Virtual
Event Title
Overview: Clinical Pharmacology Considerations for Food Effect Studies
June 15, 2023
Event Title
Overview: Clinical Pharmacology Considerations for Food Effect Studies
- Date:
- June 15, 2023
- Time:
- 1:00 PM - 2:00 PM ET
| Topic & Presentation |
Speakers |
|---|---|
| Overview: Clinical Pharmacology Considerations for Food Effect Studies |
|
| Vikram Arya, Ph.D., FCP |
|
| Q&A Discussion Panel |
Vikram Arya and Brian Booth, Ph.D. Ethan Stier, Ph.D.
|
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ABOUT THIS WEBINAR
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
INTENDED AUDIENCE
- Drug development scientists involved with food effect studies conducted to support regulatory submissions
- Scientists assessing food effect studies submitted as part of regulatory submissions
- Foreign regulators and policy makers