新兽药安全评价与评审

对国内外兽药安全评价与风险评估的概念与内容,新兽药研发流程与安全性评价流程,新兽药评审与评价区别进行了论述,并对新兽药安全性评价研究工作目的与结果评价,风险评估与食品安全,特别是每日允许摄入量（ADI）制订和最高残留限量（MRL）的制订等方面进行了论述。对国内企业开发用于食用动物的新兽药有一定指导作用。     

浅谈兽药与环境安全

随着畜牧业的发展,兽药被广泛应用.兽药在为人们带来诸多方便的同时,也造成了对人体健康和环境卫生的潜在危害,如兽药在动物性食品中的残留可导致人类变态(或过敏)反应、致畸、致突变和激素样作用等诸多方面不利影响,而由用药动物排至环境中的兽药及其代谢产物会对人类生活的环境和生态系统产生影响.因此,除进行兽药对食品动物的药理毒理学研究外,亦应重视对环境和生态影响的研究,以求创造更安全、更适于畜牧业持续发展的优良生态环境,保护人类生存环境,所以开展兽药对环境影响的研究是关系到人类健康和环境保护的重大课题.     

兽药安全使用的政策要求

正一、兽药概况(一)兽药现状经过多年的发展,我国兽药产业由小到大,从弱变强,已逐步形成门类较为齐全、品种相对多样、技术较为先进、产业链较为完整,并具有一定国际竞争力的行业。截至2013年年底,全国共有兽药生产企业1820家(许可证),其中生药企业85家,化药企业1735家,均通过了兽药GMP认证。产品涉及29个剂型,近3000余种,从业人员16.29万人。2012年兽药行业年产值达436.08亿元,销售额401.14亿元,资产总额1016.47亿元。其中生物制品68家93.47亿。全国兽药经营企业约有5     

兽药安全评价与残留检测技术研究获重大进展

旨在确保老百姓安全食用动物源食品(肉、蛋、奶、水产及其制品)的“十五”国家科技攻关“兽药安全评价与残留检测技术研究”课题。在科技部农社司鼎力资助下获重大进展。由中国农业大学沈建忠教授主持。中国兽医药品监察所和北京望尔生物技术有限公司等单位参加的课题组。经过三年努力，     

关于淘汰兽药品种及兽药安全评价品种目录的公告

2007年4月4日，中华人民共和国农业部第859号公告公布了《淘汰兽药品种目录》，现将相关内容刊出，以飨读者。     

饲料添加剂和兽药安全评价国际进展

批准使用的饲料添加剂和兽药必须安全、有效并可控,三者不可缺一。随着人们日益关注食品安全和科学技术的进步．各国在管理中更重视安全评价。     

兽药安全使用注意事项

1 兽医化学药品及制剂安全使用注意事项 1．1药物的选择治疗某种疾病,常有数种药物可以采用,但究竟采用哪一种最为恰当,可根据以下几个方面考虑决定。     

开展上市后兽药的监测与评价论建立兽医药物流行病学的必要性

新兽药在进入市场前,由于临床研究病例少、样本数有限、研究条件受严格限制,其使用、效应与上市后在动物群体中用药有显著区别。上市后兽药的监测与评价,是指对新上市兽药所进行的药物流行病学研究,旨在及时获得对上市后兽药的正确评价,以进一步指导合理用药,并为兽...     

