TY - JOUR
KW - Evaluation framework
KW - Human health
KW - new approach methodologies
KW - Risk Assessment
AU - Stanley T. Parish
AU - Michael Aschner
AU - Warren Casey
AU - Marco Corvaro
AU - Michelle R. Embry
AU - Suzanne Fitzpatrick
AU - Darren Kidd
AU - Nicole C. Kleinstreuer
AU - Beatriz Silva Lima
AU - Raja S. Settivari
AU - Douglas C. Wolf
AU - Daiju Yamazaki
AU - Alan Boobis
AB - The need to develop new tools and increase capacity to test pharmaceuticals and other chemicals for potential adverse impacts on human health and the environment is an active area of development. Much of this activity was sparked by two reports from the US National Research Council (NRC) of the National Academies of Sciences, Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) and Science and Decisions: Advancing Risk Assessment (2009), both of which advocated for “science-informed decision-making” in the field of human health risk assessment. The response to these challenges for a “paradigm shift” toward using new approach methodologies (NAMS) for safety assessment has resulted in an explosion of initiatives by numerous organizations, but, for the most part, these have been carried out independently and are not coordinated in any meaningful way. To help remedy this situation, a framework that presents a consistent set of criteria, universal across initiatives, to evaluate a NAM's fit-for-purpose was developed by a multi-stakeholder group of industry, academic, and regulatory experts. The goal of this framework is to support greater consistency across existing and future initiatives by providing a structure to collect relevant information to build confidence that will accelerate, facilitate and encourage development of new NAMs that can ultimately be used within the appropriate regulatory contexts. In addition, this framework provides a systematic approach to evaluate the currently-available NAMs and determine their suitability for potential regulatory application. This 3-step evaluation framework along with the demonstrated application with case studies, will help build confidence in the scientific understanding of these methods and their value for chemical assessment and regulatory decision-making.
BT - Regulatory Toxicology and Pharmacology
DA - 2020-04-01
DO - 10.1016/j.yrtph.2020.104592
LA - en
N2 - The need to develop new tools and increase capacity to test pharmaceuticals and other chemicals for potential adverse impacts on human health and the environment is an active area of development. Much of this activity was sparked by two reports from the US National Research Council (NRC) of the National Academies of Sciences, Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007) and Science and Decisions: Advancing Risk Assessment (2009), both of which advocated for “science-informed decision-making” in the field of human health risk assessment. The response to these challenges for a “paradigm shift” toward using new approach methodologies (NAMS) for safety assessment has resulted in an explosion of initiatives by numerous organizations, but, for the most part, these have been carried out independently and are not coordinated in any meaningful way. To help remedy this situation, a framework that presents a consistent set of criteria, universal across initiatives, to evaluate a NAM's fit-for-purpose was developed by a multi-stakeholder group of industry, academic, and regulatory experts. The goal of this framework is to support greater consistency across existing and future initiatives by providing a structure to collect relevant information to build confidence that will accelerate, facilitate and encourage development of new NAMs that can ultimately be used within the appropriate regulatory contexts. In addition, this framework provides a systematic approach to evaluate the currently-available NAMs and determine their suitability for potential regulatory application. This 3-step evaluation framework along with the demonstrated application with case studies, will help build confidence in the scientific understanding of these methods and their value for chemical assessment and regulatory decision-making.
PY - 2020
EP - 104592
T2 - Regulatory Toxicology and Pharmacology
TI - An evaluation framework for new approach methodologies (NAMs) for human health safety assessment
UR - https://www.sciencedirect.com/science/article/pii/S0273230020300180
VL - 112
Y2 - 2023-06-30
SN - 0273-2300
ER -