Defining the role of ECVAM in the development, validation and acceptance of alternative tests and testing strategies

Animal research: the need for a middle ground

“…Replacement is the option that is most attractive to animals lovers and politicians and has been actively promoted by the Fund for Replacement of Animals in Medical Experimentation (http://www.frame-uk.demon.co.uk/) and the European Centre for the Validation of Alternative Methods, which was set up by the European Union. 4 5 Replacement can be relative (using humane killing to provide cells, tissues, or organs), absolute (using permanent cultures of cells or tissues), direct (using, for example, skin in vitro rather than in vivo), indirect (replacing, for example, the pyrogen test in rabbits with a test on whole human blood), total (using a human volunteer), or partial (using non-animal methods in prescreening of toxic compounds) 2…”

Advancing alternatives analysis: The role of predictive toxicology in selecting safer chemical products and processes

“…Validation requires an objective demonstration that a test method measures the attribute that it is intended to detect in a reliable manner. Publications on formal validation outline the following major criteria: 1) reliability of the assay, 2) relevance to the scientific question being addressed, 3) fitness for purpose, 4) providing an adequate definition of the test, 5) demonstration of within‐laboratory reproducibility, 6) demonstration of the ability to transfer the test to other laboratories, and 7) demonstration of the accuracy of the test (Balls ; ICH ; DHHS ; Hartung et al ; Stokes et al ; Hartung ; Stokes and Schechtman ; Stokes and Wind ; Judson et al ). Formal validation, such as that performed by the Organisation for Economic Co‐operation and Development (OECD) or other governmental bodies, is generally required for acceptance of data from predictive toxicology tests in a regulatory context.…”

“…Other approaches involve the use of smaller animals as surrogates for higher, more complex ones. Model organisms such as the vertebrate zebrafish ( Danio rerio ) and invertebrate nematode ( Caenorhabditis elegans ) have been used in assessing complex endpoints such as reproductive and developmental toxicity (Balls ; Ferreira et al ).…”

The Role of ECVAM in Promoting the Regulatory Acceptance of Alternative Methods in the European Union

“…This paper describes the different roles of ECVAM during the evolution of alternative tests, with particular emphasis on the procedure by which ECVAM interacts with other services of the European Commission, the European Union (EU) Member States, and other organisations, to assess the scientific validity of alternative methods, and in appropriate cases, to initiate the progression of scientifically validated methods toward regulatory acceptance. This paper provides an update on a previous paper on the role of ECVAM (2), which was published in the proceedings of the ECVAM Opening Symposium.…”