Formulation and Quality
2019 PharmSci 360
This presentation will provide an overview of the enabling approaches applied from preliminary in-vivo studies in discovery to human clinical studies, through pre-clinical development. There are several approaches to consider, and at each development step, a combination of several factors including: API availability, purpose of the studies, tiemelines etc., will result in different selections.
Active ingredient properties should be assessed looking to formulation development as early as possible during the discovery step, to best prepare for the transition to pre-clinical, that, for most aspects, is a “scale-up” of magnitude and complexity comparable to that required moving from early clinical phases to the full development Phase III pivotal studies and registration.