SPD at the end of each initial 4-week treatment was used to explore the relationship with corresponding AUCcum over the treatment period or with Css at the highest dose tested in each patient. In patients who withdrew from study early, SPD measurement at the time closest to treatment end was used. The fold-change in SPD from screening to treatment end was used as the effect variable, and either AUCcum or Css was used as the exposure variable. Data were fitted to a sigmoidal inhibitory Emax model, with baseline E=Eo−(Emax×Cɣ)/(EC50ɣ+Cɣ) using Phoenix WinNonlin version 6.2.1 (Certara USA, Inc.) [24 ], where E (effect) is defined as the change in SPD from screening as a function of exposure; Eo is the baseline change in SPD without drug treatment; Emax is the maximum decrease in SPD relative to Eo; C is the exposure variable (AUCcum or Css); EC50 is the exposure parameter that lead to ½Emax; and ɣ is the sigmoidicity factor. The model fit was optimized by refining the initial estimates and applying weighting factors. The quality of model fitting was assessed by random scatter of residuals, accuracy (percent coefficient of variation, CV%) of parameter estimates, and other available diagnostic tools in Phoenix WinNonlin version 6.2.1 (Certara).
Phoenix winnonlin
Manufactured by Certara
Sourced in United States, Jersey, Sao Tome and Principe, Macao
Phoenix WinNonlin is a software application for data analysis in the field of pharmacokinetics and pharmacodynamics. It provides tools for modeling and simulation of drug concentration and response data.
Automatically generated - may contain errors
Lab products found in correlation
Sas version 9, by SAS Institute (22 mentions)
Sas software, by SAS Institute (4 mentions)
Phoenix winnonlin, by Phoenix Pharmaceuticals (3 mentions)
Formic acid, by Thermo Fisher Scientific (3 mentions)
Nonmem, by ICON Development Solutions (2 mentions)
Prism 9, by GraphPad (2 mentions)
C57bl 6 mice, by Jackson ImmunoResearch (2 mentions)
Sigmaplot, by Grafiti LLC (2 mentions)
Sas software version 9, by SAS Institute (2 mentions)
Stata 15, by StataCorp (2 mentions)
Prism 7, by GraphPad (2 mentions)
Sas 9, by SAS Institute (2 mentions)
Acquity uplc 1 class, by Waters Corporation (1 mentions)
Xevo tq s, by Waters Corporation (1 mentions)
Urea assay kit, by BioChain (1 mentions)
Spss statistic, by IBM (1 mentions)
Triple quad 5500, by AB Sciex (1 mentions)
Gyrolab xp workstation, by Gyros Protein Technologies (1 mentions)
Sd rat, by Charles River Laboratories (1 mentions)
Analyst tf, by AB Sciex (1 mentions)
421 protocols using phoenix winnonlin
1
Pharmacokinetic-Pharmacodynamic Modeling of SPD
2
Noncompartmental Pharmacokinetic Analysis of Gepotidacin
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Noncompartmental PK analyses were performed using Phoenix WinNonlin version 6.4 for the relative bioavailability study and Phoenix WinNonlin version 8 (Certara USA, Inc., Princeton, NJ) for the adult and adolescent study. Actual sampling times were used in both analyses. All data were based on total gepotidacin concentrations as plasma protein binding of gepotidacin is low (33%) (GlaxoSmithKline, unpublished data). Concentration-time data are presented as arithmetic means, and PK parameter data are presented as geometric means, unless otherwise indicated.
3
Pharmacokinetics of Indacaterol in Plasma
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Blood samples for PK analysis on Day 14 in each period were collected at pre-dose, 0.08, 0.16, 0.25, 0.50, 1, 2, 4, 8, 12 and 24 h post-dose. All blood samples were taken by either direct venipuncture or an indwelling catheter inserted in a forearm vein. At specified time points, 2 mL blood sample was collected in lithium heparin tubes. Within 15 min, the sample was centrifuged at 4 °C for 15 min at approximately 1500 g. All plasma samples were frozen within 30 min of collection and stored at − 20 °C or colder, pending analyses. Samples corresponding to treatment periods where patients received placebo were not analysed. The concentrations of indacaterol in plasma were determined by a validated liquid chromatography–mass spectrometry/ mass spectrometry (LC-MS/MS) method [19 (link)]; the Lower Limit of Quantification (LLOQ) was 5.00 pg/mL. Concentrations were expressed in pg/mL units and referred to the free base of indacaterol. Concentrations below the LLOQ were treated as zero in summary statistics of concentration data as well as PK parameter calculations. PK parameters (AUC0-24h,ss, Cmax,ss, Tmax,ss) were determined using WinNonlin Phoenix (version 6.4; Certara, Princeton, NJ, USA).
4
Pharmacokinetic Analysis of Midazolam
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PK parameters for midazolam were calculated from plasma concentration‐vs.‐time data, using noncompartmental methods with WinNonlin Phoenix version 6.4 (Certara, Mountain View, CA). The derived PK parameters included the maximum observed serum concentration (Cmax), time to reach Cmax (Tmax), area under the serum concentration from time zero to time of last measured concentration (AUClast), AUCinf, t1/2, CL/F, and Vz/F. The linear trapezoidal rule was used for AUC calculation. Regression analysis of the terminal serum elimination phase for the determination of t1/2 included at least three data points after Cmax. If the adjusted R2 value of the regression analysis of the terminal phase was <0.75, no values were reported for t1/2, AUCinf, Vz/F, and CL/F.
