POST-MARKETING

作品数：21被引量：110H指数：5
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An investigation into the current status of post-marketing signal detection for pharmaceutical products in China:An interview-based study
《Journal of Chinese Pharmaceutical Sciences》2025年第2期175-184,共10页Xuelin Sun Yatong Zhang Dongfang Qian Siyuan Tan Zixuan Zhang Pengfei Jin Xin Hu 
China National Key Research and Development Program(Grant No.2020YFC2009000 and 2020YFC2009001);National High Level Hospital Clinical Research Funding(Grant No.BJ-2023-200);the project funding from the Drug Evaluation Center of the National Medical Products Administration(Grant No.CDRW20214001).
The aim of this study was to provide insights into the current status and primary methodologies employed by marketing authorization holders(MAHs)for signal detection.These insights are intended to offer valuable refer...
关键词：PHARMACOVIGILANCE Signal Marketing authorization holder Adverse drug reactions 
Long-term tadalafil once daily in Chinese men with erectile dysfunction:a 2-year final analysis of a post-marketing,multicenter,randomized,open-label trial
《Asian Journal of Andrology》2024年第3期282-287,共6页Hui Jiang Lian-Ming Zhao Su Yan Ji-Hong Liu Zhao-Hui Zhu Jin-Dan Luo Yu-Tian Dai Fu-Biao Li Hao-Cheng Lin Zhi-Chao Zhang 
sponsored by A.Menarini China Holding Co.,Ltd.(Shanghai,China).A.Menarini China had no influence on the data and no competinginterests.
The long-term safety and effectiveness of once-daily tadalafil is crucial,but limited data are available in Chinese patients witherectile dysfunction(ED).In this post-marketing,multicenter,randomized,open-label trial ...
关键词：clinical trial erectile dysfunction long-term safety once-daily dosing TADALAFIL 
Safety profile of 0.0015%tafluprost eye drops in China:a post-marketing observational study
《International Journal of Ophthalmology(English edition)》2023年第1期108-114,共7页Xue-Li Chen Yan-Jing Fu Bo Qu Ye-Wei Wang Xin Tang Yu-Hong Wang Guo-Yi Zhou Ming-Kai Lin Jing-Yuan Shen Jin Yao Su-Yan Li Miao-Qin Wu Hua-Zong Peng Ming-Ying Lai Ren-Yi Wu Yi-Nong Zhang Yan Li Xiao-Jun Wu Ming-Chang Zhang Su-Ping Guo Xing-Huai Sun 
Supported by Santen Pharmaceutical(China)Co.,Ltd.
AIM:To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension(OH)in clinical practice in China.METHODS:This post-marketing observational study included patients who received ta...
关键词：TAFLUPROST GLAUCOMA ocular hypertension intraocular pressure adverse drug reactions 
Status and Development Trend of Evaluation of Post-Marketing Traditional Chinese Medicines in China
《World Journal of Integrated Traditional and Western Medicine》2020年第6期15-22,共8页WEI Rui-li WANG Zhi-fei XIE Yan-ming 
Evaluation of traditional Chinese medicines after the market has achieved fruitful results after years of development.The real-world research concept has been first proposed by Chief Researcher Xie Yanming in 2010 and...
关键词：Evaluation of traditional Chinese medicines after marketing Real world research Clinical safety evaluation PHARMACOVIGILANCE 
Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery:clinical trials and post-marketing experience被引量：2
《Gastroenterology Report》2019年第5期322-330,I0001,共10页Bo Shen Aimee Blake Karen Lasch Michael Smyth Fatima Bhayat 
This work was supported by Takeda Pharmaceutical Company Ltd.
Background:Patients with inflammatory bowel diseases frequently require surgery,but immunotherapies used in disease management may increase the risk of post-operative complications.We investigated frequencies of post-...
关键词：inflammatory bowel disease colorectal surgery vedolizumab 
Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial被引量：15
《Chinese Journal of Integrative Medicine》2019年第12期887-894,共8页TANG Xu-dong ZHANG Sheng-sheng HOU Xiao-hua LI Zhen-hua CHEN Su-ning FENG Pei-min YANG Xiao-nan LI Hui-zhen WU Jie-qiong XIA Pei-jun YANG Xiao-jun ZHOU Heng-jun WANG Hai-yan AI Yao-wei LI Kang 
Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy...
关键词：Tongxiening GRANULES IRRITABLE bowel syndrome with predominant diarrhea POST-MARKETING evaluation RANDOMIZED controlled TRIAL 
Analysis of Ornidazole Injection in Clinical Use at Post-marketing Stage by Centralized Hospital Monitoring System被引量：4
《Current Medical Science》2019年第5期836-842,共7页Ying ZHAO Zhe CHEN Pu HUANG Si-wei ZHENG Qi-ling XU Chen SHI 
This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and ...
关键词：ORNIDAZOLE injection CENTRALIZED HOSPITAL monitoring system POST-MARKETING REASSESSMENT clinical use ADVERSE reaction 
Post-marketing safety surveillance and reevaluation of Motherwort injection：A clinical study of 10094 cases被引量：4
《Journal of Traditional Chinese Medicine》2018年第4期625-635,共11页Cao Shan Zhang Wenhao Zhao Ziwei Heng Mingli Bu Huaien Wang Hongwu Liu Xinghui Wang Zhong Cai Yan Ma Yuyan Cui Shihong Deng Jihong Ding Guifeng Ding Yajuan Dong Linhong Duan Zhentao Fan Ling Fan Yang Fu Fen He Jing Ji Shuying Jin Lin Li Hong Li Hongying Liao Tao Lu Wei Luo Xiucui Lü Zhihui Ma Fengchun Ma Dafeng Shi Tianyun Sun Juying Sun Xiaotong Teng Hong Wang Jinhua Wang Ruihua Wang Ying Wang Zhengling Xi Jie Xu Minjuan Xu Zhihong Yan Qian Yang Cuirong Yang Yimei Yin Jie Yu Jinhua Yuan Wenjun Zhang Guanli Zhang Meihua Zhao Renfeng Zhong Yonghong Zhou Jian 
Sichuan Science and Technology Support Project:the Nested Case-control Study on Adverse Reaction Centralized Monitoring and Risk Factors of Leonurus Japonicus Injection(No.2014ZS0139);the Major State Basic Research Grant(973-program;2011CB505406);Ph.D.Programs Foundation of Ministry of Education of China(No.2013-1210110001);State Administration of Traditional Chinese Medicine "Twelve-Five" Focus on Cultivating Subjects of Chinese Preventive Medicine[(2012)170]
OBJECTIVE:To investigate the safety profiles of Motherwort injection(MI).METHODS:A multi-center,prospective and drugderived hospital intensive monitoring method was conducted to assess the safety of MI in real world a...
关键词：Safty Product surveillance postmarket-ing Drug-related side effects and adverse reac-tions Motherwort injection 
How to establish precise proprietary Chinese medicine in post-marketing reappraisal?被引量：1
《Traditional Medicine Research》2017年第4期155-160,共6页Ran Tian Liang Dai Hong-Cai Shang You-Ping Li Zhao-Xiang Bian 
The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisa...
关键词：Traditional Chinese medicine Post-marketing reappraisal Precise Chinese medicine 
ADRs and Children： Knowledge and Methodological Standard in PASS （Post Authorization Safety Studies）
《Journal of Pharmacy and Pharmacology》2017年第6期314-322,共9页Ettore Napoleone Cristiana Scasserra 
PhV （pharmacovigilance） knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ...
关键词：CHILDREN adverse drug reactions OFF-LABEL PHARMACOVIGILANCE post-marketing clinical studies. 
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