Preliminary simulations [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-05-01 15:56 (15 d 04:55 ago) – Posting: # 22947
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Hi ElMaestro,

» your post is potentially highly significant.

Potentially!

» » Is this really the intention? The wider the range in tmax, the more easily products will pass.
»
» The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?

Right, I don’t get it. I’m afraid, this is one joins the ‘methods’ of the PKWP made up out of thin air.

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.
Stephen Senn. Statistics in Drug Development. Wiley; 2004. p. 386.

‘Common sense’ is not always a good idea. The obvious is most often wrong.

It’s complicated. Like yesterday but this time no shift.

[image]


That’s what I expect.

» I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.

[image]That’s wishful thinking taking the review process into account. Deadline for comments July 31st.

» […] I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).

Yep. ƒ2 is not a statistic (depends on the number of samples and intervals). Given that, no closed form to estimate the location, its CI, power (and hence, the Type I Error) exists because the distribution is unknown. That’s similar to the situation we are facing here.


PS: Du hast Mehl in deiner Mehlkiste.

Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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