nitpicking [PK / PD]

posted by ElMaestro  – Denmark, 2012-03-21 18:32 (4440 d 12:38 ago) – Posting: # 8307
Views: 7,507

Dear HS,


[nitpick]

❝ For Cmax and AUC there’s a consensus that these metrics are lognormal.


No. There is consensus that you have to analyse the data as though they (the residuals) were normal. It does not mean it is assumed that they are. Regulators, some of them at least, know that normality sometimes really, truly isn't the case but they are willing to ignore this at the evaluation stage.

[/nitpick]

Anyways, as usual I have no qualified response to any of the core stuff you have raised in this thread. Have a good day.

Pass or fail!
ElMaestro

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