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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2020-09-01
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| Series: | Drugs in R&D |
| Online Access: | https://doi.org/10.1007/s40268-020-00321-4 |