal dialysis use within the context of the population and healthcare systems of Europe - differences, trends and future challenges.
Int J Artif Organs. 2016 Jul 4;39(5):211-9. doi: 10.5301/ijao.5000499. Epub 2016 May 26.

Oncology and Hematology

Human selenium binding protein-1 (hSP56) is a negative regulator of HIF-1α and suppresses the malignant characteristics of prostate cancer cells.
BMB Rep. 2014 Jul;47(7):411-6.
A world-wide survey and field study in clinical haemostasis laboratories to evaluate FVIII:C activity assay variability of ADYNOVATE and OBIZUR in comparison with ADVATE.
Haemophilia. 2016 Jun 28. doi: 10.1111/hae.13001. [Epub ahead of print]
Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma.
Leuk Lymphoma. 2016 Jan 12:1-14. [Epub ahead of print]
Multi-parameter in vitro toxicity testing of crizotinib, sunitinib, erlotinib, and nilotinib in human cardiomyocytes.
Toxicol Appl Pharmacol. 2013;272(1):245-55.
Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer.
Ann Oncol. 2015 Jan;26(1):179-85.
Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor.
PLoS One. 2015 Nov 16;10(11):e0142845.
A recombinant decoy comprising EGFR and ErbB-4 inhibits tumor growth and metastasis. 
Oncogene. 2012;31(30):3505-15. 
Endoglin-mediated suppression of prostate cancer invasion is regulated by activin and bone morphogenetic protein type II receptors.
PLoS One. 2013;8(8):e72407.
Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer.
Value Health. 2014 Mar;17(2):238-44. doi: 10.1016/j.jval.2013.12.005.
Phase I dose escalation study of lestaurtinib in patients with myelofibrosis.
Leuk Lymphoma. 2015;56(9):2543-51. doi: 10.3109/10428194.2014.1001986. Epub 2015 Feb 20.
Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase III trial.
J Clin Oncol. 2013 Oct 20;31(30):3791-9. doi: 10.1200/JCO.2012.47.4940. Epub 2013 Sep 9.
Comprehensive evaluation of the incidence of late effects in 5-year survivors of breast cancer.
Breast Cancer Res Treat. 2014;144(3):643-63.
KRAS mutation status is associated with enhanced dependency on folate metabolism pathways in non-small cell lung cancer cells.
Mol Cancer Ther. 2014;13(6):1611-24.
An open-label clinical trial of the effects of age and gender on the pharmacodynamics, pharmacokinetics and safety of the ghrelin receptor agonist anamorelin.
Clin Pharmacol Drug Dev. 2015 Mar;4(2):112-120.
Growing risk avoidance in Asian oncology site selection: how trends in site selection are limiting growth of the Asia cancer trial landscape.
Open Access Journal of Clinical Trials 2014:6 1–9.
All cholesterol-lowering interventions are expected to reduce stroke: Confirmatory data from IMPROVE-IT.
Data Brief. 2016 Apr 27;7:1541-50. doi: 10.1016/j.dib.2016.04.059. eCollection 2016 Jun.
Managing chronic myeloid leukemia: a coordinated team care perspective.
Clin Lymphoma Myeloma Leuk. 2012;12(2):88-93.
Translational Medicine and Patient Safety in Europe: TRANSFoRm-Architecture for the Learning Health System in Europe.
Biomed Res Int. 2015;2015:961526.
Cynomolgus monkey as a surrogate for human aldehyde oxidase metabolism of the EGFR inhibitor BIBX1382.
Drug Metab Dispos. 2014 Oct;42(10):1751-60. doi: 10.1124/dmd.114.059030. Epub 2014 Jul 17.
Activity of the oral mitogen-activated protein kinase kinase inhibitor trametinib in RAS-mutant relapsed or refractory myeloid malignancies.
Cancer. 2016 Jun 15;122(12):1871-9. doi: 10.1002/cncr.29986. Epub 2016 Mar 18.
Cancer drug development in China: recent advances and future challenges.
Drug Discov Today. 2015 Jun;20(6):766-771.
Genomic and Immunological Tumor Profiling Identifies Targetable Pathways and Extensive CD8+/PDL1+ Immune Infiltration in Inflammatory Breast Cancer Tumors.
Mol Cancer Ther. 2016 Jul;15(7):1746-56. doi: 10.1158/1535-7163.MCT-15-0353. Epub 2016 Apr 19.
Phase I dose-escalation study of the PI3K/mTOR inhibitor voxtalisib (SAR245409, XL765) plus temozolomide with or without radiotherapy in patients with high-grade glioma.
Neuro Oncol. 2015 May 26. pii: nov083. [Epub ahead of print]
Bosutinib treatment for Philadelphia chromosome-positive leukemias.
Future Oncol. 2014;10(2):179-85. 
Mortality and Vascular Events Among Elderly Patients With Chronic Myeloid Leukemia: A Retrospective Analysis of Linked SEER-Medicare Data.
Clin Lymphoma Myeloma Leuk. 2016 May;16(5):275-285.e1. doi: 10.1016/j.clml.2016.01.006. Epub 2016 Feb 6.
Phase 1 study assessing the steady-state concentration of ceftazidime and avibactam in plasma and epithelial lining fluid following two dosing regimens.
J Antimicrob Chemother. 2015 Jul 1. pii: dkv170. [Epub ahead of print]
Practice Innovations, Change Management, and Resilience in Oncology Care Settings.
Oncol Nurs Forum. 2015 Nov 1;42(6):683-7.
Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial.
Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.
Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study.
Breast. 2014 Dec;23(6):763-9. doi: 10.1016/j.breast.2014.08.004. Epub 2014 Sep 3.
Antitumor activity and safety of IMO-2055: a novel TLR9 agonist in combination with erlotinib and bevacizumab in patients with advanced or metastatic NSCLC who have progressed following prior chemotherapy.
Cancer Immunology, Immunotherapy [in press]
Radiobiological influence of megavoltage electron pulses of ultra-high pulse dose rate on normal tissue cells.
Radiat Environ Biophys. 2016 Aug;55(3):381-91. doi: 10.1007/s00411-016-0652-7. Epub 2016 May 19.
Progress in the treatment of peripheral T-cell lymphomas: an orphan no more.
Am J Ther. 2013 Sep-Oct;20(5):460-2.
Mortality and Vascular Events Among Elderly Patients With Chronic Myeloid Leukemia: A Retrospective Analysis of Linked SEER-Medicare Data.
Clin Lymphoma Myeloma Leuk. 2016 May;16(5):275-285.e1. doi: 10.1016/j.clml.2016.01.006. Epub 2016 Feb 6.
Osimertinib Western and Asian clinical pharmacokinetics in patients and healthy volunteers: implications for formulation, dose, and dosing frequency in pivotal clinical studies
Cancer Chemother Pharmacol. 2016 Apr;77(4):767-76. doi: 10.1007/s00280-016-2992-z. Epub 2016 Feb 22.
An open-label, multicenter, randomized phase Ib/II study of eribulin mesylate administered in combination with pemetrexed versus pemetrexed alone as second-line therapy in patients with advanced nonsquamous non-small-cell lung cancer.
Clin Lung Cancer. 2015 Mar;16(2):92-9.
Dysregulation of the epigenome in triple-negative breast cancers: basal-like and claudin-low breast cancers express aberrant DNA hypermethylation.
Exp Mol Pathol. 2013;95(3):276-87.
Metabolism and disposition of the DOT1L inhibitor, pinometostat (EPZ-5676), in rat, dog and human.
Cancer Chemother Pharmacol. 2015 Dec 8. [Epub ahead of print]
Single agent bevacizumab for myelofibrosis: results of the Myeloproliferative Disorders Research Consortium Trial.
Haematologica. 2013;98(9):1421-3.
Expression profile of COL2A1 and the pseudogene SLC6A10P predicts tumor recurrence in high-grade serous ovarian cancer.
Int J Cancer. 2015 Aug 27.
Tools to optimize the functionality of a leukemia clinical trial team.
Leuk Lymphoma. 2013;54(1):110-6.
Validation of high-performance liquid chromatography-tandem mass spectrometry assays quantifying omacetaxine mepesuccinate and its 4'‑des-methyl and cephalotaxine metabolites in human plasma and urine.
J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:152-9. doi: 10.1016/j.jchromb.2015.08.015. Epub 2015 Aug 18.

