Encyclopedia of Biopharmaceutical Statistics, Third Edition

Praise for Previous Editions:"I was delighted by the information and insight that was available … The authors demonstrate their expertise and knowledge in well-written material that covers each of the topics fully. …These authors are to be congratulated for a job well done."—Ralph Bucher, professor of biostatistics, University of Cincinnati, and fellow of ASA and American College of Epidemiology"… an essential desktop reference …"—Technometrics

• Acceptance SamplingActive Control TrialsAdaptive Design Methods in Clinical TrialsAdaptive Survival TrialsAdjustment for CovariatesAdverse Event ReportingAlpha Spending FunctionAmes TestAnalysis of 2 K TablesAnalysis of Clustered Binary DataAnalysis of Clustered Categorical DataAnalysis of HeritabilityAnalysis of Repeated Measures Data with Missing Values: An Overview of MethodsAnalysis of VarianceANCOVA Approach for Premarketing Shelf Life Determination with Multiple FactorsAssay DevelopmentAssay ValidationBayesian Approach to Stability AnalysisBayesian Methods in Meta-AnalysisBayesian StatisticsBayesian Designs for Phase II Oncology Clinical TrialsBinary 2 × 2 Crossover TrialsBioassayBioavailability and BioequivalenceBioinformaticsBiologicsBiomarker in Clinical TrialsBiopharmaceuticsBiosimilarity of Follow-On BiologicsBlindingBootstrap, TheBracketing DesignBridging StudiesCalibrationCanadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD)Cancer TrialsCarcinogenicity Studies of PharmaceuticalsCarry‐Forward AnalysisCase-Control Studies, Inference inCenter Weighting in Multicenter TrialsClinical Data ManagementClinical EndpointClinical PharmacologyClinical Trial ProcessClinical Trial SimulationClinical Trial Simulations for Earlier Development PhasesClinical Trial Simulations for Later Development PhasesClinical TrialsCluster TrialsClustered Study Designs: Power AnalysisCombination Drug Clinical TrialComparing Variabilities in Clinical ResearchConfidence Interval and Hypothesis TestingConfounding and InteractionContent UniformityContract Research Organization (CRO)Correlated Probit ModelCost-Effectiveness AnalysisCovariate-Adjusted Adaptive Dose-Finding in Early Phase Clinical TrialsCrossover DesignCutoff DesignsData Mining and Biopharmaceutical ResearchData Monitoring Committees (DMC)Design and Analysis for Demonstrating Disease Modification EffectsDiagnostic ImagingDose ProportionalityDose Response Analysis in Clinical TrialsDose Response Study DesignDropoutDrug DevelopmentEcologic InferenceED50/ED90Enrichment DesignEquivalence TrialsEthnic FactorsEvaluation of Linearity in Assay ValidationExpiration Dating PeriodExploratory Factor AnalysisExtra Variation ModelsFactor AnalysisFactorial DesignsFailure‐Time ModelFalse Discovery Rate (FDR)Food and Drug AdministrationGeneralizability Probability in Clinical ResearchGeneralized Estimating EquationGeneralized Estimating Equations (GEE) Method: Sample Size EstimationGeneralized InferenceGenetic Linkage and Linkage Disequilibrium AnalysisGlobal Database and SystemGood Clinical PracticeGood Programming PracticeGood Statistics PracticeGroup Sequential MethodsGroup Sequential Tests and Variance Heterogeneity in Clinical TrialsHypotheses and False Positive Rate in Active ControlNon-Inferiority TrialsHypothesis TestingImputation in Clinical ResearchImputation with Item NonrespondentsIn Vitro Bioequivalence TestingIn Vitro Dissolution Profile ComparisonIn Vitro Micronucleus TestIndividual BioequivalenceInstrument Development and ValidationIntegrated Summary ReportIntention‐to‐Treat Analyses (ITT)Interim AnalysisInternational Conference on Harmonization (ICH)Investigating Quality‐of‐Life in Clinical TrialsIVRS/IWRS