8. General Safety Assessments

  1. J. Rick Turner PhD, PGCE, MICR1 and
  2. Todd A. Durham MS2

Published Online: 16 MAY 2008

DOI: 10.1002/9780470411292.ch8

Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

How to Cite

Turner, J. R. and Durham, T. A. (2008) General Safety Assessments, in Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470411292.ch8

Author Information

  1. 1

    Chairman, Department of Clinical Research, Campbell University School of Pharmacy and Member of the Cardiac Safety Research Consortium

  2. 2

    Senior Director of Biostatistics and Data Management Inspire Pharmaceuticals and Adjunct Professor of Clinical Research Campbell University School of Pharmacy

Publication History

  1. Published Online: 16 MAY 2008
  2. Published Print: 17 OCT 2008

ISBN Information

Print ISBN: 9780470229644

Online ISBN: 9780470411292

SEARCH

Keywords:

  • drug development;
  • clinical research;
  • shift analysis;
  • responders analysis;
  • relative risk

Summary

This chapter contains sections titled:

  • Introduction

  • Statistical Analysis and Interpretation in Drug Development

  • Physical Examinations

  • Clinical Laboratory Tests

  • Vital Signs

  • Adverse Event Data

  • Issues of Multiplicity

  • Regulatory Considerations for Safety Data

  • The Contrast with Regulatory Guidance Concerning Proarrhythmic Cardiac Safety

  • Authors' Perspectives

  • Further Reading