Phoenix software

Manufactured by Pharsight

Sourced in United States

Phoenix software is a data analysis tool used for the modeling and simulation of pharmacokinetic and pharmacodynamic data in drug development. The software provides a comprehensive set of features for the analysis and visualization of experimental data.

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Lab products found in correlation

Spss 19, by IBM (1 mentions) Nonmem software, by ICON Development Solutions (1 mentions)

Close spelling variants of this product

Phoenix WinNonlin software Phoenix WinNonlin software version 6.3 Phoenix WinNolin software Phoenix NLME software Phoenix WinNonlin PK/PD Modeling and Analysis software Phoenix WinNonlin software 6·1

12 protocols using phoenix software

Pharmacokinetics and Toxicity Analysis

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Two independent samples t test was used to compare the steady state concentration of each dose group between the different severity of adverse reaction, when p < 0.05, indicating a significant difference. Genotype frequencies at each locus were tested for Hardy-Weinberg equilibrium using a χ² test. For toxicity analysis, baseline corrected toxicity scores were calculated by subtracting baseline values from the maximum recorded score in four cycles of treatment, and the HFS toxicity end point was dichotomised as higher than grade 1 (yes or no). The other toxicity end point was dichotomised as happened versus unhappened. The end-point dose reduction was dichotomised as any dose reduction within cycle 1-4 or no dose reduction. Genotype associations with toxicity events were first analyzed using univariate and multivariate logistic regression. For multivariate analyses, associations with p ≤ 0.05 were considered significant. Statistical analyses were performed using SPSS19.0 software (IBM Corp., Armonk, NY, USA).
All the result of plasma concentrations of sunitinib and the active metabolite and the patient characteristic that corrected from this study were used in the population PK study, and weight, sex, age and genotypes were included as covariates. Population pharmacokinetics study was performed using Phoenix software (Version1.4, Pharsight, A Certara Company, USA).

Zhang Y., Mai H., Guo G., Bi G., Hao G., Li Y., Wang X., Cheng L., Wang J., Dong R., Liu Z., Chen L, & Qu H. (2018). Association analysis of SNPs present in plasma with adverse events and population pharmacokinetics in Chinese sunitinib treated patients with renal cell carcinoma. Oncotarget, 9(18), 14109-14123.

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Drug Concentration Determination for Anti-TB Therapies

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Drug concentrations were determined using validated liquid chromatography tandem with mass spectrometry (LC/MS/MS) methods as we previously described (23 (link)). The observed C_max and time to C_max (T_max) were determined by inspection of the serum concentration-time graphs for each drug and AUC from time 0 to 8 hours (AUC_0–8h) was calculated using noncompartmental analysis (Phoenix Software; Pharsight Corporation, Mountain View, CA). The observed C_max of each drug below the proposed lower limit of the following references ranges in adults were considered to be low: isoniazid 3 to 6 μg/mL, rifampin 8 to 24 μg/mL and pyrazinamide 20 to 50 μg/mL and ethambutol 2 to 6 μg/mL (12 (link)). Pyrazinamide plasma C_max < 35 μg/mL was considered as low in secondary analysis as that cut off was associated with poor treatment outcome in one study in predominantly HIV-infected adults in Botswana (25 (link))

Yang H., Enimil A., Gillani F.S., Antwi S., Dompreh A., Ortsin A., Awhireng E.A., Owusu M., Wiesner L., Peloquin C.A, & Kwara A. (2018). Evaluation of the Adequacy of the 2010 Revised World Health Organization Recommended Dosages of the First-line Antituberculosis Drugs for Children. The Pediatric infectious disease journal, 37(1), 43-51.

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Pharmacokinetic Analysis of Drug Concentrations

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PK analyses of the plasma concentration-time relationships were performed with Phoenix software (version 6.2; Pharsight, USA). A noncompartmental analysis program, model 200, was used to calculate PK parameters. The maximum concentration of drug in plasma (C_max), time to C_max (T_max), elimination half-life (t_1/2), and area under the concentration-time curve (AUC) from time zero to infinity (AUC_0–∞) were estimated. AUC was computed using the trapezoidal rule (linear up and log down), and the AUC_0–∞ was considered only when the extrapolated AUC was not more than 20% of the original value. A minimum of three sample points in the terminal slope were used to calculate half-life.

Singh R., Ramachandran V., Shandil R., Sharma S., Khandelwal S., Karmarkar M., Kumar N., Solapure S., Saralaya R., Nanduri R., Panduga V., Reddy J., Prabhakar K.R., Rajagopalan S., Rao N., Narayanan S., Anandkumar A., Balasubramanian V, & Datta S. (2015). In Silico-Based High-Throughput Screen for Discovery of Novel Combinations for Tuberculosis Treatment. Antimicrobial Agents and Chemotherapy, 59(9), 5664-5674.

