Accelerated Predictive Stability (APS). Fundamentals and Pharmaceutical Industry Practices

Table of 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

Authors

Fenghe Qiu Senior Research Fellow, Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. Dr. Fenghe Qiu has over 30 years of combined academic and industry experiences as an analytical scientist and published over 50 peer reviewed articles and gave over 25 invited presentations. He received his Ph.D. in Physical Chemistry from Changchun Institute of Applied Chemistry, Chinese Academy of Sciences and a B.S. degree in Chemistry from Shandong University. He has been with Boehringer Ingelheim Pharmaceuticals Inc. for over 16 years and currently is a Senior Research Fellow in the Department of Material and Analytical Sciences. In his current role, Dr. Qiu is responsible for analytical development of new chemical entity (NCE) small molecule drugs and provides leadership role in many CMC development areas such as project management, method development/validation, elucidation of structure, impurity/mutagenic impurity control, stability/stress testing, specification, quality control, and regulatory submissions. He has led many internal innovation initiatives in areas including mutagenic impurity, stress testing, accelerated predictive stability (APS) and emerging technologies, etc. He is the inventor of the BI Mutagenic Impurity Workspace, the current organizer of the Mutagenic Impurity Advisory Council, the local process owner for stability and head of quality control. He also extensively involved in many industry initiatives under PhRMA, AAPS, USP and IQ, etc., and currently served in three IQ working groups involving accelerated predictive stability, lean stability and impurity metrics. Prior to BI, Dr. Qiu had several academic assignments including Mass Spectrometry Lab Manager, Northwestern University, Research Associate, University of Utah, and Associate Professor, National Center of Biomedical Analysis of China. Garry Scrivens Senior Principal Scientist, Pfizer Ltd, Sandwich, UK. Garry Scrivens is a Senior Principal Scientist, Analytical R&D, Worldwide Pharmaceutical Sciences (WWPS), and is based in Sandwich, Kent. He is currently a group leader responsible for the late-stage development and filing of drug products. His Ph.D in physical organic chemistry, was a spectroscopic investigation into the mechanisms and kinetics of metal-catalyzed redox reactions. He has 15 years pharmaceutical analytical development experience, and has worked on numerous APIs and drug products, from inhaled to solid oral dosage forms. He has an interest in solid-state degradation chemistry and the accurate prediction of shelf life; he is a champion of the Accelerated Stability Assessment Program (ASAP) developed at Pfizer.