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Dear All,
I would like to hear the comment if one want to do the Bioequivalence
study of modified release tablet, from US-FDA Guidance both fed- and
fast-condition need to be conducted.
1. Is it possible to waive for fed-condition if our product is
administer
one hour before meal (once daily).
2. What about the guidance of other regulatory agency such as EU or
Cannadian for modified release formulation.
3. If we want to conduct the BE of esomeprazole (pure S-enantiomer of
omeprazole), when assay the level of esomeprazole in the plasma do we
need to use the method that can separate the enantiomer! In my opinion,
if the drug is stable (no bioconversion from S- to R-enantiomer), it
should be Ok if we use the assay method for racemate
Best Regards,
Wichittra
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>Is it possible to waive for fed-condition if our product is
administered
>one hour before meal (once daily).
It would be still difficult to waive fed study. The argument could be
that extended (modified) release units are generally non-disintegrating
and are bigger in size thus it is likely that they would not empty from
stomach and so will face conditions of fed state once food is ingested.
Any other comments??
Regards
Dr. Manoj K. Paruthi
Hikma Pharmaceuticals Plc.
Sr. Manager, R&D, Ext. 564
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HI,
As there are no such clarifications and examples in the guidance-FDA
and EU.
It is mandatory to conduct fast and fed study for FDA and EU.
Hope this helps.
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