Comparability Considerations and Challenges for Expedited Development Programs for Biological Products

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 chemistry,...

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Detalles Bibliográficos
Autores principales: Schrieber, Sarah J., Putnam, Wendy S., Chow, Edwin Chiu Yuen, Cieslak, Jacek, Zhuang, Yanli, Martin, Steven W., Hanson, Paul, Maggio, Frank, Rosado, Leslie A. Rivera
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Current Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691403/
https://www.ncbi.nlm.nih.gov/pubmed/32914381
http://dx.doi.org/10.1007/s40268-020-00321-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691403/
https://www.ncbi.nlm.nih.gov/pubmed/32914381
http://dx.doi.org/10.1007/s40268-020-00321-4

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