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Phoenix winnonlin 7

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Phoenix WinNonlin 7.0 is a software tool used for pharmacokinetic and pharmacodynamic (PK/PD) data analysis. It provides a comprehensive suite of modeling and simulation capabilities to support drug development and research.

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Lab products found in correlation

Illustrator 2015, by Adobe (1 mentions) Phoenix winnonlin 7, by Phoenix Pharmaceuticals (1 mentions) Spss version 23, by IBM (1 mentions) Analyst 1, by Thermo Fisher Scientific (1 mentions)

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Phoenix WinNonlin version 7.0 Phoenix WinNonlin software Version 7.0 Phoenix WinNonlin WinNonlin 7.0 Phoenix® 7.0 WinNonlin

21 protocols using phoenix winnonlin 7

1

Pharmacokinetics of Sodium Oligomannate

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Fifty SD rats were randomly assigned to five groups consisting of equal numbers of male and female rats (n=10 in each group). The animals were fasted overnight prior to drug administration and until 4 h after administration. Rats from group 1 received an intravenous bolus injection of sodium oligomannate at a 2 mg/kg dosage. Serial blood samples (pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, and 24 h) were collected from the jugular vein into EDTA-K2 tubes. Rats from groups 2–4 received gavage doses of 100, 200, and 400 mg/kg. Serial blood samples (pre-dose, 0.167, 0.33, 0.5, 1, 2, 4, 6, 8, 10, and 24 h) were collected. For rats from group 5, multiple gavage doses of sodium oligomannate at 200 mg/kg/day were administered for 8 days before serial blood samplings (pre-dose on days 4, 5, 6, 7, and 8, and 0.167, 0.33, 0.5, 1, 2, 4, 6, 8, 10, and 24 h post-dose on day 8) were collected. Plasma was collected by centrifuging the blood at 3,000 g for 5 min and stored at −70 °C until analysis.
Pharmacokinetic parameters, including area under the plasma concentration versus time curve (AUC), plasma clearance (CLP), elimination half-life (t1/2), mean residence time (MRT), and volume of distribution (Vz), were calculated via a non-compartmental method using the Phoenix WinNonlin 7.0 software (Certara, Princeton, NJ, USA).
Lu J., Pan Q., Zhou J., Weng Y., Chen K., Shi L., Zhu G., Chen C., Li L., Geng M, & Zhang Z. (2021). Pharmacokinetics, distribution, and excretion of sodium oligomannate, a recently approved anti-Alzheimer's disease drug in China. Journal of Pharmaceutical Analysis, 12(1), 145-155.
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2

Pharmacokinetic Analysis of Compound X

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The pharmacokinetic parameters were estimated with the non-compartmental method, using Phoenix® WinNonlin® 7.0 software (Certara L.P.). kel – elimination rate constant; AUC0-t – area under the plasma concentration-time curve from zero to the time of the last measurable concentration; AUC0-∞ – area under the plasma concentration-time curve from zero to infinity; t0.5 – elimination half-life; Cl/F – clearance; Vd/F – volume of distribution; Cmax – maximum plasma concentration; tmax – time necessary to reach the maximum concentration; MRT0-t – mean residence time; AUMC0-t – area under the first moment curve.
Karbownik A., Szałek E., Sobańska K., Grabowski T., Klupczynska A., Plewa S., Wolc A., Magiera M., Porażka J., Kokot Z.J, & Grześkowiak E. (2018). The concomitant use of lapatinib and paracetamol - the risk of interaction. Investigational New Drugs, 36(5), 819-827.
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3

Pharmacokinetics of ISH0339 in Rats

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In the single-dose study, 36 Sprague–Dawley rats [Medicilon Preclinical Research (Shanghai) LLC] were assigned to six groups. Animals were administered with single dose of 25, 50, 100 and 300 mg/kg ISH0339 by IV bolus administration or 26.5 and 53.0 mg/kg ISH0339 by intranasal administration on day 1. Blood samples for pharmacokinetic analysis were collected before the intervention and at 0.083, 1, 4, 8, 24, 48, 96, 144, 216, 312, 480, 648 and 816 h post administration. Phoenix WinNonlin 7.0 software (Certara) for non-atrioventricular model was used for calculation of pharmacokinetic parameters, which automatically selects at least three elimination phases before the end elimination for half-life calculation.
Yang H., Chen Y., Jiang D., Feng X., Xu Y., Wei J., Zou Q., Yang Q., Chen J., Jiang X., Qin C., Huang Z., Wu C., Zhou Y., Li M, & Yin L. (2023). Preclinical evaluation of ISH0339, a tetravalent broadly neutralizing bispecific antibody against SARS-CoV-2 with long-term protection. Antibody Therapeutics, 6(2), 97-107.
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4

