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

Noninvasive Animal Imaging: Value-Added To Animal Studies For Safety And Efficacy

David S. Lester
Center for Drug Evaluation and Research, Office of Testing and Research, US Food and Drug Administration

The use of animals in evaluation of drug safety and efficacy is a required component of the regulatory process for approval of pharmaceuticals. There has been a significant shift in philosophy of the preclinical drug development process from classical toxicology to safety pharmacology. While standard pharmacological and toxicological procedures have been applied, there has been increasing interest by the pharmaceutical industry and the regulatory agencies in the use of noninvasive imaging. Over the last ten years, there has been an increase in the research of animal processes using such imaging modalities as Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and microComputer Assisted Tomography (?CT). These techniques all provide information regarding the animal that has not been previously available using conventional approaches. Multiparametric analyses can be performed on the same animal and at multiple times, which provides the opportunity for the same animal being treated and serving as its own control. Hence, fewer animals will be needed for future preclinical studies. In addition, as the methodology was initially developed for clinical uses, it will be possible to extend animal imaging studies to monitor similar parameters in the clinic. This will provide improved validation of animal models and will ensure optimal utilization and relevance of the animal data for clinical evaluations. While imaging does not propose replacement of animal models, it can have significant impact on the reduction of required animal numbers and the refinement of animal studies.