WorldWideScience

Sample records for veterinary drug bioequivalence

  1. 21 CFR 201.105 - Veterinary drugs.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Veterinary drugs. 201.105 Section 201.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.105 Veterinary drugs. A drug subject to the...

  2. Comparison of veterinary drugs and veterinary homeopathy: part 1

    Science.gov (United States)

    Lees, P.; Pelligand, L.; Whiting, M.; Chambers, D.; Toutain, P-L.; Whitehead, M. L.

    2017-01-01

    For many years after its invention around 1796, homeopathy was widely used in people and later in animals. Over the intervening period (1796-2016) pharmacology emerged as a science from Materia Medica (medicinal materials) to become the mainstay of veterinary therapeutics. There remains today a much smaller, but significant, use of homeopathy by veterinary surgeons. Homeopathic products are sometimes administered when conventional drug therapies have not succeeded, but are also used as alternatives to scientifically based therapies and licensed products. The principles underlying the veterinary use of drug-based and homeopathic products are polar opposites; this provides the basis for comparison between them. This two-part review compares and contrasts the two treatment forms in respect of history, constituents, methods of preparation, known or postulated mechanisms underlying responses, the legal basis for use and scientific credibility in the 21st century. Part 1 begins with a consideration of why therapeutic products actually work or appear to do so. PMID:28801498

  3. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Science.gov (United States)

    2013-12-05

    ... exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1464] Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted...

  4. Comparison of veterinary drugs and veterinary homeopathy: part 1.

    Science.gov (United States)

    Lees, P; Pelligand, L; Whiting, M; Chambers, D; Toutain, P-L; Whitehead, M L

    2017-08-12

    For many years after its invention around 1796, homeopathy was widely used in people and later in animals. Over the intervening period (1796-2016) pharmacology emerged as a science from Materia Medica (medicinal materials) to become the mainstay of veterinary therapeutics. There remains today a much smaller, but significant, use of homeopathy by veterinary surgeons. Homeopathic products are sometimes administered when conventional drug therapies have not succeeded, but are also used as alternatives to scientifically based therapies and licensed products. The principles underlying the veterinary use of drug-based and homeopathic products are polar opposites; this provides the basis for comparison between them. This two-part review compares and contrasts the two treatment forms in respect of history, constituents, methods of preparation, known or postulated mechanisms underlying responses, the legal basis for use and scientific credibility in the 21st century. Part 1 begins with a consideration of why therapeutic products actually work or appear to do so. British Veterinary Association.

  5. Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs.

    Science.gov (United States)

    Muñoz, Joel; Alcaide, Daniel; Ocaña, Jordi

    2016-05-30

    The 2010 US Food and Drug Administration and European Medicines Agency regulatory approaches to establish bioequivalence in highly variable drugs are both based on linearly scaling the bioequivalence limits, both take a 'scaled average bioequivalence' approach. The present paper corroborates previous work suggesting that none of them adequately controls type I error or consumer's risk, so they result in invalid test procedures in the neighbourhood of a within-subject coefficient of variation osf 30% for the reference (R) formulation. The problem is particularly serious in the US Food and Drug Administration regulation, but it is also appreciable in the European Medicines Agency one. For the partially replicated TRR/RTR/RRT and the replicated TRTR/RTRT crossover designs, we quantify these type I error problems by means of a simulation study, discuss their possible causes and propose straightforward improvements on both regulatory procedures that improve their type I error control while maintaining an adequate power. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  6. Veterinary Medicine Needs New Green Antimicrobial Drugs

    Directory of Open Access Journals (Sweden)

    Pierre-Louis TOUTAIN

    2016-08-01

    Full Text Available Given that: (1 the worldwide consumption of antimicrobial drugs (AMDs used in food-producing animals will increase over the coming decades; (2 the prudent use of AMDs will not suffice to stem the rise in human antimicrobial resistance (AMR of animal origin; (3 alternatives to AMD use are not available or not implementable, there is an urgent need to develop novel AMDs for food-producing animals. This is not for animal health reasons, but to break the link between human and animal resistomes. In this review we establish the feasibility of developing for veterinary medicine new AMDs, termed green antibiotics, having minimal ecological impact on the animal commensal and environmental microbiomes.We first explain why animal and human commensal microbiota comprise a turnstile exchange, between the human and animal resistomes. We then outline the ideal physico-chemical, pharmacokinetic and pharmacodynamic properties of a veterinary green antibiotic and conclude that they can be developed through a rational screening of currently used AMD classes. The ideal drug will be hydrophilic, of relatively low potency, slow clearance and small volume of distribution. It should be eliminated principally by the kidney as inactive metabolite(s. For oral administration, bioavailability can be enhanced by developing lipophilic pro-drugs. For parenteral administration, slow-release formulations of existing eco-friendly AMDs with a short elimination half-life can be developed. These new eco-friendly veterinary AMDs can be developed from currently used drug classes to provide alternative agents to those currently used in veterinary medicine and mitigate animal contributions to the human AMR problem.

  7. Bioequivalence of isoniazid in a two drug fixed dose combination and in a single drug dosage form.

    Science.gov (United States)

    Agrawal, S; Kaul, C L; Panchagnula, R

    2001-08-01

    To increase the patient compliance and reduce the risk of drug resistant strains, WHO and IUATLD recommend the use of Fixed Dose Combination (FDC) tablets as a routine therapeutic regimen in Directly Observed Treatment Shortcourse (DOTS). But the main issue in the use of FDC is the quality of the formulation. At present WHO and IUATLD suggest the bioequivalence assessment of only rifampicin from FDC compared to separate formulations. For the therapeutic effectiveness all the components of the FDCs should be bioavailable at tissue site. Also, the primary and acquired resistance rate of isoniazid is much higher compared to other anti-tubercular drugs. Hence, a comparative bioavailability study of isoniazid from a two drugs FDC compared to a separate formulation was carried out on a group of 12 healthy volunteers. When evaluated by normal or log transformed confidence interval, Two Way ANOVA and Hauschke analysis, the bioequivalence limits for AUC0-8 and AUC0-24 were within 0.8-1.25. For Cmax and Tmax, these limits were within 0.7-1.43. Hence, isoniazid from a FDC formulation was found to be bioequivalent to a separate formulation at same dose levels.

  8. Integration of in vitro biorelevant dissolution and in silico PBPK model of carvedilol to predict bioequivalence of oral drug products.

    Science.gov (United States)

    Ibarra, Manuel; Valiante, Cristian; Sopeña, Patricia; Schiavo, Alejandra; Lorier, Marianela; Vázquez, Marta; Fagiolino, Pietro

    2018-06-15

    Bioequivalence implementation in developing countries where a high proportion of similar drug products are being marketed has found several obstacles, impeding regulatory agencies to move forward with this policy. Biopharmaceutical quality of these products, several of which are massively prescribed, remains unknown. In this context, an in vitro-in silico-in vivo approach is proposed as a mean to screen product performance and target specific formulations for bioequivalence assessment. By coupling in vitro biorelevant dissolution testing in USP-4 Apparatus (flow-through cell) with physiologically-based pharmacokinetic (PBPK) modeling in PK-Sim® software (Bayer, Germany), the performance of seven similar products of carvedilol tablets containing 25 mg available in the Uruguayan market were compared with the brand-name drug Dilatrend®. In silico simulations for Dilatrend® were compared with published results of bioequivalence studies performed in fasting conditions allowing model development through a learning and confirming process. Single-dose pharmacokinetic profiles were then simulated for the brand-name drug and two similar drug products selected according to in vitro observations, in a virtual Caucasian population of 1000 subjects (50% male, aged between 18 and 50 years with standard body-weights). Population bioequivalence ratios were estimated revealing that in vitro differences in drug release would have a major impact in carvedilol maximum plasma concentration, leading to a non-bioequivalence outcome. Predictions support the need to perform in vivo bioequivalence for these products of extensive use. Application of the in vitro-in silico-in vivo approach stands as an interesting alternative to tackle and reduce drug product variability in biopharmaceutical quality. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Damle, B

    2015-03-01

    RIN(®)-150 is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg) and isoniazid (INH, 75 mg) developed for the treatment of tuberculosis. This study was conducted at a single center: the Pfizer Clinical Research Unit in Singapore. To demonstrate bioequivalence of each drug component between RIN-150 and individual products in a loose combination. This was a randomized, open-label, single-dose, two-way crossover study. Subjects received single doses of RIN-150 or two individual reference products under fasting conditions in a crossover fashion, with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (Cmax) and the area under plasma concentration-time curve (AUC). Of 28 subjects enrolled, 26 completed the study. The adjusted geometric mean ratios of Cmax and AUClast between the FDC and single-drug references and 90% confidence intervals were respectively 91.63% (90%CI 83.13-101.01) and 95.45% (90%CI 92.07-98.94) for RMP, and 107.58% (90%CI 96.07-120.47) and 103.45% (90%CI 99.33-107.75) for INH. Both formulations were generally well tolerated in this study. The RIN-150 FDC tablet formulation is bioequivalent to the two single-drug references for RMP and INH at equivalent doses.

  10. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs.

    Science.gov (United States)

    van Gelder, Teun; Gabardi, Steven

    2013-08-01

    Within the field of solid organ transplantation, the patents for a number of immunosuppressive drugs have expired in the last few years. Tacrolimus, cyclosporine, and mycophenolate mofetil are now available as generic drugs. In some countries, the market penetration of these generic formulations is as high as 70%, whereas in some other countries, this figure is below 10%. Several professional societies have published position papers on the risks and benefits of generic substitution of immunosuppressive drugs. It often appears that transplant professionals are not fully aware of the requirements for registration of generic drugs. This article describes the registration requirements with a focus on bioequivalence testing, the strengths and weaknesses in this process, and the differences between Europe and the US. © 2013 The Authors Transplant International © 2013 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

  11. Residue analysis of veterinary drugs and growth-promoting agents

    NARCIS (Netherlands)

    Stolker, A.A.M.; Zuidema, T.; Nielen, M.W.F.

    2007-01-01

    Two major trends are observed in the analysis of veterinary drugs and growth-promoting agents. First is the selection of sample material for monitoring the use of registered veterinary drugs. Traditionally meat, kidney and liver were analyzed but, due to the food scandals in which meat was very

  12. Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamics

    DEFF Research Database (Denmark)

    Kreilgaard, Mads; Kemme, M J; Burggraaf, J

    2001-01-01

    The aim of the study was to investigate the cutaneous bioequivalence of a lipophilic model drug (lidocaine) applied in a novel topical microemulsion vehicle, compared to a conventional oil-in-water (O/W) emulsion, assessed by a pharmacokinetics microdialysis model and a pharmacodynamic method....

  13. 21 CFR 558.6 - Veterinary feed directive drugs.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Veterinary feed directive drugs. 558.6 Section 558.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS General Provisions...

  14. Comparison of veterinary drugs and veterinary homeopathy: part 2

    Science.gov (United States)

    Lees, P.; Pelligand, L.; Whiting, M.; Chambers, D.; Toutain, P-L.; Whitehead, M. L.

    2017-01-01

    Part 2 of this narrative review outlines the theoretical and practical bases for assessing the efficacy and effectiveness of conventional medicines and homeopathic products. Known and postulated mechanisms of action are critically reviewed. The evidence for clinical efficacy of products in both categories, in the form of practitioner experience, meta-analysis and systematic reviews of clinical trial results, is discussed. The review also addresses problems and pitfalls in assessing data, and the ethical and negative aspects of pharmacology and homeopathy in veterinary medicine. PMID:28821700

  15. Bioequivalence of fixed-dose combination Myrin®-P Forte and reference drugs in loose combination.

    Science.gov (United States)

    Wang, H F; Wang, R; O'Gorman, M; Crownover, P; Naqvi, A; Jafri, I

    2013-12-01

    Myrin®-P Forte is a fixed-dose combination (FDC) tablet containing rifampicin (RMP, 150 mg), isoniazid (INH, 75 mg), ethambutol (EMB) hydrochloride (275 mg) and pyrazinamide (PZA, 400 mg) developed for the treatment of tuberculosis (TB). This study was conducted at a single centre--the Pfizer Clinical Research Unit in Singapore. To demonstrate the bioequivalence of each drug component of the Myrin-P Forte FDC and the individual product in loose combination. In a randomized, open-label, single-dose, two-way, crossover study, subjects received single doses of Myrin-P Forte or four individual products under fasting conditions in a crossover fashion with at least 7 days washout between doses. The primary measures for comparison were peak plasma concentration (C(max)) and the area under plasma concentration-time curve (AUC). Of 36 subjects enrolled, 35 completed the study. The adjusted geometric mean ratios and 90% confidence intervals for C(max) and AUC values were completely contained within bioequivalence limits (80%, 125%) for all four drugs in both formulations. Both treatments were generally well tolerated in the study. The Myrin-P Forte FDC tablet formulation is bioequivalent to the four single-drug references for RMP, INH, EMB hydrochloride and PZA at equivalent doses.

  16. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis

    International Nuclear Information System (INIS)

    2016-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  17. The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation.

    Science.gov (United States)

    Tsume, Yasuhiro; Amidon, Gordon L

    2010-08-02

    The Biopharmaceutical Classification System (BCS) guidance issued by the FDA allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release (IR) solid oral dosage forms only for BCS class I drugs. However, a number of drugs within BCS class III have been proposed to be eligible for biowaivers. The World Health Organization (WHO) has shortened the requisite dissolution time of BCS class III drugs on their Essential Medicine List (EML) from 30 to 15 min for extended biowaivers; however, the impact of the shorter dissolution time on AUC(0-inf) and C(max) is unknown. The objectives of this investigation were to assess the ability of gastrointestinal simulation software to predict the oral absorption of the BCS class I drugs propranolol and metoprolol and the BCS class III drugs cimetidine, atenolol, and amoxicillin, and to perform in silico bioequivalence studies to assess the feasibility of extending biowaivers to BCS class III drugs. The drug absorption from the gastrointestinal tract was predicted using physicochemical and pharmacokinetic properties of test drugs provided by GastroPlus (version 6.0). Virtual trials with a 200 mL dose volume at different drug release rates (T(85%) = 15 to 180 min) were performed to predict the oral absorption (C(max) and AUC(0-inf)) of the above drugs. Both BCS class I drugs satisfied bioequivalence with regard to the release rates up to 120 min. The results with BCS class III drugs demonstrated bioequivalence using the prolonged release rate, T(85%) = 45 or 60 min, indicating that the dissolution standard for bioequivalence is dependent on the intestinal membrane permeability and permeability profile throughout the gastrointestinal tract. The results of GastroPlus simulations indicate that the dissolution rate of BCS class III drugs could be prolonged to the point where dissolution, rather than permeability, would control the overall absorption. For BCS class III drugs with intestinal absorption patterns

  18. Application of Stable Isotope in Detection of Veterinary Drug Residues

    International Nuclear Information System (INIS)

    Wang Wei; Liu Zhanfeng; Du Xiaoning

    2010-01-01

    In recent years, there has happened a series of significant food safety events worldwide, which lower down consumers' confidence in food safety, and they are taking increasing care about the sources of their foods. The safety problem of animal-origin foods has become a global topic for discussion. Therefore, it is a pressing task to establish a precise, sensitive and reliable method for analyzing veterinary drug residue. An introduction of the present status regarding veterinary drug residue analysis was made in the paper, and it briefly summarized the limit of detection (LOD) and quantification (LOQ) which could be reached in veterinary drug residue analysis by isotopic internal standard method domestically and abroad. The paper also made a review of the progress in applied research of stable isotope labeled compound in veterinary drug residue analysis of, such as, antibiotic medicines, furans and sulfonamides. The paper elucidated the great importance of the application of stable isotopes in the sane development of China's food safety system. (authors)

  19. Assessment of veterinary drug use and determination of ...

    African Journals Online (AJOL)

    A cross-sectional study was conducted between October 2009 and January 2010 to assess veterinary drug usage by broiler chicken farmers and to determine antimicrobial residues in broiler meat in Urban district, Zanzibar, Tanzania. Fifty five smallholder farmers were interviewed on types of antimicrobials, reasons for use, ...

  20. Prudent Use of Veterinary Drugs: Impact on Safe Animal Products ...

    African Journals Online (AJOL)

    Like any other therapeutic compounds, veterinary drugs are used to alleviate diseases in animals as either therapeutic or prophylactic compounds for specific disease entities. They can also be used as production aids in food producing animals to increase market sale of these animals whereby the producers save on the ...

  1. [Drugs in veterinary medicine. The role of the veterinary drug industry].

    Science.gov (United States)

    Baars, J C

    1984-02-01

    Veterinary medicines constitute an unescapable element in the scheme of animal health and welfare. Nowadays, they are used more and more to improve health and productivity in farm animals. When a veterinary medicine is prescribed it must not only be effective but must also be safe for both animals and humans. Due to ever changing regulations and constant improvements in residue detection techniques it is necessary to conduct new investigations with existing products. It therefore costs a great deal of time and money to introduce, and maintain, a product in the market. In future, therefore, fewer medicines with more limited indications will be introduced and these will be to combat important production disorders in the more significant species only. In view of the above, research and production will be restricted to large, international, concerns. Due to our well structured agricultural industry and the existence of well organized and equipped veterinary research institutions, and practitioners, Holland is able to play an important role in the development of veterinary medicines. Close co-operation between all involved parties coupled with an efficient registration procedure is not ony of benefit to the veterinary pharmaceutical industry but also for international recognition of our national animal husbandry industry, ancillary industries and veterinary and other consultants. In this scheme of things the accent is not upon qualifications but upon the skills of veterinarians - wherever placed - who are involved in the administration of veterinary medicines.

  2. Bioequivalence of azathioprine products.

    Science.gov (United States)

    Baker, Daniel E

    2003-01-01

    All azathioprine oral tablets are considered bioequivalent by the Food and Drug Administration based on traditional testing. However, since these tests were conducted, it has been determined that some patients have a deficiency of the enzyme most responsible for the metabolism of 6-mercaptopurine-thiopurine methyltransferase (TPMT). Azathioprine is rapidly converted to 6-mercaptopurine, its active metabolite. So it is possible that differences in TPMT activity may influence the bioequivalence of azathioprine products among individuals, especially those patients deficient in TPMT enzyme activity. However, this possibility has not been evaluated.

  3. Low energy nanoemulsification to design veterinary controlled drug delivery devices

    Directory of Open Access Journals (Sweden)

    Thierry F Vandamme

    2010-10-01

    Full Text Available Thierry F Vandamme, Nicolas Anton, University of Strasbourg, Faculty of Pharmacy, Illkirch Cedex, France; UMR CNRS 7199, Laboratoire de Conception et Application de Molécules Bioactives, équipe de Pharmacie Biogalénique, Illkirch Cedex, France,  This work is selected as Controlled Release Society Outstanding Veterinary Paper Award 2010Abstract: The unique properties of nanomaterials related to structural stability and quantum-scale reactive properties open up a world of possibilities that could be exploited to design and to target drug delivery or create truly microscale biological sensors for veterinary applications. We developed cost-saving and solvent-free nanoemulsions. Formulated with a low-energy method, these nanoemulsions can find application in the delivery of controlled amounts of drugs into the beverage of breeding animals (such as poultry, cattle, pigs or be used for the controlled release of injectable poorly water-soluble drugs.Keywords: nanoemulsion, nanomedicine, low-energy emulsification, veterinary, ketoprofen, sulfamethazine

  4. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    Science.gov (United States)

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

  5. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    International Nuclear Information System (INIS)

    Szebeni, Janos; Storm, Gert

    2015-01-01

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  6. Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

    Energy Technology Data Exchange (ETDEWEB)

    Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

    2015-12-18

    Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

  7. Effect of Truncating AUC at 12, 24 and 48 hr When Evaluating the Bioequivalence of Drugs with a Long Half-Life.

    Science.gov (United States)

    Moreno, Isabel; Ochoa, Dolores; Román, Manuel; Cabaleiro, Teresa; Abad-Santos, Francisco

    2016-01-01

    Bioequivalence studies of drugs with a long half-life require long periods of time for pharmacokinetic sampling. The latest update of the European guideline allows the area under the curve (AUC) truncated at 72 hr to be used as an alternative to AUC0-t as the primary parameter. The objective of this study was to evaluate the effect of truncating the AUC at 48, 24 and 12 hr on the acceptance of the bioequivalence criterion as compared with truncation at 72 hr in bioequivalence trials. The effect of truncated AUC on the within-individual coefficient of variation (CVw) and on the ratio of the formulations was also analysed. Twenty-eight drugs were selected from bioequivalence trials. Pharmacokinetic data were analysed using WinNonLin 2.0 based on the trapezoidal method. Analysis of variance (ANOVA) was performed to obtain the ratios and 90% confidence intervals for AUC at different time-points. The degree of agreement of AUC0-72 in relation to AUC0-48 and AUC0-24, according to the Landis and Koch classification, was 'almost perfect'. Statistically significant differences were observed when the CVw of AUC truncated at 72, 48 and 24 hr was compared with the CVw of AUC0-12. There were no statistically significant differences in the AUC ratio at any time-point. Compared to AUC0-72, Pearson's correlation coefficient for mean AUC, AUC ratio and AUC CVw was worse for AUC0-12 than AUC0-24 or AUC0-48. These preliminary results could suggest that AUC truncation at 24 or 48 hr is adequate to determine whether two formulations are bioequivalent. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  8. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions.

    Science.gov (United States)

    Brendel, Erich; Weimann, Boris; Dietrich, Hartmut; Froede, Christoph; Thomas, Dirk

    2013-09-01

    To determine the bioequivalence of a nifedipine and candesartan fixed-dose combination (FDC) with the corresponding loose combination, and to investigate the pharmacokinetic drug-drug interaction potential between both drugs. 49 healthy, white, male subjects received: 60 mg nifedipine and 32 mg candesartan FDC, the loose combination of 60 mg nifedipine GITS and 32 mg candesartan, 60 mg nifedipine GITS alone, or 32 mg candesartan alone in a randomized, non-blinded, 4-period, 4-way crossover design with each dosing following overnight fasting. Treatment periods were separated by washout periods of ≥ 5 days. Plasma samples were collected for 48 hours after dosing and assayed using a validated LC-MS/MS method. Bioequivalence between the FDC and the loose combination as well as the impact of combined treatment with both drugs on candesartan pharmacokinetics was evaluated in 47 subjects, while the corresponding impact of treatment with both drugs on nifedipine pharmacokinetics was assessed in 46 patients. For AUC(0-tlast) and Cmax the 90% confidence intervals (CIs) for the ratios of the FDC vs. the corresponding loose combination were within the acceptance range for bioequivalence of 80 - 125%. When comparing AUC(0-tlast) and Cmax of nifedipine and candesartan after dosing with the loose combination vs. each drug alone, the 90% CIs remained within the range of 80 - 125% indicating the absence of a clinically relevant pharmacokinetic drug-drug interaction. Nifedipine and candesartan as well as the combinations were well tolerated. The FDC containing 60 mg nifedipine and 32 mg candesartan was bioequivalent to the corresponding loose combination following single oral doses under fasting conditions. No clinically relevant pharmacokinetic drug-drug interaction between nifedipine and candesartan was observed.

  9. Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products.

    Science.gov (United States)

    Sugihara, Masahisa; Takeuchi, Susumu; Sugita, Masaru; Higaki, Kazutaka; Kataoka, Makoto; Yamashita, Shinji

    2015-12-07

    In this study, the data of 113 human bioequivalence (BE) studies of immediate release (IR) formulations of 74 active pharmaceutical ingredients (APIs) conducted at Sawai Pharmaceutical Co., Ltd., was analyzed to understand the factors affecting intra- and intersubject variabilities in oral drug absorption. The ANOVA CV (%) calculated from area under the time-concentration curve (AUC) in each BE study was used as an index of intrasubject variability (Vintra), and the relative standard deviation (%) in AUC was used as that of intersubject variability (Vinter). Although no significant correlation was observed between Vintra and Vinter of all drugs, Vintra of class 3 drugs was found to increase in association with a decrease in drug permeability (P(eff)). Since the absorption of class 3 drugs was rate-limited by the permeability, it was suggested that, for such drugs, the low P(eff) might be a risk factor to cause a large intrasubject variability. To consider the impact of poor water solubility on the variability in BE study, a parameter of P(eff)/Do (Do; dose number) was defined to discriminate the solubility-limited and dissolution-rate-limited absorption of class 2 drugs. It was found that the class 2 drugs with a solubility-limited absorption (P(eff)/Do high intrasubject variability. Furthermore, as a reason for high intra- or intersubject variability in AUC for class 1 drugs, effects of drug metabolizing enzymes were investigated. It was demonstrated that intrasubject variability was high for drugs metabolized by CYP3A4 while intersubject variability was high for drugs metabolized by CYP2D6. For CYP3A4 substrate drugs, the Km value showed the significant relation with Vintra, indicating that the affinity to the enzyme can be a parameter to predict the risk of high intrasubject variability. In conclusion, by analyzing the in house data of human BE study, low permeability, solubility-limited absorption, and high affinity to CYP3A4 are identified as risk factors for

  10. Survey of Veterinary Drug Residues in Raw Milk in Hebei Province, China.

    Science.gov (United States)

    Han, Rong-Wei; Yu, Zhong-Na; Zhen, Tian-Yuan; Wang, Jun

    2017-10-17

    The objective of this study was to investigate the occurrence of veterinary drug residues in raw milk from Hebei, the second-largest dairy production province in the People's Republic of China. A total of 192 raw milk samples were collected from 64 milk stations in seven districts. Twenty-eight veterinary drug residues were analyzed by ultraperformance liquid chromatography with tandem mass spectrometry based on a China National Standard. Raw milk samples with multiple residues of veterinary drugs were not found in the present study. Residues of four veterinary drugs, penicillin G, sulfacetamide, trimethoprim, and lincomycin, were detected in 12 (6.25%) raw milk samples, with detection ratios of 1.04, 0.52, 3.13, and 1.56%, respectively. All veterinary drug residues detected were under the maximum residue levels as regulated by China, the European Union, the United States, and the Codex Alimentarius Commission. In general, raw milk from Hebei province was considered relatively safe for human consumption because of the low prevalence of veterinary drug residues. However, stringent control measurements for veterinary drug residues in raw milk are required because some veterinary drugs were detected in milk from some areas of Hebei province.

  11. Comprehensive screening and quantification of veterinary drugs in milk using UPLC-ToF-MS

    NARCIS (Netherlands)

    Stolker, A.A.M.; Rutgers, P.; Oosterink, J.E.; Lasaroms, J.J.P.; Peters, R.J.B.; Rhijn, van J.A.; Nielen, M.W.F.

    2008-01-01

    Ultra-performance liquid chromatography combined with time-of-flight mass spectrometry (UPLC¿ToF-MS) has been used for screening and quantification of more than 100 veterinary drugs in milk. The veterinary drugs represent different classes including benzimidazoles, macrolides, penicillins,

  12. [Bioequivalence studies of pharmaceutical preparations].

    Science.gov (United States)

    Vetchý, D; Frýbortová, K; Rabisková, M; Danecková, H

    2007-01-01

    Bioequivalence studies are very important for the development of a pharmaceutical preparation in the pharmaceutical industry. Their rationale is the monitoring of pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs. The target of such study is to evaluate the therapeutic compatibility of tested drugs (pharmaceutical equivalents or pharmaceutical alternatives). The importance of bioequivalence studies is increasing also due to the large growth of the production and consumption of generic products. Generic products represent approximately 50 % of the whole consumption in many European countries and USA. The search output of bioequivalence study is together with the pharmaceutical quality data of medical product one of the main part of the registration file submitted to a national regulatory authorities. The registration of generic products does not demand complicated and expensive clinical study contrary to original product. The comparison of the original and the generic product via bioequivalence study is suggested as sufficient. The aim of this article is to provide to a medical public a summary about the types of bioequivalence studies, their range, rules of their practise and let them gain their own attitude to this question.

  13. Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3)

    OpenAIRE

    Stavchansky, Salomon

    2008-01-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA–BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility–Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting ...

  14. Comparative assessment of saliva and plasma for drug bioavailability and bioequivalence studies in humans

    Directory of Open Access Journals (Sweden)

    Nasir M. Idkaidek

    2017-07-01

    Conclusion: Our results suggest that there is a potential in BA/BE studies for saliva to be considered as a surrogate for plasma concentration, which goes along with drug regulations. The use of saliva instead of plasma in such studies makes them non-invasive, easy and with a lower clinical burden.

  15. Comparison of Clobetasol Propionate Generics Using Simplified in Vitro Bioequivalence Method for Topical Drug Products.

    Science.gov (United States)

    Soares, Kelen Carine Costa; de Souza, Weidson Carlos; de Souza Texeira, Leonardo; da Cunha-Filho, Marcilio Sergio Soares; Gelfuso, Guilherme Martins; Gratieri, Tais

    2017-11-20

    The aim of this paper is to propose a simple in vitro skin penetration experiment in which the drug is extracted from the whole skin piece as a test valid for formulation screening and optimization during development process, equivalence assessment during quality control or post-approval after changes to the product. Twelve clobetasol propionate (CP) formulations (six creams and six ointments) from the local market were used as a model to challenge the proposed methodology in comparison to in vitro skin penetration following tape-stripping for drug extraction. To support the results, physicochemical tests for pH, viscosity, density and assay, as well as in vitro release were performed. Both protocols, extracting the drug from the skin using the tape-stripping technique or extracting from the full skin were capable of differentiating CP formulations. Only one formulation did not present statistical difference from the reference drug product in penetration tests and only other two oitments presented equivalent release to the reference. The proposed protocol is straightforward and reproducible. Results suggest the bioinequavalence of tested CP formulations reinforcing the necessity of such evaluations. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  16. Flexing the PECs: Predicting environmental concentrations of veterinary drugs in Canadian agricultural soils.

    Science.gov (United States)

    Kullik, Sigrun A; Belknap, Andrew M

    2017-03-01

    Veterinary drugs administered to food animals primarily enter ecosystems through the application of livestock waste to agricultural land. Although veterinary drugs are essential for protecting animal health, their entry into the environment may pose a risk for nontarget organisms. A means to predict environmental concentrations of new veterinary drug ingredients in soil is required to assess their environmental fate, distribution, and potential effects. The Canadian predicted environmental concentrations in soil (PECsoil) for new veterinary drug ingredients for use in intensively reared animals is based on the approach currently used by the European Medicines Agency for VICH Phase I environmental assessments. The calculation for the European Medicines Agency PECsoil can be adapted to account for regional animal husbandry and land use practices. Canadian agricultural practices for intensively reared cattle, pigs, and poultry differ substantially from those in the European Union. The development of PECsoil default values and livestock categories representative of typical Canadian animal production methods and nutrient management practices culminates several years of research and an extensive survey and analysis of the scientific literature, Canadian agricultural statistics, national and provincial management recommendations, veterinary product databases, and producers. A PECsoil can be used to rapidly identify new veterinary drugs intended for intensive livestock production that should undergo targeted ecotoxicity and fate testing. The Canadian PECsoil model is readily available, transparent, and requires minimal inputs to generate a screening level environmental assessment for veterinary drugs that can be refined if additional data are available. PECsoil values for a hypothetical veterinary drug dosage regimen are presented and discussed in an international context. Integr Environ Assess Manag 2017;13:331-341. © 2016 Her Majesty the Queen in Right of Canada

  17. Large-scale cross-species chemogenomic platform proposes a new drug discovery strategy of veterinary drug from herbal medicines.

    Directory of Open Access Journals (Sweden)

    Chao Huang

    Full Text Available Veterinary Herbal Medicine (VHM is a comprehensive, current, and informative discipline on the utilization of herbs in veterinary practice. Driven by chemistry but progressively directed by pharmacology and the clinical sciences, drug research has contributed more to address the needs for innovative veterinary medicine for curing animal diseases. However, research into veterinary medicine of vegetal origin in the pharmaceutical industry has reduced, owing to questions such as the short of compatibility of traditional natural-product extract libraries with high-throughput screening. Here, we present a cross-species chemogenomic screening platform to dissect the genetic basis of multifactorial diseases and to determine the most suitable points of attack for future veterinary medicines, thereby increasing the number of treatment options. First, based on critically examined pharmacology and text mining, we build a cross-species drug-likeness evaluation approach to screen the lead compounds in veterinary medicines. Second, a specific cross-species target prediction model is developed to infer drug-target connections, with the purpose of understanding how drugs work on the specific targets. Third, we focus on exploring the multiple targets interference effects of veterinary medicines by heterogeneous network convergence and modularization analysis. Finally, we manually integrate a disease pathway to test whether the cross-species chemogenomic platform could uncover the active mechanism of veterinary medicine, which is exemplified by a specific network module. We believe the proposed cross-species chemogenomic platform allows for the systematization of current and traditional knowledge of veterinary medicine and, importantly, for the application of this emerging body of knowledge to the development of new drugs for animal diseases.

  18. Veterinary drugs in the environment and their toxicity to plants

    Czech Academy of Sciences Publication Activity Database

    Bártíková, H.; Podlipná, Radka; Skálová, L.

    2016-01-01

    Roč. 144, FEB (2016), s. 2290-2301 ISSN 0045-6535 R&D Projects: GA ČR(CZ) GA15-05325S Institutional support: RVO:61389030 Keywords : Veterinary antibiotics * Growth promoters * Phytotoxicity Subject RIV: CE - Biochemistry Impact factor: 4.208, year: 2016

  19. Veterinary drug prescriptions: to what extent do pet owners comply ...

    African Journals Online (AJOL)

    Separate questionnaires were designed for pet owners (clients) and veterinarians to ascertain the existence and extent of noncompliance in veterinary practice in lbadan and to elucidate the influence of such factors as logistics, education, economy, attitudes and veterinarian/client relationship on non-compliance. Analyses ...

  20. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis (Spanish Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  1. Development of Analytical Method and Monitoring of Veterinary Drug Residues in Korean Animal Products.

    Science.gov (United States)

    Song, Jae-Sang; Park, Su-Jeong; Choi, Jung-Yun; Kim, Jin-Sook; Kang, Myung-Hee; Choi, Bo-Kyung; Hur, Sun Jin

    2016-01-01

    This study was conducted to determine the residual amount of veterinary drugs such as meloxicam, flunixin, and tulathromycin in animal products (beef, pork, horsemeat, and milk). Veterinary drugs have been widely used in the rearing of livestock to prevent and treat diseases. A total of 152 samples were purchased from markets located in major Korean cities (Seoul, Busan, Incheon, Daegu, Daejeon, Gwangju, Ulsan and Jeju), including Jeju. Veterinary drugs were analyzed by liquid chromatography-tandem mass spectrometry according to the Korean Food Standards Code. The resulting data, which are located within 70-120% of recovery range and less than 20% of relative standard deviations, are in compliance with the criteria of CODEX. A total of five veterinary drugs were detected in 152 samples, giving a detection rate of approximately 3.3%; and no food source violated the guideline values. Our result indicated that most of the veterinary drug residues in animal products were below the maximum residue limits specified in Korea.

  2. Quantum Dots Applied to Methodology on Detection of Pesticide and Veterinary Drug Residues.

    Science.gov (United States)

    Zhou, Jia-Wei; Zou, Xue-Mei; Song, Shang-Hong; Chen, Guan-Hua

    2018-02-14

    The pesticide and veterinary drug residues brought by large-scale agricultural production have become one of the issues in the fields of food safety and environmental ecological security. It is necessary to develop the rapid, sensitive, qualitative and quantitative methodology for the detection of pesticide and veterinary drug residues. As one of the achievements of nanoscience, quantum dots (QDs) have been widely used in the detection of pesticide and veterinary drug residues. In these methodology studies, the used QD-signal styles include fluorescence, chemiluminescence, electrochemical luminescence, photoelectrochemistry, etc. QDs can also be assembled into sensors with different materials, such as QD-enzyme, QD-antibody, QD-aptamer, and QD-molecularly imprinted polymer sensors, etc. Plenty of study achievements in the field of detection of pesticide and veterinary drug residues have been obtained from the different combinations among these signals and sensors. They are summarized in this paper to provide a reference for the QD application in the detection of pesticide and veterinary drug residues.

  3. Manual of Standard Operating Procedures for Veterinary Drug Residue Analysis (French Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    Laboratories are crucial to national veterinary drug residue monitoring programmes. However, one of the main challenges laboratories encounter is obtaining access to relevant methods of analysis. Thus, in addition to training, providing technical advice and transferring technology, the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture has resolved to develop clear and practical manuals to support Member State laboratories. The Coordinated Research Project (CRP) on Development of Radiometric and Allied Analytical Methods to Strengthen Residue Control Programs for Antibiotic and Anthelmintic Veterinary Drug Residues has developed a number of analytical methods as standard operating procedures (SOPs), which are now compiled here. This publication contains SOPs on chromatographic and spectrometric techniques, as well as radioimmunoassay and associated screening techniques, for various anthelmintic and antimicrobial veterinary drug residue analysis. Some analytical method validation protocols are also included. The publication is primarily aimed at food and environmental safety laboratories involved in testing veterinary drug residues, including under organized national residue monitoring programmes. It is expected to enhance laboratory capacity building and competence through the use of radiometric and complementary tools and techniques. The publication is also relevant for applied research on residues of veterinary drugs in food and environmental samples

  4. Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels.

    Science.gov (United States)

    Agrawal, Shrutidevi; Kaur, Kanwal Jit; Singh, Inderjit; Bhade, Shantaram R; Kaul, Chaman Lal; Panchagnula, Ramesh

    2002-02-21

    Tuberculosis (TB) needs treatment with three to five different drugs simultaneously, depending on the patient category. These drugs can be given as single drug preparations or fixed dose combinations (FDCs) of two more drugs in a single formulation. World Health Organization and International Union against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. The relative bioavailability of rifampicin (RIF), isoniazid (INH) and pyrazinamide (PYZ) was assessed on a group of 13 healthy male subjects from a four drug FDC versus separate formulations at the same dose levels. The study was designed to be an open, crossover experiment. A total of nine blood samples each of 3 ml volume were collected over a period of 24-h. The concentrations of RIF, its main metabolite desacetyl RIF (DRIF), INH and PYZ in plasma were assessed by HPLC analysis. Pharmacokinetic parameters namely AUC(0-24), AUC(0-inf), C(max), T(max), were calculated and subjected to different statistical tests (Hauschke analysis, two way ANOVA, normal and log transformed confidence interval) at 90% confidence interval. In addition, elimination rate constant (K(el)) and absorption efficiencies for each drug were also calculated. It was concluded that four drugs FDC tablet is bioequivalent for RIF, INH and PYZ to separate formulation at the same dose levels.

  5. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  6. Database dedicated to information published during the Benelux conferences on hormone and veterinary drug residue analyses

    NARCIS (Netherlands)

    Impens, S.; Brabander, H.F. de; Bergwerff, A.A.; Ginkel, L.A. van; Schilt, R.; Stephany, R.W.; Wasch, K. de; Courtheyn, D.; Peteghem, C. van

    2002-01-01

    Every other year scientists working in the field of residue analysis participate the "International Symposium on Hormone and Veterinary Drug Residue Analysis" and "Euroresidue" conferences. In each symposium a lot of innovative information is presented. In order to obtain a retrieval system for this

  7. Development of irradiation technique on degradation residue of pesticide veterinary drugs and mycotoxins in food

    International Nuclear Information System (INIS)

    He Jiang; Huang Min; Chen Hao; Wu Ling; Gao Peng; Wang Yan; Lei Qing

    2011-01-01

    Irradiation technology is a new processing technology, It was widely used in food, medicines and medical supplies, chemical and other industries. In this paper, illustrated their applications in the degradation of pesticides, veterinary drugs and mycotoxins aspects residual pollution in food. Analysis of residual contaminants in food irradiation control study limitations and look forward to the prospect of food irradiation technology. (authors)

  8. Residues of veterinary drugs in eggs and their distribution between yolk and white

    NARCIS (Netherlands)

    Kan, C.A.; Petz, M.

    2000-01-01

    Veterinary drugs and feed additives (especially some coccidiostats) can be absorbed by the digestive tract of laying hens and transferred to the egg. Physicochemical characteristics of these compounds determine their pharmacokinetic behavior and distribution to and within the egg. Traditionally the

  9. Xenobiotic-metabolizing enzymes in plants and their role in uptake and biotransformation of veterinary drugs in the environment.

    Science.gov (United States)

    Bártíková, Hana; Skálová, Lenka; Stuchlíková, Lucie; Vokřál, Ivan; Vaněk, Tomáš; Podlipná, Radka

    2015-08-01

    Many various xenobiotics permanently enter plants and represent potential danger for their organism. For that reason, plants have evolved extremely sophisticated detoxification systems including a battery of xenobiotic-metabolizing enzymes. Some of them are similar to those in humans and animals, but there are several plant-specific ones. This review briefly introduces xenobiotic-metabolizing enzymes in plants and summarizes present information about their action toward veterinary drugs. Veterinary drugs are used worldwide to treat diseases and protect animal health. However, veterinary drugs are also unwantedly introduced into environment mostly via animal excrements, they persist in the environment for a long time and may impact on the non-target organisms. Plants are able to uptake, transform the veterinary drugs to non- or less-toxic compounds and store them in the vacuoles and cell walls. This ability may protect not only plant themselves but also other organisms, predominantly invertebrates and wild herbivores. The aim of this review is to emphasize the importance of plants in detoxification of veterinary drugs in the environment. The results of studies, which dealt with transport and biotransformation of veterinary drugs in plants, are summarized and evaluated. In conclusion, the risks and consequences of veterinary drugs in the environment and the possibilities of phytoremediation technologies are considered and future perspectives are outlined.

  10. Application of PK/PD Modeling in Veterinary Field: Dose Optimization and Drug Resistance Prediction

    Directory of Open Access Journals (Sweden)

    Ijaz Ahmad

    2016-01-01

    Full Text Available Among veterinary drugs, antibiotics are frequently used. The true mean of antibiotic treatment is to administer dose of drug that will have enough high possibility of attaining the preferred curative effect, with adequately low chance of concentration associated toxicity. Rising of antibacterial resistance and lack of novel antibiotic is a global crisis; therefore there is an urgent need to overcome this problem. Inappropriate antibiotic selection, group treatment, and suboptimal dosing are mostly responsible for the mentioned problem. One approach to minimizing the antibacterial resistance is to optimize the dosage regimen. PK/PD model is important realm to be used for that purpose from several years. PK/PD model describes the relationship between drug potency, microorganism exposed to drug, and the effect observed. Proper use of the most modern PK/PD modeling approaches in veterinary medicine can optimize the dosage for patient, which in turn reduce toxicity and reduce the emergence of resistance. The aim of this review is to look at the existing state and application of PK/PD in veterinary medicine based on in vitro, in vivo, healthy, and disease model.

  11. Surveillance of veterinary drug residues in pork meat in Madagascar

    Directory of Open Access Journals (Sweden)

    M. V. Rakotoharinome

    2015-06-01

    Table I presents the results of the percentage of positive samples in the various regions of Madagascar. On average 37.2% sam­ples were contaminated by antimicrobial residues. A significant increase from 32 to 39% was observed between 2010 and 2011, respectively. No significant differences were found between samples according to sex, breed or age class in individual ani­mals. No differences between pig farm origins were found either (Figure 1. However, Amoron’i Mania Region, and particularly suburban Ambositra, was the most contaminated area in 2010 (67%; n = 9 and Melaky region (Western Madagascar in 2011. Pork meat samples originating from the same production area were less contaminated by drug residues when the animals were slaughtered in urban abattoirs compared to provincial abat­toirs. In this first step toward a national surveillance system, we confirm that drug residues in animal products are a serious public health concern for Madagascar.

  12. Screening of veterinary drug residues in food by LC-MS/MS. Background and challenges.

    Science.gov (United States)

    Delatour, Thierry; Racault, Lucie; Bessaire, Thomas; Desmarchelier, Aurélien

    2018-04-01

    Regulatory agencies and government authorities have established maximum residue limits (MRL) in various food matrices of animal origin for supporting governments and food operators in the monitoring of veterinary drug residues in the food chain, and ultimately in the consumer's plate. Today, about 200 veterinary drug residues from several families, mainly with antibiotic, antiparasitic or antiinflammatory activities, are regulated in a variety of food matrices such as milk, meat or egg. This article provides a review of the regulatory framework in milk and muscle including data from Codex Alimentarius, Europe, the U.S.A., Canada and China for about 220 veterinary drugs. The article also provides a comprehensive overview of the challenge for food control, and emphasizes the pivotal role of liquid chromatography-mass spectrometry (LC-MS), either in tandem with quadrupoles (LC-MS/MS) or high resolution MS (LC-HRMS), for ensuring an adequate consumer protection combined with an affordable cost. The capability of a streamlined LC-MS/MS platform for screening 152 veterinary drug residues in a broad range of raw materials and finished products is highlighted in a production line perspective. The rationale for a suite of four methods intended to achieve appropriate performance in terms of scope and sensitivity is presented. Overall, the platform encompasses one stream for the determination of 105 compounds in a run (based on acidic QuEChERS-like), plus two streams for 23 β-lactams (alkaline QuEChERS-like) and 10 tetracyclines (low-temperature partitioning), respectively, and a dedicated stream for 14 aminoglycosides (molecularly-imprinted polymer).

  13. Veterinary vaccinology.

    Science.gov (United States)

    Pastoret, P P

    1999-11-01

    Veterinary vaccinology is a very interesting and rapidly developing field. In fact veterinary vaccines are not only used for the prevention of infectious diseases in the animal health sector, but also help to solve problems of public health, to reduce detrimental environmental impact of the use of some veterinary drugs and prevent the emergence of resistance of micro-organisms or parasites. After a short introduction, this paper will deal with the use of vaccines for animal health and welfare, including new developments in the veterinary field such as marker vaccines and vectored vaccines, the special case of equine influenza-inactivated vaccines and the use of veterinary vaccines in public health. The conclusions will analyse the reasons as to why develop veterinary vaccines and the obstacles to their development.

  14. Biodegradable polyesters for veterinary drug delivery systems: Characterization, in vitro degradation and release behavior of Oligolactides and Polytartrate

    OpenAIRE

    Schliecker, Gesine

    2004-01-01

    This thesis deals with the degradation and release behavior of aliphatic polyesters with special respect to the influence of oligomers on the degradation rate and the potential use of these biomaterials for the development of veterinary drug delivery systems. In Chapter 1 the animal health care market is introduced with regard to opportunities and challenges of veterinary drug delivery systems. . In the second part of this chapter...

  15. Chemotherapy drug handling in first opinion small animal veterinary practices in the United Kingdom: results of a questionnaire survey.

    Science.gov (United States)

    Edery, E G

    2017-05-27

    To investigate how first opinion small animal veterinary surgeons in the UK handled chemotherapeutic agents, a questionnaire was distributed at the 2014 British Small Animal Veterinary Association congress and by internet. Chemotherapy was regularly offered by 70.4 per cent of the respondents. Gold standards defined according to available guidelines for safe handling of antineoplastic drugs were poorly followed by general practitioners with only 2 per cent of respondents complying with all of them. Dedicated facilities for preparation and administration of cytotoxic drugs were variably available among participants. The level of training of staff indirectly involved in handling chemotherapy was appropriate in less than 50 per cent of practices. No association was found between demographic characteristics of the sampled population and the decision to perform chemotherapy. The results of this study raise concerns about the safety of the veterinary staff in first opinion practices involved in handling chemotherapy. British Veterinary Association.

  16. Suspected adverse reactions to veterinary drugs reported in South Africa (January 1998 - February 2001 : special report

    Directory of Open Access Journals (Sweden)

    R. Gehring

    2001-07-01

    Full Text Available The Veterinary Pharmacovigilance Centre received 59 reports of suspected adverse drug reactions during the period January 1998 - February 2001. The number of reports received increased after the establishment of a formal procedure for recording and responding to reports. The number of reports received per species was: dogs 19, cats 15, cattle 7, sheep/ goats 6, chickens 4, pigs 3, horses 2 and giraffe 1. Many different types of adverse reactions were reported, including lack of efficacy, hypersensitivity, inappropriate use of products by non-veterinarians, known adverse effects and adverse effects encountered with extra-label use of products.

  17. Microdialysis sampling for investigations of bioavailability and bioequivalence of topically administered drugs: current state and future perspectives

    DEFF Research Database (Denmark)

    Holmgaard, R; Nielsen, J B; Benfeldt, E

    2010-01-01

    of instrumentation, calibration and experimental procedures are discussed along with the analytical considerations necessary for successful sampling. Clinical MD studies in the skin are reviewed with emphasis on pharmacokinetic studies of topically applied drugs with or without impairment of skin barrier function...

  18. Antineoplastic drugs in veterinary oncology: excretion in dogs, contamination of the environment and exposure assessment of people at risk

    NARCIS (Netherlands)

    Janssens, T.

    2012-01-01

    Anticancer drugs themselves can cause adverse health effects when administered to human patients. In addition, it has become apparent that personnel in human medicine, occupationally exposed to these anticancer drugs, may also be at risk. The past decades, the use of chemotherapy in veterinary

  19. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015

    Directory of Open Access Journals (Sweden)

    Hsin-Chun Lee

    2018-04-01

    Full Text Available Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011–2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management. Keywords: Agricultural authorities, Livestock products, Post-market monitoring, Veterinary drug residues

  20. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015

    OpenAIRE

    Hsin-Chun Lee; Chi-Min Chen; Jen-Ting Wei; Hsiu-Yi Chiu

    2018-01-01

    Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and egg...

  1. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Science.gov (United States)

    2012-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...

  2. Comparison of veterinary drug residue results in animal tissues by ultrahigh-performance liquid chromatography coupled to triple quadrupole ... use of a commercial lipid removal product

    Science.gov (United States)

    Veterinary drug residues in animal-derived foods must be monitored to ensure food safety, verify proper veterinary practices, enforce legal limits in domestic and imported foods, and other purposes. A common goal in drug residue analysis in foods is to achieve acceptable monitoring results for as m...

  3. Immunology-Based Techniques for the Detection of Veterinary Drug Residues in Foods

    Science.gov (United States)

    Reig, Milagro; Toldrá, Fidel

    Veterinary drugs are used in farm animals, via the feed or the drinking water, to prevent the outbreak of diseases or even for the treatment of diseases. However, the growth of animals may be promoted through the use of hormones and antibiotics. Depending on the type of residue and the application and washing conditions, these substances or its metabolites may remain in meat and other foods of animal origin and may cause adverse effects on consumers’ health. This is the main reason why its use is strictly regulated or even banned (case of the European Union) in different countries. Antibiotics typically used for growth promotion include chloramphenicol, nitrofurans, and enrofloxacin but others like sulphonamides, macrolides etc. may also be used (Reig & Toldrá, 2007).

  4. Analytical strategies for residue analysis of veterinary drugs and growth-promoting agents in food-producing animals - A review

    NARCIS (Netherlands)

    Stolker, A.A.M.; Brinkman, U.A.T.

    2005-01-01

    After a brief introduction into the field of veterinary drugs and growth-promoting agents, the most important EU regulations and directives for the inspection of food-producing animals and animal products regarding the residue control of these substances are presented and discussed. Main attention

  5. Desorption electrospray ionisation mass spectrometry: A rapid screening tool for veterinary drug preparations and forensic samples from hormone crime investigations

    NARCIS (Netherlands)

    Nielen, M.W.F.; Hooijerink, H.; Claassen, F.C.; Engelen, M.C.; Beek, van T.A.

    2009-01-01

    Hormone and veterinary drug screening and forensics can benefit from the recent developments in desorption electrospray ionisation (DESI) mass spectrometry (MS). In this work the feasibility of DESI application has been studied. Using a linear ion trap or quadrupole time-of-flight (TOF) MS

  6. Ectoparasites of medical and veterinary importance: drug resistance and the need for alternative control methods.

    Science.gov (United States)

    McNair, Carol M

    2015-03-01

    Despite multiple attempts at eradication, many ectoparasites of humans and domestic livestock remain a persistent problem in the modern world. For many years, a range of pesticide drugs including organophosphates, organochlorides and synthetic pyrethroids provided effective control of these parasites; but intensive use of these drugs has led to the evolution of resistance in many target species. This paper aims to review the effectiveness of current control methods and discuss potential alternatives for the long term sustainable control of ectoparasites. Important medical ectoparasites such as scabies mites, head lice and bed bugs present a significant public health problem, and so adequate control methods are essential. Ectoparasites of domestic livestock and farmed fish (for example sheep scab mites, poultry mites and sea lice) are also of concern given the increasing strain on the world's food supply. These parasites have become resistant to several classes of pesticide, making control very difficult. Recently, an increasing amount of research has focussed on alternative control methods such as insect growth regulators, biological control using essential oils or fungi, as well as vaccine development against some ectoparasites of medical and veterinary importance. Drug resistance is prevalent in all of the ectoparasites discussed in this review. A wide variety of alternative control methods have been identified, however further research is necessary in order for these to be used to successfully control ectoparasitic diseases in the future. © 2015 Royal Pharmaceutical Society.

  7. Simultaneous HPLC method for determination of sodium trimethoprim phenylpropanol disulphonate and sodium sulfaquinoxaline in veterinary drugs

    Directory of Open Access Journals (Sweden)

    Puangkaew Lakkanatinaporn

    2004-11-01

    Full Text Available A simple HPLC method has been developed for the separation and determination of sodium trimethoprim phenylpropanol disulphonate and sodium sulfaquinoxaline in veterinary preparations. Both drugs were separated well on a Kromasil C18 column (5 µm, 150 × 4.6 mm using a mixture of acetonitrile and 0.5% triethylamine in 1% acetic acid, pH 3 (18:82, v/v as the mobile phase at the flow rate of 1.5 ml/ min. The presence of both substances was monitored by UV absorption detection at 271 nm. The retention times of sodium trimethoprim phenylpropanol disulphonate and sodium sulfaquinoxaline were 3.2 and 16.0 min, respectively. The performance of the developed method was tested. Linear responses of both drugs were achieved between 48-145% of labeled amount over the concentration ranges of 35-101 µg/ml and 102-306 µg/ ml for sodium trimethoprim phenylpropanol disulphonate and sodium sulfaquinoxaline with correlation coefficients (R2 of 0.9980 and 0.9998, respectively. Accuracy expressed in term of recoveries were 101.4± 1.21% (n=6 for sodium trimethoprim phenylpropanol disulphonate and 99.7±0.92% (n=6 for sodium sulfaquinoxaline. Precision of the method in terms of the relative standard deviation is not more than 2% in all cases. These figures of merit indicated the validity of the developed method.

  8. Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015.

    Science.gov (United States)

    Lee, Hsin-Chun; Chen, Chi-Min; Wei, Jen-Ting; Chiu, Hsiu-Yi

    2018-04-01

    Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011-2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA) inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management. Copyright © 2017. Published by Elsevier B.V.

  9. Bioequivalence study on two brands of 10% enrofloxacin oral ...

    African Journals Online (AJOL)

    A bioequivalence of two brands of 10% enrofloxacin was tested in broiler chickens using a parallel design at 20 mg/kg bodyweight orally. Blood was sampled before and after drug administration for 24 hours. Plasma enrofloxacin concentrations were analyzed using microbiological assay. Peak plasma concentrations ...

  10. Bioequivalence of three florfenicol preparations in broilers

    Directory of Open Access Journals (Sweden)

    Husamettin Ekici

    2014-12-01

    Full Text Available This study was aimed to determine the bioequivalence of three different preparations of florfenicol using non-drugged broiler chickens. A total of 28 broiler chickens aging 30-day were divided into four equal groups; these were Group I, II, III, and IV. The birds of Group I (for effective substance were given intravenous (i.v. administration of florfenicol dosed at 40 mg/kg body weight (b.wt.. The birds of Group II (for reference drug, Group III (for test-1 drug, and Group IV (for test-2 drug received florfenicol preparations with water (dosed at 40 mg/kg b.wt. through intracrop administration. Blood samples were collected periodically from the birds of all four groups, and blood plasma was separated. Levels of florfenicol and its metabolite (florfenicol amine in the plasma were measured by High Performance Liquid Chromatography (HPLC. In this study, the limit of detection (LOD for florfenicol and florfenicol amine were recorded as 0.017 and 0.78 µg/mL, respectively. On the other hand, the recovery of florfenicol and florfenicol amine were 83.4-84.6 and 82.2-83.8%, respectively. Based on the values of area under the curve (AUC, maximum concentration (Cmax, and time to maximum concentration (Tmax, test-1 drug was found to be acceptable, whereas test-2 drug was remained below the acceptable limits (80-125% of AUC and Cmax. Thus, it was concluded that test-1 drug was bioequivalent as compared to the reference drug.

  11. Desorption electrospray ionisation mass spectrometry: A rapid screening tool for veterinary drug preparations and forensic samples from hormone crime investigations

    International Nuclear Information System (INIS)

    Nielen, M.W.F.; Hooijerink, H.; Claassen, F.C.; Engelen, M.C. van; Beek, T.A. van

    2009-01-01

    Hormone and veterinary drug screening and forensics can benefit from the recent developments in desorption electrospray ionisation (DESI) mass spectrometry (MS). In this work the feasibility of DESI application has been studied. Using a linear ion trap or quadrupole time-of-flight (TOF) MS instrument both full-scan and data-dependent collision-induced dissociation MS n spectra were acquired in seconds without sample preparation. Preliminary data are presented for the rapid screening of (pro)hormone supplement samples, an illegal steroid cocktail and forensic samples from veterinary drug investigations. The potential of this DESI approach is clearly demonstrated since compounds observed could be independently confirmed by liquid chromatography/TOFMS with accurate mass measurement, and/or proton nuclear magnetic resonance spectroscopy. Specific concerns related to false-positive and false-negative findings due to limitations in quantification and memory-effects are briefly discussed. It is envisaged that DESI will achieve a prominent role in hormone and veterinary drug analysis in the near future

  12. Desorption electrospray ionisation mass spectrometry: A rapid screening tool for veterinary drug preparations and forensic samples from hormone crime investigations

    Energy Technology Data Exchange (ETDEWEB)

    Nielen, M.W.F. [RIKILT Institute of Food Safety, P.O. Box 230, 6700 AE Wageningen (Netherlands); Wageningen University, Laboratory of Organic Chemistry, Dreijenplein 8, 6703 HB Wageningen (Netherlands)], E-mail: michel.nielen@wur.nl; Hooijerink, H. [RIKILT Institute of Food Safety, P.O. Box 230, 6700 AE Wageningen (Netherlands); Claassen, F.C. [Wageningen University, Laboratory of Organic Chemistry, Dreijenplein 8, 6703 HB Wageningen (Netherlands); Engelen, M.C. van [RIKILT Institute of Food Safety, P.O. Box 230, 6700 AE Wageningen (Netherlands); Beek, T.A. van [Wageningen University, Laboratory of Organic Chemistry, Dreijenplein 8, 6703 HB Wageningen (Netherlands)

    2009-04-01

    Hormone and veterinary drug screening and forensics can benefit from the recent developments in desorption electrospray ionisation (DESI) mass spectrometry (MS). In this work the feasibility of DESI application has been studied. Using a linear ion trap or quadrupole time-of-flight (TOF) MS instrument both full-scan and data-dependent collision-induced dissociation MS{sup n} spectra were acquired in seconds without sample preparation. Preliminary data are presented for the rapid screening of (pro)hormone supplement samples, an illegal steroid cocktail and forensic samples from veterinary drug investigations. The potential of this DESI approach is clearly demonstrated since compounds observed could be independently confirmed by liquid chromatography/TOFMS with accurate mass measurement, and/or proton nuclear magnetic resonance spectroscopy. Specific concerns related to false-positive and false-negative findings due to limitations in quantification and memory-effects are briefly discussed. It is envisaged that DESI will achieve a prominent role in hormone and veterinary drug analysis in the near future.

  13. Evaluation of certain veterinary drug residues in food. Eighty-first report of the Joint FAO/WHO Expert Committee on Food Additives.

    Science.gov (United States)

    2016-01-01

    This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including MRLs for generic fish species, acute reference doses (ARfDs) for veterinary drugs, an approach for dietary exposure assessment of compounds used for multiple purposes (i.e veterinary drugs and pesticides), dietary exposure assessment for less-than-lifetime exposure, and the assessment of short-term (90-day and 12-month) studies in dogs. Summaries follow of the Committee's evaluations of toxicological and residue data on a variety of veterinary drugs: two insecticides (diflubenzuron and teflubenzuron), an antiparasitic agent (ivermectin), an ectoparasiticide (sisapronil) and a β2-adrenoceptor agonist (zilpaterol hydrochloride). In addition, the Committee considered issues raised in concern forms from the Codex Committee on Residues of Veterinary Drugs in Foods on lasalocid sodium, an antiparasitic agent. Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADIs), ARfDs and proposed MRLs.

  14. Structural characterization of product ions of regulated veterinary drugs by electrospray ionization and quadrupole time-of-flight mass spectrometry (part 3) Anthelmintics, thyreostats, and flukicides

    Science.gov (United States)

    RATIONALE: Previously we have reported a liquid chromatography tandem mass spectrometry method for the identification and quantification of regulated veterinary drugs. The methods used three selected transition ions but most of these ions lacked structural characterization. The work presented here ...

  15. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.

    Science.gov (United States)

    Cai, Gengqian; Thiessen, Jake J; Baidoo, Charlotte A; Fossler, Michael J

    2010-10-01

    Studies to establish bioequivalence (BE) of a drug are important elements in support of drug applications. A typical BE study is conducted as a single dose, randomized, 2-period crossover design. For drugs with long half lives (≥ 48 hours) and evaluation of multiple BE objectives in 1 trial, this design may not be adequate. A parallel design may then be a more appropriate choice. However, parallel designs require increased sample size, which can become substantial. One option that is a compromise between the complete randomized block design and the parallel design is a partial-block crossover design. This approach came about during the development of a combination of dutasteride and tamsulosin. Previous experience with performing single-dose dutasteride studies suggested that 28 days of washout is needed between treatments because of its half-life of 7-9 days. Simulations were performed to assess the operating characteristics of this design using a previously developed PK model. Four scenarios were developed, and each scenario was simulated 500 times. The results showed that this design demonstrated acceptable consumer and producer risk. Partial-block crossover designs should be considered for studies when the half-life of the drug is long and there are more than 2 periods.

  16. Characterizing chronic and acute health risks of residues of veterinary drugs in food: latest methodological developments by the joint FAO/WHO expert committee on food additives.

    Science.gov (United States)

    Boobis, Alan; Cerniglia, Carl; Chicoine, Alan; Fattori, Vittorio; Lipp, Markus; Reuss, Rainer; Verger, Philippe; Tritscher, Angelika

    2017-11-01

    The risk assessment of residues of veterinary drugs in food is a field that continues to evolve. The toxicological end-points to be considered are becoming more nuanced and in light of growing concern about the development of antimicrobial resistance, detailed analysis of the antimicrobial activity of the residues of veterinary drugs in food is increasingly incorporated in the assessment. In recent years, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has refined its approaches to provide a more comprehensive and fit-for-purpose risk assessment. This publication describes in detail the consideration of acute and chronic effects, the estimation of acute and chronic dietary exposure, current approaches for including microbiological endpoints in the risk assessment, and JECFA's considerations for the potential effects of food processing on residues from veterinary drugs. JECFA now applies these approaches in the development of health-based guidance values (i.e. safe exposure levels) for residues of veterinary drugs. JECFA, thus, comprehensively addresses acute and chronic risks by using corresponding estimates for acute and chronic exposure and suitable correction for the limited bioavailability of bound residues by the Gallo-Torres model. On a case-by-case basis, JECFA also considers degradation products that occur from normal food processing of food containing veterinary drug residues. These approaches will continue to be refined to ensure the most scientifically sound basis for the establishment of health-based guidance values for veterinary drug residues.

  17. Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers.

    Science.gov (United States)

    Harahap, Y; Prasaja, B; Indriati, E; Lusthom, W; Lipin

    2007-06-01

    Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtained prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and24h after drug administration. Plasma concentrations of ciprofloxacin were monitored using high-performance liquid chromatography over a period of 24 h after administration. The pharmacokinetics parameter AUC0-24h, AUC0-infinity and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax were evaluated non-parametrically. The point estimates and 90% confidence intervals for AUC0-24h, AUC0-infinity and Cmax were 97.55% (92.71 - 102.6%), 97.63% (92.90 - 102.59%) and 95.84% (89.95 - 102.10%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. These results indicate that two medications of ciprofloxacin are bioequivalent and, thus, may be prescribed interchangeably.

  18. Survey study: The antibacterial drugs used for treatment of the animals in the teaching veterinary hospital in Kirkuk province

    Directory of Open Access Journals (Sweden)

    Y.J. Mousa

    2017-06-01

    Full Text Available The aim of this survey is to collect data relating to antibacterial drugs used to treat different animals in the veterinary teaching hospital in the province of Kirkuk, which is taking place for the first time at the province level for the purpose of knowing the types of drugs most commonly used and the outcome whether these drugs used are optimal. Data were collected from the veterinary teaching hospital in Kirkuk province for 6 consecutive months and for the period between 1/7/2016 and until 1/1/2017 period included both the summer and autumn and winter seasons. The results show that the most commonly used drugs were Oxytetracycline, Oxytetracycline, Doxycycline-Colistin compound by 26, 57 and 36% in cattle, sheep-goats and Poultry, respectively. While the least commonly used drugs were Tylosin, Gentamicin and Gentamicin-Tylosin compound by 10, 5 and 4% in cattle, sheep-goats and poultry, respectively. Based on the results obtained from this survey, we recommend the use of Penicillin-Streptomycin compound because it has a synergistic effect against most of the resistant bacteria and not to increase usage of Oxytetracycline because of its side effects and lack of effectiveness in recent times due to the abundance of resistant germs. Also, using antibacterial drugs, we would like to note the need for optimal scientific use of these drugs and to give attention to the period in which it takes the medicine to withdraw from the animal body before milking animals or slaughtering it, so that the bacterial resistance does not develop against these drugs in the future.

  19. Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.

    Science.gov (United States)

    Ting, Tricia Y; Jiang, Wenlei; Lionberger, Robert; Wong, Jessica; Jones, Jace W; Kane, Maureen A; Krumholz, Allan; Temple, Robert; Polli, James E

    2015-09-01

    To test the current U.S. Food and Drug Administration (FDA) bioequivalence standard in a comparison of generic and brand-name drug pharmacokinetic (PK) performance in "generic-brittle" patients with epilepsy under clinical use conditions. This randomized, double-blind, multiple-dose, steady-state, fully replicated bioequivalence study compared generic lamotrigine to brand-name Lamictal in "generic-brittle" patients with epilepsy (n = 34) who were already taking lamotrigine. Patients were repeatedly switched between masked Lamictal and generic lamotrigine. Intensive PK blood sampling at the end of each 2-week treatment period yielded two 12-h PK profiles for brand-name and generic forms for each patient. Steady-state area under the curve (AUC), peak plasma concentration (Cmax ), and minimum plasma concentration (Cmin ) data were subjected to conventional average bioequivalence (ABE) analysis, reference-scaled ABE analysis, and within-subject variability (WSV) comparisons. In addition, generic-versus-brand comparisons in individual patients were performed. Secondary clinical outcomes included seizure frequency and adverse events. Generic demonstrated bioequivalence to brand. The 90% confidence intervals of the mean for steady-state AUC, Cmax , and Cmin for generic-versus-brand were 97.2-101.6%, 98.8-104.5%, and 93.4-101.0%, respectively. The WSV of generic and brand were also similar. Individual patient PK ratios for generic-versus-brand were similar but not identical, in part because brand-versus-brand profiles were not identical, even though subjects were rechallenged with the same product. Few subjects had seizure exacerbations or tolerability issues with product switching. One subject, however, reported 267 focal motor seizures, primarily on generic, although his brand and generic PK profiles were practically identical. Some neurologists question whether bioequivalence in healthy volunteers ensures therapeutic equivalence of brand and generic antiepileptic drugs

  20. Workshop report: the 2012 antimicrobial agents in veterinary medicine: exploring the consequences of antimicrobial drug use: a 3-D approach.

    Science.gov (United States)

    Martinez, M; Blondeau, J; Cerniglia, C E; Fink-Gremmels, J; Guenther, S; Hunter, R P; Li, X-Z; Papich, M; Silley, P; Soback, S; Toutain, P-L; Zhang, Q

    2014-02-01

    Antimicrobial resistance is a global challenge that impacts both human and veterinary health care. The resilience of microbes is reflected in their ability to adapt and survive in spite of our best efforts to constrain their infectious capabilities. As science advances, many of the mechanisms for microbial survival and resistance element transfer have been identified. During the 2012 meeting of Antimicrobial Agents in Veterinary Medicine (AAVM), experts provided insights on such issues as use vs. resistance, the available tools for supporting appropriate drug use, the importance of meeting the therapeutic needs within the domestic animal health care, and the requirements associated with food safety and food security. This report aims to provide a summary of the presentations and discussions occurring during the 2012 AAVM with the goal of stimulating future discussions and enhancing the opportunity to establish creative and sustainable solutions that will guarantee the availability of an effective therapeutic arsenal for veterinary species. © Published (2014). This article is a U.S. Government work and is in the public domain in the USA.

  1. Determination of pesticides and veterinary drug residues in food by liquid chromatography-mass spectrometry: A review

    Energy Technology Data Exchange (ETDEWEB)

    Masiá, Ana [Food and Environmental Safety Research Group, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); Research Center on Desertification (CIDE, UV-CSIC-GV), Carretera Moncada-Náquera, Moncada (Spain); Suarez-Varela, Maria Morales; Llopis-Gonzalez, Agustin [Unit of Public Health, Hygiene and Environmental Health, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); CIBER Epidemiología y Salud Pública (CIBERESP), Madrid (Spain); Center for Advanced Research in Public Health (CSISP-FISABIO), Valencia (Spain); Picó, Yolanda, E-mail: Yolanda.Pico@uv.es [Food and Environmental Safety Research Group, Department of Preventive Medicine and Public Health, Food Science, Toxicology and Legal Medicine, University of Valencia, Valencia (Spain); Research Center on Desertification (CIDE, UV-CSIC-GV), Carretera Moncada-Náquera, Moncada (Spain); CIBER Epidemiología y Salud Pública (CIBERESP), Madrid (Spain)

    2016-09-14

    Monitoring of pesticides and veterinary drug residues is required to enforce legislation and guarantee food safety. Liquid chromatography-mass spectrometry (LC-MS) is the prevailing technique for assessing both types of residues because LC offers a versatile and universal separation mechanism suitable for non-gas chromatography (GC) amenable and the majority of GC-amenable compounds. This characteristic becomes more relevant when LC is coupled to MS because the high sensitivity and specificity of the detector allows to apply generic sample preparation procedures, which simultaneously extract a wide variety of residues with different physico-chemical properties. Determination of metabolites and degradation products, non-target suspected screening of an increasing number of residues, and even unknowns identification are also becoming inherent LC-MS advantages thanks to the latest advances. For routine analysis and, in particular, for official surveillance purposes in food control, analytical methods properly validated following strict guidelines are needed. After a brief introduction and an outline of the legislation applicable around the world, aspects such as improvement of specificity of high-throughput methods, resolution and mass accuracy of identification strategies and quantitative accuracy are critically reviewed in this article. In them, extraction, separation and determination are emphasized. The main objective is to offer an assessment of the state of the art and identify research needs and future trends in determining pesticide and veterinary drug residues in food by LC-MS. - Highlights: • An overview of status and future trends in this field. • Analytical method's compliance with guidelines to ensure reliability. • QuEChERS platform is a referent to extract both, pesticides and veterinary drugs in food. • The progress that liquid chromatography has shown in recent years is revised. • Determination of target, non-target and unknowns is

  2. Quantitative analysis of veterinary drugs in bovine muscle and milk by liquid chromatography quadrupole time-of-flight mass spectrometry.

    Science.gov (United States)

    Saito-Shida, Shizuka; Sakai, Takatoshi; Nemoto, Satoru; Akiyama, Hiroshi

    2017-07-01

    A simple and reliable multiresidue method for quantitative determination of veterinary drugs in bovine muscle and milk using liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) was developed. Critical MS parameters such as capillary voltage, cone voltage, collision energy, desolvation gas temperature and extraction mass window were carefully optimised to obtain the best possible sensitivity. Analytical samples were prepared using extraction with acetonitrile and hexane in the presence of anhydrous sodium sulphate and acetic acid, followed by ODS cartridge clean-up. The developed method was validated for 82 veterinary drugs in bovine muscle and milk at spike levels of 0.01 and 0.1 mg kg - 1 . With the exception of cefoperazone and phenoxymethylpenicillin, all these compounds exhibited sufficient signal intensity at 0.01 μg ml -1 (equivalent to 0.01 mg kg - 1 ), indicating the high sensitivity of the developed method. For most targets, the determined accuracies were within 70-120%, with repeatability and reproducibility being below 20% at both levels. Except for sulfathiazole in bovine muscle, no interfering peaks at target compound retention times were detected in the blank extract, indicating that the developed method is highly selective. The absence of sulfathiazole in bovine muscle was confirmed by simultaneous acquisition at low and high collision energies to afford exact masses of molecular adduct and fragment ions. Satisfactory linearity was observed for all compounds, with matrix effects being negligible for most targets in bovine muscle and milk at both spike levels. Overall, the results suggest that the developed LC-QTOF-MS method is suitable for routine regulatory-purpose analysis of veterinary drugs in bovine muscle and milk.

  3. Determination of pesticides and veterinary drug residues in food by liquid chromatography-mass spectrometry: A review

    International Nuclear Information System (INIS)

    Masiá, Ana; Suarez-Varela, Maria Morales; Llopis-Gonzalez, Agustin; Picó, Yolanda

    2016-01-01

    Monitoring of pesticides and veterinary drug residues is required to enforce legislation and guarantee food safety. Liquid chromatography-mass spectrometry (LC-MS) is the prevailing technique for assessing both types of residues because LC offers a versatile and universal separation mechanism suitable for non-gas chromatography (GC) amenable and the majority of GC-amenable compounds. This characteristic becomes more relevant when LC is coupled to MS because the high sensitivity and specificity of the detector allows to apply generic sample preparation procedures, which simultaneously extract a wide variety of residues with different physico-chemical properties. Determination of metabolites and degradation products, non-target suspected screening of an increasing number of residues, and even unknowns identification are also becoming inherent LC-MS advantages thanks to the latest advances. For routine analysis and, in particular, for official surveillance purposes in food control, analytical methods properly validated following strict guidelines are needed. After a brief introduction and an outline of the legislation applicable around the world, aspects such as improvement of specificity of high-throughput methods, resolution and mass accuracy of identification strategies and quantitative accuracy are critically reviewed in this article. In them, extraction, separation and determination are emphasized. The main objective is to offer an assessment of the state of the art and identify research needs and future trends in determining pesticide and veterinary drug residues in food by LC-MS. - Highlights: • An overview of status and future trends in this field. • Analytical method's compliance with guidelines to ensure reliability. • QuEChERS platform is a referent to extract both, pesticides and veterinary drugs in food. • The progress that liquid chromatography has shown in recent years is revised. • Determination of target, non-target and unknowns is covered.

  4. Evaluation of certain veterinary drug residues in food. Seventy-eighth report of the Joint FAO/WHO Expert Committee on Food Additives.

    Science.gov (United States)

    2014-01-01

    This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues of food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including extrapolation of maximum residue limits (MRLs) to minor species, MRLs for veterinary drug residues in honey, MRLs relating to fish and fish species, dietary exposure assessment methodologies, the decision-tree approach to the evaluation of residues of veterinary drugs and guidance for JECFA experts. Summaries follow of the Committee's evaluations of toxicology and residue data on a variety of veterinary drugs: two anthelminthic agents (derquantel, monepantel), three antiparasitic agents (emanectin benzoate, ivermectin, lasalocid sodium), one antibacterial, antifungal and anthelminthic agent (gentian violet), a production aid (recombinant bovine somatotropins) and an adrenoceptor agonist and growth promoter (zilpaterol hydorchloride). Annexed to the report is a summary of the Committee's recommendations on these drugs, including acceptable daily intakes (ADIs)) and proposed MRLs.

  5. [Scientific basis in the setting of residue limits for veterinary drugs in food of animal origin taking into account the presence of their metabolites].

    Science.gov (United States)

    Mitsumori, K

    1993-01-01

    Maximum residue level (MRL) for veterinary drugs in food of animal origin has been proposed by FAO/WHO, as a new evaluation procedure taking into account the presence of metabolites for the regulation of veterinary drug residues. The MRL is the maximum concentration of residue resulting from the use of a veterinary drug that is recommended to be legally permitted as acceptable in a food. It is established from the Acceptable Daily Intake (ADI) obtained from the data of toxicological studies, the residue concentration of the drug when used according to good practice in the use of veterinary drugs, and the lowest level consistent with the practical analytical methods available for routine residue analysis. Among the veterinary drugs, some chemicals contain a large amount of bound residues that are neither extractable from tissues by the analytical method identical with that used in parent chemicals. Especially, the bioavailable residues which are probably absorbed when the food is ingested are of great toxicological concern. In this case, the FAO/WHO recommends that the MRL can be established after the calculation of daily intake of residues of toxicological concern by the addition of both the extractable and bioavailable bound residues.

  6. Reported prevalence and quantitative LC-MS methods for the analysis of veterinary drug residues in honey: a review.

    Science.gov (United States)

    Venable, Ryan; Haynes, Carion; Cook, Jo Marie

    2014-04-01

    Insect pollination increases the value and productivity of three-quarters of crop species grown for food. Declining beehive health in commercial apiaries has resulted in numerous reports from government laboratories worldwide of contamination with antimicrobial chemicals in honey. This review includes pertinent discussion of legislation and events leading to increased government oversight in the commercial honey market. A detailed summary of the variety and prevalence of veterinary drug residues being found in honey as well as a selection of robust quantitative and confirmatory LC-MS methods with an emphasis on those adopted by government testing laboratories are presented.

  7. Veterinary drug usage and antimicrobial resistance in bacteria of animal origin

    DEFF Research Database (Denmark)

    Aarestrup, Frank Møller

    2005-01-01

    In the production of food animals, large amounts of antimicrobial agents are used for therapy and prophylaxis of bacterial infections and in feed to promote growth. There are large variations in the amounts of antimicrobial agents used to produce the same amount of meat among the different Europe...... monitoring the occurrence and development of resistance and consumption of antimicrobial agents are strongly desirable, as is research into the most appropriate ways to use antimicrobial agents in veterinary medicine....

  8. High-throughput untargeted screening of veterinary drug residues and metabolites in tilapia using high resolution orbitrap mass spectrometry.

    Science.gov (United States)

    Jia, Wei; Chu, Xiaogang; Chang, James; Wang, Perry G; Chen, Ying; Zhang, Feng

    2017-03-08

    An analytical method was developed and validated for simultaneous analysis of one hundred and thirty-seven veterinary drug residues and metabolites from sixteen different classes in tilapia utilizing an improved fully non-targeted way of data acquisition with fragmentation. The automated on-line extraction procedure was achieved in a simple disposable pipet extraction. Ultrahigh-performance liquid chromatography and electrospray ionization quadrupole Orbitrap high-resolution mass spectrometry (UHPLC Q-Orbitrap) was used for the separation and detection of all the analytes. The methodology was validated by taking into consideration the guidelines specified in European SANCO/12571/2013 Guideline 2013 and Commission Decision 2002/657/EC. The extraction recoveries ranged from 81% to 111%. The limits of decision ranged from 0.01 to 2.73 μg kg -1 and the detection capabilities ranged from 0.01 to 4.73 μg kg -1 . The one hundred and thirty-seven compounds behave dynamic 0.1-500 μg kg -1 , with correlation coefficient >0.99. The fully non-targeted data acquisition way improves both sensitivity and selectivity for the fragments, which is beneficial for screening performance and identification capability. This validated method has been successfully applied on screening of veterinary drug residues and metabolites in muscle of tilapia, an important and intensively produced fish in aquaculture. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Bioequivalence of two lansoprazole delayed release capsules 30 mg in healthy male volunteers under fasting, fed and fasting-applesauce conditions: a partial replicate crossover study design to estimate the pharmacokinetics of highly variable drugs.

    Science.gov (United States)

    Thota, S; Khan, S M; Tippabhotla, S K; Battula, R; Gadiko, C; Vobalaboina, V

    2013-11-01

    An open-label, 2-treatment, 3-sequence, 3-period, single-dose, partial replicate crossover studies under fasting (n=48), fed (n=60) and fasting-applesauce (n=48) (sprinkled on one table spoonful of applesauce) modalities were conducted in healthy adult male volunteers to evaluate bioequivalence between 2 formulations of lansoprazole delayed release capsules 30 mg. In all the 3 studies, as per randomization, either test or reference formulations were administered in a crossover manner with a required washout period of at least 7 days. Blood samples were collected adequately (0-24 h) to determine lansoprazole plasma concentrations using a validated LC-MS/MS analytical method. To characterize the pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞, Tmax, Kel and T1/2) of lansoprazole, non-compartmental analysis and ANOVA was applied on ln-transformed values. The bioequivalence was tested based on within-subject variability of the reference formulation. In fasting and fed studies (within-subject variability>30%) bioequivalence was evaluated with scaled average bioequivalence, hence for the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞, the 95% upper confidence bound for (μT-μR)2-θσ2 WR was ≤0, and the point estimates (test-to-reference ratio) were within the regulatory acceptance limit 80.00-125.00%. In fasting-applesauce study (within-subject variability<30%) bioequivalence was evaluated with average bioequivalence, the 90% CI of ln-transformed data of Cmax, AUC0-t and AUC0-∞ were within the regulatory acceptance limit 80.00-125.00%. Based on these aforesaid statistical inferences, it was concluded that the test formulation is bioequivalent to reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  10. 21 CFR 320.26 - Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

    Science.gov (United States)

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... test product and the reference material should be administered to subjects in the fasting state, unless...

  11. Effect of Different Sampling Schedules on Results of Bioavailability and Bioequivalence Studies: Evaluation by Means of Monte Carlo Simulations.

    Science.gov (United States)

    Kano, Eunice Kazue; Chiann, Chang; Fukuda, Kazuo; Porta, Valentina

    2017-08-01

    Bioavailability and bioequivalence study is one of the most frequently performed investigations in clinical trials. Bioequivalence testing is based on the assumption that 2 drug products will be therapeutically equivalent when they are equivalent in the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed and becomes available at the site of drug action. In recent years there has been a significant growth in published papers that use in silico studies based on mathematical simulations to analyze pharmacokinetic and pharmacodynamic properties of drugs, including bioavailability and bioequivalence aspects. The goal of this study is to evaluate the usefulness of in silico studies as a tool in the planning of bioequivalence, bioavailability and other pharmacokinetic assays, e.g., to determine an appropriate sampling schedule. Monte Carlo simulations were used to define adequate blood sampling schedules for a bioequivalence assay comparing 2 different formulations of cefadroxil oral suspensions. In silico bioequivalence studies comparing different formulation of cefadroxil oral suspensions using various sampling schedules were performed using models. An in vivo study was conducted to confirm in silico results. The results of in silico and in vivo bioequivalence studies demonstrated that schedules with fewer sampling times are as efficient as schedules with larger numbers of sampling times in the assessment of bioequivalence, but only if T max is included as a sampling time. It was also concluded that in silico studies are useful tools in the planning of bioequivalence, bioavailability and other pharmacokinetic in vivo assays. © Georg Thieme Verlag KG Stuttgart · New York.

