chintan98 ● 2006-07-12 11:18 (6726 d 12:27 ago) Posting: # 166 Views: 7,317 |
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What are the differences between EMEA and FDA guidelines for Biovailability / Bioequivalence study. Regards, Chintan Mehta |
Helmut ★★★ Vienna, Austria, 2006-07-12 14:32 (6726 d 09:14 ago) @ chintan98 Posting: # 167 Views: 5,616 |
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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! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |