Europe/USA/Canada [Regulatives / Guidelines]

posted by alagu – India, 2013-09-07 13:34 (4672 d 14:40 ago) – Posting: # 11457
Views: 2,726

Dear All,

Request to clarify the below details,

If drug approved in the form Esomeprazole magnesium, not in the form of Esomeprazole Strontium, can we do the Bioequivalence study in Europe or Canada or USA in the form Esomeprazole Strontium?

What are the requirments needed for BE studies?

Regards,
AR_A

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