Steady state BE study dosing [Design Issues]

posted by NK – India, 2024-01-19 05:24 (87 d 07:24 ago) – Posting: # 23832
Views: 1,335

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
22,983 posts in 4,822 threads, 1,648 registered users;
31 visitors (0 registered, 31 guests [including 6 identified bots]).
Forum time: 13:48 CEST (Europe/Vienna)

Complex, statistically improbable things are by their nature
more difficult to explain than
simple, statistically probable things.    Richard Dawkins

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