Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies

  Рет қаралды 480

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

This webinar discussed the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024. FDA subject matter experts addressed 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.
Timestamps
06:58 - Background and Overview
13:20 - Considerations for Designing Mass Balance Studies and Reporting
23:58 - Q&A Discussion Panel
Speakers | Panelists:
Anuradha Ramamoorthy, Ph.D. FCP
Master Scientist & Policy Lead
Guidance & Policy Team
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER | FDA
Zhixia (Grace) Yan Danielsen, Ph.D.
Deputy Director
Division of Infectious Disease Pharmacology
OCP | OTS | CDER | FDA
Suresh Doddapaneni, Ph.D.
Deputy Director
Division of Inflammation and Immune Pharmacology
OCP | OTS | CDER | FDA
Learn more at: www.fda.gov/dr...
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