Bioequivalence and Bioavailability Forum

Hi KG, sorry for partially hijacking your thread:

Hi Helmut,

❝ Justification for the lognormal distribution in BE:

❝     (...)

❝     ● Serial dilutions in bioanalytics lead to multiplicative errors.

I can see that diluting X times would lead to the error being multiplied by X, but is this really a proper argument for using the multiplicative model in BE in any way? I can't readily see how it fits in. For simplicity we can consider just Cmax: Since dilution (as in dilution integrity) affects a subset of the samples, any impact on the error will be on just those samples. This would just speak against any parametric method, unless someone can make a parametric bi-modal model, right?

Or perhaps you referred to the plain dilution any sample undergoes during the assay? I still can't see how this fits in the argumentation. Let me please know your thoughts. Especially if there is a potential for simulating something, haha