Winnonlin software

Manufactured by Pharsight

Sourced in United States

WinNonlin is a software application designed for the analysis of pharmacokinetic and pharmacodynamic data. It provides tools for modeling and simulating drug concentration and effect data over time.

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125 protocols using winnonlin software

Tulathromycin PK/PD Modeling and Efficacy

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The PK profiles of tulathromycin were analyzed by the non-compartmental model with uniform weighting using WinNonlin software (version 5.2; Pharsight, CA, USA). The surrogate marker of antibacterial effectiveness, AUC_168h/MIC, was calculated using in vitro MIC values and PK parameters obtained from lung tissue samples from three individuals treated with IM administrations of tulathromycin. The effectiveness of tulathromycin was expressed as a reduction of H. parasuis loading calculated by subtracting loading of the treatment group from the control group. The in vivo PK/PD relationship of tulathromycin was described using a sigmoid inhibitory E_max model with the WinNonlin software (version 5.2; Pharsight, CA, USA) where the equation is as follows:
where E is the antibacterial effect measured as the reduction in log₁₀ CFU/lung after administration of tulathromycin compared to that of the log₁₀ CFU/lung in the untreated control group; E_max is the reduction in log₁₀ CFU/lung for the untreated control guinea pigs; E₀ is the maximum reduction after administration and represents the maximum antibacterial effect; Ce is the AUC/MIC_serum parameter; EC₅₀ is the AUC/MIC_serum value required to achieve 50% of the maximal antibacterial effect; and N is the Hill coefficient that describes the steepness of the AUC/MIC_serum and effect curve.

Guo L.L., Gao R.Y., Wang L.H., Lin S.J., Fang B.H, & Zhao Y.D. (2021). In vivo Pharmacokinetic/Pharmacodynamic (PK/PD) Profiles of Tulathromycin in an Experimental Intraperitoneal Haemophilus parasuis Infection Model in Neutropenic Guinea Pigs. Frontiers in Veterinary Science, 8, 715887.

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Pharmacokinetic-Pharmacodynamic Modeling of Tiamulin

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The PK profiles of tiamulin were analyzed by the non-compartmental model with uniform weighting using the WinNonlin software (version 6.1; Pharsight, CA, USA). The surrogate marker of antibacterial activity, AUC_24h/MIC were calculated using in vitro MIC value and PK parameters obtained from three doses of i.m. administrations of tiamulin. The bacteria loading for each animal was calculated according to C_t values and the in vitro standard DNA curve. The efficacy of tiamulin was evaluated by the reduction of M. gallisepticum compared to the initial bacteria count before drug treatment. The in vivo PK/PD relationship of tiamulin against M. gallisepticum was studied using the sigmoid E_max model WinNonlin software (version 6.1; Pharsight, CA, USA) with the equation as follows:

E = E_{0} + \frac{E_{max} \times C_{e}^{N}}{{EC}_{50}^{N} + C_{e}^{N}}

where E₀ is the change in log₁₀ ccu equivalents/mL in the control sample (absence of tiamulin), E_max is the difference in log₁₀ ccu equivalents/mL of the greatest amount of kill, C_e is the AUC_24h/MIC in the effect compartment, EC₅₀ is the AUC_24h/MIC value producing a 50% reduction in bacterial counts, and N is the Hill coefficient that describes the steepness of the curve (25 ).

Xiao X., Sun J., Yang T., Fang X., Cheng J., Xiong Y.Q, & Liu Y.H. (2016). Pharmacokinetic/Pharmacodynamic Profiles of Tiamulin in an Experimental Intratracheal Infection Model of Mycoplasma gallisepticum. Frontiers in Veterinary Science, 3, 75.

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Pharmacokinetic Analysis of Brain Striatum

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The analyte concentration (C) in brain striatum at each time point was calculated from its probe recovery (R_dial) and determined concentration (C_d) in dialysate by the equation, C = C_d/R_dial. The following pharmacokinetic parameters, peak concentration (C_max), time to peak concentration (T_max), area under the concentration-time curve from zero to time (AUC_0−t) or infinity (AUC_INF), apparent volume of distribution (Vd_λz/F), total body clearance (CL/F), mean residence time from zero to time (MRT_0−t) or infinity (MRT_inf) and half-life (t_1/2) were estimated by analyzing drug concentration vs. time profile of each rat using non-compartmental model of WinNonlin software (Pharsight Corporation, Mountain View, CA, USA, Version 6.0).

