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syrup hybrid application [Regulatives / Guidelines]

posted by Aga - US, 2017-09-07 11:52  - Posting: # 17791
Views: 292

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

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