Preclinical Development – Chemical
2019 PharmSci 360
The design and development of drug products for both oral and non-oral drug candidate compounds requires a thorough understanding of the biopharmaceutics properties of the compound and formulation. Quantitative biopharmaceutics aims to integrate the preclinical (in vitro and in vivo) and eventually the clinical data to facilitate decision making. Industry case studies will be presented to demonstrate how design of preclinical experiments, coupled with the use of modeling and simulation tools, can facilitate translation of preclinical observations to the clinical setting. The case studies will cover both formulation and clinical decisions across the different stages of drug development . Current challenges and opportunities in advancing the field will be discussed.