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

posted by Roy – India, 2020-06-12 10:44 (1385 d 16:56 ago) – Posting: # 21529
Views: 1,591

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
70 visitors (0 registered, 70 guests [including 7 identified bots]).
Forum time: 02:40 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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