MaggieSantos
☆    

Portugal,
2018-07-03 20:41
(2095 d 03:26 ago)

Posting: # 19015
Views: 1,181
 

 Topical Drugs- IVRT [Regulatives / Guidelines]

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Regarding the new draft guidance on acyclovir ointment I have performed an IVRT test to compare the test and reference formulations.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During the validation of the test system, I applied the described parameters on draft guidance for acyclovir cream, namely, IVRT Discrimination Sensitivity, Specificity and Selectivity.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?:confused:

Kind Regards

MeggieSantos
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
67 visitors (0 registered, 67 guests [including 11 identified bots]).
Forum time: 23:07 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5