Principles of Anticancer Drug Development [electronic resource] /
Garrett-Mayer, Elizabeth.editor.
A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
Principles of Anticancer Drug Development; Blurb; Preface; Contents; Contributors; Part I; Chapter 1: Basic Biostatistics for the Clinical Trialist; 1.1 Introduction; 1.2 Example; 1.3 Aims, Endpoints, and Data Analysis; 1.4 Variable Types; 1.4.1 Continuous Variables; 1.4.2 Categorical Variables; 1.4.3 Time-to-Event Variables; 1.4.4 Variable Transformation; 1.5 Data Description and Displays; 1.5.1 Continuous Variables; 1.5.2 Categorical Variables; 1.5.3 Time-to-Event Variables; 1.5.4 Confidence Intervals; 1.5.5 Confidence Intervals for Means and Differences in Means
1.5.6 Confidence Intervals for Proportions and Comparisons of Proportions1.5.7 Confidence Intervals for Time-to-Event Parameters; 1.6 Hypothesis Testing; 1.6.1 From Research Question to Statistical Hypothesis; 1.6.2 Evaluating Evidence Through p-values; 1.6.3 Types of Errors; 1.7 Common One- and Two-Sample Tests; 1.7.1 Comparing Proportions; 1.7.2 Comparing Means; 1.7.3 The Chi-Square Test; 1.7.4 Fisher's Exact Test; 1.7.5 Testing Paired Data; 1.7.6 Comparing Survival Times; 1.8 How Many Subjects Do I Need?; 1.8.1 Precision-Based Calculations; 1.8.2 Test-Based Calculations
1.9 Multivariable Regression Analyses1.9.1 Logistic Regression; 1.9.2 Cox Proportional Hazards Regression; References; Chapter 2: Fundamental Concepts in Clinical Pharmacology; 2.1 Introduction; 2.2 Glossary; 2.2.1 Pharmacokinetic Terms; 2.2.2 Pharmacodynamic Terms; 2.2.3 Modeling Terms; 2.3 Sampling Schedule and Study Design; 2.4 Patient Numbers and Sampling Intensity; 2.5 What is the Goal of the PK Study?; 2.6 Pharmacokinetics; 2.7 Pharmacokinetic Models; 2.7.1 Compartmental Modeling; 2.7.1.1 One-Compartment Model; 2.7.1.2 Multicompartment Models; 2.7.2 Nonlinear Pharmacokinetics
2.7.3 Noncompartmental Pharmacokinetics2.7.4 Physiologically Based Pharmacokinetic Models; 2.7.5 Population Pharmacokinetics; References; Chapter 3: Bioanalytical Methods in Clinical Drug Development; 3.1 Introduction; 3.2 Methods for Sample Preparation; 3.2.1 Total Drug Measurements; 3.2.1.1 Protein Precipitation; 3.2.1.2 Solid Phase Extraction; 3.2.1.3 Liquid-Liquid Extraction; 3.2.2 Unbound Drug Measurements; 3.2.2.1 Equilibrium Dialysis; 3.2.2.2 Ultrafiltration; 3.2.2.3 Ultracentrifugation; 3.2.2.4 Protein Precipitation; 3.2.2.5 Microdialysis (Extracellular Fluid)
3.3 Methods for Sample Separation3.3.1 Liquid Chromatography; 3.3.1.1 Ultraviolet and Visible Spectroscopy; 3.3.1.2 Fluorescence; 3.3.1.3 Electrical Conductivity; 3.3.1.4 Mass Spectrometry; 3.3.2 Gas Chromatography; 3.3.3 Atomic Spectroscopy; 3.3.3.1 Atomic Absorption Spectroscopy; 3.3.3.2 Inductively Coupled Plasma Mass Spectrometry; 3.4 Validation Requirements; 3.4.1 Range of Reliable Response, Linearity, and Calibration Curves; 3.4.2 Selectivity or Specificity; 3.4.3 Sensitivity; 3.4.4 Accuracy; 3.4.5 Reproducibility; 3.4.6 Stability; 3.4.7 Matrix Effect in LC-MS/MS Based Methods
3.4.8 Recovery
"A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs"--P.v.
Includes bibliographical references and index.
A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
Cancer research.
Cancer Research.
Cancer Drug Discovery and Development