Winnonlin

Manufactured by Certara

Sourced in United States

WinNonlin is a software application used for pharmacokinetic and pharmacodynamic data analysis. It provides tools for modeling and simulation of drug concentration and response data.

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Lab products found in correlation

Sas 9, by SAS Institute (7 mentions) Sas version 9, by SAS Institute (4 mentions) Teklad global diet 2014, by Inotiv (2 mentions) Sas software, by SAS Institute (2 mentions) Metabolitepilot version 2, by AB Sciex (1 mentions) Analyst tf version 1, by AB Sciex (1 mentions) Multiquant version 2, by AB Sciex (1 mentions) Peakview version 2, by AB Sciex (1 mentions) Automation extension, by Bayer (1 mentions) Sas system release 9, by SAS Institute (1 mentions) Phoenix winnonlin 6, by Phoenix Pharmaceuticals (1 mentions) Softmax pro, by Molecular Devices (1 mentions) Sas software version 9, by SAS Institute (1 mentions) Phoenix winnonlin, by Certara (1 mentions) Phoenix 64, by Certara (1 mentions) Winnonlin professional, by Certara (1 mentions) Matlab, by MathWorks (1 mentions) Tq xs, by Waters Corporation (1 mentions) Stata 12, by StataCorp (1 mentions) Sas software 9, by SAS Institute (1 mentions)

95 protocols using winnonlin

Pregnancy Pharmacokinetics of TAF and TFV

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TAF and TFV pharmacokinetic parameters were determined with noncompartmental analysis using WinNonlin (Phoenix 64 version 8.3, Certara) and were described as geometric mean (GM) and associated coefficient of variation (%CV). To evaluate the influence of pregnancy on the pharmacokinetics, a linear mixed-model (with pregnancy as fixed-effect and random effect for participant) was used on the log transformed pharmacokinetic parameters to calculate the geometric mean ratios (GMRs) and 90% confidence interval (CI). A stratified analysis for treatment with TAF 10 mg coadministered with cobicistat, and TAF 25 mg was also performed and is included in the Supplementary Data.
An exposure-response analysis of TAF reported a similar virologic response over the wide range of observed TAF area under the curve (AUC_tau) deciles; the median TAF AUC_tau in the lowest decile was 53.1 ng∗h/mL [20 ]. Accordingly, the proportion of pregnant and postpartum women with AUC_last below 53.1 ng∗h/mL was determined in our study.

Bukkems V.E., Necsoi C., Hidalgo Tenorio C., Garcia C., Alba Alejandre I., Weiss F., Lambert J.S., van Hulzen A., Richel O., te Brake L.H., van der Meulen E., Burger D., Konopnicki D, & Colbers A. (2021). Tenofovir Alafenamide Plasma Concentrations Are Reduced in Pregnant Women Living With Human Immunodeficiency Virus (HIV): Data From the PANNA Network. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 75(4), 623-629.

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Quantitative Analysis of α-Amanitin

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Data acquisition and a LC-qTOF-MS operation were conducted using Analyst^® TF Version 1.6 (Sciex, Foster City, CA, USA). α-Amanitin was quantified by MultiQuant^® Version 2.1.1 (Sciex, Foster City, CA, USA) using peak integration. The PK parameters of α-amanitin were calculated by WinNonlin^® version 8.1.0 (Certara, Princeton, NJ, USA) in a non-compartment analysis. For MetID analysis, PeakView^® Version 2.2 (Sciex, Foster City, CA, USA) and MetabolitePilot™ Version 2.0.2 (Sciex, Foster City, CA, USA) were used for the structural elucidation of α-amanitin metabolites. Excel 2016 spreadsheet (Microsoft^®) was also used to process the statistical analysis of results.

Lee J., Lee B.I., Choi J., Park Y., Park S.J., Park M., Lim J.H., Hwang S., Lee J.M, & Shin Y.G. (2022). Investigation of In Vitro and In Vivo Metabolism of α-Amanitin in Rats Using Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometric Method. Molecules, 27(23), 8612.

