BE study design issue [Design Issues]

posted by jag009  – NJ, 2019-12-14 00:26 (1084 d 23:46 ago) – Posting: # 20973
Views: 3,625

Hi everyone,

Question, if one conducted a study comparing ER to an immediate release reference but not following the recommended dosage regimen of the IR. Example, as per product monograph IR is given every 4 hrs and the new ER is given every 8 hrs, but the guy designed the pk study comparing ER vs 2xIR with both give at time 0, The design is obviously wrong (due to IR dosing regimen) but would a regulatory body reject the study (assume the study pass the BE objective which is BE needed only for auc). A pivotal study not pilot.

PS, not me! Doing some due diligence..
Thx
J

Complete thread:

UA Flag
Activity
 Admin contact
22,426 posts in 4,694 threads, 1,600 registered users;
14 visitors (2 registered, 12 guests [including 9 identified bots]).
Forum time: 00:12 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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