Accelerated Predictive Stability (APS)

Fundamentals and Pharmaceutical Industry Practices

Nonfiction, Science & Nature, Science, Chemistry, Analytic, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Accelerated Predictive Stability (APS) by , Elsevier Science
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Author: ISBN: 9780128027851
Publisher: Elsevier Science Publication: June 28, 2018
Imprint: Academic Press Language: English
Author:
ISBN: 9780128027851
Publisher: Elsevier Science
Publication: June 28, 2018
Imprint: Academic Press
Language: English

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
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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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