My observations… [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-08-24 13:32 (947 d 23:34 ago) – Posting: # 22537
Views: 2,450

Merhaba akif,

❝ Is there any study that evaluate statistically failed BE studies?


Not that I recall. Sponsors don’t publish failed studies and – if at all – submit them to agencies. For the only review I know, see this post.

❝ I wonder what is the most common cause(s) of unsuccessful BE studies. Can some one who have experience about unsuccessful BE study share here? what was the cause for failure?


My personal ranking:
  1. Overly optimistic assumptions about the T/R-ratio leading to a too small sample size.
  2. Assuming a unrealistically low CV.
  3. Design issues (too short washout, metabolite instead of parent drug,…).

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
22,957 posts in 4,819 threads, 1,636 registered users;
120 visitors (0 registered, 120 guests [including 10 identified bots]).
Forum time: 12:06 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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