Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 4 August 2022.

This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including: (1) deciding whether and when to conduct the study, (2) designing the study, and (3) reporting results. This guidance does not cover animal mass balance studies, safety testing of drug metabolites, or recommendations for selecting the radioactive dose.

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