Pharmacokinetics linearity [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-05-28 16:14 (3542 d 17:07 ago) – Posting: # 14867
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Hi both,

❝ ❝ 3. If Cmax and AUC data are available for the dose 25 mg and 50mg and lndose vs lnAUC pass through 0 can linearity be assumed for 5 mg also?


❝ OMG! General principles of linear regression: Never extrapolate beyond your data range actually measured.


I guess this means never extrapolate, only interpolate? Bioanalysts will yay this proposal :-)

I don't like the "lndose vs lnAUC" thing; it sounds a bit wrong. It must be AUC as function of dose -without logs- that gives a straight line through origo. Anyways, (0,0) is usually the most accurately known point on the entire curve.

Pass or fail!
ElMaestro

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