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Encyclopedia of Biopharmaceutical Statistics

Edited by: Shein-Chung Chow

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273
 Cite  Marc Record

Book description

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences.

Features of the Fourth Edition:

1. 78 new and revised entries have been added for a total of 308 chapters and a third volume has been added to encompass the increased number of chapters.

2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies.

3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development.

4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics.

About the Editor:

Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Table of contents

Prelims Download PDF
Chapter  1:  Acceptance Sampling Download PDF
Chapter  2:  Hypotheses and False Positive Rate in Active Control Non-Inferiority Trials Download PDF
Chapter  3:  Active Control Trials Download PDF
Chapter  4:  Active Controlled Clinical Trials: Noninferiority Analysis Download PDF
Chapter  5:  Adaptive Design Clinical Trials: Case Studies Download PDF
Chapter  6:  Adaptive Design Methods in Clinical Trials Download PDF
Chapter  7:  Adaptive Survival Trials Download PDF
Chapter  8:  Adverse Event Reporting Download PDF
Chapter  9:  Alpha Spending Function Download PDF
Chapter  10:  Ames Test Download PDF
Chapter  11:  Analysis of 2 × K Tables Download PDF
Chapter  12:  Analysis of Clustered Binary Data Download PDF
Chapter  13:  Analysis of Clustered Categorical Data Download PDF
Chapter  14:  Analysis of Heritability Download PDF
Chapter  15:  Analysis of Variance (ANOVA) Download PDF
Chapter  16:  Analytical Similarity Assessment Download PDF
Chapter  17:  ANCOVA Approach: Premarketing Shelf Life Determination with Multiple Factors Download PDF
Chapter  18:  Assay Development Download PDF
Chapter  19:  Assay Validation Download PDF
Chapter  20:  Assay Validation: Evaluation of Linearity Download PDF
Chapter  21:  Bayesian Designs: Phase II Oncology Clinical Trials Download PDF
Chapter  22:  Bayesian Estimate: Concordance Correlation Coefficient Download PDF
Chapter  23:  Bayesian Methods: Meta-Analysis Download PDF
Chapter  24:  Bayesian Methods: Stability Analysis Download PDF
Chapter  25:  Bayesian Model: Prior Effective Sample Size Download PDF
Chapter  26:  Bayesian Statistics Download PDF
Chapter  27:  Bayesian Statistics: Medical Device Clinical Trials Download PDF
Chapter  28:  Binary 2 × 2 Crossover Trials Download PDF
Chapter  29:  Bioassay Download PDF
Chapter  30:  Bioavailability and Bioequivalence Download PDF
Chapter  31:  Bioinformatics Download PDF
Chapter  32:  Biologics Download PDF
Chapter  33:  Biomarker Development with Applications to Genetics Data: Statistical Tests Download PDF
Chapter  34:  Biomarker: Clinical Trials Download PDF
Chapter  35:  Biopharmaceutics Download PDF
Chapter  36:  Biosimilar Studies: Sample Size Download PDF
Chapter  37:  Biosimilar Studies: Three-Arm Design Download PDF
Chapter  38:  Biosimilarity Assessment Download PDF
Chapter  39:  Biosimilarity of Follow-On Biologics Download PDF
Chapter  40:  Bivariate Zero-Inflated Poisson Populations: Statistical Test for Homogeneity Download PDF
Chapter  41:  Blinded Sample Size Re-Estimation Download PDF
Chapter  42:  Blinding Download PDF
Chapter  43:  Bootstrap, The Download PDF
Chapter  44:  Botanical Drug Product Development: Scientific Issues Download PDF
Chapter  45:  Bracketing Design Download PDF
Chapter  46:  Bridging Studies Download PDF
Chapter  47:  Bridging Studies: Statistical Methods Download PDF
Chapter  48:  Calibration Download PDF
Chapter  49:  Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD) Download PDF
Chapter  50:  Cancer Chemotherapy: Maximum Tolerable Dose Download PDF
Chapter  51:  Cancer Trials Download PDF
Chapter  52:  Carcinogenicity Studies of Pharmaceuticals Download PDF
Chapter  53:  Carry-Forward Analysis Download PDF
Chapter  54:  Case-Control Studies: Inference in Download PDF
