Bicalutamide having Long Half Life [Design Issues]

posted by udayk – India, 2019-10-04 10:06  – Posting: # 20664
Views: 311

Dear All,

We need clarification on study design of BE of Bicalutamide 50mg tablets since, its long half life is around 150 hours and most of the available literatures have shown as parallel BE study with last time point as 672 hours and two-way cross over study with last time point as 672 hours.

Please suggest on study design of BE/BA study with Time-points to cover the AUC.

Regards,
Udaya Kumar K.
Biostatistician

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,897 posts in 4,215 threads, 1,366 registered users;
online 11 (0 registered, 11 guests [including 11 identified bots]).
Forum time (Europe/Vienna): 23:59 UTC

A mathematician is a blind man
in a dark room looking for a black cat
which isn’t there.    attributed to Charles Darwin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5