VICH血药法生物等效性指导原则概述

血药法生物等效性试验是开展兽药比对试验工作的重要手段之一。VICH血药法生物等效性指导原则介绍了除多次采血困难的靶动物(如蜂、鱼)的动物血药法生物等效性的实验建议,使基本药代动力学试验、生物等效性试验设计和统计分析原则等在VICH地区得到互认。该指导原则2016年8月开始实施。     

VICH GL43指导原则适用性研究

兽用药品注册技术要求国际协调会(VICH)指导原则转化是补充我国兽药技术指导原则的一种途径。对VICH GL43在我国兽药注册中的适用性进行研究，并与我国发布的相关指导原则技术要点进行比较，分析和讨论一般靶动物安全试验和其他情形靶动物安全性试验在动物选择、研究设计、给药方案、实验参数等方面的考虑和要求，并评估其适用性，为兽药研发和技术评审相关人员提供参考。     

提高畜禽免疫力新型中兽药对靶动物鸡的安全性评价

提高畜禽免疫力新型中兽药主要由黄英、山楂和麦芽等6味药材经过一定的工艺提取而成的口服液,为了考察其在临床上对靶动物鸡的安全性,本试验根据《兽用中药、天然药物临床试验技术指导原则》,对靶动物鸡的安全性进行评价,测定产品对靶动物鸡的生长性能和靶器官等的可能性损害情况,为临床研究和安全用药提供科学依据。     

中国加入兽药注册技术要求国际协调会（VICH）可行性与利弊分析

介绍了兽药注册技术要求国际协调会(VICH)基本情况,分析了我国兽药注册技术要求与VICH指南的差异,并从两者兽药注册规则的角度,研究我国加入VICH的可行性及利弊问题,以期为决策提供参考。     

VICH及其工作进展介绍

介绍了VICH的历史、组织构成、作用等基本情况,指导原则制定情况及制定步骤,并提出了我国参与VICH的建议。     

犬猫用抗肿瘤药指导原则要点分析

宠物用抗肿瘤药正在成为研发热点,美国FDA于2009年发布了伴侣动物用抗肿瘤药指导原则,EMA发布了犬猫用抗肿瘤药指导原则并于2022年1月28日开始实施。本文采用EMA的框架维度对两个指导原则安全性和有效性评价的关键技术要点进行分析,为研发者提供参考。     

FDA食品动物用来自发酵的新兽药和饲料添加剂安全性评价指导原则

美国食品药品监督管理局兽药中心1996年7月颁布了"评价食品动物用化合物安全性的一般原则".本文是其中第Ⅵ部分"来自发酵的新兽药和饲料添加剂安全性评价指导原则"的译文,供我国对这类兽药、饲料添加剂的安全性评价参考.     

《兽药注册的国际技术要求》翻译体会与心得

本文从《兽药注册的国际技术要求》[Veterinary International Conference on Harmonization(VICH)Guidance Documents]翻译入手,重点介绍了《兽药注册的国际技术要求》的体例结构与内容编排、标题与段落处理方式,归纳总结了直译与意译相结合、兽药专业用语、缩略语的翻译经验,以期为深入理解和准确把握VICH、促进我国兽药走向国际提供参考和帮助。     

非泼罗尼对犬安全性研究分析

<正>随着宠物行业的不断发展,宠物用药的安全性也越来越受到临床医生的高度重视。药物对靶动物的安全性试验是新型宠物药研发过程中的重要环节。某公司生产的10%非泼罗尼滴剂适用于驱杀犬、猫等宠物的体外寄生虫。试验以《宠物用药物对靶动物安全性试验指导原则》为依据,对该药的临床使用安全性作出评价。试验从聊城几家宠物医院选取40头杂种犬,随机分为4组,每组10头,以推荐剂量为基础,分     

银翘蓝芩口服液对鸡的安全性试验

依据兽药研究技术指导原则,开展银翘蓝芩口服液对靶动物鸡的安全性研究,为其临床应用的安全性提供数据资料。按银翘蓝芩口服液临床推荐剂量的1、3、5倍连续饮水给药7d,给药前后,逐只称重。试验结束后采集血液和组织器官,进行血常规、血液生化指标、脏器指数及病理组织学观察。结果表明,与对照组相比,各给药组鸡只的体重、血常规、血液生化及脏器指数等指标差异均不显著(P0.05),各组织器官未见明显的病理组织学变化。说明银翘蓝芩口服液饮水给药对靶动物鸡是安全的。     

International harmonisation of anthelmintic efficacy guidelines (Part 2).

The "International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)" is an international programme of co-operation between regulatory authorities and the animal health industries of the European Union, Japan and the United States of America which aims to harmonise the technical requirements for the registration of veterinary medicinal products. Australia and New Zealand participate as active observers. The objective of this second paper is to present additional guidelines established by the Working Group on anthelmintic guidelines: (1) efficacy of anthelmintics: specific recommendations for equine (VICH GL15), (2) efficacy of anthelmintics: specific recommendations for porcine (VICH GL16), (3) efficacy of anthelmintics: specific recommendations for canine (VICH GL19), (4) efficacy of anthelmintics: specific recommendations for feline (VICH GL20) and (5) efficacy of anthelmintics: specific recommendations for poultry (VICH GL21). These guidelines do not consist of rigid stipulations, but make clear recommendations on the minimal standards needed. To the veterinary profession, livestock producers and animal owners, harmonisation should mean quicker access to safer and more effective veterinary anthelmintics. In general, products should be relatively more affordable because of the reduction in registration costs and efficient use of resources by the regulatory authorities.     

