3) Method validation and Method development steps?

Question

Accepted Answer

Method validation and development are crucial steps in ensuring accuracy and reliability of analytical methods.

Method validation involves testing the method to ensure it meets specific criteria for accuracy, precision, specificity, and sensitivity.
Method development involves designing and optimizing a new analytical method to meet specific requirements.
Validation steps include determining the limit of detection, limit of quantification, linearity, accuracy, precision, and specificity.
Development steps include selecting appropriate instrumentation, optimizing parameters such as sample preparation, chromatography conditions, and detection methods.
Both validation and development require documentation and adherence to regulatory guidelines.
Examples of methods include HPLC, GC, ELISA, and PCR.

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