Dieselpunk [RSABE / ABEL]

posted by Astea – Russia, 2020-12-02 16:28 (732 d 23:21 ago) – Posting: # 22104
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Dear Helmut!

Thank you for the explanation!

❝ Here you err. In (a) all is good. In (b) everything is in a flux; the applicant and agency agree only that the acceptable risk may be either 20% or 25%.


I just meant to say that the acceptable risk of either 20% or 25% is anyway less or equal to 25%.

❝ Oops, one more degree of freedom! In the 2-sequence 4-period replicate design we have df = 3n – 4 for the pooled CVw. Following the EMA’s model for the estimation of CVwR we have one factor (the treatment) less in the model and therefore, df = 3n – 3:


How does this df correspond to the residual df of ANOVA for getting CVWR? I thought that there should be only
40-2=38 degrees of freedom - because from the point of view of the reference drug the full replicate turns to standart 2-way, is it right?

"Being in minority, even a minority of one, did not make you mad"

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