krishna tiwari
☆    

India,
2016-04-26 13:24
(2893 d 10:13 ago)

(edited by Ohlbe on 2016-04-26 14:14)
Posting: # 16240
Views: 2,705
 

 ANVISA regulatory requirements [Regulatives / Guidelines]

Dear All,

we are going to conduct BA/BE study in ANVISA regulatory requirements. in indian population.

please let me know .... we are conduct the study or not.

or study will be conducted only brazilian population only??

which anvisa guideline resolution clearly says pls let me know.

thanks
krishna


Edit: category changed [Ohlbe]
felipeberlinski
☆    

Brazil,
2016-04-27 17:07
(2892 d 06:30 ago)

@ krishna tiwari
Posting: # 16249
Views: 2,154
 

 ANVISA regulatory requirements

Hi Krishna

There is no such need. You can conduct in Indian population.

Take a look on RE 1170/06 there you'll find valuable information about ANVISA requirements, it is important to read the guidelines.
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
72 visitors (0 registered, 72 guests [including 4 identified bots]).
Forum time: 22:37 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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