Laboratory automation -some perspectives on the challenges in the implementation of the technology in pharmaceutical development.

N North, S Smith
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引用次数: 2

Abstract

The intensifying pressure on reducing the development time for new pharmaceutical products is resulting in an increasing need for laboratory automation. A key element for the successful implementation of robotics for drug product analysis is the establishment of a reliable process for interaction of the automation team with its various customers, for example development product team and manufacturing group. The reduction of cycle time for product development appears to be resulting in more stability studies to support NDA/MAA filings for several reasons. Key clinical information may not be available before initiation of the stability studies and simultaneous world-wide development may result in an increase in the number of product strength and pack options.

实验室自动化-在制药开发中实施该技术的挑战的一些观点。
减少新药开发时间的压力越来越大,导致对实验室自动化的需求日益增加。成功实施药物产品分析机器人技术的一个关键因素是建立一个可靠的流程,用于自动化团队与其各种客户(例如开发产品团队和制造团队)之间的交互。由于几个原因,产品开发周期的缩短似乎导致了更多的稳定性研究,以支持NDA/MAA申请。在稳定性研究开始之前,可能无法获得关键的临床信息,同时全球范围内的开发可能导致产品强度和包装选择数量的增加。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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