Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting

Abstract

Abstract: Due to the complexity of targeted population and environment, new safety and efficacy problems of post-marketing drugs may be found differrent from the Conclusion s of clinical trials, while the PBRER is an important pharmacovigilance tool. It can be a means of determining changes in the benefit-risk profile and an indicator for the need of risk management initiatives. This paper introduced the content of the new Periodic Benefit-Risk Evaluation Reporting, aiming to understand the new concepts and principles of PBRER, and provide reference for related work in our country in the future.

Key words: PSUR, PBRER, signal, risk assessment

CLC Number:

R954

YUAN Li ,YANG Yue. Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting [J]. Chinese Journal of Pharmacovigilance, 2013, 10(11): 650-654.

[1]	WANG Shan, XIE Bo, LIU Huimin, LI Zhihao. Adverse event signals for celecoxib based on FAERS database [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 190-194.
[2]	GUO Longxin, GAO Yunjuan, WU Chengzhao, LONG Minjuan, ZHU Shengkai, SONG Haibo, ZHAO Xu, XIAO Xiaohe. Exploring new risk signals and susceptibility factors of traditional Chinese medicine-induced hepatotoxicity based on big data from adverse reaction monitoring [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 15-19.
[3]	YANG Zhenzhen, CHANG Cheng, GAO Na, ZHANG Xiaolin, SONG Yinsen, LIU Ying, FAN Tianli. Molecular mechanism of luteolin for inhibiting esophageal squamous cell carcinoma based on network pharmacology and in vitro studies [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 992-1001.
[4]	HE Huizhen, GUO Yixian, SUN Wanling. Research progress on targeting CD47 in treatment of lymphoma [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1071-1077.
[5]	MEI Yu, ZHU Yue, ZHANG Huiting, XIAO Chengrong, GAO Yue, MA Zengchun. Protective mechanism of Chinese medicine compound CB001 against low dose radiation based on network pharmacology and experimental verification [J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 872-879.
[6]	ZAN Ke, ZHAO Lei, JIANG Dacheng, WANG Ying, JIN Hongyu, MA Yu, MA Shuangcheng. Determination of 135 pesticide residues in Farfarae Flos by UPLC-MS/MS and risk assessment [J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 885-890.
[7]	WANG Ran, LI Yifan, LIU Xiaoyan, FENG Xin. One case of pharmaceutical care of drug exposure during pregnancy [J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 933-934.
[8]	WANG Ran, FENG Xin, DU Boran. Advances in risk assessment and pharmaceutical care of pregnancy medication exposure during perinatal period [J]. Chinese Journal of Pharmacovigilance, 2023, 20(7): 836-840.
[9]	CHEN Xiao, GUO Xiaojing, XU Jinfang, WEI Lianhui, CHEN Chenxin, LIANG Jizhou, ZHENG Yi, YE Xiaofei. Machine learning method in the detection of adverse drug reaction signals of brigatinib based on FAERS database [J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 639-645.
[10]	WEI Lianhui, ZHANG Pengpeng, LIU Yongmei, GUO Xiaojing, XU Jinfang, CHEN Xiao, CHEN Chenxin, YE Xiaofei. Overlap weighting in detection of adverse drug reaction signals: a simulated study [J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 646-650.
[11]	CHEN Chenxin, ZHANG Pengpeng, LIU Yongmei, YE Xiaofei, HE Jia. Combination of zero-inflated model and Dirichlet process in detection of adverse reaction signals during post-marketing surveillance [J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 651-654.
[12]	NIE Lixing, WANG Xinping, LI Jing, DAI Zhong, KANG Shuai, MA Shuangcheng. Content analysis and risk assessment of aristolochic acids in Chinese medicinal materials (decoction pieces) [J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 553-559.
[13]	YAO Keyu, ZHANG Shuqi, JIN Rui, LIU Lihong, ZHU Yan. Comparative study on data set of drug-induced liver injury [J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 568-573.
[14]	NIE Lixing, CHEN Jia, ZHANG Ye, ZHAO Hui, DAI Zhong, MA Shuangcheng. Comprehensive tests and risk assessment of exogenous harmful residues in Isatidis Radix [J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 379-382.
[15]	ZHENG Yujing, ZHAO Zinan, JIN Pengfei, ZHAO Fei, HU Xin, ZHANG Yatong. Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system [J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 441-443.

Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics