Handbook of Stability Testing in Pharmaceutical Development

1. Introduction
Kim Huynh-Ba

2. Critical Regulatory Requirements for a Stability Program
Alvin J. Melveger, Kim Huynh-Ba

3. Understanding ICH Guidelines Applicable to Stability Testing
Kim Huynh-Ba, Manuel Zahn

4. Global Stability Practices
Manuel Zahn

5. Post-approval Changes – Stability Requirements and Regulations
Frank J. Diana

6. Understanding and Predicting Pharmaceutical Product Shelf-Life
Kenneth C. Waterman

7. Development of Stability Indicating Methods
Anne-Françoise Aubry, Peter Tattersall, Joan Ruan

8. Method Validation and Transfer
Frank J. Diana

9. Overview of USP-NF Requirements for Stability Purposes
Susan Schniepp

10. Non-chromatographic Methods to Support Stability Program
Timothy Rhines

11. Vibrational Spectroscopic Methods for Quantitative Analysis
Frederick H. Long

12. Impact of Solid-State Characteristics to the Physical Stability of Drug Substance and Drug Product
Yushen Guo

13. Evaluation of Stability Data
Nanda Subbarao, Kim Huynh-Ba

14. Qualification, Calibration, and Maintenance of Stability Chambers
Jack B. Davis

15. Stability Operation Practices
Kim Huynh-Ba

16. Combination Products/Drugs in Devices
Jon V. Beaman, Roisin Wallace

17. Stability Studies for Biologics
Anthony Mazzeo, Patrick Carpenter

Keywords: TECHNOLOGY & ENGINEERING / Biomedical TEC059000