GUIDANCE DOCUMENT
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies May 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-0113
- Docket Number:
- FDA-2022-D-0113
- Issued by:
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Guidance Issuing OfficeCenter 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.