Accelerated Predictive Stability (APS) : fundamentals and pharmaceutical industry practices / Fenghe Qiu, Garry Scrivens.

Includes bibliographical references and index.

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.