Typos… [Regulatives / Guidelines]

posted by Shatha – 2022-03-21 11:02 (798 d 08:56 ago) – Posting: # 22852
Views: 1,452

❝ 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]

Complete thread:

UA Flag
 Admin contact
23,035 posts in 4,835 threads, 1,645 registered users;
60 visitors (0 registered, 60 guests [including 4 identified bots]).
Forum time: 20:59 CEST (Europe/Vienna)

That which is static and repetitive is boring.
That which is dynamic and random is confusing.
In between lies art.    John Locke

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz