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GUIDANCE DOCUMENT

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies May 2022

Draft

Not for implementation. Contains non-binding recommendations.

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0113.

 
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