OSD

In vitro release testing (IVRT) has increasingly garnered attention and weight in product development in recent years. It is also being harnessed in the regulatory assessment of complex drug products, such as nanoemulsions, suspensions, multivesicular liposomes and microspheres. A key reason for this is that IVRT provides valuable information about the quality and performance of drug products, and of semisolid dosage forms in particular.

In this white paper, we will explore the development of appropriate IVRT methods for the product sponsor and the results of the testing.

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