Thai FDA [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2012-05-16 15:01 (5153 d 22:13 ago) – Posting: # 8574
Views: 6,729

สวัสดี Boonchai!

❝ Let see announcement number สธ1009.4/ว.11243 from Thai FDA date 13 Sep 2011.


Interesting. If the announcement is available online can you provide us the URL?
  1. Resonable.
  2. Hhm; that’s nitpicking. We plan studies in such a way that we don’t expect carry-over with the minimum washout stated in the protocol. Even if there is a small carry-over it would be even lower for subjects in the group(s) with longer washouts. BE is based on within-subject comparisons – so what?
  3. I wouldn’t call that stupid but consistent. BTW, testing for a group effect is based on a between-subject comparison which has very low statistical power.

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
23,655 posts in 4,993 threads, 1,570 registered users;
347 visitors (0 registered, 347 guests [including 12 identified bots]).
Forum time: 13:15 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

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