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Phoenix winnonlin version

Manufactured by Pharsight
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Phoenix WinNonlin is a software application for pharmacokinetic and pharmacodynamic data analysis. It provides tools for the modeling and simulation of drug concentration and response data.

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Lab products found in correlation

Sas version 8.2 or higher, by SAS Institute (1 mentions) Sas software version 9, by SAS Institute (1 mentions)

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WinNonlin Phoenix Version 6.2.1 or higher Phoenix WinNonlin software version 6.3 Phoenix WinNonlin version 6.3 Phoenix WinNonlin version 7.0 Phoenix™ WinNonlin® Professional Version 6.3 Phoenix WinNonlin version 8.1 Phoenix WinNonlin WinNonlin

8 protocols using phoenix winnonlin version

1

Pharmacokinetics and Immunogenicity of TQB2450

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Blood samples were collected at baseline and at scheduled time points after a dose of TQB2450 for the determination of PK parameters and immunogenicity analysis. PK parameters, including maximum serum concentration (Cmax), terminal half-life (T1/2λ), the volume of distribution (Vd), clearance (CL), and area under the concentration–time curve (AUC), were estimated using Phoenix WinNonlin version 6.4 (Pharsight Corporation, Mountain View, CA, USA) with a non-compartmental model. The antibody to TQB2450 [anti-drug antibody (ADA)] was assessed by characterizing the total ADA concentrations. Confirmed-positive samples would be further characterized by titration and with a neutralizing antibody assay. Detailed information on the sampling schedule and analytical methods for PK and immunogenicity are presented in Supplemental Appendix 1.
Xue J., Xue L., Tang W., Ge X., Zhao W., Li Q., Peng W., Dai C., Guo Y, & Li J. (2024). TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Therapeutic Advances in Medical Oncology, 16, 17588359231220516.
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2

Pharmacokinetic Parameter Estimation

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Values for the pharmacokinetic parameters were estimated by noncompartmental methods using Phoenix WinNonlin, version 6.1 (Pharsight Corporation, Mountain View, California) or SAS version 8.2 or higher (SAS Institute, Inc., Cary, North Carolina). Pharmacokinetic parameters included the maximum observed plasma concentration (Cmax), area under the plasma concentration‐time curve (AUC) during a dosing interval (AUC24 for once‐daily administration, AUC12 for twice‐daily administration, AUCt for time zero to the time of the last measurable concentration, or AUC∞ for time zero to infinity, as appropriate), and Tmax. Additional pharmacokinetic parameters included t½ and trough concentration (Ctrough).
Polepally A.R., Ng J.W., Salem A.H., Dufek M.B., Parikh A., Carter D.C., Kamradt K., Mostafa N.M, & Shebley M. (2020). Assessment of Clinical Drug‐Drug Interactions of Elagolix, a Gonadotropin‐Releasing Hormone Receptor Antagonist. Journal of Clinical Pharmacology, 60(12), 1606-1616.
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3

Quantification of Clopidogrel and Metabolites

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A high‐performance liquid chromatography tandem mass spectrometry assay was developed and validated for the simultaneous determination of clopidogrel, metabolite stereoisomers (H3 and H4), and internal standard carbamazepine in human plasma and mixtures of liver S9 fraction. The representative tandem mass spectrometry spectrum and liquid chromatography mass spectrometry profiles are shown in Supplementary Figure S5 online. The PK parameters of clopidogrel, H3, and H4 were estimated using the noncompartmental analysis function in Phoenix WinNonlin version 6.3 software (Pharsight, Cary, NC).
Zhong W., Wu H., Chen J., Li X., Lin H., Zhang B., Zhang Z., Ma D., Sun S., Li H., Mai L., He G., Wang X., Lei H., Zhou H., Tang L., Liu S, & Zhong S. (2017). Genomewide Association Study Identifies Novel Genetic Loci That Modify Antiplatelet Effects and Pharmacokinetics of Clopidogrel. Clinical Pharmacology and Therapeutics, 101(6), 791-802.
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4

Noncompartmental Darbe Pharmacokinetics Analysis

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A noncompartmental approach using Phoenix WinNonLin, version 5.1 (Pharsight, Mountain View, CA) and R 3.0.2 (R Foundation for Statistical Computing, Vienna, Austria) was used to estimate Darbe pharmacokinetic parameters. The median Epo concentration from the placebo group at each time point was subtracted from each Darbe treated patient to isolate the fraction of the erythropoietin concentration that was attributable to the administration of Darbe. The area under the concentration-time curve extrapolated to infinity (AUCinf) (calculated using the log-linear trapezoidal method), the half-life (t1/2), and the mean residence time for the Darbe treatment groups were estimated for the first and second doses. The maximum plasma concentration (Cmax) and clearance (CL) were only determined for the first dose due to limited sampling times following the second dose. The area under the urinary excretion rate curve from 0–24 h (AURC0–24) was determined for each treatment group for the first dose. The Wilcoxon rank-sum test was used to compare Darbe pharmacokinetics between the treatment groups. A P value of ≤0.05 was considered significant.
Baserga M.C., Beachy J.C., Roberts J.K., Ward R.M., DiGeronimo R.J., Walsh W.F., Ohls R.K., Anderson J., Mayock D.E., Juul S.E., Christensen R.D., Loertscher M.C., Stockmann C., Sherwin C.M., Spigarelli M.G, & Yoder B.A. (2015). Darbepoetin administration to neonates undergoing cooling for encephalopathy: a safety and pharmacokinetic trial. Pediatric research, 78(3), 315-322.
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5

