Metabolite Safety in Drug Development by Suzanne L. Iverson and Dennis A. Smith
English | 2016 | ISBN: 111894965X | 352 pages | PDF | 5 MB
A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA.
Reviews the analytical techniques and experimental designs critical for metabolite studies
Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation
Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions
Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines