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1.
The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2003 to February 2004 is given. A total of 20 reports was received. This had declined from the previous year. The general apathy with regards to the reporting of adverse drug reaction has prompted the Medicines Control Council to make reporting a legal obligation on all members of the veterinary and medical profession as from August 2004. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. Veterinarians predominantly administered these products. Only two reports were received from a veterinary pharmaceutical company. 相似文献
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生物药剂学分类系统(Biopharmaceutics classification system,BCS)是根据药物的溶解性与渗透性进行分类的一种科学框架,已被欧洲药品管理局(EMEA)、美国食品药品管理局(FDA)、世界卫生组织(WHO)等认可并用作仿制药物生物等效性豁免的判断依据。随着人药BCS的发展,一些研究人员尝试将BCS引入到兽药领域,以指导兽用仿制药的开发和管理。针对BCS分类标准和概念、BCS在人药研发和管理中的应用、兽药BCS发展现状及其面临的挑战进行了总结,以期为兽药BCS分类系统的发展提供有益的借鉴和指导,为新兽药的开发和老药的改造提供参考。 相似文献
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Takayuki Anzai Masamichi Kaminishi Keizo Sato Laura Kaufman Hijiri Iwata Dai Nakae 《Journal of toxicologic pathology》2015,28(2):57-64
The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers. 相似文献
4.
Naidoo V 《Journal of the South African Veterinary Association》2003,74(4):137-140
The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2002 to February 2003 is given. In total, 40 reports were received. This had declined from the previous year. Most reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were Stock Remedies. The animal owner predominantly administered these products. Only 1 report was received from a veterinary pharmaceutical company. Increasing numbers of reports are being received from veterinarians. 相似文献
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B. SAN MARTIN J. CORNEJO L. LAPIERRE D. IRAGÜEN F. PÉREZ H. HIDALGO F. ANDRE 《Journal of veterinary pharmacology and therapeutics》2010,33(3):246-251
San Martin, B., Cornejo, J., Lapierre, L., Iragüen, D., Pérez, F., Hidalgo, H., Andre, F. Withdrawal time of four pharmaceutical formulations of enrofloxacin in poultry according to different maximum residues limits. J. vet. Pharmacol. Therap. 33 , 246–251. To ensure delivery of safe animal products to consumers, the withdrawal time (WDT) of drugs must be respected. Property differences among pharmaceutical formulations, for the same drugs, can lead to differences in the WDTs estimation. The WDTs of four commercial formulations of enrofloxacin (ENRO) in broiler chickens, considering MRLs established by different countries, were studied. Two hundred‐thirty‐four broiler chicks were allotted among four groups; the formulations were orally administered daily with 10 mg/kg bw. After treatment, six chickens of each group and two controls were slaughtered daily until day 9 post‐treatment. Samples of muscle and liver were collected, and analyzed using HPLC‐MS‐MS. The WDTs among formulations of ENRO showed differences of 24 and 48 h. Based on the European Community and Chile MRLs of 100 μg/kg (muscle) and 200 μg/kg (liver), the WDTs did not exceed 5 days. When Japan MRL was considered (10 μg/kg,), the WDTs increased up to 8 days. These results indicate that for WDTs determination, the differences among pharmaceutical formulations of a drug must be considered as well as the MRLs. 相似文献
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《中药制药工程学》是制药工程专业不多的几门工程学课程之一,对培养学生的工程能力很重要。为了让学生通过《中药制药工程学》的学习,得到基本的系统工程训练,对课堂教学进行了改革实践,注重理论联系实际,将生产实践中的工程问题引入课堂;加强工程教育,力求从工程角度分析问题;突出中药工程的特点;并变更了考试模式,将基本知识和能力的考查结合起来。着重培养学生的工程思想和解决中药制药实际工程问题的能力,受到制药工程专业学生的普遍欢迎。 相似文献
8.