Mefloquine Pharmacokinetic Modeling

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Mefloquine concentrations were modeled using a standard two-compartment pharmacokinetic model with first-order absorption. Mean mefloquine concentrations and a mean dose of 2.04 mg were used for calculations. Primary parameters were the absorption rate constant ka, the apparent clearance after extravascular administration CL/F, the intercompartment clearance CLd/F, and the apparent volumes of the central and peripheral compartment V1/F and V2/F. A secondary parameter was the terminal elimination half-life T½. Expected steady-state minimum (Cmin) and maximum (Cmax) concentrations were derived by simulating continued mefloquine dosing. Pharmacokinetic calculations were done using Phoenix WinNonlin 7.0 (Certara, Princeton, NJ, USA) and Figures prepared in Microsoft Excel (2010) and in Adobe Illustrator 2015.1.0.
Rufener R., Ritler D., Zielinski J., Dick L., da Silva E.T., da Silva Araujo A., Joekel D.E., Czock D., Goepfert C., Moraes A.M., de Souza M.V., Müller J., Mevissen M., Hemphill A, & Lundström-Stadelmann B. (2018). Activity of mefloquine and mefloquine derivatives against Echinococcus multilocularis. International Journal for Parasitology: Drugs and Drug Resistance, 8(2), 331-340.
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5

Noncompartmental Pharmacokinetic Analysis

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All noncompartmental PK analyses, summary tables, and figures were generated using Phoenix WinNonlin 7.0 (Certara, Princeton, New Jersey). The primary study end points (expressed as total [bound and unbound] and free [unbound]) were Cmax, area under the concentration–time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast), and AUC from time 0 to infinity (AUCinf), calculated from AUClast by the addition of the constant Clast/λz, where Clast is the last observed quantifiable concentration and λz is the terminal elimination rate constant. Exploratory end points were the level of drug excreted in urine from time 0 to time t (Aet), the fraction of administered dose of drug excreted in urine (fe), and renal clearance (CLR).
Czerniak R., Cieslarová B., Kupčová V., Rosario M., Lock R., Dong C, & Dukes G. (2022). The Effect of Hepatic Impairment on the Pharmacokinetics of Intravenously Administered Felcisetrag (TAK‐954). Journal of Clinical Pharmacology, 62(8), 1006-1017.
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6

Quantification of rh-aFGF Pharmacokinetics

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After validation of the double-sandwich ELISA method, the rh-aFGF concentrations in skin tissue homogenates and serum samples were measured at the indicated time points. Pharmacokinetic parameters, namely, the time to peak (Tmax), maximum concentration (Cmax), and area under the curve (AUC(0–t)), were calculated via Phoenix WinNonlin 7.0 (Certara, USA). The relative bioavailability (F) of rh-aFGF in the skin was calculated as the ratio of the AUC(0–10h) between the rh-aFGF hydrogel and the commercial rh-aFGF-Ai.
Hui Q., Yang R., Lu C., Bi J., Li L., Gong J., Zhang L., Jin Z., Li X, & Wang X. (2020). Validation of a Double-Sandwich Enzyme-Linked Immunoassay for Pharmacokinetic Study of an rh-aFGF Hydrogel in Rat Skin and Serum. Frontiers in Pharmacology, 11, 700.
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7

Pharmacokinetic Parameter Estimation

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Descriptive and 2-compartment pharmacokinetic parameters were estimated with Phoenix WinNonlin 7.0 (Certara, Princeton, NJ).
Zolkowska D., Wu C.Y, & Rogawski M.A. (2018). Intramuscular Allopregnanolone and Ganaxolone in a Mouse Model of Treatment Resistant Status Epilepticus. Epilepsia, 59(Suppl 2), 220-227.
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8

