Typos… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-03-20 17:32 (708 d 21:08 ago) – Posting: # 22848
Views: 1,299

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.

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