Statistical Methods for Evaluating Safety in Medical Product Development.pdf
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature.
Preface List of Contributors Chapter 1. Introduction A. Lawrence Gould Chapter 2. Safety Graphics A. Lawrence Gould Chapter 3. QSAR Modeling: Prediction of Biological Activity from Chemical Structure Andy Liaw and Vladimir Svetnik Chapter 4. Ethical and Practical Issues in Phase I Trials in Healthy Volunteers Stephen Senn Chapter 5. Phase I Trials A. Lawrence Gould Chapter 6. Summarizing Adverse Event Risk A. Lawrence Gould Chapter 7. Statistical Analysis of Recurrent Adverse Events Liqun Diao, Richard J. Cook, and Ker-Ai Lee Chapter 8. Cardiovascular Toxicity, Especially QT/QTc Prolongation Arne Ring and Robert Schall Chapter 9. Hepatic Toxicity Donald C. Trost Chapter 10. Neurotoxicity A. Lawrence Gould Chapter 11. Safety Monitoring Jay Herson Chapter 12. Sequential Testing for Safety Evaluation Jie Chen Chapter 13. Evaluation of Post-Marketing Safety Using Spontaneous Reporting Databases Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter Chapter 14. Pharmacovigilance Using Observational/Longitudinal Databases and Web-based Information A. Lawrence Gould