Dieselpunk [RSABE / ABEL]

posted by Astea – Russia, 2020-12-02 15:28 (242 d 05:59 ago) – Posting: # 22104
Views: 1,907

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"

Complete thread:

 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Sunday 22:28 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz