Bioequivalence and Bioavailability Forum

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

posted by Achievwin – US, 2024-05-06 17:56 (262 d 16:59 ago) – Posting: # 23990
Views: 3,611

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

High sample size is because it is an NTID and they have to document an additional parameter based on the variance ratios....

In my previous life we did two 3-period replicate design, satisfied guidance on the day we were supposed to submit the ANDA revised guidance was published brought the whole story to the start.

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 replicateAchievwin 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