Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena PDF
Preview Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena
LIGAND-BINDING ASSAYS DEVELOPMENT, VALIDATION, AND IMPLEMENTATION IN THE DRUG DEVELOPMENT ARENA Editedby Masood N. Khan John W.A. Findlay LIGAND-BINDING ASSAYS LIGAND-BINDING ASSAYS DEVELOPMENT, VALIDATION, AND IMPLEMENTATION IN THE DRUG DEVELOPMENT ARENA Editedby Masood N. Khan John W.A. Findlay Copyright(cid:2)2010byJohnWiley&Sons,Inc.Allrightsreserved. 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Wileyalsopublishesitsbooksinavarietyofelectronicformats.Somecontentthatappearsinprintmay notbeavailableinelectronicformats.FormoreinformationaboutWileyproducts,visitourwebsiteat www.wiley.com. LibraryofCongressCataloging-in-PublicationData: Ligandbindingassays : development,validation,andimplementationinthe drugdevelopmentarena / [editedby]MasoodN.Khan,JohnW.A.Findlay. p.;cm. ISBN9780470041383(cloth) 1. Radioligandassay. 2. Drugdevelopment. I. Khan,MasoodN. II. Findlay, JohnW.A. [DNLM: 1. DrugDesign. 2. Immunoassay. 3. Ligands. 4. ProteinBinding. QV744L7232009] RS425.L542009 6150.19 dc22 2009036489 PrintedintheUnitedStatesofAmerica 10987654321 CONTENTS Preface xi Contributors xv 1 Ligand-BindingAssaysinDrugDevelopment:Introduction andHistoricalPerspective 1 JohnW.A.FindlayandMasoodN.Khan 1.1 General 1 1.2 HistoricalReview 2 1.3 LBAsforMacromolecules 3 1.4 AdvantagesandLimitationsofLBAs 4 1.5 Ligand-BindingAssayBioanalyticalFocusGroupofAAPS 4 1.6 ScopeofthePresentVolume 8 References 11 2 Ligand-BindingAssaystoSupportDispositionStudies ofMacromolecularTherapeutics 15 MarianM.Kelley,MarjorieA.Mohler,andJohnW.A.Findlay 2.1 Introduction 15 2.2 DifferencesBetweenLowMolecularWeightMolecules andMacromolecules 16 2.3 LBAAssayConsiderationsRelativetoResearch andDevelopmentStage 23 2.4 CriticalFutureChallengesforLigand-BindingAssays 30 2.5 Conclusions 32 References 32 3 DevelopmentofLigand-BindingAssaysforDrug DevelopmentSupport 39 MasoodN.Khan,ProveenD.Dass,JohnH.Leete,RichardF.Schuman, MicheleGunsior,andChanchalSadhu 3.1 Introduction 39 3.2 InherentComplexitiesofImmunoassayDevelopment 42 3.3 StepsintheDevelopmentofaValidatableImmunoassay 45 3.4 DevelopmentandOptimizationofanImmunoassay 58 v vi CONTENTS 3.5 OptimizationofCommercialKit-BasedAssays 70 3.6 TroubleshootingImmunoassays 70 3.7. Conclusions 75 Acknowledgments 76 References 76 4 ValidationofLigand-BindingAssaystoSupport PharmacokineticAssessmentsofBiotherapeutics 81 BinodhS.DeSilvaandRonaldR.Bowsher 4.1 Introduction 81 4.2 AssayDevelopmentandValidationParadigm 83 4.3 PrestudyValidationPhase 84 4.4 AnalyticalPerformanceCharacteristics 85 4.5 In-StudyValidationPhase 105 4.6 PartialValidations/MethodTransfer/Cross-Validation 107 4.7 Documentation 108 4.8 Conclusions 108 References 109 5 StatisticalConsiderationsintheValidation ofLigand-BindingAssays 111 BrunoBoulanger,ViswanathDevanarayan, andWalthe(cid:2)reDewe(cid:3) 5.1 Introduction 111 5.2 ObjectivesofAssayValidation 113 5.3 ValidationCriteria 115 5.4 EstimatingAssayPerformanceCharacteristics 119 5.5 DecisionRulesandRiskAssessmentinPrestudyValidation 122 5.6 DecisionRulesDuringIn-StudyPhase andAssociatedRisks 123 5.7 ReconcilingValidationandRoutineDecisionRules 124 5.8 Conclusions 126 References 126 6 DevelopmentandValidationofLigand-BindingAssays forBiomarkers 129 JeanW.Lee,YangPan,PeterJ.O’Brien,andRenXu 6.1 Introduction 129 6.2 PreanalyticalConsiderationsandMethodFeasibility 134 6.3 MethodDevelopmentandMethodQualification forExploratoryApplications 142 6.4 MethodDevelopmentandMethodValidation forAdvancedApplications 151 CONTENTS vii 6.5 PartialValidationforChangeControl 154 6.6 Documentation,RecordKeeping,andReporting 154 6.7 RegulatoryIssues 155 6.8 In-studyValidation 156 6.9 Conclusions 157 Acknowledgments 158 References 158 7 TheUseofCommercialAssayKitsforPK/PDAnalysis inDrugDevelopment 163 JohnL.AllinsonandJohnD.Chappell 7.1 Introduction 163 7.2 ValidationDefinitionsThatMaybeInterpreted Inconsistently 166 7.3 ValidationExperiments 168 7.4 Stability 180 7.5 ReoptimizingReagentConcentrations 184 7.6 TheUseofCommercialKitsforPKandTKAssays 186 7.7 MatrixProblems 189 7.8 ChangingMethodProtocol 190 7.9 Conclusions 191 References 191 8 DevelopmentandValidationofImmunogenicityAssays forPreclinicalandClinicalStudies 193 ThomasH.Parish,DeborahFinco,andViswanathDevanarayan 8.1 Introduction 193 8.2 ImmunogenicityRisk-BasedStrategy 194 8.3 RegulatoryGuidance 195 8.4 AssayDesign 196 8.5 OptimizationandValidation:TotalBindingAntibodyAssays 204 8.6 OptimizationandValidation:NeutralizingAntibodyAssays 213 8.7 AssaysandRiskAssessment 220 8.8 ApplicationandInterpretationofData 224 8.9 Conclusions 225 8.10 Appendix8.A IllustrationofScreeningCutPointEvaluation 227 References 234 9 MacromolecularReferenceStandardsforBiotherapeutic PharmacokineticAnalysis 239 MarieT.RockandStephenKeller 9.1 Introduction 239 9.2 UnitedStatesPharmacopeia 241
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