Significance of Analytical method validation
Analytical method validation is a critical process in the drug development phase that ensures an analytical method is accurate, precise, and reliable for its intended purpose. This involves a comprehensive assessment to confirm that the method meets performance standards like specificity and reproducibility in compliance with international guidelines, such as those by the International Conference on Harmonization. The validation process provides documented evidence that an analytical procedure consistently produces results meeting predetermined specifications, thereby ensuring its suitability for pharmaceutical analysis.
Synonyms: Method verification, Assay validation
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The concept of Analytical method validation in scientific sources
Analytical method validation is the process of confirming that an analytical method meets its intended use by assessing its specificity, precision, accuracy, linearity, and sensitivity, ensuring that it provides valid and reliable results.
From: World Journal of Pharmaceutical Research
(1) A process checked for compliance with regulatory guidelines that involves parameters like linearity, accuracy, method precision, specificity, system suitability, robustness, and ruggedness.[1] (2) Process of confirming the reliability and accuracy of the RP-HPLC method for pharmaceutical analysis, including parameters like precision and recovery.[2] (3) The confirmation that an analytical method meets the necessary requirements, including parameters like precision, accuracy, and robustness.[3] (4) The process of demonstrating that an analytical method is reliable, accurate, and reproducible, as performed in this study for the RP-HPLC method.[4] (5) The process of verifying that the developed method meets predefined specifications in terms of accuracy, precision, specificity, and consistency for analytical testing.[5]
From: International Ayurvedic Medical Journal
(1) The process of assessing an analytical method to ensure it meets predefined criteria for accuracy, precision, linearity, and sensitivity.[6]