Winnonlin professional software

Manufactured by Pharsight

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WinNonlin Professional is a software application used for the analysis of pharmacokinetic and pharmacodynamic data. It provides tools for data visualization, model fitting, and reporting.

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WinNonlin professional software version 8.0 WinNonlin Professional Software Version 5.2.1 WinNonlin professional software version 6.3 WinNonlin Professional WinNonlin software WinNonlin

10 protocols using winnonlin professional software

Quantification of GSK744 in Plasma and Tissues

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Whole blood was collected using K2EDTA tubes, centrifuged to obtain plasma and stored at −80°C until analysis. Tissues were rinsed in saline (unless indicated), blotted dry, weighed, snap frozen and stored at −80°C until analysis. GSK744 concentrations were monitored by HPLC-MS/MS following protein precipitation with acetonitrile containing [¹³C¹⁵N²H₂] GSK744 as an internal standard as previously described (11 ). The calibration range for GSK744 was 10 to 10,000 ng/mL for plasma or 2.5 to 1000 ng/mL for tissues. PK analyses were performed using WinNonlin Professional software (version 5.2; Pharsight Corp, Mountain View, CA) as previously described (11 ).

Andrews C.D., Yueh Y.L., Spreen W.R., St. Bernard L., Boente-Carrera M., Rodriguez K., Gettie A., Russell-Lodrigue K., Blanchard J., Ford S., Mohri H., Cheng-Mayer C., Hong Z., Ho D.D, & Markowitz M. (2015). A Long-Acting Integrase Inhibitor Protects Female Macaques from Repeated High-Dose Intravaginal SHIV Challenge. Science translational medicine, 7(270), 270ra4.

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Pharmacokinetic Analysis of Methylxanthines

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PK parameters were calculated using WinNonlin® Professional software, version 2.1 (Pharsight, Mountain View, CA). Non-compartmental analysis for IV bolus input (Model 201) and extravascular input (Model 200) were employed to estimate the PK parameters of caffeine, paraxanthine, theophylline and theobromine. Bioavailability (F) value is calculated by plugin the corresponding average AUC values from the same hour group and using the equation below:

F = \frac{AUCinf (Oral)}{AUCinf (IV)} \times \frac{Dose (IV)}{Dose (Oral)}

Estari R.K., Dong J., Chan W.K., Park M.S, & Zhou Z. (2021). Time effect of rutaecarpine on caffeine pharmacokinetics in rats. Biochemistry and Biophysics Reports, 28, 101121.

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Everolimus Pharmacokinetics Analysis Protocol

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Peripheral blood samples for everolimus PK analysis were collected into potassium-ethylene-diamine tetraacetic-acid (EDTA) tubes on days 1, 8 and 21 at 30 minutes before, and 1, 2, 5, 8 and 24 hours following, ingestion of everolimus. Samples were initially stored at 2–8°F during PK collection and subsequently stored within 60 minutes of collection in a −20°F refrigerator, after which all samples were analyzed in a single batch. Following high throughput liquid/liquid extraction, everolimus concentration was measured by a previously validated liquid chromatography (LC)/mass spectrometry (MS) method.(23 (link)) The lower limit of quantification was 0.3 ng/mL. Standard non-compartmental analysis of everolimus was performed using WinNonlin Professional software version 5.2 (Pharsight Corporation, St. Louis, Mo) according to the rule of linear trapezoids. Parameters (C_max, t_max, AUC) were determined and steady state PK measures on Days 8 and 21 were compared to those on Day 1.

Owonikoko T.K., Ramalingam S.S., Miller D.L., Force S.D., Sica G.L., Mendel J., Chen Z., Rogatko A., Tighiouart M., Harvey R.D., Kim S., Saba N.F., Pickens A., Behera M., Fu R.W., Rossi M.R., Auffermann W.F., Torres W.E., Bechara R., Deng X., Sun S.Y., Fu H., Gal A.A, & Khuri F.R. (2015). A translational, pharmacodynamic and pharmacokinetic phase IB clinical study of everolimus in resectable non-small cell lung cancer. Clinical cancer research : an official journal of the American Association for Cancer Research, 21(8), 1859-1868.

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Pharmacokinetics of Recombinant Human Antithrombin

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Male Kbs:NZW rabbits (1.5–2.0 kg; Kitayama Labes Co., Ltd., Nagano, Japan) were used for the AT clearance study. The rabbits were injected with 2.0 mg/kg body weight of the purified rhATs via the auricular ear vein. Blood samples were withdrawn from the auricular vein of the opposite ear, and were drawn into 1/10 volume of 3.8% (w/v) sodium citrate. The concentrations of the rhATs were determined by a human AT-specific ELISA using a mouse anti-human AT antibody (US Biological, Swampscott, MA) and a sheep anti-human AT peroxidase-conjugated antibody (Affinity Biologicals). The pharmacokinetic parameters were obtained by a two-compartment analysis program using the WinNonlin Professional software (version 4.1; Pharsight, Mountain View, CA). All animals were maintained at 20–24°C under a 12-h light/dark cycle and were maintained in compliance with the guidelines formulated by the Japanese Pharmacological Society. The protocol was approved by the Bioethical Committee of the Pharmaceutical Research Center, Kyowa Hakko Kirin Co., Ltd. (protocol number: 08-265).

