Enzalutamide [Design Issues]

posted by pash413 – India, 2015-12-07 14:22 (3353 d 06:34 ago) – Posting: # 15702
Views: 5,775

Dear all
I need help to understand the dose to be administered for enzalutamide 40mg Capsule BE study.
As per recently published OGD recommendation dose is "Strength: 40 mg at a dose of 160 mg (4x40mg", however reported Cmax for for 160 mg is 3.6 µg/mL.

Can we perform study with single capsule administration for studies to be perform other than USFDA submission, because looking at the reported Cmax it will be possible to measure the concentrations with single capsule (40mg Dose).
Note; As per product lable single daily dose is 160 mg (4x 40mg)


Edit: Category changed and guidance linked. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
242 visitors (0 registered, 242 guests [including 14 identified bots]).
Forum time: 20:56 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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