In vitro Bioequivalence for suspension ophthalmic [Regulatives / Guidelines]

posted by Weidson – Brazil, 2018-04-09 20:40 (1583 d 01:53 ago) – Posting: # 18658
Views: 1,491

Dear All,

Has anyone in this group ever performed an in vitro bioequivalence study with an ophthalmic suspension that was guided by the Guidance on Dexamethasone / tobramycin (reviewed June 2012, June 2013 and June 2016)? If yes, what is the acceptance criterion for bioequivalence? In the draft nothing is mentioned for the range of acceptance of the mortality rate of the microorganisms.

Thanks vary much.

Complete thread:

UA Flag
 Admin contact
22,289 posts in 4,666 threads, 1,585 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 22:34 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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