Biopharmacy of New Chemical Entities for Oral Route Administration: Contributions of Predictive Tools to Confirm Developpability and Support Proof of Concept Clinical Studies

3/13/2019 09:35 - 10:10

In the early preclinical development pharmaceutical industry, biopharm scientists support project teams at several timepoints in the pre-development and entry in to development stages, helping choosing the right molecule, the right formulation(s) for safety studies and early clinical development, minimizing trails & errors and therefore allowing to keep a fast pace.

In this presentation we will illustrate in particular:

  • The use of Drugability Classification System at precandidate stage
  • How good physicochemical profiling followed by selective drug absorption in Dog studies combined with ACAT & PBPK Dog modelling can allow to refine expectations for a given formulation strategy in Human
  • How dissolution & modelling can provide support during phase I
The presentation will rely on a multi-API analysis to better grasp the presented models strength & limits.