Table 4 Comparisons of the geometric mean Cmax and Ctrough between predicted and observed data in different population ancestry.
Clinical study | Ancestry | Dose (mg BID) /dosage form | No. of subjects | Age range/mean (year) | Proportion of female | Cmax (ng/mL, range/CV %a) | Ctrough (ng/mL, range/CV %) | Prediction/observation ratio | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
Prediction | Observation | Prediction | Observation | Cmax ratio | Ctrough ratio | ||||||
Fong et al.10 | Caucasian | 200/Capb | 17 | 19–82 | 0.67 | 4618 (3686–6854) | 5620 (2830–17,100) | 658 (276–999) | 960 (210–2950) | 0.82 | 0.69 |
400/Cap | 6 | 9283 (7418–13,806) | 7650 (5280–10,500) | 1340 (558–2029) | 1290 (660–3890) | 1.21 | 1.04 | ||||
600/Cap | 5 | 14,034 (11,225–20,905) | 11,500 (6490–17,600) | 2072 (861–3126) | 2180 (390–5950) | 1.22 | 0.95 | ||||
Dean et al.11 | 200/Cap | 4 | 22–71 | 1.0 | 4747 (3530–6015) | 4700 (35.6%) | 698 (134–2055) | 500 (191.2%) | 1.01 | 1.40 | |
400/Cap | 4 | 33–60 | 0.75 | 9750 (7468–12,080) | 9100 (27.2%) | 1544 (357–3721) | 1600 (46.1%) | 1.07 | 0.97 | ||
Mateo et al.22 | 400/ Cap | 10 | 50.9 | 0.91 | 9659 (7244–12,075) | 5710 (2380–10,900) | 1489 (319–3872) | 1860 (530–6670) | 1.69 | 0.80 | |
400/ Cap | 17 | 52.5 | 1.0 | 9428 (7487–11,458) | 6360 (3880–13,300) | 1398 (362–2992) | 1040 (230–8490) | 1.48 | 1.34 | ||
200/Tabc | 13 | 59.1 | 1.0 | 6605 (5159–8302) | 6880 (4010–10,400) | 892 (148–2813) | 1000 (280–3100) | 0.96 | 0.89 | ||
300/Tab | 17 | 55.8 | 1.0 | 9944 (7762–1250) | 9370 (2280–14,700) | 1358 (225–4254) | 1840 (340–3830) | 1.06 | 0.74 | ||
400/Tab | 10 | 54.2 | 1.0 | 13,320 (10,387–16,747) | 12,000 (8450–16,900) | 1845 (308–5735) | 2010 (760–3610) | 1.11 | 0.92 | ||
Plummer et al.23 | 300/Tab | 27 | 29–71 | 0.87 | 10,062 (8091–12,379) | 9500 (4800–19,700) | 1444 (296–3697) | 2000 (600–11,400) | 1.06 | 0.72 | |
Yamamoto et al.12 | Japanese | 200/Cap | 3 | 54–67 | 0.33 | 4971 (4228–6177) | 4800 (31.6%) | 696 (460–1084) | 855 (NRd) | 1.04 | 0.81 |
400/Cap | 6 | 39–69 | 0.66 | 10,017 (8481–24,350) | 5900 (19.7) | 1413 (934–2202) | 1220 (NR) | 1.70 | 1.16 | ||
Yonemori et al.20 | 200/Tab | 3 | 37–55 | 0.57 | 6480 (4453–9037) | 7670 (46.9%) | 675 (376–1357) | 610 (157%) | 0.84 | 1.11 | |
300/Tab | 6 | 44–64 | 1.0 | 9749 (6693–13,604) | 8430 (35.1%) | 1025 (567–2065) | 1290 (157.6%) | 1.16 | 0.79 | ||
Yuan et al21 | Chinese | 300/Tab | 20 | 50–65 | 0.65 | 11,303 (9482–16,019) | 8270 (35%) | 1019 (459–2838) | 800 (118%) | 1.37 | 1.27 |
