Opportunities and challenges for applying model‐informed drug development approaches to gene therapies
Abstract As part of the US Food and Drug Administration (FDA)'s Prescription Drug User Fee Act (PDUFA) VI commitments, the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are conducting a model‐informed drug development (MIDD) pilot program...
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| Main Authors: | , , , |
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| Format: | Book |
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Wiley,
2021-04-01T00:00:00Z.
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Internet
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A1234.567 |
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