Risk management of biological agents in phase I clinical trials: Case sharing / 中国临床药理学与治疗学

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.