ABSTRACT
Alternative tests, within the context of the Food and Drug Administration (FDA) Division of Toxicological Research research program, are defined to include in vitro, various ex vivo, and in vivo tests. The in vitro tests are used primarily as rapid screens for toxicity or to study potential mechanisms of toxicity, although under highly selective circumstances they may be used to replace animal studies. Ex vivo tests generally involve an in vitro assessment of cells, tissues, organs, or embryos obtained from animals treated with a chemical(s) of interest. In vivo alternative tests typically involve test strategies that enable, in comparison with traditional regulatory toxicology studies, a reduction in animal usage, enhanced humanitarian treatment of animals, or more rapid generation of study results. The judicious use of various computer
modeling techniques and structure-activity relationships (SAR) for predicting pharmacokinetic parameters and toxicity, respectively, also is considered as alternative testing for application in an integrated toxicology research program.
