accelerated predictive stability

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Accelerated Predictive Stability  APS
Author :
Publisher : Academic Press
Release Date :
ISBN 10 : 0128027851
Pages : 512 pages
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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. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience

Accelerated Predictive Stability  APS

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

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Methods for Stability Testing of Pharmaceuticals

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Determining accurate shelf life data for foods is essential for assuring food quality and protecting consumers from the effects of degradation. With a proper balance of theory and practical examples, Shelf Life Assessment of Food presents the essential criteria and current methodologies for obtaining accurate and reliable shelf life dating.

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The Fundamentals of Stability Testing

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Distributed Model Predictive Control Made Easy

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Statistical Design and Analysis of Stability Studies

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.

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