Bioequivalence and Bioavailability Forum • Pre-Dose sample required to steady state

Pre-Dose sample required to steady state [Regulatives / Guidelines]

posted by Roy – India, 2020-06-12 10:44 (1408 d 02:17 ago) – Posting: # 21529
Views: 1,678

Dear All,

Please Help!!!

Please find Below detail for my question,

Design: two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady state, oral bioequivalence study.

Dosing Day: Day 1 to Day 8.

Blood Sample collection on: Day 4 to Last time Point for both period.

Wash out: 10 Days.

Question:

Pre-dose Blood sample collection for Day1, Day2 and Day3 are required?

Thanks in advance.

Complete thread:

Pre-Dose sample required to steady stateRoy 2020-06-12 08:44
- Achievement of steady state Helmut 2020-06-12 10:17