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June 06, 2007
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METHOD VALIDATION Method validation is a systematic and well-defined process of demonstrating or confirming the performance characteristics of an analytical method. The key performance characteristics are accuracy and precision. Simply put, validation is demonstrating that the method is suitable for its intended purpose. Nobody has more experience in method validation for dietary supplements than TBAR. Dr. Roman authored and was instructor of the AOAC course on single laboratory validation of chemical test methods, and co-authored and is instructor for Blaze Science Industries' course on method development and validation. He has been interviewed and quoted many times in trade journal articles on analytical method validation, most recently in Nutritional Outlook. As the AOAC Dietary Supplement Subject Matter Expert, he is responsible for helping develop and review single laboratory validation and collaborative study protocols and reports. He is author or co-author on several published validation manuscripts, including ephedrine alkaloids (which is now the AOAC official method of analysis), biogenic amines in Citrus aurantium, chondroitin sulfate, and coenzyme Q10. TBAR follows AOAC guidelines for single laboratory validations, which are the most rigorous and statistically based validation protocols of any organization. Performance characteristics that are assessed during a single laboratory validation include: (1) Accuracy (2) Repeatability (within-lab precision) (3) Selectivity (4) Calibration function (5) Linearity/range (6) Ruggedness (Youden ruggedness trial) (7) Limit of detection/Limit of quantitation (if applicable) (8) Scope and Applicability TBAR will not only determine these performance characteristics, but provide in-depth statistical analysis, and explain in plain terms the validation results. If you would like to take your method to the next level of validation, Dr. Roman also has extensive experience serving as study director for multi-laboratory collaborative studies, and is author and instructor for the AOAC training course on design and management of collaborative studies. To learn more about AOAC and their method validation program, visit their website at www.aoac.org. |
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