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Back to the forum  2018-06-22 18:54 CEST (UTC+2h)

syrup hybrid application [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-09-06 14:44  - Posting: # 17786
Views: 1,975

Hi Aga,

» How could we proof equivalence for syrups, to authorise strength 5 mg/ml when only lower strength of reference product is available (2 mg/ml)? BEQ? In vitro?
» The substance is present for more than half of a century on the market and efficacy for tablet (10 and 25 mg) and syrup lower strength (2 mg/ml) is documented in the literature.

Since you use the term "hybrid" I assume you imply EU submission? If so, get a scientific advice at three agencies. You might well see that they perceive such a case completely differently among the various agencies; some might allow this as a bibliographical application, some might want you to go 10.3 and others yet may think this is something else. If you run into someone fresh out of university this could easily get impractical especially if the syrup is not a solution.

if (3) 4

Best regards,

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