Steady state BE study dosing [Design Issues]

posted by NK – India, 2024-01-19 05:24 (88 d 23:03 ago) – Posting: # 23832
Views: 1,339

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!


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

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