All statistical analyses were conducted using SAS version 9.2 (SAS Institute, Inc., Cary, NC, USA) and WinNonlin® version 6.3 (Pharsight). Baseline demographic characteristics were summarized using descriptive statistics. The PK and PD data were analyzed using descriptive statistics and compared among the treatment groups. Demographic characteristics were analyzed using the Kruskal-Wallis test for the comparison of groups. Differences in AUECs among groups were analyzed by the one-way ANOVA test. The safety data are presented using descriptive statistics.
Winnonlin version 6
Manufactured by Pharsight
Sourced in United States
WinNonlin version 6.3 is a software tool designed for pharmacokinetic and pharmacodynamic analysis. It provides a platform for modeling and simulation of data related to the behavior of drugs in the body.
Automatically generated - may contain errors
26 protocols using winnonlin version 6
1
Pharmacokinetics and Pharmacodynamics Analysis
2
Non-compartmental PK Analysis of Atorvastatin and Ezetimibe
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Non-compartmental analysis was performed using WinNonlin® Version 6.3 (Pharsight, Mountain View, CA, USA) to determine the following PK parameters of atorvastatin, 2-hydroxyatorvastatin, free ezetimibe, and total ezetimibe: the maximum plasma concentration at steady state (Cmax,ss), time to reach Cmax (Tmax,ss), area under the concentration-time curve within a dosing interval at steady state (AUCτ,ss), AUC from dosing time extrapolated to infinity at steady state (AUCinf,ss), terminal elimination half-life (t1/2), apparent clearance (CLss/F), and apparent volume of distribution (Vdss/F). Plasma drug concentration-time profiles are presented in linear and log-transformed scales. Cmax,ss and Tmax,ss were measured, and AUC was calculated by using the linear trapezoidal rule. The t1/2 was calculated from the ratio of the natural logarithm of 2 and terminal elimination rate constant.
3
Permeability Coefficient and Efflux Ratio Determination
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The apparent permeability coefficient (Papp) was determined according to the following equation: Papp = dQ/dt × (1/AC0), where dQ/dt is the permeability rate, A is the area of the inserts, and C0 is the initial concentration. The efflux ratio was defined as the ratio of Papp in the basolateral-to-apical direction divided by Papp in the apical-to-basolateral direction.
All statistics were calculated using GraphPad Prism 8.0 software (San Diego, CA, USA) designed for one-way ANOVA. Pharmacokinetic parameters were calculated with a non-compartmental analysis using WinNonlin Version 6.3 (Pharsight, Mountain View, CA, USA). ADMET predictor V10.0 (Simulations Plus, Inc., Lancaster, CA, USA) and Microsoft Excel (Microsoft, Redmond, WA, USA) were used to process the data (i.e., half-life (t1/2) and hepatic clearance (CLhep) determination). Data were expressed as means ± standard deviations (SD). Results were considered statistically significant if the p-value <0.05, <0.01 and <0.001.
All statistics were calculated using GraphPad Prism 8.0 software (San Diego, CA, USA) designed for one-way ANOVA. Pharmacokinetic parameters were calculated with a non-compartmental analysis using WinNonlin Version 6.3 (Pharsight, Mountain View, CA, USA). ADMET predictor V10.0 (Simulations Plus, Inc., Lancaster, CA, USA) and Microsoft Excel (Microsoft, Redmond, WA, USA) were used to process the data (i.e., half-life (t1/2) and hepatic clearance (CLhep) determination). Data were expressed as means ± standard deviations (SD). Results were considered statistically significant if the p-value <0.05, <0.01 and <0.001.
4
Pharmacokinetic Analysis of Ramosetron
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The pharmacokinetic parameters of ramosetron were analyzed by noncompartmental methods using WinNonlin version 6.3 (Pharsight Co., Mountain View, CA, USA). The maximum concentration (Cmax) and time to Cmax (Tmax) were obtained directly from the concentration-time data. The area under the concentration-time curve of ramosetron from zero to the last measurable concentration (AUClast) was calculated using the linear trapezoidal rule. From the terminal slope of the concentration time curve, the elimination rate constant was estimated using linear regression, and the terminal half-life (T1/2), clearance (CL), and volume of distribution at the steady state (Vss) were calculated.
5
Pharmacokinetic Evaluation of Bictegravir Dosing
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Safety evaluations included recording of adverse events (AEs), concomitant medications, physical examinations, laboratory evaluations, and 12-lead electrocardiograms. We collected intensive PK plasma samples on days 1 and 10, predose PK samples on days 7, 8, and 9, and single-point PK plasma samples on days 14 and 17 after the last dose on day 10. We analyzed plasma samples using a validated high-performance liquid chromatography–tandem mass spectrometry method to determine BIC concentrations at QPS laboratories (Newark, DE). Single-dose PK parameters included Cmax, Tmax, Clast, Tlast, AUC0-24; multiple-dose PK parameters included Cmax, Tmax, Clast, Tlast, area under the concentration versus time curve AUC0-last, AUC0-24, Ctau, t1/2, AUCtau, Vz/F, CLss/F, AR_AUC (AUC accumulation ratio on day 10), AR_Cmax (Cmax accumulation ratio on day 10). PK parameters were estimated based on the observed concentration–time data by the noncompartmental PK approach using WinNonlin version 6.3 (Pharsight Corporation, Mountain View, CA). The t1/2 values were determined using plasma concentrations through 168 hours (day 17) after the last dose on day 10.