  12. Bioequivalence assessment of two formulations of ibuprofen

    Directory of Open Access Journals (Sweden)

    Al-Talla ZA

    2011-10-01

    Full Text Available Zeyad A Al-Talla1, Sabah H Akrawi2, Luke T Tolley3, Salim H Sioud1, Mohammed F Zaater4, Abdul-Hamid M Emwas1 1Analytical and NMR Core Laboratories, King Abdullah University of Science and Technology, Thuwal, Kingdom of Saudia Arabia; 2College of Pharmacy, Al-Ain University, Al-Ain, United Arab Emirates; 3Department of Chemistry and Biochemistry, Southern Illinois University Carbondale, Carbondale, IL, USA; 4Department of Chemistry, Jordan University of Science and Technology, Jordan University of Science and Technology, Irbid, Jordan Background: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz®, produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen®, manufactured by Boots Company, Nottingham, UK. Methods and results: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference of ibuprofen (100 mg ibuprofen/5 mL suspension were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC parameters were found to be within the predetermined acceptable interval of 80%–125% set by the US Food and Drug Administration. Conclusion: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and

  13. Effectiveness of Action in India to Reduce Exposure of Gyps Vultures to the Toxic Veterinary Drug Diclofenac

    Science.gov (United States)

    Cuthbert, Richard; Taggart, Mark A.; Prakash, Vibhu; Saini, Mohini; Swarup, Devendra; Upreti, Suchitra; Mateo, Rafael; Chakraborty, Soumya Sunder; Deori, Parag; Green, Rhys E.

    2011-01-01

    Contamination of their carrion food supply with the non-steroidal anti-inflammatory drug diclofenac has caused rapid population declines across the Indian subcontinent of three species of Gyps vultures endemic to South Asia. The governments of India, Pakistan and Nepal took action in 2006 to prevent the veterinary use of diclofenac on domesticated livestock, the route by which contamination occurs. We analyse data from three surveys of the prevalence and concentration of diclofenac residues in carcasses of domesticated ungulates in India, carried out before and after the implementation of a ban on veterinary use. There was little change in the prevalence and concentration of diclofenac between a survey before the ban and one conducted soon after its implementation, with the percentage of carcasses containing diclofenac in these surveys estimated at 10.8 and 10.7%, respectively. However, both the prevalence and concentration of diclofenac had fallen markedly 7–31 months after the implementation of the ban, with the true prevalence in this third survey estimated at 6.5%. Modelling of the impact of this reduction in diclofenac on the expected rate of decline of the oriental white-backed vulture (Gyps bengalensis) in India indicates that the decline rate has decreased to 40% of the rate before the ban, but is still likely to be rapid (about 18% year−1). Hence, further efforts to remove diclofenac from vulture food are still needed if the future recovery or successful reintroduction of vultures is to be feasible. PMID:21589920

  14. Development of an improved high resolution mass spectrometry based multi-residue method for veterinary drugs in various food matrices.

    Science.gov (United States)

    Kaufmann, A; Butcher, P; Maden, K; Walker, S; Widmer, M

    2011-08-26

    Multi-residue methods for veterinary drugs or pesticides in food are increasingly often based on ultra performance liquid chromatography (UPLC) coupled to high resolution mass spectrometry (HRMS). Previous available time of flight (TOF) technologies, showing resolutions up to 15,000 full width at half maximum (FWHM), were not sufficiently selective for monitoring low residue concentrations in difficult matrices (e.g. hormones in tissue or antibiotics in honey). The approach proposed in this paper is based on a single stage Orbitrap mass spectrometer operated at 50,000 FWHM. Extracts (liver and kidney) which were produced according to a validated multi-residue method (time of flight detection based) could not be analyzed by Orbitrap because of extensive signal suppression. This required the improvement of established extraction and clean-up procedures. The introduced, more extensive deproteinzation steps and dedicated instrumental settings successfully eliminated these detrimental suppression effects. The reported method, covering more than 100 different veterinary dugs, was validated according to the EU Commission Decision 2002/657/EEC. Validated matrices include muscle, kidney, liver, fish and honey. Significantly better performance parameters (e.g. linearity, reproducibility and detection limits) were obtained when comparing the new method with the older, TOF based method. These improvements are attributed to the higher resolution (50,000 versus 12,000 FWHM) and the superior mass stability of the of the Orbitrap over the previously utilized TOF instrument. Copyright © 2010 Elsevier B.V. All rights reserved.

  15. The bootstrap and Bayesian bootstrap method in assessing bioequivalence

    International Nuclear Information System (INIS)

    Wan Jianping; Zhang Kongsheng; Chen Hui

    2009-01-01

    Parametric method for assessing individual bioequivalence (IBE) may concentrate on the hypothesis that the PK responses are normal. Nonparametric method for evaluating IBE would be bootstrap method. In 2001, the United States Food and Drug Administration (FDA) proposed a draft guidance. The purpose of this article is to evaluate the IBE between test drug and reference drug by bootstrap and Bayesian bootstrap method. We study the power of bootstrap test procedures and the parametric test procedures in FDA (2001). We find that the Bayesian bootstrap method is the most excellent.

  16. Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

    Science.gov (United States)

    Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

    2015-07-01

    Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

  17. The veterinary drug ivermectin influences immune response in the yellow dung fly (Scathophaga stercoraria)

    International Nuclear Information System (INIS)

    West, Helen M.; Tracy, Saoirse R.

    2009-01-01

    Phenoloxidase (PO) is a key enzyme involved in the immune response of insects. We show that egg-to-adult exposure to residues of 0.001, but not 0.0005 mg kg -1 ivermectin elevated PO activity in yellow dung flies (Scathophaga stercoraria) developing in cattle dung. Fly fat content was unaffected by the treatments. Therefore, the response of PO was a direct effect of ivermectin and not an indirect one caused by an alteration in body 'condition'. This supports the non-intuitive conclusion that flies surviving exposure to faecal residues may have enhanced immune function. To our knowledge, this is the first study to assess the effects on PO activity of insecticidal residues in livestock dung. The non-target effects of such residues are of wide interest, given the global use of veterinary products. - Phenoloxidase activity in Scathophaga stercoraria is enhanced by ivermectin and that effect is transferred to the adult fly from the larval stage

  18. Quality Attributes and In Vitro Bioequivalence of Different Brands of Amoxicillin Trihydrate Tablets.

    Science.gov (United States)

    Al-Tabakha, Moawia M; Fahelelbom, Khairi M S; Obaid, Dana Emad Eddin; Sayed, Sadik

    2017-05-20

    Bacterial resistance and antibiotic drug effectiveness can be related to administering generic products with a subtherapeutic dose or poor in vivo drug release. The aim of this study was to investigate whether locally marketed amoxicillin tablets have the required chemical and physical attributes, including in vitro bioequivalence performance. Five generic products (T1, T2, T3, T4, and T5) containing combination of amoxicillin trihydrate and potassium clavulanate as 1 g strength present in immediate release tablets were compared to the reference listed drug product Augmentin® (R) for weight variation, friability, resistance to crushing, and chemical content of amoxicillin. Difference (ƒ1) and similarity (ƒ2) factors were calculated to assess in vitro bioequivalence requirements. The tablets from different products have shown compliance with the pharmacopeial requirements of the performed tests. The measured resistance to crushing of tablets did not influence the dissolution time. Three generic products released more than 85% of amoxicillin by the first 15 min as did the reference product and were considered as bioequivalent products. T1 and T4 had ƒ1 values of 16.5% and 25.4% respectively and their ƒ2 values were 44.5 and 34.6 respectively, indicating failure to meet in vitro bioequivalence requirements. Tablet formulations can play an important role in achieving bioequivalence. Independent investigations such as this study serve as an important tool to reveal possible inferior or noncompliant products that may find their way to the market.

  19. Multiclass method for the quantification of 92 veterinary antimicrobial drugs in livestock excreta, wastewater, and surface water by liquid chromatography with tandem mass spectrometry.

    Science.gov (United States)

    Gao, Jinfang; Cui, Yonghui; Tao, Yanfei; Huang, Lingli; Peng, Dapeng; Xie, Shuyu; Wang, Xu; Liu, Zhenli; Chen, Dongmei; Yuan, Zonghui

    2016-11-01

    A simple multiresidue method was developed for detecting and quantifying 92 veterinary antimicrobial drugs from eight classes (β-lactams, quinolones, sulfonamides, tetracyclines, lincomycins, macrolides, chloramphenicols, and pleuromutilin) in livestock excreta and water by liquid chromatography with tandem mass spectrometry. The feces samples were extracted by ultrasound-assisted extraction with a mixture of acetonitrile/water (80:20, v/v) and edetate disodium, followed by a cleanup using solid-phase extraction with an amino cartridge. Water samples were purified with hydrophilic-lipophilic balance solid-phase extraction column. Urine samples were extracted with acetonitrile and edetate disodium. Detection of veterinary antimicrobial drugs was achieved by liquid chromatography with tandem mass spectrometry using both positive and negative electrospray ionization mode. The recovery values of veterinary antimicrobial drugs in feces, urine, and water samples were 75-99, 85-110, and 85-101% and associated relative standard deviations were less than 15, 10, and 8%, respectively. The limits of quantification in feces, urine, and water samples were 0.5-1, 0.5-1, and 0.01-0.05 μg/L, respectively. This method was applied to determine real samples obtained from local farms and provides reliable quantification and identification results of 92 veterinary antimicrobial drugs in livestock excreta and water. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. The importance of bioequivalence study: focus on clopidogrel

    Directory of Open Access Journals (Sweden)

    Arini Setiawati

    2011-05-01

    Full Text Available Bioequivalence (BE study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown to be BE to the innovator product Plavix® and they contain API (active pharmaceutical ingredient clopidogrel form 1 that complies with USP 30, 1997 requirements: the R-enantiomer content is not more than 1%. A proof that bioequivalence (BE means therapeutic equivalence (TE is also provided for cardiovascular drugs. Clopidogrel has 2 polymorphic forms, form 1 and form 2, which have the same indications. At least one pivotal study of clopidogrel, CAPRIE, used clopidogrel form 1. An atherothrombotic event may be associated with clopidogrel resistance, which occur in about 4 to 30% of patients treated with conventional doses of clopidogrel. (Med J Indones 2011; 20:149-53Keywords: bioequivalent, clopidogrel

  1. Ion-exchange solid-phase extraction combined with liquid chromatography-tandem mass spectrometry for the determination of veterinary drugs in organic fertilizers.

    Science.gov (United States)

    Zhao, Zhiyong; Zhang, Yanmei; Xuan, Yanfang; Song, Wei; Si, Wenshuai; Zhao, Zhihui; Rao, Qinxiong

    2016-06-01

    The analysis of veterinary drugs in organic fertilizers is crucial for an assessment of potential risks to soil microbial communities and human health. We develop a robust and sensitive method to quantitatively determine 19 veterinary drugs (amantadine, sulfonamides and fluoroquinolones) in organic fertilizers. The method involved a simple solid-liquid extraction step using the combination of acetonitrile and McIlvaine buffer as extraction solvent, followed by cleanup with a solid-phase extraction cartridge containing polymeric mixed-mode anion-exchange sorbents. Ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) was used to separate and detect target analytes. We particularly focused on the optimization of sample clean-up step: different diluents and dilution factors were tested. The developed method was validated in terms of linearity, recovery, precision, sensitivity and specificity. The recoveries of all the drugs ranged from 70.9% to 112.7% at three concentration levels, with the intra-day and inter-day relative standard deviation lower than 15.7%. The limits of quantification were between 1.0 and 10.0μg/kg for all the drugs. Matrix effect was minimized by matrix-matched calibration curves. The analytical method was successfully applied for the survey of veterinary drugs contamination in 20 compost samples. The results indicated that fluoroquinolones had higher incidence rate and mean concentration levels ranging from 31.9 to 308.7μg/kg compared with other drugs. We expect the method will provide the basis for risk assessment of veterinary drugs in organic fertilizers. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. VETSTAT - the Danish system for surveillance of the veterinary use of drugs for production animals

    DEFF Research Database (Denmark)

    Stege, H.; Bager, Flemming; Jacobsen, Erik

    2003-01-01

    The Danish Ministry of Food, Agriculture and Fisheries funds a monitoring system based on drug usage information collected at the herd level: VETSTAT. VETSTAT is constructed as a relational database and data originates from three sources: pharmacies, veterinarians and feed mills. All administration...... of drugs for use in animal production is reported on a monthly basis. Pharmacies provided 95% of the total weight antimicrobial compounds used in Denmark in 2001. More than 80% of the antimicrobial compounds reported by pharmacies were sold on prescription to end-users (owners) and included information...

  3. 21 CFR 530.5 - Veterinary records.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Veterinary records. 530.5 Section 530.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS General Provisions § 530.5 Veterinary records...

  4. Bioequivalence assessment of two formulations of ibuprofen

    KAUST Repository

    Al-Talla, Zeyad

    2011-10-19

    Background: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz , produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen , manufactured by Boots Company, Nottingham, UK. Methods and results: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration. Conclusion: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen. 2011 Al-Talla et al, publisher and licensee Dove Medical Press Ltd.

  5. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

    Science.gov (United States)

    Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

    2017-12-05

    The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  6. Veterinary Compounding: Regulation, Challenges, and Resources

    OpenAIRE

    Davidson, Gigi

    2017-01-01

    The spectrum of therapeutic need in veterinary medicine is large, and the availability of approved drug products for all veterinary species and indications is relatively small. For this reason, extemporaneous preparation, or compounding, of drugs is commonly employed to provide veterinary medical therapies. The scope of veterinary compounding is broad and focused primarily on meeting the therapeutic needs of companion animals and not food-producing animals in order to avoid human exposure to ...

  7. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...

  8. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Science.gov (United States)

    2012-02-22

    ... recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug... the process that would be used to make product-specific BE recommendations available to the public on... ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make...

  9. Multi-class multi-residue analysis of veterinary drugs in meat using enhanced matrix removal lipid cleanup and liquid chromatography-tandem mass spectrometry.

    Science.gov (United States)

    Zhao, Limian; Lucas, Derick; Long, David; Richter, Bruce; Stevens, Joan

    2018-05-11

    This study presents the development and validation of a quantitation method for the analysis of multi-class, multi-residue veterinary drugs using lipid removal cleanup cartridges, enhanced matrix removal lipid (EMR-Lipid), for different meat matrices by liquid chromatography tandem mass spectrometry detection. Meat samples were extracted using a two-step solid-liquid extraction followed by pass-through sample cleanup. The method was optimized based on the buffer and solvent composition, solvent additive additions, and EMR-Lipid cartridge cleanup. The developed method was then validated in five meat matrices, porcine muscle, bovine muscle, bovine liver, bovine kidney and chicken liver to evaluate the method performance characteristics, such as absolute recoveries and precision at three spiking levels, calibration curve linearity, limit of quantitation (LOQ) and matrix effect. The results showed that >90% of veterinary drug analytes achieved satisfactory recovery results of 60-120%. Over 97% analytes achieved excellent reproducibility results (relative standard deviation (RSD) meat matrices. The matrix co-extractive removal efficiency by weight provided by EMR-lipid cartridge cleanup was 42-58% in samples. The post column infusion study showed that the matrix ion suppression was reduced for samples with the EMR-Lipid cartridge cleanup. The reduced matrix ion suppression effect was also confirmed with 30%) for all tested veterinary drugs in all of meat matrices. The results showed that the two-step solid-liquid extraction provides efficient extraction for the entire spectrum of veterinary drugs, including the difficult classes such as tetracyclines, beta-lactams etc. EMR-Lipid cartridges after extraction provided efficient sample cleanup with easy streamlined protocol and minimal impacts on analytes recovery, improving method reliability and consistency. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Wide-Scope Screening Method for Multiclass Veterinary Drug Residues in Fish, Shrimp, and Eel Using Liquid Chromatography-Quadrupole High-Resolution Mass Spectrometry.

    Science.gov (United States)

    Turnipseed, Sherri B; Storey, Joseph M; Lohne, Jack J; Andersen, Wendy C; Burger, Robert; Johnson, Aaron S; Madson, Mark R

    2017-08-30

    A screening method for veterinary drug residues in fish, shrimp, and eel using LC with a high-resolution MS instrument has been developed and validated. The method was optimized for over 70 test compounds representing a variety of veterinary drug classes. Tissues were extracted by vortex mixing with acetonitrile acidified with 2% acetic acid and 0.2% p-toluenesulfonic acid. A centrifuged portion of the extract was passed through a novel solid phase extraction cartridge designed to remove interfering matrix components from tissue extracts. The eluent was then evaporated and reconstituted for analysis. Data were collected with a quadrupole-Orbitrap high-resolution mass spectrometer using both nontargeted and targeted acquisition methods. Residues were detected on the basis of the exact mass of the precursor and a product ion along with isotope pattern and retention time matching. Semiquantitative data analysis compared MS 1 signal to a one-point extracted matrix standard at a target testing level. The test compounds were detected and identified in salmon, tilapia, catfish, shrimp, and eel extracts fortified at the target testing levels. Fish dosed with selected analytes and aquaculture samples previously found to contain residues were also analyzed. The screening method can be expanded to monitor for an additional >260 veterinary drugs on the basis of exact mass measurements and retention times.

  11. Structural characterization of product ions by electrospray ionization and quadrupole time-of-flight mass spectrometry to support regulatory analysis of veterinary drug residues in foods Part 2: Benzimidazoles nitromidaz.....

    Science.gov (United States)

    RATIONALE: Analysis for identification and quantification of regulated veterinary drug residues in foods are usually achieved by liquid chromatography coupled to tandem mass spectrometry. The instrument method requires the selection of characteristic ions, but structure elucidation is seldom perform...

  12. Molecular Target Homology as a Basis for Species Extrapolation to Assess the Ecological Risk of Veterinary Drugs

    Science.gov (United States)

    Increased identification of veterinary pharmaceutical contaminants in aquatic environments has raised concerns regarding potential adverse effects of these chemicals on non-target organisms. The purpose of this work was to develop a method for predictive species extrapolation ut...

  13. Activities and influence of veterinary drug marketers on antimicrobial usage in livestock production in Oyo and Kaduna States, Nigeria

    Directory of Open Access Journals (Sweden)

    Olufemi Ernest Ojo

    2017-09-01

    Full Text Available Antimicrobial usage in animals contributes to the emergence of antimicrobial resistant bacterial strains. Investigations were carried out on how the characteristics, knowledge, attitude and practices of antimicrobial marketers influenced antimicrobials usage in animal production in Oyo and Kaduna States, Nigeria. Focus group discussions, in-depth interviews and structured questionnaires were used to gather information about the characteristics and activities of antimicrobial marketers. Overall, 70 (56.9 % of 123 marketers had post-secondary education while 76 (61.8 % were trained on the use of antimicrobials. Eighteen (14.6 % of the marketers were licensed veterinarians. Only 51 (41.5 % marketers displayed adequate knowledge about antimicrobials and antimicrobial usage. Sixty-seven (54.6 % marketers requested a prescription before selling antimicrobials while 113 (91.9 % marketer recommended antimicrobials for use in animals. Two-third of the marketers (66.7 % prescribed antimicrobials without physically examining sick animals but based their prescriptions on verbal reports of clinical signs by farmers and on their personal experience. Marketers with higher educational qualification displayed more adequate knowledge of antimicrobials and antimicrobial usage than those with basic education background only. More years of experience in antimicrobial marketing did not translate to better knowledge on antimicrobial usage. Only 45 (36.6 % respondents were aware of the existence of regulatory agencies monitoring the use of antimicrobials in animals. Farmers ignored the services of veterinarians in the diagnosis and control of animal diseases but resorted to drug marketers for help. Effective communication of existing legislations on antimicrobial usage, improved access to veterinary services and strict enforcement of regulatory policies are recommended for checking non-judicious use of antimicrobial agents in animal production. Sales of

  14. Bioequivalence of a new cyclosporine a formulation to Neoral.

    Science.gov (United States)

    David-Neto, Elias; Kakehashi, Erica; Alves, Cristiane Feres; Pereira, Lilian M; de Castro, Maria Cristina R; de Mattos, Renata Maciel; Sumita, Nairo Massakazu; Romano, Paschoalina; Mendes, Maria Elizabete; Nahas, William Carlos; Ianhez, Luiz Estevam

    2004-02-01

    New cyclosporine A (CsA) formulations must prove their bioequivalence to Neoral, the reference CsA formulation, to allow free prescription for the patients. The aim of this study was to compare the pharmacokinetics (PK) of a new CsA formulation (Zinograf-ME), produced by Strides-Arcolab, to Neoral and to demonstrate their interchangeability in stable renal transplant recipients. Twelve-hour PK studies were obtained from 18 (13 M/5 F) adult patients (mean age 44.7 +/- 12 years). They received their renal allografts from 13 cadaver and 5 living donors. Before enrollment, all patients were receiving a third generic CsA for a mean of 48 months. Nine patients were also under azathioprine and 9 under mycophenolate mofetil; 17 received prednisone. A single oral dose of either Zinograf or Neoral was administered. The first PK study was performed with one formulation, and 1 week later, a second PK was done with the other formulation. During the washout period, patients continued taking the third CsA formulation. The drug substitution was done milligram-for-milligram. The CsA whole-blood level was measured by TDx immunoassay. Mean +/- SD of area under the curve (AUC), maximum concentration (C(max)), and concentration at the second hour (C2) of Zinograf were not statistically different from those with Neoral (4019 +/- 1466 vs 3971 +/- 1325 ng x h/mL, 998 +/- 376 vs 1021 +/- 356 ng/mL, and 707 +/- 254 vs 734 +/- 229 ng/mL, respectively). In the same way, the Zinograf 90% confidence interval for either C(max) (-123, +77 ng/mL) or AUC (-214, +311 ng.mL/h) were within the Neoral bioequivalence interval for the same parameters (+/-204 ng/mL and +/-794 ng x mL/h, respectively). These data demonstrate that the ZinografME CsA formulation is bioequivalent to Neoral.

  15. MARKETING STUDIES OF VETERINARY PHARMACY ORGANIZATIONS ASSORTMENT

    Directory of Open Access Journals (Sweden)

    A. A. Deltsov

    2015-01-01

    Full Text Available Nowadays there is an active growth of veterinary pharmacy organizations and consumed medicinal drugs for veterinary use. Content-analysis showed that there was an insufficient number of studies devoted to the activity of veterinary pharmacies. The purpose of our work was the analysis of correspondence of range fullness of veterinary pharmacies to the contemporary state of pharmaceutical market of drugs for veterinary use. Veterinary clinics and pharmacies of Moscow and Moscow oblast were the object of our study. We have applied sociological methods (questionnaire, interview, marketing and statistic analysis methods. We have established that liquid dosage forms (53% occupy the biggest part of drugs in the State Registry of Veterinary Drugs. Solutions occupy 68% of this amount. Antimicrobial drugs for systematic use (40% are the most numerous drugs from pharmacotheraperutic group represented in the State Registry. Assortment of veterinary drugs is targeted mainly on a farm livestock (more than 50%. 58% of the market share is domestic drugs. Principal commodity groups which are released by veterinary pharmacies are feed-stuff (31% and drugs (30%. Pharmacy organizations does not have sufficient number of drugs in their assortment (fullness coefficient 7.9% which speaks about nonconformity of the assortment fullness.

  16. Proposing the Use of Partial AUC as an Adjunctive Measure in Establishing Bioequivalence Between Deltoid and Gluteal Administration of Long-Acting Injectable Antipsychotics.

    Science.gov (United States)

    Lee, Lik Hang N; Choi, Charles; Gershkovich, Pavel; Barr, Alasdair M; Honer, William G; Procyshyn, Ric M

    2016-12-01

    The maximum plasma concentration (C max ) and the area under the plasma concentration-time curve (AUC) are commonly used to establish bioequivalence between two formulations of the same oral medication. Similarly, these pharmacokinetic parameters have also been used to establish bioequivalence between two sites of administration for the same injectable formulation. However, these conventional methods of establishing bioequivalence are of limited use when comparing modified-release formulations of a drug, particularly those with rates of absorption that are amenable to change with the site of injection. Inherent differences in the rate of absorption can result in clinically significant differences in early exposure and drug response. Here, we propose the use of the partial AUC (pAUC) as a measure of early exposure to aid in the assessment of bioequivalence between the gluteal and the deltoid site of administration for long-acting injectable antipsychotics.

  17. Comparative bioequivalence assessment of aspirin tablets marketed ...

    African Journals Online (AJOL)

    Purpose: In the last few years, aspirin has become a life saver against cardiovascular accidents. This investigation was carried out to determine possible bioequivalence between regular aspirin and soluble aspirin tablets marketed in Nigeria. Methods: The in vivo bioavailability profiles of three commercial brands of aspirin ...

  18. Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation.

    Science.gov (United States)

    Pai, Amy Barton

    2017-11-01

    Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting. © 2017 New York Academy of Sciences.

  19. Simultaneous detection for three kinds of veterinary drugs: Chloramphenicol, clenbuterol and 17-beta-estradiol by high-throughput suspension array technology

    Energy Technology Data Exchange (ETDEWEB)

    Liu Nan; Su Pu [Institute of Hygiene and Environmental Medicine, Tianjin 300050 (China); Gao Zhixian [Institute of Hygiene and Environmental Medicine, Tianjin 300050 (China)], E-mail: gaozhx@163.com; Zhu Maoxiang; Yang Zhihua; Pan Xiujie [Institute of Radiation Medicine, Beijing 100850 (China); Fang Yanjun; Chao Fuhuan [Institute of Hygiene and Environmental Medicine, Tianjin 300050 (China)

    2009-01-19

    Suspension array technology for simultaneous detection of three kinds of veterinary drugs, chloramphenicol (CAP), clenbuterol and 17-beta-estradiol has been developed. Conjugates of chloramphenicol and clenbuterol coupled with bovine serum albumin were synthesized and purified. Probes of suspension array were constituted by coupling the three conjugates on the fluorescent microspheres/beads and the microstructures of the beads' surface were observed by scanning electron microscopy which was a direct confirmation for the successful conjugates' coupling. The optimal addition of conjugates and the amounts of antibodies were optimized and selected, respectively. Standard curves were plotted and the coefficient of determination-R{sup 2} was greater than 0.989 which suggested good logistic correlation. The detection ranges for the three veterinary drugs are 40-6.25 x 10{sup 5} ng L{sup -1}, 50-7.81 x 10{sup 5} ng L{sup -1} and 1 x 10{sup 3-}7.29 x 10{sup 5} ng L{sup -1}, respectively and the lowest detection limits (LDLs) of them are 40, 50 and 1000 ng L{sup -1}, respectively. The suspension array is specific and has no significant cross-reactivity with other chemicals. Meanwhile, unknown samples were detected by suspension array and ELISA in comparison with each other. The errors between found and real for the detection of the unknown samples were relatively small to both of the two methods, whereas, the detection ranges of suspension array are broader and sensitive than that of the traditional ELISA. The high-throughput suspension array is proved to be a novel method for multi-analysis of veterinary drugs with simple operation, high sensitivity and low cost.

  20. Carry-over of veterinary drugs from medicated to non-medicated feeds in commercial feed manufacturing plants

    NARCIS (Netherlands)

    Stolker, A.A.M.; Zuidema, T.; Egmond, van H.J.; Deckers, E.R.; Herbes, R.; Hooglught, J.; Olde Heuvel, E.; Jong, de J.

    2013-01-01

    Different compound feeds have to be manufactured in the same production line. As a consequence, traces of the first produced feed may remain in the production and get mixed with the next feed batches. This "carry-over" is unavoidable, and so non-medicated feed can be contaminated with veterinary

  1. Quality Control Guidelines for Disk Diffusion and Broth Microdilution Antimicrobial Susceptibility Tests with Seven Drugs for Veterinary Applications

    Science.gov (United States)

    Odland, Brant A.; Erwin, Meredith E.; Jones, Ronald N.

    2000-01-01

    This multicenter study proposes antimicrobial susceptibility (MIC and disk diffusion methods) quality control (QC) parameters for seven compounds utilized in veterinary health. Alexomycin, apramycin, tiamulin, tilmicosin, and tylosin were tested by broth microdilution against various National Committee for Clinical Laboratory Standards (NCCLS)-recommended QC organisms (Staphylococcus aureus ATCC 29213, Enterococcus faecalis ATCC 29212, Streptococcus pneumoniae ATCC 49619, Escherichia coli ATCC 25922, and Pseudomonas aeruginosa ATCC 27853). In addition, disk diffusion zone diameter QC limits were determined for apramycin, enrofloxacin, and premafloxacin by using E. coli ATCC 25922, P. aeruginosa ATCC 27853, and S. aureus ATCC 25923. The results from five or six participating laboratories produced ≥99.0% of MICs and ≥95.0% of the zone diameters within suggested guidelines. The NCCLS Subcommittee for Veterinary Antimicrobial Susceptibility Testing has recently approved these ranges for publication in the next M31 document. PMID:10618141

  2. Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development.

    Science.gov (United States)

    Siska, William; Gupta, Aradhana; Tomlinson, Lindsay; Tripathi, Niraj; von Beust, Barbara

    Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests. Additionally, strong emphasis is often placed on statistical analysis and use of reference intervals for interpretation of test article-related clinical pathology changes, with limited attention given to the critical scientific review of clinically, toxicologically, or biologically relevant changes. The purpose of this communication from the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology is to provide current recommendations for clinical pathology testing and data interpretation in target animal safety studies and thereby enhance the value of clinical pathology testing in these studies.

  3. High-throughput screening of pesticide and veterinary drug residues in baby food by liquid chromatography coupled to quadrupole Orbitrap mass spectrometry.

    Science.gov (United States)

    Jia, Wei; Chu, Xiaogang; Ling, Yun; Huang, Junrong; Chang, James

    2014-06-20

    A new analytical method was developed and validated for simultaneous analysis of 333 pesticide and veterinary drug residues in baby food. Response surface methodology was employed to optimize a generic extraction method. Ultrahigh-performance liquid chromatography and electrospray ionization quadrupole Orbitrap high-resolution mass spectrometry (UHPLC-ESI Q-Orbitrap) was used for the separation and detection of all the analytes. The method was validated by taking into consideration the guidelines specified in Commission Decision 2002/657/EC and SANCO/12571/2013. The extraction recoveries were in a range of 79.8-110.7%, with coefficient of variation 0.99. The limits of detection for the analytes are in the range 0.01-5.35μgkg(-1). The limits of quantification for the analytes are in the range 0.01-9.27μgkg(-1). This method has been successfully applied on screening of pesticide and veterinary drugs in ninety-three commercial baby food samples, and tilmicosin, fenbendazole, tylosin tartrate and thiabendazole were detected in some samples tested in this study. The present study is very useful for fast screening of different food contaminants. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. High-throughput screening and confirmation of 22 banned veterinary drugs in feedstuffs using LC-MS/MS and high-resolution Orbitrap mass spectrometry.

    Science.gov (United States)

    Wang, Xufeng; Liu, Yanghong; Su, Yijuan; Yang, Jianwen; Bian, Kui; Wang, Zongnan; He, Li-Min

    2014-01-15

    A new analytical strategy based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) combined with accurate mass high-resolution Orbitrap mass spectrometry (HR-Orbitrap MS) was performed for high-throughput screening, confirmation, and quantification of 22 banned or unauthorized veterinary drugs in feedstuffs according to Bulletin 235 of the Ministry of Agriculture, China. Feed samples were extracted with acidified acetonitrile, followed by cleanup using solid-phase extraction cartridge. The extracts were first screened by LC-MS/MS in a single selected reaction monitoring mode. The suspected positive samples were subjected to a specific pretreatment for confirmation and quantification of analyte of interest with LC-MS/MS and HR-Orbitrap MS. Mean recoveries for all target analytes (except for carbofuran and chlordimeform, which were about 35 and 45%, respectively) ranged from 52.2 to 90.4%, and the relative standard deviations were screening of real samples obtained from local feed markets and confirmation of the suspected target analytes. It provides a high-throughput, sensitive, and reliable screening, identification, and quantification of banned veterinary drugs in routine monitoring programs of feedstuffs.

  5. Wide-scope analysis of pesticide and veterinary drug residues in meat matrices by high resolution MS: detection and identification using Exactive-Orbitrap.

    Science.gov (United States)

    Gómez-Pérez, María Luz; Romero-González, Roberto; Plaza-Bolaños, Patricia; Génin, Eric; Martínez Vidal, José Luis; Garrido Frenich, Antonia

    2014-01-01

    A multiresidue and multiclass method for the simultaneous determination of more than 350 compounds including pesticides, biopesticides and veterinary drugs in different meat matrices (beef, pork and chicken) by ultra-high performance liquid chromatography coupled to Orbitrap MS has been developed. In the present study, the determination of fragments was accomplished as an essential tool for a reliable identification of compounds using high resolution MS. To obtain these fragments, different strategies have been carried out in order to ensure an appropriate fragment assignment and identification. The analytical method is suitable for qualitative analysis, and it was also evaluated for quantitative analysis. Generic extraction conditions were optimized, obtaining adequate recovery and precision values for most of the studied analytes (>290). The limits of detection ranged from 2 to 16 µg kg(-1). Limits of quantification were 10 µg kg(-1) with the exception of few compounds with a higher value (50 or 100 µg kg(-1)). Limits of identification were also established, and they ranged from 2 to 150 µg kg(-1). This method was applied to the analysis of 18 meat samples and some veterinary drugs as enrofloxacin and sulfadiazine were detected and further identified/quantified (with triple quadrupole) in two different samples at 33 µg kg(-1) and trace levels, respectively. No pesticides were detected in the analyzed samples. Copyright © 2014 John Wiley & Sons, Ltd.

  6. Analysis of Veterinary Drug and Pesticide Residues Using the Ethyl Acetate Multiclass/Multiresidue Method in Milk by Liquid Chromatography-Tandem Mass Spectrometry

    Directory of Open Access Journals (Sweden)

    Husniye Imamoglu

    2016-01-01

    Full Text Available A rapid and simple multiclass, ethyl acetate (EtOAc multiresidue method based on liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS detection was developed for the determination and quantification of 26 veterinary drugs and 187 total pesticide residues in milk. Sample preparation was a simple procedure based on liquid–liquid extraction with ethyl acetate containing 0.1% acetic acid, followed by centrifugation and evaporation of the supernatant. The residue was dissolved in ethyl acetate with 0.1% acetic acid and centrifuged prior to LC-MS/MS analysis. Chromatographic separation of analytes was performed on an Inertsil X-Terra C18 column with acetic acid in methanol and water gradient. The repeatability and reproducibility were in the range of 2 to 13% and 6 to 16%, respectively. The average recoveries ranged from 75 to 120% with the RSD (n=18. The developed method was validated according to the criteria set in Commission Decision 2002/657/EC and SANTE/11945/2015. The validated methodology represents a fast and cheap alternative for the simultaneous analysis of veterinary drug and pesticide residues which can be easily extended to other compounds and matrices.

  7. Targeting the environmental assessment of veterinary drugs with the multi-species-soil system (MS{center_dot}3) agricultural soil microcosms: the ivermectin case study

    Energy Technology Data Exchange (ETDEWEB)

    Carbonell-Martin, G.; Pro-Gonzalez, J.; Aragones-Grunert, P.; Babib-Vich, M. M.; Fernandez-Rorija, C.; Tarazona-Lafarga, J. V.

    2011-07-01

    The environmental risk assessment of the veterinary pharmaceutical ivermectin is receiving significant attention. This paper assesses the capacity of the MS{center_dot}3 soil microcosm as a tool for targeting the environmental impact assessment of veterinary drugs, using ivermectin as model. Two screening MS{center_dot}3 were performed using different European soils; one with a soil collected in an agricultural station near to Madrid, Spain and a second with a soil collected in a farm area close to York, UK. Soils were fortified with ivermectin at the following ranges: 0.01-10 mg kg{sup -}1 and 0.1-100 mg kg{sup -}1 in the Madrid and York studies, respectively. The effects on earthworms, plants and soil microorganisms were assessed in the Madrid soil. Toxicity tests on aquatic organisms (algae, cladocerans and in vitro fish cell line RTLW1) were also conducted with the leachates. No effects were observed in earthworms and plants at any tested concentration; reduction in the respiration rate (< 5%) of soil microorganisms was detected. Earthworm/soil bioconcentration factors decreased with the increase in soil concentrations and were higher for the York soil. Effects on daphnids were observed in tested leachates; based on measured levels of ivermectin in the leachates an EC50 of about 0.5{mu}gL{sup -}1 can be estimated. Comparisons based on toxicity data and equilibrium partitioning confirmed that the main risk is expected to be related to the high sensitivity of cladocerans. The results confirm that MS{center_dot}3 systems are cost-effective tools for assessing the impact of veterinary pharmaceuticals when applied to agricultural land, as previously demonstrated for antimicrobials. (Author) 39 refs.

  8. Assessment of veterinary drugs in plants using pharmacokinetic approaches: The absorption, distribution and elimination of tetracycline and sulfamethoxazole in ephemeral vegetables

    Science.gov (United States)

    Chen, Hui-Ru; Rairat, Tirawat; Loh, Shih-Hurng; Wu, Yu-Chieh; Vickroy, Thomas W.

    2017-01-01

    The present study was carried out to demonstrate novel use of pharmacokinetic approaches to characterize drug behaviors/movements in the vegetables with implications to food safety. The absorption, distribution, metabolism and most importantly, the elimination of tetracycline (TC) and sulfamethoxazole (SMX) in edible plants Brassica rapa chinensis and Ipomoea aquatica grown hydroponically were demonstrated and studied using non-compartmental pharmacokinetic analysis. The results revealed drug-dependent and vegetable-dependent pharmacokinetic differences and indicated that ephemeral vegetables could have high capacity accumulating antibiotics (up to 160 μg g-1 for TC and 38 μg g-1 for SMX) within hours. TC concentration in the root (Cmax) could reach 11 times higher than that in the cultivation fluid and 3–28 times higher than the petioles/stems. Based on the volume of distribution (Vss), SMX was 3–6 times more extensively distributed than TC. Both antibiotics showed evident, albeit slow elimination phase with elimination half-lives ranging from 22 to 88 hours. For the first time drug elimination through the roots of a plant was demonstrated, and by viewing the root as a central compartment and continuous infusion without a loading dose as drug administration mode, it is possible to pharmacokinetically monitor the movement of antibiotics and their fate in the vegetables with more detailed information not previously available. Phyto-pharmacokinetic could be a new area worth developing new models for the assessment of veterinary drugs in edible plants. PMID:28797073

  9. Veterinary radiobiology

    International Nuclear Information System (INIS)

    Kirshin, V.A.; Belov, A.D.; Budarkov, V.A.; Prochazka, Z.

    1989-01-01

    The monograph summarizes the authors' experience and data from Soviet and foreign scientific literature. It consists of the following chapters: radioactive sources; utilization of ionizing radiation and radioactive isotopes; biological effects of ionizing radiation; radiation sickness in animals; combined post-irradiation syndromes; prophylaxis of radiation injury; therapy of irradiated animals; and veterinary radiation hygiene control of the environment, fodder, animals and animal products. (P.A.)

  10. Multi-drug-resistant Acinetobacter calcoaceticus-Acinetobacter baumannii complex infection outbreak in dogs and cats in a veterinary hospital.

    Science.gov (United States)

    Kuzi, S; Blum, S E; Kahane, N; Adler, A; Hussein, O; Segev, G; Aroch, I

    2016-11-01

    Members of the Acinetobacter calcoaceticus-Acinetobacter baumannii complex cause severe outbreaks in humans, and are increasingly reported in animals. A retrospective study, describing a severe outbreak in dogs and cats caused by a multidrug resistant member of the Acinetobacter calcoaceticus-Acinetobacter baumannii complex in a veterinary hospital, between July 2010 and November 2012. The study included 19 dogs and 4 cats. Acinetobacter calcoaceticus-Acinetobacter baumannii complex bacteria were isolated from urine (9 animals), respiratory tract (11), tissues (3) and blood (1). The most common infection-associated findings included fever, purulent discharge from endotracheal tubes, hypotension, and neutropaenia. Infections led to pneumonia, urinary tract infection, cellulitis and sepsis. Infection was transmitted in the intensive care unit, where 22 of 23 animals were initially hospitalised. The mortality rate was 70% (16 of 23 animals), and was higher in cases of respiratory infection compared to other infections. Aggressive environmental cleaning and disinfection, with staff education for personal hygiene and antisepsis, sharply decreased the infection incidence. Health care-associated outbreaks with multidrug resistant Acinetobacter calcoaceticus-Acinetobacter baumannii complex in dogs and cats are potentially highly fatal and difficult to eradicate, warranting monitoring, antiseptic techniques and judicious antibiotic use. © 2016 British Small Animal Veterinary Association.

  11. 75 FR 4576 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-28

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory... Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl...

  12. Assessment of veterinary services in central Ethiopia: A case study ...

    African Journals Online (AJOL)

    services, and black-market drug dealers were found to be challengers associated .... veterinary service, private veterinarians, traditional healers and NGOs mainly ... timeliness, effectiveness and affordability of the veterinary service providers.

  13. An update discussion on the current assessment of the safety of veterinary antimicrobial drug residues in food with regard to their impact on the human intestinal microbiome.

