ATLA::Alternatives to Laboratory Animals

Volume 25, Number 1

Progress toward the validation of alternative tests.

ATLA 25, 33-43, January/February 1997

Michael Balls and Julia H. Fentem

ECVAM (European Centre for the Validation of Alternative Methods), JRC Environment Institute, 21020 Ispra (Va), Italy

SUMMARY

ECVAM's role in the practical validation of replacement alternative methods for use in regulatory testing is reviewed, including an outline of the criteria which have been used in determining ECVAM's priorities. Some of the difficulties which have arisen in validation studies are discussed, and solutions to these are proposed, with particular emphasis on ensuring that methods are sufficiently well-developed to enter the validation process, and on the ECVAM prevalidation scheme for encouraging protocol optimisation and the prior assessment of interlaboratory transferability. Comments are made on problems encountered in selecting test materials backed by adequate in vivo data and in undertaking appropriate in vivo/in vitro comparisons.

Keywords: alternatives, ECVAM, in vitro, replacement, test methods, validation