Head of Early Development Biopharmacy Sanofi Cambridge, Massachusetts
The second presentation can provide an overview of the non-compendial in-vivo predictive tools used in early drug product development where there is limited API availability and pre-clinical understanding. Based on the API physicochemical properties, what are the risks and proper tools to understand them earlier in the development?
Learning Objectives:
upon completion, participants will learn the value of the merging in vitro tools and simulations for excipient selection
Participants will learn about the setup for in vitro precipitation models
Paricipants will learn how flexible the precipitation model to select formulation components