Yamada T., Kanda Y., Takayama M., Hashimoto A., Sugihara T., Satoh-Kubota A., Suzuki-Takanami E., Yano K., Iida S, & Satoh M. (2016). Comparison of biological activities of human antithrombins with high-mannose or complex-type nonfucosylated N-linked oligosaccharides. Glycobiology, 26(5), 482-492.

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Pharmacokinetics of CIGB-300 in Humans

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Blood samples were drawn by venipuncture immediately, 5, 15, 30 min and 1, 2, 4, 8, 12 and 24 h after the first CIGB-300 administration. Subsequently, plasma from each sample was obtained and CIGB-300 was quantified by an in-house validated immune competition-based enzyme immunoassay (EIA). Drug disposition analysis was performed individually by a non-compartmental method with a combined linear/log–linear trapezoidal rule approach. All the pharmacokinetic parameters were determined by using the WinNonlin professional software (version 5.1, Pharsight Inc., 2005, Princetone, NJ, USA).

Sarduy M.R., García I., Coca M.A., Perera A., Torres L.A., Valenzuela C.M., Baladrón I., Solares M., Reyes V., Hernández I., Perera Y., Martínez Y.M., Molina L., González Y.M., Ancízar J.A., Prats A., González L., Casacó C.A., Acevedo B.E., López-Saura P.A., Alonso D.F., Gómez R, & Perea-Rodríguez S.E. (2015). Optimizing CIGB-300 intralesional delivery in locally advanced cervical cancer. British Journal of Cancer, 112(10), 1636-1643.

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Pharmacokinetic Simulation Analysis of Warfarin

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In the corresponding PK data analyses, datasets of every individual patient were used (Suppl. material, Tables S2). One advantage of PK simulations is that it no longer depends on measurement of S-warfarin concentrations; this increases its applicability given that data relating to warfarin plasma levels are rarely available [6 (link)]. A PK simulation analysis of each individual dataset was performed by one-compartmental analysis using a modified Levenberg-Marquardt algorithm. A time zero value was considered for extrapolation purposes. Parameters were computed with their corresponding variance estimates and extrapolated to infinity (i.e. model-predicted). Computing these parameters based on the last observed level was discouraged in order to avoid larger estimation errors. Time to peak values were also determined as the time in which the maximum level was observed (i.e. maximum plasma concentration) considering the entire curve; and peak level was that corresponding to the above mentioned time to peak value. The maximum concentration to area under the curve ratio (Cmax/AUC) was also computed as an indicator of the extent of bioavailability. For all these purposes the WinNonlin® professional software (Version 6.3, Pharsight, Inc. / Certara, 2014, NC, USA) was used.

Reyes-González S., de las Barreras C., Reynaldo G., Rodríguez-Vera L., Vlaar C., Lopez Mejias V., Monbaliu J.C., Stelzer T., Mangas V, & Duconge J. (2020). Genotype-Driven Pharmacokinetic Simulations of Warfarin Levels in Puerto Ricans. Drug metabolism and personalized therapy.

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Pharmacokinetic Analysis of Drug Bioavailability

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We calculated pharmacokinetic parameters employing a non-compartmental analysis with WinNonLin Professional Software (version 8.3, Pharsight Corporation, California, USA).
The primary variables for assessing bioavailability were defined as follows [18 –20 ]:

AUC_0-t Area under the time versus drug concentration curve from 0 to the last observation calculated according to the linear trapezoidal rule.

AUC_0-inf Area under the time versus drug concentration curve from 0 to infinity.

C_max Observed maximum plasma drug concentration.

We calculated the AUC_0–t following the trapezoidal rule. The terminal rate constant (ke) was calculated by linear regression of the log-linear part of the concentration–time curve. The AUC between t and infinity was estimated as Ct/ke (AUC_t-inf). The AUC between 0 and ∞ was calculated as AUC_0-t + AUC_t-inf (AUC_0-inf). We determined half-life (t_½) was calculated as −ln 2/ke. The remaining pharmacokinetic parameters were directly obtained from the concentration–time curves: maximum concentration (C_max) and time to reach C_max (t_max).
For bioavailability assessment, the confidence interval (CI) of 90% for the corresponding mean ratios (test over reference) must be within the predefined bioavailability acceptance range of 80.00–125.00%. According to EMA guidelines, a statistical evaluation of t_max is not required [19 ].

