Stability Programs for Formulation Studies

Abstract

AbstractThe theme of this presentation is based on the premise that, despite the existence of differences in specific stability testing protocols between different types of products of the same manufacturer and between similar products of different manufacturers, it is possible to generalize somewhat and to identify elements common to any stability testing program. In terms of stability testing, a drug product may be viewed as passing through a series of distinct, identifiable stages in its development, which represents a progression of stability testing with product maturation. Within this progression, a range of testing protocols, methods and mathematical models may be utilized with each successive program designed to augment the data base of the product and thereby strengthen and expand the conclusions reached during each preceding phase. Differing types and amounts of information are sought at each stage which are important to the assignment of an expiration date, thus giving rise to widely differing ...