Metabolite Safety in Drug Development

Dennis A Smith editor Suzanne L Iverson editor

Format:Hardback

Publisher:John Wiley & Sons Inc

Published:23rd Sep '16

Currently unavailable, and unfortunately no date known when it will be back

Metabolite Safety in Drug Development cover

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

"Written by individuals who collectively possess hundreds of years of experience within the drug metabolism field, the wealth of information and insight contained is amazing. The purpose of the tome is to provide the reader with, �... a comprehensive overview of why and how metabolites are studied during drug development in the pharmaceutical industry� (page 13). This objective is certainly achieved in a lucid, scholarly and engaging manner. I would not hesitate to recommend this book to anyone interested in this subject and also for those who may wish to delve into this area." (ISSX Newsletter, April 2017)

ISBN: 9781118949658

Dimensions: 234mm x 158mm x 23mm

Weight: 612g

352 pages