Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Draft Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies." This draft guidance describes the FDA's recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing the study, and reporting results.
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