Xiao B., Sun Z., Cao F., Wang L., Liao Y., Liu X., Pan R, & Chang Q. (2017). Brain Pharmacokinetics and the Pharmacological Effects on Striatal Neurotransmitter Levels of Pueraria lobata Isoflavonoids in Rat. Frontiers in Pharmacology, 8, 599.

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Tilmicosin Quantification in Medium

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The concentrations of tilmicosin in the medium were analyzed using high-performance liquid chromatography–tandem mass spectrometry (HPLC-MS/MS). Referring to the standard of Announcement No. 1025 of the Ministry of Agriculture in China, pretreatment of the samples was optimized and acetonitrile was selected as the only extractant. The mobile phase consisted of solution A (water with 0.1% formic acid, V/V) and solution B (acetonitrile) at 0.25ml/min flow rate. The gradient elution was: 0–1.5 min, 10% B; 1.5–6 min, 95% B; 6–6.5 min, 5% B; and 6.5–12.5 min, 5% B. The injection volume was 5 μl. The PK parameters were calculated using WinNonlin Software (version 6.1; Pharsight Corporation, Mountain View, Sunnyvale, CA, USA).

Huang Z., Wu Y., Zhou Z., Xia X., Gu X., Cai Q., Shen X., Yang H, & Ding H. (2019). Pharmacokinetic and Pharmacodynamic Integration and Resistance Analysis of Tilmicosin Against Mycoplasma gallisepticum in an In Vitro Dynamic Model. Frontiers in Pharmacology, 10, 670.

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Efficacy of AQ-13 for Malaria Treatment

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Sample size estimates were based on a 15% non-inferiority margin, 95% cure for those given artemether with lumefantrine, and 20% attrition after treatment¹⁰ (link) with the power (1 – β=80%) to detect a 15% or greater decrease in efficacy, which yielded sample sizes of 33 per group and 66 participants in total. Testing of the primary and secondary outcomes was done with the Fisher's exact test, t test, or Mann-Whitney U test. These statistical tests were done in GraphPad Prism (version 6.07). Times to parasite and fever clearance were compared with Kaplan-Meier survival curves and tested for significance using the log-rank test. Pharmacokinetic parameters for AQ-13 from phase 2 efficacy studies were based on non-compartmental analysis with the use of the Win Nonlin software in Pharsight (version 6.5) and compared with t tests for which p values less than 0·05 were considered significant. Two-sided testing was used for all statistical comparisons.
The data and safety monitoring board did an interim analysis after 33 patients were enrolled in the study. This trial was registered at ClinicalTrials.gov, number NCT01614964.

Koita O.A., Sangaré L., Miller H.D., Sissako A., Coulibaly M., Thompson T.A., Fongoro S., Diarra Y., Ba M., Maiga A., Diallo B., Mushatt D.M., Mather F.J., Shaffer J.G., Anwar A.H, & Krogstad D.J. (2017). AQ-13, an investigational antimalarial, versus artemether plus lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria: a randomised, phase 2, non-inferiority clinical trial. The Lancet. Infectious Diseases, 17(12), 1266-1275.

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Danofloxacin Pharmacokinetic Analysis

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PK parameters were calculated from the concentration of danofloxacin in plasma and lung tissue by WinNonlin software (version 5.2.1, Pharsight Corporation, Mountain View, CA, USA). A two-compartment model in WinNonlin software obtained the PK parameters according to the characteristics of the concentration-time figures.

Wang S., Huang A., Gu Y., Li J., Huang L., Wang X., Tao Y., Liu Z., Wu C., Yuan Z, & Hao H. (2022). Rational Use of Danofloxacin for Treatment of Mycoplasma gallisepticum in Chickens Based on the Clinical Breakpoint and Lung Microbiota Shift. Antibiotics, 11(3), 403.

