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迈向临床试验的 4.0 时代:未来导向的视角。

Towards Pharma 4.0 in clinical trials: A future-orientated perspective.

机构信息

Department of Pharmacology and Toxicology, Ankara University, Ankara, Turkey; Smart Engineering and Health Research Group, Hacettepe University, Ankara, Turkey.

Smart Engineering and Health Research Group, Hacettepe University, Ankara, Turkey; Department of Industrial Engineering, Hacettepe University, Ankara, Turkey.

出版信息

Drug Discov Today. 2022 Jan;27(1):315-325. doi: 10.1016/j.drudis.2021.09.002. Epub 2021 Sep 16.

Abstract

Pharma 4.0, a technology ecosystem in drug development analogous to Industry 4.0 in healthcare, is transforming the traditional approach to drug discovery and development, aligning product quality with less time to market, and creating intelligent stakeholder networks through effective collaborations. The wide range of potential Pharma 4.0 networks have produced several conceptualizations, which have led to a lack of clarity and definition. The main emphasis of this paper is on the clinical trial stage of drug development in the Pharma 4.0 era. It highlights the merged computerized technologies that are currently used in clinical research, and proposes a framework for integrating Pharma 4.0 technologies. The impact of and barriers to employing the proposed framework are discussed, highlighting its potential and some future research applications.

摘要

制药 4.0 是药物开发中的一种技术生态系统,类似于医疗保健中的工业 4.0,正在改变传统的药物发现和开发方法,通过有效的协作将产品质量与更短的上市时间联系起来,并创建智能利益相关者网络。广泛的潜在制药 4.0 网络产生了几种概念化,这导致了缺乏清晰度和定义。本文的主要重点是制药 4.0 时代药物开发的临床试验阶段。它强调了当前在临床研究中使用的合并计算机技术,并提出了一个整合制药 4.0 技术的框架。讨论了采用所提出框架的影响和障碍,强调了其潜力和一些未来的研究应用。

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