Huynh-Ba, Kim
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
- Author(s)
- Huynh-Ba, Kim
- Publisher
- Springer
- Publication year
- 2009
- Language
- en
- Edition
- 1
- Category
- Medicine, Health Care, Mode
- Format
- Ebook
- eISBN (PDF)
- 9780387856278