The science and regulatory perspectives of pharmaceutical suspensions

Abstract

This chapter details the requirements of the U.S. Food and Drug Administration pertaining to suspension drug products. Extensive information is provided on nomenclature, regulatory filing requirements for new drug applications and abbreviated new drug applications, as well as postapproval changes and supplements. The global move to the common technical document format is also discussed. Finally, the authors present an overview of how quality by design principles can be effectively applied to suspension drug product technology.