Is a bioequivalence study needed? [Regulatives / Guidelines]
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.
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.
