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

Ways To Implement 3Rs In The Pharmaceutical Industry

Andrew Rowan
Humane Society of the United States

David Lester
CDER,FDA

Robert Osterberg
CDER,FDA

The 3Rs in animal research refer to Reduction, Refinement and Replacement. The order in which these 3 terms are listed relates to process of development of alternative methodologies for animal testing. In terms of reduction of animals and research in the pharmaceutical arena, the following questions will be addressed. What is the role of classical animal toxicity studies in the drug development process? Will transgenic models result in fewer or more animals being used? How do US requirements for animal studies compare to international standards presently in use and what are future directions? Refinement of animal usage will be discussed in terms of better usage of animals in research and the impact on the quality of data obtained. What is the impact of the introduction of innovative technologies, such as imaging? Do we need better animal models? Will these changes reduce the present amount of time for the drug development process? What is the economic impact of such refinements? In terms of replacement, the use of in vitro systems and models will be discussed. Questions to be addressed include whether in vitro systems will have an impact on toxicity studies? What sort of information relevant to the drug development process can be gathered from in vitro studies? Can this information be incorporated into the regulatory process? Are cellular systems capable of replacing animal studies? Also, the use of computer simulations in modeling preclinical studies will be discussed. In conclusion, what is the prospect for animal usage in pharmaceutical research? Will there be a day when animal studies are not required?