International harmonisation of anthelmintic efficacy guidelines

The "International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)" is an international programme of co-operation between regulatory authorities and the animal health industries of the European Union, Japan, and the United States of America which aims to harmonise the technical requirements for the registration of veterinary medicinal products. Australia and New Zealand participate as active observers. The objective of the present paper is to present the guidelines established by the working group on Anthelmintic Efficacy Guidelines: (1) efficacy of anthelmintics: general requirements (VICH GL7); (2) efficacy of anthelmintics: specific recommendations for bovines (VICH GL12); (3) efficacy of anthelmintics: specific recommendations for ovines (VICH GL13); (4) efficacy of anthelmintics: specific recommendations for caprines (VICH GL14). These guidelines do not consist of rigid stipulations, but make clear recommendations on the minimal standards needed. To the veterinary profession, livestock producers and animal owners, harmonisation should mean quicker access to safer and more effective veterinary anthelmintics. In general, products should be relatively more affordable because of the reduction in registration costs and efficient use of resources by the regulatory authorities.     

World association for the advancement of veterinary parasitology (WAAVP): second edition of guidelines for evaluating the efficacy of anthelmintics in swine

Guidelines are provided for evaluating the efficacy of anthelmintics in swine which, in conjunction with other sets of guidance such as those of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL7 and VICH GL16), should encourage the adoption of uniform registration requirements globally. Testing of efficacy should be carried out according to the principles of "Good Clinical Practice" (VICH GL9, 2000). Data obtained according to these guidelines should be internationally acceptable for the registration of anthelmintics for swine. Further, the use of the guidelines should expedite development, government review, and approval of anthelmintics for swine, as well as contribute towards reducing costs and the number of experimental animals used for drug testing.     

兽药注册技术要求国际协调会成员国家或地区自家疫苗的监管控制

传染病对畜牧业生产构成巨大威胁,自用疫苗的合理使用可以帮助控制和预防畜/禽群中的传染病,从而保障动物健康,护航养殖发展。伴随对于加强自用疫苗注册监管呼声日益增强,本文从总体情况、法规指南、批准类型、评审材料要求、使用限制等几个方面,对VICH成员国家关于自用疫苗的监管控制进行梳理,为构建我国兽用自用疫苗的审批监管制度提供参考。     

Establishing bioequivalence of veterinary premixes (Type A medicated articles)

a) Key issues concerning Premix (Type A medicated articles) Bioequivalence evaluations: 1) This is a complex issue concerning both route of administration and formulation. 2) If the animal is not at the bunk/trough, the animal is not self-administering (eating medicated feed), thus there can be no drug absorption. b) Differing opinions among scientists and regulatory authorities/expert bodies regarding: 1) No harmonization on how to design, conduct, and interpret in vivo studies. 2) Applicability of biowaivers to Type A (premix) products. 3) Why are topdress and complete feed considered differently? Are they different formulations or different routes of administration? 4) Single dose vs. multi-dose studies. 5) What is the final formulation? c) What are the next steps: 1) Harmonize current bioequivalence guidelines through the VICH process. 2) Determine the applicability/non-applicability of the Biopharmaceutical Classification System (BCS). 3) Establish the Total Mixed Ration (i.e. formulation) effects. 4) Define the test subject (individual, pen, etc.).     

Cleavage line patterns in beagle dogs: as a guideline for use in dermatoplasty

We prepared a map of the cleavage lines for beagle dogs, as a guideline for use of cleavage lines in dermatoplasty. The cleavage lines at the head resembled the orientation of the underlying muscles. Although the cleavage lines in the trunk were perpendicular to the body axis, those in the thoraco-abdominal region were parallel to the body axis. The cleavage lines at the limbs were parallel to the long axis of the limb on the cranial surface, but were perpendicular to the long axis of the limb on the lateral and caudal surfaces. Also, we recorded in detail the cleavage lines in the distal regions of the limbs.     

Animal welfare guideline of Lower Saxony for the keeping of dairy cows

In May 2007 a working group passed a guideline, which deals with requirements for the indoor keeping of dairy cows to perform Article 2 of the animal welfare legislation.The guideline should support the local district veterinary authorities and the stockman in the animal welfare judgement both of new and rebuilding as well as already existing stables. Whereas for new buildings minimum standards for the protection of cows are put together and beyond that additional recommendations for more "cow comfort" are given, for old buildings only standard values are presented. The guideline mentioned especially those aspects, which from previous experience always gives cause for discussion. For example: size and construction of cubicles, width and floor design of passageways or the relation between the number of animals and the number of feeding places and cubicles. All together the guideline enables the local district veterinary authorities in Lower Saxony to judge the keeping of dairy cows following equal standards.This leads to confidence in planning and investment for the livestock owners.