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Winnonlin professional version 5

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WinNonlin Professional Version 5.2 is a software application for pharmacokinetic and pharmacodynamic data analysis. It provides tools for modeling and simulating drug concentration and effect data.

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Sas software, by SAS Institute (2 mentions)

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WinNonlin Professional Software Version 5.2.1 WinNonlin® Professional version WinNonlin Version 5.3 WinNonlin Professional WinNonlin 5.2 WinNonlin

9 protocols using winnonlin professional version 5

1

Pharmacokinetic Analysis of Ewha-18278 in Rats

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WinNonlin® Professional version 5.2 software (Pharsight Corporation, Mountain View, CA, USA) was used to estimate the PK parameters following intravenous or oral administration of Ewha-18278 to rats. Non-compartmental analysis was performed using the plasma Ewha-18278 concentration-time profiles to obtain the following PK parameters: initial plasma concentration (C0), area under the plasma concentration-time curve from zero time to infinity (AUCinf), elimination half-life (t1/2), apparent volume of distribution (Vd), total clearance (Clt), apparent volume of distribution following oral administration (Vd/F), and oral clearance (Clt/F). The maximum plasma concentration (Cmax) and the time required to reach Cmax (Tmax) were directly measured from the plasma Ewha-18278 concentration-time curve. The absolute BA (F, %) of Ewha-18278 was calculated by using the equation:
Lee S.G., Lee J., Kim K.M., Lee K.I., Bae Y.S, & Lee H.J. (2019). Pharmacokinetic Study of NADPH Oxidase Inhibitor Ewha-18278, a Pyrazole Derivative. Pharmaceutics, 11(9), 482.
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2

Pharmacokinetics of J2 and NA49 in Rats

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J2 and NA49 were dissolved in 10% DMAc and 10% Tween® 80 solution in saline to a concentration of 2.5 mg/mL for pharmacokinetic studies. The common carotid artery of the rat was catheterized under anesthesia using isoflurane the day before administration of J2 and NA49 [27 (link)]. Rats were divided into four groups. J2 and NA49 were administered to rats by intravenous (IV) injection at doses of 2 mg/kg and 10 mg/kg, respectively. Blood samples (0.2~0.25 mL) were collected at 0, 0.033, 0.083, 0.167, 0.33, 0.67, 1, 2, 3, 5, 7, 9, and 24 h following IV administration. The plasma samples obtained after centrifugation of the blood samples were stored at −20°C until HPLC analysis. The following pharmacokinetic parameters of J2 and NA49 were estimated by non-compartmental analysis using WinNonlin® Professional version 5.2 software (Pharsight Corporation, Mountain View, CA, USA): Initial drug concentration (C0), area under the plasma concentration–time curve from 0 h to the final sampling time point (AUC0-last), elimination half-life (t1/2), apparent volume of distribution (Vd), and total clearance (Cl).
Yoo H., Choi S.K., Lee J., Park S.H., Park Y.N., Hwang S.Y., Shin J.H., Na Y., Kwon Y., Lee H.J, & Lee Y.S. (2021). Drug-Like Small Molecule HSP27 Functional Inhibitor Sensitizes Lung Cancer Cells to Gefitinib or Cisplatin by Inducing Altered Cross-Linked Hsp27 Dimers. Pharmaceutics, 13(5), 630.
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3

Pharmacokinetics and Pharmacodynamics of Verinurad

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PK and PD were assessed as described previously.18 PK parameters were derived using WinNonlin Professional, version 5.2 (Pharsight Corporation, Mountain View, CA, USA) and noncompartmental analysis. Plasma PK parameters included maximum observed plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration–time curve (AUC) from 0–24 hours (AUC0–24) or from zero to infinity (AUC0–∞), and terminal half-life (t1/2). Urinary PK parameters included fraction of the verinurad dose (% dose) excreted unchanged in urine from time 0–24 hours post-dose (fe0–24) and renal clearance of verinurad (CLR0–24). The latter was calculated as the amount of verinurad excreted unchanged in urine from time 0–24 hours postdose divided by the verinurad plasma AUC0–24.
PD parameters were calculated using SAS® software (SAS Institute Inc., Cary, NC, USA). The maximum percent change from baseline and the time of the maximum percent change in sUA were obtained directly from the concentration versus time data. Renal clearance of uric acid (CLUR0–24) was obtained by dividing the amount of uric acid in urine (AeUR) by the plasma urate AUC from time 0–24 hours postdose. Fractional excretion of uric acid (FEUA0–24) was calculated as CLUR0–24 divided by creatinine clearance × 100.
Hall J., Gillen M., Liu S., Miner J.N., Valdez S., Shen Z, & Lee C. (2018). Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy Japanese and non-Asian male subjects. Drug Design, Development and Therapy, 12, 1799-1807.
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4

