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White Papers - Phase II/III
To learn more about a particular aspect of Quintiles’ pharma services, biotech development or drug commercialization services, select a topic at left. If you’ve already specified a choice, you may narrow your search by selecting additional categories in any order. For example, for information on oncology drug development, start by selecting oncology. Then you can narrow your search to Central Lab, News Releases and Europe.
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EMA’s Guidance on New Antidiabetic Drug Development
May 12, 2010
Assessing the EMA’s Guidance on New Antidiabetic Drug Development In January 2010, the European Medicines Agency (EMA) issued a draft guideline on antidiabetic drug development -
FDA Requirements for Clinical Studies in Pediatric Patients
April 1, 2010
FDA Requirements for Clinical Studies in Pediatric Patients FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy -
Integration of Molecular Biomarkers into Clinical Development
March 29, 2010
Examining the challenges and opportunities in co-developing a biomarker and drug, this is the first white paper in a new series focusing on oncology. -
Regulations for Clinical Studies in Pediatric Patients in the European Union
March 10, 2010
After the United States issued pediatric drug study requirements, the European Union (EU) passed a regulation that created major changes to clinical studies for pediatric -
Key Trends in Multiple Myeloma Treatment
February 26, 2010
An overview of the latest studies into novel drug combinations and new therapies in early stage testing in multiple myeloma. -
Biomarker Trends in Breast Cancer Research
February 24, 2010
Dr. Hill discusses the implications and questions that will drive future R&D efforts to develop targeted breast cancer therapies. -
New FDA Guidance on Antidiabetic Therapies
December 11, 2009
Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program. -
Chasing Influenza
November 30, 2009
The rise in influenza strains like H1N1 — and the demand for new vaccines — signals a new era in vaccines. Learn how flu vaccines have evolved and where they’re headed. -
Monitoring for Quality
May 22, 2008
Scott Cooley, Executive Director, Phase IIIb/IV Product Management, Quintiles, discusses innovative and traditional resources in a risk-based monitoring program.
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