Winnonlin professional

Manufactured by Certara

Sourced in United States

WinNonlin Professional is a software package designed for pharmacokinetic and pharmacodynamic analysis. It provides tools for modeling and simulating drug concentration and effect data.

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Winnonlin, by Certara (1 mentions)

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8 protocols using winnonlin professional

Pharmacokinetic Evaluation of Veterinary Formulations

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Descriptive PK parameters were obtained with WinNonlin Professional software (Version 5.2.1) (Certara, USA). The maximum plasma concentrations (C_max) and time to C_max (T_max) were obtained from the plasma concentration versus time data. AUC were calculated by the linear trapezoidal rule until the last sampling time (AUC_0–144h) and with extrapolation to infinity (AUC_0–∞). T_1/2 was calculated from the terminal slope (β) estimated by log-linear regression according VICH guideline.
Analysis of variance (ANOVA) was used to compare and assess the effect of the formulations on the test formulation compared with the classical ones, with logarithmically transformed parameters of AUC_0–144h, AUC_0–∞ (Bioequivalence, August 2015) as recommended by technical guidelines for veterinary drug in China (29 , 30 (link)). However, T_max comparison was performed with a Wilcoxon signed rank test. Parametric 90% confidence intervals (CIs) of the mean of test/reference ratios of AUC_0–144h, AUC_0–∞, and C_max were calculated using the residual variance of ANOVA with the assumption of a multiplicative model. CIs were calculated with SPSS analysis (IBM, USA).

Lei Z., Liu Q., Yang B., Ahmed S., Xiong J., Song T., Chen P., Cao J, & He Q. (2017). Evaluation of Bioequivalence of Two Long-Acting 20% Oxytetracycline Formulations in Pigs. Frontiers in Veterinary Science, 4, 61.

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Inhibition Kinetics and Drug-Drug Interactions

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For all inhibition studies, values were corrected for passive diffusion by subtracting the average velocity of control cells from the velocity at each concentration in transfected cells.
The inhibitor concentration resulting in 50% inhibition (IC50 value) was determined by nonlinear regression analysis using WinNonLin Professional, version 6.4 (Certara L.P., Princeton, NJ), using the following equation:

P e r c e n t o f C o n t r o l = Y_{M i n} + \frac{(Y_{m a x} - Y_{M i n})}{(1 + (\frac{[I]}{I C_{50}}) s l o p e)}

where [I] is inhibitor concentration, Y_min is minimum percentage activity in relation to control, Y_max is percentage activity when there is no inhibitor present, and slope is the slope of the curve. Four-parameter fitting was used for the IC50 estimation for all fittings.
Combined DDI index for each transporter was calculated by adding unbound Cmax (I_u) divided by IC50 of abemaciclib, M2, and M20 as described by Lutz and Isoherranen ^{37 (link)}:

Combined DDI index = \frac{I u A b e m a c i c l i b}{I C 50 a b e m a c i c l i b} + \frac{I u M 2}{I C 50 M 2} + \frac{I u M 20}{I C 50 M 20}

Chappell J.C., Turner P.K., Pak Y.A., Bacon J., Chiang A.Y., Royalty J., Hall S.D., Kulanthaivel P, & Bonventre J.V. (2018). Abemaciclib Inhibits Renal Tubular Secretion Without Changing Glomerular Filtration Rate. Clinical Pharmacology and Therapeutics, 105(5), 1187-1195.

