药学专业英语视听说教程课件下篇 lecture 7-1 Post-market Surveillance.pptx

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药学专业英语视听说教程课件下篇 lecture 7-1 Post-market Surveillance.pptx

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Lecture7Post-marketSurveillance

meta-analysissafetyspecificationwithdrawalpharmacovigilancedispenser

triageblackboxwarningpsychiatrypediatricsteratogenic

FTTTT

OnlyasmallpercentageofpatientsparticipateinclinicaltrialsandsubsequentlyaverysmallpercentageofadversedrugreactionscanbedetectedduringthisperiodClinicaltrialsmainlyaimtoprovetheefficacyofadrugandthusasimpleprotocolthatremovesvariousinterferingfactorsisadoptedChildrenandpatientsover75yearsoldareusuallyexcludedfromclinicaltrials,buttheymaybeexposedtothedrugafterapprovalAllfactorssuchastheadministrationtimingofdrugs,testingscheduleandmonitoringarecontrolledunderprotocolsandspecialistsThedurationofaclinicaltrialisusuallyoneyear,shorterthanthedurationofreal-worldtreatment

Thepossibilityofsafety-relatedproblemsishighatthebeginningduetolimitedinformation,butwillgraduallydecreaseduetotheaccumulationofsafety-relatedinformationsafetyandefficacyinformationofdrugsinactualclinicalpracticeaftermarketingappropriatefeedbacktopatients

positivebalanceriskminimizationadverseeffectassessed

stakeholdersspecificationcharacterizeprofilemitigation

1.InOctober2004,theFDAannouncedblackboxwarningassociatedwiththeuseofantidepressantsinpatientsundertheageof18.WhatwasthebasisfortheFDAtoissuethisblackboxwarning?TheFDAissuedthisblackboxwarningbasedonameta-analysisof24randomizedcontrolledtrialsthatlookedatyouthonantidepressants,includingSSRIsaswellasnon-SSRIs.Itwasfoundthattherewasanincreasedriskofsuicidalthinkingandbehavioramongpatientsreceivingtheactivedrugcomparedtothosereceivingplacebo.

2.Aftertheblackboxwarningonantidepressantwasissued,therewasafollow-upstudythatwascompletedin2007.Whatdidthefollow-upstudyfind?----Thefollow-upstudyfoundthattherateofsuicidalityinthea

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药学专业英语视听说教程课件下篇 lecture 7-1 Post-market Surveillance.pptx