Chapter  55:  Center Weighting: Multicenter Trials Download PDF
Chapter  56:  Clinical Data Management Download PDF
Chapter  57:  Clinical Endpoint Download PDF
Chapter  58:  Clinical Data Management Download PDF
Chapter  59:  Clinical Inspection: Statistical Process Download PDF
Chapter  60:  Clinical Pharmacology Download PDF
Chapter  61:  Clinical Research: Benefit and Risk Assessment Download PDF
Chapter  62:  Clinical Research: Comparing Variabilities Download PDF
Chapter  63:  Clinical Research: Outlier Detection Download PDF
Chapter  64:  Clinical Research: Reproducibility Probability Download PDF
Chapter  65:  Clinical Trial Design: Statistical Assurance Download PDF
Chapter  66:  Clinical Trial Designs with Prospective Patient Population Enrichment by Response Download PDF
Chapter  67:  Clinical Trial Process Download PDF
Chapter  68:  Clinical Trial Simulation Download PDF
Chapter  69:  Clinical Trial Simulations: Earlier Development Phases Download PDF
Chapter  70:  Clinical Trial Simulations: Later Development Phases Download PDF
Chapter  71:  Clinical Trial: Combination Drug Development Download PDF
Chapter  72:  Clinical Trial: Failure-Time Model Download PDF
Chapter  73:  Clinical Trial: N-of-1 Design Analysis Download PDF
Chapter  74:  Clinical Trials Download PDF
Chapter  75:  Clinical Trials: Controversial Issues Download PDF
Chapter  76:  Clinical Trials: Interval-censored Failure Time Data Download PDF
Chapter  77:  Clinical Trials: Investigating Quality-of-Life Download PDF
Chapter  78:  Clinical Trials: Meta-Analysis using R Download PDF
Chapter  79:  Clinical Trials: Response-Adaptive Repeated Measurement Designs Download PDF
Chapter  80:  Clinical Trials: Selection of Control Download PDF
Chapter  81:  Clinical Trials: Vaccine Development Download PDF
Chapter  82:  Cluster Randomized Trials: Sample Size Download PDF
Chapter  83:  Cluster Trials Download PDF
Chapter  84:  Clustered Study Designs: Power Analysis Download PDF
Chapter  85:  Companion Diagnostics Download PDF
Chapter  86:  Comparability Studies: Statistical Considerations Download PDF
Chapter  87:  Confidence Interval and Hypothesis Testing Download PDF
Chapter  88:  Confounding and Interaction Download PDF
Chapter  89:  Content Uniformity Download PDF
Chapter  90:  Continual Reassessment Methods Download PDF
Chapter  91:  Contract Research Organization (CRO): Early 2000s Download PDF
Chapter  92:  Contract Research Organization (CRO) Download PDF
Chapter  93:  Controlled Clinical Trials: P-Values, Evidence, and Multiplicity Considerations Download PDF
Chapter  94:  Correlated Probit Model Download PDF
Chapter  95:  Cost-Effectiveness Analysis Download PDF
Chapter  96:  Covariate-Adjusted Adaptive Dose-Finding: Early Phase Clinical Trials Download PDF
Chapter  97:  Covariates: Adjustment for Download PDF
Chapter  98:  Crossover Design Download PDF
Chapter  99:  Crossover Design: Rank-Based Robust Analysis Download PDF
Chapter  100:  Cutoff Designs Download PDF
Chapter  101:  Data Mining and Biopharmaceutical Research Download PDF
Chapter  102:  Data Monitoring Committees (DMC) Download PDF
Chapter  103:  Diagnostic Device Evaluation Download PDF
Chapter  104:  Diagnostic Imaging Download PDF
Chapter  105:  Diagnostic Procedure: Sensitivity and Specificity Download PDF
Chapter  106:  Disease Modification Effects: Design and Analysis Download PDF
Chapter  107:  Dissolution Profile Comparison: Statistical Methods Download PDF
Chapter  108:  Dissolution Profiles Comparison: Model-Independent Approaches Download PDF
Chapter  109:  Dosage Units Using Small and Large Sample Sizes: Uniformity Download PDF
Chapter  110:  Dose Finding Clinical Trials Using R Download PDF
Chapter  111:  Dose Proportionality Download PDF
Chapter  112:  Dose Response Analysis in Clinical Trials Download PDF
Chapter  113:  Dose Response Study Design Download PDF
Chapter  114:  Dose-Ranging Studies: Design Considerations Download PDF
Chapter  115:  Dropout Download PDF
