Regulatory submissions [Design Issues]

posted by rajasekharkakarla – India, 2018-09-14 14:13 (801 d 06:31 ago) – Posting: # 19288
Views: 2,966

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:

Activity
 Admin contact
21,205 posts in 4,425 threads, 1,481 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Monday 19:44 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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