Encyclopedia of Biopharmaceutical Statistics, Third Edition

In recent years, there has been an explosive growth of biopharmaceutical and clinical research, including the development of new medicines for treating severe or life-threatening diseases. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation, but also that the pharmaceutical product possesses good drug characteristics, such as identity, strength, purity, quality, stability, and reproducibility. Widely used by pharmaceutical scientists, clinical researchers, and biostatistics, the Encyclopedia of Biopharmaceutical Statistics, Third Edition is an essential resource on the evolving state of this important field. New to the Third Edition 89 new chapters, bringing the total number of chapters to 230Updated information on changes in regulatory requirements for drug review/approval processesRecent developments in statistical design and methodologyImportant topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine Also Available OnlineThis Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for researchers, students, and librarians, including:  Citation tracking and alerts  Active reference linking  Saved searches and marked lists  HTML and PDF format options Contact Taylor and Francis for more information or to inquire about subscription options and print/online combination packages.US: (Tel) 1.888.318.2367; (E-mail) e-reference@taylorandfrancis.comInternational: (Tel) +44 (0) 20 7017 6062; (E-mail) online.sales@tandf.co.uk Table of ContentAcceptance Sampling Active Control Trials Adaptive Design Methods in Clinical Trials Adaptive Survival Trials Adjustment for Covariates Adverse Event Reporting Alpha Spending Function Ames Test Analysis of 2 K Tables Analysis of Clustered Binary Data Analysis of Clustered Categorical Data Analysis of Heritability Analysis of Repeated Measures Data with Missing Values: An Overview of Methods Analysis of Variance ANCOVA Approach for Premarketing Shelf Life Determination with Multiple Factors Assay Development Assay Validation Bayesian Approach to Stability Analysis Bayesian Methods in Meta-Analysis Bayesian Statistics Bayesian Designs for Phase II Oncology Clinical Trials Binary 2 × 2 Crossover Trials Bioassay Bioavailability and Bioequivalence Bioinformatics Biologics Biomarker in Clinical Trials Biopharmaceutics Biosimilarity of Follow-On Biologics Blinding Bootstrap, The Bracketing Design Bridging Studies Calibration Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD) Cancer Trials Carcinogenicity Studies of Pharmaceuticals Carry‐Forward Analysis Case-Control Studies, Inference in Center Weighting in Multicenter Trials Clinical Data Management Clinical Endpoint Clinical Pharmacology Clinical Trial Process Clinical Trial Simulation Clinical Trial Simulations for Earlier Development Phases Clinical Trial Simulations for Later Development Phases Clinical Trials Cluster Trials Clustered Study Designs: Power Analysis Combination Drug Clinical Trial Comparing Variabilities in Clinical Research Confidence Interval and Hypothesis Testing Confounding and Interaction Content Uniformity Contract Research Organization (CRO) Correlated Probit Model Cost-Effectiveness Analysis Covariate-Adjusted Adaptive Dose-Finding in Early Phase Clinical Trials Crossover Design Cutoff Designs Data Mining and Biopharmaceutical Research Data Monitoring Committees (DMC) Design and Analysis for Demonstrating Disease Modification Effects Diagnostic Imaging Dose Proportionality Dose Response Analysis in Clinical Trials Dose Response Study Design Dropout Drug Development Ecologic Inference ED50/ED90 Enrichment Design Equivalence Trials Ethnic Factors Evaluation of Linearity in Assay Validation Expiration Dating Period Exploratory Factor Analysis Extra Variation Models Factor Analysis Factorial Designs Failure‐Time Model False Discovery Rate (FDR) Food and Drug Administration Generalizability Probability in Clinical Research Generalized Estimating Equation Generalized Estimating Equations (GEE) Method: Sample Size Estimation Generalized Inference Genetic Linkage and Linkage Disequilibrium Analysis Global Database and System Good Clinical Practice Good Programming Practice Good Statistics Practice Group Sequential Methods Group Sequential Tests and Variance Heterogeneity in Clinical Trials Hypotheses and False Positive Rate in Active