细胞和基因治疗(Cell and Gene Therapy,简称CGT)近年来获得快速发展。由于CGT的起始物料差异大,工艺流程具有特异性等特点,造成研发数据完整性合规难度大等的问题。文章介绍了一种根据CGT研发特点而开发的计算机化系统:它整合了电子实...细胞和基因治疗(Cell and Gene Therapy,简称CGT)近年来获得快速发展。由于CGT的起始物料差异大,工艺流程具有特异性等特点,造成研发数据完整性合规难度大等的问题。文章介绍了一种根据CGT研发特点而开发的计算机化系统:它整合了电子实验记录本(ELN)及部分实验室信息管理系统(LIMS)的功能,可最大程度确保研发人员的操作、记录符合GMP规范,确保研发数据真实可靠,符合数据完整性和新药申报要求。展开更多
This paper critically reviews the progress in ecosystem integrity(health)assessment of inland waters and provides future directions for assessment.Current biotic integrity assessments mainly use multimetric indices an...This paper critically reviews the progress in ecosystem integrity(health)assessment of inland waters and provides future directions for assessment.Current biotic integrity assessments mainly use multimetric indices and predictive models to evaluate overall health status;the criteria largely rely on pristine reference sites,but such an approach is not applicable to unique natural waters and irreversibly modified waters.Biotic diagnostic assessments are still in the exploratory stage and can only diagnose possible stressor types and wide-ranges of their intensities through empirical models linking stressors and species-trait-indices.Current chemical integrity assessments mainly use criteria determined by small-scale ecotoxicity tests,rather than quantitative relationships developed between chemical factors and biotic effects in real ecosystems,thus potentially under or overestimating pollutant toxicity.Current physical integrity assessments focus on overall habitat quality,rather than quantitative habitat requirements,and thus cannot provide quantitative support for ecological restoration and conservation.Current hydrological integrity(environment flow)assessments largely depend on quantitative relationships between hydrological regimes with a few species and single groups,rather than with whole communities,and fail to comprehensively diagnose hydrological causes of biotic resource decline.In the future,integrity assessments need to be based on ecosystem integrity requirements of ecosystem service targets:first,there is a need to build quantitative relationships between biotic integrity and ecosystem services,assess requirements of community structure and function for service goals,and establish biotic integrity assessment methods;second,we must build quantitative relationships between biotic integrity and abiotic integrity in real ecosystems,assess chemical,physical,and hydrological integrity requirements of biotic needs,and establish diagnostic assessment methods.展开更多
随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段...随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段应对不足的矛盾。目前,多个重要国家和组织陆续发出了计算机化系统验证和数据完整性管理的法规和指南,并积累了丰富的监管经验。本文梳理并总结了经济合作与发展组织(Organization for Economic Co-operation and Development,OECD)、国际制药工程协会(International Society of Pharmaceutical Engineers,ISPE)、国际药品认证合作组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)、欧洲原料药委员会(Active Pharmaceutical Ingredients Committee,APIC)等重要机构的数据完整性和计算机化系统要求,结合生态毒理GLP机构的发展需求,根据风险质量管理、计算机化系统验证和数据完整性管理的要求,建立了一种基于数据完整性的计算机化系统分级管理策略。通过信息收集、分类分级、措施评估和措施管理四步法,提出了计算机化系统管理中数据完整性措施的管理思路,该方法具有集约化、策略化和科学化的特点,有助于生态毒理GLP机构提升计算机化系统应用和管理能力,推进我国GLP机构国际化发展进程。展开更多
文摘细胞和基因治疗(Cell and Gene Therapy,简称CGT)近年来获得快速发展。由于CGT的起始物料差异大,工艺流程具有特异性等特点,造成研发数据完整性合规难度大等的问题。文章介绍了一种根据CGT研发特点而开发的计算机化系统:它整合了电子实验记录本(ELN)及部分实验室信息管理系统(LIMS)的功能,可最大程度确保研发人员的操作、记录符合GMP规范,确保研发数据真实可靠,符合数据完整性和新药申报要求。
基金Strategic Priority Research Program of the Chinese Academy of Sciences(XDA23040402)National Key R&D Program of China(2021YFC3200103).
文摘This paper critically reviews the progress in ecosystem integrity(health)assessment of inland waters and provides future directions for assessment.Current biotic integrity assessments mainly use multimetric indices and predictive models to evaluate overall health status;the criteria largely rely on pristine reference sites,but such an approach is not applicable to unique natural waters and irreversibly modified waters.Biotic diagnostic assessments are still in the exploratory stage and can only diagnose possible stressor types and wide-ranges of their intensities through empirical models linking stressors and species-trait-indices.Current chemical integrity assessments mainly use criteria determined by small-scale ecotoxicity tests,rather than quantitative relationships developed between chemical factors and biotic effects in real ecosystems,thus potentially under or overestimating pollutant toxicity.Current physical integrity assessments focus on overall habitat quality,rather than quantitative habitat requirements,and thus cannot provide quantitative support for ecological restoration and conservation.Current hydrological integrity(environment flow)assessments largely depend on quantitative relationships between hydrological regimes with a few species and single groups,rather than with whole communities,and fail to comprehensively diagnose hydrological causes of biotic resource decline.In the future,integrity assessments need to be based on ecosystem integrity requirements of ecosystem service targets:first,there is a need to build quantitative relationships between biotic integrity and ecosystem services,assess requirements of community structure and function for service goals,and establish biotic integrity assessment methods;second,we must build quantitative relationships between biotic integrity and abiotic integrity in real ecosystems,assess chemical,physical,and hydrological integrity requirements of biotic needs,and establish diagnostic assessment methods.
文摘随着科学技术的进步,越来越多先进的自动化设备和计算机化系统进入良好实验室规范(GLP)领域,在享受着高新技术手段带来的高效和便利之时,实验室数据完整性管理也不断受到挑战,主要就是科学技术现代化水平不断升级与实验室内部管理手段应对不足的矛盾。目前,多个重要国家和组织陆续发出了计算机化系统验证和数据完整性管理的法规和指南,并积累了丰富的监管经验。本文梳理并总结了经济合作与发展组织(Organization for Economic Co-operation and Development,OECD)、国际制药工程协会(International Society of Pharmaceutical Engineers,ISPE)、国际药品认证合作组织(Pharmaceutical Inspection Co-operation Scheme,PIC/S)、欧洲原料药委员会(Active Pharmaceutical Ingredients Committee,APIC)等重要机构的数据完整性和计算机化系统要求,结合生态毒理GLP机构的发展需求,根据风险质量管理、计算机化系统验证和数据完整性管理的要求,建立了一种基于数据完整性的计算机化系统分级管理策略。通过信息收集、分类分级、措施评估和措施管理四步法,提出了计算机化系统管理中数据完整性措施的管理思路,该方法具有集约化、策略化和科学化的特点,有助于生态毒理GLP机构提升计算机化系统应用和管理能力,推进我国GLP机构国际化发展进程。
