Author: [AUTHOR] Published on 8/9/2024 12:00:00 AM
FDA Announces Availability of a Final Guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On July 18, 2024, the US Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies, replacing the May 2022 draft guidance on this topic. This final 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.
A human radiolabeled mass balance study is a direct method to obtain quantitative information on the absorption, distribution, metabolism, and excretion of the drug in the human body. Data from such studies can help to:
- Provide information on which metabolites should be structurally characterized and which metabolites should undergo nonclinical safety assessment or drug-drug interaction (DDI) evaluation
- Assess whether renal or hepatic impairment studies or certain DDI studies are recommended for the investigational drug
- Assess the extent of absorption of the investigational drug
Please refer to the final guidance for more details.
The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below select Clinical Pharmacology Corner under Drugs.
We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.
This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
Subscribe Now
