Best Practices for Drug Substance Stress and Stability Studies During Early Stage Development. Part III—How to Make Science- and Risk-based Stability Testing Decisions for Drug Substance Batches Produced after Manufacturing Process Changes
Titel:
Best Practices for Drug Substance Stress and Stability Studies During Early Stage Development. Part III—How to Make Science- and Risk-based Stability Testing Decisions for Drug Substance Batches Produced after Manufacturing Process Changes
Auteur:
Li, Q. Chan Qiu, Fenghe McWilliams, Will Pape, Cheryl Song, Jinhua J. Swanek, Frank Wang, Xiao-jun Cohen, Kenneth O’Connor, Dennis