ABSTRACT
A key aspect of any new drug product is its safety and efficacy as demonstrated in controlled clinical trials. The time and expense associated with such trials make them unsuitable as routine quality control methods to reestablish comparability in quality and performance following a change in formulation or method of manufacture. Therefore, in vitro and in vivo surrogate tests are often used to assure that product quality and performance are maintained over time. In addition, an appropriate in vitro dissolution test is used as a market release test to assure batch-to-batch consistency for product performance. The focus of this chapter is the application of in vitro release approaches in the documentation of performance of semisolid dosage forms.
