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

posted by Achievwin – US, 2024-05-06 17:56 (42 d 22:18 ago) – Posting: # 23990
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❝ ❝ ❝ 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.
:confused::confused::confused:

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