Webster Gregory K, Kumar Shailendra
Global Pharmaceutical Research and Development, AbbVie, Inc. North Chicago, Illinois 60064, United States.
Anal Chem. 2014 Dec 2;86(23):11474-80. doi: 10.1021/ac502871w. Epub 2014 Nov 13.
In response to the changing market pressures being applied to the pharmaceutical industry, a greater emphasis is being made to advance new drugs to market with minimal investment in early development stages. The use of quantitative NMR (q-NMR) has been shown to be a single point replacement for routine early development testing which previously combined elements of identity testing, chromatographic assay, moisture analysis, residual solvent analysis, and elemental analysis. This Feature will highlight the applications of q-NMR to early phase drug development testing and its efficient potency, solvent quantification, and relative response factor determinations.
为应对制药行业面临的不断变化的市场压力，人们更加重视在早期开发阶段以最少的投资将新药推向市场。定量核磁共振（q-NMR）已被证明可单点替代常规早期开发测试，常规早期开发测试此前综合了鉴别测试、色谱分析、水分分析、残留溶剂分析和元素分析等内容。本专题将重点介绍q-NMR在早期药物开发测试中的应用及其在效价测定、溶剂定量和相对响应因子测定方面的高效性。
