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10:32
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FDA-NIH 2024 | D1S05 - Overview of CDER Nonclinical Resources and Guidance for Approaching First...
This presentation provided comprehensive guidance on CDER's nonclinical resources for approaching First-in-Human (FIH) studies in oncology. The session emphasized using ICH S9 as a starting point and highlighted the importance of Good Laboratory Practice standards. Key recommendations included investing in quality GLP toxicology studies ...
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