An overview of reports of suspected adverse drug reactions received by the Veterinary Pharmacovigilance and Medicines Information Centre during the period March 2001 to February 2002 is given. A total of 77 reports were received. The majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most products implicated in the reports were Stock Remedies. The products were predominantly administered either by veterinarians or trained paraveterinary professionals. Although the majority of reports were received from veterinary pharmaceutical companies, the proportion of reports received directly from veterinarians increased compared with previous years. 相似文献
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The first transgenic livestock were produced in 1985 by microinjection of foreign DNA into zygotic pronuclei. This was the method of choice for more than 20 years, but more efficient protocols are now available, including somatic cell nuclear transfer and lentiviral transgenesis. Typical applications include carcass composition, lactational performance and wool production, as well as enhanced disease resistance and reduced environmental impact. Transgenic farm animal production for biomedical applications has found broad acceptance. In 2006 the European Medicines Agency (EMA) approved commercialization of the first recombinant pharmaceutical protein, antithrombin, produced in the mammary gland of transgenic goats. As the genome sequencing projects for various farm animal species are completed, it has become feasible to perform precise genetic modifications employing the emerging tools of lentiviral vectors, small interfering ribonucleic acids, meganucleases, zinc finger nucleases and transposons. We anticipate that genetic modification of farm animals will be instrumental in meeting global challenges in agricultural production and will open new horizons in biomedicine. 相似文献
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There was an increase in reports of suspected adverse reactions to veterinary medicines in 1989 with 329 reports (compared with 206 in 1988), from veterinary surgeons, farmers and the public, comments the Veterinary Medicines Directorate (VMD). Suspected adverse reactions to clostridial/pasteurella vaccines in sheep were a dominant feature and important experience was gained both in terms of liaison with the farming press, and in handling large scale incidents involving PML products. The general trend towards increased reporting of adverse drug effects continues. The UK is the only EC member state to have a PML system and the VMD is looking with some urgency at ways of ensuring the more representative reporting of all categories of drug. Substantial liaison with the veterinary pharmaceutical industry occurred during the year and 204 product reports were requested from companies. 相似文献
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为探究表达牛乳铁蛋白肽的重组鸡源乳酸杆菌pPG-XLFEC/M11对雏鸡抵抗传染性法氏囊病病毒(IBDV)感染的作用,本研究利用IBDVCEF94株感染DF-1细胞,通过CCK-8法检测病毒感染后的细胞活性,利用qRT-PCR检测病毒载量,结果显示重组乳酸菌表达的牛乳铁蛋白肽可以抑制IBDV在DF-1细胞内的增殖;以重组乳酸菌pPG-XLFEC/M11饲喂雏鸡,利用IBDV强毒UK661株进行攻毒实验,结果显示饲喂重组菌的雏鸡相比于对照组,IBDV的感染对其组织器官的损伤较小,总免疫球蛋白IgG和SIgA含量增加,细胞因子IL-6、IL-8、TNF-琢和IFN-酌以及TLR2的mRNA转录水平均显著升高,且提高了雏鸡的存活率。本实验结果表明,重组鸡源乳酸杆菌表达的牛乳铁蛋白肽可以增强机体的免疫应答水平,对雏鸡具有一定的抗IBDV感染的作用。本研究为表达牛乳铁蛋白肽的重组鸡源乳酸杆菌在生产中的应用以及为禽类疾病的预防奠定基础。 相似文献
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J. M. Bermudez A. G. Cid M. V. Ramírez‐Rigo D. Quinteros A. Simonazzi S. Snchez Bruni S. Palma 《Journal of veterinary pharmacology and therapeutics》2014,37(2):105-124
An important frontier in the administration of therapeutic drugs to veterinary species is the use of different polymers as drug delivery platforms. The usefulness of polymers as platforms for the administration of pharmaceutical and agricultural agents has been clearly recognized in the recent decades. The chemical versatility of polymers and the wide range of developed controlled‐release strategies enhance the possibilities for the formulation of active molecules. In particular, the veterinary area offers opportunities for the development of novel controlled‐release drug delivery technologies adapted to livestock or companion animal health needs. In some cases, it also allows to improve profitability in meat production or to meet the safety criteria related to drug residues. A number of factors affect the selection of polymers and subsequent properties of the controlled‐release drug delivery system. However, their selection also dictates the release kinetics of the drug from the delivery system. Such choices are therefore crucial as they affect the success and potential of the delivery system for achieving the therapeutic goals of the veterinarian. It is the intention of this review to give an overview of the most relevant polymers, which are used or have been tested as drug delivery release rate modifiers in the veterinary field. The article highlights some recent developments focusing on their advantages and applications and analyzes the future direction of the scientific and technological advancements in this area. 相似文献
