Combined Retrospective and Prospective APT Validation Results
| ICH Q2(R1) Validation Characteristic | Retrospective Data/Results | Prospective Data/Results | Option(s) and Consideration(s) (see also Table IV) |
|---|---|---|---|
| Accuracy | No | Yes | Number of spiked levels; Number of replicates |
| Repeatability | No (see option) | Yes | Could consider using initial AMV study results if insufficient replicates (see above) |
| Intermediate Precision | Yes | No | Use long-term AMM assay control data instead or in addition to initial AMV study results |
| Specificity | No | Yes (see option) | Only infer lack of matrix interference from Accuracy study |
| Linearity | No | Yes | Number of spiked levels; Number of replicates (see Accuracy) |
| Assay Range | No | Yes | Number of spiked levels; Number of replicates (see Accuracy) |
| QL | No | Yes | Number of spiked levels; Number of replicates (see Accuracy) |
| Robustness | Yes | No | N/A |
| System Control(s) | Yes | No | Use AMM data or combination of data sets (Initial AMV plus AMM) |
Note: AMM, analytical method maintenance; AMV, analytical method validation; APT, analytical platform technology; ICH, International Conference for Harmonisation; QL, quantitation limit.