Docket Number: FDA-2022-D-0113 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
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.
Additional Guidance Resources:
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Content current as of:
09/25/2024
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