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Elsevier

Accelerated Predictive Stability (APS)

Fundamentals and Pharmaceutical Industry Practices

  • 1st Edition - May 14, 2018
  • Latest edition
  • Editors: Fenghe Qiu, Garry Scrivens
  • Language: English

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry… Read more

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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.

Key features

  • 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

Readership

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

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 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

Product details

  • Edition: 1
  • Latest edition
  • Published: May 14, 2018
  • Language: English

About the editors

FQ

Fenghe Qiu

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.
Affiliations and expertise
Senior Research Fellow, Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

GS

Garry Scrivens

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.
Affiliations and expertise
Senior Principal Scientist, Pfizer Ltd, Sandwich, UK

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