Chapter  116:  Drug Development Download PDF
Chapter  117:  Drug Interchangeability: Biosimilar Products Download PDF
Chapter  118:  Drug Interchangeability: Criteria and Design Download PDF
Chapter  119:  Drug Interchangeability: Meta-Analysis for Safety Monitoring Download PDF
Chapter  120:  Drug Interchangeability: Generic Products, Prescribability and Switchability Download PDF
Chapter  121:  Ecologic Inference Download PDF
Chapter  122:  Ed/Ed  Download PDF
Chapter  123:  Enrichment Design Download PDF
Chapter  124:  Enrichment Design with Patient Population Augmentation Download PDF
Chapter  125:  Equivalence Trials Download PDF
Chapter  126:  Ethnic Factors Download PDF
Chapter  127:  Expiration Dating Period Download PDF
Chapter  128:  Exploratory Factor Analysis Download PDF
Chapter  129:  Extra Variation Models Download PDF
Chapter  130:  Factor Analysis Download PDF
Chapter  131:  Factorial Designs Download PDF
Chapter  132:  False Discovery Rate (FDR) Download PDF
Chapter  133:  GEE in Cancer Research Download PDF
Chapter  134:  Generalizability Probability in Clinical Research Download PDF
Chapter  135:  Generalized Estimating Equation Download PDF
Chapter  136:  Generalized Inference Download PDF
Chapter  137:  Genetic Linkage and Linkage Disequilibrium Analysis Download PDF
Chapter  138:  Global Database and System Download PDF
Chapter  139:  Good Clinical Practice (GCP) Download PDF
Chapter  140:  Good Laboratory Practice (GLP) Download PDF
Chapter  141:  Good Programming Practice (GPP) Download PDF
Chapter  142:  Good Statistics Practice (GSP) Download PDF
Chapter  143:  Good Validation Practice (GVP) Download PDF
Chapter  144:  Group Sequential Methods Download PDF
Chapter  145:  Group Sequential Tests and Variance Heterogeneity: Clinical Trials Download PDF
Chapter  146:  Human Drug Abuse Trials Download PDF
Chapter  147:  Hypothesis Testing Download PDF
Chapter  148:  Imputation with Item Nonrespondents Download PDF
Chapter  149:  Imputation: Clinical Research Download PDF
Chapter  150:  In Vitro Testing: Bioequivalence Download PDF
Chapter  151:  In Vitro Testing: Dissolution Profile Comparison Download PDF
Chapter  152:  In Vitro Testing: Micronucleus Test Download PDF
Chapter  153:  Individual Bioequivalence Download PDF
Chapter  154:  Instrument Development and Validation Download PDF
Chapter  155:  Integrated Summary Report Download PDF
Chapter  156:  Intention-to-Treat Analyses (ITT) Download PDF
Chapter  157:  Interchangeability: Generic Drugs Download PDF
Chapter  158:  Interim Analysis Download PDF
Chapter  159:  International Conference on Harmonization (ICH) Download PDF
Chapter  160:  Item Response Theory Download PDF
Chapter  161:  IVRS/IWRS for Randomization Download PDF
Chapter  162:  Japan: Ministry of Health, Labour and Welfare and Pharmaceutical Administration Download PDF
Chapter  163:  Kaplan–Meier Estimator Download PDF
Chapter  164:  Kappa Coefficients: Medical Research Download PDF
Chapter  165:  Kruskal-Wallis Test for Ordered Categorical Data: Power Calculation Download PDF
Chapter  166:  Kullback–Leibler Divergence for Evaluating Equivalence Download PDF
Chapter  167:  Laboratory Analyses Download PDF
Chapter  168:  Latent Class Analysis Download PDF
Chapter  169:  Lilly Reference Ranges Download PDF
Chapter  170:  Local Influence Analysis Download PDF
Chapter  171:  LOCF: Validity Download PDF
Chapter  172:  Logistic Regression Download PDF
Chapter  173:  Logistic Regression Process: Predictive Model Building in Clinical Research Download PDF
Chapter  174:  Logistic Regression: Three-Point Designs Download PDF
Chapter  175:  McNemar’s Test Download PDF
Chapter  176:  MCP-Mod: Dose–Response Testing and Estimation Download PDF
Chapter  177:  Measuring Agreement Download PDF
Chapter  178:  MedDRA: Impact on Pharmaceutical Development Download PDF
Chapter  179:  Medical Devices Download PDF
Chapter  180:  Meta-Analysis of Therapeutic Trials Download PDF
Chapter  181:  Microarray Gene Expression Download PDF
