Designation:E2935−15AnAmericanNationalStandardStandardPracticeforConductingEquivalenceTestinginLaboratoryApplications1ThisstandardisissuedunderthefixeddesignationE2935;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticeprovidesstatisticalmethodologyforcon-ductingequivalencetestingonnumericaldatafromtwosourcestodetermineiftheirtruemeansdifferbynomorethanpredeterminedlimits.1.2Applicationsinclude(1)equivalencetestingforbiasagainstanacceptedreferencevalue,(2)determiningequiva-lenceoftwotestmethods,testapparatus,instruments,reagentsources,oroperatorswithinalaboratory,and(3)equivalenceoftwolaboratoriesinamethodtransfer.1.3Thecurrentguidanceinthisstandardappliesonlytoexperimentsconductedonasinglematerial.Guidanceisgivenfordeterminingtheamountofdatarequiredforanequivalencetrial.1.4Thestatisticalmethodologyfordeterminingequivalenceusedisthetwoone-sidedtests(TOST)procedure.Thecontrolofrisksassociatedwiththeequivalencedecisionisdiscussed.1.5ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E177PracticeforUseoftheTermsPrecisionandBiasinASTMTestMethodsE456TerminologyRelatingtoQualityandStatisticsE2282GuideforDefiningtheTestResultofaTestMethodE2586PracticeforCalculatingandUsingBasicStatistics3.Terminology3.1Definitions—SeeTerminologyE456foramoreexten-sivelistingofstatisticalterms.3.1.1acceptedreferencevalue,n—avaluethatservesasanagreed-uponreferenceforcomparison,andwhichisderivedas:(1)atheoreticalorestablishedvalue,basedons...
