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Winnonlin professional

Manufactured by Pharsight
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WinNonlin Professional is a software application designed for pharmacokinetic and pharmacodynamic (PK/PD) data analysis. It provides tools for modeling and simulation of drug concentration and response data.

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Lab products found in correlation

Wistar rats, by Taconic Biosciences (1 mentions) Sigmaplot, by Grafiti LLC (1 mentions) 2470 wizard2, by PerkinElmer (1 mentions) Winnonlin software, by Pharsight (1 mentions)

Close spelling variants of this product

WinNonLin professional version 4.1 WinNonlin Professional Software Version 5.2.1 WinNonlin Professional 4.0.1 WinNonlin professional software version 8.0 WinNonlin Professional, Version 6.4 Phoenix WinNonlin Professional WinNonlin Professional Edition Version 2.1 Phoenix™ WinNonlin® Professional Version 6.3 WinNonlin Professional Version 5.2 WinNonlin Professional Edition

59 protocols using winnonlin professional

1

Dose-Dependent Pharmacokinetic Analysis

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Descriptive summary statistics were grouped according to the dose group, by separate sexes as well as combined sexes. All descriptive statistics calculations were performed using validated WinNonlin Professional, Version 5.2 (Pharsight Corporation, Mountain View, CA, USA). Dose linearity was assessed using linear regression analysis.
Geometric mean ratios of plasma exposure between dose levels were assessed by comparing natural log-transformed PK parameters (Cmax, AUC[0–inf]). Estimates of geometric least squares means and geometric mean ratios with the corresponding 90% CI (confidence interval) were performed by statistical tests in the bioequivalence wizard tool in Win-Nonlin Professional, Version 5.2 (Pharsight Corporation).
Shen Z., Gillen M., Tieu K., Nguyen M., Harmon E., Wilson D.M., Kerr B, & Lee C.A. (2016). Supratherapeutic dose evaluation and effect of lesinurad on cardiac repolarization: a thorough QT/QTc study. Drug Design, Development and Therapy, 10, 3509-3517.
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2

Noncompartmental Pharmacokinetic Analysis

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Example 5

The plasma concentration vs. time data obtained using the MS were modeled by fitting data to a non-compartmental model with extravascular output (WinNonlin Professional, version 4.0, Pharsight Corporation, Mountain View, Calif.) to obtain pharmacokinetic parameters like area under the curve (AUC), maximum plasma concentration (Cmax) and time to maximum plasma concentration (Tmax).

US10022366B2. Extending and maintaining micropore viability of microneedle treated skin with lipid biosynthesis inhibitors for sustained drug delivery (2018-07-17). None [US], None [US]. Inventors: Audra L. Stinchcomb [US], Priyanka Ghosh [US].
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3

Pharmacokinetic Analysis of Sotatercept

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No formal sample size calculations were performed and no formal hypothesis testing was planned. The study was not designed for inferential analysis. Any patterns should be considered as numerical rather than as stochastically demonstrated patterns. The data were analysed using Dunnett's comparisons of the sotatercept-treated dose groups to the placebo control group. Non-parametric inferential analyses were not done for the P-values. Summary tables are presented by visit and treatment group, as appropriate. Descriptive statistics were used to summarize continuous variables and frequency distributions were used to summarize categorical variables.
All pharmacokinetic analyses were performed using standard techniques as implemented in WinNonlin® Professional, version 5.0.1 (Pharsight Corporation, Mountain View, CA, USA). Estimates of pharmacokinetic parameters were obtained using either a one-compartment model with first-order absorption and elimination (Ka, CL/F, V/F, K10, and t½), or a non-compartmental model (t½, z).
Abdulkadyrov K.M., Salogub G.N., Khuazheva N.K., Sherman M.L., Laadem A., Barger R., Knight R., Srinivasan S, & Terpos E. (2014). Sotatercept in patients with osteolytic lesions of multiple myeloma. British Journal of Haematology, 165(6), 814-823.
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4

