chintan98
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2006-07-12 09:18

Posting: # 166
Views: 4,603
 

 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
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2006-07-12 12:32

@ chintan98
Posting: # 167
Views: 3,718
 

 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!

Cheers,
Helmut Schütz
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