Revisions of the PSGLs final [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2023-06-23 15:29 (158 d 18:27 ago) – Posting: # 23612
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Hi ElMaestro & all,

❝ ❝ Is this really the intention? The wider the range in tmax, the more easily products will pass. Counterintuitive.

❝ The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?

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

❝ I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, 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).


Final revisons of the PSGLs were published yesterday.Practically all comments/suggestions were  ignored  not accepted. The only relevant change is 80.00–125.00% of the reference’s median (from 80.00–120.00%). Good luck in sampling every five minutes. :thumb down:
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