BE studies register in EU [Regulatives / Guidelines]

posted by Beholder  – Russia, 2018-01-19 14:10 (2373 d 23:31 ago) – Posting: # 18226
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Dear Ohlbe,

❝ Well, BE trials are clinical trials, aren't they ? If you type "bioequivalence" you'll get 55 hits, so at least "a number" of them have been entered.

Ok, they are clinical trials as well. However there is such point that BE studies are smth special and more connected with testing than with real clinical trial where amount of really new information is quite big.

Hm. 55 hits...In RF register I found approximately 900 finished BE studies starting from 2010 when register was firstly created. ok, companies in RF must perform studies exactly in RF but I find 55 hits - quite small amount for Union with 500 mln people. Or almost all clinical parts of BE studies are performed outside EU so we dont see them?

Best regards

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