The pharmacokinetic parameters of VPA were calculated by noncompartmental analysis of individual plasma concentration–time data using Phoenix® WinNonlin® 6.3 software (Certara, St Louis, MO, USA). The maximum concentration (Cmax) and the time to Cmax (tmax) were obtained from the observed data. The area under the plasma concentration–time curve from time 0 to the last quantifiable concentration (AUClast) and the partial AUC from 4 hours to 12 hours (AUC4–12) as an estimate of EHC were determined using the linear/log trapezoidal method. The elimination half-life (t1/2) was calculated as: t1/2= ln(2)/kel, where kel was the elimination rate constant. kel was calculated by linear regression of the log-linear concentration–time curve.
Phoenix winnonlin 6
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Phoenix WinNonlin 6.4 is a comprehensive software application for pharmacokinetic and pharmacodynamic (PK/PD) data analysis. It provides a robust set of tools for modeling and simulation to support drug development and regulatory submissions.
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Prism 6, by GraphPad (3 mentions)
Sas 9, by SAS Institute (2 mentions)
Phoenix winnonlin 6, by Phoenix Pharmaceuticals (2 mentions)
Infinite 200, by Tecan (1 mentions)
Nexera x2, by Shimadzu (1 mentions)
Qtrap 4500, by AB Sciex (1 mentions)
Spss statistics 19, by IBM (1 mentions)
R software, by R Project for Statistical Computing (1 mentions)
Power lab 8 sp data, by ADInstruments (1 mentions)
Statistica 12, by StatSoft (1 mentions)
Atlantis t3, by Waters Corporation (1 mentions)
Api 4000, by AB Sciex (1 mentions)
Labsolution, by Shimadzu (1 mentions)
Prism 5, by GraphPad (1 mentions)
76 protocols using phoenix winnonlin 6
1
Pharmacokinetic Analysis of Valproic Acid
2
Pharmacokinetics of Tα1-PAS in Wistar Rats
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A PK study in female Wistar rats at 8–9 weeks of age was conducted at the Aurigon Toxicological Research Center (ATRC, Dunakeszi, Hungary). Up to 3 animals per cage were housed in a controlled environment at 22 ± 3 °C with a relative humidity of 50 ± 20%, 12 h light and 12 h dark. Endotoxin-free purified Tα1-PAS (3.4 mg/kg) was administered subcutaneously via a single injection into the rat dorsal area. Blood samples (100 µL) were taken from 5 animals each at various time points. Following collection in tubes containing tri-potassium ethylenediaminetetraacetic acid (K3-EDTA) (Greiner Bio-One, Frickenhausen, Germany), samples were centrifuged at room temperature for 10 min (3000× g) and the resulting plasma was stored at −15 to −30 °C. Tα1-PAS in these samples was quantified using sandwich ELISA (see below) and the data were analyzed using the Phoenix WinNonlin 6.3 software (Certara, Princeton, NJ, USA) using a one-compartment model assuming 1st order absorption and elimination.
3
Pharmacokinetic Analysis of LY2875358, Erlotinib, and Gefitinib
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Blood samples were collected for pharmacokinetic analysis during Cycle 1 as follows: before the infusion on Day 1, mid-infusion, at the end of the infusion, 2, 4, 6, 8, and 24 h (Day 2) after the end of the infusion, Day 4–6 at any time, Day 8, before the infusion on Day 15, at the end of the infusion, 2, 4, and 6 h after the end of the infusion, and Day 22. Blood samples were collected for pharmacokinetic analysis during Cycle 2 as follows: before the infusion on Day 1, mid-infusion, at the end of the infusion, 2 and 4 h after the end of the infusion, Day 8, before the infusion on Day 15, and at the end of the infusion. The pharmacokinetic parameters for LY2875358, erlotinib, and gefitinib were computed by standard noncompartmental methods using Phoenix WinNonlin 6.3 software (Certara USA, Inc., Princeton, NJ, USA).
4
Pharmacokinetic Analysis of Drug Bioavailability
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The PK parameters were determined using a non-compartmental method implemented in Phoenix® WinNonlin® 6.2 (Certara, L.P., St. Louis, MO, USA). The maximum plasma concentration (Cmax) and time to reach Cmax (Tmax) were determined directly from the observed individual plasma concentration-time profiles. Terminal elimination half-life (t1/2) was calculated as the natural logarithm of 2 divided by λz, which is the terminal elimination rate constant estimated in the linear portion of the decline of natural logarithmic-transformed individual plasma concentrations. The area under the concentration-time curve (AUC) from dosing to the last quantifiable concentration (AUClast) was calculated using the linear trapezoidal method, and AUC from dosing to infinity (AUCinf) was calculated as the sum of AUClast and Ct/λz. CL/F was defined as an apparent total clearance of the drug from plasma after oral administration, and Vd/F was defined as an apparent volume of distribution after non-intravenous administration.
