GMP Pre-Conference Workshop

Title: First in Human (FIH) Dose Selection: from Basic Concepts to Novel Considerations
Date/Time: Tuesday, October 17, 2023, from 9:30 am – 6:00 pm
Presenter: François Bouzom, Director, Simulations Studies will present as part of the workshop from 11:30 am – 12:10 pm on PBPK for FIH
First-in-Human (FIH) Dose Selection is a key consideration in the drug development of new promising drug candidates. Such estimation involving cross-functional expertise and collaborations is essential for the design of efficient and successful Phase 1 clinical trials. FIH dose is based on the Regulatory requirements and the concept and strategy differ depending on drug modality, from small molecules to innovative biotherapeutics.

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