Bioequivalence and Bioavailability Forum

My observations… [Study Assessment]

posted by Helmut – Vienna, Austria, 2021-08-24 13:32 (975 d 00:06 ago) – Posting: # 22537
Views: 2,565

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:

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

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Helmut Schütz

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Complete thread:

What is most common reason of failure of BE study? akif 2021-08-24 09:42 [Study Assessment]
- My observations…Helmut 2021-08-24 11:32
  - My observations… akif 2021-08-24 13:59
    - Inveterate optimists… Helmut 2021-08-24 14:21
  - My observations… Ohlbe 2021-08-24 15:47
- What is most common reason of failure of BE study? ElMaestro 2021-08-24 12:27
  - What is most common reason of failure of BE study? akif 2021-08-24 14:03
    - The Man in the Armani suit Ohlbe 2021-08-24 15:41
  - Management… Helmut 2021-08-24 14:07

My observations… [Study As­sess­ment]

Complete thread:

My observations… [Study Assessment]