StatSoft DPC Dissolution Profiles Comparison is an application designed for evaluation of the similarity between dissolution profiles. The application allows: selection of an appropriate profile comparison method for a given case, standardization of the performed statistical analyzes and interpretation of the results and generation of a report for registration documentation. The methods used in the module comply to the recommendations of the EU EMA and the US FDA. The application is validated according to cGxP requirements.
Check out our latest solution: StatSoft DCP SaaS
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Main functionalities:
- Defining the objective, description, and study context
- Saving/opening raw data in Excel or Statistica format
- Selecting statistical data analysis methods
- Generating reports in Word or PDF format
- Saving/opening complete studies along with selected settings
- Option: saving the dissolution study results to a dedicated database
- Model independent methods:
- Similarity factor f2
- Difference factor f1, f1’
- Similarity factor f2 bootstrap
- Similarity factor EXP(f2) bootstrap
- Multivariate statistical distance using approximate confidence limit (ACLMD)
- Multivariate statistical distance using Hotelling’s T2 statistic (T2EQ)
- Model dependent methods:
- Model parameters comparison using approximate confidence limit (ACLMD)
- Model parameters comparison using Hotelling’s T2 statistic (T2EQ)
- Model parameters comparison using confidence region (CR)
- Dissolution curves comparison using maximum distance (Dmax)
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