蚕用兽药的现状与应用

本文综述了我国目前蚕用兽药的种类和特点,认为消毒剂是养蚕必备的蚕用兽药,抗菌剂是辅助用蚕用兽药。同时,介绍了鉴别蚕用兽药的途径。     

中国农业科学院兽药安全评价与残留研究重点开放实验室

中国农业科学院兽药安全评价与残留研究重点开放实验室挂靠于中国农业科学院上海兽医研究所,依托于该所动物药学研究室。实验室按GLP要求建设和管理,现有来自兽医药理学与毒理学、生物化学、药物化学、分析化学等学科的各级各类专业人才数十名,     

Clinical evaluation of new products for small animals

Extract

The discovery and development of sulphonamides and antibiotics marked the beginning of serious efforts to study in depth the efficacy and other sequelae of therapeutic agents. Before the sulphonamide/antibiotic era, pharmacological tests earned out on laboratory animals were considered adequate for most medicaments. Now, more exact information is required about modern drugs used in man and animals. Staff of several disciplines are needed to devise laboratory techniques, controlled experiments, methods of measuring results, and their statistical analysis. Moreover, tests with laboratory animals were not enough, and the much more difficult task of clinical evaluation had to be devised. This has led to a specialization in the testing of drugs by clinicians in human and veterinary medicine. A new discipline, Clinical Pharmacology, has been established for the scientific evaluation of therapeutics.     

The use of microbiological end-points in the safety evaluation and elaboration of maximum residue limits for veterinary drugs intended for use in food producing animals

The safety evaluation of veterinary drugs intended for use in food producing animals relies heavily on the results of toxicity studies in laboratory animals, supported where possible by any data resulting from human exposure. The general approach involves the calculation of an acceptable daily intake which in turn can be used to elaborate maximum residue limits. It is an approach used in the European Union, in other countries and at the international level. In recent years, concern has been expressed over the presence of microbiologically active residues of veterinary drugs in food and their possible effects on the human gastrointestinal microflora. Methodologies for conducting microbiological safety studies have been investigated and approaches to microbiological safety assessments have been debated. The whole approach has proved to be controversial, partly because there are considerable doubts over the ability of low concentrations of antibiotic substances to produce adverse effects on the human gut flora and partly because there are no validated methods for testing for these attributes. This paper reviews the problems in some detail and discusses the regulatory consequences.     

Blastocystis in humans and animals: new insights using modern methodologies

Among the waterborne protozoan parasites of medical and veterinary importance, Blastocystis is perhaps one of the less well-understood. However, in recent years, there has been a surge of interest in the organism, fueled in part by the possible association of Blastocystis infection with intestinal disorders, and its unusual taxonomic affiliations. Although there is information on the parasite's morphology, taxonomy and mode of transmission, its pathogenicity, life cycle, and function of certain organelles continue to baffle investigators. The clinical relevance of Blastocystis will be better answered once an animal model is found. Blastocystis infections have a worldwide distribution but prevalence is highest in areas with poor hygiene and deficient sanitation services and facilities. Application of modern molecular tools has advanced knowledge of the organism's genetic diversity, taxonomy and zoonotic potential.     

Ethological basis for the evaluation of animal welfare in housing systems for agricultural animals and laboratory animals]

The Swiss Federal Act on Animal Protection (1978) requires the sale of mass-produced housing systems for farm animals to be authorized by the Federal Veterinary Office. Authorization is only granted for housing systems that safeguard the animals' welfare. A concept for the assessment of Animal Welfare has to provide a high forensic value. The capacity of farm animals to adapt to an intensive housing system can be directly examined, whereas the existence and extent of subjective feelings can only be assumed. In our concept the examination focuses on the interaction of individuals with their artificial environment. The main question is whether or not the individuals are able to cope with given nonspecific (e.g. temperature, humidity) and specific (e.g. drinking troughs, behaviour of conspecifics) stimuli in order to reach the immediate (e.g. drinking, make way for) and ultimate (survival, reproduction success) goals. Animals of the same breed are observed in a highly diverse environment in order to determine normal behaviour. Whether behavioural expressions which differ significantly from normal behaviour are adaptive to the restrictive housing conditions is judged by the behaviours' consequences for both, the individuals and the environment. Many studies prove the concept's high forensic value and the authorities prefer conclusions based on this concept to others referring to the animals' motivational and emotional state. However more research has to be done with respect to animal welfare in farm and laboratory animal breeding as well as in the use of laboratory animals for experimental studies.