Phoenix winnonlin professional

Manufactured by Pharsight

Sourced in United States

Phoenix WinNonlin Professional is a software application designed for non-compartmental pharmacokinetic and pharmacodynamic analysis. It is used to analyze data from clinical trials and preclinical studies. The software provides tools for data visualization, model fitting, and reporting.

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Phoenix™ WinNonlin® Professional Version 6.3 WinNonlin Professional Phoenix WinNonlin WinNonlin

10 protocols using phoenix winnonlin professional

PK Analysis of Encorafenib and Metabolites

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Human PK plasma samples were analyzed for quantitation of all PK analytes at PPD (Middleton, WI, USA) using validated, sensitive, and specific high-performance liquid chromatography-mass spectrometry/mass spectrometry (HPLC-MS/MS) methods in compliance with laboratory standard operating procedures.
CP-I concentrations were measured retrospectively from remaining PK samples (0–6 h and sparse PK) collected from patients with colorectal cancer who received encorafenib and were analyzed using a validated HPLC-MS/MS. Further details on the study design are reported separately.
PK parameters including, but not limited to, C_max and AUC_last, were calculated for each participant using noncompartmental analysis methods using the WinNonlin software package (Phoenix WinNonlin Professional, version 8.0; Pharsight Corporation, Mountain View, CA, USA) for PK analytes, including rosuvastatin, bupropion, hydroxybupropion, encorafenib and its metabolite LHY746, and binimetinib and its metabolite AR00426032.

Piscitelli J., Reddy M.B., Wollenberg L., Del Frari L., Gong J., Wood L., Zhang Y., Matschke K, & Williams J.H. (2024). Clinical Evaluation of the Effect of Encorafenib on Bupropion, Rosuvastatin, and Coproporphyrin I and Considerations for Statin Coadministration. Clinical Pharmacokinetics, 63(4), 483-496.

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Pharmacokinetic Evaluation of Novel Formulation

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No formal statistical hypotheses were tested. Sample size was based on feasibility. No formal calculation of power for parts 1 and 2 was performed. For part 3, 18 participants were enrolled to ensure at least 12 participants completed the study. Safety endpoints were summarized descriptively and not subjected to formal statistical analyses. Plasma concentration‐time data were calculated with standard non‐compartmental methods using Phoenix WinNonlin Professional (Pharsight Corporation). For each PK parameter, summary statistics were calculated by treatment group. Dose proportionality of selected single‐ and repeat‐dose PK parameters was assessed by the power model. Accumulation ratios in part 2 were calculated as Day 14, 15, or 18 to Day 1.
For assessment of relative bioavailability in part 3, the log_e‐transformed PK parameters were analyzed using separate mixed‐effect models with a fixed‐effect term for fed versus fasted and tablet versus PiB. Participants were treated as a random effect in each model. Point estimates and their associated 90% CIs were calculated for the difference in AUC from 0 to 24 (AUC_0‐24), AUC_0‐∞, and C_max. The point estimates and their associated 90% CIs were back‐transformed to provide point estimates and 90% CIs in PK parameter values on the original scale.

Benn P.D., Zhang Y., Kahl L., Greene T.J., Bainbridge V., Fishman C., Wen B, & Gartland M. (2023). A phase I, first‐in‐human study investigating the safety, tolerability, and pharmacokinetics of the maturation inhibitor GSK3739937. Pharmacology Research & Perspectives, 11(3), e01093.

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Pharmacokinetics of Navitoclax and Rituximab

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Plasma samples for navitoclax assay were collected on Week 1 Day 2 at 0 (predose), 2, 4, 6, 8, and 24 hours. Serum samples for rituximab were collected on Week 1 Day 1 (before and immediately following first rituximab infusion), Week 4 Day 1 (before and immediately following fourth rituximab infusion), Week 5 Day 1 (1 week after fourth infusion), Week 8 Day 1 (1 month after fourth infusion), and Week 17 Day 1 (3 months after fourth infusion). Plasma concentrations of navitoclax were determined using a validated liquid chromatography method with tandem mass spectrometric detection. Serum concentrations of rituximab were determined using a validated sandwich enzyme-linked immunosorbent assay method. Pharmacokinetic parameters of navitoclax and rituximab were estimated using noncompartmental methods with Phoenix^® WinNonlin^®-Professional™, version 6.2 (Pharsight Corporation, Mountain View, CA).

