OBJECTIVE: To illustrate the application of the Consensus on the Rational Use of Antithrombotics in Veterinary Critical Care (CURATIVE) guidelines to the management of dogs and cats at risk of developing thrombosis using a case-based approach.
BACKGROUND: Dogs and cats become at risk of developing thrombosis from a wide range of conditions. These conditions often involve a specific insult followed by an inflammatory response and when combined with other contributing factors (eg, hypercoagulability, vascular endothelial injury, hemodynamic changes) create favorable conditions for thrombosis.
METHODS: Development of thrombosis in small animals remains challenging to demonstrate. Compatible clinical signs, the presence of known risk factors, and supporting diagnostic tests may be highly suggestive of the development of thrombosis.
METHODS: Therapeutic recommendations in accordance with the CURATIVE guidelines for dogs and cats are described in specific case vignettes presented. Discussion is centered on antithrombotic drug choices and dosing protocols, as outlined in Domains 2 and 3 of the CURATIVE guidelines. Where appropriate, guidelines related to therapeutic monitoring (Domain 4) and discontinuation of antithrombotics (Domain 5) were included.
CONCLUSIONS: In small animals at risk of developing thrombosis, overall prognosis may be improved by following consensus-based recommendations on the use of antithrombotics as outlined in the CURATIVE guidelines. Whether such interventions have any impact on outcome requires further investigation.

This guideline is intended to assist in the planning and execution of studies designed to assess the efficacy of ectoparasiticides for fish. It is the first ectoparasite-specific guideline to deal with studies set in the aquatic environment and therefore provides details for the maintenance of environmental standards for finfish. Information is included on a range of pre-clinical study designs as well as clinical studies in commercial/production sites, set within a regulatory framework. It provides information on the study animals, their welfare, husbandry and environmental requirements during the study. The most commonly pathogenic ectoparasites are presented with relevant points regarding life history, host challenge and numeric evaluation. Preparation and presentation of both topical and oral test treatments is provided, together with guidance on data collection and analysis. The guideline provides a quality standard or efficacy studies on finfish, which will assist researchers and regulatory authorities worldwide and contribute to the wider objective of harmonisation of procedures.

The epidemic of antimicrobial resistant infections continues to challenge, compromising animal care, complicating food animal production and posing zoonotic disease risks. While the overall role of therapeutic antimicrobial use in animals in the development AMR in animal and human pathogens is poorly defined, veterinarians must consider the impacts of antimicrobial use in animal and take steps to optimize antimicrobial use, so as to maximize the health benefits to animals while minimizing the likelihood of antimicrobial resistance and other adverse effects. This consensus statement aims to provide guidance on the therapeutic use of antimicrobials in animals, balancing the need for effective therapy with minimizing development of antimicrobial resistance in bacteria from animals and humans.

The main chemicals used against varoa are acaricides, and the antibiotics used for the control of bee bacterial diseases are mainly tetracyclines, streptomycins, sulfonamides and chloramphenicol. No maximum residue limits (MRLs) have been set for any antibiotics in honey. Therefore, in the European Union, minimum recommended concentrations (RC) for the analytical performance of methods to control a certain set of these non-authorised chemicals in honey were published by the European Union Reference Laboratory (EU-RL) in 2007. Concerning the strategy for the control for antibiotic residues in honey, there is still a great need for a cheap and single multi-residue method. Biochip array technology is an innovative assay technology for the multi-analyte screening of biological samples in a rapid and easy-to-use format. A multi-array system, called Evidence Investigator™ (Randox, Crumlin, Co., Antrim, UK), was evaluated in our laboratory. It is a semi-automated biochip system designed for research, clinical applications and veterinary use. A competitive chemiluminescent immunoassay is employed for the detection of antimicrobials. The MicroArray II kit (AM II) dedicated to the screening of six different families of antibiotic residues was validated according to the European guideline for the validation of screening methods for residues of veterinary medicines. The specificity was proven to be very satisfactory, and applicability to different kinds of honey was demonstrated. The detection capabilities (CCβ) of six antibiotic residues were determined and were below the RCs when exist. The AM II kit could detect at least six quinolones, four tetracyclines and three epimers, three aminoglycosides, three macrolides, thiamphenicol, florfenicol and ceftiofur along with one of its stabilised metabolites, the desfuroylceftiofurcysteine disulfide (DCCD).

