Shein-Chung Chow

Statistical Design and Analysis of Stability Studies

• Gebundenes 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 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 stability studies.

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 331
• Erscheinungstermin: 30. Mai 2007
• Englisch
• Abmessung: 242mm x 163mm x 24mm
• Gewicht: 635g
• ISBN-13: 9781584889052
• ISBN-10: 1584889055
• Artikelnr.: 22745111

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.