Houston, we have a problem! [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-11-30 14:42 (236 d 01:04 ago) – Posting: # 22099
Views: 2,233

Dear Osama,

» Thank you for the brilliant explanation.

You are welcome! In the meantime I added more stuff to my post.
If my interpretation of the GL is correct (is it?) and applied as such by members of the GCC, we have a problem if the CVwR observed in the study is ≤30%.

What could be done?
  1. In the EU lots of accepted studies with 75.00–133.33%. Prior to 2001 limits of 70–143% were not uncommon for Cmax. Sometimes even for AUC…
  2. An often overlooked detail. Regularly difficult to provide for generic companies with no access to the originator’s data. Generally just a lot of :blahblah: in the protocol.

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
21,589 posts in 4,512 threads, 1,530 registered users;
online 8 (0 registered, 8 guests [including 6 identified bots]).
Forum time: Saturday 16:47 CEST (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous.    Hannah Arendt

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