A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 1055-1056; pp. 61 - 71
• Main Authors: Fachi, Mariana Millan, Leonart, Letícia Paula, Cerqueira, Letícia Bonancio, Pontes, Flavia Lada Degaut, de Campos, Michel Leandro, Pontarolo, Roberto
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 15-06-2017
• Subjects: Animals; Antidiabetic agents; Bioanalytical method; Chemistry Techniques, Analytical - methods; Drug Monitoring - methods; Humans; Hypoglycemic Agents - blood; Reproducibility of Results; Sensitivity and Specificity; Systematic review; Validation; Validation Studies as Topic; Validation; Systematic review; Bioanalytical method; Antidiabetic agents
• ISSN: 1570-0232; 1873-376X
• DOI: 10.1016/j.jchromb.2017.04.024

•A systematic review was conducted on validated bioanalytical methods.•The validation process was evaluated according to international recommendations.•Several problems regarding method validation were identified among the articles.
A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical