Accelerated Predictive Stability (APS)
  • Release Date : 28 June 2018
  • Publisher : Academic Press
  • Genre : Medical
  • Pages : 512 pages
  • ISBN 13 : 9780128027851
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Download or read book entitled Accelerated Predictive Stability (APS) by author: Fenghe Qiu which was release on 28 June 2018 and published by Academic Press with total page 512 pages . This book available in PDF, EPUB and Kindle Format. 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