Framework for Validation and Implementation of In Vitro Toxicity Tests: Report of the Validation and Technology Transfer Committee of the Johns Hopkins Center for Alternatives to Animal Testing

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