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.
| ISBN: | 9780128027868 |
| Publication date: | 16th May 2018 |
| Author: | Fenghe (Senior Research Fellow, Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA) Qiu |
| Publisher: | Academic Press Inc an imprint of Elsevier Science Publishing Co Inc |
| Format: | Hardback |
| Pagination: | 512 pages |
| Genres: |
Pharmacology Analytical chemistry |