Bioequivalence and Bioavailability Forum

Pharmacokinetics linearity [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-05-28 16:14 (3692 d 01:25 ago) – Posting: # 14867
Views: 4,796

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.

Complete thread:

• Pharmacokinetics linearity pjs 2015-05-20 10:25 [Regulatives / Guidelines] 
  • Pharmacokinetics linearity pjs 2015-05-28 12:26
    • Pharmacokinetics linearity nobody 2015-05-28 13:44
      • Pharmacokinetics linearityElMaestro 2015-05-28 14:14
        • Pharmacokinetics linearity Dr_Dan 2015-05-28 14:32
          • Pharmacokinetics linearity pjs 2015-05-28 14:58
            • Pharmacokinetics linearity nobody 2015-05-28 15:50
              • Pharmacokinetics linearity pjs 2015-05-28 16:11
                • Pharmacokinetics linearity Dr_Dan 2015-05-29 09:03