cytarabine were observed within 1 hour of dosing and ranged from <START:cmax> 30 to 50 mcg/mL <END> . The terminal half-life for the free CSF cytarabine ranged from
2 MG DAILY a,b Multiple Dose (daily dose) Solution Tablets Cmax <START:cmax> (ng/mL) 14.4  5.3 <END> 15.0  4.9 tmax (hr) 2.1  0.8 3.5  2.4
Multiple Dose (daily dose) Solution Tablets Cmax (ng/mL) 14.4  5.3 <START:cmax> 15.0  4.9 <END> tmax (hr) 2.1  0.8 3.5  2.4 AUC (ng&#x2022;h/mL) 194
in humans. In humans, a mean maximum plasma concentration of about <START:cmax> 80 ng/mL <END> occurs within 1 to 4 days after a 3 mg monocular
plasma concentration versus time Curve (AUC). A mean Cmax of approximately <START:cmax> 43 to 49 mcg/mL <END> occurred at Week 5 during the initial loading dose period using
7 1 n = 12 Last n = 9 Parameters Cmax <START:cmax> (mcg/mL) 7.3  3.8 <END> 12.2  4.9 17.2  7.1 31.4  17.8 57.6 
12 Last n = 9 Parameters Cmax (mcg/mL) 7.3  3.8 <START:cmax> 12.2  4.9 <END> 17.2  7.1 31.4  17.8 57.6  21 83 
= 9 Parameters Cmax (mcg/mL) 7.3  3.8 12.2  4.9 <START:cmax> 17.2  7.1 <END> 31.4  17.8 57.6  21 83  35.2 AUC0-24 (mcg&#x2022;hr/mL)
Cmax (mcg/mL) 7.3  3.8 12.2  4.9 17.2  7.1 <START:cmax> 31.4  17.8 <END> 57.6  21 83  35.2 AUC0-24 (mcg&#x2022;hr/mL) 27  14
 3.8 12.2  4.9 17.2  7.1 31.4  17.8 <START:cmax> 57.6  21 <END> 83  35.2 AUC0-24 (mcg&#x2022;hr/mL) 27  14 60  20
 4.9 17.2  7.1 31.4  17.8 57.6  21 <START:cmax> 83  35.2 <END> AUC0-24 (mcg&#x2022;hr/mL) 27  14 60  20 65  33
for 21 days. The Mean (1SD) Cmax of megestrol acetate was <START:cmax> 753 (539) ng/mL <END> . The mean AUC was 10476 (7788) ng x hr/mL .
oral suspension for 14 days. Mean Cmax and AUC values were <START:cmax> 490 (238) ng/mL <END> and 6779 (3048) hr x ng/mL , respectively. The median Tmax
therapy with daily doses of 10, 15, and 20 mg were <START:cmax> 6600  1330; 16,000  2200; and 27,000  3100 ng/mL <END> , respectively. Metabolism and Elimination: The pegvisomant molecule contains covalently bound
was 8 hours . The mean Cmax and AUC values were <START:cmax> 8545 g/dL <END> and 31305 hr&#x2022;g/dL , respectively, which were 1.42- and 1.67-fold higher
taking 180 mcg PEGASYS , but peak concentrations were similar ( <START:cmax> 9 vs. 10 ng/mL <END> ) in those older and younger than 62 years. Pediatric Patients
13680 703626074(h&#x2022;ng/mL) CL 12 345  100 302 148783(mL/h) Cmax 13 <START:cmax> 1220 <END>  64 1230 9191720(ng/mL) a Dosewasadministeredasa1hourinfusion. Theplasmaclearance(CL)of Marqibo isslow, 345mL/h ,atadoseof
345  100 302 148783(mL/h) Cmax 13 1220  64 1230 <START:cmax> 9191720(ng/mL) <END> a Dosewasadministeredasa1hourinfusion. Theplasmaclearance(CL)of Marqibo isslow, 345mL/h ,atadoseof 2.25mg/m2 . Thisisincomparisontotherapidclearanceofnonliposomal vincristinesulfate
Distribution Half-Life (minutes) 3.5 3.5 Elimination Half-Life (hours) 27.5 28.2 Cmax <START:cmax> (g/mL) 2.6 <END> 2.9 AUCss (g/mL&#x2022;h) 29 36 In addition, the pharmacokinetics of amphotericin
(minutes) 3.5 3.5 Elimination Half-Life (hours) 27.5 28.2 Cmax (g/mL) 2.6 <START:cmax> 2.9 <END> AUCss (g/mL&#x2022;h) 29 36 In addition, the pharmacokinetics of amphotericin B
(L/h/kg) 0.028 Distribution Half-Life (minutes) 38 Elimination Half-Life (hours) 39 Cmax <START:cmax> (g/mL) 2.9 <END> AUCss (g/mL&#x2022;h) 36 An analytical assay that is able to distinguish
a Pharmacokinetic Parameter Mean  SD Mean  SD Peak Concentration <START:cmax> (g/mL) 1.7  0.8 <END> (n=10)b 1.1  0.2 (n=5)Concentration at End of Dosing Interval (g/mL)
( n = 9 ) Parameter Mean SD Mean SD Cmax <START:cmax> ( ng / mL ) 7 . 1 <END> 3 . 4 23 . 8 12 . 8 tmax (
