Pharmacokinetic parameters were calculated using the noncompartmental model (NCA module) on WinNonlin 8.2 (Pharsight Corporation, Mountain View, CA, USA). Statistical analysis was performed with SAS 9.4 Statistical Package (SAS Institute Inc., Cary, NC, USA). In Part I, the confidence interval method was used to analyze the linear relationship of AUC and Cmax with the dose. The natural logarithm of AUC and Cmax was used to perform linear regression analysis with the dose. The slope of the linear regression equation and 90% confidence interval were observed. In Part II, natural log-transformed AUC0-t, AUC0-∞, and Cmax were analyzed by analysis of variance with a mixed-effects model. Treatment sequence, formulation, and period were the fixed effect variables, and participant was the random effect variable. The relative bioavailability of the test drug and reference drug was evaluated based on average bioequivalence (ABE) or reference-scaled average bioequivalence (RSABE). In Part III, the least-squares mean ratios and 90% confidence intervals of Cmax, AUC0-t, and AUC0-∞ of abiraterone in the plasma were calculated after oral administration under different feeding conditions. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (test/reference) and 90% CIs for the ratios.
Winnonlin 8
Manufactured by Pharsight
Sourced in United States
WinNonlin 8.1 is a pharmacokinetic and pharmacodynamic software package used for the analysis of clinical trial data. The software provides tools for noncompartmental analysis, compartmental modeling, and simulation.
Automatically generated - may contain errors
Lab products found in correlation
12 protocols using winnonlin 8
1
Pharmacokinetics Study of Abiraterone
2
Pharmacokinetic Analysis of Active Ingredients
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
To determine the pharmacokinetic parameters of the four active ingredients, the concentration–time data were analyzed using the WinNonLin 8.2 pharmacokinetic program (Pharsight Corporation, Phoenix, AZ, USA) with the non-compartmental method. The comparisons of pharmacokinetic data between the two groups were performed using the SPSS (IBM SPSS Statistics 20.0 Developer, IBM Corp, New, York, NY, USA) software with analysis of variance. The results were compared by independent sample t-test. All the results are expressed as arithmetic mean ± standard deviation (SD).
3
Pharmacokinetic Analysis of Saliva-Plasma Ratio
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
The PK parameters (Cmax, Tmax, AUC, T1/2) of ATB KACs were calculated by the non-compartmental method, using WinNonlin 8.2 (Pharsight Corporation, Mountain View, CA, USA). The ratio of drug concentration in plasma and saliva were calculated using Equations (1) and (2).
4
Metformin Pharmacokinetics Evaluation
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
PK samples for metformin were drawn at Hour 0 (pre‐dose) and Hours 6, 12, and 24 following the first metformin dose on Cycle 1 Day 1. Additional PKs were drawn at Hour 0 before the Cycle 1 Day 8 dose and Hour 6 post‐dose. One ml of whole blood was shipped on cold packs overnight to NMS Labs (Willow Grove, PA) where metformin concentration was determined using a previously published assay.31 Briefly summarized, pharmacokinetic analysis was conducted using non‐compartmental methods (WinNonlin 8.1; Pharsight). Area under the curve (AUC) for samples obtained up to 12 h were calculated using Linear Trapezoidal Linear Interpolation rule.32 The observed time to maximum concentration (Tmax), observed maximum plasma concentration (Cmax) and average plasma concentration at steady‐state (Cssavg) were summarized using descriptive statistics.
5
Pharmacokinetic Analysis of Intravenous Injection
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Data are expressed as mean ± standard deviation (SD). Data were analyzed using a two-tailed unpaired Student’s t-test and one-way analysis of variance ANOVA. Statistical significance was set as P < 0.05. Pharmacokinetic parameters for intravenous injection were determined individually as a non-compartmental model using WinNonlin 8.1 software (Pharsight, Princeton, NJ, USA). Statistical comparison of PK parameters was performed using Student’s t-test.
6
Pharmacokinetic Analysis with Statistical Significance
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Pharmacokinetic parameters were evaluated with WinNonlin 8.1 (Pharsight, St. Louis, MO, USA). As for statistical significance, it was determined using GraphPad Prism 8.0 (GraphPad Software, Inc., San Diego, CA, USA) via a two-tailed Student’s t-test. Statistical differences were considered significant when p < 0.05.
7
Non-Compartmental Pharmacokinetic Analysis
8
Pharmacokinetic Analysis of Pharmacological Agents
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Plasma concentrations versus time for each cow were analyzed using WinNonlin 8.1 (Pharsight Corporation, Mountain View, CA, USA) software that provides noncompartmental analyses of the experimental data. Least-squares nonlinear regression was used to fit the pharmacokinetic parameters to the weighed (y = l/y2) experimental data. The pharmacokinetic parameters of IMD for each cow were obtained, and the main pharmacokinetic parameters were compared between the two groups. Also, the three pharmacokinetic parameters of AUC0-t, AUC∞ and Cmax were used to analyze the bioequivalence of the two preparations.
9
Pharmacokinetic Parameter Determination
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
In vitro Km and Vmax for metabolic reactions in RLMs were calculated based on the Michaelis-Menten equation using Sigma Plot software (Jandel Scientific, San Rafael, CA, USA). CLint was calculated by dividing the Vmax by the Km. Percentage (%) of free form was calculated by the concentration of buffer chamber by dividing the concentration of plasma chamber in the protein binding study. The following pharmacokinetic parameters were determined by non-compartmental analysis using WinNonlin® 8.3 (Pharsight Co., Mountain View, CA, USA): total area under the plasma concentration versus time curve from time zero to infinity (AUC); total body clearance (CL), elimination half-life (t1/2); apparent distribution volume at the steady-state (Vss); the first moment of AUC (AUMC); and the mean residence time (MRT). CLR was obtained by dividing the accumulated drug amount excreted in urine over 24 h by AUC [11 (link)], assuming the urinary recovery of the drug was completed 24 h after drug administration. Moreover, CLNR was calculated to subtract CLR from CL.
10
Pharmacokinetic Analysis of Compounds
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Pharmacokinetic parameters, including total area under the plasma concentration versus time curve from time zero to infinity (AUC∞), total body clearance (CL), apparent distribution volume at the steady state (Vss), and mean residence time (MRT) were determined using non-compartmental analysis with WinNonlin® 8.3 (Pharsight Co., Mountain View, CA, USA).
Differences were considered statistically significant at p < 0.05, as determined by using the two-tailed Student’s t-test between unpaired average values for control and treated groups. Results are presented as the means ± standard deviations (SDs).
Differences were considered statistically significant at p < 0.05, as determined by using the two-tailed Student’s t-test between unpaired average values for control and treated groups. Results are presented as the means ± standard deviations (SDs).
About PubCompare
Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.
We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.
However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.
Ready to get started?
Sign up for free.
Registration takes 20 seconds.
Available from any computer
No download required
Revolutionizing how scientists
search and build protocols!