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Review Open access Aug 2026

Risk Management in First-in-Human Trials of Intravenous Drugs: Current Practices and Future Perspectives

A conceptual, stratified risk management framework is proposed that categorizes trials into low-, moderate-, and high-risk levels based on drug-related, procedural, and participant-specific variables and optimizes safety assurance in high-risk trials while avoiding the overutilization of resources in low-risk settings.

Wei Zhang, Dan-Dan Yang, Rong Shao et al. · 0 citations

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