5
Noncompartmental Analysis of APAP PK
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APAP and APAP metabolites serum concentration versus time data from each patient were analyzed by noncompartmental analysis in WinNonlin Phoenix software (version 8.3; Certara, Princeton, NJ), and PK parameters (e.g., serum concentration maximum [Cmax], time to Cmax [Tmax], area under the curve [AUC], total body serum clearance, terminal‐phase elimination serum half‐life [t1/2], and volume of distribution [Vd]) were determined.
6
Pharmacokinetic Parameter Estimation
7
Dose-Dependent Pharmacokinetics of Cenobamate
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PK parameters were derived by noncompartmental methods using Phoenix WinNonlin (version 7.0; Certara USA). The maximum plasma concentration (Cmax) and time to reach Cmax (Tmax) were obtained from the observed plasma concentration‐time profiles of cenobamate, and the area under the plasma concentration‐time curve (AUC) from 0 to 24 h postdose (AUC0–24 h) and AUC from time 0 to last measurable time point (AUClast) were calculated by a linear‐up and log‐down trapezoidal rule. The AUC from time 0 to infinity (AUCinf) was calculated as AUClast + Clast/λz, where Clast is the last measurable concentration and λz is the terminal elimination rate constant. Apparent clearance (CL/F) was calculated as dose/AUCinf, and t1/2 was calculated as ln2 /λz.
To investigate the dose‐related PK properties of cenobamate over the dose range from 50 to 400 mg, dose‐normalized Cmax (Cmax/D) and dose‐normalized AUCinf (AUCinf/D) were compared among the dose groups by Kruskal‐Wallis test. Additionally, a power model was used to assess dose‐proportionality, and linear regression analyses between log‐transformed dose and log‐transformed Cmax or AUCinf were performed.
To investigate the dose‐related PK properties of cenobamate over the dose range from 50 to 400 mg, dose‐normalized Cmax (Cmax/D) and dose‐normalized AUCinf (AUCinf/D) were compared among the dose groups by Kruskal‐Wallis test. Additionally, a power model was used to assess dose‐proportionality, and linear regression analyses between log‐transformed dose and log‐transformed Cmax or AUCinf were performed.
8
Pharmacokinetics of PIT in NAFLD
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The pharmacokinetics of PIT was determined via noncompartmental analysis methods using Phoenix WinNonlin (v8.3; Certara, Princeton, NJ). PIT area under the concentration-time profile (AUC) was determined using the linear up/log down trapezoidal method and reported as the geometric mean (upper and lower 90% confidence interval). Cmax and time to Cmax (tmax) were obtained directly from the concentration-time profiles and are represented as arithmetic mean (SD) and median (range), respectively. Half-life (t1/2) was calculated as (ln 2)/λz where λz is terminal elimination rate constant calculated by linear regression of at least three data points in the elimination phase of the concentration-time profile and presented as arithmetic mean (SD). The AUC ratios (AUCRs) were calculated as the ratio of the AUC of PIT in the presence of a NAFLD-inducer (i.e., diet or tunicamycin) and/or silymarin over the AUC of PIT in the absence of a NAFLD-inducer and silymarin (i.e., control diet and vehicle).
9
Pharmacokinetic Assessment of Victim Drug with Patiromer
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The key PK parameters describing the rate and extent of systemic exposure of the victim drug with and without patiromer were derived from plasma (or serum) concentration data by noncompartmental methods (Phoenix® WinNonlin® version 6.3; Certara USA, Inc., Princeton, NJ). The area under the plasma concentration–time curve (AUC) from dosing (time 0) until the last measureable time point (AUC0-t), the AUC from dosing, extrapolated to infinity (AUC0-∞), and maximum concentration (Cmax) constituted the primary end points. Other exploratory observed and estimated PK parameters such as Tmax and t1/2 were also determined. For levothyroxine only, due to the presence of endogenous circulating T4 hormone, the PK parameters were adjusted for baseline (endogenous) circulating T4, and the AUC0-48 was employed as the primary AUC end point.
10
Pharmacokinetics of THC and 11-OH-THC
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Noncompartmental analysis was performed using Phoenix WinNonlin software version 6.3 (Certara, L.P./Pharsight Ltd) to determine the pharmacokinetics of THC and 11-OH-THC. The following pharmacokinetic parameters were calculated for the 24-h period: terminal half-life (t1/2), area under the curve (AUC) from 0 to 24 h (AUC0–24 h), and apparent clearance (CL/F, being the dose/AUC0–24 h). The following parameters were calculated for the two curves (curve 1, 0–6 h after the first THC dose; curve 2, 6–24 h after the second dose) separately: the maximum plasma concentration (Cmax), the time to reach Cmax (Tmax), AUC from 0 to 6 h (AUC0–6 h), and AUC from 6 to 24 h (AUC6–24 h), using the linear-up log-down trapezoidal rule. Concentration-time graphs were plotted for the two doses. Geometric means plus 95 % confidence intervals were calculated for each pharmacokinetic parameter for each dose. The coefficients of variation (CV%) of the geometric means were calculated to describe the interindividual variability in pharmacokinetic parameters. The geometric mean ratio (GMR) plus 90 % confidence intervals of AUC0–24 h, CL/F, and t1/2 of the 1.5-mg dose versus the 0.75-mg dose were also calculated.
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