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Back to the forum  Query: 2017-11-23 19:27 CET (UTC+1h)

syrup hybrid application [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-09-07 14:10  - Posting: # 17792
Views: 606

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,

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.

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