ABSTRACT
Stability testing and ancillary analytical work are undoubtedly the most resourceintensive activities in the chemistry, manufacturing, and controls (CMC) area of drug development. Stability studies are required in the preclinical phase, throughout the clinical trials, in support of regulatory registra-tions, in support of changes to the approved product, and for as long as the product is marketed. Stability data are a key element in assuring the quality of both the active pharmaceutical ingredient (API) and the formulated drug product during all phases of development and marketing.