5
Pharmacokinetics of Tegoprazan and Metabolite
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Plasma tegoprazan and M1 concentration–time profiles after a single oral administration were obtained from a previous comparative pharmacokinetic study comparing two formulations of tegoprazan in healthy Korean male subjects (IRB number: CUH 2015-03-007) [34 (link)]. This study was designed as a randomized, open-label, single-dose, two-sequence, and two-period crossover study. A total of 12 volunteers participated, and the mean ± standard deviation of age, height, and weight were 23.9 ± 1.3 years, 173.1 ± 7.6 cm, and 68.4 ± 8.2 kg, respectively. All subjects were administered a single tegoprazan film-coated 100 mg tablet orally of formulation type 1 or 2 (HK inno.N Corp., Seoul, Korea), and pharmacokinetic profiles were analyzed. For pharmacokinetic analysis, 8 mL of blood was collected to measure the plasma tegoprazan and M1 concentrations during each period at the following time points: pre-dose (0 h) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 h post-dose. Plasma tegoprazan and M1 concentrations were measured by liquid chromatography–tandem mass spectrometry (LC–MS/MS). Individual concentration–time profiles were used to develop and verify tegoprazan and M1 PBPK models. The PK parameters were calculated using a non-compartmental analysis (NCA) performed by Phoenix® WinNonlin® 6.2 (Certara, Princeton, NJ, USA).
6
Comparative Pharmacokinetics of Antibody Drugs
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At five weeks after the first immunization, the arthritis scores were assessed and eight CIA mice were assigned to the ozoralizumab-Alexa 680 group (n = 4) or adalimumab-Alexa 680 group (n = 4) with comparable body weights and arthritis scores. Age-matched naive mice were also divided into the same two groups. The day after arthritis score evaluation and assignment, each mouse received a subcutaneous injection of 2 mg/kg ozoralizumab-Alexa 680 or adalimumab-Alexa 680 in the back. At 1, 2, 4, 6, 8, 24, 48, and 72 h after the injection, 40–50 µL of blood was collected at each time-point from the tail vein. The blood was centrifuged (11,200 × g, 4 °C, 6 min) to separate the serum. The antibody concentrations in the serum were determined using a fluorescence microplate reader (Infinite 200, Tecan Group Ltd.) at an excitation wavelength of 640 nm and emission wavelength of 702 nm. The serum concentration–time profiles of ozoralizumab-Alexa 680 and adalimumab-Alexa 680 were analyzed using Phoenix WinNonlin 6.2 (Certara) by 1-compartmental analysis for the absorption rate constant (ka), and by non-compartmental analysis for the maximum concentration (Cmax), time-to-maximum concentration (tmax), area under the serum concentration–time curve from 0 to 72 h (AUC0–72 h), and the elimination half-life (t1/2).
7
Oxycodone Pharmacokinetics and Abuse Potential
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Blood samples were obtained within one hour predose and at 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose. In subjects who experienced emesis within one hour after dosing, PK samples were not collected for the duration of the treatment period. Plasma oxycodone concentrations were assessed by means of a validated liquid chromatography, tandem mass spectrometry method (calibration range = 0.398–99.620 ng/mL); the lower limit of quantitation was 0.398 ng/mL. PK parameters, including maximum observed plasma concentration (Cmax), time to Cmax (Tmax), and terminal half-life (t1/2), were calculated using a noncompartmental model (Phoenix WinNonlin 6.2, Certara, Princeton, NJ, USA). Linear trapezoidal estimation was used to calculate area under the plasma concentration time curve from 0 hours to the last measurable concentration (AUC0-t), extrapolated to infinity (AUC0-∞), and at various times during the study (e.g., AUC0–0.5 h, AUC0–1 h, AUC0–2 h). The abuse quotient (AQ; Cmax/Tmax), a measure associated with drug liking and abuse potential [16 (link),17 ], was also calculated.
8
Paclitaxel Quantification in Plasma and Lung
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Plasma samples were thawed immediately before analysis and were assayed through UPLC-MS methods already mentioned to quantify paclitaxel concentration at the specified necropsy time points. Right lung lobes were thawed, homogenized with PBS at a ratio of 4:1 (water–lung tissue), and underwent a similar protein precipitation with acetonitrile before UPLC-MS analysis. Quantification was conducted with a matrix-based calibration curve, with a lower level of quantification determined from the biological sample verification methods already mentioned. Noncompartmental analysis (Phoenix WinNonlin 6.2 [Certara, Princeton, NJ]) was conducted on average data at each time point from the plasma and lung tissue concentrations. Noncompartmental analysis was performed to calculate Cmax, T1/2, AUC(last), and AUCD(last).
9
Pharmacokinetic Analysis of Dexmedetomidine
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All pharmacokinetic analyses were performed using Phoenix WinNonlin 6.2 (Certara, Princeton, NJ). Nonlinear least squares regression was performed on the plasma dexmedetomidine concentration-time data. Data were weighted by the reciprocal of the observed plasma concentrations squared (D12.5, dexmedetomidine in D25M600) or the reciprocal of the predicted concentrations squared (D25, M300, MK-467 in D25M600) and fitted to 2-, and 3-compartment models with bolus input into, and elimination from the central compartment. The appropriate model was selected by observation of the residuals plot and by use of Akaike's information criterion. Parameters estimated by the model were A, B, α and β in the equation C t =A´e -at +B´e -bt , where C t is the plasma drug concentration at time t. Other pharmacokinetic parameters were calculated by use of standard pharmacokinetic equations.
10
Pharmacokinetic Analysis of Cu-ATSM/ATSM
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Data were expressed as the means with corresponding standard deviations (SDs). Pharmacokinetic parameters in plasma were determined with Phoenix WinNonlin 6.4 software (Certara, Princeton, NJ). To compare the vehicle group vs. Cu-ATSM/ATSM-treated groups, Bartlett and Dunnett tests were performed. In the case of heterogeneous group variances, the Steel test was performed. P values less than .05 were considered statistically significant.
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