Why Proactive AME Studies are Critical to Accelerating Your Approval Journey
Conversations in Drug Development Trends
FEBRUARY 21, 2024
While traditionally conducted during Phase 2 or later, the FDA has recently been requesting data sooner in the development process, making it critical to implement proactive AME studies to lay the groundwork for advanced phases of your clinical program. To accomplish this, we pay careful attention to both dosing and sample collection.
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