作者对约尔格·普茨克等人的回复。评论：“美国上市的癌症支持性护理生物类似药的安全性：使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行的不成比例性分析” - Suppr

Suppr

超能文献

Author's Reply to Joerg Putzke et al. Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".

作者信息

Qian Jingjing, Truong Cong Bang, Tanni Kaniz Afroz

机构信息

Department of Health Outcomes Research and Policy, Auburn University Harrison School of Pharmacy, Auburn, Alabama, USA.

出版信息

BioDrugs. 2021 May;35(3):375-377. doi: 10.1007/s40259-021-00474-x. Epub 2021 Apr 16.

DOI:10.1007/s40259-021-00474-x

PMID:33860920

Abstract

摘要

相似文献

Author's Reply to Joerg Putzke et al. Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".作者对约尔格·普茨克等人的回复。评论：“美国上市的癌症支持性护理生物类似药的安全性：使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行的不成比例性分析”

BioDrugs. 2021 May;35(3):375-377. doi: 10.1007/s40259-021-00474-x. Epub 2021 Apr 16.

Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the U.S.: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".关于《美国市售癌症支持性护理生物类似药的安全性：使用食品药品监督管理局不良事件报告系统（FAERS）数据库的不成比例性分析》的评论

BioDrugs. 2021 May;35(3):373-374. doi: 10.1007/s40259-021-00476-9. Epub 2021 Apr 16.

Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.美国已上市的癌症支持性治疗生物类似药的安全性：利用食品和药物管理局不良事件报告系统（FAERS）数据库进行的比例失调分析。

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Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States.美国已上市生物类似药和生物单克隆抗体癌症治疗药物的不良事件报告

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Nomenclature and traceability debate for biosimilars: small-molecule surrogates lend support for distinguishable nonproprietary names.生物类似药的命名与可追溯性辩论：小分子替代物为可区分的通用名提供支持。

Adv Ther. 2015 Mar;32(3):270-83. doi: 10.1007/s12325-015-0193-5. Epub 2015 Mar 13.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database.氨磺必利的新型不良事件：美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的不成比例性分析。

Curr Drug Saf. 2019;14(1):21-26. doi: 10.2174/1574886313666181026100000.

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices.评估两种专利过期生物制品的不良事件报告，为未来生物类似药的命名和报告实践提供参考。

Drug Saf. 2015 Aug;38(8):687-92. doi: 10.1007/s40264-015-0310-z.

Drug-Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database.药物相关性急性肾损伤在美国食品和药物管理局不良事件报告系统数据库中的识别。

Pharmacotherapy. 2018 Aug;38(8):785-793. doi: 10.1002/phar.2152. Epub 2018 Jul 13.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).美国食品药品监督管理局不良事件报告系统（FAERS）中品牌药、仿制药与授权仿制药不良事件报告比较的方法学考量

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Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database.美国已上市生物类似单克隆抗体癌症治疗药物的安全性：使用食品药品监督管理局不良事件报告系统（FAERS）数据库进行的不成比例分析。

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本文引用的文献

BioDrugs. 2021 May;35(3):373-374. doi: 10.1007/s40259-021-00476-9. Epub 2021 Apr 16.

Post-Marketing Safety Concerns with Esketamine: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System.依他佐辛上市后安全性担忧：向 FDA 不良事件报告系统自发报告提交数据的比例失调分析。

Psychother Psychosom. 2021;90(1):41-48. doi: 10.1159/000510703. Epub 2020 Aug 27.

Assessment of factors associated with completeness of spontaneous adverse event reporting in the United States: A comparison between consumer reports and healthcare professional reports.评估与美国自发性不良事件报告完整性相关的因素：消费者报告与医疗保健专业人员报告之间的比较。

J Clin Pharm Ther. 2020 Jun;45(3):462-469. doi: 10.1111/jcpt.13086. Epub 2019 Nov 25.

Significance of data mining in routine signal detection: Analysis based on the safety signals identified by the FDA.数据挖掘在常规信号检测中的意义：基于美国食品药品监督管理局（FDA）识别出的安全信号的分析

Pharmacoepidemiol Drug Saf. 2018 Dec;27(12):1402-1408. doi: 10.1002/pds.4672. Epub 2018 Oct 15.

Applying quantitative methods for detecting new drug safety signals in pharmacovigilance national database.应用定量方法在药物警戒国家数据库中检测新药安全信号。

Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1136-40. doi: 10.1002/pds.1459.

Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs.与相关对照药物相关的药物警戒信号的数据挖掘分析。

Eur J Clin Pharmacol. 2002 Oct;58(7):483-90. doi: 10.1007/s00228-002-0484-z. Epub 2002 Sep 3.

On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios.关于自发报告系统中药物不良反应的评估：漏报对比值比的影响。

Stat Med. 2002 Jul 30;21(14):2027-44. doi: 10.1002/sim.1157.

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