Pediatrics

Data-driven asthma endotypes defined from blood biomarker and gene expression data.
PLoS One. 2015 Feb 2;10(2):e0117445.
The importance and challenge of pediatric trials of hemophilia drugs.
Nat Med. 2014;20(5):465-6.
Hypertension and hemodialysis: pathophysiology and outcomes in adult and pediatric populations.
Pediatr Nephrol. 2012;27(3):339-50.
Healthcare transition from pediatric to adult medical homes in diabetes mellitus.
Endocr Pract. 2014 Jul;20(7):715-21. doi: 10.4158/EP13369.RA.
Sponsors meet scientists to speed pediatric medicines development.
Sci Transl Med. 2015 Mar 18;7(279):279fs11. doi: 10.1126/scitranslmed.aaa2045.

Advisory Services and Consulting

Cost-effectiveness analysis of pancreatin minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis. 
J Med Econ. 2012;15(Suppl 1):15-25. 
Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.
Pharmacoepidemiol Drug Saf. 2015 Oct 7.
Implications of a data-driven approach to treatment with growth hormone in children with growth hormone deficiency and Turner syndrome.
Appl Health Econ Health Policy. 2013;11(3):237-49.

Public Health & Government

Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives.
Pharmacoepidemiol Drug Saf. 2015 Mar;24(3):319-28.
Quality-adjusted cost of care: a meaningful way to measure growth in innovation cost versus the value of health gains.
Health Aff (Millwood). 2015 Apr;34(4):555-61. doi: 10.1377/hlthaff.2014.0639.
A comparison of models for predicting early hospital readmissions.
J Biomed Inform. 2015 Jun 1.
Using observational studies for comparative effectiveness: finding quality with GRACE.
J Comp Eff Res. 2013 Sep;2(5):413-8.
Translational toxicology: a developmental focus for integrated research strategies.
BMC Pharmacol Toxicol. 2013 Sep 30;14:51.
Systematic literature review to evaluate and characterize the health economics and outcomes research studies in India.
Perspect Clin Res. 2015 Jan-Mar;6(1):20-33.
Balancing the interests of patient data protection and medication safety monitoring in a public-private partnership.
JMIR Med Inform. 2015 Apr 15;3(2)
Prepubertal Serum Concentrations of Organochlorine Pesticides and Age at Sexual Maturity in Russian Boys.
Environ Health Perspect. 2015 May 22. [Epub ahead of print]

Regulatory Affairs

The role of regulatory agencies in new drug development: a global perspective.
Journal for Clinical Studies. 2014;6(1): 20-2.
US Biosimilar guidelines: Summary and insights. 
Regulatory Focus. April 2012.
Pharmaceutical competitive intelligence for the regulatory affairs professional. 
New York: Springer; 2012.
Regulatory implications of technology platforms for patient centric services. 
Regulatory Focus 16:11 24-34.

