Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2023-08-01 DOI:10.1016/j.biologicals.2023.101665

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

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Abstract

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.

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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

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。

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来源期刊

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.

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