Non-compartmental PK data analysis was performed using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA). The maximum observed peak plasma concentration (Cmax) was determined by inspection of the observed data using WinNonlin. The terminal elimination half-life (t½) was determined using the equation ln(2)/λz, where λz is the slope of the terminal portion of the natural-log concentration-time curve, determined by linear regression of at least the last 3 time points. The systemic exposure was determined by calculating the area under the curve for the plasma concentration versus time graph (AUClast) from the start of dosing to the time of last measurable concentration using the linear/log trapezoidal rule. Area under the curve for the plasma-concentration vs. time graph from time 0 to infinity (AUC∞) was calculated as: AUClast + Clast/λz, where Clast is the last quantifiable concentration. Clearance (CL) was calculated by dose/AUC∞, and steady state volume of distribution (Vss) was calculated as: (AUMC∞×CL)/AUC∞, where AUMC∞ is the area under the curve from the first moment extrapolated to infinity. PK parameters were summarized statistically and presented as mean and one standard deviation.
Phoenix 64 winnonlin 6
Manufactured by Pharsight
Sourced in United States
Phoenix 64 WinNonlin 6.3 is a comprehensive software package designed for pharmacokinetic and pharmacodynamic data analysis. It provides a user-friendly interface for modeling and simulation of drug concentration and response data.
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Lab products found in correlation
5 protocols using phoenix 64 winnonlin 6
1
Non-Compartmental PK Analysis Protocol
2
Phase 1b/2a MEDI8897 Pharmacokinetics
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As this phase 1b/2a study did not involve the statistical testing of a hypothesis, a formal sample size was not determined. The planned number of subjects was considered adequate to evaluate PK, ADA and safety and tolerability of MEDI8897 before initiating a phase 2b trial. Baseline values were defined as those observed on day 1 (before dosing). In cases of missing data points, only observed data were analyzed. Data were analyzed using SAS version 9.3 or higher (SAS Institute, Inc., Cary, NC) on a UNIX platform.
PK parameters were estimated by noncompartmental analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA). RSV antibody neutralization levels were summarized by mean (standard deviation) log2 half-maximal inhibitory concentration (IC50) values and geometric mean fold rise for each treatment group. The relationship between MEDI8897 PK and RSV-neutralizing antibody present in serum was evaluated using a parametric correlation analysis.
The number and percentage of infants positive for ADA at baseline and positive at any postbaseline time point were summarized. The effect of MEDI8897 ADA on PK was evaluated by visual examination of PK profiles because of the limitations of the currently available data. A model-based approach will be utilized to determine the impact of ADA on PK with additional data from a subsequent study.
PK parameters were estimated by noncompartmental analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA). RSV antibody neutralization levels were summarized by mean (standard deviation) log2 half-maximal inhibitory concentration (IC50) values and geometric mean fold rise for each treatment group. The relationship between MEDI8897 PK and RSV-neutralizing antibody present in serum was evaluated using a parametric correlation analysis.
The number and percentage of infants positive for ADA at baseline and positive at any postbaseline time point were summarized. The effect of MEDI8897 ADA on PK was evaluated by visual examination of PK profiles because of the limitations of the currently available data. A model-based approach will be utilized to determine the impact of ADA on PK with additional data from a subsequent study.
3
Pharmacokinetics of Ethinyl Estradiol and Gestodene
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The pharmacokinetic parameters of EE and GSD were calculated by non-compartmental analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA, USA). The maximum plasma concentration (Cmax) and the time to reach the Cmax (tmax) were determined directly from the observed data. The area under the plasma concentration–time curve (AUC) from 0 to the last time (AUC0–last) was calculated using a linear trapezoidal rule. The terminal elimination rate constant (λZ) was estimated by log-linear regression analysis. The elimination half-life (t1/2) and the apparent plasma clearance (CL/F) were calculated from the equations t1/2 =0.693/λZ and CL/F = dose/AUC, respectively. AUC from 0 to infinity (AUC0–∞) was calculated from the equation AUC0–∞ = AUC0–last + Ct/λZ. The apparent volume of distribution (Vd/F) was obtained by the calculation from CL/F and λZ.
4
Pharmacokinetic Analysis of CKD-519
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The PK parameters of CKD-519 were calculated by non-compartmental analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA, USA). The maximum plasma concentration (Cmax) and the time to reach the Cmax (tmax) were determined directly from the observed data. The area under the plasma concentration–time curve from 0 to last time (AUClast) was calculated using a linear trapezoidal rule. The terminal elimination rate constant (ke) was estimated by log-linear regression analysis. The elimination half-life (t1/2) and the apparent plasma clearance (CL/F) were calculated from the equations t1/2= ln(2)/ke and CL/F = dose/AUC, respectively. AUC from 0 to infinity (AUCinf) was obtained by summation of AUClast and Clast/ke. The apparent volume of distribution (Vd/F) was calculated from the equation, Vd/F = Dose/(ke·AUCinf).
5
Noncompartmental PK Analysis of IV Bolus
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A sparse sampling noncompartmental model for a bolus intravenous administration was used for PK data analysis using Phoenix 64 WinNonlin 6.3 (Pharsight, Mountain View, CA). The maximum observed peak plasma concentration (C max ) and the time at which it was observed (T max ) were determined by inspection of the observed data using WinNonlin. The terminal elimination half-life (t ½ ) was determined using the equation ln(2)/ l z , where l z is the slope of the terminal portion of the natural log concentration-time curve, determined by linear regression of at least the last 3 time points. The systemic exposure was determined by calculating the area under the plasma concentration versus time curve (AUC last ) from the start of dosing to the time of last measurable concentration using the linear/log trapezoidal rule. Area under the plasma concentration-time curve from time 0 to infinity (AUC ¥ ) was calculated as follows: AUC last þ C last /l z , where C last is the last quantifiable concentration. Clearance was calculated by Dose/AUC∞, and steady-state volume of distribution (V ss ) was calculated as: (AUMC ∞ $CL)/AUC ∞ , where AUMC ∞ is the area under the first moment extrapolated to infinity. PK parameters were summarized statistically and presented as mean and one standard deviation.
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