Observational research - registries

Using real-world evidence to inform decision making
Chinese Journal of Pharmacoepidemiology [in press]
Using observational studies for comparative effectiveness: finding quality with GRACE
J Comp Eff Res. 2013;2(5):413-8.
Algorithms for identification of Guillain-Barré Syndrome among adolescents in claims databases.
Vaccine. 2013;31(16):2075-9.
Developing a protocol for observational comparative effectiveness research (OCER): a user's guide.
Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jan.
Prevalence of co-morbidities and basline characteristics of LAPBAND-AP subjects in the Helping Evaluate Reduction in Obesity (HERO) Study.
PLoS One. 2013;8(11):e78971.
Building a strategic framework for comparative effectiveness research in complementary and integrative medicine. 
Evid Based Complement Alternat Med. 2012;2012:531096. 
How the biopharmaceutical industry can navigate a healthcare ecosystem increasingly driven by demands for comparative effectiveness research (CER). 
Pharmaceutical Medicine. 2011;25(6):361-365. 
Adverse reaction signaling and disproportionality analysis: an update.
Therapeutic Innovation & Regulatory Science. 2012;46(6):708-714.
Chart audit and budget impact analysis of pasireotide versus second-line therapies in the treatment of Cushing's disease in Germany.
Value in Health - November 2012 (Vol. 15, Issue 7, Page A497)
The use of observational health-care data to identify and report on off-label use of biopharmaceutical products.
Clin Pharmacol Ther. 2012;91(5):937–42.
Incorporating stakeholder perspectives in developing a translation table framework for comparative effectiveness research.
J Comp Eff Res. 2012;1(3):281-92.
A prospective observational safety study on MF59(®) adjuvanted cell culture-derived vaccine, Celtura(®) during the A/H1N1 (2009) influenza pandemic.
Vaccine. 2012;30(45):6436-43.
Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.
Pharmacoepidemiol Drug Saf. 2012;21(12):1350-8.
Prospective observational studies to assess comparative effectiveness: ISPOR good research practices task force report. 
Value Health. 2012;15(2):217-30. 
Patient registries to elevate the role of outcomes research for biopharma and medtech.
Scrip Regulatory Affairs. 19 August 2013
The association between cytomegalovirus immune globulin and long-term recipient and graft survival following liver transplantation.
Transplant Infectious Disease. 2012;14(2):1121–31.
Public health innovation: biopharmaceuticals lost in translation? 
Therapeutic Innovation & Regulatory Science. 2013;47(3):306-311.

Real-World Late Phase

Using real-world evidence to inform decision making
Chinese Journal of Pharmacoepidemiology [in press]
Using observational studies for comparative effectiveness: finding quality with GRACE
J Comp Eff Res. 2013;2(5):413-8.
Algorithms for identification of Guillain-Barré Syndrome among adolescents in claims databases.
Vaccine. 2013;31(16):2075-9.
Developing a protocol for observational comparative effectiveness research (OCER): a user's guide.
Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jan.
Prevalence of co-morbidities and basline characteristics of LAPBAND-AP subjects in the Helping Evaluate Reduction in Obesity (HERO) Study.
PLoS One. 2013;8(11):e78971.
Building a strategic framework for comparative effectiveness research in complementary and integrative medicine. 
Evid Based Complement Alternat Med. 2012;2012:531096. 
Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices.
JAMA Ophthalmol. 2016 Jul 7. doi: 10.1001/jamaophthalmol.2016.2101. [Epub ahead of print]
How the biopharmaceutical industry can navigate a healthcare ecosystem increasingly driven by demands for comparative effectiveness research (CER). 
Pharmaceutical Medicine. 2011;25(6):361-365. 
Adverse reaction signaling and disproportionality analysis: an update.
Therapeutic Innovation & Regulatory Science. 2012;46(6):708-714.
Chart audit and budget impact analysis of pasireotide versus second-line therapies in the treatment of Cushing's disease in Germany.
Value in Health - November 2012 (Vol. 15, Issue 7, Page A497)
Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy.
JMIR Public Health Surveill. 2015 Dec 22;1(2):e22. doi: 10.2196/publichealth.4939. eCollection 2015 Jul-Dec.
Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.
Pharmacoepidemiol Drug Saf. 2015 Oct 7.
Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.
J Rheumatol. 2015 Sep 15. pii: jrheum.141423.
An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.
JMIR Public Health Surveill. 2016 Mar 18;2(1):e13. doi: 10.2196/publichealth.5366. eCollection 2016 Jan-Jun.
The use of observational health-care data to identify and report on off-label use of biopharmaceutical products.
Clin Pharmacol Ther. 2012;91(5):937–42.
Incorporating stakeholder perspectives in developing a translation table framework for comparative effectiveness research.
J Comp Eff Res. 2012;1(3):281-92.
A prospective observational safety study on MF59(®) adjuvanted cell culture-derived vaccine, Celtura(®) during the A/H1N1 (2009) influenza pandemic.
Vaccine. 2012;30(45):6436-43.
Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.
Pharmacoepidemiol Drug Saf. 2012;21(12):1350-8.
Prospective observational studies to assess comparative effectiveness: ISPOR good research practices task force report. 
Value Health. 2012;15(2):217-30. 
Patient registries to elevate the role of outcomes research for biopharma and medtech.
Scrip Regulatory Affairs. 19 August 2013
The association between cytomegalovirus immune globulin and long-term recipient and graft survival following liver transplantation.
Transplant Infectious Disease. 2012;14(2):1121–31.
Public health innovation: biopharmaceuticals lost in translation? 
Therapeutic Innovation & Regulatory Science. 2013;47(3):306-311.

