目的介绍美国食品药品监督管理局(Food and Drug Administration,FDA)鼻用制剂监管科学进展,为中国鼻用制剂开发、生产、质量控制、监管提供参考和借鉴。方法通过对法规和文献进行翻译、整理与研究,介绍FDA关于鼻用制剂的监管科学研究...目的介绍美国食品药品监督管理局(Food and Drug Administration,FDA)鼻用制剂监管科学进展,为中国鼻用制剂开发、生产、质量控制、监管提供参考和借鉴。方法通过对法规和文献进行翻译、整理与研究,介绍FDA关于鼻用制剂的监管科学研究项目和最新进展,并分析目前鼻用制剂发展中遇到的难点和未来的发展方向。结果FDA鼻用制剂监管科学主要方向为评价潜在的生物等效性方法作为比较临床终点生物等效性研究的替代方案,运用数字技术建立计算机模型研究鼻部吸收影响因素、药动学和药效学特征,以及儿童用药研究、鼻脑递送等,旨在开发新工具、新方法、新标准,为优化监管策略、提高监管效率提供科学依据。结论本文总结了FDA鼻用制剂监管科学最新研究成果,为监管机构管理人员提供参考,为提升中国药品监管质量和效率、实现国际接轨提供新思路与新方法。展开更多
Landslide susceptibility mapping is a very important tool to identify potential landslide-prone areas. In this work, weight of evidence method is applied to obtain landslide susceptibility assessment. Weight of eviden...Landslide susceptibility mapping is a very important tool to identify potential landslide-prone areas. In this work, weight of evidence method is applied to obtain landslide susceptibility assessment. Weight of evidence model is commonly applied in the landslide study as it is widely acceptable and easy to use. The objective of this paper is to prepare the landslide susceptibility map of Lung Khola catchment, Pyuthan District of Nepal. Altogether, 84 landslides were identified after landslide inventory. The thematic layers of all causative factors and existing landslides are prepared in Arc GISsoftware. Mainly, Digital Elevation Model (DEM) based causative factors and field data were used to prepare the data layers of the causative factors. In this research, 8 intrinsic factors were used for the landslide assessment. South East and East facing aspects, slope >60 degrees, elevation ranges 1300 - 1700 m, phylitic rocks and agricultural land followed by forest are the major contributors of landslide hazard in the study area. The weight of evidence model was validated by using area under curve method. The success rate curve showed the accuracy of 73.16%. It can be concluded that weight of evidence model is suitable model for landslide susceptibility analysis and the area is highly susceptible to landslide occurrence.展开更多
文摘目的介绍美国食品药品监督管理局(Food and Drug Administration,FDA)鼻用制剂监管科学进展,为中国鼻用制剂开发、生产、质量控制、监管提供参考和借鉴。方法通过对法规和文献进行翻译、整理与研究,介绍FDA关于鼻用制剂的监管科学研究项目和最新进展,并分析目前鼻用制剂发展中遇到的难点和未来的发展方向。结果FDA鼻用制剂监管科学主要方向为评价潜在的生物等效性方法作为比较临床终点生物等效性研究的替代方案,运用数字技术建立计算机模型研究鼻部吸收影响因素、药动学和药效学特征,以及儿童用药研究、鼻脑递送等,旨在开发新工具、新方法、新标准,为优化监管策略、提高监管效率提供科学依据。结论本文总结了FDA鼻用制剂监管科学最新研究成果,为监管机构管理人员提供参考,为提升中国药品监管质量和效率、实现国际接轨提供新思路与新方法。
文摘Landslide susceptibility mapping is a very important tool to identify potential landslide-prone areas. In this work, weight of evidence method is applied to obtain landslide susceptibility assessment. Weight of evidence model is commonly applied in the landslide study as it is widely acceptable and easy to use. The objective of this paper is to prepare the landslide susceptibility map of Lung Khola catchment, Pyuthan District of Nepal. Altogether, 84 landslides were identified after landslide inventory. The thematic layers of all causative factors and existing landslides are prepared in Arc GISsoftware. Mainly, Digital Elevation Model (DEM) based causative factors and field data were used to prepare the data layers of the causative factors. In this research, 8 intrinsic factors were used for the landslide assessment. South East and East facing aspects, slope >60 degrees, elevation ranges 1300 - 1700 m, phylitic rocks and agricultural land followed by forest are the major contributors of landslide hazard in the study area. The weight of evidence model was validated by using area under curve method. The success rate curve showed the accuracy of 73.16%. It can be concluded that weight of evidence model is suitable model for landslide susceptibility analysis and the area is highly susceptible to landslide occurrence.
