One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of the biological and pharmacologic phenomena which determine in vivo PK in animals and humans. Consequently, PBPK models are well-posed to make robust predictions of in vivo PK exposures, even when based on the limited data available during the initial stages of drug development. As such, PBPK approaches are being increasingly employed to strengthen the FIH dose rationale.
Other applications of PBPK in early development include guiding early formulation development and facilitating lead candidate selection. This eChalkTalk will focus on how PBPK modeling can be applied during early drug development with a particular focus on optimal FIH candidate and dose selection, thereby enhancing the odds of a successful IND and subsequent clinical development.
In this webinar you will learn about:
- Basic PBPK concepts
- Paradigms for applying PBPK to FIH dose selection
- Other potential applications for PBPK in the discovery and pre-clinical phases of drug development