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FDA | CDER | Small Business and Industry Assistance (SBIA)
Clinical Pharmacology Considerations for Radiolabeled
Mass Balance Studies
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November 12, 2024 | 11:00 AM - 12:00 PM ET
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This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024. This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs. Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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