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Equiv Test/PK 是一等效统计分析及药物吸收软件，药物吸收分析很⌒ 容易使用也不必写程序，是根据FDA及CPMP的条文，独特的优点是合乎工业标准，评估等效的测试及可靠度区间。
What is EquivTest/PK?
EquivTest/PK is a suite of tools that provides the user with a comprehensive set of pharmacokinetic calculations as well as extensive tests and confidence intervals for equivalence testing.
EquivTest/PK provides a range of tests and confidence intervals for the statistical analysis of Equivalence Studies. Researchers working in clinical equivalence and bioavailability studies can now use this equivalence testing software to investigate equivalence according to FDA and CPMP guidelines.
PK Parameters
EquivTest/PK now has the added feature of simple-to-use, built-in pharmacokinetic functions. It provides a fast and easy means of calculating and plotting the most commonly used pharmacokinetic parameters such as;
Cmax, Tmax, Lag Time, AUC(0-t), AUC(t-∞), AUC(0-∞), AUC(0-t)/AUC(0-∞), Mean Residence Time, AUMC(0-t), AUMC(0-∞), Half-Life, Elimination Rate Constant (λ ).
All of the PK calculations in EquivTest/PK are based on noncompartmental methods of analysis for the estimation of pharmacokinetic parameters. (See What’s New Section).
Once the PK parameters have been calculated, there is no need to export data to another application, because EquivTest/PK can proceed to perform the bioequivalence phase of the study.
Analyze your equivalence studies with EquivTest/PK
EquivTest™ provides test and confidence interval procedures for three types of clinical trials:
Noninferiority trial: Such a study might be designed to demonstrate that a new treatment is not relevantly inferior to a standard, a typical clinical trial goal.
Equivalence Trial: Such a study might be designed to demonstrate equivalence with respect to a rate and extent of drug absorption between a reference and a generic version, a typical bioequivalence goal.
Superiority Trial: Such a study is the most convincing way to establish the efficacy of a new investigational treatment by demonstrating that the new one is better than a control group, e.g. placebo or a standard.
Equivalence Tests can be performed on the following parameters without any need for data management.
Difference between means
Difference between means of log transform
Ratio of means
Difference in proportions
Ratio of Proportions
Odds ratio
EquivTest/PK also provides:
Interactive concentration/time curves to simplify PK analysis.
Option to interpolate between missing values for PK calculations.
Pre-programmed equivalence statements for inclusion in your reports and submissions.
Unique data management feature accepts data stored in rows or columns.
Industry standard, validated equivalence tests and confidence intervals.
Other Major Features
Editable output reports with detailed option selection, analysis results, and plots.
Non-parametric analyses ( Hodges-Lehmann confidence interval and Wilcoxon-Mann-Whitney tests).
Developed according to specifications by leading statisticians, EquivTest™ provides industry-accepted, validated equivalence procedures for reliable statistical analysis.
Test and Confidence Interval methods for equivalence of proportions include: Santer & Snell’s Conditional method, Fisher’s Exact, Hauck-Anderson, Newcombe-Wilson and Farrington-Manning.
Techniques for testing the ratio of means for normally distributed data.
Published references for each test are documented in every output report.
