Overview: Clinical Pharmacology Considerations for Food Effect Studies June 15, 2023

Virtual | Virtual

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• Date: June 15, 2023
• Time: 1:00 PM - 2:00 PM ET

Topic & Presentation	Speakers
Overview: Clinical Pharmacology Considerations for Food Effect Studies
Clinical Pharmacology Considerations for Food Effect Studies: An Overview of the FDA Food Effect Guidance.pdf	Vikram Arya, Ph.D., FCP Associate Director for Therapeutic Review Division of Infectious Disease Pharmacology Office of Clinical Pharmacology | CDER | FDA
Q&A Discussion Panel	Vikram Arya and Brian Booth, Ph.D. Director Division of Cancer Pharmacology I Office of Clinical Pharmacology | CDER | FDA Ethan Stier, Ph.D. Associate Director for Lifecycle Management Immediate Office | Office of Clinical Pharmacology | CDER | FDA

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ABOUT THIS WEBINAR

In this webinar, FDA will discuss:

• Importance of assessing the effect of food on drugs and reasons for issuing the final guidance
• Timing of conducting food effect studies during drug development
• General considerations for designing food effect studies
• Other considerations related to assessing the effect of food on a drug

TOPICS COVERED

• Timing of conducting food effect studies during drug development
• Type of meals to be evaluated
• General considerations for designing food effect studies

LEARNING OBJECTIVES

• Understand the importance of assessing the effect of food on drugs
• Comprehend general considerations for designing food effect studies
• Discuss data analysis considerations related to food effect assessment

INTENDED AUDIENCE

• Drug development scientists involved with food effect studies conducted to support regulatory submissions
• Scientists assessing food effect studies submitted as part of regulatory submissions
• Foreign regulators and policy makers

FDA RESOURCES

• Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations