Download PDF by Suzanne L. Iverson,Dennis A. Smith: Metabolite Safety in Drug Development

By Suzanne L. Iverson,Dennis A. Smith

ISBN-10: 111894965X

ISBN-13: 9781118949658

A reference on drug metabolism and metabolite protection within the improvement part, this publication reports the analytical suggestions and experimental designs severe for metabolite reports. It beneficial properties case reviews of classes discovered and actual international examples, besides regulatory views from the U.S. FDA and EMA.

•    Reviews the analytical ideas and experimental designs serious for metabolite studies
•    Covers tools together with chirality, species variations, mass spectrometry, radiolabels, and in vitro / in vivo correlation
•    Discusses goal pharmacology, in vitro structures aligned to toxicity assessments, and drug-drug interactions
•    Includes views from authors with firsthand involvement in and the research of drug metabolites, together with viewpoints that experience prompted regulatory guidelines

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Metabolite Safety in Drug Development by Suzanne L. Iverson,Dennis A. Smith


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