Results 41 to 50 of about 26,695,458 (198)

Comments/clarifications to the publication by Xin et al. (2025)

Ecotoxicology and Environmental Safety
Xin et al. (2025) try to apply New Approach Methodologies (NAMs) for hazard identification and risk assessment using DINCH (cyclohexane-1,2-dicarboxylic acid, diisononyl ester, CAS Reg No 166412-78-8) as a model substance.
R. Otter, A. Langsch, P. Harmon, R. David   +3 more
doaj   +1 more source

An evaluation framework for new approach methodologies (NAMs) for human health safety assessment

Regulatory Toxicology and Pharmacology, 2020
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 ...
Stanley T. Parish, Michael Aschner, Warren Casey, Marco Corvaro, Michelle R. Embry, Suzanne Fitzpatrick, Darren Kidd, Nicole C. Kleinstreuer, Beatriz Silva Lima, Raja S. Settivari, Douglas C. Wolf, Daiju Yamazaki, Alan Boobis   +12 more
openaire   +2 more sources

A framework for establishing scientific confidence in new approach methodologies

, 2022
Robust and efficient processes are needed to establish scientific confidence in new approach methodologies (NAMs) if they are to be considered for regulatory applications.
BARROSO João, HENRY Tala R., PERRON Monique, LOWIT Anna, VAN DER ZALM Anna, BROWNE Patience, KLEINSTREUER Nicole, CASEY Warren, GORDON John, CLIPPINGER Amy J.   +9 more
core   +1 more source

Neurotoxicity of propylene glycol butyl ether: Multiomic evidence from human brainspheres

Environment International
Exposure to solvents may contribute to the development of neurodevelopmental and neurodegenerative diseases. Glycol ethers consist in a widely used class of organic solvents leading to workers and consumers exposure via many applications. Ethylene glycol
David Lopez-Rodriguez, David Pamies, Julien Boccard, Isabel Meister, Mathieu Galmiche, Tatjana Sajic, Estelle Maret, Noéline Héritier, Massimo Frangiamone, Aurélien Thomas, Nancy B. Hopf, Serge Rudaz, Marie-Gabrielle Zurich   +12 more
doaj   +1 more source

Epilepsy as a Multiscale Network Disorder: Integrating Precision Therapeutics and Emerging Experimental Platforms

Pharmaceutics
Background/Objectives: Epilepsy remains a major neurological disorder, with approximately one-third of patients continuing to experience pharmacoresistant seizures despite the availability of numerous antiseizure medications (ASMs).
Wonseok Chang, Amy Seomin Kwak, Seung Ho Han, Dae Yong Song, Hong Il Yoo, Jung Ho Lee   +5 more
doaj   +1 more source

Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science. [PDF]

Clin Pharmacol Ther
New Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Blinova K, Chiu K, Chaturbedi A, Cooper J, Feaster TK, Hyland PL, Stavitskaya L, Wu WW, Florian J, Rouse R.   +9 more
europepmc   +2 more sources

Balancing chemical safety and animal welfare considerations in the application of new approach methodologies for chemical safety assessment

NAM Journal
Despite some considerable advancement in developing different forms of new approach methodologies (NAMs) to assess the risk of chemicals, there is still limited progress in their application for regulatory purposes in the European Union (EU).
Aleksandra Čavoški, Laura Holden, Leonie Mueller, Robert Lee   +3 more
doaj   +1 more source

New approach methodologies (NAMs): The strategic vision in science

ALTEX
Meeting report of the Sixth International Summer School of the Lake Como School of Advanced ...
Caloni, Francesca, Cazzaniga, Alessandra, Gutleb, Arno C, Hartung, Thomas, Kandarova, Helena, Meloni, Marisa, Pintea, Adela, Rashidi, Hassan, Wilflingseder, Doris, Buscarini, Alessandra   +9 more
openaire   +2 more sources

Biomaterials for modulating cellular responses of endogenous tendon stem/progenitor cells: A promising avenue for tendon regeneration

BMEMat, EarlyView.
This review comprehensively summarizes emerging biomaterial‐based strategies and underlying mechanisms for modulating endogenous tendon stem/progenitor cells (TSPCs). It offers the most recent insights into TSPC physiology and potential applications of tissue engineering and regenerative medicine in tendons.
Zeyu Zhu, Renwang Sheng, Mumin Cao, Ludvig J. Backman, Yucheng Gao, Hao Wang, Cheng Zhang, Jialin Chen, Wei Zhang, Yunfeng Rui   +9 more
wiley   +1 more source

Toward Rigorous Materials Production: New Approach Methodologies Have Extensive Potential to Improve Current Safety Assessment Practices.

, 2020
<p>Advanced material development, including at the nanoscale, comprises costly and complex challenges coupled to ensuring human and environmental safety.
Sørli, Jorid Birkelund, Sabina Halappanavar, Fransman, Wouter, Dekkers, Susan, García-Bilbao, Amaia, Grafström, Roland, Niels Hadrup, Martine Bakker, Wouter Fransman, Karin Sørig Hougaard, Koivisto, Antti Joonas, Greco, Dario, Keld Alstrup Jensen, Poikkimäki, Mikko, Jorid Birkelund Sørli, Franken, Remy, Remy Franken, Rodriguez-Llopis, Isabel, Rob Stierum, Hongisto, Vesa, Dario Greco, Mary Gulumian, Stierum, Rob, Vesa Hongisto, Hadrup, Niels, Kohonen, Pekka, Gulumian, Mary, Miikka Dal Maso, Roland Grafström, Susan Dekkers, Dal Maso, Miikka, Hougaard, Karin Sørig, Oosterwijk, Thies, Nymark, Penny, Thies Oosterwijk, Amaia García‐Bilbao, Jensen, Keld Alstrup, Bakker, Martine, Isabel Rodriguez‐Llopis, Antti Joonas Koivisto, Penny Nymark, Halappanavar, Sabina, Pekka Kohonen, Mikko Poikkimäki, Greco, D, Dekkers, S, Fransman, W, Garcia-Bilbao, A, Franken, R, Halappanavar, S, Nymark, P,, Bakker, M, Hadrup, N, Gulumian, M   +53 more
core   +1 more source