Bioequivalence and Bioavailability Forum

My record: ≈400 [Design Issues]

posted by Helmut  – Vienna, Austria, 2024-05-03 15:34 (373 d 12:08 ago) – Posting: # 23976
Views: 4,341

Hi Achievwin,

❝ I came across a parallel BE study protocol that has around 900 subjects, has anyone seen BE study of this magnitude for a BE study in patients?

Define magnitude.  If you mean hundreds, yes. Multi-center in patients.
BTW, I have seen 4-period full replicate studies with 180 healthy volunteers…

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Large sample size in a BE study Achievwin 2024-05-03 13:28 [Design Issues] 
  • My record: ≈400Helmut 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-ratio Helmut 2024-05-08 16:18
          • n=180 4-period full replicate Achievwin 2024-05-17 13:45