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]

Complete thread:

UA Flag
 Admin contact
22,074 posts in 4,629 threads, 1,565 registered users;
online 9 (0 registered, 9 guests [including 8 identified bots]).
Forum time: Monday 20:29 CEST (Europe/Vienna)

Rules are for the guidance of wise men
and the blind obedience of fools.    attributed to Solon

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