Reversed procedure? [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-07-04 11:50 (808 d 06:33 ago) – Posting: # 19018
Views: 28,796

Thank you Lampshade! :-D LMAO at the to watch the movie!

Very comforting that you see it this way too. And I found a precedent where the CHMP ruled on this very issue during an arbitration hearing, though the initial application was 10a and shouldn't have been eligible, or needed, to use the BCS biowaiver option.

I'd love to go to Prague. Love it the first time I went. I'd noticed that Henrike Potthast would be there and worked on ICH M9, with Jan Welink from the EU side. Might be able to convince someone around here that it's worth attending! Thanks again, Helmut.

Complete thread:

 Admin contact
21,068 posts in 4,392 threads, 1,465 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time: Saturday 18:24 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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