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Quantitative Drug Safety and Benefit-Risk Evaluation最新文献

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Analysis Considerations for Real-World Evidence and Clinical Trials Related to Safety 与安全性相关的真实证据和临床试验的分析考虑
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-15
Richard C. Zink, M. Munsaka, B. Emir, Yong Ma, Judy X. Li, William W. Wang, D. Bennett
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引用次数: 0
Post-Market Safety Assessment Using Observational Studies and the Food and Drug Administration Sentinel System 使用观察性研究和食品药品监督管理局哨兵系统的上市后安全性评估
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-14
Yong Ma, R. Izem, Ellen Snyder, Wei Liu
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引用次数: 0
Bayesian Safety Methodology 贝叶斯安全方法学
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-9
M. Fries, Matilde Kam, Judy X. Li, Satrajit Roychoudhury, Mat Soukup, Brian Waterhouse
{"title":"Bayesian Safety Methodology","authors":"M. Fries, Matilde Kam, Judy X. Li, Satrajit Roychoudhury, Mat Soukup, Brian Waterhouse","doi":"10.1201/9780429488801-9","DOIUrl":"https://doi.org/10.1201/9780429488801-9","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122455118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Monitoring of Aggregate Safety Data in Clinical Development 临床开发中总体安全数据的监测
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-3
Lothar Tremmel, B. Hendrickson
{"title":"Monitoring of Aggregate Safety Data in Clinical Development","authors":"Lothar Tremmel, B. Hendrickson","doi":"10.1201/9780429488801-3","DOIUrl":"https://doi.org/10.1201/9780429488801-3","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130924927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety Monitoring through External Committees 通过外部委员会进行安全监测
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-5
Amitava Bhattacharyya, William W. Wang, James Buchanan
{"title":"Safety Monitoring through External Committees","authors":"Amitava Bhattacharyya, William W. Wang, James Buchanan","doi":"10.1201/9780429488801-5","DOIUrl":"https://doi.org/10.1201/9780429488801-5","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115065904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Overview of Statistical Methodologies for Safety Monitoring and Benefit-Risk Assessment 安全监测和利益风险评估的统计方法综述
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-7
William W. Wang, Ed Whalen, M. Munsaka, Judy X. Li
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引用次数: 0
Quantitative Methods for Blinded Safety Monitoring 盲法安全监测的定量方法
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-8
M. Munsaka, Kefei Zhou
{"title":"Quantitative Methods for Blinded Safety Monitoring","authors":"M. Munsaka, Kefei Zhou","doi":"10.1201/9780429488801-8","DOIUrl":"https://doi.org/10.1201/9780429488801-8","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122598952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Emergence of Aggregate Safety Assessment across the Regulatory Landscape 总体安全评估在监管领域的出现
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-2
James Buchanan, William W. Wang
{"title":"The Emergence of Aggregate Safety Assessment across the Regulatory Landscape","authors":"James Buchanan, William W. Wang","doi":"10.1201/9780429488801-2","DOIUrl":"https://doi.org/10.1201/9780429488801-2","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115263629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety Signaling and Causal Evaluation 安全信号和因果评价
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-4
James Buchanan, Mengchun Li
{"title":"Safety Signaling and Causal Evaluation","authors":"James Buchanan, Mengchun Li","doi":"10.1201/9780429488801-4","DOIUrl":"https://doi.org/10.1201/9780429488801-4","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133583085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Meta-Analysis of Drug Safety Assessment 药物安全性评价的meta分析
Quantitative Drug Safety and Benefit-Risk Evaluation Pub Date : 2021-12-02 DOI: 10.1201/9780429488801-11
R. Dimova, S. Santra, M. Munsaka
{"title":"Meta-Analysis of Drug Safety Assessment","authors":"R. Dimova, S. Santra, M. Munsaka","doi":"10.1201/9780429488801-11","DOIUrl":"https://doi.org/10.1201/9780429488801-11","url":null,"abstract":"","PeriodicalId":300850,"journal":{"name":"Quantitative Drug Safety and Benefit-Risk Evaluation","volume":"81 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130748401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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