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.
Joseph E Henriquez +2 more
exaly +3 more sources
State of the industry: integration of 3Rs principles and new approach methodologies in non-clinical product development through fit-for-purpose [PDF]
Frontiers in MedicineRegulators, such as the FDA and EMA, are increasingly signaling expectations for broader and earlier adoption of New Approach Methodologies (NAMs) to reduce, refine, and, where justified, replace animal studies (3Rs principle)—particularly where NAMs can
Sabine M. Poppenborg +2 more
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Impact of the FDA roadmap and perspectives for regulatory use of new approach methodologies in Japanese pharmaceutical companies [PDF]
NAM JournalPharmaceutical scientists develop and apply increasingly complex technologies from an expanding toolbox to create more effective and safer drugs.
Tetsuro Araki +10 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 PharmacologyThe 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 +5 more
doaj +2 more sources
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 ...
Alicia Paini +2 more
exaly +3 more sources
Advancing chemical mixture toxicity assessment using advanced in vitro NAMs: current status and future perspectives [PDF]
Frontiers in ToxicologyChemical exposure in real-world settings occurs predominantly as mixtures, whereas toxicological assessment has long been shaped by single-substance paradigms.
Hyunwoo Kim, Donghyeon Kim, Jinhee Choi
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Water exchange process and bulk composition regulate slab dynamics and deep earthquakes [PDF]
Nature CommunicationsWater strongly influences deep mantle processes, including geochemical cycles, slab dynamics, and deep-focus earthquakes. Yet the stability and interactions of hydrous minerals with nominally anhydrous minerals (NAMs) under the water-undersaturated ...
Jintao Zhu +3 more
doaj +2 more sources
Drug Delivery, 2023 DC Beads and CalliSpheres are commonly used microspheres in clinical transcatheter arterial chemoembolization, but these microspheres cannot be visualized by themselves.
Yiwei He +13 more
doaj +1 more source
Advancing food safety risk assessment in China: development of new approach methodologies (NAMs)
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 +6 more
doaj +1 more source
Emergent properties of patch shapes affect edge permeability to animals. [PDF]
PLoS ONE, 2011 Animal travel between habitat patches affects populations, communities and ecosystems. There are three levels of organization of edge properties, and each of these can affect animals. At the lowest level are the different habitats on each side of an edge,
Vilis O Nams
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