VALIDAT Laboratory Software for Drug Release
Administer your dissolution data using VALIDAT
Drug release requirements
Dissolution tests for pharmaceutical products are performed during the development of a new dosage form, and even as early as during the quality control stage for stability testing, in order to allow the bioavailability of an active ingredient to be predicted. The development, performance, analysis, evaluation and reporting involved are very extensive and cumbersome. Information is collected from dissolution machines and analytical devices, then assessed and processed graphically in context. Central documentation is important for later research and for the purposes of comparison.
Our VALIDAT software solution
The dissolution module in VALIDAT laboratory software offers extensive functionalities for planning and the manual and automatic recording of measurements. This data may constitute measurements from dissolution machines or data from measuring instruments and systems, but also calculations and assessments (e.g. extension of the scope of the experiment), a statistical evaluation or the graphical visualisation of the data or the reporting and documentation of dissolution experiments. This also guarantees the calculation of all relevant parameters, including the f1/f2 values for profile comparison.
The individual dissolution experiments for drug release are available in a comparative database, which allows for fast, flexible research and facilitates the amalgamation of comparative projects in laboratory software for drug release.
YOUR BENEFITS AT A GLANCE
Import of legacy data
There is no need to lose your data. Your old data pools can be imported into the central database by means of an import function.
Investigation data from drug release (dissolution), but also data from the development of stability tests and quality control are documented centrally and uniformly, regardless of the instruments and analytical methods used. The related documents are also archived in the DMS.
Simple, secure transfer of measurements
There is no possibility of manual data transfer errors, since the data is imported automatically by VALIDAT – whether directly from the dissolution machine (e.g. WinSOTAX), from measuring systems such as Agilent, UV-VIS devices (e.g. Cary UV-Vis), CDS systems (Waters Empower, Thermo-Fisher Chromeleon, Agilent EZChrom, etc.) or from a LIMS (e.g. LABS/Q®).
Uniform evaluation and assessment
In VALIDAT, evaluation and assessment of results is always performed directly and accurately on the basis of the validated processes and functions.
Uniform release reports are created based on report templates from VALIDAT laboratory software, and are documented in the DMS. The document can be printed, exported in .rtf, .doc or .html format or shown as a .pdf file.