GMP (Groupe de Metabolisme) et Pharmacocinetique will be hosting a workshop “Chasing Optimum First-In-Human (FIH) dose: A key consideration to design Phase I clinical drug development; case studies for synthetics and biologics modalities on Friday, May 31st at the Espace Diderot, in Paris, France.

Click here to view the full workshop agenda.

Can’t Miss Presentation
Title: Physiologically Based PharmacoKinetics (PBPK) for 1st in Human studies
Presenter: François Bouzom, Director, Simulations Studies at Simulations Plus
Date/Time: Friday, May 31st from 10:00 am – 12:00 pm CEST

The First In Human (FIH) study is a key study in the drug development. The purpose of FIH trials is to evaluate a potential new drug in humans for the first time, to study the human pharmacology, tolerability, and safety.  Consequently, the non-clinical data in PD, PK and toxicology and their translation to human are important basis for planning and designing a FIH study.

Physiologically based pharmacokinetic (PBPK) modeling is routinely used during drug discovery for in-vitro to in-vivo translation and pharmacokinetic modeling in preclinical species. This can lead to the application of verified PBPK models for first-in-human (FIH) pharmacokinetic predictions.

The aim of this session will be to present, first, a consistent cross-industry strategy with integrated decision trees to highlight the value that appropriate use of PBPK modelling can add to FIH predictions for new chemical entities (NCE). Then, case study will be shared to allow the attendees to discuss and work together to anticipate the FIH study based on a non-clinical package.