ABSTRACT

The discovery and development of a new chemical entity (NCE) requires the testing of its biological activity at various stages of development. For systemically acting drugs, animal studies are carried out at early stages of development using parenteral administration of a solubilized form of the drug. As drug development proceeds to later stages, human clinical studies are preferred with an orally administered dosage form that is both simple to formulate and provides adequate bioavailability. Preferred drug product (DP) dosage form choices are determined based on the drug substance’s (DS) physicochemical properties, patient and disease state preferences, manufacturability, and commercial potential. An oral tablet dosage form is usually the most preferred, unless there are signi­cant obstacles to its successful development.