Clinical Bundle – a professional package for data analysis in bioequivalence studies
The Clinical Bundle is a dedicated package for statistical analysis of clinical equivalence studies of drugs, substances, or more generally various treatments. This package ensures convenience, efficiency, and compliance with regulatory recommendations (EMA, FDA). It streamlines the entire process and covers the whole statistical analysis, from the planning phase to the analysis of the obtained data.
The Clinical Bundle is add-on to Statistica and uses Statistica as its computational environment, providing access to a comprehensive range of analytical methods.
User benefits:
Comprehensive support for data analysis during equivalence studies, including verification of data against assumptions and execution of key analyses with a statistical test indicating whether equivalence is the case or not
✔ AUC and its cognates
✔ Maximum concentration
✔ Maximum concentration time
✔ Half-life
✔ Elimination constant
Analyses
✔ Sample size estimation
✔ Power analysis
✔ Random assignment to groups
✔ Shapiro-Wilk test
✔ Levene’s test
✔ Tukey’s test
✔ Grubbs’ Test
✔ Schuirmann’s test (TOST)
✔ Anderson-Hauck test
✔ Wilcoxon’s test
Do you have questions?
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