ارزیابی کمی ایمنی در توسعه دارو: طراحی، تحلیل و گزارش دهی ۲۰۱۴
Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting 2014

1. Front Cover

2. Contents

3. Preface

4. Editors

5. Contributors

6. Chapter 1: Incorporating Quantitative Safety Evaluation into Risk Management

7. Chapter 2: Bayesian Meta-Experimental Design for Evaluating Cardiovascular Risk

8. Chapter 3: Non-Inferiority Study Design and Analysis for Safety Endpoints

9. Chapter 4: Program Safety Analysis Plan: An Implementation Guide

10. Chapter 5: Why a DMC Safety Report Differs from a Safety Section Written at the End of the Trial

11. Chapter 6: Safety Surveillance and Signal Detection Process

12. Chapter 7: Bayesian Adaptive Trials for Drug Safety

13. Chapter 8: Observational Safety Study Design, Analysis, and Reporting

14. Chapter 9: Emerging Role of Observational Health-Care Data in Pharmacovigilance

15. Chapter 10: Roadmap for Causal Inference in Safety Analysis

16. Chapter 11: Safety Graphics

17. Chapter 12: Bayesian Network Meta-Analysis for Safety Evaluation

18. Chapter 13: Regulatory Issues in Meta-Analysis of Safety Data

19. Chapter 14: Bayesian Applications for Drug Safety Evaluation

20. Chapter 15: Risk-Benefit Assessment Approaches

21. Chapter 16: Detecting Safety Signals in Subgroups

22. Chapter 17: Overview of Safety Evaluation and Quantitative Approaches during Preclinical and Early Phases of Drug Development

23. Back Cover