Early Assessment of Exposure of Drug Metabolites in Humans Using Mass Spectrometry

Author:

Penner Natalia A.1,Zgoda-Pols Joanna2,Prakash Chandra1

Affiliation:

1. Biogen Idec, Inc.; Cambridge MA USA

2. Merck & Co., Inc.; Rahway NJ USA

Publisher

John Wiley & Sons, Ltd

Reference75 articles.

1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Pharmacology and Toxicology, Safety Testing of Drug Metabolites 2008

2. Dose-proportionality of a final market image sitagliptin formulation, an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers;Bergman;Biopharm. Drug Dispos.,2007

3. Pharmacology and toxicology, M3(R2): guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals;F. a. D. A. U.S. Department of Health and Human Services, Center for Drug Evaluation and Research;Fed. Regist.,2010

4. Cross-species comparison of the metabolism and excretion of zoniporide: contribution of aldehyde oxidase to interspecies differences;Dalvie;Drug Metab. Dispos.,2010

5. Metabolism, pharmacokinetics, and excretion of a cholesteryl ester transfer protein inhibitor, torcetrapib, in rats, monkeys, and mice: characterization of unusual and novel metabolites by high-resolution liquid chromatography-tandem mass spectrometry and 1H nuclear magnetic resonance;Prakash;Drug Metab. Dispos.,2008

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