Development and validation of a new LC–MS/MS method for the determination of mefatinib in human plasma and its first application in pharmacokinetic studies

Journal of Analytical Science and Technology

Table 5 The measured and predicted main PK parameters in NSCLC patients after an oral dose of MET306 tablets at different doses

Administration	Dose group (mg)	Subject number	Measured value of C_max (ng mL⁻¹)	Predicted value of C_max (ng mL⁻¹)	Bias (%)	Measured value of AUC_0−t (ng h mL⁻¹)	Predicted value of AUC_0−t (ng h mL⁻¹)	Bias (%)
Single dose	105	20	148.8	122.4	− 17.72	2971	2721	− 8.41
	105	21	195.6	160.01	− 18.20	3811	3207	− 15.84
	105	22	57.87	50.13	− 13.37	949.6	1010	6.36
	105	23	254.8	223.79	− 12.17	5967	5256	− 11.91
	105	24	64.34	78.67	22.27	1275	1801	41.30
	140	25	131.1	131.1	0.02	2582	2363	− 8.48
Multiple dose	105	21	192.5	193.3	0.41	5628	5299	− 5.85
	105	23	258.1	231.2	− 10.43	6587	6217	− 5.61
	105	24	102.5	96.60	− 5.77	2314	2188	− 5.42
	140	25	194.2	183.3	− 5.63	4740	5297	11.75