CPhaMAS: The first pharmacokinetic analysis cloud platform developed by China.

Abstract

Objectives: Software for pharmacological modeling and statistical analysis is essential for drug development and individualized treatment modeling. This study aims to develop a pharmacokinetic analysis cloud platform that leverages cloud-based benefits, offering a user-friendly interface with a smoother learning curve.

Methods: The platform was built using Rails as the framework, developed in Julia language, and employs PostgreSQL 14 database, Redis cache, and Sidekiq for asynchronous task management. Four commonly used modules in clinical pharmacology research were developed: Non-compartmental analysis, bioequivalence/bioavailability analysis, compartment model analysis, and population pharmacokinetics modeling. The platform ensured comprehensive data security and traceability through multiple safeguards, including data encryption, access control, transmission encryption, redundant backups, and log management. The platform underwent basic function, performance, reliability, usability, and scalability testing, along with practical case studies.

Results: The CPhaMAS cloud platform successfully implemented the 4 module functionalities. The platform provides a list-based navigation for users, featuring checkbox-style interactions. Through cloud computing, it allows direct online data analysis, saving computer storage and minimizing performance requirements. Modeling and visualization do not require programming knowledge. Basic functionality achieved 100% completion, with an average annual uptime of over 99%. Server response time was between 200 to 500 ms, and average CPU usage was maintained below 30%. In a practical case study, cefotaxime sodium/tazobactam sodium injection (6꞉1 ratio) displayd near-linear pharmacokinetics within a dose range of 1.0 to 4.0 g, with no significant effect of tazobactam on the pharmacokinetic parameters of cefotaxime, validating the platform's usability and reliability.

Conclusions: CPhaMAS provides an integrated modeling and statistical tool for educators, researchers, and industrial professionals, enabling non-compartmental analysis, bioequivalence/bioavailability analysis, compartmental model building, and population pharmacokinetic modeling and simulation.