Noncompartmental analysis was performed using Phoenix WinNonlin version 7.0 (Pharsight, Mountain View, CA) to determine AZD3965 pharmacokinetic parameters. Area under the plasma concentration-time curve (AUC) was determined using the trapezoidal method; with AUC values extrapolated to time infinity. The terminal half-life (t½) was calculated as 0.693/k, where k was the slope of the terminal regression line. Vz/F (apparent volume of distribution/bioavailability (F)) represents the apparent volume of distribution estimated from the terminal phase. The maximal concentration (Cmax) was also determined by visual inspection. Oral clearance (clearance/F) was determined by the oral dose/AUC. All the data are presented as mean ± SD. Data analysis was performed using GraphPad Prism (GraphPad Software Inc., San Diego CA). Student’s t-test was used to assess the statistical significance with p value < 0.05.
Phoenix winnonlin version 7
Manufactured by Pharsight
Sourced in United States
Phoenix WinNonlin version 7.0 is a software application for pharmacokinetic and pharmacodynamic analysis. It provides tools for data visualization, model building, and statistical analysis of drug concentration and response data.
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Lab products found in correlation
5 protocols using phoenix winnonlin version 7
1
Pharmacokinetic Analysis of AZD3965
2
Pharmacokinetics of Tigilanol Tiglate
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The PK population consisted of all enrolled patients who received any dose of tigilanol tiglate and had an evaluable plasma concentration profile. Blood for PK and biomarker analysis was collected within 30 min prior to dosing and then 5, 15, and 30 min and 1 h, 2 h, 4 h, 6 h, 8 h and 24 h after dosing. Plasma samples were assayed for tigilanol tiglate maximum observed concentration (Cmax), time of Cmax (Tmax), area under the plasma concentration-time curve from time zero to the last quantifiable sampling point post-dose, area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞), elimination half-life, and systemic clearance in accordance with CPR analytical laboratory method ALM-084. PK parameters were determined using Phoenix WinNonlin version 7·0 (Pharsight Corporation, USA).
3
Pharmacokinetics and Dose-Escalation of TSR-011
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To evaluate PK and establish the RP2D, blood samples were collected from all patients in the phase 1 dose-escalation trial at daily doses of 30–480 mg.
A liquid chromatography–tandem mass spectrometry (LC–MS/MS) method (API 5500, Applied Biosystems, Waltham, MA, USA) using a Gemini C18 column (Phenomenex, Torrance, CA, USA; 50 × 2.0 mm, 3 µm) for the analysis of TSR-011 in K2EDTA human plasma was developed and fully validated by Agilux Laboratories (Worcester, MA, USA). Plasma samples were processed through a Biotage (Uppsala, Sweden) ISOLUTE SLE + 200 μL of a 96-well-supported liquid extraction plate. TSR-011 was determined using electrospray ionisation in positive ion mode, with the multiple reaction monitoring transitions of 578/435 for TSR-011 and 596/453 for TSR-012 as its internal standard. The validated range was 0.87–433.25 nmol/L. The assay interbatch precision, expressed as percent coefficients of variation, ranged from 6.6 to 11.7%, and the interbatch accuracy, expressed as percent bias, ranged from –4.7 to 0.5%.
PK parameters were calculated using noncompartmental analysis (Phoenix WinNonlin version 7.0, Pharsight Corporation, Mountain View, CA, USA).
A liquid chromatography–tandem mass spectrometry (LC–MS/MS) method (API 5500, Applied Biosystems, Waltham, MA, USA) using a Gemini C18 column (Phenomenex, Torrance, CA, USA; 50 × 2.0 mm, 3 µm) for the analysis of TSR-011 in K2EDTA human plasma was developed and fully validated by Agilux Laboratories (Worcester, MA, USA). Plasma samples were processed through a Biotage (Uppsala, Sweden) ISOLUTE SLE + 200 μL of a 96-well-supported liquid extraction plate. TSR-011 was determined using electrospray ionisation in positive ion mode, with the multiple reaction monitoring transitions of 578/435 for TSR-011 and 596/453 for TSR-012 as its internal standard. The validated range was 0.87–433.25 nmol/L. The assay interbatch precision, expressed as percent coefficients of variation, ranged from 6.6 to 11.7%, and the interbatch accuracy, expressed as percent bias, ranged from –4.7 to 0.5%.
PK parameters were calculated using noncompartmental analysis (Phoenix WinNonlin version 7.0, Pharsight Corporation, Mountain View, CA, USA).
4
Chidamide Pharmacokinetics and Safety in NHL
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The incidence, nature, severity, and relatedness of AEs were graded according to the NCI-CTCAE version 4.02. Tumor assessment was carried out by the investigator using response criteria for NHL at screening, every 6 weeks for combination treatment and every 12 weeks for maintenance treatment (14 (link)). The best response of CR/CRu or partial response (PR) had to be confirmed after 4−6 weeks. Patients were withdrawn from the study if they developed progressive disease or unacceptable toxicity. Survival follow-up was performed every 6 months.
A pharmacokinetic study of chidamide was conducted in the dose-escalation part. Blood samples were collected at pre-dose and 1, 2, 4, 8, 12, 24, 48 and 72 h after the first dose in the run-in period and during the first cycle of combination treatment. The plasma concentration of chidamide was assayed according to a validated high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) method. Individual pharmacokinetic parameters were estimated following noncompartmental methods using Phoenix WinNonlin Version 7.0 (Pharsight Corporation Mountain View, CA, USA) and SAS version 9.4 (SAS Institute Inc., Cary, NC, USA).
A pharmacokinetic study of chidamide was conducted in the dose-escalation part. Blood samples were collected at pre-dose and 1, 2, 4, 8, 12, 24, 48 and 72 h after the first dose in the run-in period and during the first cycle of combination treatment. The plasma concentration of chidamide was assayed according to a validated high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS) method. Individual pharmacokinetic parameters were estimated following noncompartmental methods using Phoenix WinNonlin Version 7.0 (Pharsight Corporation Mountain View, CA, USA) and SAS version 9.4 (SAS Institute Inc., Cary, NC, USA).
5
Pharmacokinetics of Volanesorsen via SC and IV
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The pharmacokinetic parameters of volanesorsen were calculated by noncompartmental analysis using Phoenix WinNonlin Version 7.0 (Pharsight Corporation, Mountain View, CA). The maximum observed drug concentration in plasma (Cmax) and the time to reach Cmax (Tmax) were obtained directly from the observed concentration/time data. Area under the plasma concentration/time curve from time 0 up to 24 h (AUC0–24h) was calculated using the linear trapezoidal rule. The absolute bioavailability after SC administration, as an approximation, was calculated as the ratio of AUC0–24h after SC and AUC0–24h after IV.
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