krinaj@gmail.com
Weight of Evidence Approach for Waiving Long Term Toxicity Studies for Monoclonal Antibodies
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
Read More »Physiologically-Based Pharmacokinetic (PBPK) Models
PBPK is a computational approach that predicts how a drug moves through the body - how it is absorbed, distributed, metabolized, and eliminated. Unlike traditional methods that rely heavily on animal studies, PBPK models can use lab-based (in vitro) and physicochemical property data to simulate drug behavior in humans before any in vivo testing. This makes PBPK
Read More »A Priori NAM Workflows
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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