Science vs. regulations [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-03-06 14:30 (2993 d 07:44 ago) – Posting: # 10161
Views: 19,101

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 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,462 posts in 4,487 threads, 1,514 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Sunday 23:14 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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