Pharmacokinetics of Romiplostim in Patients

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All below the limit of quantification values of PK were entered as 0. The safety set included all participants who received ≥1 dose of romiplostim. The PD set included all participants who received a full dose of romiplostim on day 1 and had at least 1 platelet counting collected after administration. Finally, the PK set included all participants who received a full dose of romiplostim on day 1 and had at least 1 serum romiplostim concentration collected after administration. According to the previous studies,17, 18, 19, 20 8 participants per dose were needed to evaluate the PK changes.
Descriptive statistics were used. All continuous variables are presented as medians (ranges) and means (standard deviations). The categorical and ranked data are presented as n (%). Statistical analyses were performed using the SAS Drug Development 4.5.2 (SAS 9.4; SAS Institute, Cary, North Carolina). Phoenix WinNonlin 7.0 (Certara, Princeton, New Jersey) was used to calculate the PK parameters.
Qi J., Zheng L., Hu B., Zhou H., He Q., Liu H., Kawai H, & Yang R. (2021). Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clinical Pharmacology in Drug Development, 11(3), 379-387.
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9

Pharmacokinetics of Busulfan in Patients

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Blood samples (5 mL) for the PK analysis of Bu were obtained at the timing of the 1st and 13th Bu infusions. These samples were timed for the first dose before the start of Bu administration on the first day and the first dose on the last (fourth) day of Bu administration. For the two timings of analysis, blood samples were obtained just before starting an infusion of Bu, and 0, 120, and 240 min after the end of the infusion. Separated plasma samples were immediately cryopreserved until the Bu concentration measurements. Plasma Bu concentrations were measured by highperformance liquid chromatography basically as previously reported [18, 19] . The PK parameters of AUC and clearance were calculated from the blood concentration data using the PK analysis software Phoenix ® WinNonlin ® 7.0 (Certara LP, Princeton, NJ, USA).
Kikuchi T., Mori T., Ohwada C., Onoda M., Shimizu H., Yokoyama H., Onizuka M., Koda Y., Kato J., Takeda Y., Hino Y., Mishina T., Sakaida E., Shono K., Nagao Y., Yokota A., Matsumoto K., Morita K, & Okamoto S. (2021). Pharmacokinetics of intravenous busulfan as condition for hematopoietic stem cell transplantation: comparison between combinations with cyclophosphamide and fludarabine. International journal of hematology, 113(1).
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10

Pharmacokinetic Analysis of Drug Bioavailability

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The PK population was defined as all randomized subjects in the safety population (who had received ≥ one dose of study treatment) excluding subjects without any valid PK measurement. Patients with major protocol deviations significantly affecting PK were excluded from PK analysis for the period of the deviation, but not from the PK population.
All PK variables were calculated using non-compartmental analysis (NCA) with Phoenix WinNonlin 7.0 (Certara, Inc., Princeton, NJ, USA). The PK outcomes of this study were the ratio between the area under the curve from 0 to 24 h and daily dose (AUC0–24h)/daily dose) as an index of relative oral bioavailability, percentage peak-to-trough fluctuation [maximum whole-blood drug concentration (Cmax) − minimum whole-blood drug concentration (Cmin) × 100/average whole-blood drug concentration (Cavg)] and time to peak concentration (tmax) on days 1, 3, 7 and 14. Additional outcomes included AUC0– 24h, Cmax, Cavg and Cmin on days 1, 3, 7 and 14; trough levels [whole-blood trough drug concentration 24 h post dose (C24h)] daily from day 2 to day 8 and on days 14, 15, 21 and 28; proportion of patients with trough levels lower than, within and higher than the target range; proportion of patients with trough levels within the target range between day 2 to 4; and number of dose adjustments.
Kamar N., Cassuto E., Piotti G., Govoni M., Ciurlia G., Geraci S., Poli G., Nicolini G., Mariat C., Essig M., Malvezzi P., Le Meur Y., Garrigue V., Del Bello A, & Rostaing L. (2018). Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Advances in Therapy, 36(2), 462-477.
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