New FDC - BE reference products [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2015-11-03 10:27 (3460 d 07:07 ago) – Posting: # 15609
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Dear all
If you develop a new fixed dose combination with known APIs and you have shown BE of the combination against the US mono reference products do you need to repeat the study with European reference products in case you aim not for substitution indication (according to §10(b)) but go for a mixed application according to §8.3? What is your experience?
Looking forward to your replies.
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan

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