Research graph
References from New approach methodologies in pharmaceutical development: Survey insights on adoption, infrastructure, and the path to broader implementation. Local targets link to admitted publications; unresolved targets remain external evidence.
An FDA/CDER perspective on nonclinical testing strategies: classical toxicology approaches and new approach methodologies (NAMs)
10.1016/j.yrtph.2020.104662 · 2020 · External reference
The current status and use of microphysiological systems by the pharmaceutical industry: the International Consortium for Innovation and Quality microphysiological systems affiliate survey and commentary
10.1124/dmd.123.001510 · 2024 · External reference
New approach methodologies in human health risk assessment across European regulatory frameworks: status quo, barriers and drivers for regulatory acceptance and use
10.1016/j.envint.2025.109279 · 2025 · External reference
Application of new approach methodologies for nonclinical safety assessment of drug candidates
10.1038/s41573-025-01182-9 · 2025 · External reference
Considerations from the pharmaceutical industry (IQ MPS Affiliate) workshop on animal microphysiological systems and 3Rs in drug development
2025 · External reference
3Rs at the european medicines agency: past and future activities
10.1016/j.namjnl.2026.100086 · 2026 · External reference
Unresolved reference
2024 · External reference
Unresolved reference
2021 · External reference
Unresolved reference
2025 · External reference
Unresolved reference
2026 · External reference
Unresolved reference
2026 · External reference
Unresolved reference
2024 · External reference
Eliminating unnecessary animal testing
10.1001/jama.2026.7074 · 2026 · External reference
International harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines
2023 · External reference
Never-ending acronym madness: proposing a harmonized definition for NAMs
10.1016/j.namjnl.2026.100085 · 2026 · External reference
Biology-inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare
2025 · External reference
Collection of alternative methods for regulatory application (CAMERA)
2025 · External reference
Concordance of the toxicity of pharmaceuticals in humans and in animals
10.1006/rtph.2000.1399 · 2000 · External reference
Unresolved reference
2021 · External reference
Unresolved reference
2023 · External reference
A call to action: advancing new approach methodologies (NAMs) in regulatory toxicology through a unified framework for validation and acceptance
10.1016/j.yrtph.2025.105904 · 2025 · External reference
Ways to broaden the awareness, consideration and adoption of new approach methodologies (NAMs)
2025 · External reference
Considerations for the general toxicity evaluation of monoclonal antibodies
2026 · External reference
Opportunities and challenges for human microphysiological systems in drug development
2025 · External reference
Accelerating adoption of new approach methodologies in regulatory decision making: an industry perspective
10.1038/d41573-025-00038-6 · 2025 · External reference
Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment
10.1016/j.drudis.2025.104328 · 2025 · External reference
Modernizing toxicology: the importance of accessible NAM training
10.1016/j.toxlet.2025.02.011 · 2025 · External reference
Adoption of organ-on-chip platforms by the pharmaceutical industry
10.1038/s41573-021-00323-0 · 2021 · External reference
FDA/CDER/OND experience with new approach methodologies (NAMs)
10.1177/10915818251384270 · 2026 · External reference
