TIE depends on CVwR (and n) [RSABE / ABEL]

posted by pjs – India, 2018-03-01 07:35 (1335 d 21:28 ago) – Posting: # 18488
Views: 8,386

Dear Helmut,

Thanks for the feedback.

Just need some clarification.

For FDA limits are scaled from 0.25 but applied at 0.294 unlike EU in which limits are scaled from 0.294.

Hence at any Swr limits would be more wider for FDA compared to EU. Hence chances of establishing BE would be more for USFDA compared to EU in the nearby CV from cutoff limit of 30%. Considering the same There is more possibility for difference in BE results when applying two different methods Scaling and ABE incase of FDA for study conclusion. Hence alpha inflation should be more for FDA instead of EU. Please correct me if i have misunderstood the concept.

Also incase of EU scaling is applicable for Cmax parameter only and not for AUC parameter in contrary to FDA for which scaling is applicable for all the primary metric. This could also play certain role in the calculation of alpha inflation.


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