Quality by design approach with design of experiment for sample preparation techniques

• Published in: Advances in sample preparation Vol. 7; p. 100079
• Main Authors: Özcan, Saniye, Levent, Serkan, Can, Nafiz Öncü
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.08.2023; Elsevier
• Subjects: Analytical quality by design; Design of experiment; Quality by design; Sample preparation; Failure Mode and Impact Analysis; Design Space; Analytical quality by design; Critical Analytical Attributes; Quality Target Method Profile; Analytical Control Area; Method Operable Design Region; Normal Operating Range; Critical Material Attribute; Critical Quality Attribute; Critical Method Variables; Sample preparation; Quality Risk Management; Quality Target Product Profile; Quality by design; Design of experiment; Analytical Target Profile; Analytical Method Performance Characteristic; Analytical Design Space; Critical Analytical Parameter
• ISSN: 2772-5820; 2772-5820
• DOI: 10.1016/j.sampre.2023.100079

The quality by design (QbD) based approach has begun to be embedded in various method development. Studies show that with the design of experiment tool, the analysis process has become more efficient, faster, and easier. The analysis has two components: Method development and sample preparation. Sample preparation can be at least as difficult as method development, and sometimes even more difficult. Therefore, in addition to the new techniques and materials developed in sample preparation, the QbD approach can significantly reduce the workload of the analysts and provide analysis with high accuracy and precision. So far, very limited studies have been come across in the literature about the QbD approach. The review in question has been prepared to encourage and guide researchers on this subject, and will greatly support this deficiency. [Display omitted]