chintan98
●    

2006-07-12 11:18
(6469 d 21:55 ago)

Posting: # 166
Views: 6,534
 

 differences between EMEA and FDA guidelines [Regulatives / Guidelines]

What are the differences between EMEA and FDA guidelines for Biovailability / Bioequivalence study.

Regards,

Chintan Mehta
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2006-07-12 14:32
(6469 d 18:41 ago)

@ chintan98
Posting: # 167
Views: 5,057
 

 EMEA and FDA guidelines

Hello Chintan,

it’s simply not possible to list everything here in the forum – somewhere in the depths of the database I have set a limit to the length of posts. ;-)

Essentially there are more similarities than differences.
Generally European Guidelines are more flexible and leave more space for interpretation, although the current regulatory practice – at least in some countries – became more restrictive in the last couple of years.

You may find the Guidance page helpful:
EU-EMEA Guidelines and Regulations
US-FDA Guidelines and Regulations

If you have more specific questions, don’t dare asking in the forum!

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
104 visitors (0 registered, 104 guests [including 6 identified bots]).
Forum time: 08:14 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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