Linear regression analysis demonstrated a significant relation between the level of renal function and blood clearance of Gd3+.Īlthough mean blood clearance and renal clearance values progressively declined with increasing degree of renal impairment, based on the safety profile and the fact that the administered dose was double the standard dose used for MRI purposes, there appears to be no need for dose reduction in this population. Mean values for Gd3+ recovery in urine and feces for moderate and severe groups were 74% and 6%, and 69% and 8% of the dose, respectively. No Gd(3+)-related adverse events occurred. Values for the severe group were 1347 (366) micrograms.h/mL, 31 (7) mL/min, 19 (6) L, 22 (7) mL/min, and 21 (8) mL/min. Evaluation of performance of distributed delay model for chemotherapy-induced myelosuppression. Mean (SD) values for Gd3+ area under the curve, blood clearance, steady-state volume of distribution, renal clearance, and creatinine clearance for the moderate group were 862 (392) micrograms.h/mL, 56 (25) mL/min, 21 (5) L, 47 (23) mL/min, and 46 (16) mL/min.
#WINNONLIN 6 SOFTWARE#
Gd3+ blood concentration/time data were analyzed nonparametrically and parametrically using the software program WinNonlin VI.1. Blood samples (up to 72 hours) and urine and fecal samples (up to 216 hours) were assayed for total Gd3+ content by inductively coupled plasma atomic emission spectroscopy. Phoenix WinNonlin 6.0 is the cornerstone of Phoenix TM, Pharsight's new desktop software platform that is designed to advance model-based drug development by providing an integrated environment.
Subjects with moderate or severe renal impairment (creatinine clearances of 31 to 60 or 10 to 30 mL/min, respectively) received a 0.2-mmol/kg intravenous bolus of Gd3+ or saline placebo. The safety and pharmacokinetic profile of gadobenate dimeglumine, a gadolinium (Gd3+) chelate complex in development as a contrast agent for MRI, were evaluated in a placebo-controlled, double-blind, multicenter trial.
The participants will practice pkpd concepts by means of the WinNonlin 6 and MAXSIM2 software.
To determine the safety and pharmacokinetics of gadobenate dimeglumine in a group of subjects with moderate or severe renal impairment. phoenix winnonlin, phoenix winnonlin user guide, phoenix winnonlin download, phoenix winnonlin tutorial, phoenix winnonlin software price, phoenix winnonlin. analysis of PK and PD data and physiological concepts.