ABSTRACT
Drug release can be tested either in vivo or in vitro. If in vitro methods are ''verified'' by in vivo data, they may be used as surrogates for clinical trials. This so-called in vivo verification of in vitro specifications is necessary to interpret dissolution profiles obtained from investigations in any stage of a drug product's lifecycle. From the early phase of technological development through scaling-up procedures to the pharmaceutical quality control of marketed batches at the time of release and the end of shelf life, meaningful in vitro data are mandatory to evaluate possible changes or differences in drug release in the context of drug product safety and efficacy.
