Deviating from a guidance [Design Issues]

posted by Pharma_88 – India, 2024-05-21 10:32 (406 d 20:21 ago) – Posting: # 24005
Views: 3,913

Dear Helmut,

Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed?

Regards,
Pharma_88

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,676 registered users;
89 visitors (0 registered, 89 guests [including 9 identified bots]).
Forum time: 06:53 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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