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Measuring Functional Dupilumab in Serum

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Blood samples were collected at various time points over 57 days (64 days in R668‐HV‐1108) to measure concentrations of functional dupilumab in serum. Serum concentrations of functional dupilumab (which represent antibody molecules with at least 1 available binding site, that is, the sum of free dupilumab [2 available binding sites] and dupilumab present in a 1:1 human IL‐4Rα/dupilumab complex) were determined using a validated ELISA method (Regeneron Pharmaceuticals, Inc., Tarrytown, New York).²⁸, ³², ³³ The lower limit of quantification was 0.078 mg/L. The following PK parameters were determined using noncompartmental methods: arithmetic mean of peak concentration (C_max), median time to C_max (t_max), and arithmetic mean (±SD) of area under the concentration‐time curve to time of last measurable concentration (AUC_last, calculated using actual times). Noncompartmental analyses were performed using WinNonLin software (WinNonLin Professional, version 5.2.1; Certara, Princeton, New Jersey) to derive PK parameters. Postdose samples were ascribed a 0 when concentrations were less than the lower limit of quantification.

Li Z., Radin A., Li M., Hamilton J.D., Kajiwara M., Davis J.D., Takahashi Y., Hasegawa S., Ming J.E., DiCioccio A.T., Li Y., Kovalenko P., Lu Q., Ortemann‐Renon C., Ardeleanu M, & Swanson B.N. (2020). Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clinical Pharmacology in Drug Development, 9(6), 742-755.

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Concentration-Dependent PEPT1 Prodrug Uptake

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The concentration dependent uptake of [¹⁴C]LY2140023, ranging from 5 up to 149 μM, was determined in PEPT1 transfected HeLa cells with 2- to 3-minute incubation at room temperature. The mean passive diffusion of prodrug at each concentration was obtained in parallel experiments in HeLa cells transfected with pcDNA3.1 empty vector and subtracted from the uptake mediated by PEPT1. The corrected data were fitted by WinNonlin Professional, version 5.0.1 or 5.3 (Certara, L.P., St. Louis, MO). The kinetic parameters of the prodrug mediated by PEPT1 were estimated by utilizing the following equation: where S is the substrate concentration (μM), V_max is the maximum uptake rate (pmol/min/mg), and K_m is the concentration where uptake reaches a half of V_max (μM).

Pak Y.A., Long A.J., Annes W.F., Witcher J.W., Knadler M.P., Ayan-Oshodi M.A., Mitchell M.I., Leese P, & Hillgren K.M. (2017). In Vitro and Clinical Evaluations of the Drug-Drug Interaction Potential of a Metabotropic Glutamate 2/3 Receptor Agonist Prodrug with Intestinal Peptide Transporter 1. Drug Metabolism and Disposition, 45(2), 137-144.

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Exploratory Study of JNJ-64530440 Pharmacokinetics

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For this exploratory study, no formal sample size calculation was performed. Demographic, baseline characteristics and safety data (including AEs) were descriptively summarized.
When HBV-DNA was 20 IU/mL (target detected) or <20 IU/mL (target not detected) values of 15 IU/mL or 5 IU/mL, respectively, were imputed for statistical analyses. HBV virological breakthrough was defined as an on-treatment HBV DNA increase by >1 log₁₀ from nadir, or confirmed on-treatment HBV DNA >200 IU/mL in patients with HBV DNA 10 copies/mL). For HBcrAg, levels <3.0 log₁₀ U/mL were imputed as 2.7 log₁₀ U/mL. Mean changes from baseline for all virological parameters were calculated and presented graphically per cohort.
Plasma concentration–time data were plotted, and JNJ-64530440 pharmacokinetic parameters were calculated using non-compartmental analyses (WinNonlin Professional, Certara, Princeton, NJ, USA). Key pharmacokinetic parameters included maximum plasma concentration (C_max), plasma concentration after dosing (C_tau; i.e. at 24 h post dose for 750 mg once-daily or 12 h post dose for 750 mg twice-daily), time to C_max (t_max), and area under the plasma concentration–time curve at the end of the dosing period (AUC_tau). Descriptive statistics were used to summarize plasma concentrations and derived pharmacokinetic parameters of JNJ-64530440. The ratio of C_tau to paEC₉₀ was calculated.

