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Does anyone know any reference that gives the number of healthy
volunteer for a bioequivalence study of oxcarbazepine?
Do I need to determine the metabolite?
Should I use 95% confidence interval?
Any help would be appreciated.
Regards
Elisabete Moraes
Clinical Pharmacology Unit
Federal University of Ceara - Brasil
Elisabete Moraes,Back to the Top
I believe that this information is important for you.
a.. Mandrioli, R. et al. Liquid Chromatographic Determination of
Oxcarbazepine and its Metabolites in Plasma of Epileptic Patients after
Solid-Phase Extraction. Journal of Chromatography B, 783 (2003)
253-263.
b.. http://www.fda.gov/cder/guidance/index.htm
Sincerely you,
Piedad
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You can refer SBOA information for this. Further The subject number for
any bioequivalence study is determined by our T/R ratio, Intrasubject
CV%
and the required power (minimum of 80%). For Bioequivalence studies 90%
C.I is required.
Manoj Kumar Vishwakarma
Group-Leader
Biopharmaceutics
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Are you trying to develop a generic drug for trileptal.
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To get the idea about no of volunteers for biostudy, you need to have
preliminary data of your test formulations. And if you are conducting
it for the
first time, it is preferable to conduct study with min 12 volunteers.
Yes, you must analyze the metabolite. If you go through FOI available
on
FDA.GOV/cder, they have estimated parent as well as metabolite.
You can go with 90% CI for BE study.
Hope this will serve ur purpose.
Regards
Mitesh Gandhi
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