Multiple dose design Sample size [Power / Sample Size]

posted by Researcher101 – Egypt, 2020-10-14 10:21 (210 d 18:59 ago) – Posting: # 21997
Views: 832

Dears, I just wanna know if Steadystate Cmax intrasubject variability will be considered in sample size calculations of multiple dose BE? or just Cmax of single dose?

Also is it in the safe side to estimate sample size based on Cmax single dose not multiple dose?

Edit: Category changed; see also this post #1[Helmut]

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