Drug development

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

Laura Lotfi, T. William O’Neill, Angela Wilcox, Steven Bulera. Virtual control groups in nonclinical research: A Re-analysis of 20 studies using virtual control group data. Regulatory Toxicology and Pharmacology. 2026;168:106077. doi:10.1016/j.yrtph.2026.106077

Ryan Posey, Alican Özkan, Donald E. Ingber. Human organ-on-a-chip technology as a catalyst for drug discovery. Advanced Drug Delivery Reviews. 2026;236:115920. doi:10.1016/j.addr.2026.115920

Dilyana Filipova, Wolfgang Boomgaarden, Leyla Fox, et al. Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure. NAM Journal. 2026:100119. doi:10.1016/j.namjnl.2026.100119

Mariana Dias, Catarina A. Custódio, João F. Mano. Human protein-based biomaterials in preclinical modelling. Nature Reviews Bioengineering. 2026;4(5):399-400. doi:10.1038/s44222-026-00425-7

Natalie Burden. New approach methodologies to reduce reliance on animal toxicity testing. Nature Reviews Bioengineering. 2026:1-2. doi:10.1038/s44222-026-00480-0

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

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

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

Thomas Hartung, Lena Smirnova. A path forward advancing microphysiological systems. ALTEX - Alternatives to animal experimentation. 2025;42(2):183-203. doi:10.14573/altex.2504091