Bioequivalence and Bioavailability Forum • n=180 4-period full replicate

n=180 4-period full replicate [Design Issues]

posted by Helmut – Vienna, Austria, 2024-05-04 00:25 (431 d 16:29 ago) – Posting: # 23983
Views: 5,208

Hi nobody,

❝ ❝ BTW, I have seen 4-period full replicate studies with 180 healthy volunteers…

❝

❝ Photos or it didn't happen. At least intraind CV :-P

Incidentally I know the backstory of #1 of the post above. It was very difficult to develop a new formulation. Pilot studies (plural!) with 80 subjects. No reference-scaling; however, CV was not the main problem. Sample size based on a best-guess T/R-ratio of 0.85. Do the maths.

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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 replicateHelmut 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-ratio Helmut 2024-05-08 16:18
        n=180 4-period full replicate Achievwin 2024-05-17 13:45