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

posted by Helmut Homepage – Vienna, Austria, 2024-05-04 00:25 (45 d 17:41 ago) – Posting: # 23983
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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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