SETTING OF BIORELEVANT IN VITRO RELEASE SPECIFICATIONS

BioVista prepares all necessary support work for reporting or filing the in vitro release data.
This comprizes:

	Calculation of the difference factor f1 and/or the similarity factor f2 for dissolution profiles of test and reference different products
	Setting of in vitro release specifications which are based on an IVIVC and thus biorelevant
	Calculation of the in vitro profiles of side batches which are still bioequivalent to the registered product
	Selecting the in vitro release methodology which is most relevant and discriminating with respect to the in vivo performance of the product