Pharmacokinetics of Lesinurad Assessed

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Pharmacokinetic parameters for lesinurad were calculated using noncompartmental analysis. Plasma pharmacokinetic parameters included maximum observed plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration–time curve (AUC) from zero to infinity (AUC[0–inf]) and from zero to 24 hours (AUC[0–24h]), and half-life (t1/2). Cmax and Tmax were obtained from experimental observations. AUC was calculated using the linear trapezoidal rule. The apparent oral clearance (CL/F) was also determined. Urinary pharmacokinetic parameters included the amount of lesinurad excreted unchanged in urine over a time interval (Ae), the fraction of the lesinurad dose (% dose) excreted unchanged in urine following dosing (fe), and the renal clearance of lesinurad (CLR). Ae was calculated as concentration measured × volume, while CLR was calculated as Ae divided by plasma AUC over the same time interval. Pharmacokinetic parameters were derived using WinNonlin Professional, version 5.2 (Pharsight Corporation, St Louis, MO, USA).
Shen Z., Rowlings C., Kerr B., Hingorani V., Manhard K., Quart B., Yeh L.T, & Storgard C. (2015). Pharmacokinetics, pharmacodynamics, and safety of lesinurad, a selective uric acid reabsorption inhibitor, in healthy adult males. Drug Design, Development and Therapy, 9, 3423-3434.
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5

Pharmacokinetic Analysis of PRT062607

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Pharmacokinetic calculations based on PRT062607 plasma concentrations were performed by Quintiles Inc (Durham, North Carolina) using noncompartmental analysis and appropriate models (Model 200 extravascular administration) in WinNonlin Professional Version 5.2 (Pharsight Corporation, Mountain View, California). Individual plasma concentration data from each subject and the exact time points for blood sampling were used throughout the analysis. Pharmacokinetic parameters calculated from plasma PRT062607 concentrations included, but were not limited to, maximum plasma concentration (Cmax), time of maximum concentration (tmax), area under the plasma concentration‐time curve from time 0 to time of last measurable concentration (AUClast), area under the plasma concentration‐time curve from time 0 extrapolated to infinity (AUC0‐∞), apparent terminal rate constant (λz), and apparent terminal half‐life (t1/2). Dose‐normalized values for Cmax and AUClast were calculated and captured as Cmax/D and AUC/D, respectively. From urine data, cumulative amount excreted from time 0 to 96 hours postdose (Ae0‐96) and cumulative fraction of dose excreted unchanged in the urine from time 0 to 96 hours postdose (fe0‐96) were also determined.
Coffey G., Rani A., Betz A., Pak Y., Haberstock‐Debic H., Pandey A., Hollenbach S., Gretler D.D., Mant T., Jurcevic S, & Sinha U. (2016). PRT062607 Achieves Complete Inhibition of the Spleen Tyrosine Kinase at Tolerated Exposures Following Oral Dosing in Healthy Volunteers. Journal of Clinical Pharmacology, 57(2), 194-210.
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6

