DPC Dissolution Profiles Comparison is a software 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,
- automatic report generation in tabular and/or graphical form for submission of registration documentation.
All you need is to enter the data and press a button to get a full report in the form of a Microsoft Word or PDF document. The report includes results of the statistical analyses and comments to facilitate the interpretation of the obtained results.
Optionally, the data can be stored in a dedicated database.
The methods used in the module comply to the recommendations of the EU EMA and the US FDA.
The software has been validated according to cGxP requirements.
- Model independent methods:
- Similarity factor f2
- Difference factor f1, f1’
- Similarity factor f2 bootstrap
- Similarity factor EXP(f2)
- 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 deviation (Dmax)
- Time points truncation according to the rules of EMA, FDA, WHO
- Generation of reports in Word, e-CTD, PDF, Statistica formats
- Configuration of report content with selection of statistical analysis methods
- Creation of templates, containing the configured range of statistical analyses
- Option: saving the results to a database with audit trail
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