【英文标准名称】:StandardPracticeforDetailedClinicalObservationsofTestAnimals
【原文标准名称】:试验动物详细临床观察的标准实施规范
【标准号】:ASTME2045-1999(2009)
【标准状态】:现行
【国别】:美国
【发布日期】:1999
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E47.02
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:adversereactions;animals;clinicalcodes;clinicalsigns;toxicity;Adversereactions;Animalhabitats;Clinicalcodes/signs;Cutaneoussigns;Gastrointestinalanalysis;Generalclinicalcodes/signs;Laboratoryanimals;Neuromuscularsigns;Ocularsign
【摘要】:Thispracticepertainstoallformsoftoxicologicaltesting(acute,subchronic,orchronic)performedbyanyrouteofadministration(inhalation,oral,dermal,ocular,orother).TheU.S.EnvironmentalProtectionAgency,GoodLaboratoryPracticesforNonclinicalLaboratoryStudies,aslistedin40CFR,requiresthatatestingfacilitymaintainspecificstandardoperatingprocedures(SOPs)includinganSOPcoveringclinicalobservationsintestanimals.Thispracticeservesasabasisforconsistencyinclinicalobservations.Actualproceduresandformstobeusedinrecordingobservationsmustbedescribedinindividualstudyprotocols.1.1Thispracticedescribesthetermsusedinobservingandrecordingcutaneous,gastrointestinal,respiratory,reproductive,neuromuscular,ocular,andgeneralclinicalsignsofanimalsundergoingtoxicologicaltesting.Thispracticealsoassistsinproperlyobservingandassessinglaboratoryanimalsforsignsofdiseaseoradverseeffectsofcompoundadministration.1.2Thispracticeincludescodesanddescriptionsforawidevarietyofclinicalsigns,anatomicallocations,andotherdescriptivequalifiers,andatechniqueforscoringtheextentorseverityofclinicalsigns.1.3Thispracticeassumesthatthereaderisknowledgeableinanimaltoxicologyandrelatedpertinentareasandistrainedinmakingclinicalobservations.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C05
【国际标准分类号】:11_220
【页数】:9P.;A4
【正文语种】:英语