What are Method development parameters as per ICH

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Method development parameters as per ICH

ICH guidelines provide recommendations for method development in the pharmaceutical industry
Parameters include specificity, linearity, range, accuracy, precision, robustness, and system suitability
Specificity ensures that the method measures only the analyte of interest
Linearity determines the relationship between analyte concentration and response
Range defines the concentration range over which the method is accurate and precise
Accuracy measures how close the measured value is to the true value
Precision assesses the repeatability and reproducibility of the method
Robustness evaluates the method's ability to remain unaffected by small variations
System suitability ensures that the analytical system is suitable for the intended use
Example: ICH Q2(R1) provides guidelines for validation of analytical procedures

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