Risk management of biological agents in phase I clinical trials: Case sharing

doi:10.12092/j.issn.1009-2501.2020.01.006

Abstract

Abstract: To point out the importance of risk management for biological agents in phase I clinical trials, taking a healthy subject for an example who suffered from agranulocytosis after the application of Tozumab. In order to ensure the safety of the subjects and smooth progress of clinical trials, risk management should be implemented in several aspects such as: informing, screening, administration, subject training, and adverse event management and so on.

Key words: biological agents, phase I clinical trials, safety, risk management

CLC Number:

R969.4

YANG Haijing, YU Jicheng, WANG Jingjing, LI Nanyang, WU Jufang, ZHANG Hai, XUE Tao, DAI Weiguo, DING Tianling, CAO Guoying. Risk management of biological agents in phase I clinical trials: Case sharing[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, doi: 10.12092/j.issn.1009-2501.2020.01.006.

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