Strategy

Weight of Evidence Approach for Waiving Long Term Toxicity Studies for Monoclonal Antibodies

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A paper by FDA authors [Hao et al., 2026] systematically evaluated the contribution of chronic 6-month non-human primates (NHP) toxicity studies to human safety assessment for monoclonal antibodies (mAbs). Three key points stand out: • Long-term NHP toxicity studies rarely altered regulatory conclusions regarding human risk. • Long-term studies generally did not identify unexpected off-target […]

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A Priori NAM Workflows

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In “a priori NAM workflow”, we propose the use of non-animal methods at the very start of preclinical development to generate human-relevant insights before any in vivo studies. By predicting drug behavior upfront, this approach helps reduce the number and scope of animal experiments needed later. Mechanistic modeling - PBPK and QSP - enables simulation

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