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suchit_bhavsar ★ India, 2011-06-07 15:10 (5088 d 10:55 ago) Posting: # 7091 Views: 4,330 |
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Hello to all of you, Suppose We have two drug formulations, one formulation having active ingredient in salt form and other having active ingredient without salt form (i.e in base form). Then wheather both the formulations can be said pharmaceutical equivalent or pharmaceutical alternative ? Thanks Suchit Bhavsar |
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Dr_Dan ★★ Germany, 2011-06-08 10:40 (5087 d 15:25 ago) @ suchit_bhavsar Posting: # 7097 Views: 3,558 |
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Dear Suchit Bhavsar Medicinal products are pharmaceutically equivalent if they contain the same amount of the same active substance(s) in the same dosage forms that meet the same or comparable standards. Medicinal products are pharmaceutical alternatives if they contain the same active moiety but differ in chemical form (salt, ester, etc.) of that moiety. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz