Canada: Sample size for Cmax? [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2012-12-18 19:04 (4118 d 01:15 ago) – Posting: # 9730
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Dear all,

any idea how to estimate sample size for Cmax (PE within 80–125%; no 90% CI)? Nothing is mentioned in the final guidance; the draft stated in Appendix 1 (lines 752–753):

Sample size calculations, based on a standard where only the mean estimate is required to fall within the bioequivalence interval, are not possible.

Don’t agree. It’s easy enough through simulations (i.e., θ0 0.95, CVintra 40%, n 12, power 82.2%). What puzzles me is the lacking consideration of the patient’s risk. With a θ0 at the limits of the acceptance range by definition 50% of studies will pass – independent from CV and sample size.

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Reminds me on this goodie. :-D No wonder that HPB didn’t introduce scaling for Cmax.

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