Comparability Considerations and Challenges for Expedited Development Programs for Biological Products

Comparability Considerations and Challenges for Expedited Development Programs for Biological Products

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...

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Bibliographic Details
Main Authors: Sarah J. Schrieber, Wendy S. Putnam, Edwin Chiu Yuen Chow, Jacek Cieslak, Yanli Zhuang, Steven W. Martin, Paul Hanson, Frank Maggio, Leslie A. Rivera Rosado
Format: Article
Language:English
Published: Adis, Springer Healthcare 2020-09-01
Series:Drugs in R&D
Online Access:https://doi.org/10.1007/s40268-020-00321-4

Internet

https://doi.org/10.1007/s40268-020-00321-4

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