艾美球虫
食品药品监督管理局
生物
药品
功效
药理学
微生物学
标识
DOI:10.1016/s0020-7519(98)00024-1
摘要
Anticoccidial drugs undergo a vigorous series of tests during development in order to demonstrate their efficacy and safety. Evaluation of efficacy may also be necessary after a drug is utilised in the field in order to establish whether resistance has developed. The principles and procedures used to evaluate anticoccidial efficacy were reviewed in a series of papers presented at a symposium held at the University of Georgia in May 1969 [1]. It is a testimony to the quality of this symposium that much of the information presented remains valid today. In the USA, general procedures that should be followed in new drug investigations are given in various guidelines and memoranda issued by the Food and Drug Administration. Specific guidelines [2]relate to anticoccidial investigations. Although not a legal requirement, they provide a standard for those investigators seeking approval of a new anticoccidial drug. These guidelines are periodically revised, and investigators should consult the FDA for advice on specific protocols. Many of these procedures are also appropriate for the determination of drug resistance.
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