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RegisterTypos… [Regulatives / Guidelines]
» 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]
» 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]
Complete thread:
- Corrections for Potency Shatha 2022-03-20 14:51 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Typos… Helmut 2022-03-20 15:08
- Typos… Shatha 2022-03-20 15:57
- Typos… Helmut 2022-03-20 16:32
- Typos…Shatha 2022-03-21 10:02
- Typos… Helmut 2022-03-20 16:32
- Typos… Shatha 2022-03-20 16:03
- Wrong formula for CV Helmut 2022-03-20 16:57
- Typos… Shatha 2022-03-20 15:57
- Typos… Helmut 2022-03-20 15:08
Ing. Helmut Schütz