Regulatory submissions [Design Issues]

posted by rajasekharkakarla – India, 2018-09-14 16:13 (1844 d 00:43 ago) – Posting: # 19288
Views: 3,671

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
22,764 posts in 4,776 threads, 1,628 registered users;
13 visitors (0 registered, 13 guests [including 4 identified bots]).
Forum time: 16:56 CEST (Europe/Vienna)

The object of statistics is information.
The objective of statistics is the understanding of information
contained in data.    Irwin and Marylees Miller

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