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1、GoodLaboratoryPractice–theWhyandtheHowJürgP.SeilerGoodLaboratoryPractice–theWhyandtheHowWith38Figuresand1Table13JürgP.SeilerHölzlistrasse383475RiedtwilSwitzerlandISBN3-540-25348-3Springer-VerlagBerlinHeidelbergNewYorkLibraryofCongressControlNumber:2005923264Thisworkissubjecttocopyright.Allrights
2、arereserved,whetherthewholeorpartofthematerialisconcerned,specificallytherightsoftranslation,reprinting,reuseofillustrations,recitation,broadcasting,reproductiononmicrofilmorinanyotherway,andstorageindatabanks.DuplicationofthispublicationorpartsthereofispermittedonlyundertheprovisionsoftheGermanCo
3、pyrightLawofSeptember9,1965,initscurrentversion,andpermissionforusemustalwaysbeobtainedfromSpringer.ViolationsareliabletoprosecutionundertheGermanCopyrightLaw.SpringerisapartofSpringerScience+BusinessMediaspringeronline.com©Springer-VerlagBerlinHeidelberg2005PrintedintheEuropeanUnionTheuseofregi
4、sterednames,trademarks,etc.inthispublicationdoesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexemptfromtherelevantprotectivelawsandregulationsandthereforefreeforgeneraluse.Productliability:Thepublisherscannotguaranteetheaccuracyofanyinformationabouttheapplicationofoperativetechni
5、quesandmedicationscontainedinthisbook.Ineveryindividualcasetheusermustchecksuchinformationbyconsultingtherelevantliterature.Editor:ThomasMager,HeidelbergDevelopmentEditor:AndrewSpencer,HeidelbergProductionEditor:FrankKrabbes,HeidelbergTypesetting:CamerareadybytheauthorCoverdesign:design&producti
6、on,HeidelbergSPIN:1096626614/2109fk–543210–Printedonacid-freepaperPrefacePrefacePrefaceAftermorethantwentyyearsofuseGoodLaboratoryPractice,orGLP,hasattainedasecureplaceintheworldoftestingchemicalsandother“testitems”withregardtotheirsafetyforhumansandtheenvironment.GonearethedayswhentheGLPregulat
7、ionswerehotlydebatedamongstscientistsinacademiaandindustryandwereaccusedofstiflingflexibilityin,imaginativeapproachesto,andscience-basedconductof,allkindsofstudiesconcernedwithtoxiceffectsandotherparametersimportantfortheeva
