In this episode, I discuss the 2022 FDA guidance on food effect studies. I discuss the timing of these studies in your development programs, various aspects of study design, and some unique exceptions to the standard food effect study.
Links discussed in the show:
• Here’s the current FDA guidance for food effect studies
• You can connect with me on LinkedIn and send me a message
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In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission requirements for population PK models. Links…
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