Bioequivalence and Bioavailability Forum • Steady state BE study dosing

Steady state BE study dosing [Design Issues]

posted by NK – India, 2024-01-19 05:24 (500 d 15:34 ago) – Posting: # 23832
Views: 4,101

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:

Steady state BE study dosingNK 2024-01-19 04:24 [Design Issues]
- Circadian rhythm? Helmut 2024-01-20 12:50
- Steady state BE study dosing dshah 2024-01-22 10:09
  - AUC in steady state Helmut 2024-01-27 22:01
    - AUC in steady state dshah 2024-01-27 22:06
      - AUC in steady state Helmut 2024-01-27 22:16