Outline of the Book
The book begins with a review of statistical problems arising in pharmaceutical drug development (Chapter 1, "Statistics in Drug Development"). This introductory chapter is followed by thirteen chapters that deal with statistical approaches used in drug discovery experiments, animal toxicology studies and clinical trials. Since some of the chapters discuss methods that are relevant at multiple stages of drug development (e.g., nonparametric methods), the chapters in this book are not grouped by the development stage. Table helps the reader identify chapters that deal with a particular area in pharmaceutical statistics.
| Chapter | Drug discovery | Animal toxicology | Clinical trials |
|---|---|---|---|
| Chapter 2, "Modern Classification Methods for Drug Discovery" | • | ||
| Chapter 3, "Model Building Techniques in Drug Discovery" | • | ||
| Chapter 4, "Statistical Considerations in Analytical Method Validation" | • | ||
| Chapter 5, "Some Statistical Considerations in Nonclinical Safety Assessment" | • | ||
| Chapter 6, "Nonparametric Methods in Pharmaceutical Statistics" | • | • | |
| Chapter 7, "Optimal Design of Experiments in Pharmaceutical Applications" | • | • | |
| Chapter 8, "Analysis of Human Pharmacokinetic Data" | • | ||
| Chapter 9, "Allocation in Randomized Clinical Trials" | • | ||
| Chapter 10, "Sample-Size Analysis for Traditional Hypothesis Testing: Concepts and Issues" | • | ||
| Chapter 11, "Design and Analysis of Dose-Ranging Clinical Studies" | • | ||
| Chapter 12, "Analysis of Incomplete Data" | • | ||
| Chapter 13, "Reliability and Validity: Assessing the Psychometric Properties of Rating Scales" | • | ||
| Chapter 14, "Decision Analysis in Drug Development" | • |
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