Roberts A.W., Advani R.H., Kahl B., Persky D., Sweetenham J.W., Carney D.A., Yang J., Busman T.B., Enschede S.H., Humerickhouse R.A, & Seymour J.F. (2015). Phase 1 Study of the Safety, Pharmacokinetics, and Antitumour Activity of the BCL2 Inhibitor Navitoclax in Combination With Rituximab in Patients With Relapsed or Refractory CD20+ Lymphoid Malignancies. British journal of haematology, 170(5), 669-678.

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Pharmacokinetics of Fenbendazole in Animals

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A full description is presented in Supplementary materials.
Plasma concentration versus time data from each animal given FBZ iv (5 mg/kg; n=5) were subjected to compartmental analysis (Pharsight Corporation, Phoenix WinNonlin professional, version 6.3; St Louis, MO, USA). The number of exponential terms required to describe the serum concentration versus time data for each animal was determined by evaluation of concentration versus time curves, applying Akaike’s information criterion and examination of residuals.8
A full description of data analysis is presented in Supplementary materials.

Lakritz J., Linden D., Anderson D.E, & Specht T.A. (2015). Plasma concentrations of fenbendazole (FBZ) and oxfendazole in alpacas (Lama pacos) after single intravenous and oral dosing of FBZ. Veterinary Medicine : Research and Reports, 6, 71-81.

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Pharmacokinetics of Verinurad and Allopurinol

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Parameters from individual plasma concentration−time profiles of verinurad and allopurinol were determined using noncompartmental methods. Plasma PK parameters estimated for verinurad and allopurinol included the time to maximum concentration (T_max), the maximum observed plasma concentration (C_max), and the area under the plasma concentration−time curve from time 0 to 24 hours postdose (AUC_0‐24). Urine PK parameters included the amount of drug excreted in urine unchanged (Ae), fraction of drug excreted in urine unchanged (f_e), and the renal clearance of drug (CL_R). A_e was calculated as concentration measured × volume, and CL_R was calculated as A_e divided by plasma AUC over the same time interval. Plasma PK parameters were derived using the validated program Phoenix WinNonlinProfessional, version 6.3 (Pharsight, Mountain View, California).

Kankam M., Hall J., Gillen M., Yang X., Shen Z., Lee C., Liu S., Miner J.N., Walker S., Clauson V., Wilson D, & Nguyen M. (2018). Pharmacokinetics, Pharmacodynamics, and Tolerability of Concomitant Multiple Dose Administration of Verinurad (RDEA3170) and Allopurinol in Adult Male Subjects With Gout. Journal of Clinical Pharmacology, 58(9), 1214-1222.

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Phase I/II Trial of TAS-114 + S-1 in Solid Tumors

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No formal sample size calculations were performed. To obtain preliminary information on the MTD and safety, we planned a maximum enrollment of 80 patients for DLT evaluations (Part 1) and a maximum enrollment of 40 patients for the full analysis set (FAS) (Part 2). DLTs were evaluated based on the patients in Part 1 who experienced DLTs and those who did not experience DLTs but received ≥80% of the planned total dose of the study drug in Cycle 1. Safety data were analyzed in patients who received at least one dose of TAS-114 and S-1. The efficacy analysis was based on the FAS, defined as all patients who received study treatment in Part 1 or Part 2, those who met all inclusion criteria and none of the exclusion criteria and provided at least one measured value for efficacy endpoints after the start of study drug administration.
The incidences of AEs and grade ≥3 AEs and the number of patients with AEs were calculated by event and severity. ORR and PFS were analyzed in the FAS; 95% confidence intervals (CIs) were estimated. Summary statistics were presented by dose level. The estimation of plasma PK parameters was performed using Phoenix WinNonlin Professional (Version 6.1 or later; Pharsight Corporation, Sunnyvale, CA, USA) according to the non-compartmental method.

Doi T., Yoh K., Shitara K., Takahashi H., Ueno M., Kobayashi S., Morimoto M., Okusaka T., Ueno H., Morizane C., Okano N., Nagashima F, & Furuse J. (2018). First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Investigational New Drugs, 37(3), 507-518.

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Quantitation of PK Analytes via HPLC/MS/MS

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Human PK plasma samples were analyzed for quantitation of all PK analytes at PPD (Middleton, Wisconsin, US) using validated, sensitive, and specific HPLC/MS/MS methods in compliance with laboratory SOPs.
PK parameters including, but not limited to, C max and AUC last were calculated for each participant using noncompartmental analysis (NCA) methods using the WinNonlin software package (Phoenix WinNonlin Professional, version 8.0 Pharsight Corporation, Mountain View, California) for PK analytes including encorafenib and its metabolite LHY746, and binimetinib and its metabolite AR00426032.

