Validation of standardized methods involves several steps: 1. Pre-validation: Initial testing to determine feasibility and preliminary performance. 2. Inter-laboratory Studies: Conducting the same tests across multiple laboratories to assess reproducibility. 3. Statistical Analysis: Evaluating the data to confirm reliability, sensitivity, and specificity. 4. Peer Review: Reviewing the methods and results by experts in the field. 5. Regulatory Approval: Gaining acceptance from regulatory bodies like FDA (Food and Drug Administration).
