821-Plavix Brand Name

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1、OFFICEOFCLINICALPHARMACOLOGYREVIEWNDA:20-839/S051SubmissionDate:July15,2010®BrandNamePlavixGenericNameclopidogrelbisulfatePharmacometricsReviewerKevinKrudys,Ph.D.PharmacometricsTeamLeaderPravinJadhav,Ph.D.ClinicalPharmacologyElenaV.Mishina,Ph.D.ReviewerClinicalPharmacologyTeamLeaderRajanikanthMadabu

2、shi,Ph.D.OCPDivisionDivisionofClinicalPharmacology1ONDDivisionDivisionofCardio-RenalDrugProductsApplicantsanofi-aventisU.S.Inc.(b)(4)Formulation;strength(s)dosedReconstitutedsolutionat;0.2mg/kg/dayinthetrialIndicationforthissupplementReductionofall-causemortalityandshunt-relatedmorbidityinneonatesor

3、infantswithcyanoticcongenitalheartdiseasepalliatedwithasystemic-topulmonaryarteryshuntReviewTypePediatricSupplement1EXECUTIVESUMMARY..........................................................................................................31.1Recommendations...........................................

4、....................................................................31.2SummaryofClinicalPharmacologyandBiopharmaceuticsFindings..................................3(b)(4)1.4QuestionBasedReview........................................................................................................41.4.

5、1Whatarethedesignfeaturesoftheclinicalpharmacologyandclinicalstudiesusedtosupportdosingorclaims?..........................................................................................................41.4.2Whatisthebasisforselectingtheresponseendpointsorbiomarkersandhowaretheymeasuredinclinicalpha

6、rmacologyandclinicalstudies?............................................................41.4.3Whatarethecharacteristicsoftheexposure-responserelationshipsforefficacy?.......51.4.4Whatarethecharacteristicsoftheexposure-responserelationshipsforsafety?..........71.4.5Arethedrugconcentrationsachievedinp

7、ediatricpatientssimilartoobservedadultconcentrationsattheapproveddose?........................................................................................7ReferenceID:288241911.4.6Wasthereadose-re