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New drug development: design, methodology, and analysis

Author: Turner, J. Rick Series: Statistics in practice Publisher: Wiley, 2007.Language: EnglishDescription: 270 p. : Graphs/Ill. ; 24 cm.ISBN: 9780470073735Type of document: BookBibliography/Index: Includes bibliographical references and index
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Item type Current location Collection Call number Status Date due Barcode Item holds
Book Europe Campus
Main Collection
Print HC2000 .P4 T87 2007
(Browse shelf)
001243291
Available 001243291
Total holds: 0

Includes bibliographical references and index

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New Drug Development Design, Methodology, and Analysis Contents FOREWORD PREFACE PART I INTRODUCTION CHAPTER 1. NEW DRUG DEVELOPMENT 1.1 Introduction 1.2 Origin and Goals of the Book 1.3 The Discipline of Statistics 1.4 A Lifecycle Perspective on New Drug Development 1.5 Design, Methodology, and Analysis 1.6 Drug Discovery 1.7 Nonclinical Development 1.8 Clinical Development 1.9 Pharmaceutical Manufacturing 1.10 Definitions of Clinical Research and Clinical Trials 1.11 The Fourth Central Character in This Book--Biology CHAPTER 2. THE REGULATORY ENVIRONMENT FOR NEW DRUG DEVELOPMENT 2.1 Introduction 2.2 The Food and Drug Administration 2.3 cGMP, cGLP, and cGCP 2.4 Regulatory Aspects of New Drug Development 2.5 Sponsor and Regulatory Agency Responsibilities 2.6 The Investigational New Drug Application 2.7 The New Drug Application 2.8 The Common Technical Document PART II DRUG DISCOVERY AND NONCLINICAL RESEARCH CHAPTER 3. DRUG DISCOVERY 3.1 Introduction 3.2 Overview of Pharmaceutics, Pharmacokinetics, and Pharmacodynamics 3.3 Medicinal Chemistry 3.4 Cheminformatics, Bioinformatics, and Computer-Aided Molecular Design 3.5 Future Trends in Small-Molecule Drug Development 3.6 Biopharmaceuticals 3.7 Clinical Trials for Small-Molecule and Biopharmaceutical Drug Candidates XIII XV 3 4 4 6 6 7 7 8 11 12 13 17 18 20 20 21 22 25 27 31 32 36 39 40 41 45 CHAPTER 4. NONCLINICAL RESEARCH 4.1 Introduction 4.2 Pharmacokinetics 4.3 Pharmacology 4.4 Toxicological Studies 4.5 Design, Methodology, and Analysis Considerations PART III DESIGN, METHODOLOGY, AND ANALYSIS CHAPTER 5. DESIGN AND METHODOLOGY IN CLINICAL TRIALS 5.1 Introduction 5.2 Design 5.3 Methodology 5.4 Ethical Aspects of Design and Methodology 5.5 Study Design in Drug Clinical Trials 5.6 Central Principles of Experimental Design in Clinical Trials 5.7 The Clinical Study Protocol 5.8 Collecting Data: The Case Report Form 5.9 Clinical Data Management 5.10 Monitoring Clinical Trials 5.11 Project Management 5.12 Blood Pressure and Blood Pressure Measurement CHAPTER 6. STATISTICAL ANALYSIS 6.1 Introduction 6.2 Types of Clinical Data 6.3 Descriptive Statistics: Summarizing Data 6.4 Inferential Statistics: Hypothesis Testing 6.5 Probability 6.6 The Normal Distribution 6.7 Analysis of Association CHAPTER 7. STATISTICAL SIGNIFICANCE: EMPLOYMENT OF HYPOTHESIS TESTING 7.1 Introduction 7.2 Creating a Research Question and Associated Hypotheses 7.3 Precise Expression of the Research Hypothesis and the Null Hypothesis: The Concept of Statistical Significance 7.4 Hypothesis Testing 7.5 Conducting a Statistical Test and Obtaining a Test Statistic 7.6 The Independent Groups t-Test 7.7 The Dependent Measures t-Test 7.8 Analysis of Variance 7.9 One-Factor Independent Groups ANOVA 47 47 50 53 56 61 61 61 62 62 66 71 73 74 76 77 77 83 84 86 87 90 93 96 101 101 102 103 104 104 110 111 112 7.10 General Comments on Multiple-Comparison Testing 7.11 Possible Clinical Interpretations of Statistical Results CHAPTER 8. CLINICAL SIGNIFICANCE: EMPLOYMENT