Validated Methods
LC/MS Biomarkers | Immunoassay Biomarkers | LC/MS Drug Assays
Advion Bioanalytical Labs specializes in validated LC/MS methods development to support drug-drug interaction (DDI), biomarker, or comparison studies with established therapeutic compounds. Non-proprietary, validated methods offer a cost-effective and timely solution for clients.
Click on the validated method name to request additional information such as the anticoagulant used, accuracy and precision, and stability details for the assay.
Advion Bioanalytical Labs is happy to partner with new and existing clients to develop assays that have value to the pharmaceutical industry. If there is a method you feel we should offer, please email us at clinical@quintiles.com.
Validated LC/MS/MS Methods (PDF of Validated Methods)
| Analyte/Metabolite | Range | Extraction Volume | Matrix/Anticoagulant |
|---|---|---|---|
| Acyclovir/Valaciclovir | 10 - 1000 ng/mL | 50 µL | Human plasma/ K3EDTA |
| Amlodipine | 0.1 - 10 ng/mL | 100 µL | Human plasma/ heparinized |
| D-Amphetamine, L-Amphetamine (chiral) | 0.5 - 75 ng/mL | 200 µL | Human plasma/ sodium EDTA |
Available soon | 0.5 - 200 ng/mL | 100 µL | Human plasma/ sodium EDTA |
| Atorvastatin/o-Hydroxyatorvastatin; p-Hydroxyatorvastatin | 0.25 - 25 ng/mL | 200 µL | Human plasma/ sodium heparin |
| Bortezomib | 0.1 - 25 ng/mL | 100 µL | Human plasma/ K3EDTA and sodium heparin |
| Capecitabine/5'-DFCR; 5'-DFUR; 5-FU; FBAL | 10 - 5000 ng/mL 50 - 25000 ng/mL 2 - 1000 ng/mL 15 - 7500 ng/mL | 200 µL | Human plasma/ sodium EDTA |
| Carbamazepine/ Carbamazepine-10, 11 epoxide | 20 - 5000 ng/mL 20 - 500 ng/mL | 50 µL | Human plasma/ sodium EDTA |
| Clopidogrel; Clopidogrel Carboxylic Acid; Clopidogrel Active Metabolite | 0.05 - 50 ng/mL 5 - 5000 ng/mL 0.0706 - 70.6 ng/mL | 200 µL | Human plasma/ K2EDTA |
| Cytarabine | 25 - 1000 ng/mL | 20 µL | Human plasma/ sodium heparin |
| Daunorubicin/Daunorubicinol | 1 - 500 ng/mL | TBD | Human plasma/ K2EDTA |
| Digoxin | 0.1 - 20 ng/mL | 200 µL | Human serum |
| Digoxin | 5 - 1000 ng/mL | 100 µL | Human urine |
| Available soon Docetaxel | 1 - 2500 ng/mL | 200 µL | Human plasma/ K2EDTA |
| Donepezil | 0.2 - 100 ng/mL | 200 µL | Human plasma/ sodium heparin |
0.2 - 200 ng/mL 0.5 - 500 ng/mL | 50 µL | Human plasma/ K3EDTA | |
| Erlotinib | 1 - 3000 ng/mL | 50 µL | Human plasma/ sodium heparin |
| 5-Fluorouracil (5-FU) | 10 - 10000 ng/mL | 100 µL | Human plasma/ sodium heparin and K2EDTA |
| Fenofibric Acid | 20 - 10000 ng/mL | 100 µL | Human plasma/ sodium EDTA |
| Gemcitabine | 10 - 10000 ng/mL | 25 µL | Human plasma/ lithium heparin |
| Glyburide | 0.025 - 2 ng/mL | 100 µL | Human PFF (non-protein bound) |
| Glyburide (total) | 1 - 250 ng/mL | 200 µL | Human plasma/ sodium heparin |
