title: Alternative testing in drug research and development-The validation issue.
abstract: As ECVAM (the European Centre for the Validation of Alternative Methods) intensifies its work, it is worth discussing the aspects of alternative testing in drug research and development as well as the implication of validating tests-and the possible role of ECVAM in this. Substituting animal in vivo tests with alternative testing has always been a major target in the pharmaceutical industry, for ethical and practical reasons. In vitro tests have an important role, especially in the first phase of drug discovery (the substance-finding phase) but to a lesser extent in safety testing. In the further development of a new drug, validation becomes more important for safety tests than for the initial screening and substance-finding tests. That also implies that diverse safety and toxicity testing of pharmaceuticals should be based on worldwide accepted and validated protocols. ECVAM has a role here, in informing the scientific and regulatory community about promising (validated) tests in drug discovery or development and pressing for worldwide harmonization, especially of safety testing.
authors.affiliation: Bayer AG Leverkusen, PF-Centre, D-51368 Leverkusen, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Garthoff