Improving preclinical assays to enhance the prediction of the in vivo behavior of oral drug products

To reliably predict human dose and pharmacokinetics of oral drugs as well as to assess the feasibility of product development for novel drug candidates, accurate measurements of intestinal drug solubility and permeability are urgently needed in preclinical development. This project aims to improve preclinical assays used for predicting the performance of oral drug compounds and products. For this purpose, the project will focus on the design, validation and implementation of optimized tools for solubility and permeability measurements in biorelevant conditions. This shall be achieved through the following work packages: (1) Improved understanding of the differences in drug solubility in simulated, animal and human intestinal fluids, (2) Design of species-relevant media for solubility and permeability determinations, (3) Development of preclinical tools to measure permeability of BCS IV compounds, and (4) Combined dissolution/permeability experiments to study formulation performance.