大韩民国化学品风险评估和化学品登记的跨读应用的当前趋势。

IF 6.4 2区 医学 Q1 ENVIRONMENTAL SCIENCES Journal of Toxicology and Environmental Health-Part B-Critical Reviews Pub Date : 2022-11-17 DOI:10.1080/10937404.2022.2133033
Sang Hee Lee, Jongwoon Kim, Jinyong Kim, Jaehyun Park, Sanghee Park, Kyu-Bong Kim, Byung-Mu Lee, Seok Kwon
{"title":"大韩民国化学品风险评估和化学品登记的跨读应用的当前趋势。","authors":"Sang Hee Lee,&nbsp;Jongwoon Kim,&nbsp;Jinyong Kim,&nbsp;Jaehyun Park,&nbsp;Sanghee Park,&nbsp;Kyu-Bong Kim,&nbsp;Byung-Mu Lee,&nbsp;Seok Kwon","doi":"10.1080/10937404.2022.2133033","DOIUrl":null,"url":null,"abstract":"<p><p>Read-across, an alternative approach for hazard assessment, has been widely adopted when <i>in vivo</i> data are unavailable for chemicals of interest. Read-across is enabled via <i>in silico</i> tools such as quantitative structure activity relationship (QSAR) modeling. In this study, the current status of structure activity relationship (SAR)-based read-across applications in the Republic of Korea (ROK) was examined considering both chemical risk assessments and chemical registrations from different sectors, including regulatory agencies, industry, and academia. From the regulatory perspective, the Ministry of Environment (MOE) established the Act on Registration and Evaluation of Chemicals (AREC) in 2019 to enable registrants to submit alternative data such as information from read-across instead of <i>in vivo</i> data to support hazard assessment and determine chemical-specific risks. Further, the Ministry of Food and Drug Safety (MFDS) began to consider read-across approaches for establishing acceptable intake (AI) limits of impurities occurring during pharmaceutical manufacturing processes under the ICH M7 guideline. Although read-across has its advantages, this approach also has limitations including (1) lack of standardized criteria for regulatory acceptance, (2) inconsistencies in the robustness of scientific evidence, and (3) deficiencies in the objective reliability of read-across data. The application and acceptance rate of read-across may vary among regulatory agencies. Therefore, sufficient data need to be prepared to verify the hypothesis that structural similarities might lead to similarities in properties of substances (between source and target chemicals) prior to adopting a read-across approach. In some cases, additional tests may be required during the registration process to clarify long-term effects on human health or the environment for certain substances that are data deficient. To improve the quality of read-across data for regulatory acceptance, cooperative efforts from regulatory agencies, academia, and industry are needed to minimize limitations of read-across applications.</p>","PeriodicalId":49971,"journal":{"name":"Journal of Toxicology and Environmental Health-Part B-Critical Reviews","volume":null,"pages":null},"PeriodicalIF":6.4000,"publicationDate":"2022-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Current trends in read-across applications for chemical risk assessments and chemical registrations in the Republic of Korea.\",\"authors\":\"Sang Hee Lee,&nbsp;Jongwoon Kim,&nbsp;Jinyong Kim,&nbsp;Jaehyun Park,&nbsp;Sanghee Park,&nbsp;Kyu-Bong Kim,&nbsp;Byung-Mu Lee,&nbsp;Seok Kwon\",\"doi\":\"10.1080/10937404.2022.2133033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Read-across, an alternative approach for hazard assessment, has been widely adopted when <i>in vivo</i> data are unavailable for chemicals of interest. Read-across is enabled via <i>in silico</i> tools such as quantitative structure activity relationship (QSAR) modeling. In this study, the current status of structure activity relationship (SAR)-based read-across applications in the Republic of Korea (ROK) was examined considering both chemical risk assessments and chemical registrations from different sectors, including regulatory agencies, industry, and academia. From the regulatory perspective, the Ministry of Environment (MOE) established the Act on Registration and Evaluation of Chemicals (AREC) in 2019 to enable registrants to submit alternative data such as information from read-across instead of <i>in vivo</i> data to support hazard assessment and determine chemical-specific risks. Further, the Ministry of Food and Drug Safety (MFDS) began to consider read-across approaches for establishing acceptable intake (AI) limits of impurities occurring during pharmaceutical manufacturing processes under the ICH M7 guideline. Although read-across has its advantages, this approach also has limitations including (1) lack of standardized criteria for regulatory acceptance, (2) inconsistencies in the robustness of scientific evidence, and (3) deficiencies in the objective reliability of read-across data. The application and acceptance rate of read-across may vary among regulatory agencies. Therefore, sufficient data need to be prepared to verify the hypothesis that structural similarities might lead to similarities in properties of substances (between source and target chemicals) prior to adopting a read-across approach. In some cases, additional tests may be required during the registration process to clarify long-term effects on human health or the environment for certain substances that are data deficient. To improve the quality of read-across data for regulatory acceptance, cooperative efforts from regulatory agencies, academia, and industry are needed to minimize limitations of read-across applications.</p>\",\"PeriodicalId\":49971,\"journal\":{\"name\":\"Journal of Toxicology and Environmental Health-Part B-Critical Reviews\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.4000,\"publicationDate\":\"2022-11-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Toxicology and Environmental Health-Part B-Critical Reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/10937404.2022.2133033\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ENVIRONMENTAL SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Toxicology and Environmental Health-Part B-Critical Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10937404.2022.2133033","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENVIRONMENTAL SCIENCES","Score":null,"Total":0}
引用次数: 1

