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

✍ Scribed by Q. Chan Li,Fenghe Qiu,Will McWilliams…

• Book ID: 126364637
• Publisher: Springer US
• Year: 2013
• Tongue: English
• Weight: 243 KB
• Volume: 8
• Category: Article
• ISSN: 1872-5120
• DOI: 10.1007/s12247-013-9163-0