OF CONFIDENCE INTERVALS 8.1 Introduction 8.2 The Logic of Confidence Intervals 8.3 Confidence Intervals for a Sample Mean 8.4 Confidence Intervals for the Difference Between Treatment Group Means 8.5 Relationship of the 95% CI and 99% CI to the 0.05 and 0.01 p-Values 8.6 The Additional Benefit of Using Confidence Intervals CHAPTER 9. SAMPLE-SIZE ESTIMATION 9.1 Introduction 9.2 Ethical Issues in Sample-Size Estimation 9.3 Variables Involved in Sample-Size Estimation 9.4 Type I And Type II Errors 9.5 Choosing the Variables Needed for Sample-Size Estimation 9.6 Using the Appropriate Formula to Yield the Sample Size 9.7 Influences on the Sponsor's Choice of These Values 9.8 Choosing the Objective(s) on Which to Base the Sample-Size Estimation 9.9 Other Issues to Keep in Mind PART IV LIFECYCLE CLINICAL DEVELOPMENT CHAPTER 10. SAFETY ASSESSMENT IN CLINICAL TRIALS 10.1 Introduction 10.2 Classification of Clinical Trials 10.3 The Wide Variety of Clinical Assessments Conducted 10.4 Human Pharmacology Trials 10.5 Therapeutic Exploratory Studies 10.6 Therapeutic Confirmatory Clinical Trials 10.7 Therapeutic Use Trials 10.8 The Term "Dose" 10.9 Clinical Pharmacokinetics and Pharmacodynamics 10.10 Pharmacokinetic Parameters 10.11 Mechanisms of Genetic Influences on Metabolism 10.12 Investigation of Pharmacokinetics in Special Populations 10.13 Types of Safety-Related Data 10.14 Acquisition of Safety Data 10.15 Common Laboratory Tests 10.16 Analysis Populations Used for Safety Data 10.17 Presentation of Data in Regulatory Clinical Study Reports 117 118 121 121 122 123 124 124 127 128 129 130 131 133 133 134 135 139 139 140 142 143 144 144 144 145 146 149 150 153 156 158 159 160 CHAPTER 11. EFFICACY ASSESSMENT IN CLINICAL TRIALS 11.1 Introduction 11.2 Analysis Populations for Efficacy Analyses 11.3 Hypothesis Testing Is Integral to All of the Designs Discussed Here 11.4 Superiority Trials 11.5 Equivalence Trials 11.6 Noninferiority Trials 11.7 Bioequivalence Studies 11.8 Group Sequential Designs 11.9 Adaptive Designs 11.10 Bayesian Approaches to Analyzing Clinical Trials 165 166 168 169 173 177 179 180 186 189 CHAPTER 12. PHARMACEUTICAL AND BIOPHARMACEUTICAL DRUG MANUFACTURING 12.1 Introduction 191 12.2 Nonclinical Development 192 12.3 Drug Products for Clinical Trials 192 12.4 Commercial Manufacturing 194 12.5 Quality Control: Building Quality into the Process 195 12.6 Stability Studies 196 12.7 Immediate Release and Modified Release Tablets and Capsules 196 12.8 Producing Recombinant Protein Biopharmaceuticals 197 CHAPTER 13. POSTMARKETING SURVEILLANCE AND EVIDENCEBASED MEDICINE 13.1 Introduction 13.2 Limitations of Preapproval Clinical Trials 13.3 Postmarketing Surveillance 13.4 The Institute of Medicine's 2006 Report on Drug Safety 13.5 Effectiveness 13.6 Publishing Clinical Research in Peer-Reviewed Clinical Journals 13.7 Evidence-Based Medicine PART V INTEGRATIVE DISCUSSION CHAPTER 14. UNIFYING THEMES AND CONCLUDING COMMENTS 14.1 Introduction 14.2 Ethical Considerations 14.3 Design, Methodology, and Analysis 14.4 Pharmacokinetics and Pharmacodynamics 14.5 Decision Making 14.6 Pharmacogenetics 14.7 Pharmacogenomics 201 202 203 205 206 207 212 217 217 218 222 222 225 227 14.8 Pharmacoproteomics: Proteomics and Drug Therapy 14.9 The Costs of Pharmaceutical Development 14.10 FDA's Critical Path Report and Critical Path Opportunities List 14.11 Coming Full Circle: Revisiting the Book's "Opening Quotes" 14.12 Concluding Comments 228 235 236 238 239 APPENDIX. ADDITIONAL RESOURCES FOR TRAINING EXECUTIVES AND PROFESSORS Main Resources 242 Supplemental Materials 243 Websites 244 REFERENCES INDEX ABOUT THE AUTHOR 245 259 271

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