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Accelerated Predictive Stability (APS): Fundamentals and
Pharmaceutical Industry Practices provides coverage of both the
fundamental principles and pharmaceutical industry applications of
the APS approach. Fundamental chapters explain the scientific basis
of the APS approach, while case study chapters from many innovative
pharmaceutical companies provide a thorough overview of the current
status of APS applications in the pharmaceutical industry. In
addition, up-to-date experiences in utilizing APS data for
regulatory submissions in many regions and countries highlight the
potential of APS in support of registration stability testing for
certain regulatory submissions. This book provides high level
strategies for the successful implementation of APS in a
pharmaceutical company. It offers scientists and regulators a
comprehensive resource on how the pharmaceutical industry can
enhance their understanding of a product's stability and predict
drug expiry more accurately and quickly.
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