FRAMEWORK FOR VALIDATION AND IMPLEMENTATION OF IN-VITRO TOXICITY TESTS

The development and application of in vitro alternatives designed to r educe or replace the use of animals, or to lessen the distress and dis comfort of laboratory animals, is a rapidly developing trend in toxico logy. 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 th e effective transfer of new technologic developments from the research laboratory into practical use. This committee has identified four ess ential 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 endpoint s 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 commu nity-academics, industry, and government. This is best achieved by ear ly and frequent communication among parties and agreement on common go als. It is hoped that the creation of a validation infrastructure comp osed of the elements described in this report will facilitate scientif ic acceptance and utilization of alternative methodologies and speed i mplementation of replacement, reduction, and refinement alternatives i n toxicity testing.