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KNOWLEDGE FOR A BETTER FUTURE
Method Validation
What is method validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use.
Validation is the process of demonstrating or confirming the performance characteristics of a method of analysis.
Why method validation is required?
Method Validation is required for the following reasons
Assuring quality of test results
Mandatory requirement purposes for accreditation as per ISO 17025 guidelines
For an investigational new drug,
Mandatory requirement for registration of any pharmaceutical product
Validated methods are only acceptable for undertaking proficiency testing.
Following are the various parameters studied for Method Validation
Accuracy
Precision
Specificity
Limit of Detection
Limit of Quantitation
Linearity and Range
Ruggedness
Robustness
Measurement of Uncertainty
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