Typos… [Regulatives / Guidelines]

posted by Shatha – 2022-03-21 10:02 (56 d 09:27 ago) – Posting: # 22852
Views: 376

» 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.

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

It is also applicable for unbalanced design, right?


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

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