Table 2.

Bioanalytical method performance for vilaprisan (VPR)

	LLOQ	Calibrators > LLOQ		Calibrators at LLOQ		QC samples
		Accuracy (%)	Precision (%)	Accuracy (%)	Precision (%)	Accuracy (%)	Precision (%)
VPRa	0.100 µg/L	96.2–107	≤ 10.3	100	10.1	102–112	3.26–6.37
VPRb	0.100 µg/L	98.8–101	≤ 4.4	100	3.9	96.9–98.3	3.3–4.8
M-4c	1.00 µg/L	96.8–104	≤ 10.9	101	7.8	98.1–109	6.7–11.7.
[14C]VPRd	0.502 ng/L	N/A	N/A	N/A	N/A	N/A	N/A
ITZe	1.00 µg/L	98.4–103	≤ 4.24	98.8	3.94	97.7–101	3.38–4.88

DDI drug–drug interaction, ITZ itraconazole, LC–MS/MS liquid chromatography-tandem mass spectrometry, LLOQ lower limit of quantitation, MB mass balance, M-4 BAY 1139463 (metabolite of vilaprisan), N/A not applicable, QC quality control, UHPLC ultra high-performance liquid chromatography

^aMB study: LC–MS/MS; calibrators: 0.100–50.0 µg/L; QC samples: 0.250–40.0 µg/L

^bDDI study: LC–MS/MS; calibrators: 0.100–50.0 µg/L; QC samples: 0.300–40.0 µg/L

^cDDI study: LC–MS/MS; calibrators: 1.00–50.0 µg/L; QC samples: 1.00–40.0 μg/L

^dDDI study: UHPLC + AMS; calibrators: 0.502–44.9 pg/mL

^eDDI study: LC–MS/MS; calibrators: 1.00–1000 µg/L; QC samples: 3.00–750 µg/L