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Milk Concentration Pharmacokinetics in Cows

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Using Phoenix software (version 8.1, Pharsight, United States), analyze the relationship between milk concentration and time in each cow. Parameter analysis was performed using non-compartmental models, and the major pharmacokinetic parameters of two groups were compared. The pharmacokinetic parameters were presented as the mean plus or minus the standard deviation (SD). Based on previous research, the calculation formula for relative bioavailability (RBA) is as follows:

Li S., Yu N., Tang Y., Liu C., Zhang Y., Chen X., Wu H., Li X, & Liu Y. (2024). Pharmacokinetics and relative bioavailability study of two cefquinome sulfate intramammary infusions in cow milk. Frontiers in Veterinary Science, 11, 1384076.

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Efavirenz Pharmacokinetics in Pregnant Women

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Pharmacokinetic blood sampling was performed after at least 4 weeks of ART during pregnancy and at least 6 weeks postpartum. In addition, a random blood sample (when feasible) from mother and cord blood were collected at delivery. Given the CNS side effects of EFV, ART was administered at night but on the day of PK sampling, ART was administered in the morning after an overnight fast. Blood samples were collected at times 0, 1, 2, 3, 12 and 24 hours post-dose for determination of EFV concentrations. Blood samples collected in EDTA-coated tubes were centrifuged within 30 minutes at 3000 g for 10 minutes. Plasma was stored at −80°C until shipment on dry ice to University of Cape Town, Cape Town, South Africa for EFV concentrations assays. Efavirenz plasma concentrations were measured using validated liquid chromatography tandem with mass spectrometry (LC/MS/MS) methods.^{14 (link)} Lower limit of quantification (LLOQ) for the assay was 0.0844 μg/ml. The maximum or peak EFV concentration (C_max), time to C_max (T_max) and C_min were determined by inspection of the plasma concentration-time graphs. The calculations of AUC_0–24h, estimated and apparent oral clearance (CL/F) were performed using noncompartmental analysis (Phoenix Software; Pharsight Corporation, Mountain View, CA).

Lartey M., Kenu E., Lassey A., Ntumy M., Ganu V., Sam M., Boamah I., Gilani F.S., Yang H., Burch G.M., Norman J., Peloquin C.A, & Kwara A. (2020). Pharmacokinetics of Efavirenz 600 mg Once daily during Pregnancy and Postpartum in Ghanaian Women Living with Human Immunodeficiency Virus. Clinical therapeutics, 42(9), 1818-1825.

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Tumor Xenograft Pharmacokinetics and Pharmacodynamics

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Overall, 5 × 10⁶ of MPS1-doxycycline (Dox)-inducible DLD-1 human colorectal carcinoma cells were injected s.c. bilaterally into the flanks. Once tumours reached a mean diameter of 8–10 mm, animals were put on Dox diet for 3 days and given an oral gavage bolus of Dox (6 mg/mouse) 24 h before dosing of compounds. Animals (n=3 per group) were dosed once daily with CCT271850 (50 or 100 mg/kg po) or vehicle (10% DMSO, 5% Tween 20, 85% saline). Mice were culled at 2, 6, 12 and 24 h after dosing. Heparinised plasma was collected and tumours were snap-frozen for pharmacokinetics (PK) and PD biomarker analysis. For PK examination, compounds were extracted from whole blood, plasma and tissue homogenates with methanol-containing internal standards using established protocols. CCT271850 concentrations were determined using liquid chromatography/tandem mass spectrometry and PK were calculated using the Pharsight Phoenix Software (Mountain View, CA, USA, version 6.3). For PD examination, samples were lysed and analysed by MSD for pT33pS37and GFP levels and ratio of P-MPS1 (pT33pS37)/Total-MPS1 (GFP) in tumour samples at various time points after 50 and 100 mg/kg dosing were calculated.

Faisal A., Mak G.W., Gurden M.D., Xavier C.P., Anderhub S.J., Innocenti P., Westwood I.M., Naud S., Hayes A., Box G., Valenti M.R., De Haven Brandon A.K., O'Fee L., Schmitt J., Woodward H.L., Burke R., vanMontfort R.L., Blagg J., Raynaud F.I., Eccles S.A., Hoelder S, & Linardopoulos S. (2017). Characterisation of CCT271850, a selective, oral and potent MPS1 inhibitor, used to directly measure in vivo MPS1 inhibition vs therapeutic efficacy. British Journal of Cancer, 116(9), 1166-1176.

