The Center for Alternatives to Animal Testing is an academic center affiliated with the Division of Toxicological Sciences in the Department of Environmental Health Sciences of the Johns Hopkins University Bloomberg School of Public Health.

 

Johns Hopkins School of Public Health

Abstract for TestSmart--Pharmaceuticals: An Efficient and Humane Approach to Predictors of Potential Toxic Effects of Drugs

The Biotechnology Revolution and the Evolution of Regulatory Toxicology: Preparing for the Future

James T. MacGregor
National Center for Toxicological Research, US Food and Drug Administration

The molecular biology revolution has facilitated rapid advances in our understanding of the molecular basis of cellular structure, function, and defense. An appreciation of the evolution of inducible defense systems and the cellular responses to molecular damage, combined with the availability of powerful genomic, proteomic, and informatics technologies, has created an unprecedented opportunity to identify improved biomarkers of cell and tissue damage. Additionally, new imaging technologies make possible noninvasive monitoring of molecular biomarkers in animal and human studies. Toxicology research has already been impacted by these advances and has begun to establish a basis for improved regulatory approaches. Some of these opportunities, and the process required to transform them into regulatory methods and approaches, will be discussed.