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Winnonlin enterprise version 5

Manufactured by Pharsight
Sourced in United States

WinNonlin Enterprise Version 5.2 is a software application developed by Pharsight for the analysis of pharmacokinetic and pharmacodynamic data. It provides a comprehensive set of tools for the modeling and simulation of drug concentration and response data.

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Lab products found in correlation

4 protocols using winnonlin enterprise version 5

1

Pharmacokinetic Analysis of AZD5069

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Pharmacokinetic parameters were estimated by non-compartmental analysis using WinNonLin Enterprise Version 5.2 or later (Pharsight Corporation, Mountain View, CA, USA) or SAS® Version 9.2 (SAS Institute Inc., Cary, NC, USA). The plasma parameters assessed for AZD5069 were maximum (peak) drug concentration (Cmax), time to reach maximum concentration (tmax), area under plasma concentration–time curve from zero to infinity after a single dose (AUC), AUC from zero to time 12 h (AUC0–12), AUC from zero to time 24 h (AUC0–24), AUC during a dose interval at steady state (AUCss), terminal elimination rate constant (λz), terminal half-life (t½), apparent oral plasma clearance (CL/F), renal clearance (CLR) and apparent oral volume of distribution during terminal phase (Vz/F).
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2

Dexlansoprazole Pharmacokinetics Across Doses

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Pharmacokinetic analyses included all patients with at least one estimable dexlansoprazole pharmacokinetic parameter on day 7. Dexlansoprazole pharmacokinetic parameters were determined from the plasma concentration–time profiles for all dose groups on day 7, using actual, rather than scheduled, sampling times. Pharmacokinetic parameters were derived using noncompartmental methods, with WinNonlin® Enterprise Version 5.2 (Pharsight Corp, St Louis, MO, USA). Pharmacokinetic parameters were summarized using descriptive statistics for each dose group. In addition, pharmacokinetic parameters were summarized by patient body weight and age groups.
Analysis of covariance (ANCOVA) models, with baseline weight as a continuous factor and dose group as a fixed factor, were used for tmax and the natural logarithm of dose-normalized Cmax and AUC. Pairwise comparisons between dose groups were conducted. Dose proportionality was assessed using the ratios of dose-normalized Cmax and AUC central values.
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3

Pharmacokinetics of MIV-711 in Plasma

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Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 h post-dose and processed into plasma for the measurement of concentrations of MIV-711. The PK analysis was conducted using WinNonlin Enterprise Version 5.2 (Pharsight Corporation, Mountain View, CA, USA).
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4

Pharmacokinetic Analysis of PRT062607

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Pharmacokinetic calculations based on PRT062607 plasma concentrations were performed by Covance Laboratories (Princeton, New Jersey) using noncompartmental analysis in WinNonlin Enterprise Version 5.2 (Pharsight Corporation, Mountain View, California). Individual plasma concentration data from each subject and the exact time points for blood sampling were used throughout the analysis. Pharmacokinetic parameters calculated from plasma PRT062607 concentrations included, but were not limited to, Cmax, tmax, AUC0‐24, λz, and t1/2. Dose‐normalized values for Cmax and AUC0‐24 were calculated and captured as Cmax/D and AUC/D, respectively. Accumulation ratio based on Cmax was calculated as Cmax,day 10/Cmax,day 1 and for AUC as AUC0‐24,day 10/AUC0‐24,day 1. Peak‐to‐trough ratio was computed as the ratio of Cmax on day 10 to the 24‐hour concentration postdose on day 10. Fluctuation on day 10 was calculated as (Cmax ‐ Cmin)/Cavg where Cmin is the minimum concentration and Cavg is the average concentration. From urine data, cumulative amount excreted from time 0 to 24 hours postdose (Ae0‐24) and cumulative fraction of dose excreted unchanged in the urine from time 0 to 24 hours postdose (fe0‐24) were also determined. Renal clearance (CLr) was calculated as the ratio of Ae0‐24 to AUC0‐24 on day 10.
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