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This is regarding the bioequivalence of Enantiomeric molecules.
For the bioequivalence studies of Enantiomer specific molecules BE
criteria should be applied to both if they match all four criteria of
the US FDA. But US FDA doesn't say anything about the Certificate of
analysis (COA) of this types of molecules. Should the COA provide
assay value for both the enantiomers separately?
If content of both enantiomers is different in both the formulation,
then they will not be bioequivalent and there are chances of even
more safety related issues. There can also be unnecessary research on
human. There can be more side effects even due to one enantiomer
which is toxic and present in one formulation in higher amount.
Should the CRO ask for the COA containing assay of both enantiomers
separately? What should be the criteria for that assay values?
Experts comments required.
Thanks and regards,
Accutest Research Lab.
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