Noncompartmental Pharmacokinetic Analysis

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Non-compartmental PK parameters were derived from each individual plasma MPA concentration–time profile using WinNonlin Professional (v.5.2) software (Pharsight Corporation, Mountain View, CA, United States). The corresponding AUC0–12h were calculated by the linear-trapezoidal rule. Cmax was defined as the maximum daytime MPA concentration after dosing with MPA within the dosing interval. Tmax was defined as the time to reach the maximum daytime MPA concentration. MRT was defined as mean residence time. t1/2 was defined as the time required for the highest concentration of the drug in plasma to decrease by half. CL/F was defined as the plasma volume of the drug removed per hour.
Xiang H., Zhou H., Zhang J., Sun Y., Wang Y., Han Y, & Cai J. (2021). Limited Sampling Strategy for Estimation of Mycophenolic Acid Exposure in Adult Chinese Heart Transplant Recipients. Frontiers in Pharmacology, 12, 652333.
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5

Pharmacokinetics and Pharmacodynamics of IdeS

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Each subject underwent serial PK sampling for 3 weeks after IdeS infusion. Serum concentrations of IdeS were determined with a validated electrochemiluminescence immunoassay where IdeS was captured by a coated hen anti‐IdeS antibody. Bound IdeS was detected by using a biotinylated rabbit anti‐IdeS antibody followed by streptavidin‐Sulfo (assay range 100 ng/mL‐3000 ng/mL). All serum samples were diluted in dissociation buffer before analysis to avoid interactions between IdeS and anti‐IdeS antibodies.
PK evaluations were performed by using WinNonlin Professional (Pharsight Corporation, St Louis, MO).
Each subject underwent serial sampling for pharmacodynamics (PD) during the study period. PD was analyzed with the use of a validated quantitative ELISA measuring serum IgG captured on the F(ab')2 part and detected on the Fc part of the IgG molecule.18
Lorant T., Bengtsson M., Eich T., Eriksson B., Winstedt L., Järnum S., Stenberg Y., Robertson A., Mosén K., Björck L., Bäckman L., Larsson E., Wood K., Tufveson G, & Kjellman C. (2018). Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti‐HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. American Journal of Transplantation, 18(11), 2752-2762.
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6

Pharmacokinetics of Dalantercept in Patients

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Serum samples for determination of pharmacokinetic parameters were collected predose in cycles 1 through 3, on day 8 during the first 2 cycles, and on day 15 of the first cycle. Serum dalantercept concentrations were determined by enzyme-linked immunosorbent assay, and pharmacokinetic parameters were estimated by noncompartmental analysis of dalantercept concentration data, using actual collection times, with WinNonlin Professional (Pharsight, Mountain View, Calif). Concentrations that were below the limit of quantification were set to 0 for noncompartmental analysis.
Jimeno A., Posner M.R., Wirth L.J., Saba N.F., Cohen R.B., Popa E.C., Argiris A., Grossmann K.F., Sukari A., Wilson D., Zhang X., Sun J., Glasser C., Attie K.M., Sherman M.L., Pandya S.S, & Weiss J. (2016). A Phase 2 Study of Dalantercept, an Activin Receptor-Like Kinase-1 Ligand Trap, in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. Cancer, 122(23), 3641-3649.
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7

Pomalidomide Pharmacokinetics and Dosage

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Patients eligible for efficacy evaluation included patients who received one or more doses of study drug and had a baseline and one or more postbaseline efficacy assessments. All patients who received one or more doses of pomalidomide and had evaluable PK data were included in the PK population. The PK parameters were calculated from pomalidomide plasma concentration–time data using non‐compartmental methods. Pomalidomide plasma concentrations and PK parameters were summarized by treatment and study days using descriptive statistics. The mean (± SD) and individual plots of plasma concentrations vs time were determined in both linear scale and semilogarithmic scales. Dose proportionality was explored for single dose and multiple doses separately by visual inspection of data as well as by the statistical model. Software used for PK data analysis and presentation included WinNonlin Professional, version 5.2 (Pharsight Corporation, Mountain View, CA, USA) and SAS, version 9.1.3 (SAS Institute, Inc., Cary, NC, USA).
Matsue K., Iwasaki H., Chou T., Tobinai K., Sunami K., Ogawa Y., Kurihara M., Midorikawa S., Zaki M., Doerr T, & Iida S. (2015). Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. Cancer Science, 106(11), 1561-1567.
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8

