For those who participate or support food effect studies a good opportunity to hear FDA perspectives on their guidance.
Date: June 15, 2023 Time:1:00 PM - 2:00 PM ET
Registration link
From the announcement:
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
FDA SPEAKERS
Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review, Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA
Panelists
Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review, Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA
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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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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