| Document Type
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BL
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| Record Number
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1026910
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| Doc. No
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b781280
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| Title & Author
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Principles of anticancer drug development /\ edited by Manuel Hidalgo [and others].
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| Publication Statement
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New York :: Springer,, ©2011.
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| Series Statement
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Cancer Drug Discovery and Development
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| Page. NO
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1 online resource (xvii, 673 pages) :: illustrations (some color)
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| ISBN
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1441973575
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: 1441973583
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: 9781441973573
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: 9781441973580
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9781441973573
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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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
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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
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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
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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)
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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
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| Abstract
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This is a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
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| Subject
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Antineoplastic agents-- Development.
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Cancer-- Treatment.
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Drug development.
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Antineoplastic Agents-- pharmacokinetics.
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Cancer Vaccines-- therapeutic use.
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Clinical Trials as Topic.
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Neoplasms-- drug therapy.
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Antineoplastic agents-- Development.
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Cancer-- Treatment.
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Drug development.
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Médecine.
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MEDICAL-- Pharmacology.
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| Dewey Classification
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615/.798
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| LC Classification
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RC271.C5P7435 2011eb
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RC271.C5P75 2011
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| NLM classification
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2011 C-566
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QV 269
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| Added Entry
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Hidalgo, Manuel,MD.
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