This article provides a comprehensive, step-by-step guide for researchers and drug development professionals on designing and executing method comparison studies, a critical component of assay validation. It covers foundational principles of validation versus verification, detailed methodological planning for accuracy and precision assessment, advanced troubleshooting for handling real-world data challenges like method failure, and final verification against regulatory standards. The content synthesizes current best practices and statistical methodologies to ensure reliable, defensible, and compliant analytical results in biomedical and clinical research.
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