医疗设备和药品的接口:第2部分。

Medical device technology Pub Date : 2008-05-01

S L Willis, A L Lewis

{"title":"医疗设备和药品的接口:第2部分。","authors":"S L Willis, A L Lewis","doi":"","DOIUrl":null,"url":null,"abstract":"The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.","PeriodicalId":80066,"journal":{"name":"Medical device technology","volume":"19 3","pages":"38-43"},"PeriodicalIF":0.0000,"publicationDate":"2008-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The interface of medical devices and pharmaceuticals: Part II.\",\"authors\":\"S L Willis, A L Lewis\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.\",\"PeriodicalId\":80066,\"journal\":{\"name\":\"Medical device technology\",\"volume\":\"19 3\",\"pages\":\"38-43\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2008-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Medical device technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Medical device technology","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

摘要

在这篇由两部分组成的文章的第一部分中讨论了开发组合产品的技术挑战。第二部分回顾了使用药物洗脱支架和药物洗脱珠作为示例所需的临床前测试和保质期测试。还审查了监管方面的考虑和简化发展的方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

微信好友朋友圈 QQ好友复制链接

本刊更多论文

The interface of medical devices and pharmaceuticals: Part II.

The technical challenges of developing combination products were addressed in Part I of this two part article. Part II reviews the preclinical tests and shelf-life testing that are required using drug eluting stents and drug eluting beads as examples. Regulatory considerations and ways to simplify development are also examined.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

Medical device technology

自引率

0.00%

发文量

期刊最新文献

Control Freaks Make a mark. Wearable Computers and Augmented Reality: Musings and Future Directions MDT's five-minute interview. Live cells and cytotoxicity assessment.