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3D 打印技术在医疗保健领域的应用、监管理解、知识产权库和临床试验现状。

3D printing technology in healthcare: applications, regulatory understanding, IP repository and clinical trial status.

机构信息

Department of Pharmaceutics, School of Pharmaceutical Education and Research (SPER), Jamia Hamdard, New Delhi, India.

Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.

出版信息

J Drug Target. 2022 Feb;30(2):131-150. doi: 10.1080/1061186X.2021.1935973. Epub 2021 Jun 10.

DOI:10.1080/1061186X.2021.1935973
PMID:34047223
Abstract

Mass consumerization of three-dimensional (3D) printing innovation has revolutionised admittance of 3D-printing in an expansive scope of ventures. When utilised predominantly for industrial manufacturing, 3D-printing strategies have rapidly attained acquaintance in different parts of health care industry. 3D-printing is a moderately new technology that has discovered promising applications in the medication conveyance and clinical areas. This review intends to explore different parts of 3D- printing innovation concerning pharmaceutical and clinical applications. Review on pharmaceutical products like tablets, caplets, films, polypills, microdots, biodegradable patches, medical devices (uterine and subcutaneous), patient specific implants, cardiovascular stents, etc. and prosthetics/anatomical structures, surgical models, organs and tissues created utilising 3D-printing is being presented. In addition, the regulatory understanding and current IP and clinical trial status pertaining to 3D fabricated products/medical applications have also been funnelled, garnering information from different web portals of regulatory agencies and databases. It is additionally certain that for such new innovations, there would be difficulties and questions before these are acknowledged as protected and viable. The circumstance demands purposeful and wary endeavours to acquire regulations which would at last prompt the accomplishment of this progressive innovation, thus various regulatory challenges faced have been conscientiously discussed.

摘要

三维(3D)打印技术的大规模商业化创新彻底改变了 3D 打印在广泛领域的应用。当主要用于工业制造时,3D 打印技术在医疗保健行业的不同领域迅速获得认可。3D 打印是一项相对较新的技术,在药物输送和临床领域已经发现了有前途的应用。本文旨在探讨 3D 打印创新在制药和临床应用方面的各个方面。对制药产品(如片剂、胶囊、薄膜、多丸剂、微丸、可生物降解贴片、医疗器械(子宫和皮下)、患者专用植入物、心血管支架等)和使用 3D 打印技术制造的假肢/解剖结构、手术模型、器官和组织进行了综述。此外,还对与 3D 制造产品/医疗应用相关的监管理解、当前的知识产权和临床试验状况进行了探讨,从监管机构和数据库的不同网络门户收集了信息。此外,可以肯定的是,对于这些新的创新,在它们被确认为安全和可行之前,会存在一些困难和问题。这种情况需要有目的和谨慎的努力来制定法规,最终将推动这项创新技术的成功,因此,认真讨论了所面临的各种监管挑战。

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