Validation of the Cytosensor™ Microphysiometer for In Vitro Cytotoxicity Testing

Abstract

Regulatory agencies addressing human risk assessment of new pharmaceuticals, pesticides, food additives, cosmetics, and other chemicals currently require submission of a large battery of in vivo toxicity data derived from tests utilizing laboratory animals. Although fairly well proven for evaluating toxicity, the use of laboratory animals may have limited predictive values for human risk assessment because of differences in factors, such as bioavailability, pharmacokinetics, metabolism, receptor sensitivity, and repair mechanisms. The use of cell cultures for measuring drug toxicity is becoming increasingly acceptable. Accordingly, in vitro toxicity tests have been in demand and numerous organizations (e.g., Fund for Replacement of Animals in Medical Experiments [FRAME], European Research Group for Alternate Testing [ERGAT], Center for Alternatives to Animal Testing [CAAT], and the International Multi-Center Evaluation of In Vitro Cytotoxicity [MEIC]) are encouraging the development of alternative testing protocols.