Acceptance Sampling
Active Control Trials
Adaptive Designs in Clinical Research
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 for Stability Analysis
Bayesian Methods in Meta-Analysis
Bayesian Statistics
Bayesian Two-Stage Design for Phase II Clinical Trials
Binary 2×2 Cross-over 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
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-Modifying 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 Control Non-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 Endpoints
Multiple-Dose Bioequivalence Studies
Multiple-Stage Designs for Phase II Cancer Trials
Multiplicative Intensity Models
Multiplicity in Clinical Trials
Multivariate Meta-Analysis
Noninferiority Analysis in Active Controlled Clinical Trials
Nonparametric 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 Analysis
Proportion of Treatment Effect
Proportional Hazards Regression Model
Protocol Development
QT Analysis
Randomization
Rank Regression in Stability Analysis
Rank-Based Robust Analysis for Crossover Design
Release Targets
Reliability
Reproducibility Probability in Clinical Research
Reproductive/Developmental Studies
Response Surface Methodology
Response-Adaptive Designs
Response-Adaptive Repeated Measurement Designs for Clinical Trials
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
Structual 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
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 (ZIP) Distribution
Active Control Trials
Adaptive Designs in Clinical Research
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 for Stability Analysis
Bayesian Methods in Meta-Analysis
Bayesian Statistics
Bayesian Two-Stage Design for Phase II Clinical Trials
Binary 2×2 Cross-over 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
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-Modifying 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 Control Non-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 Endpoints
Multiple-Dose Bioequivalence Studies
Multiple-Stage Designs for Phase II Cancer Trials
Multiplicative Intensity Models
Multiplicity in Clinical Trials
Multivariate Meta-Analysis
Noninferiority Analysis in Active Controlled Clinical Trials
Nonparametric 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 Analysis
Proportion of Treatment Effect
Proportional Hazards Regression Model
Protocol Development
QT Analysis
Randomization
Rank Regression in Stability Analysis
Rank-Based Robust Analysis for Crossover Design
Release Targets
Reliability
Reproducibility Probability in Clinical Research
Reproductive/Developmental Studies
Response Surface Methodology
Response-Adaptive Designs
Response-Adaptive Repeated Measurement Designs for Clinical Trials
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
Structual 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
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 (ZIP) Distribution
Dr Shein-Chung Chow, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
Dr. Chow is currently a professor at the Department of Biostatistics and Bioinformatics at the Duke University School of Medicine and a professor of Clincial Sciences at Duke-NUS (National University of Singapore) in Singapore. Dr. Chow received a B.S. in mathematics from National Taiwan University, Taiwan, and a Ph.D. in statistics from the University of Wisconsin in Madison, Wisconsin.
Prior to joining Duke University, he was the Director of the Taiwan Cooperative Oncology Group Statistical Center and the Executive Director of the National Clinical Trial Network Coordination Center. Dr. Chow has also held various positions in the pharmaceutical industry, including vice president of biostatistics, data management, and medical writing at Millennium Pharmaceuticals, Inc., and executive director of statistics and clinical programming at Covance, Inc.
At the Duke University’s Clinical Research Unit, Dr. Chow identifies the best statistical and data management practices; organizes and leads working parties for the development of statistical designs, analyses and presentation applications; and participates in Data Safety Monitoring Boards in clinical research and development.
Dr. Chow's professional activities include playing key roles in many professional organizations. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. He was the recipient of the DIA Outstanding Service Award (1996), ICSA Extraordinary Achievement Award (1996), and Chapter Service Recognition Award of the American Statistical Association (1998).
Dr. Chow is the author or co-author of 190 methodology papers and 18 books, including this latest Edition of the Encyclopedia of Biopharmaceutical Statistics.
Dr. Chow is currently a professor at the Department of Biostatistics and Bioinformatics at the Duke University School of Medicine and a professor of Clincial Sciences at Duke-NUS (National University of Singapore) in Singapore. Dr. Chow received a B.S. in mathematics from National Taiwan University, Taiwan, and a Ph.D. in statistics from the University of Wisconsin in Madison, Wisconsin.
Prior to joining Duke University, he was the Director of the Taiwan Cooperative Oncology Group Statistical Center and the Executive Director of the National Clinical Trial Network Coordination Center. Dr. Chow has also held various positions in the pharmaceutical industry, including vice president of biostatistics, data management, and medical writing at Millennium Pharmaceuticals, Inc., and executive director of statistics and clinical programming at Covance, Inc.
At the Duke University’s Clinical Research Unit, Dr. Chow identifies the best statistical and data management practices; organizes and leads working parties for the development of statistical designs, analyses and presentation applications; and participates in Data Safety Monitoring Boards in clinical research and development.
Dr. Chow's professional activities include playing key roles in many professional organizations. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. He was the recipient of the DIA Outstanding Service Award (1996), ICSA Extraordinary Achievement Award (1996), and Chapter Service Recognition Award of the American Statistical Association (1998).
Dr. Chow is the author or co-author of 190 methodology papers and 18 books, including this latest Edition of the Encyclopedia of Biopharmaceutical Statistics.
Reviews for the previous (Second) Edition
"…an essential desktop reference….fine for taking some pertinent topic in biostatistics and quickly learning about it." - Technometrics
"…an impressively presented hardback….you receive plenty for your money." - The Statistician
"…the contributors are well-known…highly recommended." - Choice
“Excellent compendium on stat[istical] methods in biostatistics. Chow has done an excellent job of collecting articles from the leading researchers in the pharmaceutical and biologics industries, including FDA employees. The terms are specialized but important to those industries. The articles are scholarly and informative…. This is a particularly good reference for statisticians who work on clinical trials regulated by the FDA.” - Michael R Chernick, Manager, Biostatistical Services, Lankenau Institute for Medical Research
"…an essential desktop reference….fine for taking some pertinent topic in biostatistics and quickly learning about it." - Technometrics
"…an impressively presented hardback….you receive plenty for your money." - The Statistician
"…the contributors are well-known…highly recommended." - Choice
“Excellent compendium on stat[istical] methods in biostatistics. Chow has done an excellent job of collecting articles from the leading researchers in the pharmaceutical and biologics industries, including FDA employees. The terms are specialized but important to those industries. The articles are scholarly and informative…. This is a particularly good reference for statisticians who work on clinical trials regulated by the FDA.” - Michael R Chernick, Manager, Biostatistical Services, Lankenau Institute for Medical Research
