Brewer Edward, Bollin Ernest
Tandem Labs, A LabCorp Company, 115 Silvia Street, West Trenton, NJ 08628, USA.
Bioanalysis. 2009 Oct;1(7):1201-8. doi: 10.4155/bio.09.100.
Analytical standards are used in bioanalytical analysis for the quantitative measurement of large and small molecules in the pharmaceutical industry. This article will introduce the reader to the common, acceptable practices for the use of calibration curves in chromatographic and ligand-binding assays. The discussion presented is a combination of regulatory requirements and the authors' experience in performing bioanalysis. While all possible techniques are not covered, generally acceptable practices are described to serve as a starting point for novice practitioners.
分析标准品用于制药行业生物分析中大分子和小分子的定量测定。本文将向读者介绍在色谱分析和配体结合分析中使用校准曲线的常见可接受做法。所呈现的讨论结合了法规要求和作者进行生物分析的经验。虽然未涵盖所有可能的技术，但描述了一般可接受的做法，作为新手从业者的起点。
