1. Regulatory Guidelines on Stability Testing and Trending of Requirements
Dilip Kumar Singh, Saranjit Singh, and Sanjay Bajaj
2. The Stability Dossier: Common Deficiencies and Ways to Improve
Paul Marshall
3. In Silico Drug Degradation Prediction
Mohammed A. Ali, Rachel Hemingway, and Martin A. Ott
4. Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach
Markus Zimmer
5. A Model Approach for Developing Stability-Indicating Analytical Methods Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, and Koen Vanhoutte
6. Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities
Steven Hostyn, Peter Persich, Shalu Jhajra, and Koen Vanhoutte
7. Stability Studies: Facility and Systems
Ashish Gogia and Sumathi V. Rao
8. User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity
Susan Cleary, Parsa Famili, and Pedro Jorge
9. Stability Considerations in the Life Cycle of Generic Products
Sanjay Bajaj, Srinivasan Rajamani, and Mona Gogia
10. Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies
Helen Williams
11. Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life
Suresh Kumar BV, Priyanka Kulshrestha, and Sandeep Shiromani
12. Estimation of Stability Based on Monitoring of Shipment and Storage
Manuel Zahn
13. Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products
Kamla Pathak and Satyanarayan Pattnaik
14. Stability Testing Issues and Test Parameters for Herbal Medicinal Products
Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, and Rahul Singh Negi
15. Stability Testing Considerations for Biologicals and Biotechnology Products
Christine P. Chan
