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Rethinking the paradigm for the development of inhaled drugs

机译：重新思考吸入药物开发的范例

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Nebulized treatment is an important delivery option for the young, elderly, and those with severe chronic respiratory disease, but there is a lack of new nebulized drug products being produced for these patients, leading to the potential for under-treatment. This communication describes a new drug development paradigm as a timely solution to this issue. Often, drug development is initiated with nebulizers in the early stages, to provide cheaper and faster drug development, and then switched to inhaler devices in later clinical trials to address the majority of patients. However, the waste of resource on parallel development of the inhaler can be large due to the high early attrition rate of new drug development. The new paradigm uses the nebulizer to continue drug development through to market, and initiates inhaler development after completion of the riskier early phase studies. New drug safety and efficacy can be assessed faster and more efficiently by using a nebulized formulation rather than developing an inhaler. The results of calculations of expected net present value showed that the new paradigm produced higher expected net present values than the conventional model over a range of economic scenarios. This new paradigm could therefore provide improved returns on investments, as well as more modern drugs in nebulized form for those patients unable to use inhalers. (C) 2015 Elsevier B.V. All rights reserved.
机译：雾化治疗对年轻人，老年人和患有严重慢性呼吸系统疾病的人来说是重要的分娩选择，但是，针对这些患者的新雾化药物生产不足，导致了治疗不足的可能性。本交流描述了一种新的药物开发范例，可以作为对此问题的及时解决方案。通常，药物开发是在早期使用雾化器开始的，以提供更便宜，更快速的药物开发，然后在后来的临床试验中切换到吸入器设备，以治疗大多数患者。然而，由于新药开发的早期消耗率高，吸入器并行开发的资源浪费可能很大。新的范例使用雾化器继续进行药物开发直至上市，并在完成风险较高的早期研究后启动吸入器开发。通过使用雾化制剂而不是开发吸入器，可以更快，更有效地评估新药的安全性和功效。预期净现值的计算结果表明，在一系列经济情景下，新范例产生的预期净现值高于传统模型。因此，这种新范例可以为无法使用吸入器的患者提供更高的投资回报率，以及更现代的雾化药物。 （C）2015 Elsevier B.V.保留所有权利。

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