for RandomizationKaplan–Meier EstimatorKappa Coefficients in Medical ResearchKullback–Leibler Divergence for Evaluating EquivalenceLaboratory AnalysesLatent Class AnalysisLilly Reference RangesLocal Influence AnalysisLogistic RegressionLogistic Regression in Three‐Point DesignsMaximum Tolerable Dose for Cancer ChemotherapyMcNemar's TestMeasuring AgreementMedDRA and Its Impact on Pharmaceutical DevelopmentMedical DevicesMeta-Analysis of Therapeutic TrialsMicroarray Gene ExpressionMinimization ProcedureMinimum Effective DoseMinistry of Health, Labour and Welfare and Pharmaceutical Administration in JapanMissing Values in Repeated Measurement DesignsMixed Effects ModelsMixed-Outcome DataMMRM with Missing DataModified Large Sample MethodMulticenter TrialsMulticollinearityMultidimensional Data Analysis: An Overview of Penalized Regression MethodsMultinational Clinical TrialMultiple ComparisonsMultiple‐Dose Bioequivalence StudiesMultiple EndpointsMultiple-Stage Designs for Phase II Cancer TrialsMultiplicity in Clinical TrialsMultivariate Meta-AnalysisNoninferiority Analysis in Active Controlled Clinical TrialsNon-Parametric RegressionOdds RatioOnset of ActionOrdered Multiple Class Receiver Operating Characteristic (ROC) AnalysisOutlier Detection in Clinical ResearchP-ValuesP-Values, Evidence, and Multiplicity Considerations for Controlled Clinical TrialsParallel DesignPatient CompliancePercentile Charts on Correlated MeasuresPharmacodynamic IssuesPharmacodynamics with CovariatesPharmacodynamics with No CovariatesPharmacoeconomicsPhase I Cancer Clinical TrialsPlacebo EffectPopulation BioequivalencePopulation PK/PD AnalysisPostmarketing Adverse Drug Event SignalingPostmarketing SurveillancePowerPrediction TreesPrincipal Component AnalysisPrior Effective Sample Size of a Bayesian ModelProcess ValidationProfile AnalysisPropensity Score Analysis and Its Application in Regulatory SettingsProportion of Treatment EffectProportional Hazards Regression ModelProtocol DevelopmentQT AnalysisRandomizationRank-Based Robust Analysis for Crossover DesignRank Regression in Stability AnalysisRelease TargetsReliabilityReproducibility Probability in Clinical ResearchReproductive/Developmental StudiesResponse-Adaptive DesignsResponse-Adaptive Repeated Measurement Designs for Clinical TrialsResponse Surface MethodologyRisk Ratio AnalysisROC CurveSample Size Calculation Based on Nonparametric StatisticsSample Size Calculation for Survival DataSample Size DeterminationSample Size Re‐Estimation Based on Observed Treatment DifferenceScreening DesignSelection of Control in Clinical TrialsSemi-Parametric Time-Varying Regression ModelsSequential Estimation for the Additive Hazards Rate Model with Staggered EntrySlope Approach for Assessment of Dose Proportionality/Linearity under a Crossover DesignSpatio-Temporal ModelingSpecificationsSROC CurveStability Analysis for Frozen Drug ProductsStability Matrix DesignsStatistical GeneticsStatistical Principles for Clinical TrialsStatistical Process ControlStatistical SignificanceStatistical Tests for Biomarker Development with Applications to Genetics DataStructural Equation ModelStuart–Maxwell TestSubgroup AnalysisSubject-Treatment InteractionSurrogate EndpointSurvival AnalysisTargeted Clinical TrialsTest for Ordered Categorical DataTesting for Qualitative InteractionTherapeutic EquivalenceTitration DesignToxicological StudiesTraditional Chinese Medicine—General ConsiderationTranslational Medicine: Concepts, Statistical Methods, and Related IssuesTrend EstimationTwo-Stage Design: Phase II Cancer Clinical TrialsUSP TestsVaccine Clinical TrialsValidation of Quantitative and Qualitative AssaysValidity of LOCFZ-ScoreZero-Inflated Poisson Distribution