Table III.

Summary of Method Validation of In-house EILSA, Inter-assay Accuracy and Precision for Formulation Lots A and B

			Quality control levels
			Nominal concentration (ng/mL)
Formulation lot	Characteristic	Statistic	ULOQ 2000	HQC 1200	MQC 400	LQC 60.0	LLOQ 20.0
A	Accuracy	Mean bias (%RE)	−2.13	−1.47	−2.57	−1.22	−3.74
	Precision	Interbatch (%CV)	4.81	5.42	3.20	3.66	5.85
	Total Error	|Mean| + interbatch	6.94	6.89	5.77	4.88	9.32
B	Accuracy	Mean bias (%RE)	−2.03	−3.19	−2.48	−1.25	0.01
	Precision	Interbatch (%CV)	4.94	3.94	3.79	2.64	17.8
	Total error	|Mean| + interbatch	6.97	7.13	6.27	3.89	17.8

% RE %recovery, %CV %coefficient of variation, Total Error: Sum of accuracy (mean Bias) and inter-batch precision, ULOQ upper limit of quantification, HQC high quality control, MQC middle quality control, LQC low quality control, LLOQ lower limit of quantification