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使药物化学更有效——应用精益西格玛改进流程、提高速度和质量。

Making medicinal chemistry more effective--application of Lean Sigma to improve processes, speed and quality.

机构信息

Medicinal Chemistry, AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden.

出版信息

Drug Discov Today. 2009 Jun;14(11-12):598-604. doi: 10.1016/j.drudis.2009.03.005. Epub 2009 Mar 11.

DOI:10.1016/j.drudis.2009.03.005
PMID:19508922
Abstract

The pharmaceutical industry, particularly the small molecule domain, faces unprecedented challenges of escalating costs, high attrition as well as increasing competitive pressure from other companies and from new treatment modes such as biological products. In other industries, process improvement approaches, such as Lean Sigma, have delivered benefits in speed, quality and cost of delivery. Examining the medicinal chemistry contributions to the iterative improvement process of design-make-test-analyse from a Lean Sigma perspective revealed that major improvements could be made. Thus, the cycle times of synthesis, as well as compound analysis and purification, were reduced dramatically. Improvements focused on team, rather than individual, performance. These new ways of working have consequences for staff engagement, goals, rewards and motivation, which are also discussed.

摘要

制药行业,尤其是小分子领域,面临着成本不断上升、高淘汰率以及来自其他公司和新型治疗模式(如生物制品)日益加剧的竞争压力等前所未有的挑战。在其他行业,精益西格玛等流程改进方法已经在速度、质量和交付成本方面带来了效益。从精益西格玛的角度审视药物化学对设计-制造-测试-分析的迭代改进过程的贡献,发现可以进行重大改进。因此,合成、化合物分析和纯化的循环时间大大缩短。改进侧重于团队,而不是个人绩效。这些新的工作方式对员工的参与度、目标、奖励和激励都有影响,本文也对此进行了讨论。

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