1×2 ≠ 2×1 [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2019-12-14 00:42 (683 d 11:19 ago) – Posting: # 20974
Views: 2,596

Hi John,

» The design is obviously wrong (due to IR dosing regimen) …

Yep.

» … but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc).

I hope so. Imagine you have capacity-limited elimination. You would partly saturate the enzymes with the 1×2 regimen and see a higher AUC than with 2×1. Hence, the T/R-ratio will be positively biased. In an extreme case the study passes with the wrong design but would have failed with the correct one.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,758 posts in 4,550 threads, 1,545 registered users;
online 4 (0 registered, 4 guests [including 1 identified bots]).
Forum time: Wednesday 13:02 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5