Workshop report: FDA workshop on improving cardiotoxicity assessment with human-relevant platforms

L Pang, P Sager, X Yang, H Shi, F Sannajust… - Circulation …, 2019 - Am Heart Assoc
Given that cardiovascular safety concerns remain the leading cause of drug attrition at the
preclinical drug development stage, the National Center for Toxicological Research of the …

Human induced pluripotent stem cell (iPSC)-derived cardiomyocytes as an in vitro model in toxicology: strengths and weaknesses for hazard identification and risk …

SD Burnett, AD Blanchette, WA Chiu… - Expert opinion on drug …, 2021 - Taylor & Francis
Introduction Human induced pluripotent stem cell (iPSC)-derived cardiomyocytes is one of
the most widely used cell-based models that resulted from the discovery of how non …

Key characteristics of cardiovascular toxicants

L Lind, JA Araujo, A Barchowsky… - Environmental …, 2021 - ehp.niehs.nih.gov
Background: The concept of chemical agents having properties that confer potential hazard
called key characteristics (KCs) was first developed to identify carcinogenic hazards …

Risk characterization and probabilistic concentration–response modeling of complex environmental mixtures using new approach methodologies (NAMs) data from …

NH Hsieh, Z Chen, I Rusyn… - Environmental Health …, 2021 - ehp.niehs.nih.gov
Background: Risk assessment of chemical mixtures or complex substances remains a major
methodological challenge due to lack of available hazard or exposure data. Therefore, risk …

Population-based toxicity screening in human induced pluripotent stem cell-derived cardiomyocytes

SD Burnett, AD Blanchette, FA Grimm, JS House… - Toxicology and applied …, 2019 - Elsevier
The potential for cardiotoxicity is carefully evaluated for pharmaceuticals, as it is a major
safety liability. However, environmental chemicals are seldom tested for their cardiotoxic …

Cardiotoxicity hazard and risk characterization of toxcast chemicals using human induced pluripotent stem cell-derived cardiomyocytes from multiple donors

SD Burnett, AD Blanchette, WA Chiu… - Chemical research in …, 2021 - ACS Publications
Heart disease remains a significant human health burden worldwide with a significant
fraction of morbidity attributable to environmental exposures. However, the extent to which …

Model systems and organisms for addressing inter-and intra-species variability in risk assessment

I Rusyn, WA Chiu, FA Wright - Regulatory Toxicology and Pharmacology, 2022 - Elsevier
Addressing inter-and intra-species differences in potential hazardous effects of chemicals
remains a long-standing challenge in human health risk assessment that is typically …

Cardiovascular effects of polychlorinated biphenyls and their major metabolites

FA Grimm, WD Klaren, X Li, HJ Lehmler… - Environmental …, 2020 - ehp.niehs.nih.gov
Background: Xenobiotic metabolism is complex, and accounting for bioactivation and
detoxification processes of chemicals remains among the most challenging aspects for …

[HTML][HTML] Rapid hazard characterization of environmental chemicals using a compendium of human cell lines from different organs

Z Chen, Y Liu, FA Wright, WA Chiu, I Rusyn - Altex, 2020 - ncbi.nlm.nih.gov
The lack of adequate toxicity data for the vast majority of chemicals in the environment has
spurred the development of new approach methodologies (NAMs). This study aimed to …

A Bayesian Method for Population-wide Cardiotoxicity Hazard and Risk Characterization Using an In Vitro Human Model

AD Blanchette, SD Burnett, FA Grimm… - Toxicological …, 2020 - academic.oup.com
Human induced pluripotent stem cell (iPSC)-derived cardiomyocytes are an established
model for testing potential chemical hazards. Interindividual variability in toxicodynamic …