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Pharmacokinetic Profiling of BAT2206 and Ustekinumab

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To study the PK profile, the blood samples were collected at the following timepoints: 0 hours (pre-dose), 4 hours, 12 hours, and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 15, 22, 29, 43, 57, 71, 85, 99, and 113 days post-dose. After 0.5 hour at room temperature, blood samples were centrifuged at 2000g at 4 °C for 15 minutes. The serum samples were stored at − 60 °C until subsequent measurement of the drug concentration by a validated enzyme-linked immunosorbent assay (Covance Inc., Shanghai, China). The lower limits of quantification of the assay for serum BAT2206 or ustekinumab were 50.0 ng/mL, and the calibration range was 50.0–1600 ng/mL. The accuracy was − 2.5 to 3.2%, with the precision within the 3.9% coefficient of variation.
Pharmacokinetic evaluations included the following parameters: C_max, time to C_max, area under the plasma concentration–time curve from time 0 to 672 hours (AUC_0–672), AUC over the dosing interval (AUC_0–t), AUC_0–inf, elimination half-life, first-order rate constant of drug associated with the terminal portion of the curve, apparent clearance (CL/F), and apparent volume of distribution. The calculation of PK parameters was performed using WinNonlin software (version 8.0; Pharsight Corporation, St. Louis, MO, USA) with the non-compartment model.

Wu M., Li X., Yang D., Wang M., Zhang H., Li C., Mai J., Yang L., Qi Y., Yu J.C., Yang X., Wang Z., Gu C, & Ding Y. (2022). Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. Biodrugs, 37(1), 89-98.

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Dasatinib Pharmacokinetics Analysis

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Peripheral blood samples were frozen at −80°C. All samples from each experiment were thawed and analyzed for dasatinib concentration at the same time. Once thawed, dasatinib concentrations were determined using an assay developed to monitor a structurally similar compound IM by LC/LC-MS/MS (27 (link)), with minor modifications. Using this assay, concentrations of dasatinib in whole blood can be determined with a lower limit of detection of 50pg/ml. PK parameters such as half-life (T_½), peak concentration (C_max), and area under the curve (AUC_inf) were calculated using WinNonlin software (Pharsight, St. Louis, MO).

Gardner L.A., Klawitter J., Gregory M.A., Zaberezhnyy V., Baturin D., Pollyea D.A., Takebe N., Christians U., Gore L., DeGregori J, & Porter C.C. (2014). Inhibition of calcineurin combined with dasatinib has direct and indirect anti-leukemia effects against BCR-ABL1+ leukemia. American journal of hematology, 89(9), 896-903.

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Nicotine Pharmacokinetic Analysis in Rats

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Nicotine concentrations in serum samples were measured by gas chromatography with nitrogen phosphorus detection using a standard protocol in our laboratory (Harris et al., 2008 ; LeSage et al., 2003 (link)). Single dose nicotine pharmacokinetic parameters were estimated after completion of the dose-reduction protocol using our previously reported methods (Harris et al., 2008 ). In brief, rats were anesthetized with droperidol (2 mg/kg)/fentanyl (0.04 mg/kg) i.m. and implanted with a femoral catheter. They received nicotine 0.1 mg/kg i.v. over 10 sec via the catheter used for self-administration (see below), and blood was obtained via the femoral catheter at 15, 30, 60, 120, 180, and 240 min for measurement of the serum nicotine concentration (Harris et al., 2008 ). Parameter estimates (e.g., volume of distribution, half-life, clearance, and area under the curve (AUC)) were obtained using standard non-compartmental methods using WinNonlin software (version 4.1, Pharsight, Mountain View, CA).

Grebenstein P.E., Burroughs D., Roiko S.A., Pentel P.R, & LeSage M.G. (2015). Predictors of the nicotine reinforcement threshold, compensation, and elasticity of demand in a rodent model of nicotine reduction policy. Drug and alcohol dependence, 151, 181-193.

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Pharmacokinetic Analysis of Drug Formulation

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All data were analyzed using the SPSS 21.0 software package. All data are expressed as the mean ± standard deviation (SD). Comparisons between multiple groups were analyzed by the one-way analysis of variance, followed by the least significant difference test. p < 0.05 was considered statistically significant. In addition, the pharmacokinetic (PK) parameters were calculated by noncompartmental analysis in WinNonlin software with a sparse sampling algorithm (Pharsight 6.2, Cary, NC, United States).

Fu Y., Xiao Z., Tian X., Liu W., Xu Z., Yang T., Hu Y., Zhou X., Fang J., Gao S., Zhang D., Mu Y., Zhang H., Hu Y., Huang C., Chen J, & Liu P. (2021). The Novel Chinese Medicine JY5 Formula Alleviates Hepatic Fibrosis by Inhibiting the Notch Signaling Pathway. Frontiers in Pharmacology, 12, 671152.

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