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Martinez M Modric S Sharkey M Troutman L Walker L Mealey K 《Journal of veterinary pharmacology and therapeutics》2008,31(4):285-300
Despite advancements in pharmacogenetics in human medicine, the incorporation of pharmacogenetics into veterinary medicine is still in its early stages of development. To date, efforts to understand the pharmacologic impact of genetic variation in veterinary species have largely focused on genes encoding for the membrane transporter, P-glycoprotein (P-gp). The emphasis on the role of P-gp is largely because of safety concerns associated with the use of some macrocyclic lactones in dogs. Because of the body of information available on this topic, we use P-gp as a platform for understanding the importance of population diversity in veterinary medicine. The impact of P-gp on drug pharmacokinetics and pharmacodynamics is considered, along with endogenous and exogenous factors that can modulate P-gp activity. The review includes discussion of how population diversity in P-gp activity can lead to susceptibility to certain diseases or alter patient response to environmental stress or pharmaceutical intervention. In addition, phenotypic diversity also needs to be considered, as demonstrated by the impact of P-gp up-regulation and drug resistance. The aim of this review was to set the stage for further exploration into the impact of genetic and phenotypic variability on drug pharmacokinetics, disease propensity, product formulation and drug response in both companion and food-producing animals. 相似文献
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R. J. G. ZWIJNENBERG A. G. VULTO† A. S. J. P. A. M. VAN MIERT† J. T. LUMEIJ DVM PhD 《Journal of veterinary pharmacology and therapeutics》1992,15(4):364-378
Antibiotics and chemotherapeutics marketed for use in racing pigeons (Columba livia var. domestica) were evaluated by comparing the dosages and indications given by the manufacturers with the data obtained by pharmacokinetic, bacteriological and efficacy studies. This comparison showed that only three of the recommended dosages and indications of the 60 formulations marketed in The Netherlands are scientifically sound and in accordance with the literature. It is to be expected that the majority of the antimicrobials for pigeons will not satisfy the requirements for final registration as a pigeon therapeutic under the Dutch Veterinary Medicines Act of 1985. Several factors affecting drug availability are discussed, such as the different routes of administration and the influence of food. The public health aspects of the consumption of medicated pigeons is also discussed. Although there is no legislation with regard to this subject, a recommended withdrawal time of 10 days for the majority of the antimicrobials seems advisable. 相似文献
16.
Clinical efficacy and safety of imepitoin in comparison with phenobarbital for the control of idiopathic epilepsy in dogs 
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下载免费PDF全文 A. Tipold T. J. Keefe W. Löscher C. Rundfeldt F. de Vries 《Journal of veterinary pharmacology and therapeutics》2015,38(2):160-168
The anticonvulsant activity and safety of imepitoin, a novel antiepileptic drug licensed in the European Union, were evaluated in a multicentre field efficacy study as well as in a safety study under laboratory conditions. Efficacy of imepitoin was compared with phenobarbital in 226 client‐owned dogs in a blinded parallel group design. The administration of imepitoin twice daily in incremental doses of 10, 20 or 30 mg/kg demonstrated comparable efficacy to phenobarbital in controlling seizures in dogs. The frequency of adverse events including somnolence/sedation, polydipsia and increased appetite was significantly higher in the phenobarbital group. In phenobarbital‐treated dogs, significantly increased levels of alkaline phosphatase, gamma‐glutamyl‐transferase and other liver enzymes occurred, while no such effect was observed in the imepitoin group. In a safety study under laboratory conditions, healthy beagle dogs were administered 0, 30, 90 or 150 mg/kg imepitoin twice daily for 26 weeks. A complete safety evaluation including histopathology was included in the study. A no‐observed‐adverse‐event level of 90 mg/kg twice daily was determined. These results indicate that imepitoin is a potent and safe antiepileptic drug for dogs. 相似文献