Immunology

HMGB1 and microparticles as mediators of the immune response to cell death.
Antioxid Redox Signal. 2011;15(8):2209-19.
Sleep disorders, depressive symptoms and health-related quality of life: a cross-sectional comparison between kidney transplant recipients and wait-listed patients on maintenance dialysis.
Nephrol Dial Transplant. 2011;26(3):1058-65.
Disease models of chronic inflammatory airway disease: applications and requirements for clinical trials.
Curr Opin Pulm Med. 2014;20(1):37-45.
Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial.
Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.
Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.
Value Health. 2015 Sep;18(6):817-23.
Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study.
Ann Rheum Dis. 2015 Jun;74(6):979-84.
Understanding the diagnosis and treatment of COPD and asthma to better inform site selection and patient recruitment planning.
Therapeutic Innovation & Regulatory Science. 2013;47(4):468-73.
Data-driven asthma endotypes defined from blood biomarker and gene expression data.
PLoS One. 2015 Feb 2;10(2):e0117445.
Determinants of antiviral effectiveness in influenza virus A subtype H5N1.
J Infect Dis. 2012;206(9):1359-66.
Development of a disease activity and responder index for psoriatic arthritis: report of the Psoriatic Arthritis Module at OMERACT 11.
J Rheumatol. 2014;41(4):782-91.
Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.
Rheumatology (Oxford). 2012;51(7):1226-34.
Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis.
Lancet. 2015 May 2;385(9979):1738-47. doi: 10.1016/S0140-6736(14)62002-X. Epub 2015 Mar 18.
Inhalant-related psychiatric disorders.
Medscape. Updated: May 21, 2014.
Antigen modulation confers protection to red blood cells from antibody through Fcγ receptor ligation.
J Immunol. 2013;191(10):5013-25.
Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia.
Open Access Journal of Clinical Trials. 2013;5:33–8.
Dendritic cell migration through the lymphatic vasculature to lymph nodes.
Adv Immunol. 2013;120:51-68.
Initiation and regulation of complement during hemolytic transfusion reactions.
Clin Dev Immunol. 2012;2012:307093.
Conditional depletion of mast cells has no impact on the severity of experimental epidermolysis bullosa acquisita.
Eur J Immunol. 2015 May;45(5):1462-70.
The properties of microparticles from RAW 264.7 macrophage cells undergoing in vitro activation or apoptosis.
Innate Immun. 2014;20(3):239-48.
Microparticles as a source of extracellular DNA.
Immunol Res. 2011;49(1-3):227-34.
Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis.
BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
The interferon type I/III response to respiratory syncytial virus infection in airway epithelial cells can be attenuated or amplified by antiviral treatment.
J Virol. 2015 Nov 25. pii: JVI.02417-15.
Lymphatic vasculature mediates macrophage reverse cholesterol transport in mice.
J Clin Invest. 2013;123(4):1571-9.
Key feasibility considerations when conducting vaccine clinical trials in Asia-Pacific countries.
Vaccine: Development and Therapy. 2013;3:1-9.
The 2 + 1 paradigm: an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials.
Gastroenterol Rep (Oxf). 2015 Sep 11.
Challenges in conducting tuberculosis clinical trials in developing countries: lessons learned.
Journal for Clinical Studies. 2013;5(1):36-42.
Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomized, double-blind, placebo-controlled, parallel-group phase III trial.
Arthritis Rheum. 2012;64(2):360-70.
Navigating the vaccine clinical trial landscape in emerging markets: lessons learned.
Journal for Clinical Studies. 2012;4(4):14-8. 
Effects of Fostamatinib on the Pharmacokinetics of Oral Contraceptive, Warfarin, and the Statins Rosuvastatin and Simvastatin: Results From Phase I Clinical Studies.
Drugs R D. 2016 Jan 9. [Epub ahead of print]
Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.
Pharmacoepidemiol Drug Saf. 2015 Oct 7.
Psychometric validation of the Brief Pain Inventory-Short Form in patients with systemic lupus erythematosus in the United States.
Lupus. 2015 Jun 1. pii: 0961203315588972. [Epub ahead of print]
Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.
J Rheumatol. 2015 Sep 15. pii: jrheum.141423.
Association of sweat chloride concentration at time of diagnosis and CFTR genotype with mortality and cystic fibrosis phenotype.
J Cyst Fibros. 2015 Feb 3.
Normal dendritic cell mobilization to lymph nodes under conditions of severe lymphatic hypoplasia.
J Immunol. 2013 May 1;190(9):4608-20.
Certolizumab Pegol Remains an Equally Efficacious Treatment of Rheumatoid Arthritis Over a Range of Background Methotrexate Regimens.
Arthritis Care Res (Hoboken). 2015 Aug 3.
IκB kinase 2 is essential for IgE-induced mast cell de novo cytokine production but not for degranulation.
Cell Rep. 2014 Sep 11;8(5):1300-7.
Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects.
Arthritis Res Ther. 2015 Oct 8;17:282.
Autoantigen-specific immunosuppression with tolerogenic peripheral blood cells prevents relapses in a mouse model of relapsing-remitting multiple sclerosis.
J Transl Med. 2016 May 1;14(1):99. doi: 10.1186/s12967-016-0860-6.
Launching the BIOSPIT initiative: harmonizing sputum outcomes in multicenter trials.
Pulm Pharmacol Ther. 2013;26(3):400-1.
Is there a difference in systemic lupus erythematosus with and without Raynaud's phenomenon?
Rheumatol Int. 2013;33(4):859-65.
Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12.
J Rheumatol. 2015 Feb 15.
H5N1 avian influenza in children.
Clin Infect Dis. 2012;55(1):26-32. 
Strengthening observational evidence to antiviral effectiveness in H5N1.
J Infec Dis. 2011;204(5):810-1.
Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. 
Rheumatology (Oxford). 2012;51(9):1628-38.
Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.
Rheumatology (Oxford). 2012;51(12):2204-14.
Mechanisms of autoimmunity in human diseases: a critical review of current dogma.
Curr Opin Rheumatol. 2014;26(2):197-203.
Recognizing true H5N1 infections in humans during confirmed outbreaks.
J Infect Dev Ctries. 2014;8(2):202-7.
Timing of the availability and administration of influenza vaccine through the vaccines for children program. 
Pediatr Infect Dis J. 2011;30(2):100-6. 
New and existing pharmacotherapeutic options for persistent asthma and COPD. 
Neth J Med. 2011;69(11):486-99. 
Microparticles as mediators and biomarkers of rheumatic disease.
Rheumatology (Oxford). 2012;51(10):1737-46.
Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.
Clin Ther. 2015 Oct 26. pii: S0149-2918(15)01149-2.

