Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies." This guidance describes 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.
Abstract as published in the Federal Register.
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