ABSTRACT

This chapter examines the issues related to the in vitro characterization of solid oral dosage forms.The importance and utility of in vitro characterization are discussed in relation to the factors in£uencing in vitro drug release, including those intrinsic to the drug substance, the drug product and manufacturing process, and relevant dissolution test methodology. A discussion is also provided on practical issues that may be faced during the conduct and evaluation of in vitro dissolution testing and the application of in vitro drug product performance testing.