Pharmacological mechanism-based drug safety assessment and prediction

D. R. Abernethy, J. Woodcock, L. J. Lesko

Research output: Contribution to journalArticlepeer-review

Abstract

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

Original languageEnglish (US)
Pages (from-to)793-797
Number of pages5
JournalClinical pharmacology and therapeutics
Volume89
Issue number6
DOIs
StatePublished - Jun 1 2011

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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