Comparability Considerations and Challenges for Expedited Development Programs for Biological Products

• Main Authors: Sarah J. Schrieber (Author), Wendy S. Putnam (Author), Edwin Chiu Yuen Chow (Author), Jacek Cieslak (Author), Yanli Zhuang (Author), Steven W. Martin (Author), Paul Hanson (Author), Frank Maggio (Author), Leslie A. Rivera Rosado (Author)
• Format: Book
• Published: Adis, Springer Healthcare, 2020-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes. As expedited development does not lessen the quality expectations, one challenge is providing adequate c...