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Pharmacokinetic Parameters Correlation in Rats

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The following three
PK parameters were selected for investigation: clearance (CL) (mL/min/kg),
elimination half-time (T1/2) (h), and mean residence time (MRT) (h)
from iv studies in rat. All three PK parameters were (natural) log
transformed and provided as mean estimates based on noncompartmental
analysis (NCA) of individual animal concentration–time profiles
applying WinNonlin (Certara, CA, U.S.). The calculation of the area
under the plasma concentration–time curve extrapolated to infinity
(AUC) was based on the “linear-up log-down”²⁶ method, and uniform weighting was used for estimation
of the terminal rate constant. MRT extrapolated to infinity was calculated
as the area under the first moment curve (AUMC) extrapolated to infinity
divided by the AUC. The PK parameters are highly correlated as in
agreement with the general understanding of the three PK parameters
and their relations.²⁷ The observed correlations
were 0.95 between MRT and T1/2, −0.93 between CL and MRT, and
a correlation of −0.89 between CL and T1/2.

Einarson K.A., Bendtsen K.M., Li K., Thomsen M., Kristensen N.R., Winther O., Fulle S., Clemmensen L, & Refsgaard H.H. (2023). Molecular Representations in Machine-Learning-Based Prediction of PK Parameters for Insulin Analogs. ACS Omega, 8(26), 23566-23578.

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Pharmacokinetic Analysis of Fexofenadine

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The peak plasma concentration (C_max), time to C_max (T_max), area under the concentration‐time curve (AUC_0–∞), AUC_0–8, AUC_0–24, and elimination half‐life (t_1/2), were calculated by noncompartmental analysis using WinNonlin software (version 5.1; Certara, Princeton, NJ). The renal clearance was obtained from the equation CL_renal = A_e/AUC_0–24, in which A_e is the amount of fexofenadine excreted into urine up to 24 hours.

Misaka S., Ono Y., Taudte R.V., Hoier E., Ogata H., Ono T., König J., Watanabe H., Fromm M.F, & Shimomura K. (2022). Exposure of Fexofenadine, but Not Pseudoephedrine, Is Markedly Decreased by Green Tea Extract in Healthy Volunteers. Clinical Pharmacology and Therapeutics, 112(3), 627-634.

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Pharmacokinetic Analysis of Mifepristone and Ketoconazole

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For each individual, pharmacokinetic parameters were computed for mifepristone and its metabolites and ketoconazole using a non-compartmental analysis method using WinNonlin version 6.4 (Certara Inc, St. Louis, Missouri). Parameters included maximum plasma concentration (C_max), area under the curve (AUC) using the linear trapezoidal rule, and time to maximum plasma concentration (t_max). For ketoconazole, AUC was calculated as AUC extrapolated to infinity (AUC_inf) for day − 1 and AUC_0–12 for day 17.

Nguyen D, & Mizne S. (2017). Effects of Ketoconazole on the Pharmacokinetics of Mifepristone, a Competitive Glucocorticoid Receptor Antagonist, in Healthy Men. Advances in Therapy, 34(10), 2371-2385.

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Pharmacokinetic Analysis of Macrolides

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To obtain pharmacokinetic parameters for macrolides, non-compartmental pharmacokinetic analysis was conducted using WinNonlin^® Version 6.3 software (Certara USA, Inc., Princeton, NJ, USA). The area under the plasma concentration–time curve from time of dosing to infinity (AUC_0–∞) and that under the first moment curve to the last measured plasma concentration from time of dosing to infinity (AUMC_0–∞) were determined by the linear trapezoidal rule. The terminal slope (λ_z) was calculated by linear regression using at least three data points from the terminal portion of the plasma concentration–time curve using the Best Fit program in WinNonlin^®. The half-life (t_{1/2, z}) was calculated by the formula t_{1/2, z} = ln2/λ_z. The mean residence time (MRT) was calculated using the formula AUMC_0–∞/AUC_0–∞. Total plasma clearance (CL_tot) was calculated using the formula D/AUC_0–∞; where, D is the administered dose of macrolides. The distribution volume (Vd) was calculated by multiplying CL_tot by MRT.

Kobuchi S., Kabata T., Maeda K., Ito Y, & Sakaeda T. (2020). Pharmacokinetics of Macrolide Antibiotics and Transport into the Interstitial Fluid: Comparison among Erythromycin, Clarithromycin, and Azithromycin. Antibiotics, 9(4), 199.

