Steady state BE study dosing [Design Issues]

posted by NK – India, 2024-01-19 05:24 (44 d 21:51 ago) – Posting: # 23832
Views: 926

Dear All,

We are planning a steady state bioequivalence study on healthy subject with tid dosing (every 8 hours) on day 1 to day 4. Serial PK blood sample collections are planned on Day 5 after morning dosing(expected to reach steady state concentration on day 5).

Kindly clarify, whether 2nd and 3rd dose on day 5 need to be administered or not? and sampling should be continued for 24 hours?

Thanks in advance!

Regards
NK


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,919 posts in 4,807 threads, 1,643 registered users;
34 visitors (0 registered, 34 guests [including 5 identified bots]).
Forum time: 03:16 CET (Europe/Vienna)

The analysis of variance is not a mathematical theorem,
but rather a convenient method of arranging the arithmetic.    R.A. Fisher

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