Risk management of biological agents in phase I clinical trials: Case sharing
10.12092/j.issn.1009-2501.2020.01.006
- VernacularTitle: 生物制剂I期临床试验中的风险管控:案例分享
- Author:
Haijing YANG
1
Author Information
1. Phase I Clinical Trial Center, Huashan Hospital of Fudan University
- Publication Type:Journal Article
- Keywords:
Biological agents;
Phase I clinical trials;
Risk management;
Safety
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(1):44-48
- CountryChina
- Language:Chinese
-
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.
