In vitro release testing (IVRT) is an FDA required test used to support post-approval manufacturing changes in compliance with SUPAC-SS requirements. IVRT is used in topical generic drug development as an accepted method of comparison to brand products. During topical drug product development, IVRT may be used to profile the performance characteristics of several prototypes formulations as a screening tool.
Tergus has a large bank of 120+ vertical Franz diffusion cells to support IVRT studies. We have developed specialized testing protocols to meet the needs of clients with challenging APIs. Our team has expertise in the design of discriminatory IVRT methods.