Posting: # 166
What are the differences between EMEA and FDA guidelines for Biovailability / Bioequivalence study.
Posting: # 167
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!
The quality of responses received is directly proportional to the quality of the question asked. ☼