. 2020 Jul 31;9(8):456–465. doi: 10.1002/psp4.12541

Table 2.

Verification results using the established models

Drug	Scenario	IV or Oral dosing	References	C_max ratio (predicted/observed) ^a		AUC ratio (predicted/observed) ^a
Drug	Scenario	IV or Oral dosing	References	Gastroplus	Simcyp	Gastroplus	Simcyp
Tapentadol	IV dose	34 mg single infusion for 15 min	15	0.92	0.96	1.11	1.13
	Oral dose 1 ^b	80 mg single dose, IR ^c tablet	15	0.84	0.95	1.04	0.88
	Oral dose 2 ^d	129 mg single dose, IR capsule	15	0.72	0.79	0.97	0.82
	Oral dose 3 ^e	64 mg single dose, IR capsule	15	0.88	1.03	1.14	0.96
	Fed state ^e	100 mg single dose, IR tablet with food	15	0.68	0.92	0.76	0.75
Saxagliptin	IV dose	0.04 mg, single infusion for 15 mins	39	0.99	0.86	0.92	0.88
	Oral dose 1 ^b	100 mg single dose, IR tablet	40	0.99	0.98	1.06	1.02
	Oral dose 2 ^e	5 mg single dose, IR tablet	39	1.08	1.10	1.13	1.18
	Oral dose 3 ^e	50 mg single dose, solution	41	0.98	1.00	1.16	1.27
	Fed state ^e	10 mg single dose, IR tablet, with food	36	0.68	0.87	0.97	1.11
Darunavir ^f	IV dose	150 mg, single infusion for 1 hour	37	1.07	1.20	1.00	1.05
	Dose 1 ^b	600 mg single dose, IR tablet, with food	37	0.85	0.88	0.88	0.76
	Dose 2 ^e	400 mg single dose, IR tablet, with food	37	0.71	0.74	0.78	0.74
	Dose 3 ^e	800 mg single dose, IR, with food	New Drug Submission	0.89	0.89	1.12	0.87
	Fasted state ^e	400 mg single dose, IR tablet	37	1.01	0.95	1.27	0.93
Erlotinib	IV dose	25 mg, single infusion for 30 mins	42	0.85	1.14	1.15	1.44
	Dose 1 ^b	150 mg single dose, IR tablet	3	0.81	1.01	1.15	1.06
	Dose 2 ^e	100 mg single dose, IR tablet	43	0.86	1.19	1.23	1.28
	Dose 3 ^e	200 mg single dose, IR tablet	16	0.78	0.97	0.96	0.83
	Fed state ^e	150 mg single dose, IR tablet, with food	38	0.68	1.01	1.09	1.42

^{^a}

The value represents the ratio of predicted and observed C_max or AUC_0‐∞.

^{^b}

The study was used for model refinement when needed. The C_max ratio and AUC_0‐∞ ratio represent the result after model refinement.

^{^c}

IR: Immediate‐release.

^{^d}

The study was used for Gastroplus model refinement, but not for Simcyp model refinement.

^{^e}

The study was used for model external verification. It was not used for model refinement.

^{^f}

The model for darunavir was developed with the studies in the presence of 100 mg ritonavir, BID.