Grouping of UVCB substances with new approach methodologies (NAMs) data. [PDF]
ALTEX, 2021 One of the most challenging areas in regulatory science is assessment of the substances known as UVCB (unknown or variable composition, complex reaction products and biological materials). Because the inherent complexity and variability of UVCBs present considerable challenges for establishing sufficient substance similarity based on chemical ...
House JS +11 more
europepmc +5 more sources
FDA/CDER/OND Experience With New Approach Methodologies (NAMs) [PDF]
International Journal of ToxicologyThe U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), and Office of New Drugs (OND) has continuously encouraged the submission of nonclinical tests utilizing new approach methodologies (NAMs) and sponsor engagement with regulators to optimize NAM utility in supporting the safety and efficacy of new drugs ...
Paul Brown, Dakshesh Patel
exaly +4 more sources
New approach methodologies (NAMs) for human-relevant biokinetics predictions [PDF]
ALTEX, 2020 For almost fifteen years, the availability and regulatory acceptance of new approach methodologies (NAMs) to assess the absorption, distribution, metabolism and excretion (ADME/biokinetics) in chemical risk evaluations are a ...
Blaauboer, B.J. +3 more
core +5 more sources
New approach methodologies (NAMs): identifying and overcoming hurdles to accelerated adoption. [PDF]
Toxicology ResearchAbstract New approach methodologies (NAMs) can deliver improved chemical safety assessment through the provision of more protective and/or relevant models that have a reduced reliance on animals. Despite the widely acknowledged benefits offered by NAMs, there continue to be barriers that prevent or limit their application for decision ...
Fiona Sewell, Susy Brescia, Clive Roper
exaly +4 more sources
Nordic Workshop on New Approach Methodologies (NAMs)
, 2022 New Approach Methodologies (NAMs) are an emerging tool in toxicology for performing chemical risk assessment. NAMs reduce animal testing while increasing robustness, throughput and providing a mechanistic understanding of chemical modes-of-actions, in ...
Marcin W. Wojewodzic, Monica Andreassen
openaire +2 more sources
RE-Place: A Unique Project Collecting Expertise on New Approach Methodologies
Frontiers in Pharmacology, 2022 By applying “New Approach Methodologies (NAMs)” based on innovative technologies such as computer modeling, high throughput testing, omics, and sophisticated cell cultures, the use of experimental animals in the life sciences can be reduced or sometimes ...
Mieke Van Mulders +5 more
doaj +2 more sources
AI-driven parametrization of Michaelis–Menten maximal velocity: Advancing in silico new approach methodologies (NAMs) [PDF]
NAM JournalThe development of mechanistic systems biology models necessitates the utilization of numerous kinetic parameters once the enzymatic mode of action has been identified.
Achilleas Karakoltzidis +2 more
doaj +2 more sources
Nonclinical human neural new approach methodologies (NAMs): Electrophysiological assessment of opioid agonist and antagonist combination [PDF]
NAM JournalBackground and Purpose: New approach methodologies (NAMs) including microphysiological systems in combination with human induced pluripotent stem cell (hiPSC)-derived neural cells and multielectrode array (MEA) have demonstrated utility for evaluating ...
Carlos Serna, III +3 more
doaj +2 more sources
Review on new approach methods to gain insight into the feto-maternal interface physiology [PDF]
Frontiers in Medicine, 2023 Non-human animals represent a large and important feature in the history of biomedical research. The validity of their use, in terms of reproducible outcomes and translational confidence to the human situation, as well as ethical concerns surrounding ...
Ramkumar Menon +3 more
doaj +2 more sources
Independent testing infrastructure for new approach methodologies: the UC Davis NAMs testing center [PDF]
Frontiers in Medical TechnologyAs biomedical research moves toward greater use of human-based experimental systems, the practical problem is no longer simply how to develop new models, but how to determine when they are valid and predictable for a particular use.
K. C. Kent Lloyd
doaj +2 more sources