Any opinions on whether there is any use in calculate dose normalisation on Cmax (Cmax/ dose given) between various formulations and doses given of the same drug? Such calculations with the same formulations are useful for linearity, but what can they add when comparing different formulations?
Such calculations can also be assessed for statistical significant differences.
Clinical or regulatory implications?
Hi,
When comparing the PK between 2 formulations, I suppose the equivalend if not equal doses/quantities are put in the 2 formulations to evaluate the relative BA. Thereofre, there is no sense to dose normalise any PK parameter when comparing 2 formulations.
In case you do not have the same doses/quantities in different formulations your stat analysis should be performed on PK parameters devided to dose in order to bring equivalent PK measurements and to have only one variable to compare, i;e. the formulation. An other option will be to include in the stat model ANOVA a factor of dose.
Do not hesiatet to contact me if needed.
Narine
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