目的:将临床数据交换标准协会(Clinical Data Inter-change Standards Consortium,CDISC)标准推广到临床试验中,推动临床试验数据的标准化。方法:结合分析数据模型(Analysis Data Model,ADaM)实施指南以及实际数据的常见问题,介绍分析...目的:将临床数据交换标准协会(Clinical Data Inter-change Standards Consortium,CDISC)标准推广到临床试验中,推动临床试验数据的标准化。方法:结合分析数据模型(Analysis Data Model,ADaM)实施指南以及实际数据的常见问题,介绍分析数据模型ADaM在仿制药的生物等效性试验安全性中的应用。结果:针对不同类型的临床试验数据,根据可能发生的多种情形,生成了符合标准的安全性分析数据集。结论:在我国仿制药不断发展和临床试验数据标准化程度不高的背景下,在临床研究中使用CDISC标准,一方面可以推动临床试验数据的标准化,另一方面可以缩短统计分析的时间,加快药物研发的进程。展开更多
A model for liquid-gas flow （MLGF）, considering the flee movement of liquid surface, was built to simulate the wastewater velocity field and gas distribution in a full-scale Caroussel oxidation ditch with surface ae...A model for liquid-gas flow （MLGF）, considering the flee movement of liquid surface, was built to simulate the wastewater velocity field and gas distribution in a full-scale Caroussel oxidation ditch with surface aeration. It was calibrated and validated by field measurement data, and the calibrated parameters and sections were selected based on both model analysis and numerical computation. The simulated velocities of MLGF were compared to that of a model for wastewater-sludge flow （MWSF）. The results show that the free liquid surface considered in MLGF improves the simulated velocity results of upper layer and surface. Moreover, distribution of gas volume fraction （GVF） simulated by MLGF was compared to dissolved oxygen （DO） measured in the oxidation ditch. It is shown that DO distribution is affected by many factors besides GVF distribution.展开更多
文摘目的:将临床数据交换标准协会(Clinical Data Inter-change Standards Consortium,CDISC)标准推广到临床试验中,推动临床试验数据的标准化。方法:结合分析数据模型(Analysis Data Model,ADaM)实施指南以及实际数据的常见问题,介绍分析数据模型ADaM在仿制药的生物等效性试验安全性中的应用。结果:针对不同类型的临床试验数据,根据可能发生的多种情形,生成了符合标准的安全性分析数据集。结论:在我国仿制药不断发展和临床试验数据标准化程度不高的背景下,在临床研究中使用CDISC标准,一方面可以推动临床试验数据的标准化,另一方面可以缩短统计分析的时间,加快药物研发的进程。
基金Project supported by Visiting Scholar Foundation of Key Laboratory of the Resources Exploitation and Environmental Disaster Control Engineering in Southwest China (Chongqing University),Ministry of Education,China
文摘A model for liquid-gas flow （MLGF）, considering the flee movement of liquid surface, was built to simulate the wastewater velocity field and gas distribution in a full-scale Caroussel oxidation ditch with surface aeration. It was calibrated and validated by field measurement data, and the calibrated parameters and sections were selected based on both model analysis and numerical computation. The simulated velocities of MLGF were compared to that of a model for wastewater-sludge flow （MWSF）. The results show that the free liquid surface considered in MLGF improves the simulated velocity results of upper layer and surface. Moreover, distribution of gas volume fraction （GVF） simulated by MLGF was compared to dissolved oxygen （DO） measured in the oxidation ditch. It is shown that DO distribution is affected by many factors besides GVF distribution.
