Implementing New Technology in a Regulated Environment

IF 0.7 4区化学 Q4 CHEMISTRY, ANALYTICAL Lc Gc North America Pub Date : 2006-01-01 DOI:10.1201/B12039-10

M. Swartz, I. Krull

引用次数: 0

Abstract

Over the course of a drug product's life (as much as 15-20 years or more) many significant advances in technology will occur. Implementing new analytical techniques (for example, capillary electrophoresis), or advances in existing technology (for example, sub-2-μm liquid chromatography [LC]) can significantly impact business practices (return on investment) and product quality. However, in a regulated laboratory, implementing new technology can present many challenges.

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在受规管的环境下实施新科技

在药品的生命周期(长达15-20年或更长时间)中，将会发生许多重大的技术进步。实施新的分析技术(例如，毛细管电泳)或现有技术的进步(例如，亚2 μm液相色谱[LC])可以显著影响业务实践(投资回报)和产品质量。然而，在一个受监管的实验室中，实施新技术可能会带来许多挑战。

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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来源期刊

Lc Gc North America 化学-分析化学

CiteScore

1.00

自引率

55.60%

发文量

审稿时长

2 months

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