1×2 ≠ 2×1 [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2019-12-14 01:42 (2015 d 04:32 ago) – Posting: # 20974
Views: 5,146

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,676 registered users;
41 visitors (0 registered, 41 guests [including 9 identified bots]).
Forum time: 07:15 CEST (Europe/Vienna)

Complex, statistically improbable things are by their nature
more difficult to explain than
simple, statistically probable things.    Richard Dawkins

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