Quantitative Evaluation of Safety in Drug Development
eBook - PDF

Quantitative Evaluation of Safety in Drug Development

Design, Analysis and Reporting

  1. 382 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Quantitative Evaluation of Safety in Drug Development

Design, Analysis and Reporting

About this book

State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product deve

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Yes, you can access Quantitative Evaluation of Safety in Drug Development by Qi Jiang,H. Amy Xia in PDF and/or ePUB format, as well as other popular books in Mathématiques & Probabilités et statistiques. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Chapman and Hall/CRC
Year
2014
eBook ISBN
9781466555471
Edition
1
Topic
Mathématiques
Subtopic
Probabilités et statistiques

Table of contents

  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