11 NDA 21 - 671 / S- 020 Page 5 Cmax <START:cmax> 9 . 4 <END> 20 . 0 18 . 6 26 . 4 22 .
- 671 / S- 020 Page 5 Cmax 9 . 4 <START:cmax> 20 . 0 <END> 18 . 6 26 . 4 22 . 6 47 .
S- 020 Page 5 Cmax 9 . 4 20 . 0 <START:cmax> 18 . 6 <END> 26 . 4 22 . 6 47 . 3 ( ng
5 Cmax 9 . 4 20 . 0 18 . 6 <START:cmax> 26 . 4 <END> 22 . 6 47 . 3 ( ng / mL )
. 4 20 . 0 18 . 6 26 . 4 <START:cmax> 22 . 6 <END> 47 . 3 ( ng / mL ) ( 5 .
. 0 18 . 6 26 . 4 22 . 6 <START:cmax> 47 . 3 <END> ( ng / mL ) ( 5 . 7 ) (
( 14.3) mcg&#x2022;hr/mL and the mean maximal aprepitant concentration (Cmax) was <START:cmax> 3.27 ( 1.16) mcg/mL <END> . The mean aprepitant plasma concentration at 24 hours postdose was
( 14.75) mcg&#x2022;hr/mL and the mean maximal aprepitant concentration (Cmax) was <START:cmax> 4.15 ( 1.15) mcg/mL <END> . Distribution Fosaprepitant is rapidly converted to aprepitant . Aprepitant is
and terminal elimination half-life values following a 3.0 mg/kg dose were <START:cmax> 22.8 mg/L <END> , 170.9 mg&#x2022;hr/L , and 2.5 hours , respectively. 8 Reference
and terminal elimination half-life values following a 1.5 mg/kg dose were <START:cmax> 12.9 mg/L <END> , 95.0 mg&#x2022;hr/L , and 2.0 hours , respectively. The mean
regimen in which 125 mg was administered in 7 minutes ( <START:cmax> 19.0 mg/L <END> ). The terminal elimination half-life for drug bound iron was approximately
/d Estradiol ) Mean AUC0-24 (pg&#x2022;hr/mL) 335.2 940.2 Cmax (pg/mL) 21.6 <START:cmax> 66.7 <END> Cave (pg/mL) 15.4 39.2 Cmin (pg/mL) 9.4 21.1 Tmax (h)a 18
1.04 mg /d Estradiol ) Mean AUC0-24 (pg&#x2022;hr/mL) 335.2 940.2 Cmax <START:cmax> (pg/mL) 21.6 <END> 66.7 Cave (pg/mL) 15.4 39.2 Cmin (pg/mL) 9.4 21.1 Tmax (h)a
, and 120 mg doses, respectively. Mean Cmax values ranged from <START:cmax> 4.3 to 8.4 ng/mL <END> during the first day. Single-dose linearity was demonstrated with respect to
observed in acromegalic patients. At steady state, mean Cmax values were <START:cmax> 3.8  0.5, 5.7  1.7, and 7.7  2.5 ng/mL <END> , increasing linearly with dose. The mean accumulation ratio index was
and the maximal plasma concentration are proportional to the dose between <START:cmax> 6 and 20 mg/m2 <END> . At the intended dose, pharmacokinetic parameters are not significantly affected
, respectively. The Cmax and time of maximum concentration (tmax) were <START:cmax> 206 mcg/mL <END> and 0.32 hr , respectively. Rate of infusion had no influence
10 mg/m2 20 mg/m2 Peak Plasma Concentration (g/mL) Plasma Clearance (L/h/m2) <START:cmax> 4.12  0.215 <END> 0.056  0.01 8.34  0.49 0.041  0.004 Steady State
Concentration (g/mL) Plasma Clearance (L/h/m2) 4.12  0.215 0.056  0.01 <START:cmax> 8.34  0.49 <END> 0.041  0.004 Steady State Volume of Distribution (L/m2) 2.83 
