Approaches to Evaluating Causation of Suspected Drug Reactions

  • Judith K. Jones
Part of the NATO ASI Series book series (NSSA, volume 224)


Knowledge about an adverse drug effect typically starts out as a signal of a possible problem, usually identified through spontaneous reports of a suspected adverse drug reaction. As diagrammed in Figure 1, this signal is verified in an iterative fashion, either through further reports or studies of its biological plausibility and, if important, it is quantitated with epidemiological or, rarely, experimental studies (clinical trials). Although often taken for granted, the driving force for this iteration is often based on the assumption or determination, through some means, that there is a cause-effect relationship between the purported risk and the pharmaceutical. This qualitative part of risk assessment which evaluates a signal is an important initial part of the process.


Adverse Drug Reaction Spontaneous Report Drug Info Biological Plausibility Causality Assessment 
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Copyright information

© Springer Science+Business Media New York 1992

Authors and Affiliations

  • Judith K. Jones
    • 1
  1. 1.The Degge Group, Ltd.Georgetown UniversityUSA

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