Setting Up Your Small Molecule for Success: Formulation, PBPK Modeling and Regulatory Strategies in Early Clinical Trials
Summary: This webinar focuses on the key considerations for transitioning small molecules from preclinical through clinical development. Experts discuss the technological aspects of drug development and describe practical approaches to improve bioavailability of poorly soluble drugs.
In addition, the speakers discuss the ways physiologically-based pharmacokinetic (PBPK) models are used to predict the pharmacokinetics (PK) of drugs in various human populations to support clinical trial design. A review of key regulatory and guideline requirements for early clinical research is also presented.