Risk management of biological agents in phase I clinical trials: Case sharing / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12): 44-48, 2020.
Article
in Chinese
| WPRIM
| ID: wpr-855911
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Etiology study
Language:
Chinese
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Year:
2020
Type:
Article
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