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Winnonlin 7

Manufactured by Certara
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WinNonlin 7.0 is a software tool for pharmacokinetic and pharmacodynamic analysis. It provides a comprehensive set of tools for the analysis and modeling of drug concentration and response data.

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3 protocols using winnonlin 7

1

Multicomponent Pharmacokinetic Analysis

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The pharmacokinetic (PK) parameters of the total ezetimibe, free ezetimibe, rosuvastatin, telmisartan, and amlodipine were calculated via the noncompartmental method using WinNonlin 7.0 (Certara USA, Princeton, New Jersey). The primary PK parameters included the maximum plasma concentration at steady state (C max,ss ) and the area under the time-concentration curve within a dosing interval at steady state (AUC tau,ss ) of each component. The AUC tau,ss was calculated using the linear trapezoidal method for the ascending concentrations and the log trapezoidal method for the descending concentrations. The time to achieve C max (T max,ss ), t 1/2 at steady state (t 1/2,ss ), apparent clearance at steady state (CL ss /F), and apparent volume of distribution at steady state (V d,ss /F) were also evaluated.
Ryu H., Kim H.C., Jeon I., Jang I.J., Cho J.Y., Kim K.T, & Oh J. (2024). Pharmacokinetic Interactions Between the Fixed-Dose Combination of Ezetimibe/Rosuvastatin 10/20 Mg and the Fixed-Dose Combination of Telmisartan/Amlodipine 80/5 Mg in Healthy Subjects. Drug design, development and therapy, 18.
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2

Pharmacokinetics of Forsythin and Metabolites

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The PK parameters were calculated with WinNonlin 7.0 (Certara, Princeton, NJ, USA) using noncompartmental analysis. As the PK parameters of the SAD study were previously reported, calculations of PK parameters for the MAD study and the food effect study were conducted in this report. In the MAD study, PK parameters of forsythin and its main metabolites M2 and M7, including Cmax, Tmax, AUC0–t, AUC0–∞, T1/2, CL/F, VZ/F, Cmin,ss, Cavg,ss, AUCss, drug fluctuation coefficient (DF) and accumulation ratio (Racc) were estimated. The Racc at steady-state after multiple doses was calculated as follows: (AUC0–8 or Cmax on day 5)/(AUC0–8 or Cmax on day 1). Steady-state status was determined by visual inspection of trough concentrations (Cτ) on days 3, 4 and 5.
Li C., Wu M., Zhang H., Zhu X., Fu L., Wang S., Lu M., Zhong D, & Ding Y. (2023). Safety, tolerability and pharmacokinetics of forsythin in healthy subjects: a double-blinded, placebo-controlled single-dose and multiple-dose escalation and food effect study. Annals of Medicine, 55(2), 2274512.
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3

Pharmacokinetics of Antibody-Drug Conjugate

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Serum samples to assess pharmacokinetics (PK) were required for the first six evaluable patients < 15 years. Samples were obtained before treatment; at the end of infusion; at 1, 2, 4, 8, and 24 hours post-infusion on day 1; and 4, 7, and 21 days postinfusion. GV was quantitated in total antibody (TA) and antibody-drug conjugate (ADC) using enzyme-linked immunosorbent assays (ELISA). Free MMAE was quantified using liquid chromatography/mass spectrometry. All assays were described previously by Ott et al. [10 (link)].
Noncompartmental analysis was performed with WinNonlin 7.0 (Certara USA, Inc.) using nominal dosing for ADC and TA (1.9 mg/kg), total MMAE per dose was based on molar coupling ratio in drug product, and respective molecular weights of GV (150 kD) and auristatin E (718 Da). Infusion models were used for TA and ADC and an extravascular model was used for free MMAE. Exposure (Cmax, AUC0–3w) was determined for ADC and TA by linear trapezoidal approximation. Terminal elimination half-life was determined by least squares fitting of experimental concentrations in the terminal phase for TA and ADC analytes, as well as for free MMAE.
Kopp L.M., Malempati S., Krailo M., Gao Y., Buxton A., Weigel B.J., Hawthorne T., Crowley E., Moscow J.A., Reid J.M., Villalobos V., Randall R.L., Gorlick R, & Janeway K.A. (2019). Phase 2 Trial of the GPNMB-Targeted Antibody-Drug Conjugate, Glembatumumab Vedotin (CDX-011) in Recurrent Osteosarcoma AOST1521: A Report from the Children’s Oncology Group (COG). European journal of cancer (Oxford, England : 1990), 121, 177-183.
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