Risk control in phase Ⅰ clinical trials of macromolecular drugs
10.13699/j.cnki.1001-6821.2024.16.026
- VernacularTitle:大分子药物Ⅰ期临床试验风险的控制
- Author:
Wen-Jing BAI
1
;
Juan WANG
;
Yue LIU
;
Ting-Ting WANG
;
Ti-Ti WANG
;
Ya-Ru WANG
;
Yu-Ying YIN
;
Xin WANG
Author Information
1. 北京医院国家老年医学中心中国医学科学院老年医学研究院临床试验研究中心,北京 100730
- Keywords:
macromolecular drugs;
phase Ⅰ clinical trials;
risk control
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(16):2424-2427
- CountryChina
- Language:Chinese
-
Abstract:
The author analyzed the characteristics of phase Ⅰ clinical trials of macromolecular drugs,the characteristics of evaluation indicators of phase Ⅰ clinical trials of macromolecular drugs,such as safety evaluation,pharmacokinetic and pharmacodynamic evaluation,and efficacy evaluation.And the control points of subjects management,management of experimental macromolecule drugs,and identified and potential risk factors of macromolecule drugs in the implementation of risk management for phase Ⅰ clinical trials of macromolecule drugs were discussed in depth based on previous clinical trial research experience.Through discussion and analysis,the author suggests that each research center can formulate risk control strategies according to the actual situation,improve the efficiency of risk control,and facilitate the smooth implementation of clinical trials and improve the quality of clinical trials.
