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Dear All,
I need your experince regarding to the Bioequivalance study of
desloratadine 5 mg tablet.
How many volunteers do I need to conduct the invivo bioequivalance study
of generic formulation versus the original tablet formulation?
Should I measure the metabolite 3-OH desloratadine?
Do you have any information about the CV of desloratadine?
Can you please advice me any IP address for further information about
desloratadine?
Best regards;
Pharm. Hatice Atkaya
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Hatice,
Following are the links to clinical pharmacology reviews for CLARINEX
(desloratidine) NDA submission posted at US FDA website. You will be
able to find %CV for varrous parameters from these documents and may
help in estimating the sample size for your study.
http://www.fda.gov/cder/foi/nda/2001/21-165_Clarinex_biopharmr_P1.pdf
http://www.fda.gov/cder/foi/nda/2001/21-165_Clarinex_biopharmr_P2.pdf
Best
Ganesh Mugundu
--
Graduate Student
Department of Pharmacokinetics & Biopharmaceutics
University of Cincinnati
Blog: http://pk-pd.blogspot.com/
WebPage: www.geocities.com/ganaish
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