Infectious Diseases

HMGB1 and microparticles as mediators of the immune response to cell death.
Antioxid Redox Signal. 2011;15(8):2209-19.
Sleep disorders, depressive symptoms and health-related quality of life: a cross-sectional comparison between kidney transplant recipients and wait-listed patients on maintenance dialysis.
Nephrol Dial Transplant. 2011;26(3):1058-65.
Disease models of chronic inflammatory airway disease: applications and requirements for clinical trials.
Curr Opin Pulm Med. 2014;20(1):37-45.
Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial.
Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.
Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.
Value Health. 2015 Sep;18(6):817-23.
Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study.
Ann Rheum Dis. 2015 Jun;74(6):979-84.
Understanding the diagnosis and treatment of COPD and asthma to better inform site selection and patient recruitment planning.
Therapeutic Innovation & Regulatory Science. 2013;47(4):468-73.
Data-driven asthma endotypes defined from blood biomarker and gene expression data.
PLoS One. 2015 Feb 2;10(2):e0117445.
Determinants of antiviral effectiveness in influenza virus A subtype H5N1.
J Infect Dis. 2012;206(9):1359-66.
Development of a disease activity and responder index for psoriatic arthritis: report of the Psoriatic Arthritis Module at OMERACT 11.
J Rheumatol. 2014;41(4):782-91.
Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.
Rheumatology (Oxford). 2012;51(7):1226-34.
Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis.
Lancet. 2015 May 2;385(9979):1738-47. doi: 10.1016/S0140-6736(14)62002-X. Epub 2015 Mar 18.
Inhalant-related psychiatric disorders.
Medscape. Updated: May 21, 2014.
Antigen modulation confers protection to red blood cells from antibody through Fcγ receptor ligation.
J Immunol. 2013;191(10):5013-25.
Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia.
Open Access Journal of Clinical Trials. 2013;5:33–8.
Dendritic cell migration through the lymphatic vasculature to lymph nodes.
Adv Immunol. 2013;120:51-68.
Initiation and regulation of complement during hemolytic transfusion reactions.
Clin Dev Immunol. 2012;2012:307093.
Conditional depletion of mast cells has no impact on the severity of experimental epidermolysis bullosa acquisita.
Eur J Immunol. 2015 May;45(5):1462-70.
The properties of microparticles from RAW 264.7 macrophage cells undergoing in vitro activation or apoptosis.
Innate Immun. 2014;20(3):239-48.
Microparticles as a source of extracellular DNA.
Immunol Res. 2011;49(1-3):227-34.
Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis.
BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
The interferon type I/III response to respiratory syncytial virus infection in airway epithelial cells can be attenuated or amplified by antiviral treatment.
J Virol. 2015 Nov 25. pii: JVI.02417-15.
Lymphatic vasculature mediates macrophage reverse cholesterol transport in mice.
J Clin Invest. 2013;123(4):1571-9.
Key feasibility considerations when conducting vaccine clinical trials in Asia-Pacific countries.
Vaccine: Development and Therapy. 2013;3:1-9.
The 2 + 1 paradigm: an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials.
Gastroenterol Rep (Oxf). 2015 Sep 11.
Challenges in conducting tuberculosis clinical trials in developing countries: lessons learned.
Journal for Clinical Studies. 2013;5(1):36-42.
Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomized, double-blind, placebo-controlled, parallel-group phase III trial.
Arthritis Rheum. 2012;64(2):360-70.
Navigating the vaccine clinical trial landscape in emerging markets: lessons learned.
Journal for Clinical Studies. 2012;4(4):14-8. 
Effects of Fostamatinib on the Pharmacokinetics of Oral Contraceptive, Warfarin, and the Statins Rosuvastatin and Simvastatin: Results From Phase I Clinical Studies.
Drugs R D. 2016 Jan 9. [Epub ahead of print]
Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.
Pharmacoepidemiol Drug Saf. 2015 Oct 7.
Psychometric validation of the Brief Pain Inventory-Short Form in patients with systemic lupus erythematosus in the United States.
Lupus. 2015 Jun 1. pii: 0961203315588972. [Epub ahead of print]
Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.
J Rheumatol. 2015 Sep 15. pii: jrheum.141423.
Association of sweat chloride concentration at time of diagnosis and CFTR genotype with mortality and cystic fibrosis phenotype.
J Cyst Fibros. 2015 Feb 3.
Normal dendritic cell mobilization to lymph nodes under conditions of severe lymphatic hypoplasia.
J Immunol. 2013 May 1;190(9):4608-20.
Certolizumab Pegol Remains an Equally Efficacious Treatment of Rheumatoid Arthritis Over a Range of Background Methotrexate Regimens.
Arthritis Care Res (Hoboken). 2015 Aug 3.
IκB kinase 2 is essential for IgE-induced mast cell de novo cytokine production but not for degranulation.
Cell Rep. 2014 Sep 11;8(5):1300-7.
Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects.
Arthritis Res Ther. 2015 Oct 8;17:282.
Launching the BIOSPIT initiative: harmonizing sputum outcomes in multicenter trials.
Pulm Pharmacol Ther. 2013;26(3):400-1.
Is there a difference in systemic lupus erythematosus with and without Raynaud's phenomenon?
Rheumatol Int. 2013;33(4):859-65.
Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12.
J Rheumatol. 2015 Feb 15.
H5N1 avian influenza in children.
Clin Infect Dis. 2012;55(1):26-32. 
Strengthening observational evidence to antiviral effectiveness in H5N1.
J Infec Dis. 2011;204(5):810-1.
Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. 
Rheumatology (Oxford). 2012;51(9):1628-38.
Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.
Rheumatology (Oxford). 2012;51(12):2204-14.
Mechanisms of autoimmunity in human diseases: a critical review of current dogma.
Curr Opin Rheumatol. 2014;26(2):197-203.
Recognizing true H5N1 infections in humans during confirmed outbreaks.
J Infect Dev Ctries. 2014;8(2):202-7.
Timing of the availability and administration of influenza vaccine through the vaccines for children program. 
Pediatr Infect Dis J. 2011;30(2):100-6. 
New and existing pharmacotherapeutic options for persistent asthma and COPD. 
Neth J Med. 2011;69(11):486-99. 
Microparticles as mediators and biomarkers of rheumatic disease.
Rheumatology (Oxford). 2012;51(10):1737-46.
Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.
Clin Ther. 2015 Oct 26. pii: S0149-2918(15)01149-2.

