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Aga
Junior

US,
2017-09-06 13:52

Posting: # 17784
Views: 1,253
 

 syrup 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
ElMaestro
Hero

Denmark,
2017-09-06 14:44

@ Aga
Posting: # 17786
Views: 1,082
 

 syrup hybrid application

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.

I could be wrong, but…


Best regards,
ElMaestro

"Moderation in moderation"
Aga
Junior

US,
2017-09-07 13:52

@ ElMaestro
Posting: # 17791
Views: 1,021
 

 syrup hybrid application

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
ElMaestro
Hero

Denmark,
2017-09-07 14:10

@ Aga
Posting: # 17792
Views: 1,018
 

 syrup hybrid application

Dear Aga,

» 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?

I really meant what I said - this can be perceived completely heterogeneously between countries. You may get as many answers as there are agencies. Therefore, take scientific advices (pl.) and try to rely on that. They may need in vivo studies, or they may not. They may need ther. equivalence in stead of bioequivalence, or they may not. They may let you get away with some in vitro work, or they may not. They may accept a bunch of literature, or they may not. They may be totally paranoid and conservative because you are doing something related to children, or they may not.
Request scientific advice. Even if there is no budget and no time.:-)

Note also that BE does not have the same definition in EU and US.

I could be wrong, but…


Best regards,
ElMaestro

"Moderation in moderation"
Aga
Junior

US,
2017-09-07 14:54

@ ElMaestro
Posting: # 17793
Views: 1,016
 

 syrup hybrid application

Dear ElMaestro,

Thank you so much for advice.
Surely we are going to ask Agency, we already contacted one.

» Note also that BE does not have the same definition in EU and US.

I didn't know that:)

best regards,
Aga
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