ABSTRACT

Background During the evolution of a new chemical entity (NCE) from a conceptual molecular structure to the dosage form of an approved active pharmaceutical ingredient (API), a multitude of trials and studies are carefully and systematically undertaken. These studies are necessary to prove that the resulting pharmaceutical product containing the API, when taken appropriately, will be effective and safe. Inherent to these activities and subsequent bulk manufacturing, a series of technology transfers are necessary to prepare the ever-increasing amounts of quality API required to satisfy both research and commercial needs.