Statistical methods for evaluating safety in medical product development /

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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Gould, Lawrence (A. Lawrence) (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Chichester, West Sussex, UK : Wiley, 2014.
Colección:Statistics in practice.
Temas:
Clinical trials > Statistical methods.
Pharmacovigilance.
Drug monitoring.
Drugs > Side effects > Reporting.
Drug Evaluation > methods
Clinical Trials as Topic
Models, Statistical
Pharmacovigilance
Safety Management > methods
Technology, Pharmaceutical > standards
Drug Monitoring
Product Surveillance, Postmarketing
Études cliniques > Méthodes statistiques.
MEDICAL > Pharmacology.
Drugs > Side effects > Reporting
Drug monitoring
Clinical trials > Statistical methods
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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