Regulatory submissions [Design Issues]

posted by rajasekharkakarla – India, 2018-09-14 14:13  – Posting: # 19288
Views: 1,446

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,604 posts in 4,158 threads, 1,340 registered users;
online 6 (0 registered, 6 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 16:53 CEST

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5