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Akademický článek

Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022Research in context

Autor: Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Xufeng Lv, Cen Wang, Haopeng Liu, Yue Zhou, Xuecai Xue, Zhuangqi Li, Jingwen Liu, Shein-Chung Chow, Yue Yang

Publikováno v: EClinicalMedicine, Vol 63, Iss , Pp 102177- (2023)

Summary: Background: Accelerated approval (AA) of novel anticancer drugs based on surrogacy has attracted considerable concern globally. China National Medical Products Administration (NMPA) also established a similar conditional approval (CA) progra

Externí odkaz: https://doaj.org/article/7835359a841d46439270663cc2de348a

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Akademický článek

Selected cutaneous adverse events in patients treated with ICI monotherapy and combination therapy: a retrospective pharmacovigilance study and meta-analysis

Autor: Wenchao Lu, Huiyun Zhang, Qixiang Guo, Zhuoyue Gou, Jiannan Yao

Publikováno v: Frontiers in Pharmacology, Vol 14 (2023)

Introduction: Cutaneous adverse events are commonly reported immune-related adverse events (irAEs), some of which are serious or even life-threatening, and it is essential to study these specific cutaneous AEs to understand their characteristics and

Externí odkaz: https://doaj.org/article/48daf8b71daf45359a1fad74489e811e

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Akademický článek

The price, efficacy, and safety of within-class targeted anticancer medicines between domestic and imported drugs in China: a comparative analysisResearch in context

Autor: Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Ruijie Tan, Yue Zhou, Zhuangqi Li, Xuecai Xue, Taifeng Li, Kaidi Le, Feng Qian, Shein-Chung Chow, Yue Yang

Publikováno v: The Lancet Regional Health. Western Pacific, Vol 32, Iss , Pp 100670- (2023)

Summary: Background: Affordability to novel anticancer drugs has become a major health issue in China. It is encouraging to note that China initiated its drug regulatory reform and national price negotiation policies since 2015. As a growing number o

Externí odkaz: https://doaj.org/article/8f04d5b36a9a47c5a3c46d0997c20b89

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Akademický článek

Pericardial Toxicities Associated With Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Autor: Zhuo Ma, Jie Pei, Ximu Sun, Lihong Liu, Wenchao Lu, Qixiang Guo, Jiayou Lyu, Yuwei Liu, Yuhui Zhang, Zhixia Zhao

Publikováno v: Frontiers in Pharmacology, Vol 12 (2021)

Introdution: Immune checkpoint inhibitors (ICIs) have significantly improved clinical outcomes for a wide range of cancers but can also lead to serious or fatal immune-related adverse events (irAEs). Although ICI-related pericardial toxicities have b

Externí odkaz: https://doaj.org/article/8fe5041cd3354560996e5bd0660ba6c7

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