Román Martinez M., García Aguilar E., Martin Vílchez S., González García J., Luquero-Bueno S., Camargo-Mamani P., Mejia-Abril G., García-Castro L., de Miguel-Cáceres A., Saz-Leal P., Abad-Santos F., Nieto Magro C, & Ochoa Mazarro D. (2022). Bioavailability of Oniria®, a Melatonin Prolonged-Release Formulation, Versus Immediate-Release Melatonin in Healthy Volunteers. Drugs in R&D, 22(3), 235-243.

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Plasma Pharmacokinetic Parameter Estimation

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The plasma pharmacokinetic parameters were estimated, which included the observed maximum plasma concentration C_max, the time to reach C_max, (T_max) and the area under the plasma concentration–time curve from 0 h to last measurable concentration (AUC_0-t) and 0 h to infinity (AUC_0-∞). C_max and T_max were directly determined from the serum concentration versus time curves. The area under the curve from 0 h to t (AUC_0-t) was calculated by the linear trapezoidal rule. The area under the curve from 0 h to infinity (AUC_0-∞) was estimated by summing the area from AUC_0-t and AUC_0-∞, where AUC_0-∞ = AUC_0-t + C_t / k_e, with ‘C_t’ defined as the last measured serum concentration at time t, and k_e is the elimination rate constant. The elimination rate constant k_e was estimated by the least squares regression of plasma concentration–time data points lying in the terminal region by using semilogarithmic dependence that corresponds to first-order kinetics. The half-life t_1/2 was calculated as 0.693/k_e. Pharmacokinetic analysis was performed by means of model independent method (Non-Compartmental Approach) WinNonlin Professional Software (Version 6.3, Pharsight Corporation, Cary, NC).

, & Abushammala I. (2014). The Effect of Pioglitazone on Pharmacokinetics of Carbamazepine in Healthy Rabbits. Saudi Pharmaceutical Journal : SPJ, 23(2), 177-181.

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Rucaparib Pharmacokinetic Analysis Protocol

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For the i.v. cohorts, plasma samples for PK analysis of rucaparib were taken during cycle 1 on D1 (pre-dose, end of infusion, 1–3 h post dose), D2 pre-dose, D4 (pre-dose, end of infusion, 1–3 h post dose), D5 pre-dose and D5 end of infusion (patients who dose escalated in the i.v. cohorts had samples taken in cycles 1 and 2). In the oral patients, PK samples were taken in cycles 1 and 2 at D1 (pre-dose, 30 min and1/1.5/2.5/4/6 h post dose), D2 pre-dose, D7 (pre-dose, 30 min and 1/1.5/2.5/4/6 h post dose), D8 pre-dose and D15 pre-dose for cohort 1. Cohort 2 (14-day dosing) D7 PKs were done on D14 and in cohort 3 (21 day dosing) and subsequent continuous dosing cohorts on D21. Analysis of rucaparib in plasma samples was performed according to a validated assay (NICR Standard Operating Procedure (SOP) 240) using LC/MS/MS. Rucaparib PK parameters were calculated by non-compartmental analysis with a linear/log-trapezoidal model for AUC using WinNonlin Professional software (Version 5.3, Pharsight, Mountain View, CA, USA).

Drew Y., Ledermann J., Hall G., Rea D., Glasspool R., Highley M., Jayson G., Sludden J., Murray J., Jamieson D., Halford S., Acton G., Backholer Z., Mangano R., Boddy A., Curtin N, & Plummer R. (2016). Phase 2 multicentre trial investigating intermittent and continuous dosing schedules of the poly(ADP-ribose) polymerase inhibitor rucaparib in germline BRCA mutation carriers with advanced ovarian and breast cancer. British Journal of Cancer, 114(7), 723-730.

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PK Simulation Analysis of Warfarin Levels

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In the corresponding PK data analyses, datasets of every individual patient were used (Supplementary Material, Tables S2). One advantage of PK simulations is that it no longer depends on measurement of S-warfarin concentrations; this increases its applicability given that data relating to warfarin plasma levels are rarely available [6] . A PK simulation analysis of each individual dataset was performed by onecompartmental analysis using a modified Levenberg-Marquardt algorithm. A time zero value was considered for extrapolation purposes. Parameters were computed with their corresponding variance estimates and extrapolated to infinity (i.e., model-predicted). Computing these parameters based on the last observed level was discouraged in order to avoid larger estimation errors. Time to peak values were also determined as the time in which the maximum level was observed (i.e., maximum plasma concentration) considering the entire curve; and peak level was that corresponding to the above mentioned time to peak value. The maximum concentration to area under the curve ratio (Cmax/AUC) was also computed as an indicator of the extent of bioavailability. For all these purposes the WinNonlin ® professional software (Version 6.3, Pharsight, Inc./Certara, 2014, NC, USA) was used.

Reyes-González S., de Las Barreras C., Reynaldo G., Rodríguez-Vera L., Vlaar C., Mejias V.L., Monbaliu J.M., Stelzer T., Mangas V, & Duconge J. (2020). Genotype-driven pharmacokinetic simulations of warfarin levels in Puerto Ricans. Drug metabolism and personalized therapy, 35(4).

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