ABSTRACT
This chapter discusses the statistical aspects of stability studies, particularly the design and analysis, and to relate the to the US regulatory requirements. In order to determine the length of time that a product remains within specifications, a study is undertaken in which the packaged final product or bulk drug substance is placed into controlled storage for an extended period of time, often years. The design and analysis of a study to set the expiration dating period of a single product in a single packaging is described, with particular emphasis on the rationale for the design and the role of batch-to-batch variation in the decision process. The Food and Drug Administration (FDA) In this chapter, the authors discuss from a regulatory perspective the use of such designs. issues guidances, documents that present the latest opinion of FDA scientific reviewers on some topic.
