Prospective APT Verification Study Design for HPSEC Method
| ICH Q2(R1) Validation Characteristic | Analyst Number | Day Number | Instrument Number | Validation Design(Spiked Analyte Concentration) |
|---|---|---|---|---|
| Accuracy | 1 | 1 | 1 | Spike A%/F% (to final %):0.5, 1.0, 2.0, 4.0% (run each 3×) |
| Repeatability | N/A | N/A | N/A | From Accuracy |
| Specificity | 1 | 1 | 1 | Formulation matrix interference (3×) (and inferred from accuracy) |
| Linearity | N/A | N/A | N/A | From Accuracy |
| Assay Range | N/A | N/A | N/A | From Accuracy |
| QL | N/A | N/A | N/A | From Accuracy |
Note: APT, analytical platform technology; HPSEC, high-performance size-exclusion chromatography; ICH, International Conference for Harmonisation; QL, quantitation limit.