Science vs. regulations [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-03-06 15:30 (4054 d 20:29 ago) – Posting: # 10161
Views: 24,545

Dear Ratnakar,

EMA’s opinion [sic] that AUCt is a reliable estimate of extent of absorption only if AUCt ≥ 80% of AUC is scientifically questionable if (!) IR formulations are concerned (absorption practically completed at 2–4× tmax). Therefore, we need more information.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,979 posts in 4,821 threads, 1,659 registered users;
25 visitors (0 registered, 25 guests [including 11 identified bots]).
Forum time: 13:00 CEST (Europe/Vienna)

Never, never, never use any software!
Never, never, never trust any computer!    Detlew Labes

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