Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances

• Published in: Organic process research & development Vol. 23; no. 9; pp. 1784 - 1802
• Main Authors: Tome, Tim, Žigart, Nina, Časar, Zdenko, Obreza, Aleš
• Format: Journal Article
• Language: English
• Published: American Chemical Society 20.09.2019
• Subjects: liquid chromatography; analytical method optimization; AQbD; pharmaceuticals; analytical method robustness; pharmaceutical analysis

This review presents the Analytical Quality by Design (AQbD) concept, an extension of Quality by Design (QbD), which was introduced in 2004 by the U.S. Food and Drug Administration (FDA) and approved in 2005 by the International Conference on Harmonisation (ICH). AQbD is a systematic approach to met...