ControlNon-Inferiority Trials Hypothesis Testing Imputation in Clinical Research Imputation with Item Nonrespondents In Vitro Bioequivalence Testing In Vitro Dissolution Profile Comparison In Vitro Micronucleus Test Individual Bioequivalence Instrument Development and Validation Integrated Summary Report Intention‐to‐Treat Analyses (ITT) Interim Analysis International Conference on Harmonization (ICH) Investigating Quality‐of‐Life in Clinical Trials IVRS/IWRS for Randomization Kaplan–Meier Estimator Kappa Coefficients in Medical Research Kullback–Leibler Divergence for Evaluating Equivalence Laboratory Analyses Latent Class Analysis Lilly Reference Ranges Local Influence Analysis Logistic Regression Logistic Regression in Three‐Point Designs Maximum Tolerable Dose for Cancer Chemotherapy McNemar's Test Measuring Agreement MedDRA and Its Impact on Pharmaceutical Development Medical Devices Meta-Analysis of Therapeutic Trials Microarray Gene Expression Minimization Procedure Minimum Effective Dose Ministry of Health, Labour and Welfare and Pharmaceutical Administration in Japan Missing Values in Repeated Measurement Designs Mixed Effects Models Mixed-Outcome Data MMRM with Missing Data Modified Large Sample Method Multicenter Trials Multicollinearity Multidimensional Data Analysis: An Overview of Penalized Regression Methods Multinational Clinical Trial Multiple Comparisons Multiple‐Dose Bioequivalence Studies Multiple Endpoints Multiple-Stage Designs for Phase II Cancer Trials Multiplicity in Clinical Trials Multivariate Meta-Analysis Noninferiority Analysis in Active Controlled Clinical Trials Non-Parametric Regression Odds Ratio Onset of Action Ordered Multiple Class Receiver Operating Characteristic (ROC) Analysis Outlier Detection in Clinical Research P-Values P-Values, Evidence, and Multiplicity Considerations for Controlled Clinical Trials Parallel Design Patient Compliance Percentile Charts on Correlated Measures Pharmacodynamic Issues Pharmacodynamics with Covariates Pharmacodynamics with No Covariates Pharmacoeconomics Phase I Cancer Clinical Trials Placebo Effect Population Bioequivalence Population PK/PD Analysis Postmarketing Adverse Drug Event Signaling Postmarketing Surveillance Power Prediction Trees Principal Component Analysis Prior Effective Sample Size of a Bayesian Model Process Validation Profile Analysis Propensity Score Analysis and Its Application in Regulatory Settings Proportion of Treatment Effect Proportional Hazards Regression Model Protocol Development QT Analysis Randomization Rank-Based Robust Analysis for Crossover Design Rank Regression in Stability Analysis Release Targets Reliability Reproducibility Probability in Clinical Research Reproductive/Developmental Studies Response-Adaptive Designs Response-Adaptive Repeated Measurement Designs for Clinical Trials Response Surface Methodology Risk Ratio Analysis ROC Curve Sample Size Calculation Based on Nonparametric Statistics Sample Size Calculation for Survival Data Sample Size Determination Sample Size Re‐Estimation Based on Observed Treatment Difference Screening Design Selection of Control in Clinical Trials Semi-Parametric Time-Varying Regression Models Sequential Estimation for the Additive Hazards Rate Model with Staggered Entry Slope Approach for Assessment of Dose Proportionality/Linearity under a Crossover Design Spatio-Temporal Modeling Specifications SROC Curve Stability Analysis for Frozen Drug Products Stability Matrix Designs Statistical Genetics Statistical Principles for Clinical Trials Statistical Process Control Statistical Significance Statistical Tests for Biomarker Development with Applications to Genetics Data Structural Equation Model Stuart–Maxwell Test Subgroup Analysis Subject-Treatment Interaction Surrogate Endpoint Survival Analysis Targeted Clinical Trials Test for Ordered Categorical Data Testing for Qualitative Interaction Therapeutic Equivalence Titration Design Toxicological Studies Traditional Chinese Medicine—General Consideration Translational Medicine: Concepts, Statistical Methods, and Related Issues Trend Estimation Two-Stage Design: Phase II Cancer Clinical Trials USP Tests Vaccine Clinical Trials Validation of Quantitative and Qualitative Assays Validity of LOCF Z-Score Zero-Inflated Poisson DistributionReview QuotePraise 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