Chapter  182:  Microdosing Studies Download PDF
Chapter  183:  Minimization Procedure Download PDF
Chapter  184:  Minimum Effective Dose Download PDF
Chapter  185:  Mixed Effects Models Download PDF
Chapter  186:  Mixed-Outcome Data Download PDF
Chapter  187:  MMRM with Missing Data Download PDF
Chapter  188:  Modified Large Sample Method Download PDF
Chapter  189:  Multicenter Trials Download PDF
Chapter  190:  Multicollinearity Download PDF
Chapter  191:  Multidimensional Data Analysis: Penalized Regression Methods Download PDF
Chapter  192:  Multinational Clinical Trials Download PDF
Chapter  193:  Multiple Comparisons Download PDF
Chapter  194:  Multiple Endpoints Download PDF
Chapter  195:  Multiple-Dose Bioequivalence Studies Download PDF
Chapter  196:  Multiple-Stage Designs: Phase II Cancer Trials Download PDF
Chapter  197:  Multiplicative Intensity Models Download PDF
Chapter  198:  Multiplicity in Clinical Trials Download PDF
Chapter  199:  Multi-Regional Clinical Trials: Consistency Test Download PDF
Chapter  200:  Multiregional Clinical Trials: Qualitative Consistency of Treatment Effects Download PDF
Chapter  201:  Multivariate Meta-Analysis Download PDF
Chapter  202:  Noninferiority Trials: Type I Error Rates Download PDF
Chapter  203:  Nonparametric Regression Download PDF
Chapter  204:  Odds Ratio Download PDF
Chapter  205:  Oncology Clinical Trials: Efficient Dose-Finding Designs Download PDF
Chapter  206:  Oncology Trials: Development Strategy Download PDF
Chapter  207:  Onset of Action Download PDF
Chapter  208:  Optimal Futility Interim Design Download PDF
Chapter  209:  Ordered Categorical Data: Test for Download PDF
Chapter  210:  Ordered Multiple Class Receiver Operating Characteristic (ROC) Analysis Download PDF
Chapter  211:  Ordinal Data: Crossover Design Analysis Download PDF
Chapter  212:  Parallel Design Download PDF
Chapter  213:  Patient Compliance Download PDF
Chapter  214:  Patient-Reported Outcomes Download PDF
Chapter  215:  Percentile Charts on Correlated Measures Download PDF
Chapter  216:  Personalized Medicine: Validation of Diagnostic Medical Devices Download PDF
Chapter  217:  Pharmaceutical Development: Statistical Designs Download PDF
Chapter  218:  Pharmacodynamic Issues Download PDF
Chapter  219:  Pharmacodynamics with Covariates Download PDF
Chapter  220:  Pharmacodynamics with No Covariates Download PDF
Chapter  221:  Pharmacoeconomics Download PDF
Chapter  222:  Pharmacoeconomics: Cost-Effectiveness Analysis Download PDF
Chapter  223:  Phase I Cancer Clinical Trials Download PDF
Chapter  224:  Phase II Clinical Development Download PDF
Chapter  225:  Phase III Clinical Trials with Response-Adaptive Allocation Download PDF
Chapter  226:  Placebo Effect Download PDF
Chapter  227:  Population Bioequivalence Download PDF
Chapter  228:  Population PK/PD Analysis Download PDF
Chapter  229:  Postmarketing Adverse Drug Event Signaling Download PDF
Chapter  230:  Postmarketing Surveillance Download PDF
Chapter  231:  Power Download PDF
Chapter  232:  Precision Medicine: Statistical Issues Download PDF
Chapter  233:  Prediction Trees Download PDF
Chapter  234:  Premarket Applications: Registries Download PDF
Chapter  235:  Principal Component Analysis Download PDF
Chapter  236:  Process Validation Download PDF
Chapter  237:  Profile Analysis Download PDF
Chapter  238:  Propensity Score Analysis and Its Application in Regulatory Settings Download PDF
Chapter  239:  Propensity Score: Methodology and Application to Clinical Studies Download PDF
Chapter  240:  Proportion of Treatment Effect Download PDF
Chapter  241:  Proportional Hazards Regression Model Download PDF
Chapter  242:  Protocol Development Download PDF
Chapter  243:  P-Values Download PDF
Chapter  244:  QT Analysis Download PDF
Chapter  245:  Quality by Design in Biopharmaceutical Development Download PDF
Chapter  246:  Randomization Download PDF
Chapter  247:  Randomized Trials with Clusters: Design and Analysis Download PDF
