Full 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.
Contents
Part I: General Chapters
1. Introduction
2. Regulatory Expectations and Industry Practice on Stability Testing
3. ASAP Theory and Fundamentals
4. Practical Considerations
5. Packaged Products
6. Data Evaluation and Statistical Methods
7. Assessing the Suitability of ASAP for the Sample
8. Application of ASAP in the Pharmaceutical Industry
9. The Value of ASAP in Early Clinical Drug Product Development
10. Embedding ASAP within Business
11. ASAP Regulatory Strategy and Acceptance and Feedback
Part II: Industry Practices
12. ASAP Application in Product Development
13. Methods for the Analysis of Data from Accelerated Stability Studies
14. ASAP Application in Packaging Selection
15. ASAP Application in Post-approval Process Development
16. Using ASAP to Predict the Retest Period of an Unusually Unstable Drug Substance and to Select Prototype Formulations
17. Shelf Life Prediction and Packaging Selection of a Humidity-sensitive Product
18. ASAP Application in Suspension and Lyophilized Products
19. ASAP Application in Generic Products
20. Application of ASAP to Nicorette® Lozenges
21. Implementing an Accelerated Stability Assessment Program
22. ASAP: Case Studies from Early and Late Pharmaceutical Development Stages
23. Application of ASAP for Dissolution Predictions
