[药物环境风险评价研究:对环境的排泄形式]。

Q4 Medicine Bulletin of National Institute of Health Sciences Pub Date : 2006-01-01
Mutsuko Hirata-Koizumi, Mitsuo Saito, Shinji Miyake, Ryuichi Hasegawa
{"title":"[药物环境风险评价研究:对环境的排泄形式]。","authors":"Mutsuko Hirata-Koizumi,&nbsp;Mitsuo Saito,&nbsp;Shinji Miyake,&nbsp;Ryuichi Hasegawa","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Environmental risk assessment of human pharmaceuticals is needed to protect aquatic life from the toxic exposure because unaltered drugs and/or the metabolites are released to environment after human use. Application for new drugs shall be accompanied by an evaluation report of environmental risk assessment on basis of predicted use volume, already in US and near future in EU. In Japan, the specialists are reviewing methodology of environmental risk assessment of drugs now. To provide the basic information, we investigated excretion forms of drugs after human use for two groups of Japanese drugs; high sale products top 20 in the 2004 fiscal year and new molecular entities approved in 2004 and 2005. The assessment targets are materials produced for direct use in US, but those are active substances or active metabolites, excluding orphan drugs, vitamins, amino acids, peptides and proteins, in EU. According to EU condition, almost two thirds of 20 high sale products and one third of recently approved new molecular entities were identified to be the targets for environmental risk assessment.</p>","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 124","pages":"83-6"},"PeriodicalIF":0.0000,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Study on environmental risk assessment of drugs: excretion forms to environment].\",\"authors\":\"Mutsuko Hirata-Koizumi,&nbsp;Mitsuo Saito,&nbsp;Shinji Miyake,&nbsp;Ryuichi Hasegawa\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Environmental risk assessment of human pharmaceuticals is needed to protect aquatic life from the toxic exposure because unaltered drugs and/or the metabolites are released to environment after human use. Application for new drugs shall be accompanied by an evaluation report of environmental risk assessment on basis of predicted use volume, already in US and near future in EU. In Japan, the specialists are reviewing methodology of environmental risk assessment of drugs now. To provide the basic information, we investigated excretion forms of drugs after human use for two groups of Japanese drugs; high sale products top 20 in the 2004 fiscal year and new molecular entities approved in 2004 and 2005. The assessment targets are materials produced for direct use in US, but those are active substances or active metabolites, excluding orphan drugs, vitamins, amino acids, peptides and proteins, in EU. According to EU condition, almost two thirds of 20 high sale products and one third of recently approved new molecular entities were identified to be the targets for environmental risk assessment.</p>\",\"PeriodicalId\":35462,\"journal\":{\"name\":\"Bulletin of National Institute of Health Sciences\",\"volume\":\" 124\",\"pages\":\"83-6\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2006-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bulletin of National Institute of Health Sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bulletin of National Institute of Health Sciences","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

人类药物的环境风险评估是保护水生生物免受毒性暴露的必要条件,因为未经改变的药物和/或代谢物在人类使用后会释放到环境中。新药申请应附有基于预测使用量的环境风险评估评估报告,已经在美国和不久的将来在欧盟。在日本,专家们正在审查药物环境风险评估的方法。为了提供基本信息,我们调查了两组日本药物在人用药后的排泄形式;2004年度畅销产品前20名,2004年和2005年获批新分子实体。评估目标是在美国生产的直接使用的材料,但这些是活性物质或活性代谢物,不包括孤儿药,维生素,氨基酸,肽和蛋白质。根据欧盟的条件,近三分之二的20个高销量产品和三分之一的最近批准的新分子实体被确定为环境风险评估的目标。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
[Study on environmental risk assessment of drugs: excretion forms to environment].

Environmental risk assessment of human pharmaceuticals is needed to protect aquatic life from the toxic exposure because unaltered drugs and/or the metabolites are released to environment after human use. Application for new drugs shall be accompanied by an evaluation report of environmental risk assessment on basis of predicted use volume, already in US and near future in EU. In Japan, the specialists are reviewing methodology of environmental risk assessment of drugs now. To provide the basic information, we investigated excretion forms of drugs after human use for two groups of Japanese drugs; high sale products top 20 in the 2004 fiscal year and new molecular entities approved in 2004 and 2005. The assessment targets are materials produced for direct use in US, but those are active substances or active metabolites, excluding orphan drugs, vitamins, amino acids, peptides and proteins, in EU. According to EU condition, almost two thirds of 20 high sale products and one third of recently approved new molecular entities were identified to be the targets for environmental risk assessment.

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
0.20
自引率
0.00%
发文量
0
期刊最新文献
[Activity report on a programe of the Ministry of Health, Labour and Welfare (MHLW) "Initiative to facilitate development of innovative drugs, medical devices, and cellular and tissue-based products" in National Institute of Health Sciences]. [Regulatory science researches of nanomedicines]. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products]. [Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases]. [Study toward practical use of oligonucleotide therapeutics].
×
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