Statistical Design and Analysis of Stability Studies
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability testing, focuses on short-term stability studies, and reviews several methods for estimating drug expiration dating periods. The author compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. The book examines the stability analysis of a linear mixed effects model and stability analyses with discrete responses, multiple components, and frozen drug products. It also explores dissolution testing, current issues, and recent developments in stabil…
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Produktdetails
- ISBN: 978-1-58488-906-9
- EAN: 9781584889069
- Produktnummer: 32248684
- Verlag: Taylor & Francis Ltd.
- Sprache: Englisch
- Erscheinungsjahr: 2007
- Seitenangabe: 349 S.
- Plattform: PDF
- Masse: 2'228 KB
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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
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