Pharmaceutical Stability Testing to Support Global Markets

1. Introduction
Kim Huynh-Ba

2. Regulatory Perspectives on Product Stability
Gary Buehler, Kim Huynh-Ba

3. Current International Harmonization Efforts
Justina A. Molzon

4. Update on the WHO Stability Guideline
Sabine Kopp

5. Development of a Regional Guideline for the Eastern Mediterranean Region
Abdel Aziz Saleh, Kim Huynh-Ba

6. The Challenge of Diverse Climates: Adequate Stability Testing Conditions for India
Saranjit Singh, Amrit Paudel, Gaurav Bedse, Rhishikesh Thakare, Vijay Kumar

7. Requirements for South East Asian Markets
Lucky S. Slamet, Kim Huynh-Ba

8. The Role of USP Monographs in Stability Testing
Karen A. Russo

9. Regulatory Requirements for Stability Testing of Generics
Gary Buehler, Kim Huynh-Ba

10. Stability Design for Consumer Healthcare Products
Jeffrey T. Needels, Mary W. Seibel, Karen L. Lucas, Rachael Carlisle Roehrig

11. Challenges of Drug/Devices Pharmaceutical Products
Duu-Gong Wu

12. Practical Challenges of Stability Testing of Nutraceutical Formulations
Jairaj Mehta

13. Setting Tolerances for Instrument Qualification USP Chapter <1058>
Horacio N. Pappa, Kim Huynh-Ba

14. The Concept of Quality-by-Design
Mark A. Staples

15. Forced Degradation and Its Relation to Real Time Drug Product Stability
Steven W. Baertschi

16. Low Level Impurities in Drug Substances and Drug Products and the Analytical Challenges in Identification and Quantitation
Ganapathy Mohan

17. Stability of Repackaged Products
Mansoor A. Khan

18. Packaging-Induced Interactions and Degradation
Mark D. Argentine, Patrick J. Jansen

19. An Overview of Physical Stability of Pharmaceuticals
Yushen Guo

20. Stability of Split Tablets
Vilayat A. Sayeed, Abhay Gupta, Mansoor A. Khan

21. Temperature Monitoring During Shipment and Storage
Conny Axelsson

22. Introducing a Science-Based Quality by Design Concept to Analytical Methods Development
Jianmei Kochling, Juma Bridgewater, Redouan Naji

23. Optimizing Stability Data Package to Facilitate NDA/MAA Approval
Frank Diana

24. Maximize Data for Post Approval Changes
Paula J. Youngberg Webb

25. Use of Statistics to Establish a Stability Trend: Matrixing
Earl Nordbrock

26. Setting Specifications for Drug Substances
Jon V. Beaman

27. Setting Specifications for Drug Products
Abbie Gentry

28. Highlights of Investigating Out-of-Specifications Test Results
Saji Thomas, Kim Huynh-Ba

29. Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs
Eda Ross Montgomery

30. Building and Developing of Relationships with Third Party Laboratories
Rob Aitchison

31. Outsourcing Stability Testing: A Tool for Resource and Risk Management
Michael D. Barron

Avainsanat: Biomedicine, Pharmacology/Toxicology