摘要

当无法获得相关化学物质的体内数据时,一种可供选择的危害评估方法Read-across已被广泛采用。通过计算机工具,如定量结构活动关系(QSAR)建模,可以实现读取。在这项研究中,基于结构活性关系(SAR)的跨读应用在韩国(ROK)的现状进行了研究,考虑了化学品风险评估和来自不同部门的化学品注册,包括监管机构、工业和学术界。从监管的角度来看,环境部(MOE)于2019年制定了《化学品注册和评估法》(AREC),使注册人能够提交替代数据,如跨读信息,而不是体内数据,以支持危害评估和确定化学品特定风险。此外,食品和药物安全部(MFDS)开始考虑根据ICH M7指南建立药品生产过程中发生的杂质的可接受摄入量(AI)限制的解读方法。尽管跨读有其优点,但这种方法也有局限性,包括:(1)缺乏监管接受的标准化标准,(2)科学证据的稳健性不一致,(3)跨读数据的客观可靠性不足。跨读的应用和接受率在各监管机构之间可能有所不同。因此,在采用跨读方法之前,需要准备足够的数据来验证结构相似性可能导致物质(源化学品和目标化学品之间)性质相似性的假设。在某些情况下,可能需要在注册过程中进行额外测试,以澄清某些缺乏数据的物质对人类健康或环境的长期影响。为了提高监管机构接受的跨读数据的质量,需要监管机构、学术界和工业界的合作努力,以最大限度地减少跨读应用程序的限制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Current trends in read-across applications for chemical risk assessments and chemical registrations in the Republic of Korea.

Read-across, an alternative approach for hazard assessment, has been widely adopted when in vivo data are unavailable for chemicals of interest. Read-across is enabled via in silico tools such as quantitative structure activity relationship (QSAR) modeling. In this study, the current status of structure activity relationship (SAR)-based read-across applications in the Republic of Korea (ROK) was examined considering both chemical risk assessments and chemical registrations from different sectors, including regulatory agencies, industry, and academia. From the regulatory perspective, the Ministry of Environment (MOE) established the Act on Registration and Evaluation of Chemicals (AREC) in 2019 to enable registrants to submit alternative data such as information from read-across instead of in vivo data to support hazard assessment and determine chemical-specific risks. Further, the Ministry of Food and Drug Safety (MFDS) began to consider read-across approaches for establishing acceptable intake (AI) limits of impurities occurring during pharmaceutical manufacturing processes under the ICH M7 guideline. Although read-across has its advantages, this approach also has limitations including (1) lack of standardized criteria for regulatory acceptance, (2) inconsistencies in the robustness of scientific evidence, and (3) deficiencies in the objective reliability of read-across data. The application and acceptance rate of read-across may vary among regulatory agencies. Therefore, sufficient data need to be prepared to verify the hypothesis that structural similarities might lead to similarities in properties of substances (between source and target chemicals) prior to adopting a read-across approach. In some cases, additional tests may be required during the registration process to clarify long-term effects on human health or the environment for certain substances that are data deficient. To improve the quality of read-across data for regulatory acceptance, cooperative efforts from regulatory agencies, academia, and industry are needed to minimize limitations of read-across applications.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
13.80
自引率
6.90%
发文量
13
审稿时长
>24 weeks
期刊介绍: "Journal of Toxicology and Environmental Health: Part B - Critical Reviews" is an academic journal published by Taylor & Francis, focusing on the critical examination of research in the areas of environmental exposure and population health. With an ISSN identifier of 1093-7404, this journal has established itself as a significant source of scholarly content in the field of toxicology and environmental health. Since its inception, the journal has published over 424 articles that have garnered 35,097 citations, reflecting its impact and relevance in the scientific community. Known for its comprehensive reviews, the journal also goes by the names "Critical Reviews" and "Journal of Toxicology & Environmental Health, Part B, Critical Reviews." The journal's mission is to provide a platform for in-depth analysis and critical discussion of the latest findings in toxicology, environmental health, and related disciplines. By doing so, it contributes to the advancement of knowledge and understanding of the complex interactions between environmental factors and human health, aiding in the development of strategies to protect and improve public health.
期刊最新文献
Neuroendocrine contribution to sex-related variations in adverse air pollution health effects. Local and systemic effects of microplastic particles through cell damage, release of chemicals and drugs, dysbiosis, and interference with the absorption of nutrients. Incorporating new approach methods (NAMs) data in dose-response assessments: The future is now! In vitro models to evaluate multidrug resistance in cancer cells: Biochemical and morphological techniques and pharmacological strategies. An integrative exploration of environmental stressors on the microbiome-gut-brain axis and immune mechanisms promoting neurological disorders.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1