Development and Approval of Inhaled Respiratory Drugs: A US Regulatory Science Perspective

Abstract

This chapter focuses on the regulatory science aspects of the postdiscovery development and approval of the inhaled respiratory drug products intended for local action. It provides a brief treatise of the CMC, in vitro and in vivo evaluations for development and approval of inhalation aerosols in the US. In addition, it includes a brief discussion on scientific considerations related to potential extendedrelease inhalation drug products. Regulatory paradigms for approval of generic inhalation drug products are also discussed. © Controlled Release Society 2011.