    Science.gov (United States)

    Cerniglia, Carl E; Pineiro, Silvia A; Kotarski, Susan F

    2016-05-01

    The human gastrointestinal tract ecosystem consists of complex and diverse microbial communities that have now been collectively termed the intestinal microbiome. Recent scientific breakthroughs and research endeavours have increased our understanding of the important role the intestinal microbiome plays in human health and disease. The use of antimicrobial new animal drugs in food-producing animals may result in the presence of low levels of drug residues in edible foodstuffs. There is concern that antimicrobial new animal drugs in or on animal-derived food products at residue-level concentrations could disrupt the colonization barrier and/or modify the antimicrobial resistance profile of human intestinal bacteria. Therapeutic doses of antimicrobial drugs have been shown to promote shifts in the intestinal microbiome, and these disruptions promote the emergence of antimicrobial-resistant bacteria. To assess the effects of antimicrobial new animal drug residues in food on human intestinal bacteria, many national regulatory agencies and international committees follow a harmonized process, VICH GL36(R), which was issued by a trilateral organization of the European Union, the USA, and Japan called the International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH). The guidance describes a general approach currently used by national regulatory agencies and international committees to assess the effects of antimicrobial new animal drug residues in animal-derived food on human intestinal bacteria. The purpose of this review is to provide an overview of this current approach as part of the antimicrobial new animal drug approval process in participating countries, give insights on the microbiological endpoints used in this safety evaluation, and discuss the availability of new information. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  14. Resident cats in small animal veterinary hospitals carry multi-drug resistant enterococci and are likely involved in cross-contamination of the hospital environment

    Directory of Open Access Journals (Sweden)

    Anuradha eGhosh

    2012-02-01

    Full Text Available In the U.S., small animal veterinary hospitals (SAVHs commonly keep resident cats living permanently as pets within their facilities. Previously, multi-drug resistant (MDR enterococci were found as a contaminant of multiple surfaces within such veterinary hospitals, and nosocomial infections are a concern. The objectives of this study were to determine whether resident cats carry MDR enterococci and if they potentially play a role in the contamination of the hospital environment. Enterococcal strains (n=180 were isolated from the feces of six healthy resident cats from different SAVHs. The concentration of enterococci ranged from 1.1 x 105 to 6.0 x 108 CFU g-1 of feces, and the population comprised E. hirae (38.3±18.6%, E. faecium (35.0±14.3%, E. faecalis (23.9±11.0%, and E. avium (2.8±2.2%. Testing of phenotypic resistance to 14 antimicrobial agents revealed multi-drug resistance (≥3 antimicrobials in 48.9% of all enterococcal isolates with most frequent resistance to tetracycline (72.8%, erythromycin (47.8%, and rifampicin (35.6%. Vancomycin resistant E. faecalis (3.9% with vanB not horizontally transferable in in vitro conjugation assays were detected from one cat. Genotyping (pulsed-field gel electrophoresis demonstrated a host-specific clonal population of MDR E. faecalis and E. faecium. Importantly, several feline isolates were genotypically identical or closely related to isolates from surfaces of cage door, thermometer, and stethoscope of the corresponding SAVHs. These data demonstrate that healthy resident cats at SAVHs carry MDR enterococci and likely contribute to contamination of the SAVH environment. Proper disposal and handling of fecal material and restricted movement of resident cats within the ward is recommended.

  15. Efficiency of the Clinical Veterinary Diagnostic Practices and Drug Choices for Infectious Diseases in Livestock in Bangladesh

    DEFF Research Database (Denmark)

    Haider, Najmul; Khan, S. U.; Islam, A.

    2017-01-01

    ) and foot-and-mouth disease (FMD). We conducted the study from May 2009 to August 2010 in three government veterinary hospitals where veterinarians collected samples from sick livestock and recorded the presumptive diagnosis on the basis of clinical presentations. Samples were tested for PPR and FMD using...... competency of these veterinarians needs to be improved and access to laboratory diagnostic facilities could help veterinarians to improve the diagnostics and outcomes. The rational use of antibiotics by veterinarians in animals must be ensured....... validation process for PPR (kappa: 0.25) and FMD (kappa 0.36) indicated a poor performance of the presumptive diagnoses. Most of the animals (93%) were treated with antibiotics. Our findings indicate that veterinarians can detect animals not infected with FMD or PPR but miss the true cases. The clinical...

  16. Analysis of banned veterinary drugs and herbicide residues in shellfish by liquid chromatography-tandem mass spectrometry (LC/MS/MS) and gas chromatography-tandem mass spectrometry (GC/MS/MS)

    International Nuclear Information System (INIS)

    Chang, Geng-Ruei; Chen, Hui-Shan; Lin, Feng-Yi

    2016-01-01

    Seafood safety is a crucial public health concern for consumers. In this study, we applied a validated method to analyze the residue of banned veterinary drugs in shellfish, namely chloramphenicol, malachite green, leucomalachite green, and nitrofuran metabolites; additionally, the QuEChERS method was employed to detect 76 herbicides by LC/MS/MS and GC/MS/MS. In total, 42 shellfish samples, which included hard clams, freshwater clams, and oysters, were collected from aquafarms and production areas in Taiwan during 2012. Our results revealed 3.8 ng/g of chloramphenicol in one hard clam, 19.9–32.1 ng/g of ametryn in two hard clams, 16.1–60.1 ng/g of pendimethalin in four hard clams, and 17.0 ng/g of mefenacet in one oyster, indicating that 19.1% of the samples contained residues from banned veterinary drugs and pesticides. These data can be used to monitor the residue of veterinary drugs and pesticides in aquatic organisms and as a reference for food safety. - Highlights: • A certified method was employed for analyzing residues of banned veterinary drugs and herbicides in shellfish samples. • The trace levels of chloramphenicol, ametryn, pendimethalin were detected in hard clam samples. • For ensuring food safety, continual monitoring of aquatic products is necessary.

  17. Fluorescence detection of tramadol in healthy Chinese volunteers by high-performance liquid chromatography and bioequivalence assessment

    Directory of Open Access Journals (Sweden)

    Zhou X

    2015-02-01

    Full Text Available Xiao Zhou, Ji Liu Department of Anesthesia, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China Abstract: This study developed a revised high-performance liquid chromatography fluorescence method to determine plasma tramadol concentration, and thereby to examine the bioequivalence of two tramadol formulations among healthy male Chinese volunteers. The study used a double-blind, randomized, 2×2 crossover-design principle. Calculated pharmacokinetic parameters for both formulations were consistent with previous reports. According to the observation of vital signs and laboratory measurement, no subjects had any adverse reactions. The geometric mean ratios (90% confidence interval of the test drug/reference drug for tramadol were 100.2% (95.3%–103.4% for the area under the plasma concentration–time curve (AUC from time zero to the last measurable concentration, 99.6% (94.2%–102.7% for the AUC from administration to infinite time, and 100.8% (93.1%–106.4% for maximum concentration. For the 90% confidence intervals of the test/reference AUC ratio and maximum concentration ratio of tramadol, both were in the acceptance range for bioequivalence. According to the two preparations by pharmacokinetic parameter statistics, the half-life, mean residence time, and clearance values showed no significant statistical differences. Therefore, the conclusion of this study was that the two tramadol formulations (tablets and capsules were bioequivalent. Keywords: tramadol hydrochloride, in vitro release, pharmacokinetic, bioequivalence, fluorescence detector

  18. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    ¹Department of Veterinary Anatomy, Faculty of Veterinary Medicine, ABU Zaria, Nigeria, ²Department of. Veterinary Physiology ... dogs, AGRs have a highly sensitive sense of smell. The rats ..... Gonadal Axis and thyroid Activity in. Male rats.

  19. Bioequivalence of a new liquid formulation of benazepril compared with the reference tablet product.

    Science.gov (United States)

    Kelers, K; Devi, J L; Anderson, G A; Zahra, P; Vine, J H; Whittem, T

    2013-08-01

    To compare the bioequivalence and 'switchability' of two formulations of benazepril (tablet and liquid) after oral administration. Randomised cross-over design, followed by parallel comparison. Twelve mixed-breed dogs were administered either a tablet (Group A) or liquid formulation (Group B) of benazepril orally at 0.45 mg/kg daily for 4 days. With no washout period, the dogs then received the alternative treatment at the same dose for a further 4 days. Blood samples taken prior to treatment and serially after treatment were analysed for plasma concentrations of benazepril and benazeprilat and the activity and concentration of angiotensin-converting enzyme (ACE). The calculated percentage inhibition of ACE was defined as the primary outcome variable. No statistically significant differences were found between groups A and B for any variable evaluated. The mean (± SD) percentage of ACE inhibition was 85.5 ± 7.04% for the liquid formulation and 85.9 ± 6.66% for the tablet formulation. The mean of the ratios was 1.00 (80% confidence interval 0.96-1.04). No evaluated effect term (sequence, formulation or period) had any statistical effect on any outcome variable. This study supports a conclusion that, based on pharmacodynamic response, the liquid formulation of benazepril is bioequivalent to the reference tablet formulation. Further, the lack of a sequence effect supports the switchability of these two formulations. © 2013 Australian Veterinary Association.

  20. Development of Radiometric and Allied Analytical Methods and Strategies to Strengthen National Residue Control Programmes for Antibiotic and Anthelmintic Veterinary Drug Residues. Final Report of a Coordinated Research Project

    International Nuclear Information System (INIS)

    2016-08-01

    Awareness of food safety is rising among consumers, and many importing countries implement food control regulations to guarantee the quality and safety of imported foods for their consumers. Many developing countries have also taken steps to put in place control systems that encourage responsible use of veterinary medicines to combat possible drug resistance, control drug residues and ensure compliance with international and national standards. However, these countries still require the necessary know-how and skills to protect local consumers and to access international markets. One significant constraint is the capacity of laboratory services to generate surveillance data using reliable and cost effective analytical methods validated to national and international standards. The IAEA coordinated research project (CRP) on the Development of Radiometric and Allied Analytical Methods to Strengthen National Residue Control Programmes for Antibiotic and Anthelmintic Veterinary Drug Residues was initiated in 2009 to conduct work on robust nuclear and related technologies suitable for the screening and confirmatory analysis of residues of veterinary medicines, including antimicrobials and anthelmintics commonly used in animal production, with public health and trade significance. The CRP also explored mechanisms to enhance networking among research institutions involved in research on pharmacologically active veterinary drug residues in food (primarily) and environmental samples. The project was implemented by the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture between 2009 and 2014 and involved eleven research contracts and one technical contract, five research agreements and one institution. The CRP was a continuation of the CRP on the Development of Strategies for the Effective Monitoring of Veterinary Drug Residues in Livestock and Livestock Products in Developing Countries and the key findings are also summarized in this publication.

  1. Nanomedicine in veterinary oncology.

    Science.gov (United States)

    Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei

    2015-08-01

    Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology. Published by Elsevier Ltd.

  2. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.

    Directory of Open Access Journals (Sweden)

    Rita R Alloway

    2017-11-01

    Full Text Available Although the generic drug approval process has a long-term successful track record, concerns remain for approval of narrow therapeutic index generic immunosuppressants, such as tacrolimus, in transplant recipients. Several professional transplant societies and publications have generated skepticism of the generic approval process. Three major areas of concern are that the pharmacokinetic properties of generic products and the innovator (that is, "brand" product in healthy volunteers may not reflect those in transplant recipients, bioequivalence between generic and innovator may not ensure bioequivalence between generics, and high-risk patients may have specific bioequivalence concerns. Such concerns have been fueled by anecdotal observations and retrospective and uncontrolled published studies, while well-designed, controlled prospective studies testing the validity of the regulatory bioequivalence testing approach for narrow therapeutic index immunosuppressants in transplant recipients have been lacking. Thus, the present study prospectively assesses bioequivalence between innovator tacrolimus and 2 generics in individuals with a kidney or liver transplant.From December 2013 through October 2014, a prospective, replicate dosing, partially blinded, randomized, 3-treatment, 6-period crossover bioequivalence study was conducted at the University of Cincinnati in individuals with a kidney (n = 35 or liver transplant (n = 36. Abbreviated New Drug Applications (ANDA data that included manufacturing and healthy individual pharmacokinetic data for all generics were evaluated to select the 2 most disparate generics from innovator, and these were named Generic Hi and Generic Lo. During the 8-week study period, pharmacokinetic studies assessed the bioequivalence of Generic Hi and Generic Lo with the Innovator tacrolimus and with each other. Bioequivalence of the major tacrolimus metabolite was also assessed. All products fell within the US Food and Drug

  3. Cyclosporine in veterinary dermatology.

    Science.gov (United States)

    Palmeiro, Brian S

    2013-01-01

    Cyclosporine is an immunomodulatory medication that is efficacious and approved for atopic dermatitis in dogs and allergic dermatitis in cats; it has also been used to successfully manage a variety of immune-mediated dermatoses in dogs and cats. This article reviews the use of cyclosporine in veterinary dermatology including its mechanism of action, pharmacokinetics, drug interactions, side effects, and relevant clinical updates. Dermatologic indications including atopic/allergic dermatitis, perianal fistulas, sebaceous adenitis, and other immune-mediated skin diseases are discussed. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Holistic pediatric veterinary medicine.

    Science.gov (United States)

    Pesch, Lisa

    2014-03-01

    Holistic veterinary medicine treats the whole patient including all physical and behavioral signs. The root cause of disease is treated at the same time as accompanying clinical signs. Herbal and nutritional supplements can help support tissue healing and proper organ functioning, thereby reducing the tendency of disease progression over time. Proper selection of homeopathic remedies is based on detailed evaluation of clinical signs. Herbal medicines are selected based on organ(s) affected and the physiologic nature of the imbalance. Many herbal and nutraceutical companies provide support for veterinarians, assisting with proper formula selection, dosing, drug interactions, and contraindications. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. 75 FR 36588 - Veterinary Feed Directive; Extension of Comment Period

    Science.gov (United States)

    2010-06-28

    ... 558 [Docket No. FDA-2010-N-0155] Veterinary Feed Directive; Extension of Comment Period AGENCY: Food... veterinary feed directive (VFD) regulation. The agency is taking this action in response to requests for an... CONTACT: Neal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500...

  6. 75 FR 52605 - Veterinary Medicine Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-08-26

    ...] Veterinary Medicine Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA). The meeting will be open to the public. Name of Committee: Veterinary Medicine Advisory..., Rockville, MD 20852, 301-468-1100. Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3...

  7. 77 FR 16806 - Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in...

    Science.gov (United States)

    2012-03-22

    ... related to the 20th Session of the CCRVDF will be accessible via the World Wide Web at the following... CCRVDF CONTACT: Kevin Greenlees, Senior Advisor for Science & Policy, Office of New Animal Drug... Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of...

  8. 75 FR 48928 - Codex Alimentarius Commission: Meeting of the Codex Committee on Residues of Veterinary Drugs in...

    Science.gov (United States)

    2010-08-12

    ... Session of the CCRVDF will be accessible via the World Wide Web at the following address: http://www... contact: Dr. Kevin Greenlees, Senior Advisor for Science & Policy, Office of New Animal Drug Evaluation... Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of...

  9. Xenobiotic-metabolizing enzymes in plants and their role in uptake and biotransformation of veterinary drugs in the environment

    Czech Academy of Sciences Publication Activity Database

    Bártíková, H.; Skálová, L.; Stuchlíková, L.; Vokřál, I.; Vaněk, Tomáš; Podlipná, Radka

    2015-01-01

    Roč. 47, č. 3 (2015), s. 374-387 ISSN 0360-2532 R&D Projects: GA ČR(CZ) GA15-05325S; GA ČR(CZ) GA14-22593S Institutional support: RVO:61389030 Keywords : Pollutants * phytoremediation * drug phytotoxicity Subject RIV: CE - Biochemistry Impact factor: 4.526, year: 2015 http://www.tandfonline.com/doi/abs/10.3109/03602532.2015.1076437

  10. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants.

    Science.gov (United States)

    Klátyik, Szandra; Bohus, Péter; Darvas, Béla; Székács, András

    2017-01-01

    Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU), and the occurrence of veterinary drug (VD) and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually) initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively), and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively). Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants) and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects between the

  11. Authorization and Toxicity of Veterinary Drugs and Plant Protection Products: Residues of the Active Ingredients in Food and Feed and Toxicity Problems Related to Adjuvants

    Directory of Open Access Journals (Sweden)

    Szandra Klátyik

    2017-09-01

    Full Text Available Chemical substances applied in animal husbandry or veterinary medicine and in crop protection represent substantial environmental loads, and their residues occur in food and feed products. Product approval is governed differently in these two sectors in the European Union (EU, and the occurrence of veterinary drug (VD and pesticide residues indicated by contamination notification cases in the Rapid Alert System for Food and Feed of the EU also show characteristic differences. While the initial high numbers of VD residues reported in 2002 were successfully suppressed to less than 100 cases annually by 2006 and on, the number of notification cases for pesticide residues showed a gradual increase from a low (approximately 50 cases annually initial level until 2005 to more than 250 cases annually after 2009, with a halt occurring only in 2016. Main notifiers of VD residues include Germany, Belgium, the UK, and Italy (63, 59, 42, and 31 notifications announced, respectively, and main consigning countries of non-compliances are Vietnam, India, China, and Brazil (88, 50, 34, and 23 notifications, respectively. Thus, countries of South and Southeast Asia are considered a vulnerable point with regard to VD residues entering the EU market. Unintended side effects of VDs and plant protection products may be caused not only by the active ingredients but also by various additives in these preparations. Adjuvants (e.g., surfactants and other co-formulants used in therapeutic agents and feed additives, as well as in pesticide formulations have long been considered as inactive ingredients in the aspects of the required main biological effect of the pharmaceutical or pesticide, and in turn, legal regulations of the approval and marketing of these additives specified significantly less stringent risk assessment requirements, than those specified for the active ingredients. However, numerous studies have shown additive, synergistic, or antagonistic side effects

  12. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Veterinary Pathology, Faculty of Veterinary Medicine, University of Ilorin, Ilorin ... One of these mutations led to an amino acid exchange at position 544 ... organs such as comb, wattle, brain, heart, .... congestion in various tissues and edema of.

  13. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    and Aji, T. G.. 1. 1Faculty of Veterinary Medicine, University of Maiduguri, Nigeria. ... limited nervous, muscle and skeletal systems development ... samples. Colloid area/volume and perimeter: This ..... BANKS, W. J., (1993): Applied Veterinary.

  14. Nigerian Veterinary Journal

    African Journals Online (AJOL)

    The Nigerian Veterinary Journal (NVJ) has been in existence since 1971. ... dogs diagnosed with parvovirus enteritis in some veterinary clinics in Nigeria · EMAIL ... Rabies vaccination status among occupationally exposed humans in Nigeria ...

  15. American Veterinary Medical Association

    Science.gov (United States)

    ... free client handout to share with them. Compounding Veterinary Compounding FDA has withdrawn its draft guidance for ... new guidance, the AVMA is working to ensure veterinary access and animal health are protected. NEWS & ALERTS ...

  16. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    2Department of Veterinary Medicine, University of Nigeria, Nsukka. 3Veterinary. Teaching ... salivation, cornea opacity, haematuria and convulsion were observed in 20, 8, 2, 4, 1 and 3 of the patients ... intravenous fluid administration either for.

  17. Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology

    DEFF Research Database (Denmark)

    Garcia Ortiz, Patricia Elodia; Hansen, S H; Shah, Surendra P.

    2011-01-01

    To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence.......To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence....

  18. Veterinary nuclear medicine

    International Nuclear Information System (INIS)

    Krzeminski, M.; Lass, P.; Teodorczyk, J.; Krajka, J.

    2004-01-01

    The veterinary use of radionuclide techniques dates back to the mid-sixties, but its more extensive use dates back to the past two decades. Veterinary nuclear medicine is focused mainly on four major issues: bone scintigraphy - with the majority of applications in horses, veterinary endocrinology - dealing mainly with the problems of hyperthyreosis in cats and hyperthyreosis in dogs, portosystemic shunts in small animals and veterinary oncology, however, most radionuclide techniques applied to humans can be applied to most animals. (author)

  19. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

    KAUST Repository

    Al-Talla, Zeyad

    2011-01-01

    Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a reference formulation (Dalacin C® 150 mg capsule) in healthy adult male volunteers. Methods: A single-dose, open-label, 2-period crossover study was conducted. Healthy male volunteers were randomly assigned to oral administration of a single treatment of the reference and test formulations. The same groups were given the alternate formulation. After dosing, serial blood samples were withdrawn for a period of 24 h. Serum harvested from the blood samples was analyzed for clindamycin by high performance liquid chromatography (HPLC) with ultraviolet detection. Pharmacokinetic parameters, including AUC0-∞, AUC 0-t, Cmax, Ke, tmax and t 1/2 were determined from the serum concentrations for both formulations (test and reference). The products were tested for bioequivalence after log-transformation of the data. Results: 24 healthy adult male volunteers from Jordan (mean [SD] age, 28.8 (7.7) years (range 19-45 years); height, 175.8 (10.6) cm (range 159.0-192.0 cm); weight, 75.6 (11.0) kg (range 58-101 kg); and body mass index, 24.4 (1.8) kg/m2 (range 21.3-28 kg/m2)) were enrolled in and completed the study. The 13C NMR spectra for both Dalacin C® and Clindox® showed 18 distinct lines associated with the 18 different carbon atoms. Conclusion: The statistical comparison suggested that Clindox® capsules are bioequivalent to Dalacin C® capsules. The 13C CPMAS results confirmed that the two drugs exhibit typical clindamycin spectra. ©2011 Dustri-Verlag Dr. K. Feistle.

  20. International Veterinary Epilepsy Task Force consensus proposal

    DEFF Research Database (Denmark)

    Bhatti, Sofie F M; De Risio, Luisa; Muñana, Karen

    2015-01-01

    with the initial drug is unsatisfactory, and 4) when treatment changes should be considered. In this consensus proposal, an overview is given on the aim of AED treatment, when to start long-term treatment in canine epilepsy and which veterinary AEDs are currently in use for dogs. The consensus proposal for drug...... treatment protocols, 1) is based on current published evidence-based literature, 2) considers the current legal framework of the cascade regulation for the prescription of veterinary drugs in Europe, and 3) reflects the authors' experience. With this paper it is aimed to provide a consensus...

  1. 76 FR 46818 - Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed...

    Science.gov (United States)

    2011-08-03

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive... distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs. DATES... of information technology. Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910- 0363...

  2. 21 CFR 510.112 - Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Antibiotics used in veterinary medicine and for... DRUGS Specific Administrative Rulings and Decisions § 510.112 Antibiotics used in veterinary medicine and for nonmedical purposes; required data. (a) An ad hoc committee, Committee on the Veterinary...

  3. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

    Science.gov (United States)

    Zhang, X; Duan, J; Kesisoglou, F; Novakovic, J; Amidon, G L; Jamei, M; Lukacova, V; Eissing, T; Tsakalozou, E; Zhao, L; Lionberger, R

    2017-08-01

    On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  4. A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.

    Science.gov (United States)

    Prasaja, Budi; Harahap, Yahdiana; Lusthom, Windy; Setiawan, Evy C; Ginting, Mena B; Hardiyanti; Lipin

    2011-06-01

    The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam(®)) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover design following an overnight fasting. A one-week wash-out period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t,) AUC(0-∞), C (max) and t (½) were determined and used for bioequivalence evaluation after log-transformation, whereas t (max) ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC(0-t,) AUC(0-∞), C (max) and t (½) were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.

  5. Veterinary Services Program

    Data.gov (United States)

    Federal Laboratory Consortium — Mission:To provide quality veterinary medical care and environmental enrichment programs for all animals, representing nine different species.To provide guidance for...

  6. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Science.gov (United States)

    2013-10-23

    ...] Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary...

  7. Veterinary microbiology and microbial disease

    National Research Council Canada - National Science Library

    Quinn, P. J

    2011-01-01

    "Veterinary Microbiology is one of the core subjects for veterinary students. Fully revised and expanded, this new edition covers every aspect of veterinary microbiology for students in both paraclinical and clinical years...

  8. Sahel Journal of Veterinary Sciences

    African Journals Online (AJOL)

    The Sahel Journal of Veterinary Sciences is the official journal of the Faculty of Veterinary Medicine, University of Maiduguri, Maiduguri, Nigeria. The journal welcomes original research articles, short communications and reviews on all aspects of veterinary sciences and related disciplines.

  9. Pharmaceutical Product Lead Optimization for Better In vivo Bioequivalence Performance: A case study of Diclofenac Sodium Extended Release Matrix Tablets.

    Science.gov (United States)

    Shahiwala, Aliasgar; Zarar, Aisha

    2018-01-01

    In order to prove the validity of a new formulation, a considerable amount of effort is required to study bioequivalence, which not only increases the burden of carrying out a number of bioequivalence studies but also eventually increases the cost of the optimization process. The aim of the present study was to develop sustained release matrix tablets containing diclofenac sodium using natural polymers and to demonstrate step by step process of product development till the prediction of in vivo marketed product equivalence of the developed product. Different batches of tablets were prepared by direct compression. In vitro drug release studies were performed as per USP. The drug release data were assessed using model-dependent, modelindependent and convolution approaches. Drug release profiles showed that extended release action were in the following order: Gum Tragacanth > Sodium Alginate > Gum Acacia. Amongst the different batches prepared, only F1 and F8 passed the USP criteria of drug release. Developed formulas were found to fit Higuchi kinetics model with Fickian (case I) diffusion-mediated release mechanism. Model- independent kinetics confirmed that total of four batches were passed depending on the similarity factors based on the comparison with the marketed Diclofenac. The results of in vivo predictive convolution model indicated that predicted AUC, Cmax and Tmax values for batch F8 were similar to that of marketed product. This study provides simple yet effective outline of pharmaceutical product development process that will minimize the formulation development trials and maximize the product success in bioequivalence studies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  10. Archives: Nigerian Veterinary Journal

    African Journals Online (AJOL)

    Items 1 - 49 of 49 ... Archives: Nigerian Veterinary Journal. Journal Home > Archives: Nigerian Veterinary Journal. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. 1 - 49 of 49 Items ...

  11. Archives: Ethiopian Veterinary Journal

    African Journals Online (AJOL)

    Items 1 - 16 of 16 ... Archives: Ethiopian Veterinary Journal. Journal Home > Archives: Ethiopian Veterinary Journal. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register · Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives. 1 - 16 of 16 Items ...

  12. Open Veterinary Journal

    African Journals Online (AJOL)

    Open Veterinary Journal is a peer reviewed international open access online and printed journal that publishes high-quality original research articles, reviews, short communications and case reports dedicated to all aspects of veterinary sciences and its related subjects. Other websites associated with this journal: ...

  13. .* Nigerian Veterinary Journal

    African Journals Online (AJOL)

    'Central Diagnostic, National Veterinary Research Institute Vom, Plateau State, Nigeria, 'Department of Veterinary Medicine. Ahmadu Bello ..... environment as reported by (Olabode et al., 2009; Okwor and Eze, 2011;Jwander et al., 2013b). Farmers who had the same complaints of. Marek's disease from the same source of.

  14. Determination of bioequivalence of lomefloxacin tablets using urinary excretion data.

    Science.gov (United States)

    Shah, Shailesh A; Rathod, Ishwarsinh S; Savale, Shrinivas S; Patel, Dharmesh B

    2002-11-07

    The present study describes development of a sensitive and simple HPTLC method for estimation of lomefloxacin (LMF) in human urine. The drug was extracted using chloroform after adjusting the pH of urine to 7.0. Chloroform extract was spotted on silica gel 60 F(254) TLC plate and was developed in a mixture of n-butanol-methanol-ethyl acetate-6 M ammonia (4:2:3:2, v/v/v/v) as the mobile phase and scanned at 290 nm. The peak for LMF resolved at R(F) of 0.40+/-0.02. The method was validated in terms of linearity (50-600 microgram/ml), precision, specificity and accuracy. The limit of detection and limit of quantification for LMF in urine were found to be 20 and 50 microgram/ml, respectively. The average recovery of LMF from urine was 91.93%. The proposed method was applied to generate urinary excretion data for LMF after administration of two market LMF tablet formulations (400 mg, Formulation R and Formulation T) to six healthy human volunteers in a two-treatment, open, crossover design. Various pharmacokinetic parameters like peak excretion rate ((dAU/dt)(max)), time for peak excretion rate (t(max)), AUC(0-48), AUC(0- infinity ), cumulative amount and % cumulative amount of LMF excreted, elimination half-life (t(1/2)), terminal elimination rate constant (k(el)) and overall elimination rate constant (K), were calculated for both the formulations. The average cumulative amounts of LMF excreted in urine after administration of Formulation R and Formulation T were found to be 321.60 mg (80.40% of dose) and 296.51 mg (74.13% of dose), respectively. The urinary excretion profiles of LMF upto 48 h for both the formulations were found to be similar. Statistical comparison (90% confidence intervals of ratio) of various pharmacokinetic parameters of Formulation T with that of Formulation R revealed that Formulation T is bioequivalent with Formulation R.

  15. Comparative bioequivalence study of rifampicin and isoniazid combinations in healthy volunteers.

    Science.gov (United States)

    Padgaonkar, K A; Revankar, S N; Bhatt, A D; Vaz, J A; Desai, N D; D'Sa, S; Shah, V; Gandewar, K

    1999-07-01

    To assess the bioavailability of rifampicin (RMP) in three brands of combination formulations of anti-tuberculosis drugs. A three-way double-blind, cross-over bioavailability study of RMP and isoniazid (INH), consisting of a comparison of a two-drug combination of tablets of RMP and INH each separately (reference brand R) and a tablet of RMP + INH (brand N), and a capsule of RMP + INH (brand L) was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of RMP as well as INH and acetylisoniazid (ACINH) by two high performance liquid chromatography (HPLC) methods. The mean values of RMP in brand N (Cmax 6.49+/-0.52 microg/mL, Tmax 2.33+/-0.18 h, AUC(0-24h) 39.83+/-3.44 microg/mL.h) were comparable with those obtained with brand R (Cmax 5.22+/-0.59 microg/mL, Tmax 2.50+/-0.12 h, AUC(0-24h) 33.33+/-3.47 microg/mL.h). The mean values of RMP in brand L (Cmax 3.05+/-0.52 microg/ mL, Tmax 3.79+/-0.57 h and AUC(0-24h) 21.78+/-3.67 microg/ mL.h) were significantly different from those in brand R. Nevertheless, all of the pharmacokinetic parameters obtained for INH and ACINH in all three brands were comparable. Using brand R as a comparison, brand N was bioequivalent and brand L was not bioequivalent.

  16. 75 FR 58411 - Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments

    Science.gov (United States)

    2010-09-24

    ...] Center for Veterinary Medicine eSubmitter Workshop; Public Workshop; Request for Comments AGENCY: Food... Drug Administration (FDA) is announcing a public workshop entitled: ``Center for Veterinary Medicine... be emailed to all registrants. Contact Person: Charles Andres, Center for Veterinary Medicine (HFV...

  17. 77 FR 22247 - Veterinary Feed Directive; Draft Text for Proposed Regulation

    Science.gov (United States)

    2012-04-13

    .... FDA-2010-N-0155] Veterinary Feed Directive; Draft Text for Proposed Regulation AGENCY: Food and Drug... the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text..., rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary...

  18. 21 CFR 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Exclusion of a veterinary anabolic steroid implant... OF JUSTICE SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.25 Exclusion of a veterinary anabolic steroid implant product; application. (a) Any person seeking...

  19. 21 CFR 1308.26 - Excluded veterinary anabolic steroid implant products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Excluded veterinary anabolic steroid implant... SCHEDULES OF CONTROLLED SUBSTANCES Excluded Veterinary Anabolic Steroid Implant Products § 1308.26 Excluded veterinary anabolic steroid implant products. (a) Products containing an anabolic steroid, that are expressly...

  20. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Corresponding author: Email: yahidauad@gmail.com; Tel No:+2348037811882 ... and veterinary medicine as potent anti-inflammatory, immunosuppressive and .... steroid skeleton, similar to hydrocortisone. ... for pregnant women at risk of preterm birth.

  1. Tanzania Veterinary Journal

    African Journals Online (AJOL)

    ... Journal are the Research Workers, Veterinary Clinicians, Animal Scientists, Field Officers ... Prevalence and risk factors for Ascaris and Cryptosporidium infestations in ... Mastitis pathogens prevalent in dairy cattle at Magadu farm, Morogoro- ...

  2. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Also, the advantage of ... antibodies. The major disadvantage of the polyclonal ... advantage of a monoclonal antibody over .... department in the veterinary school was obtained from the ..... methodology for both routine diagnostic and research ...

  3. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Control Services, Federal Ministry of Agriculture, Abuja; 9National Veterinary Research Institute, P.M.B 01 Vom,. Nigeria. *Corresponding ... because the poultry industry contributes ..... holidays have been identified as source of transmission ...

  4. Ethiopian Veterinary Journal

    African Journals Online (AJOL)

    Ethiopian Veterinary Journal. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 15, No 1 (2011) >. Log in or Register to get access to full text downloads.

  5. Teaching veterinary parasitology.

    Science.gov (United States)

    Verster, A

    1994-08-01

    The history of parasitology and the teaching of veterinary parasitology in South Africa are reviewed briefly. Courses in veterinary parasitology are presented at the faculties of veterinary science at the University of Pretoria and the Medical University of South Africa as well as at the Pretoria Technicon. At the University of Pretoria, the three disciplines of veterinary parasitology, entomology, helminthology and protozoology, are covered in 330 core lectures; from 13 to 40% of the contact time is devoted to practical classes. Teaching veterinary parasitology is both labour intensive and costly, viz. R1700 (US$570) per student per annum. Such costs are justified by the R148.8 million (US$49.6 million) spent every year in South Africa on anthelmintics, ectoparasiticides and vaccines to control parasites. Veterinary parasitology is a dynamic subject and the curriculum must be revised regularly to incorporate new information. Because the parasite faunas are so diverse no single textbook can satisfy the requirements of the various institutions worldwide which teach the subject, with the result that extensive use is made of notes. In Australia and in Europe, ticks and tick-borne diseases are less important than they are in Africa; consequently insufficient space is devoted to them in textbooks to satisfy the requirements of the subject in African countries. Parasite control under extensive and intensive conditions is dealt with adequately at the University of Pretoria, but increasing emphasis will be given to small-scale farming systems, particularly if alternative food animals are to be kept.

  6. Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

    Science.gov (United States)

    Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

    2012-05-01

    To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non

  7. Generic drugs: myths, facts, and limitations

    Directory of Open Access Journals (Sweden)

    Antonio Marzo

    2012-10-01

    Full Text Available Bioequivalence (BE has always been an important pharmaceutical area, particularly (but not solely in Mediterranean region, where the use of generic drugs is a relatively recent development. The lack of new therapeutic molecules has concentrated primary research in the hands of a few large pharmaceutical companies. For smaller companies, this has created opportunities for the development of new formulations of existing drugs (orodispersible tablets that dissolve in the mouth, extended-release tablets, transdermal delivery systems, generic drugs. These applications take advantage of the Abridged New Drug Application (ANDA procedure, which exempts them from a series of expensive investigations and limits the requirement for clinical testing to bioequivalence trials. Since 1991, bioequivalence trials have been regulated by US Food and Drug Administration (FDA and European Medicines Agency (EMA guidelines that provide precise indications on the most specific procedures to be adopted. In spite of these guidelines, however, some aspects of the process have not been fully defined, the most important of which regards the management of endogenous substances. Additional problems are how to manage bioequivalence protocols with drugs that have long half-lives and those whose clearance is characterized by high intrinsic variability. The view that bioequivalence data would be more reliable if they were based on studies in target populations is a myth to be discredited. The present paper reviews issues relative to pharmacokinetics (PK, bioavailability (BA, and bioequivalence, also from an historical viewpoint, and includes a stimulating “questions and answers” section on some key aspects of the bioequivalence of generic drugs.

  8. Database on veterinary clinical research in homeopathy.

    Science.gov (United States)

    Clausen, Jürgen; Albrecht, Henning

    2010-07-01

    The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

  9. Errors in veterinary practice: preliminary lessons for building better veterinary teams.

    Science.gov (United States)

    Kinnison, T; Guile, D; May, S A

    2015-11-14

    Case studies in two typical UK veterinary practices were undertaken to explore teamwork, including interprofessional working. Each study involved one week of whole team observation based on practice locations (reception, operating theatre), one week of shadowing six focus individuals (veterinary surgeons, veterinary nurses and administrators) and a final week consisting of semistructured interviews regarding teamwork. Errors emerged as a finding of the study. The definition of errors was inclusive, pertaining to inputs or omitted actions with potential adverse outcomes for patients, clients or the practice. The 40 identified instances could be grouped into clinical errors (dosing/drugs, surgical preparation, lack of follow-up), lost item errors, and most frequently, communication errors (records, procedures, missing face-to-face communication, mistakes within face-to-face communication). The qualitative nature of the study allowed the underlying cause of the errors to be explored. In addition to some individual mistakes, system faults were identified as a major cause of errors. Observed examples and interviews demonstrated several challenges to interprofessional teamworking which may cause errors, including: lack of time, part-time staff leading to frequent handovers, branch differences and individual veterinary surgeon work preferences. Lessons are drawn for building better veterinary teams and implications for Disciplinary Proceedings considered. British Veterinary Association.

  10. Bioequivalence of a fixed-dose repaglinide/metformin combination tablet and equivalent doses of repaglinide and metformin tablets
.

    Science.gov (United States)

    Cho, Hea-Young; Ngo, Lien; Kim, Sang-Ki; Choi, Yoonho; Lee, Yong-Bok

    2018-06-01

    This study was conducted to determine whether a fixed-dose combination (FDC) tablet of repaglinide/metformin (2/500 mg) is equivalent to coadministration of equivalent doses of individual (EDI) tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. This study was conducted as an open-label, randomized, single-dose, two-period, two-sequence crossover design in 50 healthy Korean male subjects who received an FDC tablet or EDI tablets. Plasma concentrations of repaglinide and metformin were determined for up to 24 hours using a validated UPLC-MS/MS method. Bioequivalence was assessed according to current guidelines issued by the U.S. Food and Drug Administration (FDA) and Korean legislation. Tolerability was also evaluated throughout the study via subject interview, vital signs, and blood sampling. Point estimates (90% CIs) for AUC0-t, AUC0-∞, and Cmax based on EDI tablets were 110.07 (102.25 - 118.49), 109.90 (101.70 - 118.39), and 112.60 (101.49 - 124.85), respectively, for repaglinide. They were 95.18 (89.62 - 101.05), 95.00 (89.74 - 100.65), and 98.44 (92.72 - 104.50), respectively, for metformin. These results satisfied the bioequivalence criteria of 80.00 - 125.00% proposed by the FDA and Korean legislation. Results of pharmacokinetic analysis suggested that repaglinide and metformin in FDC tablets were bioequivalent to EDI tablets of repaglinide (2 mg) and metformin (500 mg) in healthy Korean male subjects. Both formulations appeared to be well tolerated.
.

  11. Pharmacokinetic and bioequivalence study of itopride HCl in healthy volunteers.

    Science.gov (United States)

    Cho, Kyung-Jin; Cho, Wonkyung; Cha, Kwang-Ho; Park, Junsung; Kim, Min-Soo; Kim, Jeong-Soo; Hwang, Sung-Joo

    2010-01-01

    In the present study two different formulations containing 50 mg itopride HCl (N-[4-12-(dimethylamino)ethoxylbenzyl]-3,4-dimethoxybenzamide HCl, CAS 122898-67-3) were compared in 28 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, crossover design in 28 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 24 h. The serum concentrations of itopride HCl were determined using a specific and sensitive HPLC method with fluorescence detection. The detection limit of itopride HCl was 5 ng/ml and no endogenous compounds were found to interfere with analysis. The mean AUC(0-4h), AUC(0 --> infinity), C(max), T(max) and T1/2 were 865.28 ng x h/ml, 873.04 ng x h/ml, 303.72 ng/ml, 0.75 h, and 2.95 h, respectively, for the test formulations, and 833.00 ng x h/ml, 830.97 ng x h/ml, 268.01 ng/ml, 0.78 h, and 2.83 h, respectively, for the reference formulation. Both primary target parameters AUC(0 --> infinity) and C(max) were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of AUC(0 --> infinity) and C(max) were 100.57%-109.56% and 105.46%-121.18%, respectively, and were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of itopride HCl are considered to be bioequivalent.

  12. Veterinary Forensic Toxicology.

    Science.gov (United States)

    Gwaltney-Brant, S M

    2016-09-01

    Veterinary pathologists working in diagnostic laboratories are sometimes presented with cases involving animal poisonings that become the object of criminal or civil litigation. Forensic veterinary toxicology cases can include cases involving animal cruelty (malicious poisoning), regulatory issues (eg, contamination of the food supply), insurance litigation, or poisoning of wildlife. An understanding of the appropriate approach to these types of cases, including proper sample collection, handling, and transport, is essential so that chain of custody rules are followed and proper samples are obtained for toxicological analysis. Consultation with veterinary toxicologists at the diagnostic laboratory that will be processing the samples before, during, and after the forensic necropsy can help to ensure that the analytical tests performed are appropriate for the circumstances and findings surrounding the individual case. © The Author(s) 2016.

  13. Radiology in veterinary medicine

    International Nuclear Information System (INIS)

    Hrusovsky, J.; Benes, J.

    1985-01-01

    A textbook is presented for pregraduate and postgraduate students of veterinary medicine, offering an extensive review of all aspects of radiology as applied in veterinary sciences. Based on findings published in the literature and the authors' own research, the textbook familiarizes the reader with the problems of nuclear physics, biological effects of ionizing radiation on animals, the principles of biological cycles of radionuclides in the atmosphere, the fundamentals of radiochemistry, dosimetry, radiometry and nuclear medicine. Radiation protection of animals, raw materials, feeds, foodstuff and water, and the questions of the aplications of ionizing radiation and of radionuclides in veterinary medicine are discussed in great detail. The publication is complemented with numerous photographs, figures and graphs. (L.O.)

  14. Veterinary nuclear medicine

    International Nuclear Information System (INIS)

    Kallfelz, F.A.; Comar, C.L.; Wentworth, R.A.

