Fachi Mariana Millan, Leonart Letícia Paula, Cerqueira Letícia Bonancio, Pontes Flavia Lada Degaut, de Campos Michel Leandro, Pontarolo Roberto
Universidade Federal do Paraná, Department of Pharmacy,632 Lothário Meissner Avenue, 80210-170, Curitiba, PR, Brazil.
Universidade Estadual Paulista (Unesp), School of Pharmaceutical Sciences, Araraquara-Jaú Highway km 1, 14801-902, Araraquara, SP, Brazil.
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jun 15;1055-1056:61-71. doi: 10.1016/j.jchromb.2017.04.024. Epub 2017 Apr 13.
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.
对已验证用于定量人血中抗糖尿病药物组合的生物分析方法进行了系统和批判性综述。本文的目的是验证生物分析方法的验证过程是如何进行的以及已发表记录的质量。根据国际指南对验证试验进行评估。指出并讨论了验证过程中的主要问题，以帮助研究人员选择真正可靠且能成功用于其预期用途的方法。选择口服抗糖尿病药物的组合是因为这些是研究最多的一些药物，并且文献中有几种方法。此外，本文可能适用于所有生物分析的验证过程。
