PHARMACOVIGILANCE

作品数:41被引量:113H指数:5
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相关领域:医药卫生更多>>
相关作者:郑开逸叶祖光更多>>
相关机构:中国药科大学中国中医科学院更多>>
相关期刊:《Journal of Biomedical Research》《Journal of Cancer Metastasis and Treatment》《World Journal of Hepatology》《Neural Regeneration Research》更多>>
相关基金:国家自然科学基金更多>>
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Research on the Optimization of China’s Pharmacovigilance Organization Management
《Asian Journal of Social Pharmacy》2025年第1期10-19,共10页Zhang Zhi Sun Lihua 
Objective To analyze the problems of China’s pharmacovigilance organization system,and to provide targeted suggestions for improving it.Methods The relevant literature at home and abroad was reviewed to compared the ...
关键词:pharmacovigilance organization system optimization policy suggestion 
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 
The applications and advances of artificial intelligence in drug regulation:A global perspective
《Acta Pharmaceutica Sinica B》2025年第1期1-14,共14页Lixia Fu Guoshu Jia Zhenming Liu Xiaocong Pang Yimin Cui 
Artificial intelligence(AI)has emerged as a transformative force in healthcare,with applications spanning diagnostics to drug development.However,its integration into drug regulation remains nascent,with varying degre...
关键词:Artificial intelligence Machine learning Regulatory science Safety surveillance PHARMACOVIGILANCE REGULATION Emerging technology 
Biguanides and lactic acidosis:unraveling the complex relationship
《Pharmacology Discovery》2024年第3期48-51,共4页Shreyash Narade 
Biguanides,such as metformin,have long been established as frontline medications for the management of type 2 diabetes due to their glucose-lowering effects and favorable safety profiles.However,concerns regarding the...
关键词:BIGUANIDES METFORMIN lactic acidosis type 2 diabetes PHARMACOVIGILANCE 
Research on Construction of Pharmacovigilance System for Marketing Authorization Holders in China
《Asian Journal of Social Pharmacy》2024年第2期106-116,共11页Zhao Jiai Tian Lijuan 
Integration Application Status and Problems Investigation of ICH Q8,Q9,Q10 across the Product Life Cycle(No.20210605).
Objective To provide suggestions for helping marketing authorization holders(MAHs)to develop an effective and compliant pharmacovigilance system.Methods The construction strategies of pharmacovigilance system of the m...
关键词:marketing authorization holder(MAH) pharmacovigilance system good pharmacovigilance practice 
Cancer treatment with biosimilar drugs:A review
《Cancer Innovation》2024年第2期45-62,共18页Shilpa Malakar Emmanuel Nuah Gontor Moses YDugbaye Kamal Shah Sakshi Sinha Priya Sutaoney Nagendra Singh Chauhan 
Director of AYUSH(Chhattisgarh)for laboratory facilities and National Ayush Mission(NAM)Grant award year 2016-17。
Biosimilars are biological drugs created from living organisms or that contain living components.They share an identical amino-acid sequence and immunogenicity.These drugs are considered to be cost-effective and are u...
关键词:BIOLOGICS BIOSIMILARS cancer Escherichia coli monoclonal antibody next-generation sequencing PHARMACOVIGILANCE 
Why pharmacovigilance of traditional medicines used as analgesics is important?
《Traditional Medicine Research》2023年第10期47-55,共9页Subhransu Dash Neha Bajwa Abinash Choudhury Preet Amol Singh 
Traditional remedies have gained recognition for their effectiveness in treating various conditions such as diabetes,arthritic pain,liver disease,cough and cold,memory enhancement,and immunological stimulation.Their p...
关键词:herbal medicine PHARMACOVIGILANCE regulatory framework traditional medicine 
Predictive Model of Oxaliplatin-induced Liver Injury Based on Artificial Neural Network and Logistic Regression
《Journal of Clinical and Translational Hepatology》2023年第7期1455-1464,共10页Rui Huang Yuanxuan Cai Yisheng He Zaoqin Yu Li Zhao Tao Wang Xiaofang Shangguan Yuhang Zhao Zherui Chen Yunzhou Chen Chengliang Zhang 
the Medical Ethics Committee of Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology(No.TJIRB20160504).
Background and Aims:Identifying potential high-risk groups of oxaliplatin-induced liver injury(OILI)is valuable,but tools are lacking.So artificial neural network(ANN)and logistic regression(LR)models will be develope...
关键词:OXALIPLATIN Liver injury Adverse drug reaction RUCAM PHARMACOVIGILANCE 
Hearing loss and tinnitus associated with COVID-19 vaccines:An analysis from the national pharmacovigilance database in Malaysia
《Asian Pacific Journal of Tropical Medicine》2023年第7期289-295,I0002-I0004,共10页Sing Chet Lee Wee Kee Wo Hee Sheong Yeoh Sim Mei Choo Azuana Ramli 
Objective:To compare the reporting pattern of hearing loss and tinnitus across different vaccines brands used in Malaysia(BNT162b2,CoronaVac,ChAdOx1,Ad5.CoV2-S and BBIBP-CorV).Methods:This retrospective study included...
关键词:COVID-19 vaccines Hearing loss TINNITUS Adverse events following immunization 
Defining the awareness and attitude of the clinicians through pharmacovigilance in Turkey
《World Journal of Clinical Cases》2023年第20期4865-4873,共9页Ozlem Celik Aydin Sonay Aydin Hakki Zafer Guney 
BACKGROUND Pharmacovigilance(PV)is the activities and scientific studies conducted to detect,evaluate,understand or prevent adverse reactions and other drug-related problems.AIM To define the awareness and experiences...
关键词:PHARMACOVIGILANCE PHYSICIANS Knowledge level ATTITUDE Behavior Adverse drug reaction 
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