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Registersyrup hybrid application [Regulatives / Guidelines]
Dear ElMaestro,
Thank you very much for your response. Yes, EU submission is considered and the aim of the project is to make posology more practical, as with the low strength the adult is consuming the whole package in less than 2 days.
If we would go 10.3 - how we should prove equivalence with this tricky syrup? Bioequivalence - because the product is not pharmaceutically equivalent? or can we somehow prove pharmaceutical equivalence with double dose vs single dose? Is it possible?
best regards,
Aga
Thank you very much for your response. Yes, EU submission is considered and the aim of the project is to make posology more practical, as with the low strength the adult is consuming the whole package in less than 2 days.
If we would go 10.3 - how we should prove equivalence with this tricky syrup? Bioequivalence - because the product is not pharmaceutically equivalent? or can we somehow prove pharmaceutical equivalence with double dose vs single dose? Is it possible?
best regards,
Aga
Complete thread:
- syrup hybrid application Aga 2017-09-06 13:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- syrup hybrid application ElMaestro 2017-09-06 14:44
- syrup hybrid applicationAga 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 applicationAga 2017-09-07 13:52
- syrup hybrid application ElMaestro 2017-09-06 14:44
Ing. Helmut Schütz