Bioequivalence and Bioavailability Forum

Hello,

Regarding the new draft guidance on acyclovir ointment I have performed an IVRT test to compare the test and reference formulations. I used a Hanson system similar to the ones used for acyclovir creams.

During the validation of the test system, I applied the described parameters on draft guidance for acyclovir cream, namely, IVRT Discrimination Sensitivity, Specificity and Selectivity.

When comparing the lower (2.5%) and upper (7.5%) release rates to the 5% acyclovir ointment (PEG basis), the release rates were nor discriminatory.

As anyone performed this test, what results were obtained and what is the suggested reason for no discriminatory results. What is the impact?

Kind Regards

MeggieSantos