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EquivTest comprises many tests including the buildig of confidence intervals that are needed for the statistical analysis of bio-equivalence studies, which can be quickly and easily analysed by EquivTest without any programming. All statistical tests and methods that are used in the fields of clinical equivalence or bioavailability and required by the FDA and CPMP in its guidelines are included in this easy to use program. Furthermore, EquivTest is also deployable in all other areas needing statistical equality tests.
Arguments for EquivTest:
- quick and easy to use
- includes many tests and confidence intervals
- complies with the guidelines of the FDA and CPMP
What is EquivTest?
The analysis of bioequivalence studies can be quick, easy and programming-free. All statistical methods required by the FDA and CPMP guidelines are available in one easy-to-use package. EquivTest 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.
Unique User Benefits
- Pre-programmed equivalence statements for inclusion in your reports and submissions.
- Quickly generate equivalence tests from raw data and from summary statistics.
- Unique data management feature accepts data stored in rows or columns.
- Industry standard, validated equivalence tests and confidence intervals in a Windows environment.
- 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.
- Pharmacokinetic parameters such as AUC, Cmax and tmax can be calculated using the transformation options included in EquivTest. The AUC is estimated by means of linear interpolation using the trapezoidal rule.
- 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.
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
Analyze your equivalence studies with EquivTest
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 the new one is better than a control group, e.g. placebo or a standard.
Choosing Your Study Design For Equivalence Testing
EquivTest allows you to conduct equivalence testing for industry standard experimental designs with equal or unequal n's:
- Two independent groups (Means & Proportions)
- Paired outcomes (Means)
- 2 X 2 Crossover designs (Means)
|Further Requirements||CD/ROM Drive|
|Operating System||95/98/NT 4.0/2000/ME, or higher|
|Minimum CPU||486 Processor or higher|
|Min. RAM||32 MB RAM|
|Disk Space||32 MB|
- Descriptive Statistics
- Frequency Tables
- Fully interfaced to the complete BMDP Program Library
- 32-bit Application
- Study data repeated measures outcomes can be entered as multiple variables per subject or multiple records per subject
- Spreadsheet-like data entry
- Easy specification of variable attributes:
Type, Role, Grouping, Cutpoints, etc.
- Easy specification of variable transformation
- Windows data editing features such as:
Cut, Copy, Paste, Undo, Select/Unselect variables
- Comparison of Means (means +/- SD or SEM)
- Missing Data Matrix
- Customizable plotting facility
- Plots integrated within all analyses
- Wide variety of charts and plots including:
Box Plots, Scatterplots, Normal Probability Plots, Histograms
On-Line Help Features
3 Kinds of help: Procedural, Statistical usage, Statistical definition
- SAS (Unix/Windows)
- Lotus 1-2-3