Shein-Chung Chow

Statistical Design and Analysis of Stability Studies

• Broschiertes Buch

Produktbeschreibung

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

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Produktdetails

• Verlag: Chapman and Hall/CRC
• Seitenzahl: 350
• Erscheinungstermin: 30. Juni 2020
• Englisch
• Abmessung: 234mm x 156mm x 19mm
• Gewicht: 532g
• ISBN-13: 9780367577681
• ISBN-10: 0367577682
• Artikelnr.: 69895116

Autorenporträt

Shein-Chung Chow

Inhaltsangabe

Introduction. Accelerated Testing. Expiration Dating Period. Stability
Designs. Stability Analysis with Fixed Batches. Stability Analysis with
Random Batches. Stability Analysis with a Mixed Effects Model. Stability
Analysis with Discrete Responses. Stability Analysis with Multiple
Components. Stability Analysis with Frozen Drug Products. Stability Testing
for Dissolution. Current Issues and Recent Developments. Appendices.
References. Index.