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Pharmacokinetic Analysis of Drug Compound

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Non‑compartmental analysis was performed using WinNonlin^® software (Ver. 3.1, NCA200 and 201; Certara, Inc., Princeton, NJ, USA) to estimate the following pharmacokinetic parameters: total area under the plasma concentration vs. time curve from time zero to infinity (area under the curve; AUC), total body clearance (CL; calculated as dose/AUC), terminal half‑life (t_1/2), and apparent volume of distribution at steady state (V_ss). Assuming dose‑linear conditions, F_oral was calculated as the ratio of the dose‑normalized AUC between intravenous and oral administration. The peak plasma concentration (C_max) and time to reach C_max (T_max) were obtained directly from the experimental data. The statistical p‑values were estimated using the unpaired t‑test for comparison between two means or one‑way analysis of variance with post-hoc Tukey’s honestly significant difference test for comparison among three or more means; p < 0.05 was considered statistically significant. Unless otherwise indicated, all numerical data were rounded to three significant figures.

Seo S., Han D., Choi E., Seo M., Song I, & Yoon I. (2022). Factors determining the oral absorption and systemic disposition of zeaxanthin in rats: in vitro, in situ, and in vivo evaluations. Pharmaceutical Biology, 60(1), 2266-2275.

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Pharmacokinetics of Moxifloxacin and Metabolites

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Noncompartmental PK parameters were calculated for moxifloxacin, M1, and M2 from concentration data using the model-independent method and WinNonlin (Version 4.1.a; Certara USA Inc.) in conjunction with an Automation Extension (Bayer AG). C_max and time to peak concentration values were taken directly from the plasma concentration time profiles. AUCs were calculated using the log-linear trapezoidal rule. Terminal half-lives were obtained by linear regression analysis of the last data points after log-transformation of the data. The clearance of the drug was calculated as (dose/AUC). The apparent volume of distribution at steady state was determined according to the equation Vss = [CL × MRT(iv)], where MRT is the mean residence time following intravenous infusion calculated as [(AUMC/AUC) − T/2] where T is infusion time and AUMC is the area under the first moment of the concentration-time curve determined by integrating the product of time and concentration from 0 to infinity. Amounts excreted into urine were based on concentrations of drug in urine and urine volumes collected in the interval following drug administration.

Stass H., Lettieri J., Vanevski K.M., Willmann S., James L.P., Sullivan J.E., Arrieta A.C, & Bradley J.S. (2019). Pharmacokinetics, Safety, and Tolerability of Single-Dose Intravenous Moxifloxacin in Pediatric Patients: Dose Optimization in a Phase 1 Study. Journal of clinical pharmacology, 59(5), 654-667.

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Pharmacokinetic and Pharmacodynamic Analysis

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PK and PD analyses were performed in subjects who had completed the study without major deviation affecting PK and PD results. The following PK and PD parameters were calculated by non-compartmental methods using WinNonlin^® software version 8.0 (Certara USA Inc., Princeton, NJ, USA). Maximum plasma concentration (C_max) and T_max were determined directly from observed plasma concentration–time profiles, and AUC_last was calculated using linear-up and log-down trapezoidal rule. AUC from 0 to infinity (AUC_inf) was calculated with the following formula: AUC_inf = AUC_last + C_last/λ_z, in which C_last is the last measurable concentration, and λ_z is the terminal elimination rate constant. Apparent clearance was calculated as a single dose divided by AUC_inf, and terminal elimination t_1/2 was calculated as 0.693/λ_z. Area under plasma DPP-4 activity inhibition from baseline-time curve from 0 to last measurable time point (AUEC_last) was calculated using linear trapezoidal rule, and maximum inhibition of plasma DPP-4 activity (I_max) was obtained from the observed value.

Yang E., Yoo H., Jang I.J., Yu K.S, & Lee S. (2021). Pharmacokinetic and Pharmacodynamic Comparison of Two Formulations of a Fixed-Dose Combination of Gemigliptin/Rosuvastatin 50/20 mg: A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study. Drug Design, Development and Therapy, 15, 651-658.

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Multi-compartment PK Modeling of Plasma Peptides

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Experimental and simulation results are presented as mean ± standard deviation (S.D.). PK of plasma peptide concentrations were analyzed by a multi-compartmental model with WinNonLin software (Certara Inc.). Statistical tests were performed with GraphPad PRISM version 5.0 software. Raw data are provided in data file S1.

Wolska A., Lo L., Sviridov D.O., Pourmousa M., Pryor M., Ghosh S.S., Kakkar R., Davidson M., Wilson S., Pastor R.W., Goldberg I.J., Basu D., Drake S.K., Cougnoux A., Wu M.J., Neher S.B., Freeman L.A., Tang J., Amar M., Devalaraja M, & Remaley A.T. (2020). A dual apolipoprotein C-II mimetic-apolipoprotein C-III antagonist peptide lowers plasma triglycerides. Science translational medicine, 12(528), eaaw7905.

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