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Bioanalytical Method Validation must comply with the latest FDA or ICH guidelines laid out for chromatographic assays (CCs) or ligand binding assays (LBAs). Method Validation includes all applicable experiments for Reference Standards and Critical Reagents, Calibration Curve, QCs, Method Selectivity and Specificity, Method Sensitivity, Matrix Effect, Matrix Suppression, Extraction Recovery, and Carryover. Moreover, our team carries out three or six independent validation runs over multiple days for estimating Intraday and Interday Accuracy and Precision for CCs and LBAs, respectively. We perform in-process Stability experiments for Short-term Bench-Top, Freeze-Thaw Cycles, and Short-Term ULT Stability. Bioanalytical Method Validation by NorthEast BioLab includes a full report in hyperlinked pdf format and on-site/archived documentation for your FDA and ICH submission.
What is FDA or ICH Bioanalytical Method Validation?
Bioanalytical Method Validation: Align with FDA to ICH guidelines
Method validation is a process that is used to confirm whether the analytical procedure used for drug analysis is suitable for its intended use. Analytical method validation is the key to judging the quality, consistency, and reliability of sample analysis data. For most healthcare regulators, including the FDA, method validation is a mandatory step in preclinical and clinical studies for pharmacokinetic and toxicokinetic evaluation to fulfill specific performance criteria.
Bioanalytical Method validation takes place in the following cases:
- Once a method has been developed, but before it has been introduced into routine use.
- When the method that was developed gets changed to the extent that’s outside the original scope of the method.
- Whenever there is a change in conditions for which the method has already been validated.
- If samples are analyzed in more than one laboratory, cross-validation is needed to ensure consistency.
When it comes to test method validation, it’s important to follow standard guidelines like FDA bioanalytical method validation guidance for industry. If you have your own protocols, that’s great, if not, you need to develop a method validation plan. A good method validation process will test several parameters such as calibration range, linearity, and accuracy and precision, robustness, specificity, and process stability of the analyte. Good Documentation Practice (GDP) should be in place to ensure that a full description of the method is captured in enough details to be followed by an independent analyst later.