BE study design issue [Design Issues]

posted by Dr_Dan  – 2019-12-18 15:04 (237 d 22:35 ago) – Posting: # 20992
Views: 1,484

Hi John
if the recommended dosage regimen of the IR as per product monograph IR is to be given every 4 hrs then this means that higher doses have either a safety issue or the dose/effect relationship is in disfavor of higher doses. In this case AUC alone does not matter. Consequently, a regulatory body will reject the study
Hope this helps
KR
Dr_Dan

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
21,006 posts in 4,379 threads, 1,460 registered users;
online 9 (1 registered, 8 guests [including 4 identified bots]).
Forum time: Wednesday 14:40 CEST (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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