遗传毒性研究是药物非临床安全性评价的重要内容,与致癌性、生殖毒性研究密切相关。遗传毒性试验目的是检测受试物的致突变性,预测受试物的致癌性,对受试物的遗传毒性潜在性进行全面评价是药物进入临床试验及上市的重要环节。遗传毒性...遗传毒性研究是药物非临床安全性评价的重要内容,与致癌性、生殖毒性研究密切相关。遗传毒性试验目的是检测受试物的致突变性,预测受试物的致癌性,对受试物的遗传毒性潜在性进行全面评价是药物进入临床试验及上市的重要环节。遗传毒性标准试验组合包含体内和体外试验,测试终点多样,本文从人员资质、实验室管理、给药制剂、实验系统、试验实施关键阶段等方面阐述遗传毒性评价研究的关注点,为遗传毒性研究实施提供借鉴。研究机构应严格遵循药物非临床研究质量管理规范(good laboratory practice for nonclinical laboratory studies, GLP)实施评价工作,不断提高遗传毒性试验质量。展开更多
In order to directly construct the mapping between multiple state parameters and remaining useful life(RUL),and reduce the interference of random error on prediction accuracy,a RUL prediction model of aeroengine based...In order to directly construct the mapping between multiple state parameters and remaining useful life(RUL),and reduce the interference of random error on prediction accuracy,a RUL prediction model of aeroengine based on principal component analysis(PCA)and one-dimensional convolution neural network(1D-CNN)is proposed in this paper.Firstly,multiple state parameters corresponding to massive cycles of aeroengine are collected and brought into PCA for dimensionality reduction,and principal components are extracted for further time series prediction.Secondly,the 1D-CNN model is constructed to directly study the mapping between principal components and RUL.Multiple convolution and pooling operations are applied for deep feature extraction,and the end-to-end RUL prediction of aeroengine can be realized.Experimental results show that the most effective principal component from the multiple state parameters can be obtained by PCA,and the long time series of multiple state parameters can be directly mapped to RUL by 1D-CNN,so as to improve the efficiency and accuracy of RUL prediction.Compared with other traditional models,the proposed method also has lower prediction error and better robustness.展开更多
美国食品药品监督管理局(FDA)是全球首个提出并开展实施医疗器械唯一标识(UDI)系统的监管机构。2022年7月,美国FDA发布《医疗器械唯一标识:关于Ⅰ类和未分类医疗器械的合规日期、直接标记和特定医疗器械的全球医疗器械唯一标识数据库要...美国食品药品监督管理局(FDA)是全球首个提出并开展实施医疗器械唯一标识(UDI)系统的监管机构。2022年7月,美国FDA发布《医疗器械唯一标识:关于Ⅰ类和未分类医疗器械的合规日期、直接标记和特定医疗器械的全球医疗器械唯一标识数据库要求》(Unique Device Identification:Policy Regarding Compliance Dates for Class I and Unclassified Devices,Direct Marking,and Global Unique Device Identification Database Requirements for Certain Devices)指南文件,提出了对Ⅰ类和未分类医疗器械的UDI相关建议和要求。本文对该指南的发布背景、主要内容等进行详细介绍,旨在为我国UDI工作的开展提供借鉴与思路。展开更多
文摘遗传毒性研究是药物非临床安全性评价的重要内容,与致癌性、生殖毒性研究密切相关。遗传毒性试验目的是检测受试物的致突变性,预测受试物的致癌性,对受试物的遗传毒性潜在性进行全面评价是药物进入临床试验及上市的重要环节。遗传毒性标准试验组合包含体内和体外试验,测试终点多样,本文从人员资质、实验室管理、给药制剂、实验系统、试验实施关键阶段等方面阐述遗传毒性评价研究的关注点,为遗传毒性研究实施提供借鉴。研究机构应严格遵循药物非临床研究质量管理规范(good laboratory practice for nonclinical laboratory studies, GLP)实施评价工作,不断提高遗传毒性试验质量。
基金supported by Jiangsu Social Science Foundation(No.20GLD008)Science,Technology Projects of Jiangsu Provincial Department of Communications(No.2020Y14)Joint Fund for Civil Aviation Research(No.U1933202)。
文摘In order to directly construct the mapping between multiple state parameters and remaining useful life(RUL),and reduce the interference of random error on prediction accuracy,a RUL prediction model of aeroengine based on principal component analysis(PCA)and one-dimensional convolution neural network(1D-CNN)is proposed in this paper.Firstly,multiple state parameters corresponding to massive cycles of aeroengine are collected and brought into PCA for dimensionality reduction,and principal components are extracted for further time series prediction.Secondly,the 1D-CNN model is constructed to directly study the mapping between principal components and RUL.Multiple convolution and pooling operations are applied for deep feature extraction,and the end-to-end RUL prediction of aeroengine can be realized.Experimental results show that the most effective principal component from the multiple state parameters can be obtained by PCA,and the long time series of multiple state parameters can be directly mapped to RUL by 1D-CNN,so as to improve the efficiency and accuracy of RUL prediction.Compared with other traditional models,the proposed method also has lower prediction error and better robustness.
文摘美国食品药品监督管理局(FDA)是全球首个提出并开展实施医疗器械唯一标识(UDI)系统的监管机构。2022年7月,美国FDA发布《医疗器械唯一标识:关于Ⅰ类和未分类医疗器械的合规日期、直接标记和特定医疗器械的全球医疗器械唯一标识数据库要求》(Unique Device Identification:Policy Regarding Compliance Dates for Class I and Unclassified Devices,Direct Marking,and Global Unique Device Identification Database Requirements for Certain Devices)指南文件,提出了对Ⅰ类和未分类医疗器械的UDI相关建议和要求。本文对该指南的发布背景、主要内容等进行详细介绍,旨在为我国UDI工作的开展提供借鉴与思路。
