oral powder with water acceptable? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2018-04-19 18:30 (1328 d 02:16 ago) – Posting: # 18701
Views: 2,804

Hi again,

» Excuse me, but being a newbie, I need some translations:

I apologise, sometimes I write stuff that isn't very clear.

» » Perhaps I would approach the friendly people in Sweden, mention SE as RMS and AT+DE as CMS and see if they (SE) are lenient on you.
» approach = "scientific advise"?
» lenient = "accept our results as BE"? or "give us the marketing authorisation if we pass BE with water in an additional study"?

Yes something along those lines. You can never know when regulators throw a curve ball, but sometimes they take an interest in the product and will help you forward. But they don't do that in all countries.

» What might be the outcome of that?
» There seem to be sufficient samples around tmax (10, 20, 30min, every 15min til 2h, every 30min til 4h, ...)

I don't know what the outcome is. But if the outcome is suggestive of equivalence then perhaps this is the kind of thing that will make regulators be gentle to you. We are way out of the book here, and that is why you need the advice.

Pass or fail!

Complete thread:

 Admin contact
21,788 posts in 4,557 threads, 1,548 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Tuesday 19:46 CET (Europe/Vienna)

A big computer, a complex algorithm and a long time
does not equal science.    Robert Gentleman

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