    1974-01-01

    A brief review is presented of the expanding horizons of nuclear medicine, the equipment necessary for a nuclear medicine laboratory is listed, and the value of this relatively new field to the veterinary clinician is indicated. Although clinical applications to veterinary medicine have not kept pace with those of human medicine, many advances have been made, particularly in the use of in vitro techniques. Areas for expanded applications should include competitive protein binding and other in vitro procedures, particularly in connection with metabolic profile studies. Indicated also is more intensive application by the veterinarian of imaging procedures, which have been found to be of such great value to the physician. (U.S.)

  15. Infrared thermography in veterinary medicine

    International Nuclear Information System (INIS)

    Hudak, R.; Zivcak, J.; Sevcik, A.; Danko, J.

    2008-01-01

    The use of infrared thermography in veterinary medicine has been practiced since at least the 1960's, but it is only now, in approximately the last 5 years, that it has been viewed with a reasonably open mind in the veterinary community at large. One of the reasons is progress in sensors technology, which contributed for an outstanding improvement of the thermal imager parameters. Paper deals with veterinary thermography and with description of applications at the University of Veterinary Medicine in Kosice. (authors)

  16. Random-effects linear modeling and sample size tables for two special crossover designs of average bioequivalence studies: the four-period, two-sequence, two-formulation and six-period, three-sequence, three-formulation designs.

    Science.gov (United States)

    Diaz, Francisco J; Berg, Michel J; Krebill, Ron; Welty, Timothy; Gidal, Barry E; Alloway, Rita; Privitera, Michael

    2013-12-01

    Due to concern and debate in the epilepsy medical community and to the current interest of the US Food and Drug Administration (FDA) in revising approaches to the approval of generic drugs, the FDA is currently supporting ongoing bioequivalence studies of antiepileptic drugs, the EQUIGEN studies. During the design of these crossover studies, the researchers could not find commercial or non-commercial statistical software that quickly allowed computation of sample sizes for their designs, particularly software implementing the FDA requirement of using random-effects linear models for the analyses of bioequivalence studies. This article presents tables for sample-size evaluations of average bioequivalence studies based on the two crossover designs used in the EQUIGEN studies: the four-period, two-sequence, two-formulation design, and the six-period, three-sequence, three-formulation design. Sample-size computations assume that random-effects linear models are used in bioequivalence analyses with crossover designs. Random-effects linear models have been traditionally viewed by many pharmacologists and clinical researchers as just mathematical devices to analyze repeated-measures data. In contrast, a modern view of these models attributes an important mathematical role in theoretical formulations in personalized medicine to them, because these models not only have parameters that represent average patients, but also have parameters that represent individual patients. Moreover, the notation and language of random-effects linear models have evolved over the years. Thus, another goal of this article is to provide a presentation of the statistical modeling of data from bioequivalence studies that highlights the modern view of these models, with special emphasis on power analyses and sample-size computations.

  17. Tanzania Veterinary Journal: Editorial Policies

    African Journals Online (AJOL)

    Focus and Scope. The Tanzania Veterinary Journal (The Tropical Veterinarian) is a biannual Journal, which publishes original contribution to knowledge on Veterinary Science, Animal Science and Production, and allied sciences including new techniques and developments in Veterinary Medicine. The target readers of the ...

  18. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Fowlpox Virus from Backyard Poultry in Plateau State Nigeria: Isolation and Phylogeny of the P4b Gene Compared to a Vaccine Strain. Meseko, C. A.. 1. ; Shittu, I. 1. ; Bwala, D. G.. 2. ; Joannis, T. M.. 1 and Nwosuh, C. I.. 2. 1Regional Laboratory For Animal Influenza and Transboundary Animal Diseases, National Veterinary ...

  19. Zimbabwe Veterinary Journal

    African Journals Online (AJOL)

    Journal Homepage Image. Zimbabwe Veterinary Journal contains original and review papers on all aspects of animal health in Zimbabwe and SADC countries, including articles by non-veterinarians. This journal did not publish any issues between 2002 and 2015 but has been revived and and it actively accepting papers ...

  20. Veterinary Molecular Diagnostics

    NARCIS (Netherlands)

    Roest, H.I.J.; Engelsma, M.Y.; Weesendorp, E.; Bossers, A.; Elbers, A.R.W.

    2017-01-01

    In veterinary molecular diagnostics, samples originating from animals are tested. Developments in the farm animals sector and in our societal attitude towards pet animals have resulted in an increased demand for fast and reliable diagnostic techniques. Molecular diagnostics perfectly matches this

  1. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    Sonographic Measurements of Ocular Biometry of Indigenous Nigerian. Dogs in Zaria ..... between L2 and R) anesthetic risks and additional costs were ... prevalent worldwide problem (Toni et al.,. 2013). Paunknis and ... correlation with refractive error is larger for axial length than .... Veterinary Medical Association. 207:12.

  2. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    1Department of Veterinary Public Health and Preventive Medicine, Ahmadu Bello University, ... momohasabeh@gmail.com; Tel No:+2348038352906. ... in-contact humans from pig farms and abattoir. ... Momoh et al. 141 and may enhance the distribution of resistance genes into ... treating clinical infections in both man and.

  3. NIGERIAN VETERINARY JOURNAL

    African Journals Online (AJOL)

    ADEYEYE

    xyphoid cartilage to the pelvic area and aquasonic gel applied. The uterus was ... is used in both veterinary and human medicine ... Idris et al. 135 the pelvic region was gently made wet, with ... showing multiple fetuses (blue arrow). Plate IV: ... The beginning of bone formation which appears as hyperechoic structures ...

  4. Veterinary pharmacovigilance in India: A need of hour.

    Science.gov (United States)

    Kumar, Rishi; Kalaiselvan, Vivekanandan; Verma, Ravendra; Kaur, Ismeet; Kumar, Pranay; Singh, G N

    2017-01-01

    Veterinary pharmacovigilance (PV) is important for the Medicine which are used for treating disease in animals. It becomes more important when these animals are further used for producing food. Adverse drug reactions (ADRs) have a direct impact on animals and indirect impact on human beings, for example, through milk products, other animal producing food products. Currently, PV program of India is playing a vital role in assessing the safety of medicines in Indian Population. The safety of medicine in animals can be assessed by veterinary PV. The research institutes involved in animal research and veterinary hospitals can be considered as ADR monitoring centers to assess the safety of medicines on animals.

  5. Different truncation methods of AUC between Japan and the EU for bioequivalence assessment: influence on the regulatory judgment.

    Science.gov (United States)

    Oishi, Masayo; Chiba, Koji; Fukushima, Takashi; Tomono, Yoshiro; Suwa, Toshio

    2012-01-01

    In regulatory guidelines for bioequivalence (BE) assessment, the definitions of AUC for primary assessment are different in ICH countries, i.e., AUC from zero to the last sampling point (AUCall) in Japan, AUC from zero to infinity (AUCinf) or AUC from zero to the last measurable point (AUClast) in the US, and AUClast in the EU. To assure sufficient accuracy of truncated AUC for BE assessment, the ratio of truncated AUC (AUCall or AUClast) to AUCinf should be more than 80% both in Japanese and EU guidelines. We investigated how the difference in the definition of truncated AUC affects BE assessment of sustained release (SR) formulation. Our simulation result demonstrated that AUCall/AUCinf could be ≥80% despite AUClast/AUCinf being AUC affected the judgment of validity of truncated AUC for BE assessment, and AUCall could fail to detect the substantially different in vivo dissolution profile of generic drugs with SR formulation from the original drug.

  6. Drug: D08455 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available as: C18605 ... veterinary medicine Juvenile hormone mimic Larval growth inhibitor ... CAS: 95737-68-1 PubChem: ... D08455 Drug Pyriproxyfen; Cyclio [veterinary] (TN) ... C20H19NO3 D08455.gif ... Same

  7. Drug: D07613 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D07613 Drug Carbaryl (BAN); Carbaril; Flea and tick powder [veterinary] (TN) ... C12H...11NO2 D07613.gif ... Same as: C07491 ... carbamate insecticide cholinesterase inhibitor veterinary medicine ...

  8. Drug: D08251 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D08251 Drug Nandrolone laurate; Nandrolone dodecanoate; Laurabolin [veterinary] (T...14AB01 S01XA11 Chemical group: DG00142 ... Estren derivative veterinary medicine NR3C4 (AR) [HSA:367] [KO:K085

  9. New directions for veterinary technology.

    Science.gov (United States)

    Chadderdon, Linda M; Lloyd, James W; Pazak, Helene E

    2014-01-01

    Veterinary technology has generally established itself well in companion-animal and mixed-animal veterinary medical practice, but the career's growth trajectory is uncertain. Michigan State University (MSU) convened a national conference, "Creating the Future of Veterinary Technology-A National Dialogue," in November 2011 to explore ways to elevate the veterinary technician/technologist's role in the veterinary medical profession and to identify new directions in which the career could expand. Veterinary technicians/technologists might advance their place in private practice by not only improving their clinical skills, but by also focusing on areas such as practice management, leadership training, business training, conflict resolution, information technology, and marketing/communications. Some new employment settings for veterinary technicians/technologists include more participation within laboratory animal medicine and research, the rural farm industry, regulatory medicine, and shelter medicine. Achieving these ends would call for new training options beyond the current 2-year and 4-year degree programs. Participants suggested specialty training programs, hybrid programs of various types, online programs, veterinary technician residency programs of 12-18 months, and more integration of veterinary technician/technology students and veterinary medicine students at colleges of veterinary medicine.

  10. Significance of metabolites in bioequivalence: losartan potassium as a case study.

    Science.gov (United States)

    Charoo, Naseem Ahmad; Cristofoletti, Rodrigo; Khatri, Aamer Roshanali; Ali, Areeg Anwer

    2014-06-01

    Estimation of metabolite data as a supportive evidence of comparable therapeutic outcome is recommended by various guidance documents. However, a consensus on using it solely to establish bioequivalence (BE) is lacking as parent drug is believed to detect pharmacokinetic differences between test and reference formulations better. Four BE studies of losartan potassium reported in the literature are reviewed. In all the four studies, 90% confidence intervals (CIs) of geometric mean ratios of the test and reference formulations for maximum blood drug concentration (Cmax ) of losartan potassium were outside the acceptable range of 80%-125%, whereas, 90% CIs for its active metabolite, losartan carboxylic acid (LCA), were within the acceptance criteria. Although BE with respect to area under the plasma concentration versus time profile curve was demonstrated in all the cases, BE with respect to Cmax could not be established. However, marketing authorization in all the four cases was granted based on scientific evidence that LCA is 10-40 times more potent than losartan, LCA exhibited higher plasma concentration levels than losartan, pharmacodynamic effects correlate with LCA, and losartan shows wide therapeutic index. Further, widened CI limits for losartan were accepted. Losartan presents an opportunity in the diligence of the principles of quality risk management for selecting moiety on which BE decision must be based. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  11. Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.

    Science.gov (United States)

    Fourie Zirkelbach, Jeanne; Jackson, Andre J; Wang, Yaning; Schuirmann, Donald J

    2013-01-01

    Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder (ADHD). Standard bioequivalence (BE) criteria cannot be applied to these products. The performance of partial area under the drug concentration-time curve (PAUC), Cmax and AUCINF to assess BE were independently evaluated for two products. A two-stage analysis was performed on plasma data for two methylphenidate modified-release products (Product 1 and 2). Simulations using the fitted parameters determined how changes in fast absorption rate constant (K0Fast) and fraction available (F1) affected curve shape and BE determination using Cmax, AUCINF and PAUC. The sensitivity of the mean PAUC(test)/PAUC(reference) ratios to changes in K0Fast(test) are product dependent. Product 1 mean PAUC(test)/PAUC(reference) ratios for PAUC0-4h are more responsive to both decreases and increases in K0Fast(test) than Product 2. Product 2 showed a greater response in the mean PAUC(test)/PAUC(reference) ratio for PAUC0-4h when the K0Fast(test) is decreased and less response as the value is increased. PAUC estimated curve shape is sensitive to changes in absorption and are product specific, and may require a new PAUC metric for each drug. A non-product specific metric to assess curve shape is warranted.

  12. Report on the third research co-ordination meeting of the coordinated research project: 'The development of strategies for the effective monitoring of veterinary drug residues in livestock and livestock products in developing countries' (D3.20.22)

    International Nuclear Information System (INIS)

    2005-01-01

    The third RCM for the CRP on the development of strategies for the effective monitoring of veterinary drug residues in livestock and livestock products in developing countries was held in Natal, Brazil, from 11-15 April 2005. The meeting was attended by ten Research Contract Holders, a second representative of the research group of the host country, two Research Agreement Holders, two Technical Contract Holders and the Scientific Secretary. The work in the second phase of this CRP has built upon the progress reported from the first phase, resulting in good quality immunoassay reagents, confirmatory methods and a number of validated methods. It is recommended that all contracts (with one exception), including technical contracts, be renewed to facilitate the completion of the work plans agreed at the meeting. A protocol for the validation of immunoassays will be provided by a Research Agreement Holder. The protocol has already been successfully applied for validation of an RIA method in Brazil. It is recommended that this protocol be adopted by all participants in the project to harmonize the validation of immunoassay methods developed. Work on the development of the 125 I-radioimmunoassay for chloramphenicol has not been satisfactory. It is recommended that this work is transferred to the research group in Brazil. The meeting agreed that the FAO/IAEA Joint Division's INFOCRIS database and associated e-learning modules are a very useful resource for developing country scientists. It is recommended to proceed with the expansion of the database as planned. In addition, it was suggested that a database and bibliography of original literature on, for example, pharmacokinetic and metabolism studies on veterinary drugs and hormonal growth promoters should be included. Much of this data was published many years ago and is very difficult to access, but is of importance in the design and development of methods. Some of the results generated by CRP participants should be

  13. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ...] Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for...

  14. Veterinary homeopathy: an overview.

    OpenAIRE

    Vockeroth, W G

    1999-01-01

    Complementary and alternative therapies, including homeopathy, have a definite place in veterinary medicine today. The public is demanding access to a full range of conventional and complementary therapies, and the best scenario is to have all therapies available, for there is a place and a need for all of them in the right situation. In my own practice, I use both alternative and conventional therapies, as well as referring patients to specialists, for services such as ultrasound and surgery...

  15. Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

    DEFF Research Database (Denmark)

    Yacobi, Avraham; Shah, Vinod P; Bashaw, Edward D

    2014-01-01

    This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic...

  16. World Association for the Advancement of Veterinary Parasitology (WAAVP): Guideline for the evaluation of drug efficacy against non-coccidial gastrointestinal protozoa in livestock and companion animals.

    Science.gov (United States)

    Geurden, T; Olson, M E; O'Handley, R M; Schetters, T; Bowman, D; Vercruysse, J

    2014-08-29

    The current guideline was written to aid in the design, implementation and interpretation of studies for the assessment of drug efficacy against non-coccidial gastrointestinal protozoan parasites, with Giardia spp. as the leading example. The information provided in this guideline deals with aspects of how to conduct controlled studies using experimental infection models (dose determination and dose confirmation) and efficacy studies in commercial facilities (field effectiveness studies). Furthermore, the selection of suitable animals, housing, infection procedure, choice of diagnostic technique and data analysis are discussed. This guideline is intended to assist investigators in conducting specific studies, to provide specific information for registration authorities involved in the decision-making process, to assist in the approval and registration of new drugs and to facilitate the worldwide adoption of uniform procedures. The primary parameter for drug efficacy is the reduction in either parasite excretion or parasite counts and a minimum efficacy of 90% is required against non-coccidial gastrointestinal protozoa. A supporting efficacy parameter is a significant difference in the proportion of infected animals between treated and non-treated groups. Persistent efficacy is considered as an additional claim to therapeutic efficacy. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Safety and efficacy of generic drugs with respect to brand formulation

    OpenAIRE

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-01-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

  18. Proceedings of a course on veterinary nursing, Massey University 1991

    International Nuclear Information System (INIS)

    Petersen, G.V.

    1991-01-01

    This conference proceedings consists of 15 papers by 15 authors, which deal with veterinary nursing around the world, skills required for dealing with clients and selling drugs, safe handling of animals, samples and drugs, radiation safety, monitoring anaesthesia and post-operative monitoring, canine diabetes mellitus, cleaning, disinfection and sterilization and collection of blood and urine samples from dogs, cats and birds

  19. Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid.

    Science.gov (United States)

    Cuesta-Gragera, Ana; Navarro-Fontestad, Carmen; Mangas-Sanjuan, Victor; González-Álvarez, Isabel; García-Arieta, Alfredo; Trocóniz, Iñaki F; Casabó, Vicente G; Bermejo, Marival

    2015-07-10

    The objective of this paper is to apply a previously developed semi-physiologic pharmacokinetic model implemented in NONMEM to simulate bioequivalence trials (BE) of acetyl salicylic acid (ASA) in order to validate the model performance against ASA human experimental data. ASA is a drug with first-pass hepatic and intestinal metabolism following Michaelis-Menten kinetics that leads to the formation of two main metabolites in two generations (first and second generation metabolites). The first aim was to adapt the semi-physiological model for ASA in NOMMEN using ASA pharmacokinetic parameters from literature, showing its sequential metabolism. The second aim was to validate this model by comparing the results obtained in NONMEM simulations with published experimental data at a dose of 1000 mg. The validated model was used to simulate bioequivalence trials at 3 dose schemes (100, 1000 and 3000 mg) and with 6 test formulations with decreasing in vivo dissolution rate constants versus the reference formulation (kD 8-0.25 h (-1)). Finally, the third aim was to determine which analyte (parent drug, first generation or second generation metabolite) was more sensitive to changes in formulation performance. The validation results showed that the concentration-time curves obtained with the simulations reproduced closely the published experimental data, confirming model performance. The parent drug (ASA) was the analyte that showed to be more sensitive to the decrease in pharmaceutical quality, with the highest decrease in Cmax and AUC ratio between test and reference formulations. Copyright © 2015 Elsevier B.V. All rights reserved.

  20. Generic Drugs: Questions and Answers

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

  1. Application of a hybrid ordered mesoporous silica as sorbent for solid-phase multi-residue extraction of veterinary drugs in meat by ultra-high-performance liquid chromatography coupled to ion-trap tandem mass spectrometry.

    Science.gov (United States)

    Casado, Natalia; Morante-Zarcero, Sonia; Pérez-Quintanilla, Damián; Sierra, Isabel

    2016-08-12

    A quick, sensitive and selective analytical reversed-phase multi-residue method using ultra-high performance liquid chromatography coupled to an ion-trap mass spectrometry detector (UHPLC-IT-MS/MS) operating in both positive and negative ion mode was developed for the simultaneous determination of 23 veterinary drug residues (β-blockers, β-agonists and Non-Steroidal Anti-inflammatory Drugs (NSAIDs)) in meat samples. The sample treatment involved a liquid-solid extraction followed by a solid-phase extraction (SPE) procedure. SBA-15 type mesoporous silica was synthetized and modified with octadecylsilane, and the resulting hybrid material (denoted as SBA-15-C18) was applied and evaluated as SPE sorbent in the purification of samples. The materials were comprehensively characterized, and they showed a high surface area, high pore volume and a homogeneous distribution of the pores. Chromatographic conditions and extraction procedure were optimized, and the method was validated according to the Commission Decision 2002/657/EC. The method detection limits (MDLs) and the method quantification limits (MQLs) were determined for all the analytes in meat samples and found to range between 0.01-18.75μg/kg and 0.02-62.50μg/kg, respectively. Recoveries for 15 of the target analytes ranged from 71 to 98%. In addition, for comparative purpose SBA-15-C18 was evaluated towards commercial C18 amorphous silica. Results revealed that SBA-15-C18 was clearly more successful in the multi-residue extraction of the 23 mentioned analytes with higher recovery values. The method was successfully tested to analyze prepacked preparations of mince bovine meat. Traces of propranolol, ketoprofen and diclofenac were detected in some samples. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Radiation protection for veterinary practices

    International Nuclear Information System (INIS)

    Wheelton, R.; McCaffery, A.

    1993-01-01

    This brief article discusses radiation protection for diagnostic radiography in veterinary practices. It includes aspects such as a radiation protection adviser, personal dosimetry but in particular a Veterinary Monitoring Service, developed by the NRPB, which offers veterinary practitioners the convenience of making simple but essential measurements for themselves using photographic films contained in a 'vet pack' to determine the operating condition of their X-ray machine. (U.K.)

  3. About veterinary education in Iraq.

    Science.gov (United States)

    Fathalla, M

    2003-01-01

    The cons and pros of veterinary education in Iraq are described. Started as a small institution, with few students and with foreign staffs, then expanded to enroll more than hundred students each year, with all Iraqi staff. The graduates of the Veterinary College played an important role in monitoring animal health, supervising research projects involving animal welfare, some served as educators of various veterinary science specializations, others worked as private practitioners or recruited in the army. Veterinary education was very vital, as other sciences for progress of the country.

  4. Veterinary Oncology Immunotherapies.

    Science.gov (United States)

    Bergman, Philip J

    2018-03-01

    The ideal cancer immunotherapy agent should be able to discriminate between cancer and normal cells, be potent enough to kill small or large numbers of tumor cells, and be able to prevent recurrence of the tumor. Tumor immunology and immunotherapy are among the most exciting and rapidly expanding fields; cancer immunotherapy is now recognized as a pillar of treatment alongside traditional modalities. This article highlights approaches that seem to hold particular promise in human clinical trials and many that have been tested in veterinary medicine. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Pharmacokinetic and bioequivalence study of two brands of valsartan tablets in healthy male volunteers.

    Science.gov (United States)

    Zakeri-Milani, Parvin; Valizadeh, Hadi; Islambulchilar, Ziba; Nemati, Mahboob

    2010-01-01

    Valsartan (CAS 137862-53-4) is an antihypertensive drug belonging to the family of angiotensin II receptor antagonists acting at the AT1 receptor, which mediates all known effects of angiotensin II on the cardiovascular system. In the present study, the pharmacokinetic parameters of two oral formulations of valsartan tablets were compared in a randomized, single oral dose, two-treatment crossover design in 24 healthy male volunteers under fasting conditions. After an overnight fast, the volunteers received 80 mg valsartan. Blood samples were collected up to 48 h and drug concentrations were determined by a reverse-phase HPLC method with fluorescence detection. Various pharmacokinetic parameters were determined from the plasma concentration-time curves of both formulations. The obtained values for test and reference products were 3067.7 +/- 1,281.7 and 3,304.3 +/- 1,196.4 ng/ml for Cmax; 17,834.4 +/- 7,083.8 and 18,319.1 +/- 7,800.7 ng x h/ml for AUC0-48; 18,825.7 +/- 7,553.2 and 19,172.2 +/- 8,307.2 ng x h/ml for AUC0-infinity, respectively. The 90% confidence intervals obtained by analysis of variance were 86.84-100.87% for Cmax and 93.43-115.54% for AUC0-t, which are within the acceptance range of 80-125%. Therefore it can be concluded that both products are bioequivalent in terms of rate and extent of drug absorption and therefore interchangeable.

  6. Regulatory and biosafety issues in relation to transgenic animals in food and agriculture, feeds containing genetically modified organisms (GMO) and veterinary biologics

    International Nuclear Information System (INIS)

    Kochhar, H.P.S.; Gifford, G.A.; Kahn, S.

    2005-01-01

    Development of an effective regulatory system for genetically engineered animals and their products has been the subject of increasing discussion among researchers, industry and policy developers, as well as the public. Since transgenesis and cloning are relatively new scientific techniques, transgenic animals are new organisms for which there is limited information. The issues associated with the regulation and biosafety of transgenic animals pertain to environmental impact, human food safety, animal health and welfare, trade and ethics. To regulate this new and powerful technology predicated on limited background information is a challenge not only for the regulators, but also for the developers of such animals, who strive to prove that the animals are safe and merit bio-equivalency to their conventional counterparts. In principle, an effective regulatory sieve should permit safe products while forming a formidable barrier for those assessed of posing an unacceptable risk. Adoption of transgenic technology for use in agriculture will depend upon various factors that range from perceived benefits for humans and animals, to safe propagation, animal welfare considerations and integrity of species, as well as effects on bio-diversity. A regulatory framework designed to address the concerns connected with the environmental release of transgenic animals needs to also take into account the ability of genetically modified animals to survive and compete with conventional populations. Regulatory initiatives for biotechnology-derived animals and their products should ensure high standards for human and animal health; a sound scientific basis for evaluation; transparency and public involvement; and maintenance of genetic diversity. Feeds obtained by use of biotechnology have to be evaluated for animal and human safety by using parameters that define their molecular characterization, nutritional qualities and toxicological aspects, while veterinary biologics derived from

  7. Veterinary medical education in Iraq.

    Science.gov (United States)

    Khamas, Wael A; Nour, Abdelfattah

    2004-01-01

    Iraq is an agricultural country with a large population of animals: sheep, goats, cattle, water buffaloes, horses, donkeys, mules, and camels. In the 1980s, the successful poultry industry managed to produce enough table eggs and meat to satisfy the needs of the entire population; at one time, the thriving fish industry produced different types of fish for Iraqis' yearly fish consumption. There are four veterinary colleges in Iraq, which have been destroyed along with the veterinary services infrastructure. Understandably, improvements to the quality of veterinary education and services in Iraq will be reflected in a healthy and productive animal industry, better food quality and quantity, fewer zoonotic diseases, and more income-generating activities in rural areas. Thus, if undergraduate, graduate, and continuing education programs are improved, the veterinary medical profession will attract more competent students. This will satisfy the country's increased demand for competent veterinarians in both public and private sectors. Although Iraq has an estimated 5,000-7,000 veterinarians, there is a need for quality veterinary services and for more veterinarians. In addition, there is a need for the improvement of veterinary diagnostic facilities, as zoonotic diseases are always highly probable in this region. This article provides insight into the status of veterinary medical education and veterinary services in Iraq before and after the 1991 Gulf War and gives suggestions for improvement and implementation of new programs. Suggestions are also offered for improving veterinary diagnostic facilities and the quality of veterinary services. Improving diagnostic facilities and the quality of veterinary services will enhance animal health and production in Iraq and will also decrease the likelihood of disease transmission to and from Iraq. Threats of disease transmission and introduction into the country have been observed and reported by several international

  8. Piloting interprofessional education interventions with veterinary and veterinary nursing students.

    Science.gov (United States)

    Kinnison, Tierney; Lumbis, Rachel; Orpet, Hilary; Welsh, Perdi; Gregory, Sue; Baillie, Sarah

    2011-01-01

    Interprofessional education (IPE) has received little attention in veterinary education even though members of the veterinary and nursing professions work closely together. The present study investigates veterinary and veterinary nursing students' and practitioners' experiences with interprofessional issues and the potential benefits of IPE. Based on stakeholder consultations, two teaching interventions were modified or developed for use with veterinary and veterinary nursing students: Talking Walls, which aimed to increase individuals' understanding of each other's roles, and an Emergency-Case Role-Play Scenario, which aimed to improve teamwork. These interventions were piloted with volunteer veterinary and veterinary nursing students who were recruited through convenience sampling. A questionnaire (the Readiness for Interprofessional Learning Scale [RIPLS]) was modified for use in veterinary education and used to investigate changes in attitudes toward IPE over time (pre-intervention, immediately post-intervention, and four to five months afterward). The results showed an immediate and significant positive change in attitude after the intervention, highlighting the students' willingness to learn collaboratively, their ability to recognize the benefits of IPE, a decreased sense of professional isolation, and reduced hierarchical views. Although nearly half of the students felt concerned about learning with students from another profession before the intervention, the majority (97%) enjoyed learning together. However, the positive change in attitude was not evident four to five months after the intervention, though attitudes remained above pre-intervention levels. The results of the pilot study were encouraging and emphasize the relevance and importance of veterinary IPE as well as the need for further investigation to explore methods of sustaining a change in attitude over time.

  9. Computer applications in veterinary medicine | Hassan | Nigerian ...

    African Journals Online (AJOL)

    ... become essential tools in almost every field of research and applied technology. ... Computers in veterinary medicine have been used for veterinary education; ... agro-veterinary project design, monitoring and implementation; preparation of ...

  10. Second research coordination meeting of the coordinated research project 'Development of strategies for the effective monitoring of veterinary drug residues in livestock and livestock products in developing countries' (D3.20.22)

    International Nuclear Information System (INIS)

    2003-01-01

    The second RCM under this CRP was held in Pretoria, South Africa, 3 - 7 November 2003. Eleven of the twelve research contract holders, three research agreement holders and one technical contract holder attended the RCM. The three research agreement holders gave presentations on relevant aspects of veterinary drug residues analysis. The increasingly important role of bioassay techniques such as reporter gene assays for the direct screening of the effects of hormonal and other residues in animal cells and the future role of such assays to complement existing instrumental techniques was highlighted. The technical contract holder and research contract holders reviewed the results of the research and method development performed under the first phase of the CRP. Considerable progress has been made in many aspects of the overall work plan. Several commercial immunoassay methods have been critically evaluated. The main problems identified with these kits were the instability of reagents, notably the enzyme conjugates, resulting in poor performance, and the need for better sample preparation protocols applicable to a wider range of matrices. Work plans have been agreed with several laboratories to attempt to address these problems. Good progress has been made in several laboratories working on the development of in-house ELISA methods for chloramphenicol residues. The laboratories involved have produced and characterized antisera in various species and these will be used with reagents produced by technical contract holders to elaborate assay protocols. Further investigation into aspects such as reagent stability, antibody maturation and assay development using various assay formats is planned. A full set of reagents and protocols for their optimisation in a 125 I radioimmunoassay (RIA) for chloramphenicol have been developed by the technical contract holders and transferred to a research contract holder for further method development. However, this researcher was unable to

  11. Radiation protection in veterinary radiology

    International Nuclear Information System (INIS)

    Hone, C.P.

    1989-06-01

    This Code of Practice is designed to give guidance to veterinary surgeons in ensuring that workers and members of the public are adequately protected from the hazards of ionising radiation arising from the use of x-ray equipment in veterinary practice. (author)

  12. Perspectives on academic veterinary administration.

    Science.gov (United States)

    Gelberg, H B; Gelberg, S

    2001-09-15

    It is important for veterinary administrators to apply knowledge bases from other fields to their own unique administrative needs. For example, although some resources are written for business managers, the discussions of four key management competency areas, guidelines for mastering these skills, organizational assessment tools, and other self-help tools may provide interesting food-for-thought for veterinary administrators.(76) In developing their own administrative styles, administrators should seek to apply those principles that seem to intuitively fit with their personal research styles, work situations, managerial styles, administrative preferences, and unique organizational culture. Through strengthening their liaisons with community and university business programs, counseling agencies, employee assistance programs, and psychology researchers, administrators can continue to be exposed to and benefit from new paradigms for consideration in veterinary medical environments. Through these liaisons, the unique needs of veterinary medical environments are also communicated to individuals within the fields of psychology and business, thus stimulating new research that specifically targets veterinary medical environment leadership issues. Each field has unique contributions to help veterinary administrators work toward creating veterinary medical environments that are creative, energetic, visionary, pragmatic, and highly marketable in order to help administrators recruit and nurture the best and brightest veterinary researchers, teachers, and clinicians.

  13. Sokoto Journal of Veterinary Sciences

    African Journals Online (AJOL)

    Journal Homepage Image. The Journal publishes original research articles related to veterinary sciences, including livestock health and production, diseases of wild life and fish, preventive veterinary medicine and zoonoses among others. Case reports, review articles and editorials are also accepted. Other sites related to ...

  14. Bioequivalence evaluation of two brands of amoxicillin/clavulanic acid 250/125 mg combination tablets in healthy human volunteers: use of replicate design approach.

    Science.gov (United States)

    Idkaidek, Nasir M; Al-Ghazawi, Ahmad; Najib, Naji M

    2004-12-01

    The purpose of this study was to apply a replicate design approach to a bioequivalence study of amoxicillin/clavulanic acid combination following a 250/125 mg oral dose to 23 subjects, and to compare the analysis of individual bioequivalence with average bioequivalence. This was conducted as a 2-treatment 2-sequence 4-period crossover study. Average bioequivalence was shown, while the results from the individual bioequivalence approach had no success in showing bioequivalence. In conclusion, the individual bioequivalence approach is a strong statistical tool to test for intra-subject variances and also subject-by-formulation interaction variance compared with the average bioequivalence approach. copyright (c) 2004 John Wiley & Sons, Ltd.

  15. Radiological protection in veterinary practice

    International Nuclear Information System (INIS)

    Konishi, Emiko; Tabara, Takashi; Kusama, Tomoko.

    1990-01-01

    To propose measures for radiological protection of veterinary workers in Japan, X-ray exposure of workers in typical conditions in veterinary clinics was assessed. Dose rates of useful beam and scattered radiation, worker exposure doses at different stations, and effectiveness of protective clothing were determined using TLD and ion chambers. As precausions against radiation, the following practices are important: (1) use of suitable and properly maintained X-ray equipment, (2) proper selection of safe working stations, (3) use of protective clothing. Regulations are necessary to restrict the use of X-rays in the veterinary field. Because the use of X-rays in the veterinary field is not currently controlled by law, the above precautions are essential for minimizing exposure of veterinary staff. (author)

  16. Evaluation of bi-functionalized mesoporous silicas as reversed phase/cation-exchange mixed-mode sorbents for multi-residue solid phase extraction of veterinary drug residues in meat samples.

    Science.gov (United States)

    Casado, Natalia; Pérez-Quintanilla, Damián; Morante-Zarcero, Sonia; Sierra, Isabel

    2017-04-01

    A SBA-15 type mesoporous silica was synthesized and bi-functionalized with octadecylsilane (C18) or octylsilane (C8), and sulfonic acid (SO 3 - ) groups in order to obtain materials with reversed-phase/strong cation-exchange mixed-mode retention mechanism. The resulting hybrid materials (SBA-15-C18-SO 3 - and SBA-15-C8-SO 3 - ) were comprehensively characterized. They showed high surface area, high pore volume and controlled porous size. Elemental analysis of the materials revealed differences in the amount of C18 and C8. SBA-15-C18-SO 3 - contained 0.19mmol/g of C18, while SBA-15-C8-SO 3 - presented 0.54mmol/g of C8. The SO 3 - groups anchored to the silica surface of the pore walls were 0.20 and 0.09mmol/g, respectively. The bi-functionalized materials were evaluated as SPE sorbents for the multi-residue extraction of 26 veterinary drug residues in meat samples using ultra-high-performance liquid chromatography coupled to mass spectrometry detector (UHPLC-MS/MS). Different sorbent amounts (100 and 200mg) and organic solvents were tested to optimize the extraction procedure. Both silicas showed big extraction potential and were successful in the extraction of the target analytes. The mixed-mode retention mechanism was confirmed by comparing both silicas with SBA-15 mesoporous silica mono-functionalized with C18 and C8. Best results were achieved with 200mg of SBA-15-C18-SO 3 - obtaining recoveries higher than 70% for the majority of analytes. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers.

    Science.gov (United States)

    Holt, Robert J; Taiwo, Tolu; Kent, Jeffrey D

    2015-08-01

    Topical formulations of nonsteroidal anti-inflammatory drugs (NSAIDs) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption. We conducted randomized, crossover studies that compared the pharmacokinetics (PK), bioequivalence and safety of topical diclofenac sodium 2% twice daily (BID), diclofenac sodium 1.5% four times daily (QID) and oral diclofenac sodium in healthy subjects. The results of three bioequivalence studies are reviewed. Healthy adult subjects (n = 76) applied topical diclofenac sodium 2% solution (40.4 mg/2 mL) BID; or 1.5% solution (19.3 mg/40 drops) QID to each knee for 7.5 consecutive days separated by a washout period. Subjects (n = 22) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days. Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 (steady state), and diclofenac PK parameters were estimated by noncompartmental methods. The studies demonstrated comparable bioequivalence between the 2% and 1.5% topical solutions as well as lower systemic exposure compared to oral dosing (approximately 93% less). Daily systemic exposure was comparable between the two formulations with only a 12% difference in the AUCss(0-24) (p = 0.140). Furthermore, both topical solutions demonstrated delayed elimination with a t(1/2) of 4- to 6-fold longer, as compared to oral diclofenac. The 2% solution provided more consistent dosing relative to the 1.5% solution when comparing AUCss(0-24) and Cmaxss across studies. Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac. The steady-state PK profile of topical diclofenac 2% solution administered BID is similar to that of the 1.5% solution administered QID. Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration. (Study 2 was registered with ClinicalTrials.gov; NCT01202799; https

  18. En Route towards European Clinical breakpoints for veterinary antimicrobial susceptibility testing

    NARCIS (Netherlands)

    Toutain, Pierre Louis; Bousquet-Mélou, Alain; Damborg, Peter; Ferran, Aude A.; Mevius, Dik; Pelligand, Ludovic; Veldman, Kees T.; Lees, Peter

    2017-01-01

    VetCAST is the EUCAST sub-committee for Veterinary Antimicrobial Susceptibility Testing. Its remit is to define clinical breakpoints (CBPs) for antimicrobial drugs (AMDs) used in veterinary medicine in Europe. This position paper outlines the procedures and reviews scientific options to solve

  19. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  20. Comparison of parametric and bootstrap method in bioequivalence test.

    Science.gov (United States)

    Ahn, Byung-Jin; Yim, Dong-Seok

    2009-10-01

    The estimation of 90% parametric confidence intervals (CIs) of mean AUC and Cmax ratios in bioequivalence (BE) tests are based upon the assumption that formulation effects in log-transformed data are normally distributed. To compare the parametric CIs with those obtained from nonparametric methods we performed repeated estimation of bootstrap-resampled datasets. The AUC and Cmax values from 3 archived datasets were used. BE tests on 1,000 resampled datasets from each archived dataset were performed using SAS (Enterprise Guide Ver.3). Bootstrap nonparametric 90% CIs of formulation effects were then compared with the parametric 90% CIs of the original datasets. The 90% CIs of formulation effects estimated from the 3 archived datasets were slightly different from nonparametric 90% CIs obtained from BE tests on resampled datasets. Histograms and density curves of formulation effects obtained from resampled datasets were similar to those of normal distribution. However, in 2 of 3 resampled log (AUC) datasets, the estimates of formulation effects did not follow the Gaussian distribution. Bias-corrected and accelerated (BCa) CIs, one of the nonparametric CIs of formulation effects, shifted outside the parametric 90% CIs of the archived datasets in these 2 non-normally distributed resampled log (AUC) datasets. Currently, the 80~125% rule based upon the parametric 90% CIs is widely accepted under the assumption of normally distributed formulation effects in log-transformed data. However, nonparametric CIs may be a better choice when data do not follow this assumption.

  1. ASVCP quality assurance guidelines: control of general analytical factors in veterinary laboratories.

    Science.gov (United States)

    Flatland, Bente; Freeman, Kathy P; Friedrichs, Kristen R; Vap, Linda M; Getzy, Karen M; Evans, Ellen W; Harr, Kendal E

    2010-09-01

    Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance Guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. ©2010 American Society for Veterinary Clinical Pathology.

  2. Pharmacology of biosimilar candidate drugs in rheumatology: a literature review.

    Science.gov (United States)

    Araújo, F; Cordeiro, I; Teixeira, F; Gonçalves, J; Fonseca, J E

    2014-01-01

    To review current evidence concerning pharmacology of biosimilar candidates to be used in rheumatology. A PubMed search up to August 2013 was performed using relevant search terms to include all studies assessing pharmacological properties of biosimilar candidates to be used in rheumatology. Data on study characteristics, type of intervention, pharmacokinetics (PK), pharmacodynamics (PD) and bioequivalence ratios was extracted. Of 280 articles screened, 5 fulfilled our inclusion criteria. Two trials, PLANETAS and PLANETRA, compared CT-P13 and infliximab in patients with active ankylosing spondylitis and rheumatoid arthritis, respectively. PK bioequivalence was demonstrated in the phase 1 PLANETAS trial by highly comparable area under the curve (AUC) and maximum drug concentrations (Cmax), whose geometric mean ratios fell between the accepted bioequivalence range of 80-125%. Equivalence in efficacy and safety was demonstrated in the phase 3 PLANETRA trial. Two phase 1 trials comparing etanercept biosimilar candidates TuNEX and HD203 in healthy volunteers showed a high degree of similarity in AUC and Cmax, with respective geometric mean ratios between PK bioequivalence range. The last included trial referred to GP2013, a rituximab biosimilar candidate, which demonstrated PK and PD bioequivalence to reference product in three different dosing regimens in cynomolgus monkeys. Infliximab, etanercept and rituximab biosimilar candidates have demonstrated PK bioequivalence in the trials included in this review. CT-P13 has recently been approved for use in the European market and the remaining biosimilar candidates are currently being tested in patients with rheumatoid arthritis.

  3. Dental Education in Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Diana L. Eubanks

    2011-02-01

    Full Text Available Periodontal disease is among the most prevalent canine dis-eases affecting over 75% of dogs. Strengthening of the human-animal bond and the increasing education of the aver-age pet owner, have fostered a heightened awareness of periodontal care in dogs and cats. Industry support has further assisted the small animal veterinarian in providing quality dental treatments and prevention. As recently as the 1990’s, veterinary curriculums contained little or no dental training. That trend is changing as nearly every one of the 28 US Colleges of Veterinary Medicine offers some level of small animal dentistry during the four-year curriculum. Primary areas of focus are on client education, the treatment of periodontal disease, dental prophylaxis, dental radiology, endodontics, exodontics and pain control. Students receive instruction in dental anatomy during their di-dactic curriculum and later experience clinical cases. Graduate DVMs can attend a variety of continuing education courses and even choose to specialize in veterinary dentistry in both small animals and horses. Through the efforts of organizations such as the American Veterinary Dental So-ciety, The American Veterinary Dental College and The Academy of Veterinary Dentistry, many veterinarians have been able to advance their skills in dentistry and improve animal welfare. Increasing ex-pectations of the pet-owning public coupled with the recent advancements of training opportunities available for vete-rinary students, graduate DVMs and certified veterinary technicians make veterinary dentistry an emerging practice-builder among the most successful small animal hospitals.

