Cover for Accelerated Predictive Stability

Accelerated Predictive Stability

Fundamentals and Pharmaceutical Industry Practices

Book ? 2018

Edited by:

Fenghe Qiu and Garry Scrivens

Accelerated Predictive Stability

Fundamentals and Pharmaceutical Industry Practices

Book ? 2018

?

Cover for Accelerated Predictive Stability

Edited by:

Fenghe Qiu and Garry Scrivens

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Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applicat ... read full description

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About the book

Description

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.

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.

Key Features

  • 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
  • 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

Details

ISBN

978-0-12-802786-8

Language

English

Published

2018

Copyright

Copyright ? 2018 Elsevier Inc. All rights reserved.

Imprint

Academic Press

No. of pages

512

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Editors

Fenghe Qiu

Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States

Garry Scrivens

Pfizer Pharmaceuticals Ltd., Sandwich, United Kingdom