IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making
Year: 2022
Type: review
Abstract: During the past few decades, the science of toxicology has been undergoing a transformation from observational to predictive science. New approach methodologies (NAMs), including in vitro assays, in silico models, read-across, and in vitro to in vivo extrapolation (IVIVE), are being developed to reduce, refine, or replace whole animal testing, encouraging the judicious use of time and resources. Some of these methods have advanced past the exploratory research stage and are beginning to gain acceptance for the risk assessment of chemicals. A review of the recent literature reveals a burst of IVIVE publications over the past decade. In this review, we propose operational definitions for IVIVE, present literature examples for several common toxicity endpoints, and highlight their implications in decision-making processes across various federal agencies, as well as international organizations, including those in the European Union (EU). The current challenges and future needs are also summarized for IVIVE. In addition to refining and reducing the number of animals in traditional toxicity testing protocols and being used for prioritizing chemical testing, the goal to use IVIVE to facilitate the replacement of animal models can be achieved through their continued evolution and development, including a strategic plan to qualify IVIVE methods for regulatory acceptance.
Source: Toxics
Authors: Xiaoqing Chang, Yu-Mei Tan, David G. Allen, Shannon Bell, Paul C. Brown, Lauren Browning, Patricia Ceger, Jeffery Gearhart, Pertti J. Hakkinen, Shruti V. Kabadi, Nicole C. Kleinstreuer, Annie Lumen, Joanna Matheson, Alicia Paini, Heather A. Pangburn, Elijah J. Petersen, Emily N. Reinke, Alexandre J. S. Ribeiro, Nisha Sipes, Lisa M. Sweeney, John F. Wambaugh, Ronald Wange, Barbara A. Wetmore, Moiz Mumtaz
Institutions: Environmental Protection Agency, United States Food and Drug Administration, Center for Drug Evaluation and Research, Henry M. Jackson Foundation, United States Air Force Research Laboratory, Wright-Patterson Air Force Base, 711th Human Performance Wing, National Center for Biotechnology Information, Center for Food Safety and Applied Nutrition, National Institutes of Health, National Institute of Environmental Health Sciences, National Center for Toxicological Research, United States Consumer Product Safety Commission, Joint Research Centre, National Institute of Standards and Technology, United States Department of Commerce, Defense Center for Public Health - Aberdeen, UES (United States), Agency for Toxic Substances and Disease Registry
Language: English
Subfield: Small Animals
Field: Veterinary
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,885
Award: G6308604930
OpenAlex ID: W4225377975