Serial blood samples for PK analysis were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 h on day 1 and day 9 for MET and BUP, and predose, 1, 2, 3, 4, 5, 6, 8, 10 and 12 h on day 9 for TMR. Concentrations of total MET, R‐MET, S‐MET, BUP, norBUP and TMR in plasma were determined by validated liquid chromatography with tandem mass spectrometry assays. Lower limits of quantification were 5 ng/mL for R‐MET, S‐MET and TMR, and 20 pg/mL for BUP and norBUP. Calibration standards ranged from 5 to 5000 ng/mL. Plasma samples were analysed at Covance and PPD Laboratories. Individual participant PK parameter values were derived with noncompartmental methods by a validated PK analysis program (Phoenix WinNonlin Version 6.2.1, Certara, Princeton, New Jersey) using actual times. COWS, SOWS, OOWS and OOA assessments were performed predose on each day of the study. Safety was assessed throughout the study, and safety assessments were based on medical review of adverse event (AE) reports and the results of vital sign measurements, ECG, physical examinations and clinical laboratory tests. Physical examinations and ECGs were performed at screening, day 1 and discharge/day 10; blood and urine were taken for clinical laboratory evaluations on day 5 and day 9. Vital signs were measured at screening, days 1, 5 and discharge/day 10.
Phoenix winnonlin version 6
Manufactured by Certara
Sourced in United States
Phoenix WinNonlin version 6.4 is a comprehensive pharmacokinetic and pharmacodynamic (PK/PD) data analysis software. It provides tools for the analysis and modeling of drug concentration and effect data from clinical and preclinical studies.
Automatically generated - may contain errors
Lab products found in correlation
Sas version 9, by SAS Institute (8 mentions)
Phoenix winnonlin, by Phoenix Pharmaceuticals (2 mentions)
Prism 5, by GraphPad (1 mentions)
Simcyp version 17, by Certara (1 mentions)
Acquity uplc beh c18, by Waters Corporation (1 mentions)
Spss statistics v24, by IBM (1 mentions)
Sigmaplot version 13, by Grafiti LLC (1 mentions)
Sas version 9.4 or higher, by SAS Institute (1 mentions)
Xevo tq s, by Waters Corporation (1 mentions)
Xb c18 column, by Phenomenex (1 mentions)
Uplc h class system, by Waters Corporation (1 mentions)
Compound discoverer 2, by Thermo Fisher Scientific (1 mentions)
Lc 10advp hplc, by Shimadzu (1 mentions)
49 protocols using phoenix winnonlin version 6
1
Pharmacokinetics of Opioid Analgesics
2
Tumor Xenograft Model Analysis
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Statistical analysis of CT053-treated tumors versus vehicle-treated tumors or versus nontreated tumors was performed by repeated-measures ANOVA. The data from the tumor xenograft models were expressed as the means ± standard error of the mean (SEM) and were plotted as a function of time. Noncompartmental pharmacokinetic analysis was performed using Phoenix WinNonlin Version 6.2.1 (Certara Inc., NJ, USA). Demographics and laboratory results of all the subjects were summarized using descriptive statistics. The pharmacokinetic parameters Tmax and T1/2 were shown as the median (min, max) and mean ± SD, respectively. A two-sided P < 0.05 was considered to indicate statistical significance. Statistical analysis was performed by using GraphPad Prism 5.0 (GraphPad Prism, RRID : SCR_002798) and SPSS software version 19.0 (SPSS, RRID : SCR_002865).
3
Modeling Plasma Concentration-Dependent Effects
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The relationship between plasma concentrations of compound 2 and mean arterial pressure (MAP) and HR, respectively, were modeled using data generated in the swivel study, including data from start of first infusion up to 2 h after end of last infusion (Dose 1–4, equivalent to 1.9, 11, 67 and 410 μg/kg per min for 15 min at each step). The baseline value, calculated as average of measurements during the 60 min baseline recording period was used as the predose value. Temporal differences between effect measurements and blood sampling for plasma analysis were accounted for by fitting a standard two-compartment PK model to the time-concentration profile for each individual animal, and subsequently using the individual parameter estimates to simulate compound 2 plasma concentrations at the times of effect measurements. Phoenix® WinNonlin® Version 6.2.1 (Certara, L.P., Princetown, NJ) was used for modelling.
4
Talazoparib Pharmacokinetics Validation
5
Imalumab Pharmacokinetics and Pharmacodynamics
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The enrolled analysis set included all enrolled patients, the safety population comprised all patients who received ≥1 dose of imalumab and the full analysis dataset included all patients who received ≥1 dose of imalumab and had pharmacodynamic data at baseline and at least one time point after treatment. The pharmacokinetic analysis dataset included all patients who received at least one scheduled dose of imalumab and provided one or more evaluable post‐dose concentration (ie, concentration above the lower limit of quantitation of the assay).
Best overall response (assessed using RECIST v1.1) was summarized by treatment group. Plasma concentrations of imalumab, oxMIF and total MIF and pharmacokinetic parameters were summarized using descriptive statistics. Individual subject concentration‐time data were graphically presented by treatment group on linear and semilogarithmic scales.
