目的浅析国内药品定期安全性更新报告以及人用药品注册技术要求国际协调会议(international council for harmonization,ICH)定期获益-风险评估报告要求上的撰写差异。方法通过比较ICH(R1)(上市药品定期安全性更新报告,periodic safety ...目的浅析国内药品定期安全性更新报告以及人用药品注册技术要求国际协调会议(international council for harmonization,ICH)定期获益-风险评估报告要求上的撰写差异。方法通过比较ICH(R1)(上市药品定期安全性更新报告,periodic safety update reports for marketed drugs,PSUR)、ICH(R2)(定期获益-风险评估报告,periodic benefit-risk evaluation report,PBRER)以及国内相关法规内容,总结我国PSUR与ICH PBRER监管要求的差异。结果在时限上,我国所有药品撰写递交时限为60日,而ICH要求根据其药品的特性分为70个日历日或90个日历日。在内容上,我国主要是收集报告期内安全性相关内容,而ICH要求收集报告期内及累积的安全性和疗效相关的内容,并且增加了信号检测和评价方法的描述。结论尽管我国与ICH的要求还有差异,但随着药物警戒活动的深入开展,对上市许可持有人的要求越来越高,未来会更注重对药物风险获益的整体评估,逐渐缩小差异。展开更多
With the rapid development of location-aware devices such as smart phones,Location-Based Services(LBSs) are becoming increasingly popular. Users can enjoy convenience by sending queries to LBS servers and obtaining se...With the rapid development of location-aware devices such as smart phones,Location-Based Services(LBSs) are becoming increasingly popular. Users can enjoy convenience by sending queries to LBS servers and obtaining service information that is nearby.However, these queries may leak the users' locations and interests to the un-trusted LBS servers, leading to serious privacy concerns. In this paper, we propose a Privacy-Preserving Pseudo-Location Updating System(3PLUS) to achieve k-anonymity for mobile users using LBSs. In 3PLUS, without relying on a third party, each user keeps pseudo-locations obtained from both the history locations and the encountered users, and randomly exchanges one of them with others when encounters occur. As a result, each user's buffer is disordered. A user can obtain any k locations from the buffer to achieve k-anonymity locally. The security analysis shows the security properties and our evaluation results indicate that the user's privacy is significantly improved.展开更多
文摘目的浅析国内药品定期安全性更新报告以及人用药品注册技术要求国际协调会议(international council for harmonization,ICH)定期获益-风险评估报告要求上的撰写差异。方法通过比较ICH(R1)(上市药品定期安全性更新报告,periodic safety update reports for marketed drugs,PSUR)、ICH(R2)(定期获益-风险评估报告,periodic benefit-risk evaluation report,PBRER)以及国内相关法规内容,总结我国PSUR与ICH PBRER监管要求的差异。结果在时限上,我国所有药品撰写递交时限为60日,而ICH要求根据其药品的特性分为70个日历日或90个日历日。在内容上,我国主要是收集报告期内安全性相关内容,而ICH要求收集报告期内及累积的安全性和疗效相关的内容,并且增加了信号检测和评价方法的描述。结论尽管我国与ICH的要求还有差异,但随着药物警戒活动的深入开展,对上市许可持有人的要求越来越高,未来会更注重对药物风险获益的整体评估,逐渐缩小差异。
基金supported by the National Natural Science Foundation of China under Grants No.61003300,No.61272457the Fundamental Research Funds for the Central Universities under Grant No.K5051201041the China 111 Project under Grant No.B08038
文摘With the rapid development of location-aware devices such as smart phones,Location-Based Services(LBSs) are becoming increasingly popular. Users can enjoy convenience by sending queries to LBS servers and obtaining service information that is nearby.However, these queries may leak the users' locations and interests to the un-trusted LBS servers, leading to serious privacy concerns. In this paper, we propose a Privacy-Preserving Pseudo-Location Updating System(3PLUS) to achieve k-anonymity for mobile users using LBSs. In 3PLUS, without relying on a third party, each user keeps pseudo-locations obtained from both the history locations and the encountered users, and randomly exchanges one of them with others when encounters occur. As a result, each user's buffer is disordered. A user can obtain any k locations from the buffer to achieve k-anonymity locally. The security analysis shows the security properties and our evaluation results indicate that the user's privacy is significantly improved.
