Developability Assessment Of Small Molecules

Developability assessment or preformulation studies of small molecule is an important part of the drug discovery process leading to selection of New Chemical Entities (NCEs) for clinical studies. These studies include physicochemical and biopharmaceutical characterization, development of suitable formulations, physical form for pharmacokinetic, efficacy and toxicity studies and providing formulation strategy for Phase I clinical studies.

The overall objective of preformulation testing is to gather enough data in order to develop a chemically stable and therapeutically effective drug product that can be commercially produced at large scale.

Download this white paper to gain a better understanding into why we need developability assessment as well as its processes.