TABLE 6

Clinically observed and Simcyp model-predicted PK parameters of panobinostat after three times a week (Monday, Wednesday, Friday) dosing for 2 weeks

PK Parameter	Study	Dose
PK Parameter	Study	15 mg	20 mg	30 mg	40 mg	60 mg	80 mg
	B2101	3	18	4
	B2102		8	12	22	17	4
	Simulated	100	100	100	100	100	100
C_max (ng/ml)	B2101	13.2 (58)	28.8 (62)	17.3 (61)
	B2102		33.6 (49)	38.4 (61)	41.6 (88)	51.8 (56)	69.6 (39)
	Simulated	16.7 (126)	22.4 (126)	33.9 (126)	45.6 (126)	69.6 (126)	94.2 (126)
	PE (%)^a	+27	−33 to −22	−12 to +96	+10	+34	+35
AUC_0-48 ng × h/ml	B2101	149 (48)	264 (56)	235 (62)
	B2102		245 (87)	280 (59)	271 (59)	306 (50)	369 (52)
	Simulated	180 (47)	242 (48)	368 (48)	498 (48)	765 (48)	1044 (49)
	PE (%)	+21	−8 to −1	+31 to +57	+84	+150	+183
T_max^{^b} (h)	B2101	1	1	2.1
	B2102		1 (0.5–2.1)	2 (0.7–4.0)	1.1 (0.5–4.0)	1.1 (0.5–6.0)	1.5 (0.7–2.0)
	Simulated	1.3 (0.3–1.7)	1.3 (0.3–1.8)	1.3 (0.3–1.8)	1.3 (0.3–1.7)	1.3 (0.3–1.8)	1.3 (0.3–1.8)
	PE (%)	+30	+30	−38 to −35	+18	+18	−13

↵^a PE, prediction error (%) = [(predicted-observed)/observed] × 100.
↵^b Values are the median (range) for T_max and arithmetic mean (CV%) for all other parameters.