General Safety Assessments

  • J. Rick Turner


The safety of a drug is addressed at all stages in its life history: discovery and design, nonclinical research, clinical development, and postmarketing surveillance. As noted in Chapter 3, in silico modeling in the discovery phase of synthetic drugs can examine the potential interactions of centers of reactivity in a drug with nontarget receptors, interactions that can lead to undesirable effects. Such studies are intended to modify the eventual drug molecule in a beneficial manner, thereby enhancing its safety profile. Safety evaluation in nonclinical research was discussed in Chapter 4. Discussions of safety now move to safety assessments in clinical trials. This chapter discusses general safety assessments, and Chapter 14 addresses specialized cardiac and cardiovascular safety assessments that have recently become critical components of new drug development. Postmarketing surveillance is discussed later in Chapter 16.


Adverse Drug Reaction Safety Data Adverse Event Data Severe DILI Premature Withdrawal 
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Further Readings

  1. Durham TA, Turner JR, 2008, Introduction to Statistics in Pharmaceutical Clinical Trials. London: Pharmaceutical Press.Google Scholar
  2. FDA, 2009, Guidance for Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation. [See]
  3. Gad SC (Ed), 2009, Drug Safety Evaluation, 2nd Edition. Hoboken, NJ: Wiley.Google Scholar
  4. Turner JR, 2009, Drug safety, medication safety, patient safety: An overview of recent FDA guidances and initiatives. Regulatory Rapporteur, April issue, 4–8.Google Scholar
  5. Prokscha S, 2007, Practical Guide to Clinical Data Management, 2nd Edition. Boca Raton: Taylor & Francis.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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