What are Biorelevant Media?

Biorelevant Media (such as FaSSIF and FeSSIF) are analytical laboratory test solutions that simulate gastrointestinal fluids in both fasted and fed states. They have the same physiological components and properties (bile secretions, salts and pH) as the actual fluids they simulate. Developers can perform simple Biorelevant dissolution experiments in vitro to identify if these media are discriminatory. These tests can also reveal how a formulated drug will dissolve in vivo with time. 

How can Biorelevant Media help develop generic drugs?

Comparing in vitro dissolution profiles of a Test Formulation against the Reference in Biorelevant Media will reveal how similar drug release and dissolution rates will be in vivo. Matching dissolution profiles in the appropriate Biorelevant Media will help identify which Test Formulation will be bioequivalent to the Reference (so share the same release and absorption profiles).

When is it best to test generic drugs in Biorelevant Media?

Biorelevant tests are most beneficial if carried out before you evaluate your Test Formulation in human clinical bioequivalence studies (BE). This enables adjustments to be made to make your Test Formulation bioequivalent to the Reference before spending money on human trials.

Download our Biorelevant Dissolution guides here.