Statistical methods for evaluating safety in medical product development

Statistical methods for evaluating safety in medical product development / editor Lawrence Gould, Merck Research Laboratories, USA.

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 statist...

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Bibliographic Details
Other Authors: Gould, Lawrence (A. Lawrence) (Editor)
Format: eBook
Language:English
Published: Chichester, West Sussex, UK : Wiley, 2014.
Series:Statistics in practice.
Subjects:
Clinical trials > Statistical methods.
Pharmacovigilance.
Drug monitoring.
Drugs > Side effects > Reporting.
MEDICAL > Pharmacology.
Pharmacovigilance
Drugs > Side effects > Reporting
Drug monitoring
Clinical trials > Statistical methods
Online Access:Click for online access
Table of Contents:
  • Safety graphics / A. Lawrence Gould
  • QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik
  • Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn
  • Phase I trials / A. Lawrence Gould
  • Summarizing adverse event risk / A. Lawrence Gould
  • Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee
  • Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall
  • Hepatic toxicity / Donald C. Trost
  • Neurotoxicity / A. Lawrence Gould
  • Safety monitoring / Jay Herson
  • Sequential testing for safety evaluation / Jie Chen
  • Evaluation of post-marketing safety using spontaneous reporting databases / Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter / Pharmacovigilance using observational/longitudinal databases and web-based information / A. Lawrence Gould.

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