All data processing, analyses and summaries used SAS® software package (Version 9.3 or higher). Pharmacokinetic parameters were derived using noncompartmental methods with Phoenix® WinNonlin® Version 6.4 (Certara L.P., Princeton, NJ, USA) or SAS® Version 9.2, or higher (SAS Institute, Inc., Cary, NC, USA).
Best overall response (assessed using RECIST v1.1) was summarized by treatment group. Plasma concentrations of imalumab, oxMIF and total MIF and pharmacokinetic parameters were summarized using descriptive statistics. Individual subject concentration‐time data were graphically presented by treatment group on linear and semilogarithmic scales.
All data processing, analyses and summaries used SAS® software package (Version 9.3 or higher). Pharmacokinetic parameters were derived using noncompartmental methods with Phoenix® WinNonlin® Version 6.4 (Certara L.P., Princeton, NJ, USA) or SAS® Version 9.2, or higher (SAS Institute, Inc., Cary, NC, USA).
6
Pharmacokinetic Analysis of Investigational Drug
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Pharmacokinetic parameters and endpoints were derived from plasma concentrations using Phoenix WinNonlin Version 6.4 (Certara USA, Inc., Princeton, NJ) and a noncompartmental model with oral drug input. All analyses were performed using the statistical software SAS Version 9.2 (SAS Institute, Cary, NC) or higher. Pharmacokinetic parameters were summarized using descriptive statistics [number of non-missing observations (n), mean/median, standard deviation, and minimum/maximum]. The natural log-transformed parameters were summarized, and estimates of the geometric mean difference between dose and Japanese and non-Japanese groups were calculated, along with the 90% confidence intervals (CI). The geometric mean differences and the confidence limits were transformed back to the original scale in order to give estimates of the individual ratios by dose and Japanese and non-Japanese groups with 90% CIs. The CIs for the ratio of the geometric means for Cmax, AUC(0–z), and AUC(0–∞) were compared with the constant value of 1. Further information on statistical analyses can be found in Supplementary Information 2.
7
Bioequivalence Analysis of Pharmacokinetic Data
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Phoenix® WinNonlin version 6.4 (Certara LP, St Louis, MO, USA) was used to perform statistical analyses of the AUC0–72h, AUC0−∞, and Cmax by analysis of variance (ANOVA) after transformation of the data to their natural logarithmic (ln) values. The statistical power of the study would be 80% at the minimum, with α of 5% (two-sided). According to the European Medicines Agency (EMA) Guideline on the Investigation of Bioequivalence, the acceptance criteria for bioequivalence are that the 90% CIs of the geometric mean ratio for the AUC0−t and Cmax should be between 0.80 and 1.25.7 The difference in tmax in the original data was analyzed nonparametrically using Wilcoxon matched-pairs test. The difference in t½ was analyzed using the Student’s paired t-test or the Wilcoxon matched-pairs test depending on whether the differences in the paired data were normally distributed.
8
Phase I Pharmacokinetic Studies
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The planned SAD sample size, based on 13 cohorts, ranged from 8 to 104 participants, and the planned MAD sample size, based on 6 cohorts, ranged from 6 to 60 participants; the maximum sample sizes were dependent on the number of cohorts enrolled. The sample sizes were not based on formal statistical calculations; however, they were considered adequate to characterize the prespecified pharmacokinetic parameters and to provide sufficient evidence of tolerability for these Phase I studies. The plasma pharmacokinetic analyses for both studies were conducted using noncompartmental methods with Phoenix WinNonlin, version 6.4 (Certara USA Inc, Princeton, New Jersey).
9
Modeling Atorvastatin Pharmacokinetics
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All simulations were performed using Simcyp version 17 (Certara, Princeton, NJ). Noncompartmental analyses were carried out using Phoenix WinNonlin version 6.4 (Certara, Princeton, NJ). All major atorvastatin‐related species (atorvastatin, o‐hydroxyatorvastatin, atorvastatin lactone, and o‐hydroxyatorvastatin lactone) were included in the model. To incorporate the gastric conversion of atorvastatin to atorvastatin lactone, two model files were created, one for atorvastatin and one for atorvastatin lactone, to represent lactone formation in the stomach. The fraction of atorvastatin absorbed as acid/lactone at each atorvastatin dose was determined as described in Model Files below. The species included in each model file and the inputs are summarized in Table 1 . Figure 1 depicts the generalized disposition of all species included in the current model and the overall modeling strategy.
10
Quantification of CNP520 in Biological Fluids
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In the clinical studies, CNP520 concentrations were determined in plasma, urine, and CSF with a validated LC‐MS/MS method. The lower limit of quantification (LLOQ) was 1 ng/ml in plasma and 2 ng/ml in urine and CSF, except for the 3‐month study where the method for CSF was more sensitive (LLOQ 0.1 ng/ml). Plasma PK parameters were calculated using actual recorded sampling times and non‐compartmental methods with Phoenix WinNonlin version 6.4 (Certara, Inc., Princeton, NJ, USA).
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