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Dear all,
We want to do a bioequivalence study of Loratadine.According to
literature reported on MHRA website,
http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dID=28624&noSaveAs=0&Rendition=WEB
the intrasubject CV reported for Cmax is 28.7%. If we apply this in
the table given in
Statistical Approaches Establishing BE: Jan 2001(US FDA)
sample size of 40-44 subjects is needed. But the reported MHRA
submission study shows bioequivalence with 24 subjects itself (23
completed). So which sample size we have to select for the BE study of
Loratadine, considering its high variable nature? On what basis?
Please clarify.
regards,
Muhiyideen
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Dear Muhiyideen,
We have run BE studies on Loratadine in the past at Warnex and our
experience has always been with considerably higher sample sizes than
what you have listed below.
Regards,
Nick Vrentzos
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