Methods for Stability Testing of Pharmaceuticals

Front Matter ....Pages i-xiv
 Regulatory Guidelines on Stability Testing and Trending of Requirements  (Dilip Kumar Singh, Saranjit Singh, Sanjay Bajaj)....Pages 1-30
 The Stability Dossier: Common Deficiencies and Ways to Improve  (Paul Marshall)....Pages 31-51
 In Silico Drug Degradation Prediction  (Mohammed A. Ali, Rachel Hemingway, Martin A. Ott)....Pages 53-73
 Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach  (Markus Zimmer)....Pages 75-98
 A Model Approach for Developing Stability-Indicating Analytical Methods  (Peter Persich, Mario Hellings, Shalu Jhajra, Pradeep Phalke, Koen Vanhoutte)....Pages 99-121
 Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities  (Steven Hostyn, Peter Persich, Shalu Jhajra, Koen Vanhoutte)....Pages 123-141
 Stability Studies: Facility and Systems  (Ashish Gogia, Sumathi V. Rao)....Pages 143-174
 User Requirements and Implementation of a Risk-Based, Compliant Stability Management System  (Susan Cleary, Parsa Famili, Pedro Jorge)....Pages 175-193
 Stability Considerations in the Life Cycle of Generic Products  (Sanjay Bajaj, Srinivasan Rajamani, Mona Gogia)....Pages 195-212
 Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies  (Helen Williams)....Pages 213-232
 Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life  (B. V. Suresh Kumar, Priyank Kulshrestha, Sandeep Shiromani)....Pages 233-260
 Estimation of Stability Based on Monitoring of Shipment and Storage  (Manuel Zahn)....Pages 261-292
 Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products  (Kamla Pathak, Satyanarayan Pattnaik)....Pages 293-305
 Stability Testing Issues and Test Parameters for Herbal Medicinal Products  (Gulshan Bansal, Jasmeen Kaur, Nancy Suthar, Sarabjeet Kaur, Rahul Singh Negi)....Pages 307-333
 Stability Testing Considerations for Biologicals and Biotechnology Products  (Christine P. Chan)....Pages 335-347
Back Matter ....Pages 349-358