Risk Management in First-in-Human Trials of Intravenous Drugs: Current Practices and Future Perspectives
Wei Zhang, Dandan Yang, Rong Shao, Tiantian Lai, Xiuqin Feng · 2026
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Description
Zhang, Yang, Shao, Lai, and Feng review how to manage risk in first-in-human trials of drugs given by vein. Such trials join lab data to a real human body for the first time, and vein dosing acts at once with little room for error. Their 2026 review pulls together papers, guidance, and their own trial experience.
The authors list risk sources, from drug unknowns and mix related harm to dosing speed and patient differences. They cover guards such as safe starting doses, trained staff, standard drug handling, close watch, and ready emergency care. Their plan sorts trials into low, middle, and high risk tiers. Each tier gets care matched to its level, the authors propose.
Catalog record
| CREATOR | Wei Zhang, Dandan Yang, Rong Shao, Tiantian Lai, Xiuqin Feng |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 53 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |