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Statistical Methods for Evaluating Safety in Medical Product Development - A. Lawrence Gould

Descripción

Author : A. Lawrence Gould Language: English Finishing : Hardcover, 400 pages ISBN : 978-1-119-97966-1 Edition Number: 2014 Description: 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...

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Descripción completa de: Statistical Methods for Evaluating Safety in Medical Product Development - A. Lawrence Gould

Author : A. Lawrence Gould

Language: English

Finishing : Hardcover, 400 pages

ISBN : 978-1-119-97966-1

Edition Number: 2014

Description:

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.

Table Of Contents:

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

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Farmacología

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