Hello Members,
For getting qualified for a waiver for bioequivalence of ophthalmic
eye drops CDER's Bioequivalence Recommendations instructs that an in
vivo clinical endpoint bioequivalence study is requested for any
ophthalmic solution that has a different inactive ingredient or a
difference of more than 5% in the amount of any inactive ingredient
compared to that of the RLD.
The label of the RLD product does not mention the quantities of the
inactive ingredients present in their formulation except for
preservative content. We presume that this quantitative composition
of RLD product can't be obtained through FOI due to confidentiality.
In this context please guide on how to get the quantitative
composition of RLD for comparison purpose.
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Harikishan
kharikishan@promedgroup.com
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