Respiratory and Allergy

HMGB1 and microparticles as mediators of the immune response to cell death.
Antioxid Redox Signal. 2011;15(8):2209-19.
Sleep disorders, depressive symptoms and health-related quality of life: a cross-sectional comparison between kidney transplant recipients and wait-listed patients on maintenance dialysis.
Nephrol Dial Transplant. 2011;26(3):1058-65.
Disease models of chronic inflammatory airway disease: applications and requirements for clinical trials.
Curr Opin Pulm Med. 2014;20(1):37-45.
Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial.
Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.
Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.
Value Health. 2015 Sep;18(6):817-23.
Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study.
Ann Rheum Dis. 2015 Jun;74(6):979-84.
Understanding the diagnosis and treatment of COPD and asthma to better inform site selection and patient recruitment planning.
Therapeutic Innovation & Regulatory Science. 2013;47(4):468-73.
Data-driven asthma endotypes defined from blood biomarker and gene expression data.
PLoS One. 2015 Feb 2;10(2):e0117445.
Determinants of antiviral effectiveness in influenza virus A subtype H5N1.
J Infect Dis. 2012;206(9):1359-66.
Development of a disease activity and responder index for psoriatic arthritis: report of the Psoriatic Arthritis Module at OMERACT 11.
J Rheumatol. 2014;41(4):782-91.
Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX.
Rheumatology (Oxford). 2012;51(7):1226-34.
Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis.
Lancet. 2015 May 2;385(9979):1738-47. doi: 10.1016/S0140-6736(14)62002-X. Epub 2015 Mar 18.
Inhalant-related psychiatric disorders.
Medscape. Updated: May 21, 2014.
Antigen modulation confers protection to red blood cells from antibody through Fcγ receptor ligation.
J Immunol. 2013;191(10):5013-25.
Case series of feasibility considerations that impact operational delivery strategy in the highly competitive rheumatoid arthritis space in Asia.
Open Access Journal of Clinical Trials. 2013;5:33–8.
Dendritic cell migration through the lymphatic vasculature to lymph nodes.
Adv Immunol. 2013;120:51-68.
An open-label, non-randomised, phase 1, single-dose study to assess the pharmacokinetics of ceftaroline in patients with end-stage renal disease requiring intermittent haemodialysis.
Int J Antimicrob Agents. 2015 Oct 22. pii: S0924-8579(15)00330-1.
Initiation and regulation of complement during hemolytic transfusion reactions.
Clin Dev Immunol. 2012;2012:307093.
An Update on Surgical versus Expectant Management of Ovarian Endometriomas in Infertile Women.
Biomed Res Int. 2015;2015:204792.
Cost-consequence analysis of long-term prophylaxis in the treatment of von Willebrand disease in the Italian context.
Clinicoecon Outcomes Res. 2014 Dec 17;7:17-25.
Conditional depletion of mast cells has no impact on the severity of experimental epidermolysis bullosa acquisita.
Eur J Immunol. 2015 May;45(5):1462-70.
The properties of microparticles from RAW 264.7 macrophage cells undergoing in vitro activation or apoptosis.
Innate Immun. 2014;20(3):239-48.
Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder.
Neurourol Urodyn. 2015 Jul 14. doi: 10.1002/nau.22800. [Epub ahead of print]
Microparticles as a source of extracellular DNA.
Immunol Res. 2011;49(1-3):227-34.
Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis.
BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
ffect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study.
Am J Kidney Dis. 2015 Mar;65(3):464-73.
The interferon type I/III response to respiratory syncytial virus infection in airway epithelial cells can be attenuated or amplified by antiviral treatment.
J Virol. 2015 Nov 25. pii: JVI.02417-15.
Lymphatic vasculature mediates macrophage reverse cholesterol transport in mice.
J Clin Invest. 2013;123(4):1571-9.
Key feasibility considerations when conducting vaccine clinical trials in Asia-Pacific countries.
Vaccine: Development and Therapy. 2013;3:1-9.
The 2 + 1 paradigm: an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials.
Gastroenterol Rep (Oxf). 2015 Sep 11.
Challenges in conducting tuberculosis clinical trials in developing countries: lessons learned.
Journal for Clinical Studies. 2013;5(1):36-42.
Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomized, double-blind, placebo-controlled, parallel-group phase III trial.
Arthritis Rheum. 2012;64(2):360-70.
Navigating the vaccine clinical trial landscape in emerging markets: lessons learned.
Journal for Clinical Studies. 2012;4(4):14-8. 
Effects of Fostamatinib on the Pharmacokinetics of Oral Contraceptive, Warfarin, and the Statins Rosuvastatin and Simvastatin: Results From Phase I Clinical Studies.
Drugs R D. 2016 Jan 9. [Epub ahead of print]
Comparative safety of atypical antipsychotics and the risk of pneumonia in the elderly.
Pharmacoepidemiol Drug Saf. 2015 Oct 7.
Psychometric validation of the Brief Pain Inventory-Short Form in patients with systemic lupus erythematosus in the United States.
Lupus. 2015 Jun 1. pii: 0961203315588972. [Epub ahead of print]
Current State of Reporting Pain Outcomes in Cochrane Reviews of Chronic Musculoskeletal Pain Conditions and Considerations for an OMERACT Research Agenda.
J Rheumatol. 2015 Sep 15. pii: jrheum.141423.
Association of sweat chloride concentration at time of diagnosis and CFTR genotype with mortality and cystic fibrosis phenotype.
J Cyst Fibros. 2015 Feb 3.
Normal dendritic cell mobilization to lymph nodes under conditions of severe lymphatic hypoplasia.
J Immunol. 2013 May 1;190(9):4608-20.
Certolizumab Pegol Remains an Equally Efficacious Treatment of Rheumatoid Arthritis Over a Range of Background Methotrexate Regimens.
Arthritis Care Res (Hoboken). 2015 Aug 3.
IκB kinase 2 is essential for IgE-induced mast cell de novo cytokine production but not for degranulation.
Cell Rep. 2014 Sep 11;8(5):1300-7.
Oral and inhaled p38 MAPK inhibitors: effects on inhaled LPS challenge in healthy subjects.
Eur J Clin Pharmacol. 2015 Oct;71(10):1175-84. doi: 10.1007/s00228-015-1920-1. Epub 2015 Aug 13.
Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects.
Arthritis Res Ther. 2015 Oct 8;17:282.
Launching the BIOSPIT initiative: harmonizing sputum outcomes in multicenter trials.
Pulm Pharmacol Ther. 2013;26(3):400-1.
Is there a difference in systemic lupus erythematosus with and without Raynaud's phenomenon?
Rheumatol Int. 2013;33(4):859-65.
Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A.
Blood. 2015 Jul 8. pii: blood-2015-03-630897. [Epub ahead of print]
Remission in Rheumatoid Arthritis: Working Toward Incorporation of the Patient Perspective at OMERACT 12.
J Rheumatol. 2015 Feb 15.
H5N1 avian influenza in children.
Clin Infect Dis. 2012;55(1):26-32. 
Strengthening observational evidence to antiviral effectiveness in H5N1.
J Infec Dis. 2011;204(5):810-1.
Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. 
Rheumatology (Oxford). 2012;51(9):1628-38.
Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.
Rheumatology (Oxford). 2012;51(12):2204-14.
Mechanisms of autoimmunity in human diseases: a critical review of current dogma.
Curr Opin Rheumatol. 2014;26(2):197-203.
Recognizing true H5N1 infections in humans during confirmed outbreaks.
J Infect Dev Ctries. 2014;8(2):202-7.
Timing of the availability and administration of influenza vaccine through the vaccines for children program. 
Pediatr Infect Dis J. 2011;30(2):100-6. 
New and existing pharmacotherapeutic options for persistent asthma and COPD. 
Neth J Med. 2011;69(11):486-99. 
Kidney function changes with aging in adults: comparison between cross-sectional and longitudinal data analyses in renal function assessment.
Biopharm Drug Dispos. 2015 Aug 24.
Microparticles as mediators and biomarkers of rheumatic disease.
Rheumatology (Oxford). 2012;51(10):1737-46.
Effects of Fostamatinib on the Pharmacokinetics of Digoxin (a P-Glycoprotein Substrate): Results From in Vitro and Phase I Clinical Studies.
Clin Ther. 2015 Oct 26. pii: S0149-2918(15)01149-2.
Therapeutic Clearance of Amyloid by Antibodies to Serum Amyloid P Component.
N Engl J Med. 2015 Jul 15. [Epub ahead of print]