Chapter  248:  Rank Regression: Stability Analysis Download PDF
Chapter  249:  Regulatory Statistics Download PDF
Chapter  250:  Release Targets Download PDF
Chapter  251:  Reliability Download PDF
Chapter  252:  Repeated Measurement Designs: Missing Values Download PDF
Chapter  253:  Repeated Measures Data with Missing Values Analysis: Overview of Methods Download PDF
Chapter  254:  Reproductive and Developmental Studies Download PDF
Chapter  255:  Response Surface Methodology Download PDF
Chapter  256:  Response-Adaptive Designs Download PDF
Chapter  257:  Risk Ratio Analysis Download PDF
Chapter  258:  ROC Curve Download PDF
Chapter  259:  Sample Size Calculation: Nonparametrics Download PDF
Chapter  260:  Sample Size Calculation: Survival Data Download PDF
Chapter  261:  Sample Size Determination Download PDF
Chapter  262:  Sample Size Determination: Three-arm Ratio of Mean Differences Equivalence Test Download PDF
Chapter  263:  Sample Size Estimation: Generalized Estimating Equations (GEE) Method Download PDF
Chapter  264:  Sample Size for Multiregional Clinical Trials Download PDF
Chapter  265:  Sample Size Re-estimation Based on Observed Treatment Difference Download PDF
Chapter  266:  Sample Size Re-estimation Design with Robust Power Download PDF
Chapter  267:  Sample Size: Negative Binomial With Unequal Follow-Up Times Download PDF
Chapter  268:  Scaled Average Bioequivalence (SABE) Download PDF
Chapter  269:  Screening Design Download PDF
Chapter  270:  Seamless Adaptive Trial Design: Dose Selection Criteria Download PDF
Chapter  271:  Semi-Parametric Time-Varying Regression Models Download PDF
Chapter  272:  Sequential Estimation: Additive Hazards Rate Model with Staggered Entry Download PDF
Chapter  273:  Signal Detection in Pharmacovigilance Download PDF
Chapter  274:  Slope Approach: Assessment of Dose Proportionality and Linearity Under a Crossover Design Download PDF
Chapter  275:  Spatio-Temporal Modeling Download PDF
Chapter  276:  Specifications Download PDF
Chapter  277:  SROC Curve Download PDF
Chapter  278:  Stability Analysis: Frozen Drug Products Download PDF
Chapter  279:  Stability Matrix Designs Download PDF
Chapter  280:  Statistical Genetics Download PDF
Chapter  281:  Statistical Principles for Clinical Trials Download PDF
Chapter  282:  Statistical Process Control Download PDF
Chapter  283:  Statistical Significance Download PDF
Chapter  284:  Structural Equation Model Download PDF
Chapter  285:  Stuart–Maxwell Test Download PDF
Chapter  286:  Subgroup Analysis Download PDF
Chapter  287:  Subject-Treatment Interaction Download PDF
Chapter  288:  Surrogate Endpoint Download PDF
Chapter  289:  Survival Analysis Download PDF
Chapter  290:  Targeted Clinical Trials Download PDF
Chapter  291:  Testing for Qualitative Interaction Download PDF
Chapter  292:  Therapeutic Equivalence Download PDF
Chapter  293:  Thorough QT Studies Download PDF
Chapter  294:  Tiered Approach of Analytical Similarity Assessment: Statistical Methods Download PDF
Chapter  295:  Titration Design Download PDF
Chapter  296:  Toxicological Studies Download PDF
Chapter  297:  Traditional Chinese Medicine (TCM): Clinical Development Download PDF
Chapter  298:  Traditional Chinese Medicine (TCM): General Considerations Download PDF
Chapter  299:  Traditional Chinese Medicine (TCM): Unified Approach for Evaluation Download PDF
Chapter  300:  Translational Medicine: Concepts, Statistical Methods, and Related Issues Download PDF
Chapter  301:  Trend Estimation Download PDF
Chapter  302:  Two-Stage Adaptive Design: Analysis Download PDF
Chapter  303:  Two-Stage Design: Phase II Cancer Clinical Trials Download PDF
Chapter  304:  US Food and Drug Administration Download PDF
Chapter  305:  USP Tests Download PDF
Chapter  306:  Validation of Quantitative and Qualitative Assays Download PDF
Chapter  307:  Weibull Model: Group Sequential Design Download PDF
Chapter  308:  Z-Score Download PDF
Index Download PDF
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