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.
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