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Meloxicam Pharmacokinetics in Eggs

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A total of 20 blank eggs were subjected to manual separation into egg white and yolk, and each white and yolk were weighed. Subsequently, the weight ratio between white and yolk was determined for each egg, and its mean value was determined as 1.54. Based on this weight ratio combined with meloxicam concentrations in the white and yolk, drug concentrations in the whole egg were further calculated. Pharmacokinetic parameters for meloxicam in egg white, egg yolk, and whole egg were further estimated using Phoenix software (version 8.1; Pharsight; Mountain View, CA) by noncompartmental analysis. The area under the concentration-time curve (AUC_0–∞) was calculated using the linear trapezoidal rule with extrapolation to time infinity (Song et al., 2023 ). Other pharmacokinetic parameters included terminal phase rate constant (λz), terminal half-life (t_1/2_λ), peak concentration (C_max), and the time to reach it (T_max).
The Kolmogorov-Smirnov test in SPSS 20.0 software was used to determine the data normality of each pharmacokinetic parameter. The independent sample t test in SPSS 20.0 was used for parameters with normal distribution, and the Mann-Whitney U test was used for other parameters. A P value <0.05 was considered significant.

Shao H.T., Gao L., Li H.T., Zhang M., Chen J.C., Duan M.H., Li Z.E., Dai Y., Li X.P, & Yang F. (2023). Egg residue and depletion of meloxicam in Jing Hong laying hens following multiple oral doses. Poultry Science, 102(8), 102761.

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Quantification of Rifampin Plasma Levels

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Rifampin plasma concentrations were determined using HPLC with UV detection as previously described.^{11 (link)} The standard curves for plasma rifampin concentrations covered a range of 0.5 to 50 μg/ml. The within-day precision (coefficient of variation [CV]) of validation quality control samples was 2.4% to 4.6%, and the overall validation precision was 6.3% to 7.1%. The absolute recovery of rifampin from serum was 95.5%. The observed C_max for each subject were observed by inspection of the serum concentration- time graphs. Calculations of the AUC from time 0 to 24hr (AUC_0–24hr), apparent oral clearance (CL/F) clearance, and volume of distribution (Vz/F) were performed using noncompartmental analysis (Phoenix Software; Pharsight Corporation, Mountain View, CA). Efavirenz AUC_0-24h ratios (in the presence versus absence of rifampin) and body weight-normalized CL/F ratio used in the secondary analysis was previously reported.^{16 (link)}

Kwara A., Cao L., Yang H., Poethke P., Kurpewski J., Tashima K.T., Mahjoub B.D., Court M.H, & Peloquin C.A. (2014). Factors Associated with Variability in Rifampin Plasma Pharmacokinetics and the Relationship between Rifampin Concentrations and Induction of Efavirenz Clearance. Pharmacotherapy, 34(3), 265-271.

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Pharmacokinetic Analysis Using Phoenix

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The pharmacokinetic parameters were calculated using traditional, noncompartmental methods in Phoenix software (Pharsight Corp., Mountain View, California) version 6.2.1.

Groenendaal‐van de Meent D., den Adel M., Kerbusch V., van Dijk J., Shibata T., Kato K, & Schaddelee M. (2022). Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies. Clinical Pharmacology in Drug Development, 11(4), 486-501.

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Noncompartmental PK Analysis of IM Dosing

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PK parameters from concentrate-time data in the plasma were determined using noncompartmental analysis (NCA) with Phoenix software (Version 8.0; Pharsight, CA, USA). The dose proportionality of the PK parameter, including AUC_0-inf and C_max after IM dosing in rats and dogs, was evaluated by model-derived β values using a power model (PK = α × Dose^β), and the critical intervals for slope (β) were 0.84–1.16. The power model analysis, PopPK, and PK-PD modelling were performed using Phoenix NLME. The above calculations to obtain the statistical calculation of individual values and Student’s t test between two groups were completed using Microsoft Excel 2016. Bioavailability (F) was calculated using the formula F = (AUC_{0-inf, IM}/AUC_{0-inf, IV}) × (Dose _IV/Dose _IM).

Zhu X., Yuan M., Wang H., Zhangsun D., Yu G., Che J, & Luo S. (2022). Novel αO-conotoxin GeXIVA[1,2] Nonaddictive Analgesic with Pharmacokinetic Modelling-Based Mechanistic Assessment. Pharmaceutics, 14(9), 1789.

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