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

World association for the advancement of veterinary parasitology (WAAVP): Second edition of guidelines for evaluating the efficacy of anthelmintics in swine
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DOI:
10.1016/j.vetpar.2006.04.038
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发表时间:
2006-10-10
影响因子:
2.6
通讯作者:
Roepstorff, A.
Roepstorff, A.
中科院分区:
农林科学2区
文献类型:
--
作者:
Hennessy, D. R.;Bauer, C.;Roepstorff, A.

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提供了用于评价驱虫药在猪中的有效性的指导原则,该指导原则与其他指导原则(如兽药产品注册技术要求国际协调会(VICH GL 7和VICH GL 16)的指导原则)相结合,应鼓励在全球范围内采用统一的注册要求。有效性试验应按照《药物临床试验质量管理规范》(VICH GL 9,2000-http://www.vich.eudra.org/pdf/2000/G109_st7.pdf)的原则进行。根据这些指南获得的数据应在国际上可接受,用于猪用驱虫剂的注册。此外,该指南的使用应加快猪用驱虫药的开发、政府审查和批准,并有助于降低成本和减少用于药物测试的实验动物数量。(c)2006 Elsevier B. V.保留所有权利。
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-http://www.vich.eudra.org/pdf/2000/G109_st7.pdf). 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. (c) 2006 Elsevier B.V. All rights reserved.