Overview: Clinical Pharmacology Considerations for Food Effect Studies

FDA discusses the 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; and other considerations related to assessing the effect of food on a drug.
Timestamps
01:22 - Clinical Pharmacology Considerations for Food Effect Studies: An Overview of the FDA Food Effect Guidance
35:22 - Q&A Discussion Panel
Speaker:
Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review
Division of Infectious Disease Pharmacology
Office of Clinical Pharmacology | CDER | FDA
Panelists:
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
Learn more at: www.fda.gov/dr...
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