24. Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses

  1. Shayne Cox Gad

Published Online: 16 AUG 2011

DOI: 10.1002/9780470464151.ch24

Drug Safety Evaluation

Drug Safety Evaluation

How to Cite

Gad, S. C. (ed) (2010) Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses, in Drug Safety Evaluation, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470464151.ch24

Publication History

  1. Published Online: 16 AUG 2011
  2. Published Print: 21 MAY 2010

ISBN Information

Print ISBN: 9780470253168

Online ISBN: 9780470464151

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Keywords:

  • postmarketing safety;
  • adverse drug responses;
  • therapeutic drugs;
  • safety withdrawals;
  • postmarketing surveillance studies

Summary

This chapter contains sections titled:

  • Causes of Safety Withdrawals

  • Regulatory Requirements

  • Management of ADR And ADE Data

  • Causality Assessment

  • Courses of Corrective Action

  • Legal Consequences of Safety Withdrawal