Determination of cut point based on similarity of mean and variance among datasets
Cut point calculation using mean or median approach
An Integrated Bioanalytical Method Validation Software for PK, ADA, Biomarker, and Biosimilar Assays
Aegyris software is designed to enable bioanalytical scientists to perform method validation and statistical analysis in a streamlined and regulatory compliant manner.
The Aegyris software is being developed as a web-based application. The web front end of the software provides a rich user interface for data analysis and visualization. The backend integrates with a fully functional on-demand R statistical analytic engine. The application is massively scalable and supports real-time analytics by storing data in a NoSQL database. A built-in open interface module allows seamless importing and exporting of data from various third-party laboratory instrument software or LIMS.
Aegyris can save up to 90% of time and costs in method validation support activities when implemented as designed.