Analytical Tools for Physicochemical Characterization and Fingerprinting
Analytical Tools for Physicochemical Characterization and Fingerprinting
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DOI：
10.1007/978-3-030-11751-1_6
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发表时间：
2019-01-01
期刊：
影响因子：
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通讯作者：
Keire, David A.
中科院分区：
文献类型：
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作者：
Keire, David A.
在本章中，将提供复杂药物表征的可用工具的广泛概述。重点将是将现有的高分辨率和高灵敏度工具应用于复杂药物，作为充分验证的工具，用于确保药物安全性和有效性所需的多种产品属性的质量评估。此外，还将概述可能提供改进的数据流以判断复杂药物分子的质量和安全性的新兴技术。本章将介绍分析方法，可以适用于许多类复杂的药物。本章仅在必要时引用选定的文献，以提供文中所述概念的实例;本章无意对这一广泛的专题领域进行详尽的审查。
In this chapter, a broad overview of available tools for complex drug characterization will be provided. The focus will be on application of existing high-resolution and high-sensitivity tools to complex drugs as fully validated tools for quality assessment of multiple product attributes needed to assure drug safety and efficacy. In addition, an overview of emergent technologies that could possibly provide improved data streams to judge the quality and safety of complex drug molecules will be provided. The chapter will present analytical methods that can be applied to complex drugs of many classes. Only selected literature is cited where needed to provide examples of concepts described in the text; the chapter is not intended to be an exhaustive review of this wide topic area.