kaushal09
☆    

India,
2009-02-14 08:35
(6346 d 07:46 ago)

Posting: # 3237
Views: 2,264
 

 reference drug [Regulatives / Guidelines]

Dear HS and all,

If i would like done BA/BE for FDA than reference product should be from USA or from any other country can be taken?

thanks,

Kaushal
Bhavesh
☆    

India,
2009-02-14 09:08
(6346 d 07:13 ago)

(edited on 2009-02-14 11:29)
@ kaushal09
Posting: # 3238
Views: 1,824
 

 reference drug

Dear kaushal.

Its must from same market where U submit ur application for approval.

--
Edit: Full quote removed. Please see this post - and this one as well! [Jaime]
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
254 visitors (0 registered, 254 guests [including 16 identified bots]).
Forum time: 17:22 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

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