Ethypharm selected STATISTICA to improve new drug manufacturing parameters and validate lab comparison tests
公司规模
1,000+
地区
- Europe
产品
- STATISTICA
技术栈
- Data Analysis Software
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 分析与建模 - 预测分析
- 应用基础设施与中间件 - 数据可视化
适用行业
- 药品
适用功能
- 产品研发
- 质量保证
用例
- 质量预测分析
- 过程控制与优化
服务
- 软件设计与工程服务
- 系统集成
关于客户
Ethypharm is a European leader in innovative drug delivery, designing, developing, and producing oral modified released medicines through a network of 140 partners. The company’s patented technologies in new medicine development offer multiple benefits to patients, including enhanced efficiency, easier administration, facilitated compliance, and reduced side effects. Ethypharm collaborates with pharmaceutical companies worldwide to bring these advanced drug delivery solutions to market.
挑战
The pharmaceutical development staff at Ethypharm often needs to compare finished product batches manufactured under different conditions, such as varying compression presses, manufacturing sites, device parameters, and dosages. Additionally, the analytical development staff must transfer analytical methods to different laboratories, including subcontractors, to ensure all labs control final products appropriately. This requires sufficient information to guarantee consistency and accuracy across different labs.
解决方案
Ethypharm uses STATISTICA to analyze laboratory data and study the impact of various processing parameters. The software provides informative and fast answers about process variabilities, enabling scientists to quickly understand the influence of each parameter. Additionally, STATISTICA is used to compare and validate laboratory submissions by computing confidence intervals on the difference of means and comparing them to acceptance criteria. This ensures that the means of each laboratory are equivalent within practical, preset limits.
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