| Imatinib (Gleevec®)/ N-Desmethyl Imatinib | 100 - 10000 ng/mL 50 - 5000 ng/mL | 50 µL | Human plasma/ K2EDTA |
| Lamivudine (as part of Combivir®) | 2 - 1000 ng/mL | 200 µL | Human plasma/ sodium heparin |
| Lamivudine (as part of Combivir®) | 2 - 1000 ng/mL | 200 µL | Human urine |
| Lovastatin/Lovastatin Acid | 0.25 - 100 ng/mL | 500 µL | Human plasma/ sodium heparin |
| Methotrexate/ 7-Hydroxymethotrexate | 1 - 1000 ng/mL 1 - 150 ng/mL | 200 µL | Human plasma/ lithium heparin |
| Methotrexate (Low Curve)/ 7-Hydroxymethotrexate | 50 - 1000 ng/mL | 20 µL | Human urine |
| Methotrexate (High Curve)/ 7-Hydroxymethotrexate | 1000 - 50000 ng/mL 50 - 1000 ng/mL | 20 µL | Human urine |
| Methylphenidate/ α-Phenyl-α-(2-Piperidyl)Acetic Acid | 0.05 - 25 ng/mL | 100 µL | Human plasma/ acid citrate dextrose |
| Midazolam/1-Hydroxymidazolam | 0.1 - 100 ng/mL | 100 µL | Human plasma/ sodium and lithium heparin |
| Moxifloxacin | 25 - 5000 ng/mL | 50 µL | Human plasma/ K2EDTA |
| Omeprazole/ 5-Hydroxyomeprazole; Omeprazole Sulfone | 0.5 - 500 ng/mL 0.5 - 250 ng/mL | 50 µL | Human plasma/ sodium heparin |
| Paclitaxel/6-Hydroxypaclitaxel | 10 - 5000 ng/mL | 200 µL | Human plasma/ K2EDTA |
| Ritonavir | 10 - 5000 ng/mL | 50 µL | Human plasma/ K3EDTA |
| Rosiglitazone | 5 - 3000 ng/mL | 25 µL | Human plasma/ K3EDTA |
| Rosuvastatin/ Rosuvastatin Lactone; N-Desmethyl Rosuvastatin | 0.5 - 100 ng/mL 0.5 - 50 ng/mL | 100 µL | Human plasma/ K2EDTA |
| Simvastatin/Simvastatin Acid | 0.1 - 30 ng/mL | 200 µL | Human plasma/ K3EDTA |
| Tolterodine/ 5-Hydroxymethyltolterodine | 0.2 - 50 ng/mL | 100 µL | Human plasma/ sodium heparin |
| Valproic Acid | 1 - 100 µg/mL | 100 µL | Human serum |
| R-Warfarin, S-Warfarin (chiral) | 0.1 - 10 ng/mL | 200 µL | Human PFF (non-protein bound) |
| R-Warfarin, S-Warfarin (chiral) | 1 - 2500 ng/mL | 100 µL | Human plasma (total)/sodium and lithium heparin |
| Zidovudine (as part of Combivir®) | 2 - 1000 ng/mL | 200 µL | Human plasma/ sodium heparin |
| Zidovudine (as part of Combivir®) | 2 - 1000 ng/mL | 200 µL | Human urine |
| Ziprasidone | 0.5 - 150 ng/mL | 200 µL | Human plasma/ sodium heparin |
LC/MS Biomarker Methods
| Biomarker Method Development and Validation Expertise |
|---|
| Amino Acids |
| Rat Hepcidin |
| Lipids |
| Neurotransmitters |
| Nucleotides |
| Peptides |
| Proteins – immunoprecipitation, digestion, immunoaffinity LC/LC/nano LC/MS/MS |
Immunoassay Biomarker Methods
| Biomarker/Analyte on ELISA Platform | Range | Volume Required | Matrix |
|---|---|---|---|
| HER-2/neu | 2.5 - 35 ng/mL | 20 µL | Human serum |
| 1 – 500 pg/mL | 50 µL | Human serum | |
| IGF-1 (total) | 0.15 - 6 ng/mL | 20 µL | Human serum |
| IGF-1 (free) | 0.15 - 6 ng/mL | 20 µL | Human serum |
| sECAD | 0.625 - 20 ng/mL | 20 µL | Human serum |
| sEGFr | 12.5 - 300 ng/mL | 20 µL | Human serum |
