Bioequivalence and Bioavailability Forum

chintan98 ● 2006-07-12 11:18 (7266 d 13:44 ago) Posting: # 166 Views: 9,759	differences between EMEA and FDA guidelines [Regulatives / Guidelines] Post reply
	What are the differences between EMEA and FDA guidelines for Biovailability / Bioequivalence study. Regards, Chintan Mehta

Helmut
★★★

Vienna, Austria,
2006-07-12 14:32
(7266 d 10:31 ago)

@ chintan98
Posting: # 167
Views: 7,431

EMEA and FDA guidelines

Post reply

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!

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differences between EMEA and FDA guidelines [Regulatives / Guidelines]

EMEA and FDA guidelines