Pharmacokinetics of MEDI-573 and IGF-I/II

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Blood samples were collected immediately before and following MEDI-573 infusions (all cycles), as well as 2 and 6 hours postinfusion (0.5, 1.5, 5.0, 10.0, and 15.0 mg/kg and dose-expansion cohorts only) on day 1 of cycle 1. Additional samples were collected 24 and 48 hours (±2 hours) following the first infusion of cycle 1, and pre- and post-infusion (±5 minutes) for each subsequent treatment. Samples for evaluation of anti–MEDI-573 antibodies were collected at screening and before each infusion. Free MEDI-573 in serum was quantitated using a validated electrochemiluminescence assay in which unlabeled and ruthenium-labeled mouse anti-idiotype monoclonal antibodies were used as the capture and detection reagents, respectively. The PK parameters, including Cmax, Tmax, and AUC, were determined using PK data after the first dose only using a noncompartmental approach with WinNonlin Professional version 5.2 (Pharsight Corp.). Plasma concentrations of free IGFI and IGFII were measured using an electrochemiluminescence assay in which biotinylated MEDI-573 was used as the capture reagent and a ruthenium-labeled polyclonal antibody was used as the detection reagent. The OBD was defined as the dose at which all circulating free IGFI and IGFII ligands was sequestered by MEDI-573.
Haluska P., Menefee M., Plimack E.R., Rosenberg J., Northfelt D., LaVallee T., Shi L., Yu X.Q., Burke P., Huang J., Viner J., McDevitt J, & LoRusso P. (2014). Phase I Dose-Escalation Study of MEDI-573, a Bispecific, Antiligand Monoclonal Antibody against IGFI and IGFII, in Patients with Advanced Solid Tumors. Clinical cancer research : an official journal of the American Association for Cancer Research, 20(18), 4747-4757.
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7

Moxifloxacin Pharmacokinetics in Healthy Adults

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On Day 3 (all groups) and Day 4 (Groups 3 and 6), blood samples for the measurement of study drug concentrations were taken pre-dose, hourly up to 13 h, and 24 h post-dose. Only samples taken on Day 4 were analyzed for moxifloxacin in Group 3 and Group 6. Blood samples from Day 3 were taken to maintain blinded conditions relative to Groups 1, 4, and 5. Plasma concentrations were determined by validated reverse-phase liquid chromatography with tandem mass spectrometric detection methods. Pharmacokinetic parameters were derived from the time-concentration data by standard non-compartmental analysis using WinNonlin Professional Version 5.2 (Pharsight Corporation, Mountain View, CA, USA).
Funck-Brentano C., Bacchieri A., Valentini G., Pace S., Tommasini S., Voiriot P., Ubben D., Duparc S., Evene E., Felices M, & Corsi M. (2019). Effects of Dihydroartemisinin-Piperaquine Phosphate and Artemether-Lumefantrine on QTc Interval Prolongation. Scientific Reports, 9, 777.
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8

Pharmacokinetic Analysis of Edoxaban

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Plasma concentration data for edoxaban and its metabolites were analysed by noncompartmental methods using WinNonlin Professional Version 5.2 (Pharsight Corp., Mountain View, CA, USA). Key parameters included the maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration–time curve from time zero extrapolated to infinity (AUC∞) calculated using the log-linear trapezoidal method, and apparent terminal half-life (t½). Apparent total body clearance (CL/F) was calculated for edoxaban only. Pharmacokinetic parameters were estimated using actual sampling time points. Biomarker data for PT and aPTT were analysed using SAS® Version 9.1.3 (Cary, NC, USA).
Mendell J., Chen S., He L., Desai M, & Parasramupria D.A. (2015). The Effect of Rifampin on the Pharmacokinetics of Edoxaban in Healthy Adults. Clinical Drug Investigation, 35(7), 447-453.
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9

Evaluating Bremelanotide Efficacy and Safety

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Efficacy in Study B was evaluated in the intent‐to‐treat population, which included all randomized subjects who received ≥1 dose of the study drug and who had sufficient data for meaningful analysis. To be considered for analysis, data must be evaluable within the indicated timeframe or will be inspected on a case‐by‐case basis to determine if inclusion standards are met. A linear MMRM was used to evaluate differences in caloric intake between treatments, and an analysis of covariance model was used to evaluate differences in weight change from baseline between each treatment. For daily caloric intake, no correction for multiplicity was made. For both analyses, p‐values corresponding to two‐sided tests were presented. Pharmacokinetic parameters were evaluated in the pharmacokinetic population, which included all subjects who had received bremelanotide and had sufficient concentration data to allow for calculation of the specified parameters. Pharmacokinetic parameters were calculated using WinNonlin® Professional version 5.2 (Pharsight Corp, Mountain View, CA, USA) by non‐compartmental methods. Safety was evaluated in all randomized subjects who received ≥1 dose of the study drug. No adjustments were made to compensate for missing data.
Spana C., Jordan R, & Fischkoff S. (2022). Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes, Obesity & Metabolism, 24(6), 1084-1093.
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