Rules acc. to Health Canada [Outliers]
Hi Hötzi,
I am inclined to just write what the guideline says. Cross fingers, light 15 candles and say a lot of Ave Marias. Always works.
I am delighted I am not having the responsibility for taking the decision about pivotal design and sample size given that info
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.

❝ 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

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.


—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Rules acc. to Health Canada Helmut 2019-02-05 15:04 [Outliers]
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health CanadaElMaestro 2019-02-05 17:33
- Rules acc. to Health Canada Helmut 2019-02-05 16:24
- Rules acc. to Health Canada Ohlbe 2019-02-05 15:54
- Rules acc. to Health Canada Helmut 2019-02-05 17:52
- for either the test or reference product? mittyri 2019-02-05 15:58
- Discordant outliers Helmut 2019-02-05 17:42
- Rules acc. to Health Canada Shuanghe 2019-02-06 11:48
- Rules acc. to Health Canada ElMaestro 2019-02-06 12:20
- Rules acc. to Health Canada zizou 2019-02-06 20:52
- Great post! Helmut 2019-02-07 10:37
- Rules acc. to Health Canada ElMaestro 2019-02-05 15:30