Bioequivalence and Bioavailability Forum

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!