6
Vancomycin Pharmacokinetics in Critical Care
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No formal sample size calculation was done and a total of 15 subjects were enrolled. Pharmacokinetic parameters were derived by noncompartment modeling17 (link) using Winnonlin (Version 6.3; Pharsight, St. Louis, MO). The trapezoidal approach was used to estimate AUC and clearance. The Matzke equation was used to estimate vancomycin clearance for each subject.18 (link) Area under the curve was performed from 0 hour to 12 hours; hence, the AUC0–24 hours was calculated by doubling of AUC0–12.19 (link)All statistical analysis was done on Statistical Package for the Social Sciences (SPSS) software version 20 (IBM, Armonk, NY, USA). Continuous numerical variables (such as CLCR, APACHE II score, and all pk parameters) and categorical variables (such as age, gender, and weight) were assessed for the normality using the Kolmogorov–Smirnov test. Normally distributed data were expressed as mean ± SD, and that not normally distributed was presented as median (range).
7
Pharmacokinetic Assessment of Escitalopram
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Serial blood samples (5 ml) for PK assessment were collected from an indwelling catheter or by direct venipuncture prior to the administration (t = 0) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, and 120 h after the administration of escitalopram tablet. Plasma samples were isolated in blood collection tubes by centrifugation (3,500 rpm, 10 min) at 4°C within 1 h after sampling, transferred to labeled storage tubes and stored at −70°C pending workup and analysis.
Descriptive statistics of PK parameters were calculated using established noncompartmental methods, utilizing the WinNonLin version 6.3 software (Pharsight Corporation, USA). The PK parameters determined for each participant included apparent terminal half-life (t1/2), maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from the time of administration up to the last time point with a measurable concentration post-dose (AUC0-t), AUC extrapolated to infinity (AUC0-∞).
Descriptive statistics of PK parameters were calculated using established noncompartmental methods, utilizing the WinNonLin version 6.3 software (Pharsight Corporation, USA). The PK parameters determined for each participant included apparent terminal half-life (t1/2), maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from the time of administration up to the last time point with a measurable concentration post-dose (AUC0-t), AUC extrapolated to infinity (AUC0-∞).
8
Pharmacokinetic Evaluation of Probe Drugs with Rucaparib
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Cmax and AUC from time zero to the last quantifiable measure (AUC0‐t), were the primary PK parameters analyzed for caffeine, S‐warfarin, omeprazole, midazolam, and digoxin with and without rucaparib treatment. Other PK parameters analyzed for the probe drugs included AUC from time zero extrapolated to infinity (AUC0‐inf), t1/2, and Tmax. AUC0‐inf was reported if the portion extrapolated from time of last quantifiable measurement to infinity did not exceed 20%. The PK parameters analyzed for rucaparib at steady state (ss) include trough plasma concentration, Cmax,ss, Tmax,ss, and AUCτ,ss, where τ indicates the dosing interval (12 hours) at steady state. The PK parameters were calculated using noncompartmental analysis from the plasma concentration‐time data using WinNonlin version 6.3 (Pharsight, Mountain View, CA).
9
Pharmacokinetic Evaluation of Epimeric Compounds
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The pharmacokinetic parameters of 24R-epimer and 24S-epimer in rats were obtained by noncompartmental analysis using WinNonlin Version 6.3 (Pharsight Corporation, USA). For the transport assay, the apparent permeability coefficient (Papp) was calculated as in eq. 1:
ΔQ is the transport quantity (nanomoles), Δt is the time of transport (second), C0 is the initial concentration in the donor chamber, and A is the surface area of the membrane (centimeters squared). The efflux ratio (ER) was calculated as in eq. 2:
In the single-pass perfusion experiment, the absorption rate constant ka and drug permeability across rat ileum (Peff) were calculated as in eq. 3 and 4.
Cout is the outlet concentration of rhodamine 123 at specific time interval, Cin is the inlet concentration of rhodamine 123, C(PR)in and C(PR)out are the inlet and outlet concentration of phenol red, respectively, v is the flow rate through the ileum segment, r is the radius of the ileum, and l is the length of perfused segment.
The data were expressed as mean ± S.D. Pearson correlation analyses and Student's t test were used to analyze data. The difference was considered to be statistically significant if the probability value was less than 0.05 (p<0.05).
ΔQ is the transport quantity (nanomoles), Δt is the time of transport (second), C0 is the initial concentration in the donor chamber, and A is the surface area of the membrane (centimeters squared). The efflux ratio (ER) was calculated as in eq. 2:
In the single-pass perfusion experiment, the absorption rate constant ka and drug permeability across rat ileum (Peff) were calculated as in eq. 3 and 4.
Cout is the outlet concentration of rhodamine 123 at specific time interval, Cin is the inlet concentration of rhodamine 123, C(PR)in and C(PR)out are the inlet and outlet concentration of phenol red, respectively, v is the flow rate through the ileum segment, r is the radius of the ileum, and l is the length of perfused segment.
The data were expressed as mean ± S.D. Pearson correlation analyses and Student's t test were used to analyze data. The difference was considered to be statistically significant if the probability value was less than 0.05 (p<0.05).
10
Pharmacokinetic Parameter Evaluation
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A non-compartmental analysis using WinNonlin® Version 6.3 (Pharsight, Mountain View, CA, USA) was performed to calculate the following PK parameters: the maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the time-concentration curve from time zero to time of the last quantifiable concentration, (AUClast), AUC from time zero extrapolated to the infinite time (AUCinf), terminal elimination half-life (t1/2). Cmax and Tmax were directly derived from actual measurements; t1/2 was calculated from the ratio of the natural logarithm of 2 and the terminal elimination rate constant, and AUC was calculated using the linear trapezoidal rule.
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