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Protecting Human and Animal Health: The Road From Animal Models to New Approach Methods
Citation:
Kaplan, B., A. Hoberman, W. Slikker, M. Smith, E. Corsini, T. Knudsen, S. Marty, S. Sobrian, S. Fitzpatrick, M. Ratner, AND D. Mendrick. Protecting Human and Animal Health: The Road From Animal Models to New Approach Methods. PHARMACOLOGICAL REVIEWS. American Society for Pharmacology and Experimental Therapeutics, Bethesda, MD, 76(2):251-266, (2024). https://doi.org/10.1124/pharmrev.123.000967
Impact/Purpose:
The purpose of this manuscript is to provide a balanced view of the current state of use of animal models and NAMs as approaches to toxicity testing of drugs and chemicals. Animals do not provide all needed information nor do NAMs, but each can elucidate key pieces of the puzzle of human and animal biology.
Description:
Animals and animal models have been invaluable for our current understanding of human and animal biology, including physiology, pharmacology, biochemistry, and disease pathology. However, there are increasing concerns with continued use of animals in basic biomedical, pharmacological, and regulatory research to provide safety assessment for drugs and chemicals. There are concerns that animals do not provide sufficient information on toxicity and/or efficacy to protect the target population, so scientists are utilizing the principles of the 3Rs (replacement, reduction, and refinement) and increasing development and application of new approach methods (NAMs). NAMs are any technology, methodology, approach, or assay used to understand effects and mechanisms of drugs or chemicals with specific focus on applying the 3Rs. Although progress has been made in several areas with NAMs, complete replacement of animal models with NAMs is not yet attainable. The road to NAMs requires additional development, increased use, and for regulatory decision-making, usually formal validation. Moreover, it is likely that replacement of animal models with NAMs will require multiple assays to ensure sufficient biological coverage. The purpose of this manuscript is to provide a balanced view of the current state of use of animal models and NAMs as approaches to development, safety, efficacy, and toxicity testing of drugs and chemicals. Animals do not provide all needed information nor do NAMs, but each can elucidate key pieces of the puzzle of human and animal biology and contribute to the goal of protecting human and animal health.
URLs/Downloads:
DOI: Protecting Human and Animal Health: The Road From Animal Models to New Approach Methods
https://pubmed.ncbi.nlm.nih.gov/38351072/