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基本説明
A definitive statistics reference for biopharmaceutical research and manufacturing, presenting current standards and best practices for the laboratory, manufacturing, and statistical design, investigation, and analysis. Previous ed.: 2003.
Full Description
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 230
Updated information on changes in regulatory requirements for drug review/approval processes
Recent developments in statistical design and methodology
Important topics, including adaptive design in clinical research, translational medicine, statistical genetics, biomarker development, target clinical trials, follow-on biologics, and traditional Chinese medicine
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Contents
Acceptance 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 x 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 Distribution
