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alagu ☆ India, 2013-09-07 13:34 (4672 d 14:15 ago) Posting: # 11457 Views: 2,726 |
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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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Helmut ★★★   Vienna, Austria, 2013-09-07 16:25 (4672 d 11:24 ago) @ alagu Posting: # 11459 Views: 2,257 |
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Hi AR_A, please do your homework first (see this post). Read the countries’ / regions’ relevant guidances / guidelines. Hint:
“Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz