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123,50 €1 Introduction: History of Metabolite Safety in Drug Development 1
2 “Mist” and other Metabolite Guidelines in the Context of Industrial Drug Metabolism 17
3 Metabolite Technology: Qualitative and Quantitative 45
4 In Vitro Methods for Evaluation of Drug Metabolism: Identification of Active and Inactive Metabolites and the Enzymes that Generate them 87
5 Integrated Reactive Metabolite Strategies 111
6 Understanding Drug Metabolism in Humans: In Vivo 141
7 Topical Administration and Safety Testing of Metabolites 177
8 In Silico Modeling of Metabolite Kinetics 213
9 Introduction to Case Studies 239
10 A Mass Balance and Metabolite Profiling Study of Sonidegib in Healthy Male Subjects Using Microtrace Approach 243
11 Dealing with Reality: When is it Necessary to Qualify and Quantify Metabolites? Some Case Studies 261
12 The Value of Metabolite Identification and Quantification in Clinical Studies. Some Case Studies Enabling Early Assessment of Safety in Humans: GlaxoSmithKline 275
13 The Importance of Dose- and Time-Dependent Pharmacokinetics During Early Metabolite Safety Assessment in Humans 293
14 Mist and the Future 305
This book focuses on the characterization of metabolites once a drug candidate is selected, featuring case studies to illustrate lessons learned and a perspective on future directions. The emphasis is mainly aimed at stable, circulating metabolites and the discussions deal with (on and off) target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions. It provides a reference work covering all these topics of metabolite safety analysis in a comprehensive and topical manner offering clear guidance on each of the issues. Both the editors and the chapter authors have firsthand involvement with industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines.
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