品研究实验原始记录审核技术要求.pptVIP

药物研究中GLP试验室试验原始统计审核技术要求龚兆龙博士资深副总裁兼首席技术官昭衍新药研究中心1

新药研发过程2

新药研发过程质量规范

GLP历史沿革遵从GLP旳意义GLP规范基本要求原始数据核查要点非临床试验室常见错误法规对GLP或非GLP旳要求案例分析内容提要4

GLP历史–美国WhatpromptedUSFDAtoissueGLPregulations? Inthe1960sand1970s,inadditiontotheThalidomide”story,FDAfound:SelectivelysubmittedfindingsFabricateddataFalsifieddataDiscrepanciesinreporting(e.g.,betweenindividualandsummarydata)Poorlaboratoryrecordkeeping(resultingininabilitytoreconstructstudyperformance)

GLP历史–美国Inthe1960sand1970s,FDAalsofound:Noprotocols,protocolswrittenafterstudyperformance,s