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Metabolite Safety in Drug Development
ISBN-13:
9781118949665
Veröffentl:
2016
Einband:
E-Book
Seiten:
352
Autor:
Suzanne L. Iverson
eBook Typ:
PDF
eBook Format:
Reflowable
Kopierschutz:
2 - DRM Adobe
Sprache:
Englisch
Beschreibung:
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
* 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
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