Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Description

Content: Cover Half Title Title Page Copyright Page Brief Content Table of Contents Contributors Topical Table of Contents Preface About the Editor-in-Chief Volume I Acceptance Sampling Active Control Non-Inferiority Trials: Hypotheses and False Positive Rate Active Control Trials Active Controlled Clinical Trials: Noninferiority Analysis Adaptive Design Clinical Trials: Case Studies Adaptive Design Methods in Clinical Trials Adaptive Survival Trials Adverse Event Reporting Alpha Spending Function Ames Test Analysis of 2 × K Tables Analysis of Clustered Binary Data. Analysis of Clustered Categorical DataAnalysis of Heritability Analysis of Variance (ANOVA) Analytical Similarity Assessment ANCOVA Approach: Premarketing Shelf Life Determination with Multiple Factors Assay Development Assay Validation Assay Validation: Evaluation of Linearity Bayesian Designs: Phase II Oncology Clinical Trials Bayesian Estimate: Concordance Correlation Coefficient Bayesian Methods: Meta-Analysis Bayesian Methods: Stability Analysis Bayesian Model: Prior Effective Sample Size Bayesian Statistics Bayesian Statistics: Medical Device Clinical Trials. Binary 2 × 2 Crossover TrialsBioassay Bioavailability and Bioequivalence Bioinformatics Biologics Biomarker Development with Applications to Genetics Data: Statistical Tests Biomarker: Clinical Trials Biopharmaceutics Biosimilar Studies: Sample Size Biosimilar Studies: Three-Arm Design Biosimilarity Assessment Biosimilarity of Follow-On Biologics Bivariate Zero-Inflated Poisson Populations: Statistical Test for Homogeneity Blinded Sample Size Re-Estimation Blinding Bootstrap, The Botanical Drug Product Development: Scientific Issues Bracketing Design Bridging Studies. Bridging Studies: Statistical MethodsCalibration Canadian Health Products and Food Branch (HPFB) and Therapeutic Products Directorate (TPD) Cancer Chemotherapy: Maximum Tolerable Dose Cancer Trials Carcinogenicity Studies of Pharmaceuticals Carry-Forward Analysis Case-Control Studies: Inference in Center Weighting: Multicenter Trials Clinical Data Management Clinical Endpoint Clinical Endpoint BE Studies: Generic Drugs Clinical Inspection: Statistical Process Clinical Pharmacology Clinical Research: Benefit and Risk Assessment Clinical Research: Comparing Variabilities. Clinical Research: Outlier DetectionClinical Research: Reproducibility Probability Clinical Trial Design: Statistical Assurance Clinical Trial Designs with Prospective Patient Population Enrichment by Response Clinical Trial Process Clinical Trial Simulation Clinical Trial Simulations: Earlier Development Phases Clinical Trial Simulations: Later Development Phases Clinical Trial: Combination Drug Development Clinical Trial: Failure-Time Model Clinical Trial: N-of-1 Design Analysis Clinical Trials Clinical Trials: Controversial Issues Volume II.