## Uchronia [RSABE / ABEL]

Dear Helmut!

Thank you for the prompt answer!

» The problem starts already here. How reliable is Oodendijk’s result? Is it the only one?

The reliability of someone else's data - that is the question (especially when one of the authors says "waouf"

» The crucial point is what we consider a “clinically not relevant $$\small{\Delta}$$”

As far as we (and the Agency) proclaim 25% to be clinically not relevant there is no difference in the rate of the harm for the customer's health independently from the a- or b- approach. For the b-approach he'll just receive not worser drug or doesn't receive it at all.

» Try the function CVCL() in PowerTOST.

I try:

library(PowerTOST) CVCL(CV = 0.3, df = 3*40-4, side ="2-sided")  lower CL  upper CL 0.2646219 0.3466708

As CI is shifted to the right - does it mean that for these initial conditions the probability of the conclusion of HV is higher?
(By the way shouldn't we lower the degrees of freedom for the CV of the reference drug? 3*40-3 should correspond to the common CV of the Test and Reference, shouldn't it?)

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