Table 1.
Intra-run and inter-run accuracy and precision for TAK-981 in human K2EDTA plasma.
| Run Number |
LLOQ 0.100 ng/mL | LQC 0.300 ng/mL | MQC 30.0 ng/mL | HQC 75.0 ng/mL |
|---|---|---|---|---|
| 1 | 0.0938 | 0.309 | 32.0 | 79.6 |
| 0.0972 | 0.325 | 31.9 | 77.6 | |
| 0.0951 | 0.309 | 30.9 | 75.3 | |
| 0.104 | 0.317 | 32.9 | 77.5 | |
| 0.0958 | 0.288 | 30.8 | 78.8 | |
| 0.0991 | 0.307 | 32.2 | 77.6 | |
| Intra-run Mean | 0.0975 | 0.309 | 31.8 | 77.7 |
| Intra-run S.D. | 0.00367 | 0.0124 | 0.804 | 1.46 |
| Intra-run %CV | 3.8 | 4.0 | 2.5 | 1.9 |
| Intra-run %RE | −2.5 | 3.0 | 6.0 | 3.6 |
| n | 6 | 6 | 6 | 6 |
| 2 | 0.0940 | 0.342 | 28.9 | 76.2 |
| 0.0929 | 0.256 | 30.2 | 73.3 | |
| 0.108 | 0.287 | 30.1 | 72.7 | |
| 0.0854 | 0.291 | 29.5 | 74.8 | |
| 0.102 | 0.289 | 30.0 | 71.1 | |
| 0.0890 | 0.311 | 29.5 | 77.2 | |
| Intra-run Mean | 0.0952 | 0.296 | 29.7 | 74.2 |
| Intra-run S.D. | 0.00838 | 0.0286 | 0.494 | 2.28 |
| Intra-run %CV | 8.8 | 9.7 | 1.7 | 3.1 |
| Intra-run %RE | −4.8 | −1.3 | −1.0 | −1.1 |
| n | 6 | 6 | 6 | 6 |
| 3 | 0.109 | 0.323 | 31.1 | 76.7 |
| 0.107 | 0.346* | 31.6 | 74.1 | |
| 0.113 | 0.325 | 33.4 | 76.9 | |
| 0.109 | 0.320 | 32.8 | 76.6 | |
| 0.112 | 0.318 | 31.2 | 74.8 | |
| 0.105 | 0.334 | 31.1 | 75.3 | |
| Intra-run Mean | 0.109 | 0.328 | 31.9 | 75.7 |
| Intra-run S.D. | 0.00299 | 0.0106 | 0.991 | 1.16 |
| Intra-run %CV | 2.7 | 3.2 | 3.1 | 1.5 |
| Intra-run %RE | 9.0 | 9.3 | 6.3 | 0.9 |
| n | 6 | 6 | 6 | 6 |
| Inter-run Mean | 0.101 | 0.311 | 31.1 | 75.9 |
| Inter-run S.D. | 0.00817 | 0.0223 | 1.27 | 2.18 |
| Inter-run %CV | 8.1 | 7.2 | 4.1 | 2.9 |
| Inter-run %RE | 1.0 | 3.7 | 3.7 | 1.2 |
| n | 18 | 18 | 18 | 18 |
Note: *: Deviation from nominal > 15%; value included in statistics.
%CV: percent coefficient of variation; %RE: percent relative error; HQC: high-quality control; LLOQ: lower limit of quantitation; LQC: low-quality control; MQC: medium-quality control; n: number; S.D.: standard deviation.