Results 1 to 10 of about 2,070 (97)

Advancing food safety risk assessment in China: development of new approach methodologies (NAMs) [PDF]

Frontiers in Toxicology, 2023
Novel techniques and methodologies are being developed to advance food safety risk assessment into the next-generation. Considering the shortcomings of traditional animal testing, new approach methodologies (NAMs) will be the main tools for the next ...
Daoyuan Yang, Hui Yang, Miaoying Shi, Xudong Jia, Haixia Sui, Zhaoping Liu, Yongning Wu   +6 more
doaj   +4 more sources

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health [PDF]

Frontiers in Toxicology, 2022
New approach methodologies (NAMs) are increasingly being used for regulatory decision making by agencies worldwide because of their potential to reliably and efficiently produce information that is fit for purpose while reducing animal use.
Andreas O. Stucki, Tara S. Barton-Maclaren, Yadvinder Bhuller, Joseph E. Henriquez, Tala R. Henry, Carole Hirn, Jacqueline Miller-Holt, Edith G. Nagy, Monique M. Perron, Deborah E. Ratzlaff, Todd J. Stedeford, Amy J. Clippinger   +11 more
doaj   +4 more sources

Nonclinical Human Cardiac New Approach Methodologies (NAMs) Predict Vanoxerine-Induced Proarrhythmic Potential [PDF]

Journal of Cardiovascular Development and Disease
New approach methodologies (NAMs), including microphysiological systems (MPSs), can recapitulate structural and functional complexities of organs. Vanoxerine was reported to induce cardiac adverse events, including torsade de points (TdP), in a Phase III
M. Iveth Garcia, Bhavya Bhardwaj, Keri Dame, Verena Charwat, Brian A. Siemons, Ishan Goswami, Omnia A. Ismaiel, Sabyasachy Mistry, Tromondae K. Feaster, Kevin E. Healy, Alexandre J. S. Ribeiro, Ksenia Blinova   +11 more
doaj   +4 more sources

Editorial: Chemical testing using new approach methodologies (NAMs) [PDF]

Frontiers in Toxicology, 2022
Andreas O. Stucki, Amy J. Clippinger, Tala R. Henry, Carole Hirn, Todd J. Stedeford, Claire Terry   +5 more
doaj   +4 more sources

Brazil’s Regulatory Context for Using New Approach Methodologies (NAMs) on the Registration of Products [PDF]

Frontiers in Toxicology, 2022
New Approach Methodologies (NAMs) are any non-animal-based approaches that can provide information in the context of chemical hazard and safety assessment. The goal is to develop information with equivalent or better scientific quality and relevance than
Izabel Vianna Villela, Miriana da Silva Machado   +1 more
doaj   +2 more sources

Advancing New Approach Methodologies (NAMs) for Tobacco Harm Reduction: Synopsis from the 2021 CORESTA SSPT—NAMs Symposium [PDF]

Toxics, 2022
New approach methodologies (NAMs) are emerging chemical safety assessment tools consisting of in vitro and in silico (computational) methodologies intended to reduce, refine, or replace (3R) various in vivo animal testing methods traditionally used for ...
Kyeonghee Monica Lee, Richard Corley, Annie M. Jarabek, Nicole Kleinstreuer, Alicia Paini, Andreas O. Stucki, Shannon Bell   +6 more
doaj   +2 more sources

Integrating New Approach Methodologies (NAMs) into Preclinical Regulatory Evaluation of Oncology Drugs [PDF]

Biomimetics
Traditional animal-based preclinical models, including xenografts and genetically engineered mice, have been used for assessing pharmacodynamics, toxicity, efficacy, and safety for decades. Despite their limited ability to mimic human tumor heterogeneity,
Maryam Sadat Mirlohi, Tooba Yousefi, Amir Reza Aref, Amir Seyfoori   +3 more
doaj   +2 more sources

New approach methodologies (NAMs) to support regulatory assessment of developmental immunotoxicity – a new PARC project [PDF]

Frontiers in Toxicology
The current testing strategy for the assessment of developmental immunotoxicity (DIT) in European chemicals regulations has well recognised limitations.
Nicola M. Smith, Véronique M. P. de Bruijn, Rob J. Vandebriel, Rita Hargitai, Katalin Lumniczky, Aafke W. F. Janssen, Karsten Beekmann, Birol Usta, Julia Tigges, Christiane Spruck, Selma Hurem, Martina Iulini, Emanuela Corsini, Anne Bado-Nilles, Rémy Beaudouin, Ioanna Katsiadaki, Irene Cano, Marion Sebire, Humblenoble Stembridge Ayuk, Violeta Stojanovska, Violeta Stojanovska, Ana C. Zenclussen, Ana C. Zenclussen, Ana C. Zenclussen, Etienne B. Blanc, Saadia Kerdine-Römer, Rafaela Lacerda, Rafaela Lacerda, Luísa Romão, Luísa Romão, Pablo Monfort-Lanzas, Pablo Monfort-Lanzas, Johanna M. Gostner, Archibold Mposhi, Jonathan D. Turner, Giorgia Del Favero, Birgitte Lindeman   +36 more
doaj   +2 more sources

Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products [PDF]

Frontiers in Toxicology, 2022
Regulatory frameworks on tobacco and other nicotine-containing products (TNCP) continue to evolve as novel products emerge, including electronic nicotine delivery systems (e.g., electronic cigarettes or vaping products), heated tobacco products, or ...
Jacqueline Miller-Holt, Holger P. Behrsing, Amy J. Clippinger, Carole Hirn, Todd J. Stedeford, Andreas O. Stucki   +5 more
doaj   +2 more sources

From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver [PDF]

Frontiers in Pharmacology
The transition from animal-based experimentation toward New Approach Methodologies (NAMs) requires not only technological innovation but also regulatory frameworks that enable evidence-based decision-making. We discuss how the European Medicines Agency’s
Jean-Michel Dogné, Médéa Locquet, Flora Musuamba, Flora Musuamba, Flora Musuamba, Sonja Beken   +5 more
doaj   +2 more sources