Statistical Design and Analysis of Stability Studies (Chapman

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Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)
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The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies.

After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies.

To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
Country USA
Brand CRC Press
Manufacturer Chapman and Hall/CRC
Binding Hardcover
UnitCount 1
Format Illustrated
EANs 9781584889052
ReleaseDate 0000-00-00

Statistical Design and Analysis of Stability Studies (Chapman & Hall/CRC Biostatistics Series)

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Country	USA
Brand	CRC Press
Manufacturer	Chapman and Hall/CRC
Binding	Hardcover
UnitCount	1
Format	Illustrated
EANs	9781584889052
ReleaseDate	0000-00-00