International regulatory uses of acute systemic toxicity data and integration of new approach methodologies

J Strickland, E Haugabrooks, DG Allen… - Critical Reviews in …, 2023 - Taylor & Francis
… Previous publications focused specifically on the status of acute toxicity testing requirements
and data uses by US regulatory agencies (Strickland et al. Citation2018) or on current …

History of EPI Suite™ and future perspectives on chemical property estimation in US Toxic Substances Control Act new chemical risk assessments

ML Card, V Gomez-Alvarez, WH Lee… - … Science: Processes & …, 2017 - pubs.rsc.org
… prediction models and data sources used in regulatory and/or … limited data to characterize
new chemicals, the US EPA uses … and use of a new chemical. EPI Suite™ provides input …

[HTML][HTML] Artificial intelligence and real-world data for drug and food safety–A regulatory science perspective

S Thakkar, W Slikker Jr, F Yiannas, P Silva… - Regulatory Toxicology …, 2023 - Elsevier
… as drug safety and toxicity assessments. These technologies … the massive amounts of data
for this regulatory application. For … data-science tools currently in regulatory use by US-FDA, …

CATMoS: collaborative acute toxicity modeling suite

K Mansouri, AL Karmaus, J Fitzpatrick… - … health perspectives, 2021 - ehp.niehs.nih.gov
… systemic toxicity testing serves as the basis for regulatory … and US EPA’s CCTE. Briefly,
lethal dose, 50 percent L D 50 … the data set with additional toxicity data or use undersampling …

IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

X Chang, YM Tan, DG Allen, S Bell, PC Brown… - Toxics, 2022 - mdpi.com
US regulatory and public health agencies are charged with … animal toxicity testing of human
pharmaceuticals for regulatory … science approach document from Health Canada on the use

Alternatives to animal testing in toxicity testing: Current status and future perspectives in food safety assessments

N Reddy, B Lynch, J Gujral, K Karnik - Food and Chemical Toxicology, 2023 - Elsevier
used as conventional alternative to testing food additives for which the regulations require
toxicity testing data… Authority (EFSA) and the US EPA, who enable the use of in vitro and in …

Comparison of food colour regulations in the EU and the US: a review of current provisions

S Lehto, M Buchweitz, A Klimm… - Food Additives & …, 2017 - Taylor & Francis
US regulations applicable to food colours. Despite the different regulatory frameworks, the
overall approach … The health-based guidance values derived from toxicity data are different for …

Scientific and regulatory perspectives in herbal and dietary supplement associated hepatotoxicity in the United States

MI Avigan, RP Mozersky, LB Seeff - International journal of molecular …, 2016 - mdpi.com
… by US residents over the last few decades. The National Center for Health Statistics (NCHS)
has tracked trends in usage of … actions intended to prevent further cases of liver toxicity. For …

Current EU regulatory requirements for the assessment of chemicals and cosmetic products: challenges and opportunities for introducing new approach …

F Pistollato, F Madia, R Corvi, S Munn, E Grignard… - Archives of …, 2021 - Springer
used for scientific purposes and other EU regulations, such as REACH and the Cosmetic
Products Regulation advocate for a change in the way toxicity … , data on acute systemic toxicity

Impact of pharmaceuticals on the environment: risk assessment using QSAR modeling approach

S Kar, K Roy, J Leszczynski - Computational toxicology: methods and …, 2018 - Springer
… fill the data gaps, government and nongovernment regulatory authorities suggest the use of
in … to fill the screening data regarding API environmental toxicity utilizing the US EPA generic …