  4. Computer automation in veterinary hospitals.

    Science.gov (United States)

    Rogers, H

    1996-05-01

    Computers have been used to automate complex and repetitive tasks in veterinary hospitals since the 1960s. Early systems were expensive, but their use was justified because they performed jobs which would have been impossible or which would have required greater resources in terms of time and personnel had they been performed by other methods. Systems found in most veterinary hospitals today are less costly, magnitudes more capable, and often underused. Modern multitasking operating systems and graphical interfaces bring many opportunities for automation. Commercial and custom programs developed and used in a typical multidoctor mixed species veterinary practice are described.

  5. Relative bioequivalence evaluation of two oral atomoxetine hydrochloride capsules: a single dose, randomized, open-label, 2-period crossover study in healthy Chinese volunteers under fasting conditions.

    Science.gov (United States)

    Shang, D-W; Guo, W; Zhou, F-C; Wang, X-P; Li, A-N; Zhang, L; Li, W-B; Lu, W; Wang, C-Y

    2013-11-01

    To evaluate the bioequivalence of a new formulation of atomoxetine hydrochloride (CAS 82248-59-7) capsules (test) and an available branded capsules (reference) after administration of a single 40 mg dose, randomized, open-label, 2-period crossover study was conducted in 22 healthy male Chinese subjects with a 1-week wash-out period. This study was designed for/the Honglin Pharmaceutical Co. Ltd and contracted to be done by the Beijing Anding Hospital in order to satisfy Chinese regulatory requirements to allow marketing of this generic product and performed according to the criteria of SFDA. Blood samples were collected before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16 and 24 h after drug administration. Plasma concentrations were determined by high-performance liquid chromatography (HPLC) with UV detection. A non-compartmental method was used to calculate the pharmacokinetic parameters and evaluate bioequivalence of the 2 formulations. The 90% confidence interval (CI) of the ratios (test/reference) of atomoxetine for AUC0-24, AUC0-∞ and Cmax were 100.9% (93.6-108.8%), 103.1% (95.1-111.7%) and 105.2% (92.8-119.4%), respectively, which fell within the interval of 80-125% and 75-133%. No clinically significant changes or abnormalities were noted in laboratory data and vital signs. From these results it can be concluded that the test formulation of atomoxetine capsules met the regulatory criterion for bioequivalence to the reference formulation. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Bioequivalence of 2 Formulations of Sildenafil Oral Soluble Film 100 mg and Sildenafil Citrate (Viagra) 100 mg Oral Tablets in Healthy Male Volunteers.

    Science.gov (United States)

    Dadey, Eric

    Sildenafil citrate tablets (VIAGRA; Pfizer Inc) have been used since 1998 as an oral therapy for the treatment of erectile dysfunction. However, in some cases, patients may have difficulty in swallowing tablets, and the need to use water to aid in the oral administration of the tablets has the potential to interrupt the sexual encounter, reduce spontaneity, and therefore decrease the quality of the experience. Two oral soluble film (OSF) formulations of sildenafil were developed using MonoSol Rx's proprietary PharmFilm technology. Both films were formulated to dissolve rapidly on the tongue, thereby releasing the drug into the oral cavity, whereupon it is swallowed without the use of water. From a patient perspective, it is anticipated that the film formulations of sildenafil citrate will provide a more compliant and discreet dosage form. The purpose of this clinical study was to compare the bioequivalence of the 2 sildenafil OSF 100 mg formulations (MonoSol Rx, LLC) with the sildenafil citrate 100 mg tablets. The design was a single-dose, randomized, open-label, 3-period, 6-sequence, 3-treatment, single-center, crossover study conducted in 18 healthy, nonsmoking male volunteers under fasting conditions, with each treatment period separated by a 7-day washout period. Plasma sildenafil concentrations were measured predose and then periodically to 24 hours after dosing. The 90% confidence intervals for plasma sildenafil AUC0-t, AUC0-∞, and Cmax for both sildenafil OSF formulations as compared with sildenafil citrate tablets were all within the 80%-125% range, indicating bioequivalence of both film formulations to sildenafil citrate tablets. Overall, the demonstrated bioequivalence coupled with the performance advantages of an OSF dosage form (ie, rapid dissolution in the mouth, can be taken without water, and can be dosed discreetly) suggest that the sildenafil OSF may provide an attractive alternative to sildenafil citrate oral tablets.

  7. Current Issues and the Veterinary Medical Library

    Science.gov (United States)

    Nault, Andre J.

    2010-01-01

    Veterinary medical libraries and librarians are unique. There are now 33 veterinary colleges in North America, and in accordance with American Veterinary Medical Association accreditation, each has a library managed by an accredited librarian. Colleges with veterinary programs often maintain specialized branch libraries to support the degree,…

  8. The effects of veterinary antibiotics on soil microbial communities

    NARCIS (Netherlands)

    Schmitt, Heike

    2005-01-01

    The possible environmental “side effects” of pharmaceuticals to the environment have not yet been investigated extensively. Among the veterinary drugs, the antibiotics are an important group, due to their extensive use and their potential to also affect environmental bacteria. The main entry path

  9. Adverse reaction to veterinary multivitamins and vitamin B complex ...

    African Journals Online (AJOL)

    It has been reported that dogs in South-western Nigeria react adversely to injectable veterinary multivitamins and human vitamin B complex preparations. Experimentation and interview survey were concurrently conducted to identify the type of Adverse Drug Reactions (ADRs) that the indications produced. For the survey ...

  10. A Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers.

    Science.gov (United States)

    Pan, Lin; Belloni, Paula; Ding, Han Ting; Wang, Jianshuang; Rubino, Christopher M; Putnam, Wendy S

    2017-09-01

    Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an 801-mg single dose of pirfenidone as three 267-mg capsules or one 801-mg tablet under fasted and fed conditions. Pirfenidone plasma C max , AUC 0-t and AUC 0-∞ were used to assess bioequivalence. Forty-four subjects were randomized to treatment. The 801-mg tablet in the fasted state met bioequivalence criteria [90% confidence intervals (CI) 80.00-125.00%] for the GLSM ratios of natural log-transformed C max , AUC 0-t and AUC 0-∞ . Under fed conditions, the 801-mg tablet met the bioequivalence criteria for AUC 0-t and AUC 0-∞ , but slightly exceeded the bioequivalence criteria for the C max (90% CI of 108.26-125.60%). The tablet C max was approximately 17% higher than that of the capsules. In the fed state, the tablet C max , and both AUC 0-t and AUC 0-∞ were reduced by 39% and 17%, respectively, relative to the fasted state. The tablet and capsules had acceptable tolerability profiles. The pirfenidone 801-mg tablet met bioequivalence criteria when compared with three 267-mg capsules in the fasted state. The tablet C max was slightly higher relative to capsules in the fed state, but this is not expected to have a clinically meaningful impact on the benefit-risk profile of pirfenidone. This work was supported by F. Hoffmann-La Roche Ltd.

  11. Needlestick injuries in veterinary medicine.

    Science.gov (United States)

    Weese, J Scott; Jack, Douglas C

    2008-08-01

    Needlestick injuries are an inherent risk of handling needles during the course of veterinary practice. While significant effort has been expended to reduce needlestick injuries in human medicine, a relatively lax approach seems to be prevalent in veterinary medicine. It appears that needlestick injuries are very common among veterinary personnel and that serious adverse effects, while uncommon, do occur. Clients may also receive injuries in clinics during the course of animal restraint, and at home following prescription of injectable medications or fluids. Because of occupational health, personal health, and liability concerns, veterinary practices should review the measures they are taking to reduce the likelihood of needlestick injuries and develop written needlestick injury avoidance protocols.

  12. Center for Veterinary Medicine (CVM)

    Data.gov (United States)

    Federal Laboratory Consortium — As seen on the center's logo, the mission statement for FDA's Center for Veterinary Medicine (CVM) reads: "Protecting Human and Animal Health." To achieve this broad...

  13. Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia.

    Science.gov (United States)

    Estepp, Jeremie H; Melloni, Chiara; Thornburg, Courtney D; Wiczling, Paweł; Rogers, Zora; Rothman, Jennifer A; Green, Nancy S; Liem, Robert; Brandow, Amanda M; Crary, Shelley E; Howard, Thomas H; Morris, Maurine H; Lewandowski, Andrew; Garg, Uttam; Jusko, William J; Neville, Kathleen A

    2016-03-01

    Hydroxyurea (HU) is a crucial therapy for children with sickle cell anemia, but its off-label use is a barrier to widespread acceptance. We found HU exposure is not significantly altered by liquid vs capsule formulation, and weight-based dosing schemes provide consistent exposure. HU is recommended for all children starting as young as 9 months of age with sickle cell anemia (SCA; HbSS and HbSβspan(0) thalassemia); however; a paucity of pediatric data exists regarding the pharmacokinetics (PK) or the exposure-response relationship of HU. This trial aimed to characterize the PK of HU in children and to evaluate and compare the bioavailability of a liquid vs capsule formulation. This multicenter; prospective; open-label trial enrolled 39 children with SCA who provided 682 plasma samples for PK analysis following administration of HU. Noncompartmental and population PK models are described. We report that liquid and capsule formulations of HU are bioequivalent; weight-based dosing schemes provide consistent drug exposure; and age-based dosing schemes are unnecessary. These data support the use of liquid HU in children unable to swallow capsules and in those whose weight precludes the use of fixed capsule formulations. Taken with existing safety and efficacy literature; these findings should encourage the use of HU across the spectrum of age and weight in children with SCA; and they should facilitate the expanded use of HU as recommended in the National Heart; Lung; and Blood Institute guidelines for individuals with SCA. © 2015, The American College of Clinical Pharmacology.

  14. The impact of new partial AUC parameters for evaluating the bioequivalence of prolonged-release formulations.

    Science.gov (United States)

    Boily, Michaël; Dussault, Catherine; Massicotte, Julie; Guibord, Pascal; Lefebvre, Marc

    2015-01-23

    To demonstrate bioequivalence (BE) between two prolonged-release (PR) drug formulations, single dose studies under fasting and fed state as well as at least one steady-state study are currently required by the European Medicines Agency (EMA). Recently, however, there have been debates regarding the relevance of steady-state studies. New requirements in single-dose investigations have also been suggested by the EMA to address the absence of a parameter that can adequately assess the equivalence of the shape of the curves. In the draft guideline issued in 2013, new partial area under the curve (pAUC) pharmacokinetic (PK) parameters were introduced to that effect. In light of these potential changes, there is a need of supportive clinical evidence to evaluate the impact of pAUCs on the evaluation of BE between PR formulations. In this retrospective analysis, it was investigated whether the newly defined parameters were associated with an increase in discriminatory ability or a change in variability compared to the conventional PK parameters. Among the single dose studies that met the requirements already in place, 20% were found unable to meet the EMA's new requirements in regards to the pAUC PK parameters. When pairing fasting and fed studies for a same formulation, the failure rate increased to 40%. In some cases, due to the high variability of these parameters, an increase of the sample size would be required to prove BE. In other cases however, the pAUC parameters demonstrated a robust ability to detect differences between the shapes of the curves of PR formulations. The present analysis should help to better understand the impact of the upcoming changes in European regulations on PR formulations and in the design of future BE studies. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Report on the first research co-ordination meeting of the co-ordinated research project: 'The development of strategies for the effective monitoring of veterinary drug residues in livestock and livestock products in developing countries' (D3.20.22)

    International Nuclear Information System (INIS)

    2002-01-01

    The first Research Co-ordination Meeting (RCM) of the Co-ordinated Research Project (CRP) on 'the development of strategies for the effective monitoring of veterinary drug residues in livestock and livestock products in developing countries' was held in the Vienna International Centre from 2 to 6 September 2002. Twelve Research Contracts (RCs) and 3 Research Agreements (RAs) have been awarded under this CRP and all awardees, the Project Officer and a guest speaker from the Austrian Agency for Health and Food Safety (AAHFS) participated in the RCM. The objective of the RCM was to plan the first phase of the CRP, initiation of the development and validation of methods. Specific objectives were to: Agree upon a small number of veterinary drugs upon which to focus the research; Agree upon analytical methodologies to be employed; formulate individual work plans for each research contract holder within the framework of the overall work plan. Each RC holder presented an overview of residues monitoring from the perspective of their respective countries. Emphasis was placed on problems encountered and future requirements. The participants visited the Austrian National Reference Laboratory for veterinary drug residues at Moedling and discussed the activities there with Mr. Kuhn and laboratory staff. An overall framework for phase of the CRP, focusing upon the compounds and analytical techniques of major importance to the majority of participants, was formulated. Each RC holder discussed and revised their individual work plan with the RA holders and the PO. The overall framework was then reviewed and a summary of the individual work plans presented. Conclusions and recommendations were drafted

  16. Bioequivalence of 250 mg lysine clonixinate tablets after a single oral dose in a healthy female Mexican population under fasting conditions.

    Science.gov (United States)

    Marcelín-Jiménez, G; Angeles, A C P; García, A; Morales, M; Rivera, L; Martín-Del-Campo, A

    2010-05-01

    To evaluate the bioequivalence between two 250 mg-tablets of lysine clonixinate, Dorixina Forte (Siegfried Rhein, México) as reference product, and Prestodol (Farmaceúticos Rayere, S.A., México) as test formulation. 26 healthy adult female Mexican volunteers received a single oral dose of 250-mg lysine clonixinate under fasting conditions. The drug was administered following a randomized, two-period, two-sequence, cross-over design. Twelve serial blood samples were collected up to 8 h after dosing, and clonixin (CLX) was measured by ultra-performance liquid chromatography (UPLC) coupled with tandem mass spectrometry. Decimal logarithm values of Cmax and area under the curve (AUC) were used to construct a classic confidence interval at 90% (90% CI). Bioequivalence was established if 90% CI of mean ratios (test/reference) fall within the 0.8-1.25 range. Volunteers formed a homogeneous population in terms of age (27.2 +/- 6.3 years), weight (55.9 +/- 6.5 kg), height (1.6 +/- 0.04 m), and body mass index (BMI) (22.91 +/- 2.03 kg/m(2)). Reference formulation exhibited the following pharmacokinetics: C(max) (32.39 +/- 8.32 microg/ml); t(max) (0.64 +/- 0.2 h); AUC0-8h (48.92 +/- 16.51 microg x h/ml); t1/2 (1.3 +/- 0.24 h); CLapp (5.64 +/- 1.99 l/h), and Vdapp (10.22 +/- 2.9 l). Concerning bioequivalence, 90% CI were: C(max) (82.32 - 98.79), AUC0-t (94.59-106.29), and AUC(0-inf) (94.61-106.42), with a statistical power of > 0.90 at every tested interval. This single-dose study found that both 250-mg immediate-release tablets of lysine clonixinate met the Mexican regulatory criteria for bioequivalence in these volunteers.

  17. A comparison of antimicrobial usage in human and veterinary medicine in France from 1999 to 2005.

    Science.gov (United States)

    Moulin, Gérard; Cavalié, Philippe; Pellanne, Isabelle; Chevance, Anne; Laval, Arlette; Millemann, Yves; Colin, Pierre; Chauvin, Claire

    2008-09-01

    The antimicrobials allowed and amounts sold in veterinary and human medicine in France were compared to see if the same antimicrobial drugs are used in veterinary and human medicine, and to the same extent. Registers of all approved antimicrobial commercial products, kept by the French Agency for Veterinary Medicinal Products (AFSSA ANMV) for animals and the French Health Products Safety Agency (AFSSAPS) for humans, were compared to determine whether the same antimicrobials were approved in 2007 for use in both human and animal populations. Sales data were collected from pharmaceutical companies between 1999 and 2005 by the AFSSA ANMV and AFSSAPS. Usage of the different antimicrobial anatomical therapeutic chemical (ATC) classes in human and veterinary medicines was recorded. Data were expressed in tonnes of active ingredients and were then related to the animal and human biomasses to compare usages expressed in mg/kg. All antimicrobial ATC classes were used in both human and veterinary medicine. Tetracyclines accounted for the most sales in veterinary medicine. beta-Lactams predominated in human medicine. A decrease in the amounts consumed by both human and animal populations was observed during the study. In 2005, 760 tonnes were used in human medicine and 1320 tonnes in veterinary medicine, corresponding to 199 and 84 mg/kg of live weight in human and animal populations, respectively. The same antimicrobial drugs were used in human and veterinary medicines but the quantitative patterns of use were different. Expression of antimicrobial usage is a key point to address when comparing usage trends.

  18. Diagnostic microbiology in veterinary dermatology: present and future.

    Science.gov (United States)

    Guardabassi, Luca; Damborg, Peter; Stamm, Ivonne; Kopp, Peter A; Broens, Els M; Toutain, Pierre-Louis

    2017-02-01

    The microbiology laboratory can be perceived as a service provider rather than an integral part of the healthcare team. The aim of this review is to discuss the current challenges of providing a state-of-the-art diagnostic veterinary microbiology service including the identification (ID) and antimicrobial susceptibility testing (AST) of key pathogens in veterinary dermatology. The Study Group for Veterinary Microbiology (ESGVM) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified scientific, technological, educational and regulatory issues impacting the predictive value of AST and the quality of the service offered by microbiology laboratories. The advent of mass spectrometry has significantly reduced the time required for ID of key pathogens such as Staphylococcus pseudintermedius. However, the turnaround time for validated AST methods has remained unchanged for many years. Beyond scientific and technological constraints, AST methods are not harmonized and clinical breakpoints for some antimicrobial drugs are either missing or inadequate. Small laboratories, including in-clinic laboratories, are usually not adequately equipped to run up-to-date clinical microbiologic diagnostic tests. ESGVM recommends the use of laboratories employing mass spectrometry for ID and broth micro-dilution for AST, and offering assistance by expert microbiologists on pre- and post-analytical issues. Setting general standards for veterinary clinical microbiology, promoting antimicrobial stewardship, and the development of new, validated and rapid diagnostic methods, especially for AST, are among the missions of ESGVM. © 2017 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and ACVD.

  19. Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycin

    KAUST Repository

    Al-Talla, Zeyad; Akrawi, Sabah H.; Emwas, Abdul-Hamid M.

    2011-01-01

    Objective: The purpose of this study was to compare the pharmacokinetic parameters and determine the bioequivalence of a generic formulation of clindamycin that is sold in the local markets in the Middle East (Clindox® 150 mg capsule; test) with a

  20. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Science.gov (United States)

    2010-06-11

    ... available recommendations on how to design product-specific BE studies to support ANDAs. Under this process... thinking on a new process for making available to sponsors FDA guidance on how to design product-specific... ``Bioequivalence Recommendations for Specific Products.'' This guidance describes a new process for making...

  1. Application of dermal microdialysis for the evaluation of bioequivalence of a ketoprofen topical gel

    DEFF Research Database (Denmark)

    Tettey-Amlalo, Ralph Nii Okai; Kanfer, Isadore; Skinner, Michael F

    2008-01-01

    The purpose was to investigate dermal microdialysis (DMD) for the assessment of the bioavailability of a ketoprofen topical gel formulation and to evaluate this technique as a tool for the determination of bioequivalence. Four microdialysis probes were inserted into the dermis on the volar aspect...

  2. Review of hazards to female reproductive health in veterinary practice.

    Science.gov (United States)

    Scheftel, Joni M; Elchos, Brigid L; Rubin, Carol S; Decker, John A

    2017-04-15

    OBJECTIVE To review publications that address female reproductive health hazards in veterinary practice, summarize best practices to mitigate reproductive risks, and identify current knowledge gaps. DESIGN Systematized review. SAMPLE English-language articles describing chemical, biological, and physical hazards present in the veterinary workplace and associations with adverse reproductive outcomes or recommendations for minimizing risks to female reproductive health. PROCEDURES Searches of the CAB abstracts database were performed in July 2012 and in May 2015 with the following search terms: veterinarians AND occupational hazards and vets.id AND occupational hazards.sh. Searches of the PubMed database were conducted in November 2012 and in May 2015 with the following medical subject heading terms: occupational exposure AND veterinarians; anesthetics, inhalation/adverse effects AND veterinarians; risk factors AND pregnancy AND veterinarians; pregnancy outcome AND veterinarians; and animal technicians AND occupational exposure. Two additional PubMed searches were completed in January 2016 with the terms disinfectants/toxicity AND female AND fertility/drug effects and veterinarians/psychology AND stress, psychological. No date limits were applied to searches. RESULTS 4 sources supporting demographic trends in veterinary medicine and 118 resources reporting potential hazards to female reproductive health were identified. Reported hazards included exposure to anesthetic gases, radiation, antineoplastic drugs, and reproductive hormones; physically demanding work; prolonged standing; and zoonoses. CONCLUSIONS AND CLINICAL RELEVANCE Demographic information suggested that an increasing number of women of reproductive age will be exposed to chemical, biological, and physical hazards in veterinary practice. Information on reproductive health hazards and minimizing risk, with emphasis on developing a safety-focused work culture for all personnel, should be discussed starting

  3. Anxiety in veterinary surgical students

    DEFF Research Database (Denmark)

    Langebæk, Rikke; Eika, Berit; Jensen, Asger Lundorff

    2012-01-01

    The surgical educational environment is potentially stressful and this can negatively affect students' learning. The aim of this study was to investigate whether veterinary students' level of anxiety is higher in a surgical course than in a non-surgical course and if pre-surgical training...... in a Surgical Skills Lab (SSL) has an anxiety reducing effect. Investigations were carried out as a comparative study and a parallel group study. Potential participants were fourth-year veterinary students who attended a surgical course (Basic Surgical Skills) and a non-surgical course (Clinical Examination...... and 28 students from 2010). Our results show that anxiety levels in veterinary students are significantly higher in a surgical course than in a non-surgical course (p...

  4. Integrative veterinary medical education and consensus guidelines for an integrative veterinary medicine curriculum within veterinary colleges

    Science.gov (United States)

    Memon, M.A.; Shmalberg, J.; Adair, H.S.; Allweiler, S.; Bryan, J.N.; Cantwell, S.; Carr, E.; Chrisman, C.; Egger, C.M.; Greene, S.; Haussler, K.K.; Hershey, B.; Holyoak, G.R.; Johnson, M.; Jeune, S. Le; Looney, A.; McConnico, R.S.; Medina, C.; Morton, A.J.; Munsterman, A.; Nie, G.J.; Park, N.; Parsons-Doherty, M.; Perdrizet, J.A.; Peyton, J.L.; Raditic, D.; Ramirez, H.P.; Saik, J.; Robertson, S.; Sleeper, M.; Dyke, J. Van; Wakshlag, J.

    2016-01-01

    Integrative veterinary medicine (IVM) describes the combination of complementary and alternative therapies with conventional care and is guided by the best available evidence. Veterinarians frequently encounter questions about complementary and alternative veterinary medicine (CAVM) in practice, and the general public has demonstrated increased interest in these areas for both human and animal health. Consequently, veterinary students should receive adequate exposure to the principles, theories, and current knowledge supporting or refuting such techniques. A proposed curriculum guideline would broadly introduce students to the objective evaluation of new veterinary treatments while increasing their preparation for responding to questions about IVM in clinical practice. Such a course should be evidence-based, unbiased, and unaffiliated with any particular CAVM advocacy or training group. All IVM courses require routine updating as new information becomes available. Controversies regarding IVM and CAVM must be addressed within the course and throughout the entire curriculum. Instructional honesty regarding the uncertainties in this emerging field is critical. Increased training of future veterinary professionals in IVM may produce an openness to new ideas that characterizes the scientific method and a willingness to pursue and incorporate evidence-based medicine in clinical practice with all therapies, including those presently regarded as integrative, complementary, or alternative. PMID:27200270

  5. Emotions in veterinary surgical students

    DEFF Research Database (Denmark)

    Langebæk, Rikke; Eika, Berit; Pedersen, Lene Tanggaard

    2012-01-01

    A surgical educational environment is potentially stressful and can negatively affect students' learning. The aim of the present study was to investigate the emotions experienced by veterinary students in relation to their first encounter with live-animal surgery and to identify possible sources...... of positive and negative emotions, respectively. During a Basic Surgical Skills course, 155 veterinary fourth-year students completed a survey. Of these, 26 students additionally participated in individual semi-structured interviews. The results of the study show that students often experienced a combination...

  6. Veterinary medicines in the environment.

    Science.gov (United States)

    Boxall, A B A; Fogg, L A; Blackwell, P A; Kay, P; Pemberton, E J; Croxford, A

    2004-01-01

    The impact of veterinary medicines on the environment will depend on a number of factors including physicochemical properties, amount used and method of administration, treatment type and dose, animal husbandry practices, manure storage and handling practices, metabolism within the animal, and degradation rates in manure and slurry. Once released to the environment, other factors such as soil type, climate, and ecotoxicity also determine the environmental impact of the compound. The importance of individual routes into the environment for different types of veterinary medicines varies according to the type of treatment and livestock category. Treatments used in aquaculture have a high potential to reach the aquatic environment. The main routes of entry to the terrestrial environment are from the use of veterinary medicines in intensively reared livestock, via the application of slurry and manure to land, and by the use of veterinary medicines in pasture-reared animals where pharmaceutical residues are excreted directly into the environment. Veterinary medicines applied to land via spreading of slurry may also enter the aquatic environment indirectly via surface runoff or leaching to groundwater. It is likely that topical treatments have greater potential to be released to the environment than treatments administered orally or by injection. Inputs from the manufacturing process, companion animal treatments, and disposal are likely to be minimal in comparison. Monitoring studies demonstrate that veterinary medicines do enter the environment, with sheep dip chemicals, antibiotics, sealice treatments, and anthelmintics being measured in soils, groundwater, surface waters, sediment, or biota. Maximum concentrations vary across chemical classes, with very high concentrations being reported for the sheep dip chemicals. The degree to which veterinary medicines may adsorb to particulates varies widely. Partition coefficients (K(d)) range from low (0.61 L kg(-1)) to high

  7. Health risk from veterinary antimicrobial use in China's food animal production and its reduction.

    Science.gov (United States)

    Hu, Yuanan; Cheng, Hefa

    2016-12-01

    The overuse and misuse of veterinary drugs, particularly antimicrobials, in food animal production in China cause environmental pollution and wide food safety concerns, and pose public health risk with the selection of antimicrobial resistance (AMR) that can spread from animal populations to humans. Elevated abundance and diversity of antimicrobial resistance genes (ARGs) and resistant bacteria (including multi-drug resistant strains) in food-producing animals, food products of animal origin, microbiota of human gut, and environmental media impacted by intensive animal farming have been reported. To rein in drug use in food animal production and protect public health, the government made a total of 227 veterinary drugs, including 150 antimicrobial products, available only by prescription from licensed veterinarians for curing, controlling, and preventing animal diseases in March 2014. So far the regulatory ban on non-therapeutic use has failed to bring major changes to the long-standing practice of drug overuse and misuse in animal husbandry and aquaculture, and significant improvement in its implementation and enforcement is necessary. A range of measures, including improving access to veterinary services, strengthening supervision on veterinary drug production and distribution, increasing research and development efforts, and enhancing animal health management, are recommended to facilitate transition toward rational use of veterinary drugs, particularly antimicrobials, and to reduce the public health risk arising from AMR development in animal agriculture. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Quantification of sibutramine and its two metabolites in human plasma by LC–ESI-MS/MS and its application in a bioequivalence study

    Directory of Open Access Journals (Sweden)

    Venkata Suresh Ponnuru

    2012-08-01

    Full Text Available Obesity can be considered as a chronic illness of epidemic proportion and its incidents have increased exponentially in recent years. The use of anti-obesity drugs such as sibutramine is somewhat helpful. There is a need to quantify such drugs in biological samples, which is generally quite difficult. In this report, we developed and validated a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS method for the quantification of sibutramine (SB and its two metabolites N-des methyl sibutramine (DSB and N-di desmethyl sibutramine (DDSB in human plasma. Zorbax SB-C18 (4.6 mm×75 mm, 3.5 μm, 80 Å analytical column and 5 mM ammonium formate:acetonitrile (10:90, v/v mobile phase were used for chromatographic separation of SB, DSB and DDSB. Multiple reaction monitoring (MRM in the positive mode was used to detect SB, DSB and DDSB at m/z 280.3/124.9, 266.3/125.3 and 252.2/124.9, respectively. Liquid–liquid extraction was used for the extraction of analytes and internal standard from human plasma. This method was validated over a linear concentration range of 10.0–10,000.0 pg/mL for SB, DSB and DDSB with correlation coefficients (r of ≥0.9997. The drug and the two metabolites were stable in plasma samples. The validated method was successfully applied in a bioequivalence and pharmacokinetic study with human volunteers under fasting condition. Keywords: LC–ESI-MS/MS, Sibutramine, Human plasma, Bioequivalence, Pharmacokinetic study

  9. A Clinical Pharmacology Course for Veterinary Students.

    Science.gov (United States)

    Paulsen, Lynn Mulcahy

    1983-01-01

    A one-semester, two-credit course is described that was developed cooperatively by the colleges of pharmacy and veterinary medicine at Washington State University to help resolve an acute shortage of clinical pharmacologists in veterinary medicine and veterinary medical education. Course procedures, content, and evaluation are outlined (MSE)

  10. 7 CFR 371.4 - Veterinary Services.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Veterinary Services. 371.4 Section 371.4 Agriculture..., DEPARTMENT OF AGRICULTURE ORGANIZATION, FUNCTIONS, AND DELEGATIONS OF AUTHORITY § 371.4 Veterinary Services. (a) General statement. Veterinary Services (VS) protects and safeguards the Nation's livestock and...

  11. Fosfomycin: Uses and potentialities in veterinary medicine

    Directory of Open Access Journals (Sweden)

    D.S. Pérez

    2014-03-01

    Full Text Available Fosfomycin (FOS is a natural bactericidal broad-spectrum antibiotic which acts on proliferating bacteria by inhibiting cell wall and early murein/peptidoglycan synthesis. Bactericidal activity is evident against Gram positive and Gram negative bacteria and can also act synergistically with other antibiotics. Bacterial resistance to FOS may be natural or acquired. Other properties of this drug include inhibition of bacterial adhesion to epithelial cells, exopolysaccharide biofilm penetration, immunomodulatory effect, phagocytosis promotion and protection against the nephrotoxicity caused by other drugs. FOS has chemical characteristics not typically observed in organic phosphoric compounds and its molecular weight is almost the lowest of all the antimicrobials. It tends to form salts easily due to its acidic nature (disodium salt, for intravenous (IV, intramuscular (IM and subcutaneous (SC administration; calcium and trometamol salt: for oral (PO administration. FOS has a very low protein binding (<0.5% which, along with its low molecular weight and water solubility, contributes to its good diffusion into fluids (cerebrospinal fluid, aqueous and vitreous humor, interstitial fluid and tissues (placenta, bone, muscle, liver, kidney and skin/fat. In all species, important differences in the bioavailability have been found after administration in relation to the various derivatives of FOS salts. Pharmacokinetic profiles have been described in humans, chickens, rabbits, cows, dogs, horses and weaning piglets. The low toxicity and potential efficacy of FOS are the main factors that contribute to its use in humans and animals. Thus, it has been used to treat a broad variety of bacterial infections in humans, such as localized peritonitis, brain abscesses, severe soft tissue infections, cystitis and other conditions. In veterinary medicine, FOS is used to treat infectious diseases of broiler chickens and pigs. In broilers, it is administered for the

  12. Understanding veterinary leadership in practice.

    Science.gov (United States)

    Pearson, Caroline Elizabeth; Butler, Allan J; Murray, Yaqub Paul

    2018-04-21

    The Vet Futures Report has identified 'exceptional leadership' as a key ambition for the long-term sustainability of the industry. This research investigates what it is like to be a veterinary surgeon in an in-practice leadership position, applying the qualitative methodology of interpretative phenomenological analysis. Through the researchers' interpretation of the seven participants' stories of their leadership experiences, the study advances understanding of the work environment, underlying motivations and the perceived responsibilities of veterinary leaders. Findings suggest, for many, a struggle in transition to leader positions, improving with time. The increase in pace of work is relayed by participants, with an ongoing, and unchallenged, work-life imbalance. The vets involved are highly motivated, driven by enjoyment of their jobs, a desire for self-determination and a need to make a difference. Relationships form the core of the perceived responsibilities, and yet are identified as the greatest day-to-day challenge of leadership. This study offers a valuable insight for veterinary surgeons, suggesting the industry could benefit from pausing and reflecting on behaviours. With a greater understanding of the complexity of leadership and followership, progress can be made to enact positive changes for the future. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Veterinary Microbiology, 3rd Edition

    Science.gov (United States)

    Veterinary Microbiology, Third Edition is organized into four sections and begins with an updated and expanded introductory section on infectious disease pathogenesis, diagnosis and clinical management. The second section covers bacterial and fungal pathogens, and the third section describes viral d...

  14. African Journals Online: Veterinary Science

    African Journals Online (AJOL)

    Items 1 - 15 of 15 ... African Journals Online: Veterinary Science ... Browse By Category · Browse Alphabetically · Browse By Country · List All Titles · Free to read Titles This Journal is Open Access ... Life Sciences, Chemistry, Mathematics & Physics, Earth Sciences ... The Nigerian Journal of Animal Science (NJAS) is an official ...

  15. Radiation protection in veterinary medicine

    International Nuclear Information System (INIS)

    1991-01-01

    Diagnostic radiology is an essential part of present-day veterinary practice. The need for radiation protection exists because occupational exposure to ionizing radiation can result in deleterious effects that may manifest themselves not only in exposed individuals but in their descendants as well. These are respectively called somatic and genetic effects. Somatic effects are characterized by observable changes occurring in the body organs of the exposed individual. These changes may appear from within a few hours to many years later, depending on the amount and duration of exposure of the individual. In veterinary medicine, the possibility that anyone may be exposed to enough radiation to create somatic effect is extremely remote. Genetic effects are more a cause for concern at the lower doses used in veterinary radiology. Although the radiation doses may be small and appear to cause no observable damage, the probability of chromosomal damage in the germ cells, with the consequence of mutations, does exist. These mutations may give rise to genetic defects and therefore make these doses significant when applied to a large number of individuals. There are two main aspects of the problem to be considered. First, personnel working with X-ray equipment must be protected from excessive exposure to radiation during their work. Secondly, personnel in the vicinity of veterinary X-ray facilities and the general public require adequate protection

  16. Zimbabwe Veterinary Journal: Editorial Policies

    African Journals Online (AJOL)

    Focus and Scope. Zimbabwe Veterinary Journal contains original and review papers on all aspects of animal health in Zimbabwe and SADC countries, including articles by non-veterinarians. Section Policies. Articles. Checked Open Submissions, Checked Indexed, Checked Peer Reviewed. Publication Frequency.

  17. Bioequivalence assessment of rifampicin, isoniazid and pyrazinamide in a fixed dose combination of rifampicin, isoniazid, pyrazinamide and ethambutol vs. separate formulations.

    Science.gov (United States)

    Agrawal, S; Singh, I; Kaur, K J; Bhade, S R; Kaul, C L; Panchagnula, R

    2002-10-01

    Depending on the patient category, tuberculosis requires treatment with 3 to 5 drugs which means that patient's compliance to therapy may not be optimal. To increase patient's adherence to treatment schedules, these drugs can be given as single drug preparations or fixed dose combinations (FDCs) of 2 or more drugs in a single formulation. However, an important issue associated with a rifampicin-containing FDC is its quality. Hence, to avoid spurious formulations entering the market, the World Health Organization and the International Union Against Tuberculosis and Lung Disease have recommended FDCs only of proven bioavailability. In this study, the relative bioavailability of rifampicin, isoniazid and pyrazinamide was assessed in a group of 14 healthy male subjects using the FDC tablet containing 4 drugs versus separate formulations at the same dose levels. The study was designed as an open, crossover trial. A total of 9 blood samples were collected over a period of 24 h. The concentration of rifampicin, its main metabolite desacetyl rifampicin, isoniazid and pyrazinamide in plasma were assessed using HPLC analysis. The pharmacokinetic parameters AUC(0-24) and Cmax were subjected to parametric and non-parametric statistical tests at 90% confidence interval. In addition, time to reach peak concentration (tmax), elimination rate constant (Kel) and terminal elimination half-life (t1/2) for each drug were also calculated. It was concluded that the FDC tablet containing 4 drugs is bioequivalent to separate rifampicin, isoniazid and pyrazinamide formulations at the same dose levels.

  18. Veterinary clinical nutrition: success stories: an overview.

    Science.gov (United States)

    Davies, Mike

    2016-08-01

    In this overview of success stories in veterinary clinical nutrition topics in cats and dogs reviewed include the dietary management of chronic kidney disease, dissolution of urinary tract uroliths by dietary modification, the recognition that taurine and L-carnitine deficiencies can cause dilated cardiomyopathy; that clinical signs associated with feline hyperthyroidism (caused by a benign adenoma) can be controlled by a low-iodine diet alone; that dietary management of canine osteoarthritis can also reduce non-steroidal anti-inflammatory drug doses; and that disease-free intervals and survival times can be statistically longer in dogs with Stage III lymphoma managed with diet. As we discover more about nutrigenetics and nutrigenomics, and as we expand our basic understanding of idiopathic diseases we are bound to identify more nutritionally related causes, and be able to develop novel dietary strategies to manage disease processes, including the formulation of diets designed to alter gene expression to obtain beneficial clinical outcomes.

  19. Drug Development Process

    Science.gov (United States)

    ... Preclinical Research Preclinical Research Drugs undergo laboratory and animal testing to answer basic questions about safety. More Information ... Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  20. Determination of itopride hydrochloride in human plasma by RP-HPLC with fluorescence detection and its use in bioequivalence study.

    Science.gov (United States)

    Ma, Jing; Yuan, Li-Hua; Ding, Mei-Juan; Zhang, Jun; Zhang, Qing; Xu, Qun-Wei; Zhou, Xue-Min

    2009-03-01

    A sensitive, selective and simple method using a precipitation of protein with 10% perchloric acid, followed by high-performance liquid chromatography (HPLC) with fluorescence detection was developed for the determination of itopride hydrochloride in human plasma, using levofloxacin as the internal standard (IS). Chromatographic separation was obtained within 7.0 min using a reverse phase Hypersil BDS C(18) (250 mm x 4.6 mm, 5 microm) column and an isocratic mobile phase, constituting of a mixture of 0.1 mol/l ammonium acetate-methanol (30:70, v/v) flowing at 1.1 ml/min. The excitation and emission wavelengths were set at 304 and 344 nm, respectively. The method was validated over the concentration range of 5 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 5 ng/ml. The extractive recovery of itopride hydrochloride from the biological matrix was more than 80.77%. The intra-day accuracy of the drug containing serum samples was more than 82.94% with a precision of 2.81-4.37%. The inter-day accuracy was 82.91% or more, with a precision of 6.89-9.54%. The limit we have used (70-143%) is based on the local regulatory authority (SFDA). The developed method was validated and successfully applied to bioequivalence studies of itopride hydrochloride in healthy male volunteers.

  1. Veterinary Homeopathy: The Implications of Its History for Unorthodox Veterinary Concepts and Veterinary Medical Education.

    Science.gov (United States)

    Coulter, Dwight B.

    1979-01-01

    The history of veterinary homeopathy, its future and implications are discussed. The need for investigation into the validity of both allopathic and homeopathic claims is stressed and it is suggested that maintenance of quality is the key factor in any approach. (BH)

  2. Factors that influencing veterinary drug’s metabolisation

    Directory of Open Access Journals (Sweden)

    Cristina, Romeo T.

    2007-12-01

    Full Text Available The paper wants to make a recall for the vet practitioners, of the main veterinary drug's metabolism rate influencing factors. Among the most important physiological factors (pharmacokinetics, sanguine flow and urinary ones, plasmatic proteins binding, enzymatic induction and inhibition are essential. Between the animal’s bounded factors more important are: species, individuality, age, sex, pregnancy, alimentation, genetic factors, and health status and from exogenous factors, daily rhythm, influences of chemical compounds and of the stress are presented.

  3. Pharmacokinetic and bioequivalence studies of immediate release diclofenac potassium tablets (50mg) in healthy volunteers.

    Science.gov (United States)

    Ali, Huma; Shoaib, Muhammad Harris; Zafar, Farya; Hanif, Muhammad; Bushra, Rabia; Naz, Asia; Khursheed, Raheela

    2016-09-01

    This study was conducted with the aim to determine the pharmacokinetic and bioequivalence of diclofenac potassium 50 mg test (F4) tablet formulation with reference product (Caflam). Present study was single dose, randomized, two phase cross over design, conducted in 12 healthy Pakistani volunteers and planned in accordance with FDA guidelines. In this study a simple, selective, sensitive and reproducible HPLC procedure was developed and validated for the estimation of diclofenac potassium in plasma. The process was validated in the range of 50 - 0.05 µg.mL-1 and used in bioequivalence trial of two products. Multiple blood samples were collected at various time points (0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 14 hr after treating volunteers with test (F4) and marketed reference brand. Plasma separation and deproteination were carried out with acetonitrile; samples (20µL) were injected using the validated HPLC method. Various pharmacokinetic parameters (compartmental and noncompartmental) were estimated using KineticaTM 4.4.1 (Thermo Electron Corp. USA). Bioequivalence among the products was established by calculating the 90% CI with log and non log transformed data for Cmaxcalc, Tmaxcalc, AUC0-∞, AUCtot and AUClast using two way ANOVA and Schirmann's Two one sided t- test. No significant difference was found between log and non-log data. The 90% confidence interval values using log transformed data for AUC0-∞ (0.997-1.024), AUCtot (1.004-1.031), AUClast (0.997 -1.024), Cmaxcalc (0.994-1.007) and Tmaxcalc (0.996-1.013) for the trial and reference products were found within the FDA acceptable limits of 0.8-1.25. Results were further verified by the Schirmann's one-sided t test. Results showed the bioequivalence of test and reference formulations. Both the products were well tolerated.

