介绍
2010年国际输血协会（International Society of Blood Transfusion, ISBT）代表大会期间，工作组在德国柏林召开会议。会议决议：红细胞（redcellblood，RBC）血型命名仍沿用2004年颁布和2007年更新的文件，对目前使用的分类未...介绍
2010年国际输血协会（International Society of Blood Transfusion, ISBT）代表大会期间，工作组在德国柏林召开会议。会议决议：红细胞（redcellblood，RBC）血型命名仍沿用2004年颁布和2007年更新的文件，对目前使用的分类未作修改。在开罗举行的国际科学咨询委员会会议后，工作组重新命名为“红细胞免疫遗传学和血型命名工作组”，展开更多
目的综述药品遗传毒性杂质控制相关指南和法规,为制药企业执行国际标准和准则提供一些建议和思路。方法通过查找数据库如Pubmed、Medline及欧洲药品管理局(European Medicines Agency,EMA)、美国食品药品监督管理局(US Food and Drug Ad...目的综述药品遗传毒性杂质控制相关指南和法规,为制药企业执行国际标准和准则提供一些建议和思路。方法通过查找数据库如Pubmed、Medline及欧洲药品管理局(European Medicines Agency,EMA)、美国食品药品监督管理局(US Food and Drug Administratio,U.S.FDA)、人用药品注册技术要求国际协调会议(ICH)等网站,比较各指南法规关于遗传毒性控制限度和控制措施的异同点,为遗传毒性杂质的控制提供一个可行性步骤。结果通过比较发现,EMA、U.S.FDA和即将出版的ICH M7指南在关键原则的应用方面如毒理学关注阈值(threshold of toxicological concern,TTC)、风险评估步骤、杂质5分类法等基本相同,但现行EMA和U.S.FDA法规存在分歧,不利于其有效执行,而ICH M7将为遗传毒性杂质的控制提供一个可行框架。结论目前还缺乏完善有效的遗传毒性控制指南,ICH M7将解决U.S.FDA和EMA指南间分歧,更好地指导制药企业遗传毒性杂质的控制。展开更多
One of the goals of the genetic toxicology is to assess the risk to humans that derives from genotoxic agents.The risk involves both somatic and germ cells,with damage to the former resulting in cancer and damage to t...One of the goals of the genetic toxicology is to assess the risk to humans that derives from genotoxic agents.The risk involves both somatic and germ cells,with damage to the former resulting in cancer and damage to the latter in adverse effects that could be transmitted through generations.It is necessary to consider not only direct effects,but also effects that are the result of analtered environment.To perform an accurate risk assessment.it is necessary to evaluate genotoxic hazards in ways that are appropriate both methodologically and strategically.In establishing a genotoxicity assay system,international cooperation is important because it enables us to incorporate the thoughts of specialists everywhere and to learn of specific regional concerns.Here I will introduce the “Guidance on a Strategy for Testing of Chemicals for Mutagenicity” recently reported by the UK Committee on Mutagenicity (COM) and also I will briefly summarize the activities of the International Workshop on Genotoxicity Test Procedures(IWGTP).The first and the second workshops focused on methodology.we started to include the strategic issues as well as procedures in the third workshop.Starting with the 3rd IWGT,the workshop will become an activity of the International Association of EMSs.展开更多
1984年夏季荷兰容克(Junk)出版社出版了一本有关生物固氮学科研究的新书,——《固氮研究的进展》(Advances in Nitrogen Fixation Research),此书是《农业生物工艺学进展》(Advances in Agricultural Biotechnology)丛书中的一卷,[“第...1984年夏季荷兰容克(Junk)出版社出版了一本有关生物固氮学科研究的新书,——《固氮研究的进展》(Advances in Nitrogen Fixation Research),此书是《农业生物工艺学进展》(Advances in Agricultural Biotechnology)丛书中的一卷,[“第五届国际生物固氮会议论文集”(Proceeding of the 5th International Symposium on Nitrogen Fixation,Noordwijkerhout,The Netherlands,Aug.展开更多
文摘介绍
2010年国际输血协会（International Society of Blood Transfusion, ISBT）代表大会期间，工作组在德国柏林召开会议。会议决议：红细胞（redcellblood，RBC）血型命名仍沿用2004年颁布和2007年更新的文件，对目前使用的分类未作修改。在开罗举行的国际科学咨询委员会会议后，工作组重新命名为“红细胞免疫遗传学和血型命名工作组”，
文摘目的综述药品遗传毒性杂质控制相关指南和法规,为制药企业执行国际标准和准则提供一些建议和思路。方法通过查找数据库如Pubmed、Medline及欧洲药品管理局(European Medicines Agency,EMA)、美国食品药品监督管理局(US Food and Drug Administratio,U.S.FDA)、人用药品注册技术要求国际协调会议(ICH)等网站,比较各指南法规关于遗传毒性控制限度和控制措施的异同点,为遗传毒性杂质的控制提供一个可行性步骤。结果通过比较发现,EMA、U.S.FDA和即将出版的ICH M7指南在关键原则的应用方面如毒理学关注阈值(threshold of toxicological concern,TTC)、风险评估步骤、杂质5分类法等基本相同,但现行EMA和U.S.FDA法规存在分歧,不利于其有效执行,而ICH M7将为遗传毒性杂质的控制提供一个可行框架。结论目前还缺乏完善有效的遗传毒性控制指南,ICH M7将解决U.S.FDA和EMA指南间分歧,更好地指导制药企业遗传毒性杂质的控制。
文摘One of the goals of the genetic toxicology is to assess the risk to humans that derives from genotoxic agents.The risk involves both somatic and germ cells,with damage to the former resulting in cancer and damage to the latter in adverse effects that could be transmitted through generations.It is necessary to consider not only direct effects,but also effects that are the result of analtered environment.To perform an accurate risk assessment.it is necessary to evaluate genotoxic hazards in ways that are appropriate both methodologically and strategically.In establishing a genotoxicity assay system,international cooperation is important because it enables us to incorporate the thoughts of specialists everywhere and to learn of specific regional concerns.Here I will introduce the “Guidance on a Strategy for Testing of Chemicals for Mutagenicity” recently reported by the UK Committee on Mutagenicity (COM) and also I will briefly summarize the activities of the International Workshop on Genotoxicity Test Procedures(IWGTP).The first and the second workshops focused on methodology.we started to include the strategic issues as well as procedures in the third workshop.Starting with the 3rd IWGT,the workshop will become an activity of the International Association of EMSs.
文摘1984年夏季荷兰容克(Junk)出版社出版了一本有关生物固氮学科研究的新书,——《固氮研究的进展》(Advances in Nitrogen Fixation Research),此书是《农业生物工艺学进展》(Advances in Agricultural Biotechnology)丛书中的一卷,[“第五届国际生物固氮会议论文集”(Proceeding of the 5th International Symposium on Nitrogen Fixation,Noordwijkerhout,The Netherlands,Aug.
