My observations… [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-08-24 11:32 (30 d 23:38 ago) – Posting: # 22537
Views: 652

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 🖖
Helmut Schütz

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