DissolutionComplex is a program supporting pharmaceutical availability studies. It makes it possible to manage the results obtained and to assess, using different methods, the similarity of the obtained release profiles (time-release dependency curves). The design of the program and its functions take into account not only the guidelines for comparing profiles, but also the requirements for computer systems in pharmacy and the requirements resulting from the daily work of the users.

DissolutionComplex consists of two cooperating elements: a pharmaceutical availability test results input environment and a data analysis panel designed for: preliminary data evaluation, quick overview of the compared profiles and creation of reports for different methods of comparison.

The program interface uses a dedicated database structure, thanks to which the users have the possibility to do:

• free definition and description of results sets - there are no limitations on the number of attempts or time points, labels are created by the users themselves
• entering, modifying and extending sets of results and their descriptions
• store complete sets of results for reference and compared samples
• to store an unlimited number of test results in one place
• insight into the history of changes concerning the defined sets and the research results introduced
• quick import of results from Excel files

DissolutionComplexsoftware is not only a convenient tool for storing the results of pharmaceutical availability research for further analysis, but above all a historical knowledge base, which is a great help in development work and allows for a reliable evaluation of the changes introduced in the process and product.

The data analysis panel uses the data stored in the program, allowing users to easily filter and search for and then point to data sets for analysis. The user can freely define sets of reference and test sets.

In order to apply an appropriate approach to profile comparison, the program evaluates the data in terms of the number of results, their layout and properties, which allows for the selection of the correct method of their further analysis. The results of the initial evaluation of the data refer, inter alia, to the guidelines contained in this document: "Guidance for Industry; Dissolution Testing of Immediate Release Solid Oral Dosage Forms; FDA". DissolutionComplex allows you to compare profiles with several methods depending on your needs and layout of results: standard method of similarity and difference factors (f2, f1), method based on determining confidence intervals of factors f1 and f2 with the use of bootstrap technique and multidimensional or model-dependent methods.

The data analysis panel enables you to:

• use of the results stored in the database
• selection of an unlimited number of data sets for analysis
• possibility of analyzing sets of different numbers
• an initial analysis of the data sets in order to assess the assumptions of the methods used for their further analysis
• evaluation of the distribution of results between the examined sets and the variability within the subsequent time points
• the use of a set of calculation methods from different families, allowing profiles to be compared in the most appropriate way
• the use of different methods of comparison, making it possible to discover valuable information that may be unnoticed when using a single method
• automatic generation of statistical analysis results together with their appropriate interpretation
• automatic generation of reports summarizing the obtained profile evaluation

If you are interested in this solution, need additional information or want to see the program in live - please contact us.