Bioequivalence and Bioavailability Forum • My record: ≈400

My record: ≈400 [Design Issues]

posted by Helmut – Vienna, Austria, 2024-05-03 16:19 (774 d 12:46 ago) – Posting: # 23980
Views: 8,550

Hi Achievwin,

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

❝ wow for a full replicate N=400 the sponsor has deep pockets…

Nope. ≈400 (parallel), 180 4-period full replicate¹ but there are even larger ones (252 subjects started, 238 completers).² If your drug is a blockbuster¹ and you have to change the formulation, you would do it.

U.S. National Library of Medicine [2014-05-19] – Identifier NCT01290757
Davit BM, Patel DT. Bioequivalence of Highly Variable Drugs. In: Yu LX, Li BV, editors. FDA Bioequivalence Standards. New York: aapspress/Springer; 2014. p. 151–2.

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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: ≈400Helmut 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-ratio Helmut 2024-05-08 16:18
        n=180 4-period full replicate Achievwin 2024-05-17 13:45