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

posted by Roy – India, 2020-06-12 08:44 (714 d 06:42 ago) – Posting: # 21529
Views: 1,202

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.

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