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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.
- Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS)
- Presents the scientific basis of different APS models
- Includes the applications and utilities of APS that are demonstrated through numerous case studies
- Covers up-to-date regulatory experience
Scientists/managers in drug development, pharmaceutical scientists, analytical chemists, regulatory affairs officials, quality assurance and quality control professionals, professionals in regulatory agencies and pharmaceutical science graduate students
Part I: General Chapters
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
- No. of pages:
- © Academic Press 2018
- 16th May 2018
- Academic Press
- Hardcover ISBN:
- eBook ISBN:
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.
Senior Research Fellow, Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA
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.
Senior Principal Scientist, Pfizer Ltd, Sandwich, UK