Framework for validation and implementation of in vitro toxicity tests

Alan M. Goldberg, John M. Frazier, David Brusick, Michael S. Dickens, Oliver Flint, Stephen D. Gettings, Richard N. Hill, Robert L. Lipnick, Kevin J. Renskers, June A. Bradlaw, Robert A. Scala, Bellina Veronesi, Sidney Green, Neil L. Wilcox, Rodger D. Curren

Research output: Contribution to journalArticlepeer-review

12 Scopus citations


The development and application of in vitro alternatives designed to reduce or replace the use of animals, or to lessen the distress and discomfort of laboratory animals, is a rapidly developing trend in toxicology. However, at present there is no formal administrative process to organize, coordinate, or evaluate validation activities. A framework capable of fostering the validation of new methods is essential for the effective transfer of new technologic developments from the research laboratory into practical use. This committee has identified four essential validation resources: chemical bank(s), cell and tissue banks, a data bank, and reference laboratories. The creation of a Scientific Advisory Board composed of experts in the various aspects and endpoints of toxicity testing, and representing the academic, industrial, and regulatory communities, is recommended. Test validation acceptance is contingent on broad buy-in by disparate groups in the scientific community—academics, industry, and government. This is best achieved by early and frequent communication among parties and agreement on common goals. It is hoped that the creation of a validation infrastructure composed of the elements described in this report will facilitate scientific acceptance and utilization of alternative methodologies and speed implementation of replacement, reduction, and refinement alternatives in toxicity testing.

Original languageEnglish (US)
Pages (from-to)688-692
Number of pages5
JournalIn Vitro Cellular & Developmental Biology - Animal: Journal of the Society for In Vitro Biology
Issue number9
StatePublished - Sep 1993


  • alternatives
  • in vitro toxicology
  • risk assessment
  • toxicity testing
  • validation

ASJC Scopus subject areas

  • Developmental Biology
  • Cell Biology


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