## Typos… [Regulatives / Guidelines]

Hi Shata,

» So, correction for potency is no longer described in Canadian guidelines?

Yep, gone with the wind. Somewhat surprising because even the EMA accepts a potency-correction if you provide evidence that it was not possible to obtain a reference which differs ≤ 5% from the test.

» Thank you for the provided references, but I need data to validate potency correction equations.

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 (Cmax, 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.

Dif-tor heh smusma 🖖
Helmut Schütz

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