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Searchsyrup hybrid application [Regulatives / Guidelines]
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.
» 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.
—
Best regards,
ElMaestro
"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
if (3) 4 Best regards,
ElMaestro
"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
Complete thread:
- syrup hybrid application - Aga, 2017-09-06 13:52 [Regulatives / Guidelines]
![[Mix]](http://static.bebac.at/img/mix.png "Open in mix view")
- syrup hybrid application - ElMaestro, 2017-09-06 14:44
- syrup hybrid application - Aga, 2017-09-07 13:52
- syrup hybrid application - ElMaestro, 2017-09-07 14:10
- syrup hybrid application - Aga, 2017-09-07 14:54
- syrup hybrid application - ElMaestro, 2017-09-07 14:10
- syrup hybrid application - Aga, 2017-09-07 13:52
- syrup hybrid application - ElMaestro, 2017-09-06 14:44
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