I期临床研究中等效性试验生物样本全流程质量管理探讨.docxVIP

I期临床研究中等效性试验生物样本全流程质量管理探讨

摘要：等效性试验中生物样本作为承载药物信息的直接载体，其质量直接关乎着试验分析数据的真实性、可靠性及准确性，高质量的生物样本是确保试验数据真实可靠和可溯源性的有力保障。等效性研究中生物样本往往数量庞大，管理更为复杂和困难，涉及采集转运、处理分装、保存寄送等各个流程，环环相扣，每个过程中都存在着影响生物样本质量的因素。本文跟据《药物临床试验质量管理规范》《药物临床试验生物样本分析实验室管理指南（试行）》及《药物临床试验数据现场核查要点》，结合本中心2017-2022年开展的多个等效性试验，从日常管理及项目运行期间与生物样本有关的全过程进行分析总结，旨在从等效性试验的角度分析影响生物样本质量管理的因素，分析总结生物样本全流程管理要点，完善生物样本管理流程，为生物样本全流程管理提供参考，全面提高等效性研究中生物样本的质量。

关键词：等效性研究；生物样本；全过程；质量管理；

DiscussiononthewholeprocessqualitymanagementofbioequivalencetestbiologicalsamplesinphaseIclinicalstudy

Abstract:Asthedirectcarrierofdruginformation,thequalityofbiologicalsamplesintheequivalencetestisdirectlyrelatedtotheauthenticity,reliabilityandaccuracyofthetestanalysisdata.High-qualitybiologicalsamplesareapowerfulguaranteetoensuretheauthenticity,reliabilityandtraceabilityofthetestdata.Intheequivalencestudy,biologicalsamplesareoftenlargeinquantity,andthemanagementismorecomplexanddifficult,involvingvariousprocessessuchascollectionandtransportation,processingandsub-packaging,storageanddelivery,whichareinterlinked.Ineachprocess,therearefactorsthataffectthequalityofbiologicalsamples.ThispaperanalyzesandsummarizesthewholeprocessrelatedtobiologicalsamplesduringdailymanagementandprojectoperationaccordingtotheGoodClinicalPracticeforDrugClinicalTrials,GuidelinesfortheManagementofBiologicalSampleAnalysisLaboratoryinDrugClinicalTrials(Trial)andKeyPointsforOn-siteVerificationofDrugClinicalTrialsData,andincombinationwithmultipleequivalencetestsconductedbytheCenterin2017-2022,Thepurposeistoanalyzethefactorsaffectingthequalitymanagementofbiologicalsamplesfromtheperspectiveofequivalencetest,analyzeandsummarizethekeypointsofthewholeprocessmanagementofbiologicalsamples,improvethebiologicalsamplemanagementprocess,providereferenceforthewholeprocessmanageme