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  4. Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - 11/12/2024
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Virtual | Virtual

Event Title
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
November 12, 2024

Date:
November 12, 2024
Time:
11:00 a.m. - 12:00 p.m. ET

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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024. This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs.

Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study. The presenters will communicate when and how to perform these studies, as well as how the results from the mass balance studies can inform the drug development program and consequently inform the safe and effective use of drugs.

INTENDED AUDIENCE

  • Scientists in pharmaceutical companies, contract research organizations, and consultant firms who work on drug metabolism, pharmacokinetics, and clinical pharmacology
  • Regulatory reviewers and policy makers working in those areas

TOPICS COVERED

  • Recommendations for human radiolabeled mass balance studies
  • Timing of mass balance studies
  • Considerations for designing mass balance studies
  • Reporting of human radiolabeled mass balance study results

LEARNING OBJECTIVES

  • Understand whether and when to conduct human radiolabeled mass balance studies
  • Explain how results from mass balance studies can inform the drug development program
  • Describe how to design the human radiolabeled mass balance studies
  • Review how to report the study results

SPEAKERS

Anuradha Ramamoorthy, Ph.D. FCP
Master Scientist & Policy Lead
Guidance & Policy Team | Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER | FDA

Zhixia (Grace) Yan Danielsen, Ph.D.
Deputy Director
Division of Infectious Disease Pharmacology | OCP | OTS | CDER | FDA

PANELISTS

Suresh Doddapaneni, Ph.D.
Deputy Director
Division of Inflammation and Immune Pharmacology | OCP | OTS | CDER | FDA

Edwin Chow, Ph.D. (formerly of FDA)
Team Leader
Division of Cardiometabolic and Endocrine Pharmacology | OCP | OTS | CDER | FDA

FDA RESOURCES

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