Bridging bioanalytical gaps: Examining validation methods across species

[Anela R/ Stock]

Bioanalytical method validation is the backbone of effective drug discovery and development. Its pivotal role ensures the generation of reliable and reproducible data from diverse species, leading to safe and effective therapeutics. As critical as this process is, scientists face many challenges, particularly regarding validation across different species in preclinical and clinical studies.

Accommodating species differences requires an understanding of species-specific metabolic and physiologic characteristics. Therefore, customizing a validating method may involve modifying sampling procedures, adjusting analytical parameters, or incorporating species-specific biomarkers. Whether method developers and sponsors do this work in-house or call on a laboratory partner for help, successful validation is when the method consistently delivers accurate and precise results within th…

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