Pharmacokinetic Analysis of Formulations

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Pharmacokinetic analyses were performed using WinNonlin Professional version 6.4 (Pharsight Corp.) software. The linear trapezoidal rule was used to calculate the AUC0–last. In addition, the elimination rate constant (kel) determined from the terminal slope by log-linear regression, T1/2, and AUC0–∞ calculated as the addition of AUC0–last and Clast/kel, were determined for the analysis.
The one-way analysis of variance (ANOVA) for parallel design was used to assess the effect of formulations on the raw (untransformed) and logarithmically transformed data of AUC0–∞, Tmax and Cmax according VICH GL52 (Bioequivalence, August 2015) (10 ). In the case of Tmax, non-parametric tests based on Wilcoxon’s signed rank test were preferred (13 (link)). Parametric 90% confidence intervals based on the ANOVA of the mean Test/Reference ratios of AUC0–∞, and Cmax were computed under the assumption of multiplicative model using log-transformed data. Confidence intervals were determined by the method of Westlake (14 (link)).
Mestorino N., Marchetti M.L., Lucas M.F., Modamio P., Zeinsteger P., Fernández Lastra C., Segarra I, & Mariño E.L. (2016). Bioequivalence Study of Two Long-Acting Formulations of Oxytetracycline Following Intramuscular Administration in Bovines. Frontiers in Veterinary Science, 3, 50.
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9

Rivaroxaban vs Apixaban Pharmacokinetics

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Data from 12 subjects were expected to provide ≥90% probability that the lower limit of the 90% confidence interval (CI) for the geometric mean ratio of Cmax/Cmin values (rivaroxaban/apixaban) would be >1. An additional two subjects were enrolled to allow for early withdrawals. This estimate was based on the assumptions that the expected Cmax/Cmin ratio was ≥30% greater for rivaroxaban than apixaban,11 (link),12 (link) Cmax/Cmin would be log-normally distributed, and intersubject standard deviation would not be greater than 0.22.13 (link)
Mean and individual steady-state concentration–time and AXA–time profiles were plotted for both apixaban and rivaroxaban. Scatter plots of AXA versus plasma concentration were plotted for both compounds and analyzed by linear regression. Individual PK and PD parameters were estimated using noncompartmental methods with WinNonlin® Professional (v5.0.1; Pharsight Corporation, Sunnyvale, CA, USA). Terminal elimination rate constants were estimated using the WinNonlin algorithm and AUC parameters were calculated using the log-linear trapezoidal rule (WinNonlin Method 1). Actual sampling times were used for all parameter calculations. Descriptive statistics for PK and PD parameters were tabulated.
Frost C., Song Y., Barrett Y.C., Wang J., Pursley J., Boyd R.A, & LaCreta F. (2014). A randomized direct comparison of the pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban. Clinical Pharmacology : Advances and Applications, 6, 179-187.
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10

Intravenous Pharmacokinetics of Insulin Analogues in Rats

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Example 5

Intravenous Rat PK

Anaesthetized rats are dosed intravenously (i.v.) with insulin analogues at various doses and plasma concentrations of the test compound is measured using immunoassays or mass spectrometry at specified intervals for 4 hours or more post-dose. Pharmacokinetic parameters are subsequently calculated using WinNonLin Professional (Pharsight Inc., Mountain View, Calif., USA).

Non-fasted male Wistar rats (Taconic) weighing approximately 200 gram are used. Body weight is measured and rats are subsequently anaesthetized with Hypnorm/Dormicum (each compound is separately diluted 1:1 in sterile water and then mixed; prepared freshly on the experimental day). Anaesthesia is initiated by 2 mL/kg Hypnorm/Doricum mixture sc followed by two maintenance doses of 1 mL/kg sc at 30 minutes intervals, and two maintenance doses of 1 mL/kg sc with 45 minutes intervals. If required in order to keep the rats lightly anaesthetised throughout a further dose(s) 1-2 mL/kg sc is supplied. Weighing and initial anaesthesia is performed in the rat holding room in order to avoid stressing the animals by moving them from one room to another.

TABLE 4
Rat PK
TestRat PK i.v. MRT
compound(h)
Compound 124.5

US09896496B2. Derivative of an insulin analogue (2018-02-20). Novo Nordisk A/S [DK]. Inventors: Peter Madsen [DK], Tina Moeller Tagmose [DK], Helle Naver [DK], Thomas Boerglum Kjeldsen [DK].
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