Dear Members,
Good Morning.
I have a query related to Biowaiver application.
One of my controlled release tablet contains Ferrous sulphate,
Glycine and folic acid as active substance. But i haven't conducted
the BE studies for that product. (I have comparative Dissolution data
with innovator available) since Fe is a micronutrient present in the
body, so do i need to conduct BE studies or can i give a biowaiver
request or the comparative dissolution data can suffice the purpose?
If i can give a biowaiver, then what justification can work for the same?
In general, what type of Biowaiver request is applicable for products
containing micronutrients?
please provide any reference or suggestions.
Please help me for this query.
Thanks
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With Regards,
Surender Kr Kamal, M.Pharm
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