Rheumatology

Structural and functional screening in human induced-pluripotent stem cell-derived cardiomyocytes accurately identifies cardiotoxicity of multiple drug types.
Toxicol Appl Pharmacol. 2015 May 15;285(1):51-60. doi: 10.1016/j.taap.2015.03.008. Epub 2015 Apr 2.
EDA-containing fibronectin increases proliferation of embryonic stem cells
PLoS One. 2013;8(11):e80681.
Cytomics: Managing biocomplexity in drug development, clinical diagnostics, and clinical medicine. 
International Pharmaceutical Industry. 2012;4(4):46-53. 
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
AAPS J. 2015 Sep 16.
The role of replicates for error mitigation in next-generation sequencing.
Nat Rev Genet. 2014;15(1):56-62
Development of a sensitive and fast UHPLC-MS/MS method for determination of clopidogrel, clopidogrel acid and clopidogrel active metabolite H4 in human plasma.
Bioanalysis. 2015 Jul;7(12):1471-82. doi: 10.4155/bio.15.82.
Determination of cobimetinib in human plasma using protein precipitation extraction and high-performance liquid chromatography coupled to mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Dec 1;972:117-23.
A botulinum toxin-derived targeted secretion inhibitor downregulates the GH/IGF1 axis.
J Clin Invest. 2012;122(9):3295-306. 
Development and validation of a HILIC-MS/MS method for quantification of decitabine in human plasma by using lithium adduct detection.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Oct 15;969:117-22.
Accurate whole-genome sequencing and haplotyping from 10 to 20 human cells.
Nature. 2012;487(7406):190-5.
CD34+ gene expression profiling of individual children with very severe aplastic anemia indicates a pathogenic role of integrin receptors and the proapoptotic death ligand TRAIL.
Haematologica. 2012;97(9):1304-11.
Report of the GRAPPA-OMERACT Psoriatic Arthritis Working Group from the GRAPPA 2015 Annual Meeting.
J Rheumatol. 2016 May;43(5):965-9. doi: 10.3899/jrheum.160116
Epigenomes as therapeutic targets.
Pharmacol Ther. 2015 Jul;151:72-86. doi: 10.1016/j.pharmthera.2015.03.003. Epub 2015 Mar 20.
Imaging biomarkers in oncology drug development.
Journal for Clinical Studies. 2012;4(3):22-5. 
Building value through biomarkers: the ''Smarter Development'' initiative. 
Drug Information Journal. 2012;46(4):397-403.
Is there a role of synovial biopsy in drug development?
BMC Musculoskelet Disord. 2016 Apr 19;17(1):172. doi: 10.1186/s12891-016-1028-5.
Biosimilars in rheumatology: understanding the rigor of their development.
Rheumatology (Oxford). 2016 May 30. pii: kew206. [Epub ahead of print] Review.
Automated high-capacity on-line extraction and bioanalysis of dried blood spot samples using liquid chromatography/high-resolution accurate mass spectrometry.
Rapid Commun Mass Spectrom. 2014 Nov 30;28(22):2415-26.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Safety and patient response as indicated by biomarker changes to binding immunoglobulin protein in the phase I/IIA RAGULA clinical trial in rheumatoid arthritis.
Rheumatology (Oxford). 2016 Aug 7. pii: kew287. [Epub ahead of print]
Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules.
Bioanalysis. 2012;4(19):2343-56.
Low-Turnover Drug Molecules: A Current Challenge for Drug Metabolism Scientists.
Drug Metab Dispos. 2015 Sep 11. pii: dmd.115.066431.
A rat RNA-Seq transcriptomic BodyMap across 11 organs and 4 developmental stages.
Nat Commun. 2014;5:3230.
A public resource facilitating clinical use of genomes.
Proc Natl Acad Sci U S A. 2012;109(30):11920-7.
Genomic analysis identifies unique signatures predictive of brain, lung, and liver relapse. 
Breast Cancer Res Treat. 2012;132(2):523-35. 
On the design of clone-based haplotyping.
Genome Biol. 2013;14(9):R100.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Expression profile of COL2A1 and the pseudogene SLC6A10P predicts tumor recurrence in high-grade serous ovarian cancer.
Int J Cancer. 2015 Aug 27.

