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.
目的: 临床药理建模与统计分析软件是药物研发和基于模型的药物个体化治疗必不可少的基础性工具。本研究旨在基于云平台的优势，开发一个用户界面友好、学习曲线平滑的药代动力学分析云平台。方法: 平台以Rails为框架，基于Julia语言开发，使用PostgreSQL 14数据库、Redis缓存和Sidekiq异步任务管理等技术手段，开发临床药理学研究常用的4个模块：非房室分析、生物等效性/生物利用度分析、房室模型分析和群体药代动力学模型。平台通过数据加密、访问控制、传输加密、冗余备份和日志记录等多重安全措施，全面保障数据的安全性和可追溯性。对平台进行基本功能、性能、可靠性、易用性和可扩展性测试，以及典型案例实践。结果: 开发的CPhaMAS云平台实现了4个模块功能。该平台模块采用列表的方式指导用户使用，界面采用勾选式操作；使用云计算，可直接在线分析数据，不占用电脑储存空间且对计算机性能要求低；建模可视化操作无需编程；基本功能完备度达100%，年平均无故障率大于99%，服务器响应时间200~500 ms，平均CPU资源利用率控制在30%以下。典型案例结果显示，注射用头孢噻肟钠他唑巴坦钠(6꞉1)在1.0~4.0 g剂量范围内呈现近似线性药代动力学特征，且他唑巴坦钠对头孢噻肟钠的药代动力学参数无显著影响，验证了平台的功能和可靠性。结论: CPhaMAS为教育界、学术界和工业界提供了集成式的建模与统计工具，实现了非房室分析、生物等效性/生物利用度分析、房室模型分析和群体药代动力学模型的构建和仿真等功能。.
Keywords: CPhaMAS; cloud platform; pharmacokinetic.