Suppr超能文献

确保公众对数字疗法的信任：一个药典的视角。

Ensuring public trust in digital therapeutics: a pharmacopeial perspective.

机构信息

Director, Product Quality and Analytical Methods, Digital and Innovation, US Pharmacopeia, Rockville, MD.

出版信息

J Manag Care Spec Pharm. 2021 Apr;27(4):533-535. doi: 10.18553/jmcp.2021.27.4.533.

DOI:10.18553/jmcp.2021.27.4.533
PMID:33769853
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10390969/
Abstract

No funding supported the writing of this commentary. The author is employed by US Pharmacopeia. This article was requested by JMCP as a response to the companion Viewpoints article "Decision Makers Need an Approach to Determine Digital Therapeutic Product Quality, Access, and Appropriate Use" by Parcher and Coder (see page 536). Digital Therapeutics Alliance, which is mentioned in this article, is a member of the USP Convention.

摘要

本评论文章的撰写未获得任何资金支持。作者为美国药典（USP）员工。本文由《JMCP》要求撰写，以回应 Parcher 和 Coder 的观点文章“决策者需要一种方法来确定数字治疗产品的质量、可及性和合理使用”（见第 536 页）。本文中提到的数字治疗联盟（Digital Therapeutics Alliance）是 USP 大会的成员。

相似文献

1
Ensuring public trust in digital therapeutics: a pharmacopeial perspective.确保公众对数字疗法的信任：一个药典的视角。
J Manag Care Spec Pharm. 2021 Apr;27(4):533-535. doi: 10.18553/jmcp.2021.27.4.533.
2
Decision makers need an approach to determine digital therapeutic product quality, access, and appropriate use.决策者需要一种方法来确定数字治疗产品的质量、可及性和适当使用。
J Manag Care Spec Pharm. 2021 Apr;27(4):536-538. doi: 10.18553/jmcp.2021.27.4.536.
3
Dietary supplements quality analysis tools from the United States Pharmacopeia.美国药典的膳食补充剂质量分析工具
Drug Test Anal. 2016 Mar-Apr;8(3-4):418-23. doi: 10.1002/dta.1940. Epub 2016 Feb 9.
4
Pharmacopeial harmonization in biotechnology.生物技术领域的药典协调统一。
Curr Opin Biotechnol. 1998 Jun;9(3):307-11. doi: 10.1016/s0958-1669(98)80065-7.
5
US Pharmacopeia Council of Experts 2005-2010: work plans, new revision approaches, and other enhancements.美国药典专家委员会2005 - 2010年：工作计划、新修订方法及其他改进措施。
AAPS J. 2006;8(4):E661-4. doi: 10.1208/aapsj080475.
6
A mini review of scientific and pharmacopeial requirements for the disintegration test.崩解试验的科学与药典要求简述
Int J Pharm. 2007 Dec 10;345(1-2):2-8. doi: 10.1016/j.ijpharm.2007.08.045. Epub 2007 Sep 1.
7
The 1960 United States Pharmacopeial Convention.
Am J Pharm Sci Support Public Health. 1959 Jul;131:244-5.
8
The US regulatory and pharmacopeia response to the global heparin contamination crisis.美国针对全球肝素污染危机的监管及药典应对措施。
Nat Biotechnol. 2016 Jun 9;34(6):625-30. doi: 10.1038/nbt.3606.
9
Ensuring global access to quality medicines: role of the US Pharmacopeia.确保全球获得高质量药品：美国药典的作用。
J Pharm Sci. 2011 Apr;100(4):1280-7. doi: 10.1002/jps.22391. Epub 2010 Nov 24.
10
Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs.美国药典（USP）专论标准、仿制药进入市场和处方药费用之间的关系。
PLoS One. 2019 Nov 12;14(11):e0225109. doi: 10.1371/journal.pone.0225109. eCollection 2019.

引用本文的文献

1
Understanding patient perspectives on digital therapeutics and its platform for insomnia: insights from focused group interviews.理解患者对数字治疗及其失眠平台的看法：来自焦点小组访谈的见解。
BMC Health Serv Res. 2024 Jul 29;24(1):859. doi: 10.1186/s12913-024-11286-4.
2
Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder.参与或未参与阿片类物质使用障碍处方数字疗法的患者之间医疗资源利用情况的比较。
Clinicoecon Outcomes Res. 2021 Oct 29;13:909-916. doi: 10.2147/CEOR.S334274. eCollection 2021.

本文引用的文献

1
Decision makers need an approach to determine digital therapeutic product quality, access, and appropriate use.决策者需要一种方法来确定数字治疗产品的质量、可及性和适当使用。
J Manag Care Spec Pharm. 2021 Apr;27(4):536-538. doi: 10.18553/jmcp.2021.27.4.536.
2
The Value of U.S. Pharmacopeial Standards: A Review of the Literature.美国药典标准的价值：文献回顾。
J Pharm Sci. 2018 Oct;107(10):2611-2617. doi: 10.1016/j.xphs.2018.06.004. Epub 2018 Jun 13.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验