Fluticasone propionate / Salmeterol xinafoate inhalers [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2014-08-22 23:49 (4330 d 00:34 ago) – Posting: # 13422
Views: 4,751

Hi all,

new paper published about the US Fp/Sx conundrum.

It isn't difficult to conduct any of the individual trials suggested by the draft guidance, but showing equivalence in all of them is very demanding in terms of sample sizes. Especially when no good IVIVC predictor method exists.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,571 registered users;
356 visitors (0 registered, 356 guests [including 37 identified bots]).
Forum time: 00:24 CEST (Europe/Vienna)

It requires a very unusual mind
to undertake the analysis of the obvious.    Alfred North Whitehead

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