Table 6.
Assessment of accuracy and precision from quality control samples in porcine plasma
| Table 6A Irinotecan | ||||||
|---|---|---|---|---|---|---|
| Nominal (ng/mL) |
GMa (ng/mL) |
S.D. (ng/mL) |
DEV (%) |
BRP (%) |
WRP (%) |
n |
| 15 | 16.7 | 0.487 | 11.4 | - | 3.12 | 20 |
| 150 | 159.5 | 7.14 | 6.32 | - | 4.64 | 20 |
| 750 | 758.8 | 19.5 | 1.17 | 1.54 | 2.18 | 20 |
| 5000 | 5134 | 172.3 | 2.70 | 1.77 | 2.97 | 20 |
| Table 6B SN38 | ||||||
|
Nominal (ng/mL) |
GMa (ng/mL) |
S.D. (ng/mL) |
DEV (%) |
BRP (%) |
WRP (%) |
n |
| 1.5 | 1.54 | 0.080 | 2.53 | 4.07 | 3.82 | 20 |
| 15 | 15.7 | 0.853 | 4.95 | 4.76 | 3.38 | 20 |
| 75 | 78.3 | 2.52 | 4.38 | 2.32 | 2.48 | 20 |
| Table 6C SN38-G | ||||||
|
Nominal (ng/mL) |
GMa (ng/mL) |
S.D. (ng/mL) |
DEV (%) |
BRP (%) |
WRP (%) |
n |
| 1.5 | 1.54 | 0.063 | 2.68 | - | 4.16 | 20 |
| 15 | 14.9 | 0.552 | −0.94 | - | 3.83 | 20 |
| 75 | 75.9 | 3.62 | 1.25 | 3.13 | 3.87 | 20 |
a
Abbreviations: GM, grand mean; S.D., standard deviation; DEV, percent deviation from nominal value; WRP, within-run precision; BRP, between-run precision; n, total number of replicate observations within the validation runs.
*
A hyphen indicates MSwit>MSbet, thus BRP cannot be calculated and it was concluded that no additional variation was observed as a result of performing the assay in different runs.
a
Five samples at each concentration were run on four different occasions (n=20).