Accelerated Stability Assessment Program (ASAP): Fundamentals and Pharmaceutical Industry Practices

Accelerated Stability Assessment Program (ASAP): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and applications of the ASAP approach. This book includes practical knowledge and insights by presenting numerous industry case studies that cover important areas of drug development where stability testing is required, including the retest period/shelf life of a drug substance or product, support of chemical process development, and justification of use period for reference materials. Users will find a set of standard conditions on how to design an ASAP protocol. The book offers scientists and regulators a complete reference source that illustrates how the pharmaceutical industry can enhance the understanding of a product's stability attributes and more accurately, and quickly, determine drug expiry. Provides detailed information on the accelerated stability assessment program (ASAP) approach, including basic concepts and applicationsIncorporates practical examples and industry case studies to illustrate how ASAP can be effectively implemented during the development stage Offers a single and unique resource dedicated to all aspects of ASAP INDICE: 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 Nicrette® 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

• ISBN: 978-0-12-802786-8
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 416
• Fecha Publicación: 01/10/2017
• Nº Volúmenes: 1
• Idioma: Inglés