The FDA Modernization Act 2.0: Drug Testing in Animals is Rendered Optional

2023/04/18 by Eli Y. Adashi, Daniel P. O'Mahony, Daniel P. O’Mahony +1 · 30 citations
Veterinary · Medicine · Immunology and Microbiology · #Animal testing and alternatives #Biomedical Ethics and Regulation #Biosimilars and Bioanalytical Methods

paper · pdf · doi:10.1016/j.amjmed.2023.03.033

Cited by

• Critical uncertainties in preclinical research: Navigating trust, technology, and ethics
• Bridging the gap between tumor and disease: Innovating cancer and glioma models
• Exploring the potential of computer simulation models in drug testing and biomedical research: a systematic review
• An industry perspective on the FDA Modernization Act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development
• Quantitative systems toxicology: modelling to mechanistically understand and predict drug safety
• Bioethical implications of organ-on-a-chip on modernizing drug development. [europepmc]
• On the path to predicting immune responses in the lung: Modeling the pulmonary innate immune system at the air-liquid interface (ALI). [europepmc]
• Embedded 3D bioprinting - An emerging strategy to fabricate biomimetic & large vascularized tissue constructs. [europepmc]
• An in silico model of the capturing of magnetic nanoparticles in tumour spheroids in the presence of flow. [europepmc]
• A mechanistic marker-based screening tool to predict clinical immunogenicity of biologics. [europepmc]
• Vascular organs-on-chip made with patient-derived endothelial cells: technologies to transform drug discovery and disease modeling. [europepmc]
• Validation of a mouse 3D gastruloid-based embryotoxicity assay in reference to the ICH S5(R3) guideline chemical exposure list. [europepmc]
• Beyond 2D: Novel biomaterial approaches for modeling the placenta. [europepmc]
• 3D Hydrogel Culture System Recapitulates Key Tuberculosis Phenotypes and Demonstrates Pyrazinamide Efficacy. [europepmc]
• Advances in high throughput cell culture technologies for therapeutic screening and biological discovery applications. [europepmc]
• Bridging the Gap: Integrating 3D Bioprinting and Microfluidics for Advanced Multi-Organ Models in Biomedical Research. [europepmc]
• Immunogenicity risk assessment of empty capsids present in adeno-associated viral vectors using predictive innate immune responses. [europepmc]
• Development of an Oral Epithelial Ex Vivo Organ Culture Model for Biocompatibility and Permeability Assessment of Biomaterials. [europepmc]
• Bridging the gap between tumor and disease: Innovating cancer and glioma models. [europepmc]
• Fluorescent Molecular Probe for Imaging Hypoxia in 2D Cell Culture Monolayers and 3D Tumor Spheroids: The Cell Membrane Partition Model for Predicting Probe Distribution in a Spheroid. [europepmc]
• Application of a high-density microelectrode array assay using a 3D human iPSC-derived brain microphysiological system model for in vitro neurotoxicity screening of environmental compounds. [europepmc]
• Organoids in virology. [europepmc]
• Bridging the gap: how patient-derived lung cancer organoids are transforming personalized medicine. [europepmc]
• Human intestinal enteroids: Nonclinical applications for predicting oral drug disposition, toxicity, and efficacy. [europepmc]
• Exploring the potential of computer simulation models in drug testing and biomedical research: a systematic review. [europepmc]
• In Vitro Skin Models as Non-Animal Methods for Dermal Drug Development and Safety Assessment. [europepmc]
• Immunogenicity of Gene and Cell Therapies. [europepmc]
• Perspective of using in vitro models to understand immunotherapy-induced cytokine release syndrome. [europepmc]
• From mouse embryo assay to bovine embryo assay: towards an ethical and scientifically superior quality control standard in assisted reproduction technologies. [europepmc]
• Alveolus-on-a-chip: A Novel Tool for Modeling Lung Transplant Cold Storage Ischemia/Reperfusion Injury. [europepmc]