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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...