Hupcey Maggie A Z, Ekins Sean
PA Consulting Group, 600 College Road East, Suite 1120, Princeton, NJ 08540, USA.
Drug Discov Today. 2007 Oct;12(19-20):844-52. doi: 10.1016/j.drudis.2007.07.020. Epub 2007 Sep 6.
Combination devices are at the interface of both pharmaceutical and medical device research. While there have been several notable successes in bringing combination devices to market there are drug selection criteria that both the pharmaceutical and medical device companies need to consider. A successful combination device creates a product that has efficacy greater than the sum of the parts. However, failure to address some aspects of the drug or biologic properties in enough detail could result in a suboptimal product, creating a challenging legacy for future iterations. This review addresses the many dimensions including opportunities and challenges of combination device development from both the device and pharmaceutical perspectives.
组合装置处于制药和医疗器械研究的交叉领域。虽然将组合装置推向市场已经取得了一些显著的成功,但制药公司和医疗器械公司都需要考虑药物选择标准。一个成功的组合装置所创造的产品,其功效大于各部分之和。然而,如果没有足够详细地解决药物或生物特性的某些方面,可能会导致产品不理想,给未来的迭代带来具有挑战性的遗留问题。本综述从装置和制药两个角度探讨了组合装置开发的诸多方面,包括机遇和挑战。