Performance Parameters Required for Assay Validation

This document provides a detailed overview of analytical method validation, covering performance parameters, validation steps, method capability, specificity, linearity, sensitivity, ruggedness, method transfer, stability-indicating assays, and compendial method validation. Performance Parameters Required for Assay Validation (Ref. USP 25 and ICH Q2A/B) The following performance parameters are typically required for assay validation, though some may depend on the specific test: Method […]