TABST和LABST在印度药典专著中的未来:人道协会国际/印度研讨会报告

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Brinda Poojary , Laura Viviani , Alokparna Sengupta , M. Kalaivani , Sh Rajesh Verma , Vijay Teng , Vijay Makhija , Ram Prakash , Nitin Bhatia , S.N. Singh , Lukas Bruckner , Marlies Halder , Jeroen Vree
{"title":"TABST和LABST在印度药典专著中的未来:人道协会国际/印度研讨会报告","authors":"Brinda Poojary ,&nbsp;Laura Viviani ,&nbsp;Alokparna Sengupta ,&nbsp;M. Kalaivani ,&nbsp;Sh Rajesh Verma ,&nbsp;Vijay Teng ,&nbsp;Vijay Makhija ,&nbsp;Ram Prakash ,&nbsp;Nitin Bhatia ,&nbsp;S.N. Singh ,&nbsp;Lukas Bruckner ,&nbsp;Marlies Halder ,&nbsp;Jeroen Vree","doi":"10.1016/j.biologicals.2023.101665","DOIUrl":null,"url":null,"abstract":"<div><p>Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.</p></div>","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":null,"pages":null},"PeriodicalIF":16.4000,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report\",\"authors\":\"Brinda Poojary ,&nbsp;Laura Viviani ,&nbsp;Alokparna Sengupta ,&nbsp;M. Kalaivani ,&nbsp;Sh Rajesh Verma ,&nbsp;Vijay Teng ,&nbsp;Vijay Makhija ,&nbsp;Ram Prakash ,&nbsp;Nitin Bhatia ,&nbsp;S.N. Singh ,&nbsp;Lukas Bruckner ,&nbsp;Marlies Halder ,&nbsp;Jeroen Vree\",\"doi\":\"10.1016/j.biologicals.2023.101665\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.</p></div>\",\"PeriodicalId\":1,\"journal\":{\"name\":\"Accounts of Chemical Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2023-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accounts of Chemical Research\",\"FirstCategoryId\":\"99\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1045105623000039\",\"RegionNum\":1,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"99","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1045105623000039","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
引用次数: 0

摘要

印度国际人道协会(HSI India)组织并推动了一次关于“印度药典(IP)专著中目标动物批次安全性测试(TABST)和实验动物批次安全测试(LABST)的未来”的研讨会。研讨会接待了来自印度药典委员会(IPC)和中央药品标准控制组织(CDSCO)的主要印度监管机构、来自印度动物卫生公司联合会(INFAH)、亚洲动物卫生协会(AAHA)的行业代表以及代表欧洲药品质量管理局(EDQM)的国际专家,兽医产品注册技术要求协调国际合作组织(VICH)和跨国兽医产品制造商。举办研讨会是为了鼓励信息的双向流动,并讨论从知识产权的兽医疫苗专著中删除TABST和LABST的问题。该研讨会建立在国际人道协会于2019年举行的“疫苗检测要求全球协调”研讨会的基础上。本报告详细介绍了研讨会的结果,以及作为取消或放弃这些测试的下一步措施的一部分将要开展的拟议活动。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report

Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.

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
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信