The FDA requires that the sponsor should determine the stability of samples under the laboratory handling conditions that are expected for the study samples (e.g., the stability of samples maintained at room temperature or stored in an ice bucket).
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| True Concentration | Measured Concentration 1 | Measured Concentration 2 | Measured Concentration 3 |
|---|---|---|---|
| QC Level | Mean Accuracy | Standard Deviation | CV (%) |
|---|---|---|---|
| High QC | |||
| Medium QC | |||
| Low QC |