Overview: Clinical Pharmacology Considerations for Food Effect Studies

U.S. Food and Drug Administration
U.S. Food and Drug Administration
2.4 هزار بار بازدید - پارسال - FDA discusses the importance of
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: https://www.fda.gov/drugs/news-events...

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پارسال در تاریخ 1402/04/16 منتشر شده است.
2,434 بـار بازدید شده
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