Kailas Thakker, PhD, Co-founder of Tergus

Standardization of In Vitro Release test (IVRT) is a step to achieving consistency in release rate data in a market place where different types of apparatus and techniques are used frequently and continuously.  It is an important next step to ensure consistency and success.

Once some standardization has taken place, scientists and regulators will be able to use a properly developed In Vitro Release test to develop specifications and criteria for release of an API from formulation matrix.

When used in early phase of development to select a clinical candidate, it will allow scientists a better than fair chance of successful performance of that dosage form in clinic. In late phase of development, the specifications and criteria built into the release rate will assure consistency in manufacturing of that dosage form.

When applied to multiple products by the same or different manufactures, properly developed specifications for release rate and adherence thereof will allow better comparisons between dosage forms.