On February 27, 2024, the U.S. Food and Drug Administration's (FDA's) Division of Drug Information will hold a webinar entitled "FDA Drug Topics: Tips to Navigating Drug Interaction Information in the US Prescribing Information." This presentation will provide an overview of the format and content of the drug interaction information contained within the prescribing information (PI) and outline the important regulations that impact labeling development. In addition, recently published FDA drug interaction resources for healthcare providers and the increasing application of physiologically based pharmacokinetic modeling (PBPK) to identify potential drug interactions during drug development will also be discussed.
Learning Objectives:
After completion of this activity, the participant will be able to:
- Identify three key elements that must be included in the Drug Interactions section of the PI
- Distinguish between the type of information that should be included in the Drug Interactions and Clinical Pharmacology sections of the PI
- Locate examples of drugs that interact with cytochrome P450 (CYP) enzymes and transporter systems by searching the FDA resource https://www.fda.gov/CYPandTransporterInteractingDrugs
- Describe the utility of PBPK modeling for identifying potential drug interactions in drug development
Date/Time of the Webinar:
Date: February 27, 2024
Time: 1:00 p.m. – 2:00 p.m. ET
Registration is complimentary; however, you can register by clicking here.
Let us know if you find the information in webinar useful and how you apply it in your daily work.
Happy learning
Best regards
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Rakesh Gollen Ph.D.
Associate Director, Clinical Pharmacology
PTC Therapeutics, NJ
Monroe NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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