Robert Scala, Ph.D., a member of the CAAT Validation Committee, has studied relevance and reliability in ocular irritation testing since the early seventies. He said that the committee was enriched by the presence of scientists familiar with the travails and pitfalls of the validation process. The rigor of our analysis was increased because we had an earlier case study to work from. David Brusnick helped us enormously by reminding us of the mistakes that were made in validating genotoxicity assays. Once a test has been validated, it has the added benefit of reducing regulatory resistance.
Regulatory agencies are conservative in their outlook and have every right to be.
They have a tremendous responsibility in protecting the public's health. We've got to make their job easier. The next steps are to define fully the structure and function of the scientific advisory board and certification of reference laboratories. At the present time, several models are being examined as benchmarks. All rights reserved.