Issue Date: September 26, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
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: Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Guidance Snapshot Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Podcast Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies: Podcast Transcript
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