Developability assessment or preformulation studies of small molecule is an important part of 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.

Why Do We Need Developability Assessment?

A systematic approach for developability assessment of early phase molecules is critical to identify properties which pose development risks for late phase development of a molecule. The assessment should ideally be carried out at the earliest stage possible in the drug discovery process to avoid too much efforts on the molecule. A lead molecule selected for clinical development usually poses risk during the development phase in the areas of solubility and stability.

An integrated development and collaboration between various discovery teams namely – Discovery Biology, Chemistry, Pharmacology and Preformulation teams are essential for

  1. Selecting the right NCEs for late-stage development
  2. Decreasing the NCE attrition rate in late-stage development
  3. Bringing down the associated cost and timelines

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