Vaccines

Structural and functional screening in human induced-pluripotent stem cell-derived cardiomyocytes accurately identifies cardiotoxicity of multiple drug types.
Toxicol Appl Pharmacol. 2015 May 15;285(1):51-60. doi: 10.1016/j.taap.2015.03.008. Epub 2015 Apr 2.
EDA-containing fibronectin increases proliferation of embryonic stem cells
PLoS One. 2013;8(11):e80681.
Cytomics: Managing biocomplexity in drug development, clinical diagnostics, and clinical medicine. 
International Pharmaceutical Industry. 2012;4(4):46-53. 
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
AAPS J. 2015 Sep 16.
The role of replicates for error mitigation in next-generation sequencing.
Nat Rev Genet. 2014;15(1):56-62
Development of a sensitive and fast UHPLC-MS/MS method for determination of clopidogrel, clopidogrel acid and clopidogrel active metabolite H4 in human plasma.
Bioanalysis. 2015 Jul;7(12):1471-82. doi: 10.4155/bio.15.82.
Determination of the minimum fully protective dose of adenovirus-based DIVA vaccine against peste des petits ruminants virus challenge in East African goats.
Vet Res. 2016 Jan 21;47:20. doi: 10.1186/s13567-016-0306-4.
Determination of cobimetinib in human plasma using protein precipitation extraction and high-performance liquid chromatography coupled to mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Dec 1;972:117-23.
A botulinum toxin-derived targeted secretion inhibitor downregulates the GH/IGF1 axis.
J Clin Invest. 2012;122(9):3295-306. 
Development and validation of a HILIC-MS/MS method for quantification of decitabine in human plasma by using lithium adduct detection.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Oct 15;969:117-22.
Accurate whole-genome sequencing and haplotyping from 10 to 20 human cells.
Nature. 2012;487(7406):190-5.
CD34+ gene expression profiling of individual children with very severe aplastic anemia indicates a pathogenic role of integrin receptors and the proapoptotic death ligand TRAIL.
Haematologica. 2012;97(9):1304-11.
Epigenomes as therapeutic targets.
Pharmacol Ther. 2015 Jul;151:72-86. doi: 10.1016/j.pharmthera.2015.03.003. Epub 2015 Mar 20.
Imaging biomarkers in oncology drug development.
Journal for Clinical Studies. 2012;4(3):22-5. 
Building value through biomarkers: the ''Smarter Development'' initiative. 
Drug Information Journal. 2012;46(4):397-403.
Automated high-capacity on-line extraction and bioanalysis of dried blood spot samples using liquid chromatography/high-resolution accurate mass spectrometry.
Rapid Commun Mass Spectrom. 2014 Nov 30;28(22):2415-26.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules.
Bioanalysis. 2012;4(19):2343-56.
Low-Turnover Drug Molecules: A Current Challenge for Drug Metabolism Scientists.
Drug Metab Dispos. 2015 Sep 11. pii: dmd.115.066431.
A rat RNA-Seq transcriptomic BodyMap across 11 organs and 4 developmental stages.
Nat Commun. 2014;5:3230.
A public resource facilitating clinical use of genomes.
Proc Natl Acad Sci U S A. 2012;109(30):11920-7.
Genomic analysis identifies unique signatures predictive of brain, lung, and liver relapse. 
Breast Cancer Res Treat. 2012;132(2):523-35. 
On the design of clone-based haplotyping.
Genome Biol. 2013;14(9):R100.
Technical reproducibility of genotyping SNP arrays used in genome-wide association studies. 
PLoS One. 2012;7(9):e44483.
Expression profile of COL2A1 and the pseudogene SLC6A10P predicts tumor recurrence in high-grade serous ovarian cancer.
Int J Cancer. 2015 Aug 27.