  4. Bioequivalence of eslicarbazepine acetate from two different sources of its active product ingredient in healthy subjects.

    Science.gov (United States)

    Falcão, Amílcar; Lima, Ricardo; Sousa, Rui; Nunes, Teresa; Soares-da-Silva, Patrício

    2013-06-01

    To compare the bioavailability (BA) and pharmacokinetic (PK) properties and to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL) in healthy volunteers. Forty healthy male and female subjects aged 18-40 years were randomized to treatment with 400 or 800 mg ESL marketed (MF) formulation [current active pharmaceutical ingredient (API) source] and 400 or 800 mg ESL to-be-marketed (TBM) formulation (new API source) under a gender-balanced, two-period, two-sequence crossover open-label study design. Subjects were assigned to receive either 400 or 800 mg ESL dose strengths, and each was randomly administered on two occasions--either a single oral tablet of MF or a single oral tablet of TBM--separated by a washout period of at least 7 days. Formulations were to be considered bioequivalent if, for both 400 or 800 mg ESL dosage strengths, the test (TBM)/reference (MF) geometric mean ratios (GMR) and 90% confidence intervals (90% CI) of the area under the plasma concentration-time curve (AUC) and peak plasma concentration (Cmax) were within the predetermined range of 80-125%. Test/reference GMR (90% CI) for the Cmax and AUC was respectively 100% (94-109%) and 96% (94-98%) following 400 mg ESL and 100% (95-105%) and 100% (97-103%) following 800 mg ESL. Oral tablet formulations of either 400 or 800 mg ESL from the new API source were found to be bioequivalent to the corresponding marketed Zebinix® formulation according to the regulatory definition of bioequivalence.

  5. bioequivalence study on two 10% enrofloxacin oral formulations

    African Journals Online (AJOL)

    AONDOVER

    sampled before and after drug administration for 24 hours. Plasma enrofloxacin ... Pharmacokinetic studies have indicated ... variation of the inhibitory effect of antibiotics on .... These factors determine .... dependent, the in vivo performance of.

  6. Piroxicam immediate release formulations: A fasting randomized open-label crossover bioequivalence study in healthy volunteers.

    Science.gov (United States)

    Helmy, Sally A; El-Bedaiwy, Heba M

    2014-11-01

    Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated. © 2014, The American College of Clinical Pharmacology.

  7. Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulations.

    Science.gov (United States)

    Lionberger, Robert A; Raw, Andre S; Kim, Stephanie H; Zhang, Xinyuan; Yu, Lawrence X

    2012-04-01

    FDA's bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modified-release dosage forms. Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times. Deconvolution techniques, In Vitro/In Vivo Correlations, and the CAT (Compartmental Absorption and Transit) model were used to predict the PK profiles for zolpidem. Models were validated using in-house data submitted to the FDA. Using dissolution profiles expressed by the Weibull model as input for the CAT model, dissolution spaces were derived for simulated test formulations. The AUC(0-1.5) parameter was indicative of IR characteristics of early exposure and effectively distinguished among formulations that produced different pharmacodynamic effects. The AUC(1.5-t) parameter ensured equivalence with respect to the sustained release phase of Ambien CR. The variability of AUC(0-1.5) is higher than other PK parameters, but is reasonable for use in an equivalence test. In addition to the traditional PK parameters of AUCinf and Cmax, AUC(0-1.5) and AUC(1.5-t) are recommended to provide bioequivalence measures with respect to label indications for Ambien CR: onset of sleep and sleep maintenance.

  8. Veterinary vaccines against Toxoplasma gondii

    Directory of Open Access Journals (Sweden)

    Elisabeth A Innes

    2009-03-01

    Full Text Available Toxoplasma gondii has a very wide intermediate host range and is thought to be able to infect all warm blooded animals. The parasite causes a spectrum of different diseases and clinical symptoms within the intermediate hosts and following infection most animals develop adaptive humoral and cell-mediated immune responses. The development of protective immunity to T. gondii following natural infection in many host species has led researchers to look at vaccination as a strategy to control disease, parasite multiplication and establishment in animal hosts. A range of different veterinary vaccines are required to help control T. gondii infection which include vaccines to prevent congenital toxoplasmosis, reduce or eliminate tissue cysts in meat producing animals and to prevent oocyst shedding in cats. In this paper we will discuss some of the history, challenges and progress in the development of veterinary vaccines against T. gondii.

  9. Bioequivalence of generic lamotrigine 100-mg tablets in healthy Thai male volunteers: a randomized, single-dose, two-period, two-sequence crossover study.

    Science.gov (United States)

    Srichaiya, Arunee; Longchoopol, Chaowanee; Oo-Puthinan, Sarawut; Sayasathid, Jarun; Sripalakit, Pattana; Viyoch, Jarupa

    2008-10-01

    Lamotrigine is an antiepileptic drug which has been used in the treatment of epilepsy and bipolar disorder. A search of the literature did not find previously published bioequivalence and pharmacokinetic evaluations of lamotrigine in healthy Thai male volunteers. The aim of this study was to compare the pharmacokinetic parameters between 2 brands of lamotrigine in healthy Thai male volunteers. A randomized, single-dose, 2-period, 2-sequence, crossover study design with a 2-week washout period was conducted in healthy Thai males. Subjects were randomized to receive either the test or reference formulation in the first period. All subjects were required to be nonsmokers and without a history of alcohol or drug abuse. Plasma samples were collected over a 120-hour period after 100-mg lamotrigine administration in each period. A validated high-performance liquid chromatography ultraviolet method was used to analyze lamotrigine concentration in plasma. Pharmacokinetic parameters were determined using a noncompartmental method. Bioequivalence between the test and reference products, as defined by the US Food and Drug Administration (FDA), is determined when the ratio for the 90% CIs of the difference in the means of the log-transformed AUC(0-t), AUC(0-infinity), and C(max) of the 2 products are within 0.80 and 1.25. Adverse events were determined by measuring vital signs after dosing. Subjects were also asked if they suffered from undesirable effects such as nausea, vomiting, dizziness, and headache. This bioequivalence study was performed in 24 healthy Thai males (mean [SD] age, 20.5 [1.3] years; range, 19-24 years; weight, 62.5 [7.4] kg; height, 172.8 [6.9] cm; body mass index, 20.9 [2.0] kg/m(2)). The mean (SD) C(max) and T(max) of the test formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.2 (0.9) hours, respectively. The mean (SD) C(max) and T(max) of the reference formulation of lamotrigine were 1.7 (0.3) microg/mL and 1.4 (1.0) hours, respectively. The mean

  10. Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

    Directory of Open Access Journals (Sweden)

    Zhang Y

    2017-07-01

    Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

  11. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2002 – February 2003

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2003-07-01

    Full Text Available 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.

  12. Veterinary School Applicants: Financial Literacy and Behaviors.

    Science.gov (United States)

    Carr, McKensie M; Greenhill, Lisa M

    2015-01-01

    Each year the Association of American Veterinary Medical Colleges (AAVMC) conducts a survey after the close of the Veterinary Medical College Application Service (VMCAS) application. The survey provides a glimpse into applicant behavior surrounding the veterinary school application process. Additional survey questions probe into applicant financial behaviors, use of financial products and services, and pet ownership. This article examines the 2013 survey data from applicants who successfully completed the application, with a focus on applicant financial literacy and behaviors. Data from the study revealed a disconnect between applicants' perception of their ability to deal with day-to-day finances and their actual financial behaviors, particularly for first-generation college student applicants and applicants who are racially/ethnically underrepresented in veterinary medicine (URVM). Many applicants were not able to accurately report the average veterinary school graduate's student debt level, which suggests the potential need for better education about the costs associated with attending veterinary school.

  13. Veterinary Business Management Association presents program to aid future growth and stability of veterinary profession

    OpenAIRE

    Douglas, Jeffrey S.

    2008-01-01

    Spiraling veterinary student debt and the lack of a sustainable and profitable business model for many private practices in the modern business environment threaten the future growth and stability of the veterinary profession.

  14. Drug: D02601 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D02601 Drug Phenothiazine (INN); Thiodiphenylamin; Nemazine [veterinary] (TN) ... C12...H9NS D02601.gif ... veterinary medicine ... CAS: 92-84-2 PubChem: 17396771 ChEMBL: CHEMBL828 LigandBox: D02601 NIKKAJI: J3.932B ...

  15. Drug: D03867 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D03867 Drug Dirlotapide (USAN/INN); Slentrol [veterinary] (TN) ... C40H33F3N4O3 D0386...7.gif ... Not for use in humans. veterinary medicine - Treatment of obesity in companion animals (dogs) M

  16. Drug: D04140 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D04140 Drug Fenbendazole (USP/INN); Panacur [veterinary] (TN) ... C15H13N3O2S D04140....gif ... ATC code: P02CA06 ... Benzimidazole derivative veterinary medicine ... CAS: 43210-67-9 PubChem: 47206087 ChEBI: 77092 ChEMBL: CHEMBL37161 LigandBox: D04140 NIKKAJI: J15.833J ...

  17. Drug: D07730 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D07730 Drug Cloprostenol (INN); Dalmazin [veterinary] (TN) ... C22H29ClO6 D07730.gif ... ... Prostaglandin derivative veterinary medicine ... CAS: 40665-92-7 PubChem: 51092026 LigandBox: D07730 NIKKAJI: J299.284A ...

  18. Drug: D08150 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D08150 Drug Lufenuron (INN); Program [veterinary] (TN) ... C17H8Cl2F8N2O3 D08150.gif ... ... Same as: C18434 ... Benzoyl phenylurea derivative veterinary medicine ... CAS: 103055-07-8 PubChem: 96024840 ChEBI: 39384 ChEMBL: CHEMBL1364906 LigandBox: D08150 NIKKAJI: J481.190I ...

  19. Drug: D08391 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D08391 Drug Pirlimycin (INN); Pirsue [veterinary] (TN) ... C17H31ClN2O5S D08391.gif ... ... ... Antibacterial ... DG01578 ... Lincosamide antibiotic Chemical group: DG01577 ... Lincosamide Target: 50S ribosomal subunit (veterinary

  20. Drug: D10034 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D10034 Drug Tylvalosin tartrate (USAN); Aiviosin [veterinary] (TN) ... C53H87NO19. (C... 50S ribosomal subunit (veterinary) ... CAS: 63428-13-7 PubChem: 135626754 LigandBox: D10034 ... ... and porcine proliferative enteropathy caused by Lawsonia intracellularis Target:

  1. Development and validation of a liquid chromatography-tandem mass spectrometry method for topotecan determination in beagle dog plasma and its application in a bioequivalence study.

    Science.gov (United States)

    Ye, Ling; Shi, Jian; Wan, Shanhe; Yang, Xiaoshan; Wang, Ying; Zhang, Jiajie; Zheng, Dayong; Liu, Zhongqiu

    2013-11-01

    Topotecan (TPT) is an important anti-cancer drug that inhibits topoisomerase I. A sensitive and robust liquid chromatography-tandem mass spectrometry (LC-MS/MS) method that potentially determines TPT in beagle dog plasma is needed for a bioequivalence study of TPT formulations. We developed and validated LC-MS/MS to evaluate TPT in beagle dog plasma in terms of specificity, linearity, precision, accuracy, stability, extraction recovery and matrix effect. Plasma samples were treated with an Ostro(TM) sorbent plate (a robust and effective tool) to eliminate phospholipids and proteins before analysis. TPT and camptothecin (internal standard) were separated on an Acquity UPLC BEH C18 column (1.7 µm, 2.1 × 50 mm) with 0.1% formic acid and methanol as the mobile phase at a flow rate of 0.25 mL/min. TPT was analyzed using positive ion electrospray ionization in multiple-reaction monitoring mode. The obtained lower limit of quantitation was 1 ng/mL (signal-to-noise ratio > 10). The standard calibration curve for TPT was linear (correlation coefficient > 0.99) at the concentration range of 1-400 ng/mL. The intra-day and inter-day precision, accuracy, stability, extraction recovery and matrix effect of TPT were within the acceptable limits. The validated method was successfully applied in a bioequivalence study of TPT in healthy beagle dogs. Copyright © 2013 John Wiley & Sons, Ltd.

  2. Privatizing community animal health worker based veterinary ...

    African Journals Online (AJOL)

    Privatizing community animal health worker based veterinary services delivery system in West Kordofan, Southern Sudan; The needed roles of community animal health assistant (CAHA) and Pastoral unions.

  3. Use of antimicrobials in veterinary medicine and mechanisms of resistance.

    Science.gov (United States)

    Schwarz, S; Chaslus-Dancla, E

    2001-01-01

    This review deals with the application of antimicrobial agents in veterinary medicine and food animal production and the possible consequences arising from the widespread and multipurpose use of antimicrobials. The various mechanisms that bacteria have developed to escape the inhibitory effects of the antimicrobials most frequently used in the veterinary field are reported in detail. Resistance of bacteria to tetracyclines, macrolide-lincosamide-streptogramin antibiotics, beta-lactam antibiotics, aminoglycosides, sulfonamides, trimethoprim, fluoroquinolones and chloramphenicol/florfenicol is described with regard to enzymatic inactivation, decreased intracellular drug accumulation and modification/protection/replacement of the target sites. In addition, basic information is given about mobile genetic elements which carry the respective resistance genes, such as plasmids, transposons, and gene cassettes/integrons, and their ways of spreading via conjugation, mobilisation, transduction, and transformation.

  4. 78 FR 23742 - Nomination Form of Veterinary Shortage Situations for the Veterinary Medicine Loan Repayment...

    Science.gov (United States)

    2013-04-22

    ... DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Nomination Form of Veterinary Shortage Situations for the Veterinary Medicine Loan Repayment Program (VMLRP) AGENCY: National Institute... information collection for the Veterinary Medicine Loan Repayment Program (VMLRP). This notice initiates a 30...

  5. Introduction to veterinary clinical oncology

    Energy Technology Data Exchange (ETDEWEB)

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  6. Ethical dilemmas in veterinary medicine.

    Science.gov (United States)

    Morgan, Carol A; McDonald, Michael

    2007-01-01

    Veterinarians frequently encounter situations that are morally charged and potentially difficult to manage. Situation involving euthanasia, end-of-life care, economics, and inadequate provision of care create practical and moral dilemmas. Ethical tension may be attributable to differences in beliefs regarding the moral value of animals, client and veterinary responsibilities, and deciding what is best for an animal. Veterinarians can employ communication skills used in medical situations to explore the reasons underpinning ethical dilemmas and to search for solutions with clients, staff, and colleagues.

  7. 77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

    Science.gov (United States)

    2012-03-19

    ... Laboratories, Inc. The NADA provides for the veterinary prescription use of phenylpropanolamine hydrochloride... Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276... Ely Rd., Pensacola, FL 32514, filed NADA 141-324 that provides for the veterinary prescription use of...

  8. Establishment of in vitro-in vivo equivalence of highly variable drugs - a generic product development perspective.

    Science.gov (United States)

    Pathak, Shriram M; Aggarwal, Deepika; Venkateswarlu, V

    2014-06-01

    In vivo equivalence of highly variable drugs (HVD) has always been a subject of great concern, in terms of both safety and efficacy, for regulatory agencies. Successful demonstration of their bioequivalence thus presents the most crucial component of a generic application, significantly contributing toward the cost and time of development. For poorly soluble drugs, such as telmisartan, dissolution represents the rate-limiting step in the gastric region and in many cases may not be complete, thereby contributing to low and highly variable bioavailability. Consequently, simulation of gastrointestinal conditions is essential to adequately predict the in vivo behavior of drug formulations. In this study, we evaluated usefulness of physiologically relevant dissolution method over commonly used acidic media to forecast comparable in vivo performance of telmisartan formulation to that of reference samples. In the present study, telmisartan was classified as a HVD and a partial replicate design with repeating the reference product and scaling the bioequivalence for the reference variability has been presented. The design has effectively decreased sample size, without increasing patient risk. Results from this project suggest that scaled average bioequivalence (SABE) provides a good approach for evaluating the bioequivalence of HVD, meeting the need for international guidelines for bioequivalence.

  9. Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base.

    Science.gov (United States)

    García-Arieta, Alfredo; Ferrero-Cafiero, Juan Manuel; Puntes, Montse; Gich, Ignasi; Morales-Alcelay, Susana; Tarré, Maite; Font, Xavier; Antonijoan, Rosa Maria

    2016-05-01

    The purpose was to assess the impact of the use of a chiral bioanalytical method on the conclusions of a bioequivalence study that compared two ibuprofen suspensions with different rates of absorption. A comparison of the conclusion of bioequivalence between a chiral method and an achiral approach was made. Plasma concentrations of R-ibuprofen and S-ibuprofen were determined using a chiral bioanalytical method; bioequivalence was tested for R-ibuprofen and for S-ibuprofen separately and for the sum of both enantiomers as an approach for an achiral bioanalytical method. The 90% confidence interval (90% CI) that would have been obtained with an achiral bioanalytical method (90% CI: Cmax: 117.69-134.46; AUC0 (t) : 104.75-114.45) would have precluded the conclusion of bioequivalence. This conclusion cannot be generalized to the active enantiomer (90% CI: Cmax : 103.36-118.38; AUC0 (t) : 96.52-103.12), for which bioequivalence can be concluded, and/or the distomer (90% CI: Cmax : 132.97-151.33; AUC0 (t) : 115.91-135.77) for which a larger difference was observed. Chiral bioanalytical methods should be required when 1) the enantiomers exhibit different pharmacodynamics and 2) the exposure (AUC or Cmax ) ratio of enantiomers is modified by a difference in the rate of absorption. Furthermore, the bioequivalence conclusion should be based on all enantiomers, since the distomer(s) might not be completely inert, in contrast to what is required in the current regulatory guidelines. In those cases where it is unknown if the ratio between enantiomers is modified by changing the rate of absorption, chiral bioanalytical methods should be employed unless enantiomers exhibit the same pharmacodynamics. Chirality 28:429-433, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Veterinary Preventive Medicine Curriculum Development at Louisiana State University

    Science.gov (United States)

    Hubbert, William T.

    1976-01-01

    The program aims at training veterinarians, with interdepartmental faculty participation the rule rather than the exception. Included in the curriculum are: avian medicine, herd health management, veterinary public health, veterinary food hygiene, and regulatory veterinary medicine. (LBH)

  11. Pharmacokinetic bioequivalence studies of a fixed-dose combination of tamsulosin and dutasteride in healthy volunteers.

    Science.gov (United States)

    Fossler, Michael J; Collins, David A; Thompson, Meg M; Nino, Antonio; Bianco, Joseph J; Chetty, Dushen

    2014-05-01

    The combination of dutasteride and tamsulosin may be more effective for the treatment of symptomatic benign prostatic hyperplasia than either treatment alone. We report the results of three pharmacokinetics and tolerability studies, which used a dutasteride/tamsulosin HCl (0.5 mg/0.2 mg) fixed-dose combination (FDC) capsules containing a small dutasteride soft gelatin capsule (smaller than commercial Avodart™) and modified-release tamsulosin pellets that have different amounts of enteric coating. These studies compared the test products to commercial Avodart™ (dutasteride 0.5 mg) and two different commercial tamsulosin HCl 0.2 mg products, Harnal™ Capsules or Harnal-D™ Tablets, which are reportedly bioequivalent to each other. All three studies were randomized single-dose studies in healthy male adults. Study 1 [N = 86 (NCT01254071)] was a two-period crossover study of a dutasteride/tamsulosin HCl FDC versus coadministered Avodart™ and Harnal-D™ Tablets. The pharmacokinetics of both dutasteride and tamsulosin were studied. Study 2 [N = 27 (NCT01471678)] was a four-period crossover study of dutasteride/tamsulosin HCl FDC formulations versus Avodart™ and Harnal™ Capsules or Harnal-D™ Tablets. Only the pharmacokinetics of tamsulosin were studied. Study 3 [N = 40 (NCT01495026)] was a two-period study of dutasteride/tamsulosin HCl FDC formulations versus coadministered Avodart™ and Harnal-D™ Tablets. In this study, only the pharmacokinetics of tamsulosin were studied. Study 2 assessed fed-state pharmacokinetics. Studies 1 and 3 assessed fed- and fasted-state pharmacokinetics. All dutasteride/tamsulosin HCl FDC formulations and coadministered treatments were well-tolerated. In Study 1, the FDC dutasteride was bioequivalent to Avodart™ coadministered with tamsulosin under fed and fasted conditions. In Study 1, the FDC tamsulosin had a slower release than commercial Harnal-D™ Tablets coadministered with dutasteride (fed and fasted

  12. Pharmacokinetic comparison and bioequivalence evaluation of losartan/ hydrochlorothiazide tablet between Asian Indian and Japanese volunteers.

    Science.gov (United States)

    Kumar, Sudershan; Monif, Tausif; Khuroo, Arshad; Reyar, Simrit; Jain, Rakesh; Singla, Ajay K; Kurachi, Kazuya

    2014-01-01

    To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan, losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers. Randomized, open-label, crossover, bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers. One tablet either of test or of reference product was administered after 10 hours of overnight fasting. After dosing, serial blood samples were collected for a period of 48 hours for both the studies. Plasma samples were analyzed for losartan, losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method (LC-MS/MS). The pharmacokinetic parameters AUC0-t, AUC0-∞, Cmax, tmax, and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets. Statistical evaluations were done to evaluate bioequivalence between generic test formulation (EPR0001) and Japanese reference product (Preminent®). Losartan, losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions. No serious adverse events were observed. The ratios of least square means for AUC0-t and Cmax and the affiliated 90% confidence intervals were within acceptance range recommended by PMDA. Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers. The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg (EPR0001) tablets is bioequivalent to marketed Preminent® reference formulation in Asian Indian and Japanese volunteers, when administered under fasting conditions. Both test and reference formulations were well tolerated

  13. A new era in veterinary immunology

    NARCIS (Netherlands)

    Halliwell, R.E.W.; Goudswaard, J.

    1979-01-01

    The importance of the creation of a new international journal of “Veterinary Immunology and Immunopathology” is apparent following the emergence of veterinary immunology as an identifiable discipline and the vital part played by investigations of animal models of immunological diseases of

  14. The ninth international veterinary immunology symposium

    Science.gov (United States)

    This Introduction to the special issue of Veterinary Immunology and Immunopathology summarizes the Proceedings of the 9th International Veterinary Immunology Symposium (9th IVIS) held August, 2010, in Tokyo, Japan. Over 340 delegates from 30 countries discussed research progress analyzing the immune...

  15. Veterinary Forensic Pathology: The Search for Truth.

    Science.gov (United States)

    McDonough, S P; McEwen, B J

    2016-09-01

    Veterinary forensic pathology is emerging as a distinct discipline, and this special issue is a major step forward in establishing the scientific basis of the discipline. A forensic necropsy uses the same skill set needed for investigations of natural disease, but the analytical framework and purpose of forensic pathology differ significantly. The requirement of legal credibility and all that it entails distinguishes the forensic from routine diagnostic cases. Despite the extraordinary depth and breadth of knowledge afforded by their training, almost 75% of veterinary pathologists report that their training has not adequately prepared them to handle forensic cases. Many veterinary pathologists, however, are interested and willing to develop expertise in the discipline. Lessons learned from tragic examples of wrongful convictions in medical forensic pathology indicate that a solid foundation for the evolving discipline of veterinary forensic pathology requires a commitment to education, training, and certification. The overarching theme of this issue is that the forensic necropsy is just one aspect in the investigation of a case of suspected animal abuse or neglect. As veterinary pathologists, we must be aware of the roles filled by other veterinary forensic experts involved in these cases and how our findings are an integral part of an investigation. We hope that the outcome of this special issue of the journal is that veterinary pathologists begin to familiarize themselves with not only forensic pathology but also all aspects of veterinary forensic science. © The Author(s) 2016.

  16. Making a difference through veterinary public health.

    Science.gov (United States)

    2016-06-11

    More than 100 people gathered in Birmingham on April 23 for the third joint conference of the Veterinary Public Health Association and the Association of Government Vets. With the theme of 'VPH hands on - making a difference together', the meeting considered the role vets play in society through their work on public health and sustainability. Kathryn Clark reports. British Veterinary Association.

  17. Veterinary Safety's Conflicts in the EAEU

    Science.gov (United States)

    Kalymbek, Bakytzhan; Shulanbekova, Gulmira K.; Madiyarova, Ainur S.; Mirambaeva, Gulnaz Zh.

    2016-01-01

    This article is devoted to the problem of veterinary safety of the countries under the Eurasian Economic Union. Animal health's measures are provided in order to prevent the entry and spread of infectious animal diseases, including common to humans and animals, as well as goods not conforming to the common veterinary and sanitary requirements.…

  18. 9 CFR 3.110 - Veterinary care.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Veterinary care. 3.110 Section 3.110 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE ANIMAL... Mammals Animal Health and Husbandry Standards § 3.110 Veterinary care. (a) Newly acquired marine mammals...

  19. Perceptions of veterinary admissions committee members of ...

    African Journals Online (AJOL)

    Veterinary admission committees are asked to create and implement a fair, reliable, and valid system to select the candidates most likely to succeed in veterinary school from a large pool of applicants. Although numerous studies have explored grade point average (GPA) as a predictive value of later academic success, ...

  20. The use of intravenous lipid emulsion as an antidote in veterinary toxicology.

    Science.gov (United States)

    Fernandez, Alberto L; Lee, Justine A; Rahilly, Louisa; Hovda, Lynn; Brutlag, Ahna G; Engebretsen, Kristin

    2011-08-01

    To review the use of IV lipid emulsion (ILE) for the treatment of toxicities related to fat-soluble agents; evaluate current human and veterinary literature; and to provide proposed guidelines for the use of this emerging therapy in veterinary medicine and toxicology. Human and veterinary medical literature. Human data are composed mostly of case reports describing the response to treatment with ILE as variant from mild improvement to complete resolution of clinical signs, which is suspected to be due to the variability of lipid solubility of the drugs. The use of ILE therapy has been advocated as an antidote in cases of local anesthetic and other lipophilic drug toxicoses, particularly in the face of cardiopulmonary arrest and unsuccessful cardiopulmonary cerebral resuscitation. The use of ILE therapy in veterinary medicine has recently been advocated by animal poison control centers for toxicoses associated with fat-soluble agents, but there are only few clinical reports documenting successful use of this therapy. Evidence for the use of ILE in both human and veterinary medicine is composed primarily from experimental animal data. The use of ILE appears to be a safe therapy for the poisoned animal patient, but is warranted only with certain toxicoses. Adverse events associated with ILE in veterinary medicine are rare and anecdotal. Standard resuscitation protocols should be exhausted before considering this therapy and the potential side effects should be evaluated before administration of ILE as a potential antidote in cases of lipophilic drug toxicoses. Further research is waranted. © Veterinary Emergency and Critical Care Society 2011.

  1. ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

    Science.gov (United States)

    Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P

    2012-03-01

    In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

  2. Teaching Veterinary Anesthesia: A Survey-Based Evaluation of Two High-Fidelity Models and Live-Animal Experience for Undergraduate Veterinary Students.

    Science.gov (United States)

    Musk, Gabrielle C; Collins, Teresa; Hosgood, Giselle

    In veterinary medical education, reduction, replacement, and refinement (the three Rs) must be considered. Three clinical skills in anesthesia were identified as challenging to students: endotracheal intubation, intravenous catheterization, and drug dose calculations. The aims of this project were to evaluate students' perception of their level of confidence in performing these three clinical skills in veterinary anesthesia, to document the extent of students' previous experience in performing these three tasks, and to describe students' emotional states during this training. Veterinary students completed a series of four surveys over the period of their pre-clinical training to evaluate the usefulness of high-fidelity models for skill acquisition in endotracheal intubation and intravenous catheterization. In addition, practice and ongoing assessment in drug dose calculations were performed. The curriculum during this period of training progressed from lectures and non-animal training, to anesthesia of pigs undergoing surgery from which they did not recover, and finally to anesthesia of dogs and cats in a neutering clinic. The level of confidence for each of the three clinical skills increased over the study period. For each skill, the number of students with no confidence decreased to zero and the proportion of students with higher levels of confidence increased. The high-fidelity models for endotracheal intubation and intravenous catheterization used to complement the live-animal teaching were considered a useful adjunct to the teaching of clinical skills in veterinary anesthesia. With practice, students became more confident performing drug dose calculations.

  3. Bioequivalence Studies of a Reformulated Dutasteride and Tamsulosin Hydrochloride Combination Capsule and a Commercially Available Formulation.

    Science.gov (United States)

    Kurczewski, Renee; Bowen, Chet; Collins, David; Zhu, John; Serbest, Gulyeter; Manyak, Michael

    2017-09-01

    A dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg combination (DTC) capsule (Duodart ® ) was reformulated to reduce the capsule size and enhance product stability. Bioequivalence of the reformulated DTC capsule with the commercial formulation was evaluated in 2 single-dose, open-label, randomized, 2-way crossover studies in healthy adult male volunteers. Subjects in a fasted or fed state received a single oral dose of either the reformulated DTC or the commercial formulation followed by a 28-day washout period between treatments. Blood samples were taken predose and up to 72 hours postdose for pharmacokinetic (PK) analysis of dutasteride and tamsulosin serum concentrations. From the serum concentration-vs-time data, a noncompartmental method was used to calculate the maximum observed serum concentration (C max ) and area under the serum concentration-time curve (AUC 0-t ) for dutasteride and tamsulosin, and AUC 0-∞ for tamsulosin. The 90% confidence intervals for the ratios of the C max and AUC 0-t (for dutasteride and tamsulosin) and for AUC 0-∞ (for tamsulosin) were all completely contained within the range of 80% to 125%; therefore, the reformulated DTC capsule is bioequivalent to the commercial formulation under both fed and fasted states. © 2017, The American College of Clinical Pharmacology.

  4. Domestic violence shelter partnerships and veterinary student attitudes at North American veterinary schools and colleges.

    Science.gov (United States)

    Creevy, Kate E; Shaver, Stephanie L; Cornell, Karen K

    2013-01-01

    Animal abuse and domestic violence are linked issues, and pet ownership is reported to play a crucial role in the choice to leave an abusive situation. Although veterinarians witness the effects of abuse and violence over the course of their careers, they have limited training regarding these issues. One mechanism for educating veterinary students while providing a service for victims of domestic violence is the creation of partnerships between domestic violence shelters and veterinary schools. These extracurricular programs can provide both care for pets belonging to victims of domestic violence and an educational platform for student participants. The goals of this study were to determine the prevalence and characteristics of domestic violence shelter partnerships (DVSPs) at North American veterinary teaching hospitals and to determine whether the presence of a DVSP was associated with increased awareness among veterinary students regarding animal abuse and domestic violence. Nine of 33 veterinary schools surveyed described a DVSP program. Students at schools with DVSPs associated with their veterinary teaching hospitals were significantly more likely to indicate that their awareness of the link between animal abuse and domestic violence had increased during veterinary school. Most veterinary students reported that they felt poorly prepared to handle domestic violence and animal abuse issues in the workplace. This study indicates that extracurricular DVSPs are a viable means of educating veterinary students regarding domestic violence and animal abuse. A need for improved education on these topics in veterinary schools across North America is identified.

  5. The European system of veterinary specialization.

    Science.gov (United States)

    Romagnoli, Stefano

    2010-01-01

    Veterinary specialist diplomas were available in many European countries during the second half of the 20th century. However, such an early recognition of the importance of veterinary specialization actually delayed the concept of the European veterinary specialist in Europe, compared with the United States, where the first specialist colleges were established in the 1960s, because it was felt that the national system was functioning properly and there was therefore no need for a new structure in the European countries. The European Board of Veterinary Specialisation (EBVS) was established in 1996, and currently there are 23 specialist colleges with more than 2,600 veterinarians officially listed in the EBVS register as European specialists. The Advisory Committee on Veterinary Training (ACVT) approved the establishment of EBVS but never implemented a supervising body (with ACVT representation). Such a body, the European Coordinating Committee on Veterinary Training, was later implemented by the profession itself, although it still lacked a political component. Each college depends on the EBVS, which has the function to define standards and criteria for monitoring the quality of college diplomates. To become a European Diplomate, veterinarians must have gone through an intensive period of training supervised by a diplomate, after which candidates must pass an examination. Although the term European veterinary specialist still does not have any legal recognition, national specialist qualifications are being phased out in many countries because of the inherent higher quality of EBVS specialist qualifications.

  6. The need for veterinary nursing in Nigeria

    Directory of Open Access Journals (Sweden)

    Funmilayo A. Okanlawon, RN, PhD, FWACN

    2011-06-01

    Full Text Available Traditionally, nursing care has been identified as an integral part of human medicine but is not well recognised in veterinary medicine as practised in Nigeria. In caring for human beings, a nurse is expected to have the fundamental understanding of disease aetiology, manifestations, diagnosis, manage-ment, rehabilitation, prevention and control. This is equally applicable to the care of animals. The role of veterinary nursing in veterinary medicine is significant considering the multitude of issues involved in the care of animals. The keeping of domestic animals is becoming popular and consequently the spread of infectious diseases from animals to human beings is on the increase. It is vital for human beings and animals to coexist in a healthy environment. The authors examine the importance of nursing care in veterinary medicine, the current situation in Nigeria, the role of veterinary nurses, the inter-professional approach to veterinary medicine, preparedness for the emergence of infectious diseases and career opportunities for veterinary nurses. This premise falls within the context of the ‘One Health’ concept.

  7. Veterinary and human vaccine evaluation methods

    Science.gov (United States)

    Knight-Jones, T. J. D.; Edmond, K.; Gubbins, S.; Paton, D. J.

    2014-01-01

    Despite the universal importance of vaccines, approaches to human and veterinary vaccine evaluation differ markedly. For human vaccines, vaccine efficacy is the proportion of vaccinated individuals protected by the vaccine against a defined outcome under ideal conditions, whereas for veterinary vaccines the term is used for a range of measures of vaccine protection. The evaluation of vaccine effectiveness, vaccine protection assessed under routine programme conditions, is largely limited to human vaccines. Challenge studies under controlled conditions and sero-conversion studies are widely used when evaluating veterinary vaccines, whereas human vaccines are generally evaluated in terms of protection against natural challenge assessed in trials or post-marketing observational studies. Although challenge studies provide a standardized platform on which to compare different vaccines, they do not capture the variation that occurs under field conditions. Field studies of vaccine effectiveness are needed to assess the performance of a vaccination programme. However, if vaccination is performed without central co-ordination, as is often the case for veterinary vaccines, evaluation will be limited. This paper reviews approaches to veterinary vaccine evaluation in comparison to evaluation methods used for human vaccines. Foot-and-mouth disease has been used to illustrate the veterinary approach. Recommendations are made for standardization of terminology and for rigorous evaluation of veterinary vaccines. PMID:24741009

  8. Workplace safety and health for the veterinary health care team.

    Science.gov (United States)

    Gibbins, John D; MacMahon, Kathleen

    2015-03-01

    Veterinary clinic employers have a legal and ethical responsibility to provide a safe and healthy workplace. Clinic members are responsible for consistently using safe practices and procedures set up by their employer. Development and implementation of a customized comprehensive workplace safety and health program is emphasized, including an infection control plan. Occupational safety and health regulations are reviewed. The hazards of sharps, animal bites and scratches, and drugs are discussed. Strategies to prevent or minimize adverse health effects and resources for training and education are provided. Published by Elsevier Inc.

  9. Customer service in equine veterinary medicine.

    Science.gov (United States)

    Blach, Edward L

    2009-12-01

    This article explores customer service in equine veterinary medicine. It begins with a discussion about the differences between customers and clients in veterinary medicine. An overview of the nature of the veterinary-client-patient relationship and its effects on the veterinarian's services sheds light on how to evaluate your customer service. The author reviews a study performed in 2007 that evaluated 24 attributes of customer service and their importance to clients of equine veterinarians in their decision to select a specific veterinarian or hospital. The article concludes with an overview of how to evaluate your customer service in an effort to optimize your service to achieve customer loyalty.

  10. Inspections in veterinary medicine 2005; Veterinaerinspektioner 2005

    Energy Technology Data Exchange (ETDEWEB)

    Joensson, Helene

    2006-11-15

    In Sweden 300 veterinary clinics have a license for x-ray diagnostics. Six of them also have a license for nuclear medicine. During 2005 eight clinics were inspected and the results show that the radiation protection in veterinary medicine can be improved. No clinic fulfilled the regulations of categorization of workplaces and workers (SSI FS 1998:3). Half of the clinics had no Swedish manual to the x-ray equipment and just as many had not performed the annual function check. Obviously, there is a need for more information to staff in veterinary medicine.

  11. Veterinary medicine books recommended for academic libraries.

    Science.gov (United States)

    Crawley-Low, Jill

    2004-10-01

    This bibliography of in-print veterinary medical books published in English may be used as an acquisitions or evaluation tool for developing the monograph component of new veterinary medicine collections or existing science, technology, and medicine collections where veterinary medicine is in the scope of the collection. The bibliography is divided into 34 categories and consists of bibliographic information for 419 titles. The appendix contains an author/editor index. Prices for all entries are in US dollars, except where another currency is noted. The total cost of all books in the bibliography is $43,602.13 (US).

  12. 78 FR 14803 - Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications

    Science.gov (United States)

    2013-03-07

    ... the legal status of the drug products. Therefore, the Director, Center for Veterinary Medicine, is... Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453... Pharmaceuticals, LLC, Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034. The Director, Center for Veterinary Medicine...

  13. Genomics and systems biology - How relevant are the developments to veterinary pharmacology, toxicology and therapeutics?

    NARCIS (Netherlands)

    Witkamp, R.F.

    2005-01-01

    This review discusses some of the recent developments in genomics and its current and future relevance for veterinary pharmacology and toxicology. With the rapid progress made in this field several new approaches in pharmacological and toxicological research have developed and drug discovery and

  14. Antimicrobial stewardship in small animal veterinary practice

    DEFF Research Database (Denmark)

    Guardabassi, Luca; Prescott, John F

    2015-01-01

    Despite the increasing recognition of the critical role for antimicrobial stewardship in preventing the spread of multidrug-resistant bacteria, examples of effective antimicrobial stewardship programs are rare in small animal veterinary practice. This article highlights the basic requirements...

  15. Sleep hygiene among veterinary medical students.

    Science.gov (United States)

    Royal, Kenneth D; Hunt, Suzanne A; Borst, Luke B; Gerard, Mathew

    2018-01-01

    The objective of this study was to better understand veterinary medical students' sleep hygiene and identify the extent to which sleep hygiene behaviors may result in consequences (either positive or negative) for students. A total of 187 doctor of veterinary medicine (DVM) program students at a large College of Veterinary Medicine in the United States. The Epworth Sleep Scale and Daytime Sleepiness Scale were administered to 393 students enrolled in the DVM program. About 55.1% of students reported sleep per night, 28.9% reported having trouble sleeping, and 50.3% reported feeling sleepy all day. With respect to sleep quality, 5.3% described it as excellent, 52.4% as good, 34.2% as fair, and 8.0% as poor. A significant percentage of veterinary medical students exhibit poor sleep hygiene habits that may be detrimental to both their health and academic endeavors.

  16. Good veterinary governance: definition, measurement and challenges.

    Science.gov (United States)

    Msellati, L; Commault, J; Dehove, A

    2012-08-01

    Good veterinary governance assumes the provision of veterinary services that are sustainably financed, universally available, and provided efficiently without waste or duplication, in a manner that is transparent and free of fraud or corruption. Good veterinary governance is a necessary condition for sustainable economic development insomuch as it promotes the effective delivery of services and improves the overall performance of animal health systems. This article defines governance in Veterinary Services and proposes a framework for its measurement. It also discusses the role of Veterinary Services and analyses the governance dimensions of the performance-assessment tools developed by the World Organisation for Animal Health (OIE). These tools (OIE PVS Tool and PVS Gap Analysis) track the performance of Veterinary Services across countries (a harmonised tool) and over time (the PVS Pathway). The article shows the usefulness of the OIE PVS Tool for measuring governance, but also points to two shortcomings, namely (i) the lack of clear outcome indicators, which is an impediment to a comprehensive assessment of the performance of Veterinary Services, and (ii) the lack of specific measures for assessing the extent of corruption within Veterinary Services and the extent to which demand for better governance is being strengthened within the animal health system. A discussion follows on the drivers of corruption and instruments for perception-based assessments of country governance and corruption. Similarly, the article introduces the concept of social accountability, which is an approach to enhancing government transparency and accountability, and shows how supply-side and demand-side mechanisms complement each other in improving the governance of service delivery. It further elaborates on two instruments--citizen report card surveys and grievance redress mechanisms--because of their wider relevance and their possible applications in many settings, including Veterinary

  17. Clinical decision making in veterinary practice

    OpenAIRE

    Everitt, Sally

    2011-01-01

    Aim The aim of this study is to develop an understanding of the factors which influence veterinary surgeons’ clinical decision making during routine consultations. Methods The research takes a qualitative approach using video-cued interviews, in which one of the veterinary surgeon’s own consultations is used as the basis of a semi-structured interview exploring decision making in real cases. The research focuses primarily on small animal consultations in first opinion practice, how...

  18. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  19. Research data services in veterinary medicine libraries.

