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COVID-19: A Catalyst to Accelerate Global Regulatory Transformation.

作者信息

Stewart Jerry, Honig Peter, AlJuburi Lina, Autor Deborah, Berger Susan, Brady Patrick, Fitton Helen, Garner Carlos, Garvin Michael, Hukkelhoven Mathias, Kowalski Robert, Milligan Sandra, O'Dowd Liza, Reilly Edward, Roberts Khyati, Robertson Andrew S, Taisey Mark, Thakkar Roopal, Van Baelen Karin, Wegner Max

机构信息

Pfizer, Collegeville, Pennsylvania, USA.

Merck, North Wales, Pennsylvania, USA.

出版信息

Clin Pharmacol Ther. 2021 Jun;109(6):1390-1392. doi: 10.1002/cpt.2046. Epub 2020 Sep 29.

DOI:10.1002/cpt.2046
PMID:32990986
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7536913/
Abstract
摘要

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本文引用的文献

1
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic.
Stat Biopharm Res. 2020 Jul 6;12(4):399-411. doi: 10.1080/19466315.2020.1779122.
2
Cloud-based data systems in drug regulation: an industry perspective.药品监管中基于云的数据系统：行业视角
Nat Rev Drug Discov. 2020 Jun;19(6):365-366. doi: 10.1038/d41573-019-00193-7.
3
Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity.在2019冠状病毒病大流行期间开展临床研究：维护科学诚信。
JAMA. 2020 Jul 7;324(1):33-34. doi: 10.1001/jama.2020.9286.
4
Creating E-Labeling Platforms: An Industry Vision.创建电子标签平台：行业愿景。
Clin Pharmacol Ther. 2020 Oct;108(4):716-718. doi: 10.1002/cpt.1865. Epub 2020 May 19.
5
The Evolution of Federal Regulation of Human Drugs in the United States: An Historical Essay.美国联邦对人用药品监管的演变：一篇历史论文。
Am J Law Med. 2018 May;44(2-3):403-451. doi: 10.1177/0098858818789421.