Piscitelli J., Reddy M.B., Wollenberg L., Del Frari L., Gong J., Matschke K, & Williams J.H. (2024). Evaluation of the effect of modafinil on the pharmacokinetics of encorafenib and binimetinib in patients with BRAF V600-mutant advanced solid tumors. Cancer chemotherapy and pharmacology.

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Noncompartmental PK Parameter Calculation

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Noncompartmental PK parameters such as C_max, t_max, AUC_0‐t, AUC_0‐inf, t_1/2, CL/F, and Vz/F were calculated from the plasma concentration‐time data with PhoenixWinNonlin Professional version 6.3 (Pharsight, a Certara company, St. Louis, Missouri). Actual sampling times were used in the calculations. Descriptive statistics (n, mean, standard deviation [SD], coefficient of variation [CV%], geometric mean, geometric CV%, median, minimum, and maximum) were provided for concentrations at each time and for all PK parameters.

Li Y., Liu L., Wang X., Zhang C., Reyes J., Hoffmann M., Palmisano M, & Zhou S. (2018). In Vivo Assessment of the Effect of CYP1A2 Inhibition and Induction on Pomalidomide Pharmacokinetics in Healthy Subjects. Journal of Clinical Pharmacology, 58(10), 1295-1304.

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Pharmacokinetics of Entospletinib Evaluated

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The pharmacokinetic parameters of entospletinib were assessed by non-compartmental methods using a non-linear curve-fitting software package (Phoenix^® WinNonlin^® Professional, Pharsight^® Corporation, Mountain View, CA, USA). The following pharmacokinetic parameters were evaluated for entospletinib: C_max (the maximum observed concentration of the drug), t_max (the time [observed timepoint] of C_max), t_½ (the estimate of the terminal elimination half-life of the drug; calculated by dividing the natural log of 2 by the terminal elimination rate constant [λz; which is estimated by linear regression of the terminal elimination phase of the concentration of drug versus time curve]), AUC_last (area under the plasma concentration–time curve [AUC] from time zero to the time of the last quantifiable concentration), AUC_∞ (AUC extrapolated to infinity; calculated as AUC_last + C_last/λz [the last observed quantifiable concentration of the drug in plasma divided by λz]) (single dose), AUC_τ (AUC over the dosing interval [τ]), and C_trough (concentration at the end of the dosing interval) (multiple dose).

Ramanathan S., Di Paolo J.A., Jin F., Shao L., Sharma S., Robeson M, & Kearney B.P. (2016). Pharmacokinetics, Pharmacodynamics, and Safety of Entospletinib, a Novel pSYK Inhibitor, Following Single and Multiple Oral Dosing in Healthy Volunteers. Clinical Drug Investigation, 37(2), 195-205.

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Pharmacokinetic Analysis of Nebivolol and Metabolite

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The pharmacokinetic (PK) parameters of nebivolol and its active metabolite (4-0H-nebivolol), when given alone and in combination with fluvoxamine, were determined by a non-compartmental analysis using Phoenix WinNonlin Professional software (Version 6.3, Pharsight Corp., Mountain View, CA, USA). Peak plasma concentration (C max , ng/ml) and the time to reach C max (t max , h) were noted directly from the experimental data, respectively from the concentration vs. time profiles of both analytes. The area under the time-concentration curve from time 0 to the last measurable time (AUC 0-t ) was calculated using the trapezoidal rule-extrapolation method, while the area under the time-concentration curve extrapolated to infinity (AUC 0-∞ ) was obtained as follows: AUC 0-t + C t /k el (C t -the last quantifiable drug concentration, k el is the elimination rate constant). k el was calculated by linear regression analysis of the terminal phase of the log concentration-time profile and the half-life (t ½ ) was obtained using the following formula t ½ =0.693/k el .

Gheldiu A.M., Vlase L., Vlase L., Popa A., Briciu C., Muntean D., Bocsan C., Buzoianu A., Achim M., Tomuta I., Todor I, & Neag M. (2017). Investigation of a Potential Pharmacokinetic Interaction Between Nebivolol and Fluvoxamine in Healthy Volunteers. Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques, 20.

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