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Established and emerging new approach methodologies in neuroscience [PDF]
The increasing need for ethical, human-relevant, and efficient alternatives to animal testing is driving the development of New Approach Methodologies (NAMs) in safety assessment and drug development.
Dorien Imberechts +5 more
doaj +6 more sources
New approach methodologies in neurotherapeutics development [PDF]
New Approach Methodologies (NAMs) offer substantial opportunities to transform neurotherapeutics discovery, optimization, and development, reducing the timeline to translate central nervous system (CNS) innovations to patients.
Amir P. Tamiz +3 more
doaj +2 more sources
Animal research in the UK: Regulation, implementation, welfare and development of new approach methodologies [PDF]
Use of animals in biomedical research is still considered essential by many in academia, industry and regulatory authorities. Therefore, it is important that legal, governance and welfare procedures are in place to ensure that only necessary procedures ...
Ewan St. John Smith +6 more
doaj +2 more sources
Beyond monolayers: a comparative analysis of 2D cell cultures and 3D in vitro models as new approach methodologies [PDF]
Two–dimensional (2D) cell cultures have been used as in vitro models in biomedical research as fundamental tools for investigating biological processes. However, their limited capacity to recapitulate the complexity of human tissues has driven the search
Italo Rodrigo Calori +4 more
doaj +2 more sources
Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments [PDF]
Background/Objectives: The rapid expansion of New Approach Methodologies (NAMs) is transforming oral biopharmaceutics by offering mechanistically rich, human-relevant tools that can reduce reliance on animal testing while improving translational ...
Mauricio A. García +4 more
doaj +2 more sources
Impact of the FDA roadmap and perspectives for regulatory use of new approach methodologies in Japanese pharmaceutical companies [PDF]
Pharmaceutical 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
In September 2021, the European Parliament voted overwhelmingly in favour of a resolution to phase out animal use for research, testing, and education, through the adoption of an action plan.
Lindsay J. Marshall +2 more
doaj +1 more source
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 +1 more
doaj +1 more source
Revisiting 3Rs: rethinking replacement and new approach methodologies [PDF]
Jessica Rosolowski +3 more
doaj +2 more sources
Carcinogenic chemicals, or their metabolites, can be classified as genotoxic or non-genotoxic carcinogens (NGTxCs). Genotoxic compounds induce DNA damage, which can be detected by an established in vitro and in vivo battery of genotoxicity assays.
Marc Audebert +33 more
doaj +1 more source