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Considering the diversity in physiology between species and the numerous dosage forms that exist in veterinary drug products, there are numerous complex issues that arise from the development and regulation of veterinary drugs for food-producing and companion animals. Generic drugs are no exception. The main objective of this article is to illustrate the current important similarities and differences between international veterinary bioequivalence guidelines. It is concluded that since important differences are found, these may lead to barriers in international data exchange and scientific confusion, hence fostering the need for a harmonization effort in developing consistent guidelines based on sound pharmacological and statistical principles for the approval of veterinary generic drugs around the world.

Commission Decision (CD) 2002/657/EC describes detailed rules for method validation within the framework of residue monitoring programmes. The approach described in this CD is based on criteria. For (qualitative) screening methods, the most important criteria is that the CCβ has to be below any regulatory limit. Especially when microbiological or immunochemical methods are involved, the approach described in the CD is not easily applied. For example, by those methods, a large number of analytes (all antibiotics) within several different matrices (meat, milk, fish, eggs, etc.) are detected. It is not completely clear whether all those analytes and all matrices have to be taken into account during method validation. To clarify this, a working group - from EU Reference Laboratories - came up with a practical approach to validate multi-analyte multi-matrix screening methods. It describes how many analyte/matrix combinations have to be tested and how these combinations are selected. Furthermore it describes how to determine CCβ for screening methods in relation to a large list of compounds and maximum residue limits (MRLs). First for each analyte/matrix combination the \'cut-off\' level - i.e. the level at which the method separates blanks from contaminated samples - is established. The validation is preferably at the concentration of 50% of the regulatory limit. A minimum set of 20 different samples has to be tested. From the experiences with applying these guidelines it was concluded that the validation approach is very \'practical\'; however, there are some remarks. One has to be careful with selecting \'representative\' analytes and matrices and it is strongly recommended to collect additional validation data during the routine application of the method.

The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is an international tripartite cooperation programme that brings together regulatory authorities and industry representatives from the European Union, Japan and the United States, with Australia, New Zealand and Canada as observers. VICH aims to improve international coordination and cooperation to achieve greater harmonisation of the requirements for veterinary product registration in the regions concerned. VICH develops harmonised data requirements, i.e., standards for the scientific studies on quality, safety and efficacy that are required to obtain a marketing authorisation for a veterinary medicinal product. It does this by publishing guidelines that provide uniform and consistent guidance for sponsors to follow in developing data for application dossiers as well as for post-marketing safety monitoring of veterinary medicinal products. Of the 49 VICH guidelines that have been developed so far, two guidelines in particular address issues related to antimicrobial resistance.

In 2010 the German Bundestierärztekammer (Federal Chamber of Veterinarians) and the AGTAM (Working Group \"Veterinary Pharmaceuticals\") published the Guidelines for the prudent use of antibacterial veterinary pharmaceuticals in an updated version. Within the limits of therapeutic freedom, veterinarians are committed to take into account the latest scientific findings in veterinary medicine. These findings may, however, include conflicting interpretations if such an approach is expressed by an accredited university or anywhere else in the field of science. Hence, the state of science in veterinary medicine is not only defined by the Guidelines for Antibiotics, rather, the complete recognized scientific literature has to be considered. The Guidelines for Antibiotics are not legally-binding rules. They define the best approach and not the minimum standard for the use of antibiotics. The clinical examination provides the basis for medical treatment in each specific case. Further laboratory diagnostics represent an additional supportive instrument that is used by the veterinarian at his discretion depending on the necessity. Laboratory tests of bacterial sensitivity (identification of pathogens and antibiogram) may become necessary within the framework of diagnostics. As examples demonstrate, laboratory tests of bacterial sensitivity cannot be performed in every clinical case. It appears to be desirable to further discuss the use of antibacterial veterinary pharmaceuticals in the species-specific attachments in more concrete and specific terms, taking into consideration the standards of evidence-based medicine.

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