TABLE 6

Observed and predicted AUC of atRA in adult cancer patients in the presence of ketoconazole and liarozole (mean ± S.D.)

The ketoconazole study data are from Rigas et al. (1993), and liarozole data are from Miller et al. (1994). In the studies atRA was dosed for 29 days and ketoconazole or liarozole administered on days 2 and 29 while the control session pharmacokinetics studies were done on days 1 and 28.

Study	Study Day	n	AUC [ng·h/ml]
Study	Study Day	n	Observed	Predicted	Acceptance Range
Ketoconazole
Dosing control	1	31	467 ± 469	517 ± 171	234–887
All dose levels combined	2	31	531 ± 522	724 ± 443	267–1009
200 mg study control	28	7	176 ± 141	201 ± 130	88–334
200 mg	29	7	262 ± 200	404 ± 239	131–498
400 mg study control	28	6	185 ± 190	205 ± 139	93–352
400 mg	29	6	400 ± 211	547 ± 296	200–760
Liarozole
Dosing control	19	19	504 ± 549	533 ± 138	252–958
All dose levels combined	2	19	363 ± 358	482 ± 323	182–726
75 mg study control	28	5	210 ± 159	208 ± 134	105–399
75 mg	29	5	347 ± 329	257 ± 163	174–659
150 mg study control	28	8	78 ± 65	208 ± 131^{^a}	39–156
150 mg	29	8	135 ± 195	278 ± 169^{^a}	68–270
300 mg study control	28	6	140 ± 108	203 ± 130	70–280
300 mg	29	6	309 ± 138	307 ± 184	155–618

↵^a Outside of the acceptance range.