Abstract

Abstract The validation of bioanalytical methods holds critical importance for regulatory agencies and organizations dedicated to ensuring the safety, efficacy, and quality of pharmaceuticals. In this context, the recent release of the ICH M10 guideline in May 2022 represents a significant milestone in standardizing bioanalytical method validation globally. However, this guideline lacks explicit experimental protocols for implementation. In this study, we address the practical implementation of the newly released ICH M10 guideline by providing a detailed validation protocol for a bioanalytical method. Our method specifically targets tiaprofenic acid, a widely used nonsteroidal anti-inflammatory drug. Tiaprofenic acid is a critical component in bioequivalence studies, underscoring the necessity for precise and accurate quantification within complex biological matrices. The integration of the accuracy profile approach, a statistical tool, enhances the significance of this work. This approach aids in assessing the accuracy and precision of bioanalytical methods, establishing confidence intervals around measured concentrations and quantifying the level of accuracy and precision expected when using the validated method. Overall, this study contributes to advancing bioanalytical science, aligning with the latest ICH guidelines, and emphasizing the importance of validated methods supported by modern statistical approaches like the accuracy profile. It underscores the commitment to maintaining the highest standards of quality and reliability in bioanalysis, which is crucial for ensuring public health and advancing drug therapies.

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