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Registersyrup hybrid application [Regulatives / Guidelines]
Hi,
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.
best regards,
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.
best regards,
Aga
Complete thread:
- syrup hybrid applicationAga 2017-09-06 13:52
![[Mix]](https://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
Ing. Helmut Schütz