Gane E.J., Schwabe C., Berliba E., Tangkijvanich P., Jucov A., Ghicavii N., Verbinnen T., Lenz O., Talloen W., Kakuda T.N., Westland C., Patel M., Yogaratnam J.Z., Dragone L, & Van Remoortere P. (2022). Safety, antiviral activity and pharmacokinetics of JNJ-64530440, a novel capsid assembly modulator, as 4 week monotherapy in treatment-naive patients with chronic hepatitis B virus infection. Journal of Antimicrobial Chemotherapy, 77(4), 1102-1110.

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Pharmacokinetic Modeling of Donepezil

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Standard methods [69 (link)] were used to calculate the pharmacokinetic parameters using a compartmental analysis with WinNonlin Professional software (version 2.1; Certara, Princeton, NJ, USA). As a PK model of donepezil after oral administration, a two-compartment model with first-order absorption and a linear elimination was used to establish a pharmacokinetic model of donepezil. The differential equations were as follows:

\frac{d A}{d t} = - k_{a} \cdot A

\frac{d X_{c}}{d t} = - k_{a} \cdot A - k_{12} \cdot X_{c} - k_{e} \cdot X_{c} + k_{21} \cdot X_{p}

\frac{d X_{p}}{d t} = k_{12} \cdot X_{c} - k_{21} \cdot X_{p}

In the above equations, ka (1/min) is the apparent first-order absorption rate constant to the central compartment, and A (mg) is the drug amount in the absorption site. The k₁₂ (1/min) and k₂₁ (1/min) are apparent first-order intercompartmental distribution constants (or transfer rate constants), k_e (1/min) is the apparent first-order elimination rate constant from the central compartment, and X_c (mg) and X_p (mg) are the drug amount in the central and peripheral compartments, respectively. Peak plasma concentration (C_max) and time to reach C_max (T_max) were directly read from the data. All data are expressed as mean ± SD, except the median (ranges) used for T_max.

Bae M., Han S.Y., Kim E.S., You B.H., Kim Y.M., Cho J., Chin Y.W, & Choi Y.H. (2021). Effect of Water Extract of Mangosteen Pericarp on Donepezil Pharmacokinetics in Mice. Molecules, 26(17), 5246.

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Pharmacokinetics of Pemetrexed in Plasma

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Plasma pemetrexed levels were measured using a validated high-performance liquid chromatography assay. The AUC of pemetrexed and its clearance was estimated by noncompartmental analysis using WinNonlin software (WinNonlin Professional, version 6.3, Certara USA, Inc., St. Louis, MO, USA).

Gota V., Kavathiya K., Doshi K., Gurjar M., Damodaran S.E., Noronha V., Joshi A, & Prabhash K. (2014). High plasma exposure to pemetrexed leads to severe hyponatremia in patients with advanced non small cell lung cancer receiving pemetrexed-platinum doublet chemotherapy. Cancer Management and Research, 6, 261-265.

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Inhibition Kinetics of Abemaciclib Metabolites

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For all inhibition studies, values were corrected for passive diffusion by subtracting the average velocity of control cells from the velocity at each concentration in transfected cells.
The inhibitor concentration resulting in 50% inhibition (IC₅₀ value) was determined by nonlinear regression analysis using WinNonLin Professional, version 6.4 (Certara L.P., Princeton, NJ), using the following equation:

Percent of Control = Y_{\min} + \frac{(Y_{\max} - Y_{\min})}{(1 + {(\frac{[I]}{{IC}_{50}})}^{slope})}

where [I] is inhibitor concentration, Y_min is minimum percentage activity in relation to control, Y_max is percentage activity when there is no inhibitor present, and slope is the slope of the curve. Four‐parameter fitting was used for the IC₅₀ estimation for all fittings.
Combined DDI index for each transporter was calculated by adding unbound C_max (I_u) divided by IC₅₀ of abemaciclib, M2, and M20, as described by Lutz and Isoherranen36:

Combined DDI index = \frac{I_{u} Abemaciclib}{IC 50 abemaciclib} + \frac{I_{u} M 2}{IC 50 M 2} + \frac{I_{u} M 20}{IC 50 M 20}

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