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Statistical Design and Analysis of Stability Studies

By Shein-Chung Chow

Product Image: Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies

By Shein-Chung Chow

0 - Default Title
Description
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.
Product details
Edition:
1
Number of Pages:
350
Release Date:
2007-05-01
Publication Date:
2007-05-30
Publisher:
Chapman and Hall/CRC
Languages:
Original: English
ISBN10:
1584889055
ISBN13:
9781584889052
GPSR Manufacturer Reference:
[email protected]
Weight:
690 g
Height:
161 cm
Width:
240 cm
Thickness:
23 cm
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