Strengthening clinical monitoring research to ensure the safe use of biological innovative drugs
10.3760/cma.j.cn114015-20211018-01072
- VernacularTitle:加强临床监测研究 确保生物创新药的安全使用
- Author:
Aidong WEN
1
;
Meiyou LIU
1
;
Tingting FAN
1
;
Likun DING
1
;
Danjun REN
1
Author Information
1. 空军军医大学第一附属医院药剂科，西安 710032
- Publication Type:Journal Article
- Keywords:
Biopharmaceutics;
Drug monitoring;
Drug-related side effects and adverse reactions;
Safety;
Precise medication
- From:
Adverse Drug Reactions Journal
2021;23(10):505-507
- CountryChina
- Language:Chinese
-
Abstract:
With the key mechanism of disease occurrence being revealed and rapid development of modern biopharmaceutical technology, more and more biological innovative drugs have been approved for marketing. With more clinical application of innovative biological drugs in recent years, more adverse reactions were reported. Therefore, it is of great significance and urgent in clinic to construct the supervision standard and system for the safe use of biological innovative drugs. At present, the main problems hindering the clinical safety supervision of biological innovative drugs are as follows. Firstly, the mechanism of adverse drug reactions is unclear and there is a lack of specific detection indicators to predict them. Secondly, the study on the relationship of "exposure-clinical efficacy-toxic and side effects" of drugs in vivo is still insufficient, so it is difficult to support the establishment of the rule of "quantity and toxicity" for safe drug use. Thirdly, there is a lack of clinical research evidence in line with the physiological and pathological characteristics of Chinese people, and the ideal randomized controlled trials results of clinical research on new drugs are not enough to support its safe drug use in the real world. Therefore, it is necessary to strengthen the supervision awareness of the clinical safe use, accelerate the process of clinical monitoring research on biological innovative drugs, reveal more scientific evidence of clinical safe use, so as to help the construction of the supervision standards and system for the safe use of biological innovative drugs.
