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. 2019 May 20;13:1739–1749. doi: 10.2147/DDDT.S200679

Table 1.

Validation data of the analytical method used to determine total paclitaxel in human plasma

Quality control samples
Parameters LLOQ (5.00 ng/mL) Low (15.0 ng/mL) Medium (900 ng/mL) High (12,000 ng/mL)
Accuracy and Precision
 Intra-assay (%RE, %CV) 1.9~8.3, 3.3~6.2 −4.4~4.7, 2.6~3.9 −9.9~7.2, 1.1~2.8 −7.6~7.6, 1.3~5.7
 Inter-assay (%RE, %CV) 5.8, 5.4 3.2, 3.2 −8.0, 2.7 −6.7, 2.0
Recovery (%) / 119.0 106.2 110.1
 %CV / 2.0 2.3 1.4
Stability with accuracy
 −20 °C 29 days (%RE, %CV) / −1.6, 4.4 / −8.3, 2.2
 −70 °C 88 days (%RE, %CV) / 5.4, 5.5 / 0.6, 2.4
 room temperature 6 hrs (%RE, %CV) / −3.9, 3.0 / −8.6, 2.0
 3 FT (−70 °C) (%RE, %CV) / 6.2, 4.8 / −4.3, 1.9
Recovery of IS (%RE, %CV) 105, 1.8

Abbreviations: LLOQ, lower limit of quantification; RE, relative error; CV, coefficient of variations; FT, freeze-thaw cycle; IS, internal standard.