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Guidance for Industry: Impurities in New Veterinary Drug Substances, VICH GL10.Final Guidance

机译：工业指南：新兽药物质中的杂质，VICH GL10.Final Guidance

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This guidance provides guidance recommendations for applications for marketingauthorization on the content and qualification of impurities in new veterinary medicinal products produced from chemically synthesised new active substances not previously registered in a member state. Alternative approaches may be used if such approaches satisfy the requirements of applicable statutes, regulations, or both.

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年度 2000
页码 1-15
总页数 15
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Impurities; Drug industry; Chemical industry; Applications; Veterinary medicine; Guidelines; Specifications; Syntheses; Classification; Identification; Chemical reactions; Drugs;

机译：杂质;制药工业;化学工业;应用;兽医学;指南;规格;合成;分类;鉴定;化学反应;药物;

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专利

1. Guidance for Industry Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products VICH GL-40 DRAFT GUIDANCE [J] . Biotechnology Law Report . 2005,第5期

机译：行业规范指南：新生物技术/生物兽药的测试程序和验收标准VICH GL-40草案指南
2. Food and Drug Administration Guidance 209 and 213 and Veterinary Feed Directive regulations regarding antibiotic use in livestock: A survey of preparation and anticipated impacts in the swine industry [J] . Schulz Lee L., Rademacher Christopher J. Veterinary Anaesthesia and Analgesia . 2017,第3期

机译：食品和药物管理局指导209和213和兽医饲料指令法规关于牲畜的抗生素用途：猪业的准备和预期影响调查
3. Food and Drug Administration Guidance 209 and 213 and Veterinary Feed Directive regulations regarding antibiotic use in livestock: A survey of preparation and anticipated impacts in the swine industry [J] . Journal of Swine Health and Production . 2017,第5期

机译：食品和药物管理局指导209和213和兽医饲料指令法规关于牲畜的抗生素用途：猪业的准备和预期影响调查
4. The European Chemical Industry Guidance on REACH Exposure Assessment Strategies for Substances in Articles [C] . Tatsiana Dudzina, Carolyn Lee, Craig Davis, Joint annual meeting of the International Society of Exposure Science and the International Society for Environmental Epidemiology . 2018

机译：文章中有关化学物质的REACH暴露评估策略的欧洲化学工业指南
5. Guidance assistance, autonomous guidance and assisted distance guidance in precision agriculture. [D] . Gomez Gil, Jaime. 2005

机译：精准农业中的制导辅助，自主制导和辅助制导。
6. Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers [O] . European Food Safety Authority (EFSA), László Bura, Anja Friel, 2019

机译：EFSA关于以立体异构体为成分或杂质的植物保护产品活性物质以及可能具有立体异构体的活性物质转化产物风险评估的指南
7. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials” [O] . Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, 2019

机译：对行业联邦调查局指导论坛的报告：“含纳米材料的药品，包括生物产品，包括纳米材料”
8. Guidance for Industry: Stability Testing: Photostability Testing of New211 Veterinary Drug Substances and Medicinal Products, VICH GL5. Final Guidance [R] . 1999

机译：工业指南：稳定性测试：New211兽药物质和药品的光稳定性测试，VICH GL5。最终指导

Guidance for Industry: Impurities in New Veterinary Drug Substances, VICH GL10.Final Guidance

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