Bioequivalence and Bioavailability Forum • Lousy T/R-ratio

Lousy T/R-ratio [Design Issues]

posted by Helmut – Vienna, Austria, 2024-05-08 18:18 (159 d 13:19 ago) – Posting: # 23993
Views: 2,748

Hi Divyen,

❝ According to me, there is clear requirement to improve T/R ratio from 0.85 to at least 0.9 which can reduce the sample size as well.

I agree, of course, but see above. The company tried, but to no avail. I don’t remember how many times reformulation was done – always followed by a pilot study. It was not possible to do it better…

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Complete thread:

Large sample size in a BE study Achievwin 2024-05-03 13:28 [Design Issues]
- My record: ≈400 Helmut 2024-05-03 13:34
  - My record: ≈400 Achievwin 2024-05-03 13:49
    - My record: ≈400 Helmut 2024-05-03 14:19
  - My record: ≈400 nobody 2024-05-03 18:44
    - n=180 4-period full replicate Helmut 2024-05-03 22:25
      - n=180 4-period full replicate Achievwin 2024-05-06 15:56
        
        HVNTID! mittyri 2024-05-07 07:35
      - n=180 4-period full replicate dshah 2024-05-08 16:11
        
        Lousy T/R-ratioHelmut 2024-05-08 16:18
        n=180 4-period full replicate Achievwin 2024-05-17 13:45