Regulatory submissions [Design Issues]

posted by rajasekharkakarla – India, 2018-09-14 16:13 (2050 d 00:03 ago) – Posting: # 19288
Views: 3,931

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
22,993 posts in 4,828 threads, 1,653 registered users;
116 visitors (0 registered, 116 guests [including 3 identified bots]).
Forum time: 16:16 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means.    Martin Wolfsegger

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