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Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

机译：道德和药品的营销授权：在审判后和营销前授权的道德问题上会发生什么？

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摘要

European centralized procedure for authorizing medicinal products [6–8]

机译：欧洲集中手术授权药品[6-8]

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期刊名称 BMC Medical Ethics
作者
Rosemarie D. L. C. Bernabe; Ghislaine J. M. W. van Thiel; Nancy S. Breekveldt; Christine C. Gispen; Johannes J. M. van Delden;
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作者单位

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年(卷),期 2020(-1),-1
年度 2020
页码 -1
总页数 8
原文格式 PDF
正文语种
中图分类病理学;
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入库时间 2022-08-21 12:07:06

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1. Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization? [J] . Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, BMC Medical Ethics . 2020,第1期

机译：道德和药品的营销授权：在审判后和营销前授权的道德问题上会发生什么？
2. US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations [J] . Sally W. Schwarz, Clemens Decristoforo EJNMMI Radiopharmacy and Chemistry . 2019,第1期

机译：美国和欧盟的放射性药物诊断和治疗非临床研究要求，用于临床试验授权和销售授权
3. The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome [J] . Sofieke de Wilde, Maria G.H. de Jong, Alexander F. Lipka, European journal of pharmaceutical sciences . 2018,第期

机译：获得孤儿药物复合制剂的营销授权的可能性：3,4-DAP用于Lambert-eaton Myasthencic综合征
4. Ethical and social issues criteria in academic accreditation. Infusion of ethics and social issues throughout engineering, scientific and technical curricula [C] . Aiyadurai, K. . 2001

机译：学术认证中的道德和社会问题标准。在整个工程，科学和技术课程中融合道德和社会问题
5. Ethical Perceptions and Medical Implications of Pharmaceutical Marketing Strategies: A Comparative Study between India and the United States [D] . Janga, Alpha 2019

机译：药品营销策略的伦理观念和医学含义：印度和美国之间的比较研究
6. US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations [O] . Sally W. Schwarz, Clemens Decristoforo 2019

机译：美国和欧盟的放射性药物诊断和治疗非临床研究要求用于临床试验授权和销售授权
7. PHP136 PRE-Marketing Authorization Of New Medical Devices In The European Union And The United States [O] . Abraham P.S., Gholmie J., Seoane-Vazquez E., 2013

机译：PHP136欧盟和美国新医疗设备的上市前授权
8. Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Questions and Answers(R2), Revision 1. [R] . 2013

机译：行业指南：m3（R2）人体临床试验行为和药品营销许可的非临床安全性研究。问题与解答（R2），修订版1。

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

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