Is a bioequivalence study needed? [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2012-06-27 10:17 (5115 d 12:40 ago) – Posting: # 8854
Views: 1,762

Good morning everyone,

Does anyone know if a bioequivalence study is needed to put aspirin 75 mg on the market in MENA territories? Should a well-establish use application do the trick?

Any feedback is greatly appreciated.

Thank you.

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