Overview: Clinical Pharmacology Considerations for Food Effect Studies
2.4 هزار بار بازدید -
پارسال
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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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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
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...
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2022 Playlist - 2022 CDER Small Business and Industry...
SBIA LinkedIn - LinkedIn: cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - Twitter: FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
پارسال
در تاریخ 1402/04/16 منتشر شده
است.
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