推进纳米工程医疗产品的关键路径方法。

A critical path approach to advance nanoengineered medical products.

作者信息

Sanhai Wendy R, Spiegel Jack, Ferrari Mauro

机构信息

Office of the Commissioner, FDA, United States.

Office of Technology Transfer, National Institutes of Health, United States.

出版信息

Drug Discov Today Technol. 2007 Winter;4(2):35-41. doi: 10.1016/j.ddtec.2007.10.003.

DOI:10.1016/j.ddtec.2007.10.003

PMID:24980838

Abstract

Still needed in nanotechnology is a product development toolkit containing both scientific and business strategies to stimulate innovation. Among the scientific tools envisioned are evaluative and predictive test methods, such as animal- and computer-based predictive models, characterization assays, toxicity tests and quantitative imaging methods to track biodistribution of nanoparticles in complex biological systems. These tools will help bridge scientific gaps and elucidate potential benefits and risks related to use of nanoengineered medical products. In addition, relevant business strategies, if carefully designed, will help overcome many of the hurdles in this field. This article describes some needed scientific/regulatory and business tools of this field and introduces one collaborative effort underway - a Critical Path Initiative [FDA's Critical Path Initiative: //www.fda.gov/oc/initiatives/criticalpath/.] - structured to bridge some existing gaps.:

摘要

纳米技术领域仍需要一个包含科学和商业策略的产品开发工具包，以刺激创新。设想中的科学工具包括评估和预测测试方法，如基于动物和计算机的预测模型、表征分析、毒性测试以及用于追踪纳米颗粒在复杂生物系统中生物分布的定量成像方法。这些工具将有助于弥合科学差距，并阐明与使用纳米工程医疗产品相关的潜在益处和风险。此外，精心设计的相关商业策略将有助于克服该领域的许多障碍。本文介绍了该领域一些所需的科学/监管和商业工具，并介绍了一项正在进行的合作努力——关键路径计划[美国食品药品监督管理局的关键路径计划：//www.fda.gov/oc/initiatives/criticalpath/.]——其目的是弥合一些现有差距。