Regulatory submissions [Design Issues]

posted by rajasekharkakarla – India, 2018-09-14 16:13 (2044 d 09:22 ago) – Posting: # 19288
Views: 3,907

Dear All,

Please let me know the feasibility of conducting study with 3 arms where 1 arm is test product, 2nd arm is US (RLD) & third arm is UK (RLD) keeping in mind whether this is permitted & acceptable to both the regulatory authorities.

Regards,
Rajasekhar Kakarla


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,654 registered users;
88 visitors (0 registered, 88 guests [including 3 identified bots]).
Forum time: 01:36 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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