Plasma Pharmacokinetics and Pharmacodynamics Assessment

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Plasma samples were collected at prespecified intervals for pharmacokinetic and pharmacodynamic analyses at central laboratories. Pharmacokinetic assessments of human plasma and urine were analyzed using a validated hybridization-ELISA assay [25 (link)] by Pharmaceutical Product Development Laboratories (Richmond, VA). Pharmacokinetic analysis was completed on all subjects who received at least one dose of IONIS-PKKRx. Noncompartmental analysis of data was performed using Phoenix™WinNonlin®, Version 6.3 or higher (Pharsight Corp., Mountain View, VA).
Ferrone J.D., Bhattacharjee G., Revenko A.S., Zanardi T.A., Warren M.S., Derosier F.J., Viney N.J., Pham N.C., Kaeser G.E., Baker B.F., Schneider E., Hughes S.G., Monia B.P, & MacLeod A.R. (2019). IONIS-PKKRx a Novel Antisense Inhibitor of Prekallikrein and Bradykinin Production. Nucleic Acid Therapeutics, 29(2), 82-91.
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6

Pharmacokinetics of AER001 and AER002

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Sample size (n = 80) was selected to provide information on safety, tolerability, PK, and pharmacodynamics (PD) following single/multiple doses of AER001 and AER002. Prospective calculations of statistical power were not done. The safety analysis set consisted of all the participants who had undergone randomization and received at least one infusion of AER002, AER001 + AER002, or placebo. AER001 and AER002 concentrations following IV administration are shown as mean with standard deviation (SD) and predicted mean. Neutralizing antibody titers are reported as geometric mean MN80 titer (SD). AER001 and AER002 concentrations in the NLF are shown as individual values and as means. The NLF serum partition ratio refers to the relative levels of AER001 or AER002 found in the NLF compared with their serum levels, expressed as a percentage. AER001 and AER002 NLF serum partition % are shown as individual values. GraphPad Prism software (versions 8.4.3 or higher) was used for data analysis and graph production. PK parameters were calculated using non-compartmental analysis with Phoenix WinNonLin™ version 6.3 (Pharsight Corp., St. Louis, Mo, USA).
Moullan N., Asiago J., Stecco K., Hadi S., Albizem M., Tieu H., Hock B., Fenwick C., Lin K., Lengsfeld T., Poffenbarger L., Liu D., Trono D., Pantaleo G., Venkayya R, & Bhuyan P. (2024). A First-in-Human Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Neutralization Profile of Two Investigational Long-Acting Anti-SARS-CoV-2 Monoclonal Antibodies. Infectious Diseases and Therapy, 13(1), 173-187.
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7

Epacadostat Pharmacokinetics and Safety Analysis

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Final study results are reported based on a January 20, 2017, data cutoff. Safety and efficacy analyses included patients receiving ≥1 dose of epacadostat. The pharmacokinetic/pharmacodynamic–evaluable population included patients who received ≥1 dose of epacadostat and provided ≥1 post-dose plasma sample for analysis.
SAS® software, version 9.4 (SAS Institute Inc., Cary, NC) was used to generate all tables, graphs, and statistical analyses. Epacadostat pharmacokinetics was estimated by noncompartmental model analysis (Phoenix WinNonlin version 6.0 or later; Pharsight Corporation, Mountain View, CA). Descriptive statistics were used to present summaries of continuous and categorical variables. Survival data (OS, PFS) were analyzed using the nonparametric Kaplan-Meier method.
Gibney G.T., Hamid O., Lutzky J., Olszanski A.J., Mitchell T.C., Gajewski T.F., Chmielowski B., Hanks B.A., Zhao Y., Newton R.C., Maleski J., Leopold L, & Weber J.S. (2019). Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma. Journal for Immunotherapy of Cancer, 7, 80.
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8

Pharmacokinetics of Deuterated Metabolites

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For the deuterated and nondeuterated forms of the active metabolites, α‐HTBZ and β‐HTBZ, the sum total of α‐HTBZ and β‐HTBZ (total [α+β]‐HTBZ) and their O‐desmethyl metabolites, the following pharmacokinetic parameters were calculated, as appropriate, using standard noncompartmental methods by Phoenix WinNonlin version 6.3 (Pharsight Corporation, Mountain View, California): AUC0‐t, AUCinf, %AUCextrap Rac, Cmax, Tmax, Cmin, tmin, λz, t1/2, and AUC0‐12.. The accumulation ratio, Rac, was calculated as AUC0‐12 at steady state divided by AUC0‐12 following a single dose where 12 hours is the length of the dose interval used for multiple dosing. Visual inspections of trough concentrations following repeated administration of deutetrabenazine were conducted to confirm that steady state was achieved.
Schneider F., Stamler D., Bradbury M., Loupe P.S., Hellriegel E., Cox D.S., Savola J., Gordon M.F, & Rabinovich‐Guilatt L. (2020). Pharmacokinetics of Deutetrabenazine and Tetrabenazine: Dose Proportionality and Food Effect. Clinical Pharmacology in Drug Development, 10(6), 647-659.
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