New Approach Methodologies (NAMs)

Ronit Mohapatra, Dowlette-Mary Alam El Din, Hanyu Zhao, Thomas Hartung, Lena Smirnova. Towards learning and memory risk assessment with human brain organoids: barriers and opportunities. Frontiers in Toxicology. 2026;8. doi:10.3389/ftox.2026.1783893

Tyna Dao, Nakissa Sadrieh. A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs. Regulatory toxicology and pharmacology: RTP. 2026;165:106007. doi:10.1016/j.yrtph.2025.106007

Yanning Hao, Tyna Dao, Nakissa Sadrieh. Applications of in vitro new approach methodologies (NAMs) in drug development: A scoping analysis of titles of nonclinical study reports submitted to the FDA. Regulatory Toxicology and Pharmacology. 2026;172:106246. doi:10.1016/j.yrtph.2026.106246

Jonathan Blum, Markus Brüll, Jan G. Hengstler, et al. The long way from raw data to NAM-based information: Overview on data layers and processing steps. ALTEX - Alternatives to animal experimentation. 2025;42(1):167-180. doi:10.14573/altex.2412171

Eike Cöllen, Kristina Bartmann, Jonathan Blum, et al. Mapping out strategies to further develop human-relevant, new approach methodology (NAM)-based developmental neurotoxicity (DNT) testing. ALTEX - Alternatives to animal experimentation. 2025. doi:10.14573/altex.2501091

Argel Islas-Robles, Meera Ramani, Jakeb Phillips, Gertrude-Emilia Costin. New Horizons in Skin Sensitization Assessment of Complex Mixtures: The Use of New Approach Methodologies Beyond Regulatory Approaches. Toxics. 2025;13(8):693. doi:10.3390/toxics13080693

Jacintha Shenton, Imein Bousnina, Michael Oropallo, et al. Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment. Drug Discovery Today. 2025;30(4):104328. doi:10.1016/j.drudis.2025.104328

Maria T. Baltazar, Sophie Cable, Richard Cubberley, et al. Making safety decisions for a sunscreen active ingredient using next-generation risk assessment: Benzophenone-4 case study. ALTEX. 2025;42(3):511-530. doi:10.14573/altex.2501201

Alex Rittenhouse, Caroline Krall, Jesse Plotkin, et al. Microglia-containing neural organoids as brain microphysiological systems for long-term culture. Frontiers in Cellular Neuroscience. 2025;19. doi:10.3389/fncel.2025.1616470

Carlos Serna, Bhavya Bhardwaj, Tromondae K. Feaster, Ksenia Blinova. Nonclinical human neural new approach methodologies (NAMs): Electrophysiological assessment of opioid agonist and antagonist combination. NAM Journal. 2025;1:100064. doi:10.1016/j.namjnl.2025.100064