Bioequivalence and Bioavailability Forum

❝ Well, the formula given in Health Canada’s old guidance(s) is correct. In the example instead of \(\small{0.0360}\) plug in \(\small{\log_{e}\tfrac{Potency_\textrm{ R}}{Potency_{\,\textrm{ T}}}}\).

❝ Alternatively, multiply all dose-related PK metrics (C_max, AUC) of \(\small{\textrm{T}}\) with \(\small{Potency_\textrm{ R}}\) and the ones of \(\small{\textrm{R}}\) with \(\small{Potency_\textrm{ T}}\). Perform the comparison with the corrected values and you should obtain the same result than with the correction formula.

Thank you. I performed this step for a balanced design and the results were similar.

It is also applicable for unbalanced design, right?

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Edit: Standard quotes restored; see also this post #8. [Helmut]