Dose-dependent PK [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2011-11-02 23:30 (4346 d 22:26 ago) – Posting: # 7590
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Dear ElMaestro!

❝ At least for EU, I guess part of the story is to live with the BE-guideline's requirement "Assessment of linearity will consider whether differences in dose-adjusted AUC meet a criterion of ± 25%." which can be dealt with very simply.

❝ Perhaps your angle is different and that where the complexity comes in? I am eager to hear.

Yes. I’m aiming at a confirmatory study – not the stuff mentioned in the GL (“If you come up with some serious writing about the drug’s PK from the Library of Alexandria – whether it might be on parchment or papyrus – we accept that and you have to perform the study on the highest dose only.”)

❝ […] Cmax etc vs dose being a straight line, I am perfectly willing to call that linearity;

I’m not happy with assessing dose-proportionality based on Cmax. It’s a f**g composite metric.
I prefer AUC by far.

Wikipedia does an excellent job at confusing readers.

Yeah, that’s funny reading matter. Should read the talk-page as well.

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