Rules acc. to Health Canada [Outliers]

posted by ElMaestro  – Denmark, 2019-02-05 18:33 (1989 d 07:22 ago) – Posting: # 19873
Views: 7,854

Hi Hötzi,

❝ Shall I cross fingers?

I am inclined to just write what the guideline says. Cross fingers, light 15 candles and say a lot of Ave Marias. Always works.

❝ But that’s the point! This one subject drives the PE to 110% and with a CV of ~50% I end up with ~200 subjects in a 2×2. OK, for HC (and even for the EMA cause it’s a MR) I could apply reference-scaling. 28 subjects in a 2×4. Fine, but the pivotal is a little bit tricky (5 arms already, don’t ask me why). Hence, I don’t want to go there.

I am delighted I am not having the responsibility for taking the decision about pivotal design and sample size given that info :-D

On the rare occasion when I encounter clients who want 5 arms then usually those are innovators who are entering the game of generics or BE and who, one way or another, think bioequivalence is just a very simplified kind of innovator thinking. The attitude to it is quite leaned back. It results in those funny designs which don't correspond to the philosophy of guidelines and where the complications far, far exceed the advantages.
It is God's gift to my blood pressure that I don't get involved in those developments very often.:-):pirate:

Pass or fail!

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