Toxicological analyses: analytical method validation for prevention or diagnosis

• Published in: Toxicology mechanisms and methods Vol. 31; no. 1; pp. 18 - 32
• Main Authors: Abrão, Lailah Cristina de Carvalho, Silveira, Alberto Thalison, de Faria, Henrique Dipe, Machado, Simone Caetani, Mendes, Tássia Venga, Plácido, Rodrigo Vicentino, Marciano, Luiz Paulo de Aguiar, Martins, Isarita
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 02-01-2021
• Subjects: Animals; Calibration; Humans; Limit of Detection; method development; method validation; Quality Control; Reproducibility of Results; Research Design - standards; Risk Assessment; Toxicity Tests - standards; Toxicological analysis; method validation; method development; Toxicological analysis
• ISSN: 1537-6516; 1537-6524
• DOI: 10.1080/15376516.2020.1839612

The need for reliable results in Toxicological Analysis is recognized and required worldwide. The analytical validation ensures that a method will provide trustworthy information about a particular sample when applied in accordance with a predefined protocol, being able to determine a specific analyte at a distinct concentration range for a well-defined purpose. The driving force for developing method validation for bioanalytical projects comes from the regulatory agencies. Thus, the approach of this work is to present theoretical and practical aspects of method validation based on the analysis objective, whether for prevention or diagnosis. Although various legislative bodies accept differing interpretations of requirements for validation, the process for applying validation criteria should be adaptable for each scientific intent or analytical purpose.