Key Pharmacological Factors in Radiolabeled Mass Balance Research – November 12, 2024

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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar will focus on the recently published final guidance for the industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies, released in July 2024. This document outlines the FDA’s recommendations on conducting radiolabeled mass balance studies for investigational drugs.

Experts from the FDA will share insights on the guidance, including when to conduct these studies and how to properly design and report their outcomes. This session will clarify how findings from mass balance assessments can influence drug development and promote the safe and effective utilization of medications.

INTENDED AUDIENCE

• Pharmaceutical scientists, contract research organization professionals, and consultants focused on drug metabolism, pharmacokinetics, and clinical pharmacology
• Regulatory reviewers and policymakers in related fields

TOPICS COVERED

• Guidance for conducting human radiolabeled mass balance studies
• The timing for mass balance studies
• Key considerations for designing these studies
• How to report results from human radiolabeled mass balance studies

LEARNING OBJECTIVES

• Determine the necessity and timing for conducting mass balance studies
• Illustrate how mass balance findings can impact drug development
• Outline the design process for human radiolabeled mass balance studies
• Review the methodology for reporting study results

SPEAKERS

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

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

PANELISTS

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

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

FDA RESOURCES