oral powder with water acceptable? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2018-04-17 18:23 (2257 d 07:01 ago) – Posting: # 18693
Views: 3,790

❝ Assays are:

❝ test product: 101,2%

❝ reference product: 99,1%

Alter Schwede, this one is difficult.
I think your own idea is viable and that your considerations sound ok, but the whole scenario kind of sucks. Big time.
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.

One last thing: If the abs is "very fast", and I cannot quantitatively define it very well as it also has to do with your sampling regimen, then perhaps you want to try to look into partial AUCs up to around the time of Cmax.

I hope others will chime in with opinions here. This is a great case, actually.

Pass or fail!

Complete thread:

UA Flag
 Admin contact
23,059 posts in 4,841 threads, 1,663 registered users;
33 visitors (0 registered, 33 guests [including 6 identified bots]).
Forum time: 01:25 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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