共查询到16条相似文献,搜索用时 359 毫秒
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VICH兽药靶动物安全性研究指导原则概述 总被引:3,自引:2,他引:1
VICH兽药靶动物安全性研究指导原则详尽地介绍了靶动物安全性研究的试验设计、实验方法和测定的变量,从2009年7月起在VICH地区实施。该指导原则是国际统一标准,按此指导原则所做的研究在VICH地区可得到相互承认。 相似文献
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中国制定了限量标准而日本为“一律标准”的兽药/饲料添加剂可分为两种情况:一种情况是中国制定了限量标准而日本为“一律标准”的兽药/饲料添加剂,共6种;另一类情况是针对某一种产品中国制定了限量标准而日本为"一律标准"的兽药饲料添加剂,共3种,涉及6种(类)食品,6条限量指标. 相似文献
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根据安徽省宿州市当地情况及个人经验,总结了规模猪场免疫程序制定的步骤以及免疫程序制定过程中需要考虑的问题,以供有关人员参考. 相似文献
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J Vercruysse P Holdsworth T Letonja G Conder K Hamamoto K Okano S Rehbein 《Veterinary parasitology》2002,103(4):277-297
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. 相似文献
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Vercruysse J Holdsworth P Letonja T Barth D Conder G Hamamoto K Okano K;World Organization for Animal Health 《Veterinary parasitology》2001,96(3):171-193
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. 相似文献
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Hennessy DR Bauer C Boray JC Conder GA Daugschies A Johansen MV Maddox-Hyttel C Roepstorff A;World Association for the Advancement of Veterinary Parasitology 《Veterinary parasitology》2006,141(1-2):138-149
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. 相似文献
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Hunter RP Lees P Concordet D Toutain PL 《Journal of veterinary pharmacology and therapeutics》2012,35(Z1):53-63
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.). 相似文献
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LY Hardefeldt HK Crabb KE Bailey T Johnstone JR Gilkerson H Billman‐Jacobe GF Browning 《Australian veterinary journal》2019,97(9):316-322
The Australian Veterinary Prescribing Guidelines for antimicrobial prophylaxis for surgery on dogs and cats are evidence‐based guidelines for veterinary practitioners. Validation of these guidelines is necessary to ensure quality and implementability. Two validated tools, used for medical guideline appraisal, were chosen to assess the guidelines. The terminology from the GuideLine Implementability Appraisal (GLIA) and the Appraisal of Guidelines for Research and Evaluation version 2 (AGREE II) were adapted for use by veterinarians. A two‐phase evaluation approach was conducted. In the first phase of the evaluation, the GLIA tool was used by two specialist veterinary surgeons in clinical practice. The results of this phase were then used to modify the guidelines. In the second phase, the AGREE II tool was used by 6 general practitioners and 6 specialists to appraise the guidelines. In phase 1, the specialist surgeons either agreed or strongly agreed that the guidelines were executable, decidable, valid and novel, and that the guidelines would fit within the process of care. The surgeons were neutral on flexibility and measurability. Additional clarity around one common surgical procedure was added to the guidelines, after which the surgeons agreed that the guidelines were sufficiently flexible. In phase 2, 12 veterinarians completed the assessment using the AGREE II tool. In all sections the scaled domain score was greater than 70%. The overall quality of the guidelines was given a global scaled score of 76%. This assessment has demonstrated that the guidelines for antimicrobial prophylaxis for companion animal surgery are valid and appear implementable. 相似文献
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Development of new canine and feline preventive healthcare guidelines designed to improve pet health
American Animal Hospital Association-American Veterinary Medical Association Preventive Healthcare Guidelines Task Force 《Journal of the American Animal Hospital Association》2011,47(5):306-311
The American Veterinary Medical Association (AVMA) and American Animal Hospital Association (AAHA) have jointly introduced the first Canine and Feline Preventive Healthcare Guidelines. These consensus statements provide veterinarians with a new resource for improving patient care by emphasizing the value and scope of regular pet examinations. The two guidelines provide complete recommendations for comprehensive preventive healthcare programs, published as accessible, single-page documents. The guidelines are based on the subjective-objective-assessment-plan (SOAP) methodology of case management, a proven approach traditionally used with sick or injured patients. This logical and disciplined process is equally applicable to healthy patients and is designed to consistently deliver optimal patient care. The guidelines recommend visits for health examinations on at least an annual basis, recognizing that for many pets, more frequent visits may be appropriate, depending on the individual needs of the patient. The guidelines also provide detailed diagnostic, therapeutic, prevention, and follow up plans, to be accompanied by appropriate documentation. The inclusive content and concise format of the guidelines are designed to maximize their practical value and make them easy to implement. 相似文献