Table S2 Clinical bioanalysis summary information for study B
Test compound
Fostamatinib disodium
Analytical matrices
R406: plasma (K2-EDTA), DBS (K2-EDTA), whole
blood (K2-EDTA), urine (fortified with CHAPS
solution)
R406 N-glucuronide: urine (fortified with CHAPS
solution)
Analytes
Plasma, DBS, whole blood: R406
Urine: R406 and R406 N-glucuronide
Internal standard (IS)
R406-d9
Validated methods
R406 plasma
R406 DBS
R406 whole blood
R406 urine
R406 N-glucuronide urine
Lower limit of quantification
R406 plasma: 2.500 ng/mL
R406 DBS: 2.500 ng/mL
R406 whole blood: 2.500 ng/mL
R406 urine: 1.000 ng/mL
R406 N-glucuronide urine: 10.000 ng/mL
Validated range
R406 plasma: 2.500–2500 ng/mL
R406 DBS: 2.500–2500 ng/mL
R406 whole blood: 2.500–2500 ng/mL
R406 urine: 1.000–1000 ng/mL
R406 N-glucuronide urine: 10.000–5000 ng/mL
Quality control (QC) levels
R406 plasma: 7.500, 250, 2000, 20,000 ng/mL (dilution QC)
R406 DBS: 7.500, 250, 2000, 20,000 ng/mL (dilution QC)
R406 whole blood: 7.500, 250, 2000, 20,000 ng/mL (dilution
QC)
R406 urine: 3.000, 100, 800 ng/mL
1
R406 N-glucuronide urine: 30.000, 500, 4000, 50,000 ng/mL
(dilution QC)
Analytical technique/method of detection
R406 plasma: liquid-liquid extraction, LC-MS/MS
R406 DBS: liquid-liquid extraction, LC-MS/MS
R406 whole blood: liquid-liquid extraction, LC-MS/MS
R406 urine: liquid-liquid extraction, LC-MS/MS
R406 N-glucuronide urine: direct dilution, LC-MS/MS
Total number of samples analyzed
R406 plasma: 1056
R406 DBS: 744 FS-DBS, 1056 PD-DBS
R406 whole blood: 1056
R406 urine: 168
R406 N-glucuronide urine: 168
Sample storage conditions
R406 plasma: –60 to –80°C
R406 DBS: room temperature
R406 whole blood: –60 to –80°C
R406 urine: –60 to –80°C
R406 N-glucuronide urine: –60 to –80°C
CHAPS 3-[(3-cholamidopropyl) dimethylammonio]-1-propane sulphonate, FS-DBS finger stick-drawn dried
blood spot samples, PD-DBS pipette-drawn dried blood spot samples
2