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Campos M van Hoek I Peremans K Daminet S 《Journal of veterinary internal medicine / American College of Veterinary Internal Medicine》2012,26(4):853-862
Recombinant human thyrotropin (rhTSH) was developed after bovine thyrotropin (bTSH) was no longer commercially available. It was approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) as an aid to diagnostic follow-up of differentiated thyroid carcinoma in humans and for thyroid remnant ablation with radioiodine. In addition, rhTSH is used in human medicine to evaluate thyroid reserve capacity and to enhance radioiodine uptake in patients with metastatic thyroid cancer and multinodular goiter. Likewise, rhTSH has been used in veterinary medicine over the last decade. The most important veterinary use of rhTSH is thyroidal functional reserve testing for the diagnosis of canine hypothyroidism. Recent pilot studies performed at Ghent University in Belgium have investigated the use of rhTSH to optimize radioiodine treatment of canine thyroid carcinoma and feline hyperthyroidism. Radioiodine treatment optimization may allow a decreased therapeutic dosage of radioiodine and thus may improve radioprotection. This review outlines the current uses of rhTSH in human and veterinary medicine, emphasizing research performed in dogs and cats, as well as potential future applications. 相似文献
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This report describes a case of a multiple‐drug resistant strain of Acinetobacter baumannii associated with bronchopneumonia in a horse. A 6‐month‐old Thoroughbred colt was examined for a chronic lower respiratory tract disease. Prior to presentation to the University Veterinary Teaching Hospital (UVTH), the colt had been treated intensively in a private equine hospital for presumed antimicrobial‐induced enterocolitis following treatment with azithromycin and rifampin, and had been discharged on treatment of doxycycline for continued lower airway abnormalities. At the UVTH, investigation of the lower airway disease included a culture of a percutaneous transtracheal wash, which identified a multiple‐drug resistant strain of A. baumannii as the causative agent with sensitivity only to fluoroquinolones and trimethoprim sulphonamides. Following treatment with marbofloxacin there was full resolution of the bronchopneumonia. A. baumannii is a major nosocomial pathogen associated with infections in both animals and man and reports of multiple‐drug resistant strains have been documented worldwide. Outbreaks of A. baumannii infections have been reported to occur in very ill human patients housed in healthcare settings such as intensive care units, and are characterised by the rapid development of resistance to the majority of antimicrobials. The difficulties in the treatment of such cases as well as the potential risk of transmission within a veterinary clinical setting are discussed. 相似文献
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In order for a tumour to continue to grow and disseminate, it must acquire a new blood supply. Neovascularisation can be enacted by a number of different mechanisms. This dependence of tumour progression on an augmented vascular supply has been exploited by the development of anti‐angiogenic drugs, which are designed to inhibit new blood vessel formation or disrupt existing tumour‐associated vasculature, both leading to ischaemic–hypoxic tumour cell death. However, the clinical benefits of these therapeutic approaches are frequently variable and often transient, the neoplasm sometimes being able to use other neovascularisation mechanisms to maintain its blood supply and thus evade the current anti‐angiogenic therapy. Tumours may also develop a more malignant phenotype following this treatment. Clinical outcomes may be improved by simultaneously inhibiting different angiogenic pathways, abetted by more effective drug delivery regimens such as metronomic chemotherapy and the concurrent use of other antitumour modalities. 相似文献
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本文分析总结了欧盟2009至2019年来以猪、牛、绵羊和山羊养殖为主的畜牧养殖业发展动态及相应的兽药市场销售情况,并从欧盟兽药市场具体情况及其在全球兽药市场的地位角度进行了分析,认为欧盟兽药市场以驱虫药和疫苗为主,抗生素和其他兽药为辅。为国内兽药产业从业者了解欧盟兽药市场,以及国内外兽药产业对比提供了具体数据,有助于对国内外兽药产业进行全面的分析。 相似文献