    Science.gov (United States)

    Kerby, Erin E

    2016-10-01

    The study investigated veterinary medicine librarians' experience with and perceptions of research data services. Many academic libraries have begun to offer research data services in response to researchers' increased need for data management support. To date, such services have typically been generic, rather than discipline-specific, to appeal to a wide variety of researchers. An online survey was deployed to identify trends regarding research data services in veterinary medicine libraries. Participants were identified from a list of contacts from the MLA Veterinary Medical Libraries Section. Although many respondents indicated that they have a professional interest in research data services, the majority of veterinary medicine librarians only rarely or occasionally provide data management support as part of their regular job responsibilities. There was little consensus as to whether research data services should be core to a library's mission despite their perceived importance to the advancement of veterinary research. Furthermore, most respondents stated that research data services are just as or somewhat less important than the other services that they provide and feel only slightly or somewhat prepared to offer such services. Lacking a standard definition of "research data" and a common understanding of precisely what research data services encompass, it is difficult for veterinary medicine librarians and libraries to define and understand their roles in research data services. Nonetheless, they appear to have an interest in learning more about and providing research data services.

  20. Factors Associated with Veterinary Clinical Faculty Attrition.

    Science.gov (United States)

    Furr, Martin

    Faculty attrition and recruitment for veterinary clinical faculty positions have been reported as significant problems in veterinary medical education. To investigate the factors that may be important in veterinary clinical faculty retention, the perceptions and views of veterinary clinical academic faculty were determined using a web-distributed electronic survey. Responses were dichotomized by whether the respondent had or had not left an academic position and were analyzed for their association with faculty attrition. A total of 1,226 responses were recorded, and results demonstrated that factors other than compensation were associated with veterinary clinical faculty attrition, including departmental culture, work-life balance, and recognition and support of clinical medicine by the administration. Forty-four percent of respondents who had held a faculty appointment reported leaving academia either voluntarily or for non-voluntary reasons such as failure to achieve tenure, retirement, or having their position closed. Attention to correcting deficiencies in workplace culture and professional rewards could be a beneficial means by which to decrease the faculty attrition rates currently observed in clinical academic veterinary medicine.

  1. Cultural awareness in veterinary practice: student perceptions.

    Science.gov (United States)

    Mills, Jennifer N; Volet, Simone; Fozdar, Farida

    2011-01-01

    Australian veterinary classrooms are increasingly diverse and their growing internal diversity is a result of migration and large numbers of international students. Graduates interact with other students and increasingly with clients whose attitudes, beliefs, values, and behaviors differ from their own. An understanding and respect for these differences has an impact on client communication and health care outcomes. The present study explored how students understand and are likely to deal with issues of cultural diversity in veterinary professional practice as well as the educational needs that students feel should be met in regard to preparation to engage productively with diversity in professional practice. The present study also explored the extent to which the rich diversity of the undergraduate student population constitutes an educational resource. A class of final-year veterinary students was invited to participate in a workshop exploring intercultural confidence in veterinary consultation. Twelve groups of six to eight students discussed a fictitious scenario involving a challenging clinical encounter with a client from a different culture. Students were reticent to see the scenario in terms of cultural difference, although they generally recognized that awareness of cultural issues in veterinary practice was important. They also tended to not see their own ethnicity as relevant to their practice. While some felt that veterinary practice should be culture blind, most recognized a need to orient to cultural difference and to respond sensitively. Their suggestions for curricular improvements to address these issues are also included.

  2. Veterinary antimicrobial-usage statistics based on standardized measures of dosage

    DEFF Research Database (Denmark)

    Jensen, Vibeke Frøkjær; Jacobsen, Erik; Bager, Flemming

    2004-01-01

    In human medicine, the defined daily dose is used as a technical measure of drug usage, which is independent of the variations in the potency of the active compound and the formulation of the pharmaceutical product-therefore providing a measure of the relative importance of different drugs....... A national system of animal defined daily doses (ADD) for each age-group and species has been defined in VetStat (the Danish national system monitoring veterinary therapeutic drug use). The usage is further standardized according to the number of animals in the target population, acquired from production...... data on the national level or on herd size by species and age in the Danish central husbandry register (CHR). Statistics based on standardized measures of VetStat data can be used for comparison of drug usage between different herds, veterinary practices, or geographic regions (allowing subdivision...

  3. [Availability of generic drugs in the public sector and prices in the private sector in different regions of Brazil].

    Science.gov (United States)

    Miranda, Elaine Silva; Pinto, Cláudia Du Bocage Santos; dos Reis, André Luis de Almeida; Emmerick, Isabel Cristina Martins; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Osorio-de-Castro, Claudia Garcia Serpa

    2009-10-01

    A study to identify availability and prices of medicines, according to type of provider, was conducted in the five regions of Brazil. A list of medicines to treat prevalent diseases was investigated, using the medicines price methodology developed by the World Health Organization and Health Action International, adapted for Brazil. In the public sector, bioequivalent (vis-à-vis reference brand) generics are less available than multisource products. For most medicines (71.4%), the availability of bioequivalent generics was less than 10%. In the private sector, the average number of different bioequivalent generic versions in the outlets was far smaller than the number of versions on the market. There was a positive correlation between the number of generics on the market, or those found at outlets, and the price variation in bioequivalent generic products, in relation to the maximum consumer price. It is estimated that price competition is occurring among bioequivalent generic drugs and between them and multisource products for the same substance, but not with reference brands.

  4. Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

    Directory of Open Access Journals (Sweden)

    Garth Boehm

    2013-09-01

    Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

  5. SPECIAL ISSUE VETERINARY IMMUNOLOGY IMMUNOPATHOLOGY: PROCEEDINGS 8TH INTERNATIONAL VETERINARY IMMUNOLOGY SYMPOSIUM

    Science.gov (United States)

    This is the Special Issue of Vet. Immunol. Immunopathol. that summarizes the 8th International Veterinary Immunology Symposium (8 th IVIS) held August 15th-19th, 2007, in Ouro Preto, Brazil. The 8 th IVIS highlighted the importance of veterinary immunology for animal health, vaccinology, reproducti...

  6. Bioequivalence and pharmacokinetic evaluation of two formulations of risperidone 2 mg : an open-label, single-dose, fasting, randomized-sequence, two-way crossover study in healthy male Chinese volunteers.

    Science.gov (United States)

    Liu, Yun; Zhang, Meng-qi; Jia, Jing-ying; Liu, Yan-mei; Liu, Gang-yi; Li, Shui-jun; Wang, Wei; Weng, Li-ping; Yu, Chen

    2013-03-01

    Risperidone is a benzisoxazole derivate and is effective in the treatment of schizophrenia and other psychiatric illnesses in adults and children. Although there are a few reports in the literature regarding the pharmacokinetic characteristics of risperidone, insufficient data on its pharmacokinetic properties in a Chinese population are available. To meet the requirements for marketing a new generic product, this study was designed to compare the pharmacokinetic properties and bioequivalence of two 2 mg tablet formulations of risperidone: a newly developed generic formulation (test) and a branded formulation (reference) in healthy adult male Chinese volunteers. A single-dose, open-label, randomized-sequence, 2 × 2 crossover study was conducted in fasted healthy male Chinese volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive 1 tablet (2 mg each) of the test formulation (Risperidone tablet; Dr. Reddy's Laboratories Ltd., Hyderabad, India) or the reference formulation (Risperdal(®) tablet; Xian-Janssen Pharmaceutical Ltd., Xi-an, China), followed by a 2-week washout period and subsequent administration of the alternate formulation. The study drugs were administered after a 10-hour overnight fast. Plasma samples were collected over 96 hours. Plasma concentrations of the parent drug, risperidone, and its active metabolite, 9-hydroxy-risperidone, were analyzed by a liquid chromatography-tandem mass spectrometry method. The formulations would be considered bioequivalent if the 90% confidence intervals (CIs) of the natural log-transformed values were within the predetermined 80-125% equivalence range for the maximum plasma drug concentration (Cmax) and the area under the plasma concentration-time curve (AUC), in accordance with guidelines issued by the US Food and Drug Administration. Assessment of tolerability was based on recording of adverse events (AEs), monitoring of vital signs, electrocardiograms, and laboratory tests at baseline

  7. Ethnography in the Danish Veterinary Learning Environment

    Directory of Open Access Journals (Sweden)

    Camilla Kirketerp Nielsen

    2015-11-01

    Full Text Available The overall objective of this project is research-based development, implementation and evaluation of a game-based learning concept to be used in the veterinary education. Herd visits and animal contact are essential for the development of veterinary competences and skills during education. Yet veterinary students have little occasion to reach/attain a proper level of confidence in their own skills/abilities, as they have limited “training-facilities” (Kneebone & Baillie, 2008. One possible solution mightbe to provide a safe, virtual environment (game-based where students could practise interdisciplinary clinical skills in an easily-accessible, interactive setting. A playable demo using Classical Swine Fever in a pig herd as an example has been produced for this purpose. In order totailor the game concept to the specific veterinary learning environment and to ensure compliance with both learning objectives and the actual learning processes/procedures of the veterinary students, the project contains both a developmental aspect (game development and an exploration of the academic (scholastic and profession (practice oriented learning context. The initial phase of the project was a preliminary exploration of the actual learning context, providing an important starting point for the upcoming phase in which I will concentrate on research-based development, implementation and evaluation of a game-based virtual environment in this course context. In the academic (scholastic and profession (practice oriented learning context of a veterinary course in Herd Health Management (Pig module,ethnographic studies have been conducted by using multiple data collection methods; participant observation, spontaneous dialogues and interviews (Borgnakke, 1996; Hammersley & Atkinson, 2007. All courserelated activities in the different learning spaces (commercial pig herds, auditoriums, post-mortem examinations, independent group work were followed.This paper will

  8. 75 FR 38699 - Implantation or Injectable Dosage Form New Animal Drugs; Propofol

    Science.gov (United States)

    2010-07-06

    ... Fort Dodge Animal Health, Division of Wyeth. The NADA provides for veterinary prescription use of... INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration... 42d St., New York, NY 10017 filed NADA 141-303 that provides for veterinary prescription use of...

  9. 75 FR 59610 - Implantation and Injectable Dosage Form New Animal Drugs; Firocoxib

    Science.gov (United States)

    2010-09-28

    ...) filed by Merial Ltd. The NADA provides for the veterinary prescription use of firocoxib injectable... Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276...., Bldg. 500, Duluth, GA 30096-4640 filed NADA 141-313 that provides for veterinary prescription use of...

  10. Characterization of veterinary hospital-associated isolates of Enterococcus species in Korea.

    Science.gov (United States)

    Chung, Yeon Soo; Kwon, Ka Hee; Shin, Sook; Kim, Jae Hong; Park, Yong Ho; Yoon, Jang Won

    2014-03-28

    Possible cross-transmission of hospital-associated enterococci between human patients, medical staff, and hospital environments has been extensively studied. However, limited information is available for veterinary hospital-associated Enterococcus isolates. This study investigated the possibility of cross-transmission of antibiotic-resistant enterococci between dog patients, their owners, veterinary staff, and hospital environments. Swab samples (n =46 5) were obtained from five veterinary hospitals in Seoul, Korea, during 2011. Forty-three Enterococcus strains were isolated, representing seven enterococcal species. E. faecalis and E. faecium were the most dominant species (16 isolates each, 37.2%). Although slight differences in the antibiotic resistance profiles were observed between the phenotypic and the genotypic data, our antibiogram analysis demonstrated high prevalence of the multiple drug-resistant (MDR) isolates of E. faecalis (10/16 isolates, 62.5%) and E. faecium (12/16 isolates, 75.0%). Pulsed-field gel electrophoretic comparison of the MDR isolates revealed three different clonal sets of E. faecalis and a single set of E. faecium, which were isolated from different sample groups or dog patients at the same or two separate veterinary hospitals. These results imply a strong possibility of cross-transmission of the antibiotic-resistant enterococcal species between animal patients, owners, veterinary staff, and hospital environments.

  11. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2004 - February 2006 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2006-06-01

    Full Text Available 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 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again 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.

  12. Quantification of amlodipine and atorvastatin in human plasma by UPLC-MS/MS method and its application to a bioequivalence study.

    Science.gov (United States)

    Rezk, Mamdouh R; Badr, Kamal A

    2018-07-01

    A robust, rapid and sensitive UPLC-MS/MS method has been developed, optimized and validated for the determination of amlodipine (AML) and atorvastatin (ATO) in human plasma using eplerenone as an internal standard (IS). Multiple-reaction monitoring in positive electrospray ionization mode was utilized in Xevo TQD LC-MS/MS. Double extraction was used in sample preparation using diethyl ether and ethyl acetate. The prepared samples were analyzed using an Acquity UPLC BEH C 18 (50 × 2.1 mm, 1.7 μm) column. Ammonium formate and acetonitrile, pumped isocraticaly at a flow rate of 0.25 mL/min, were used as a mobile phase. Method validation was done as per the US Food and Drug Administration guidelines. Linearity was achieved in the range of 0.1-10 ng/mL for AML and 0.05-50 ng/mL for ATO. Intra-day and inter-day accuracy and precision were calculated and found to be within the acceptable range. A short run time, of <1.5 min, permits analysis of a large number of plasma samples per batch. The developed and validated method was applied to estimate AML and ATO in a bioequivalence study in healthy human volunteers. Copyright © 2018 John Wiley & Sons, Ltd.

  13. Lessons of history in veterinary medicine.

    Science.gov (United States)

    Smith, Donald F

    2013-01-01

    The future of veterinary medicine is best understood in the context of history. What began as a profession rooted in urban centers in proximity to horses, physicians, and medical schools, was transformed into a land grant-based agricultural profession with the arrival of the internal combustion engine in the early twentieth century. Most of the United States' current veterinary colleges are still located in towns or small cities in the middle section of the country, outside the largest metropolitan areas where most veterinarians practice companion-animal medicine. Throughout veterinarian history, substantial numbers of US students have been educated in foreign colleges and this continues today, creating an even greater geographic imbalance between the veterinary educational process and US population centers and major medical schools. Three themes deserve special attention as we celebrate the profession's 150th anniversary. We must first move beyond the land-grant culture and develop a more geographically balanced approach to establishing new veterinary colleges that are also in closer association with schools of medicine and public health. We must also facilitate more opportunities for women leadership in organized veterinary medicine, in practice ownership, in academia, and in the corporate structures that educate, hire, and interface with veterinarians. Finally, we need to expand our understanding of One Health to include the concept of zooeyia (the role of animals in promoting human health), as well as continue to emphasize veterinarians' special roles in the control and management of zoonotic diseases and in advancing comparative medicine in the age of the genome.

  14. Career identity in the veterinary profession.

    Science.gov (United States)

    Page-Jones, S; Abbey, G

    2015-04-25

    This research investigates vet and vet nurse career identity through the qualitative methodology of narrative enquiry. It derives learning and understanding from these empirical data to assist the veterinary profession to adjust to the changing industry landscape. Through a case series of 20 vets and vet nurses' career stories, this paper seeks understanding about career identity and its impact on individuals and organisations in the light of industry consolidation. Findings suggest that career is central to identity for many veterinary professionals who tend to have a strong sense of self; this is particularly evident around self as learner and technically competent, teacher and educator, ethical and moral and dedicated and resilient. Consequently, mismatches between 'who I am' and 'what I do' tend not to lead to identity customisation (to fit self into role or organisation) but to the search for alternative, more identity-compatible employment. This study offers a valuable insight for employers, veterinary professionals and universities. It suggests that businesses can gain competitive advantage and employees achieve validation and enrichment by working towards organisational and individual identity congruence and that teaching veterinary professionals with contemporary business in mind may develop graduates with a more sustainable identity. British Veterinary Association.

  15. Dissolution efficiency and bioequivalence study using urine data from healthy volunteers: a comparison between two tablet formulations of cephalexin

    Directory of Open Access Journals (Sweden)

    Cristina Helena dos Reis Serra

    2015-06-01

    Full Text Available The aim of the present study was to assess the bioequivalence of two cephalexin tablet formulations available in the Brazilian market (product A as reference formulation and product B as test formulation. Dissolution efficiency (DE% was calculated for both formulations to evaluate their in vitrobiopharmaceutical features. The oral bioequivalence study was performed in twenty-four healthy volunteers in a crossover design. Single oral dose (tablet containing 500 mg of cephalexin of each product was administered with two weeks of washout period. Urinary concentrations of cephalexin were measured by high-performance liquid chromatography (HPLC method and pharmacokinetics parameters were estimated by urinary excretion data. The bioequivalence was determined by the following parameters: the cumulative amount of cephalexin excreted in the urine, the total amount of cephalexin excreted in the urine and the maximum urinary excretion rate of cephalexin. DE values of immediate-release cephalexin tablets (500 mg were 68.69±4.18% for product A and 71.03±6.63% for product B. Regarding the dissolution test of the two brands (A and B analysed, both were in compliance with the official pharmacopeial specifications, since the dissolution of both formulations was superior to 80% of the amount declared in the label after 45 minutes of test (A=92.09%±1.84; B=92.84%±1.08. The results obtained indicated that the products A and B are pharmaceutical equivalents. Confidence intervals for the pharmacokinetic parameters were in compliance with the international standards, indicating that products A and B can be considered bioequivalents and, therefore, interchangeable.

  16. Veterinary Students' Recollection Methods for Surgical Procedures

    DEFF Research Database (Denmark)

    Langebaek, Rikke; Tanggaard, Lene; Berendt, Mette

    2016-01-01

    When veterinary students face their first live animal surgeries, their level of anxiety is generally high and this can affect their ability to recall the procedure they are about to undertake. Multimodal teaching methods have previously been shown to enhance learning and facilitate recall; however......, student preferences for recollection methods when translating theory into practice have not been documented. The aim of this study was to investigate veterinary students' experience with recollection of a surgical procedure they were about to perform after using multiple methods for preparation. From...... a group of 171 veterinary students enrolled in a basic surgery course, 26 students were randomly selected to participate in semi-structured interviews. Results showed that 58% of the students used a visual, dynamic method of recollection, mentally visualizing the video they had watched as part...

  17. Thermoluminescent dosimetry in veterinary diagnostic radiology

    International Nuclear Information System (INIS)

    Hernández-Ruiz, L.; Jimenez-Flores, Y.; Rivera-Montalvo, T.; Arias-Cisneros, L.; Méndez-Aguilar, R.E.; Uribe-Izquierdo, P.

    2012-01-01

    This paper presents the results of Environmental and Personnel Dosimetry made in a radiology area of a veterinary hospital. Dosimetry was realized using thermoluminescent (TL) materials. Environmental Dosimetry results show that areas closer to the X-ray equipment are safe. Personnel Dosimetry shows important measurements of daily workday in some persons near to the limit established by ICRP. TL results of radiation measurement suggest TLDs are good candidates as a dosimeter to radiation dosimetry in veterinary radiology. - Highlights: ► Personnel dosimetry in laboratory veterinary diagnostic was determined. ► Student workplaces are safe against radiation. ► Efficiency value of apron lead was determined. ► X-ray beams distribution into veterinarian laboratory was measured.

  18. Development of a new benazepril hydrochloride chewable tablet and evaluation of its bioequivalence for treatment of heart failure in dogs.

    Science.gov (United States)

    Qian, M; Chen, T; Zhou, D; Zhang, Z; Zhang, Q; Tang, S; Xiao, X

    2016-02-01

    The aim of the study was to develop a new chewable benazepril hydrochloride(BH) tablet, investigate its physical properties, and evaluate its bioequivalence with the branded formulation (Fortekor). A corrective agent was included in the formula to improve its palatability and convenience for administration to dogs. The tablet remained stable in light, heat, and humidity tests, and its physical properties such as hardness, uniformity of content, and dissolution rate were highly consistent with the technical standards. After single and repeated administrations to eight beagles and single dose to 14 mongrel dogs (0.5 mg/kg p.o.), plasma BH and its active metabolite, benazeprilat (BZ), were detected. There was no significant difference in the major pharmacokinetic parameters (Cmax , Tmax, and AUC₀₋₂₄) between the two formulations. The 90% confidence intervals calculated for the ratios of area under the time-concentration curve (AUC₀₋₂₄) were 92.4-116.3% for BH and 89.9-102.3% for BZ, within the accepted range for bioequivalence of 80-125%. The results showed our new chewable tablet is bioequivalent to the commercial product and suitable for addition to the benazepril product family for the treatment of heart failure in dogs. © 2015 John Wiley & Sons Ltd.

  19. [The organisation and future development of Veterinary Services in Latin America].

    Science.gov (United States)

    Gimeno, E

    2003-08-01

    Latin America undoubtedly has comparative advantages in the fields of animal production, animal health and the production of food of animal origin. However, countries in Latin America must build on these strengths if the continent is to become more competitive and be able to deal with the complexities of world markets. To do this, Veterinary Services must define their objectives and establish quality standards on which to base their work. For this to occur, the State must create well-defined regulations, establish systems of audit and find ways of working which allow for a high degree of coordination and collaboration between the public and private sectors. This should be done within a framework of a quality assurance system, which allows for responsible accreditation and independent audit and evaluation. The author discusses the approaches of the different countries in the region to animal health, zoonosis, food safety, veterinary drugs control, animal welfare and export-import control. All programmes relating to these issues must be based on technical information gained through epidemiological surveillance, the network of diagnostic laboratories, quarantine systems, risk analysis, identification and traceability of animals and animal products, registration and control of veterinary drugs, and food safety research. In some countries these systems are already being developed. Maintaining good international relations and cooperating with neighbouring countries is always a challenge for official Veterinary Services and international organisations such as the OIE (World organisation for animal health) have a key role to play in facilitating these relationships.

  20. Balancing knowledge and basic principles in veterinary parasitology - Competencies for future Danish veterinary graduates

    DEFF Research Database (Denmark)

    Thamsborg, Stig Milan; Johansen, Maria Vang; Nejsum, Peter

    2018-01-01

    Veterinary parasitology has always been considered to be relevant and interesting by the Danish veterinary students. Students have to acquaint themselves with many new, small creatures with complicated and varied life cycles and with intricate Latin names that are difficult to pronounce, as only...... clinician should know a range of parasites by heart as an active resource for their work. The dilemma has been tackled (partly) by introducing a veterinary paraclinical refresher course of 18 h (half practicals and half lectures) in the fourth study year. The focus here is on host(herd)-oriented clinical...

  1. Safety and efficacy of generic drugs with respect to brand formulation.

    Science.gov (United States)

    Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

    2013-12-01

    Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

  2. A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects.

    Science.gov (United States)

    Monif, T; Arora, V; Madan, S; Arora, R; Balaji, A; Jha, D; Thudi, N R

    2010-12-01

    Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in human prostate. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of benign prostatic hypertrophy. A new formulation Contiflo ICON 400 µg has been developed by Ranbaxy Laboratories Limited, India similar to Flomaxtra XL 400 µg of Astellas Pharma Limited, United Kingdom. This product is specifically designed to achieve a more consistent plasma concentration over a period of 24-h, a lower maximum plasma concentration (Cmax) and an independence of pharmacokinetics (PKs) on food intake. The objective of the present study was to evaluate the pharmacokinetics and bioequivalence of the new formulation Contiflo ICON 400 µg of Ranbaxy Laboratories Limited, India and Flomaxtra XL 400 µg prolonged release tablets (containing tamsulosin hydrochloride prolonged release 400 µg) of Astellas Pharma Limited, United Kingdom. Study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single-dose bioequivalence study in 32 adult male human subjects under fed conditions. The mean (range) age, weight and height of the study subjects were 27.03 years (19 - 40 years), 57.19 kg (48 - 72 kg) and 166.81 cm (154 - 181 cm) respectively. Blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 12, 16, 20, 24, 36, 48, 72, and 96 h post dose in each period. Plasma samples were analyzed for tamsulosin by using validated liquid chromatographic mass spectrometry (LC-MS/MS) method. The Mean ± SD of pharmacokinetic parameters tmax, Cmax, AUC24, AUClast and AUCinf for Tamsulosin were 11.741 ± 4.7201 and 12.155 ± 6.3077 h, 10.7614 ± 4.76709 and 10.4954 ± 5.08979 ng/ml, 171.4674 ± 77.39695 and 160.6738 ± 77.98628 ng.h/ml, 262.7771 ± 150.21432 and 250.6854 ± 156.75581 ng

  3. Competency-based veterinary education - An integrative approach to learning and assessment in the clinical workplace

    NARCIS (Netherlands)

    Bok, G.J.

    2014-01-01

    When graduating from veterinary school, veterinary professionals must be ready to enter the complex veterinary profession. Therefore, one of the major responsibilities of any veterinary school is to develop training programmes that support students’ competency development on the trajectory from

  4. Veterinary and human medicine: learning from each other.

    Science.gov (United States)

    Honey, Laura

    2016-03-26

    A well-attended session at this year's joint SPVS/VPMA congress considered what lessons the medical and veterinary professions might learn from one another. Laura Honey reports. British Veterinary Association.

  5. Thirtieth Annual Congress on Veterinary Acupuncture: IVAS Report

    Directory of Open Access Journals (Sweden)

    Krishna Kaphle

    2005-01-01

    Full Text Available More than 155 participants from 25 countries attended the 30th Annual IVAS Congress, September 8–11, 2004 in Oostende, Belgium. The focus was on veterinary acupuncture (AP and immunology, and the event was sponsored by the International Veterinary Acupuncture Society (IVAS. IVAS is a non-profit organization dedicated to promoting excellence in the practice of veterinary AP as an integral part of the total veterinary health care delivery system. The Society endeavors to establish uniformly high standards of veterinary AP through its educational programs and accreditation examination. IVAS seeks to integrate veterinary AP and the practice of Western veterinary science, while also noting that the science of veterinary AP does not overlook allied health systems, such as homeopathy, herbology, nutrition, chiropractic, kinesiology, etc. (www.ivas.org.

  6. Chapter 5. Assessing the Aquatic Hazards of Veterinary Medicines

    Science.gov (United States)

    In recent years, there has been increasing awareness of the widespread distribution of low concentrations of veterinary medicine products and other pharmaceuticals in the aquatic environment. While aquatic hazard for a select group of veterinary medicines has received previous s...

  7. Bioequivalence study of a generic Risperidone (Iperdal® in healthy Thai male volunteers

    Directory of Open Access Journals (Sweden)

    Werawath Mahatthanatrakul

    2008-05-01

    Full Text Available The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal® with a reference formulation (Risperdal® when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC-UV method modified from Avenosoet al. (2000. Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by “Two Way Analysis of Variance” (ANOVA. Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78 and 32.58±19.77 (range 5.29-84.56 ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48 of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32 and 144.03±127.37 (range 16.27-456.0 ng.hr/ml, respectively. The time to maximum concentration (Tmax of theinnovator and the generic product were 0.97±0.41(range 0.5-2 and 1.02±0.32 (range 0.5-1.5 hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption.

  8. Evaluating the economic and noneconomic impacts of the veterinary medical profession in Michigan.

    Science.gov (United States)

    Lloyd, J W; Dartt, B A

    2000-01-01

    This study reaffirms the diversity and breadth of the veterinary profession. As it turns out, some of the furthest-reaching impacts of the veterinary medical profession were largely non-quantifiable. The veterinary medical profession had a substantial direct economic impact in Michigan during 1995. The total economic contribution of the veterinary medical profession to Michigan during 1995 that was attributable to expenditures on salaries, supplies, services, and their multiplier effect was approximately $500 million. In addition, the profession was associated with nearly 8,500 jobs (combined professional and lay positions). The veterinary medical profession was also considered to have an impact on the prosperity of the live-stock, equine, and pet food industries in Michigan, even though the economic contribution in these areas could not be directly quantified. Economic well-being of the individual businesses in these industries is directly related to the health and productivity of the associated animals, and improvements in output or productivity that accompany improved animal health likely carry substantial economic benefits in these sectors. In addition, progressive animal health management provides a crucial method of managing risk in the animal industries. Similarly, although the economic contribution could not be quantified, the veterinary medical profession enhances the safety and quality of human food through research, regulation, and quality assurance programs in livestock production, minimizing the risk of drug residues and microbial contamination. During 1995, approximately 5.3 million Michigan residents benefitted from the physical, psychological, and emotional well-being that accompanies companion animal ownership. By preserving the health and longevity of companion animals, veterinarians sustain and enhance these aspects of the human-animal bond. As Michigan enters a new century, it is likely that the state's veterinary medical profession will

  9. In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.

    Science.gov (United States)

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L

    2012-10-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE results and in vitro dissolution results for BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH of 6.0. Further the experimental dissolution of ibuprofen tablets in a low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol l (-1) /pH) was dramatically reduced compared with the dissolution in SIF (the average buffer capacity 12.6 mmol l (-1) /pH). Thus these predictions for the oral absorption of BCS class II acids indicate that the absorption patterns depend largely on the intestinal pH and buffer strength and must be considered carefully for a bioequivalence test. Simulation software may be a very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. Copyright © 2012 John Wiley & Sons, Ltd.

  10. In Silico Prediction of Drug Dissolution and Absorption with variation in Intestinal pH for BCS Class II Weak Acid Drugs: Ibuprofen and Ketoprofen§

    Science.gov (United States)

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L.

    2012-01-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS Class III and BCS class II have been proposed, particularly, BCS class II weak acids. However, a discrepancy between the in vivo- BE results and in vitro- dissolution results for a BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH=6.0. Further the experimental dissolution of ibuprofen tablets in the low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol L-1/pH) was dramatically reduced compared to the dissolution in SIF (the average buffer capacity 12.6 mmol L -1/pH). Thus these predictions for oral absorption of BCS class II acids indicate that the absorption patterns largely depend on the intestinal pH and buffer strength and must be carefully considered for a bioequivalence test. Simulation software may be very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. PMID:22815122

  11. Veterinary Technician Program Director Leadership Style and Program Success

    Science.gov (United States)

    Renda-Francis, Lori A.

    2012-01-01

    Program directors of American Veterinary Medical Association (AVMA) accredited veterinary technician programs may have little or no training in leadership. The need for program directors of AVMA-accredited veterinary technician programs to understand how leadership traits may have an impact on student success is often overlooked. The purpose of…

  12. Veterinary education in Africa: current and future perspectives.

    Science.gov (United States)

    Swan, G E; Kriek, N P J

    2009-03-01

    Veterinary education commenced in South Africa in 1920 at the Onderstepoort Veterinary Institute in South Africa in association with the Transvaal University College, now the University of Pretoria. Sir Arnold Theiler, Director of Veterinary Research and Education, was the first Dean. Today there are 46 veterinary training institutions in Africa of which 21 are in sub-Saharan Africa. Veterinary services are indispensable to the sustained health and wellbeing of animals and humans, and agricultural economies of countries worldwide. Veterinary education, postgraduate training, and research, and adequate numbers of veterinarians, are essential to satisfy the millennium development goals, the objectives of NEPAD and the African Union, and the agreements regulating international trade. The relevance of the veterinary profession internationally is currently subject to profound scrutiny. Its contributions are assessed against major environmental, demographic, political, disease, technological and economic needs. The scope of veterinary training in future will have to emphasise veterinary public health, food safety, emerging diseases, international trade, bioterrorism, and biomedical research, within the context of a one-health system focusing on the interface between wildlife, domesticated animals, humans, and their environment. Within the context of time available, it would mean reducing the time allocated to training in the field of companion animals. A brief history and scope of veterinary education; current international trends in veterinary education and provisioning; and some perspectives on future veterinary training and initiatives applicable to Africa are provided.

  13. Undergraduates\\' view of the veterinary profession: A study of ...

    African Journals Online (AJOL)

    ... the veterinary profession: A study of Ahmadu Bello University, Zaria – Nigeria. ... the university, however only 33.7% believed that they obtain veterinary services ... of the opinion that both veterinary and medical students study similar courses. ... that veterinarians, pharmacists and physicians can work together in the Food ...

  14. The Mississippi State University College of Veterinary Medicine Shelter Program

    Science.gov (United States)

    Bushby, Philip; Woodruff, Kimberly; Shivley, Jake

    2015-01-01

    Simple Summary First initiated in 1995 to provide veterinary students with spay/neuter experience, the shelter program at the Mississippi State University College of Veterinary Medicine has grown to be comprehensive in nature incorporating spay/neuter, basic wellness care, diagnostics, medical management, disease control, shelter management and biosecurity. Junior veterinary students spend five days in shelters; senior veterinary students spend 2-weeks visiting shelters in mobile veterinary units. The program has three primary components: spay/neuter, shelter medical days and Animals in Focus. Student gain significant hands-on experience and evaluations of the program by students are overwhelmingly positive. Abstract The shelter program at the Mississippi State University College of Veterinary Medicine provides veterinary students with extensive experience in shelter animal care including spay/neuter, basic wellness care, diagnostics, medical management, disease control, shelter management and biosecurity. Students spend five days at shelters in the junior year of the curriculum and two weeks working on mobile veterinary units in their senior year. The program helps meet accreditation standards of the American Veterinary Medical Association’s Council on Education that require students to have hands-on experience and is in keeping with recommendations from the North American Veterinary Medical Education Consortium. The program responds, in part, to the challenge from the Pew Study on Future Directions for Veterinary Medicine that argued that veterinary students do not graduate with the level of knowledge and skills that is commensurate with the number of years of professional education. PMID:26479234

  15. 78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination

    Science.gov (United States)

    2013-11-22

    .... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...

  16. 75 FR 57658 - National Veterinary Accreditation Program; Correcting Amendment

    Science.gov (United States)

    2010-09-22

    ... [Docket No. APHIS-2006-0093] RIN 0579-AC04 National Veterinary Accreditation Program; Correcting Amendment..., Docket No. APHIS-2006-0093), and effective on February 1, 2010, we amended the National Veterinary... Veterinary Accreditation Program, VS, APHIS, 4700 River Road Unit 200, Riverdale, MD 20737; (301) 851-3401...

  17. 9 CFR 107.1 - Veterinary practitioners and animal owners.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Veterinary practitioners and animal... FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND UNREVOKED LICENSE § 107.1 Veterinary practitioners and...)(1) Products prepared by a veterinary practitioner (veterinarian) solely for administration to...

  18. Entrepreneurship Education and Veterinary Medicine: Enhancing Employable Skills

    Science.gov (United States)

    Henry, Colette; Treanor, Lorna

    2010-01-01

    Purpose: This paper has the purpose of exploring the potential for entrepreneurship education within veterinary medicine. It aims to examine some of the key themes in the entrepreneurship education literature, discuss the make-up of the UK veterinary sector, consider veterinary curricula requirements and illustrate how entrepreneurship education…

  19. European veterinary specialists denounce alternative medicine

    NARCIS (Netherlands)

    Horzinek, M.C.; Venker-van Haagen, Anjop

    On November 19, the Federation of Veterinarians in Europe (FVE) issued a policy statement urging its 200,000 members "to work only on the basis of scientifically proven and evidence-based methods and to stay away from non-evidence-based methods." The Swedish Veterinary Association banned its members

  20. Approach to complexity in veterinary epidemology

    DEFF Research Database (Denmark)

    Ducrot, C.; Calavas, D.; Legay, J.-M.

    1996-01-01

    One of the main goals of veterinary epidemiology is to analyse the determinants of disease, commonly called risk factors. The analysis of such systems is usually based on a pluridisciplinary approach, a planned observation of the natural state, and a judicious use of various methods to analyse...

  1. Improving Student Engagement in Veterinary Business Studies.

    Science.gov (United States)

    Armitage-Chan, Elizabeth; Jackson, Elizabeth

    2018-01-01

    Improving Student Engagement in Veterinary Business StudiesIn a densely packed veterinary curriculum, students may find it particularly challenging to engage in the less overtly clinical subjects, yet pressure from industry and an increasingly competitive employment market necessitate improved veterinary student education in business and management skills. We describe a curriculum intervention (formative reflective assignment) that optimizes workplace learning opportunities and aims to provide better student scaffolding for their in-context business learning. Students were asked to analyze a business practice they experienced during a period of extra-mural studies (external work placement). Following return to the college, they were then instructed to discuss their findings in their study group, and produce a group reflection on their learning. To better understand student engagement in this area, we analyzed individual and group components of the assignment. Thematic analysis revealed evidence of various depths of student engagement, and provided indications of the behaviors they used when engaging at different levels. Interactive and social practices (discussing business strategies with veterinary employees and student peers) appeared to facilitate student engagement, assist the perception of relevance of these skills, and encourage integration with other curriculum elements such as communication skills and clinical problem solving.

  2. Mergers and acquisitions involving equine veterinary practices.

    Science.gov (United States)

    Jackman, Brad R; McCafferty, Owen E

    2009-12-01

    This article discusses mergers and acquisitions involving equine veterinary practices. Combining practices can be professionally and economically advantageous but requires a great deal of thought, planning, and implementation. If due diligence is performed and true business teamwork is undertaken, the benefits can be enormous and rewarding.

  3. Prose Learning for Veterinary Educators: Facilitating Acquisition

    Science.gov (United States)

    Harkness, John E.

    1978-01-01

    A prose text in veterinary medicine can be arranged and supplemented to facilitate efficient and effective acquisition into short-term memory. Methods include: variation in textual format; relating new information to previous knowledge and future goals; providing specific, test-relevant objectives or introductions, describing mnemonic devices; and…

  4. Veterinary Medicine and Animal Health Technology Handbook.

    Science.gov (United States)

    New York State Education Dept., Albany. Office of the Professions.

    The laws, rules, and regulations of the New York State Education Department that govern professional veterinary medicine and animal health technology practice in the state are presented. Licensure requirements are described, and complete application forms and instructions for obtaining license and first registration as a licensed veterinarian and…

  5. Sokoto Journal of Veterinary Sciences: Submissions

    African Journals Online (AJOL)

    Author Guidelines. The Editorial Board of the Sokoto Journal of Veterinary Sciences (SJVS) wishes to invite research articles, case reports and review articles for ... be accompanied by a cover letter verifying that the final manuscript has been seen and approved by all authors and transferring copyright ownership to SJVS.

  6. Research data services in veterinary medicine libraries

    Directory of Open Access Journals (Sweden)

    Erin E. Kerby, MSI

    2017-01-01

    Conclusions: Lacking a standard definition of ‘‘research data’’ and a common understanding of precisely what research data services encompass, it is difficult for veterinary medicine librarians and libraries to define and understand their roles in research data services. Nonetheless, they appear to have an interest in learning more about and providing research data services.

  7. Veterinary Fusarioses within the United States

    Science.gov (United States)

    Multilocus DNA sequence data was used to retrospectively assess the genetic diversity and evolutionary relationships of 67 Fusarium strains from veterinary sources, most of which were from the United States. Molecular phylogenetic analyses revealed that the strains comprised 23 phylogenetically dist...

  8. Enhancing cognitive learning in Veterinary Osteology through ...

    African Journals Online (AJOL)

    at Veterinary anatomy education. The objective was to assess the importance of student participation in skeletal preparation. The hypothesis that the students would be more interested in the discipline if the teaching methodology used is based on creative and constructivist methods. Thirteen animal skeletons were ...

  9. Comparative oncology: Integrating human and veterinary medicine ...

    African Journals Online (AJOL)

    Cancer constitutes the major health problem both in human and veterinary medicine. Comparative oncology as an integrative approach offers to learn more about naturally occurring cancers across different species. Canine models have many advantages as they experience spontaneous disease, have many genes similar ...

  10. Integrative veterinary medical education and consensus guidelines ...

    African Journals Online (AJOL)

    Increased training of future veterinary professionals in IVM may produce an openness to new ideas that characterizes the scientific method and a willingness to pursue and incorporate evidence-based medicine in clinical practice with all therapies, including those presently regarded as integrative, complementary, ...

  11. Cone beam computed tomography in veterinary dentistry

    NARCIS (Netherlands)

    van Thielen, B.; Siguenza, F.; Hassan, B.

    2012-01-01

    The purpose of this study was to assess the feasibility of cone beam computed tomography (CBCT) in imaging dogs and cats for diagnostic dental veterinary applications. CBCT scans of heads of six dogs and two cats were made. Dental panoramic and multi-planar reformatted (MPR) para-sagittal

  12. International Veterinary Epilepsy Task Force recommendations for a veterinary epilepsy-specific MRI protocol

    DEFF Research Database (Denmark)

    Rusbridge, Clare; Long, Sam; Jovanovik, Jelena

    2015-01-01

    Epilepsy is one of the most common chronic neurological diseases in veterinary practice. Magnetic resonance imaging (MRI) is regarded as an important diagnostic test to reach the diagnosis of idiopathic epilepsy. However, given that the diagnosis requires the exclusion of other differentials...... sequences, imaging planes and/or particular techniques used in performing the MRI scan. As a result, there is a need to standardize MRI examination in veterinary patients with techniques that reliably diagnose subtle lesions, identify post-seizure changes, and which will allow for future identification...... of underlying causes of seizures not yet apparent in the veterinary literature.There is a need for a standardized veterinary epilepsy-specific MRI protocol which will facilitate more detailed examination of areas susceptible to generating and perpetuating seizures, is cost efficient, simple to perform and can...

  13. Guidelines for zoo and aquarium veterinary medical programs and veterinary hospitals.

    Science.gov (United States)

    Backues, Kay; Clyde, Vickie; Denver, Mary; Fiorello, Christine; Hilsenroth, Rob; Lamberski, Nadine; Larson, Scott; Meehan, Tom; Murray, Mike; Ramer, Jan; Ramsay, Ed; Suedmeyer, Kirk; Whiteside, Doug

    2011-03-01

    These guidelines for veterinary medical care and veterinary hospitals are written to conform with the requirements of the Animal Welfare Act, which states that programs of disease prevention and parasite control, euthanasia, and adequate veterinary care shall be established and maintained under the supervision of a veterinarian. Ideally the zoo and aquarium should be providing the best possible veterinary medical care for the animals in their collections. Many of these animals are rare and endangered and the institutions should endeavor both to provide for the long term health and well being of these animals and to advance the field of non-domestic animal medicine. It is hoped that this publication will aid in this process.

  14. 77 FR 77008 - Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan...

    Science.gov (United States)

    2012-12-31

    ... clients can reasonably be expected to pay for professional veterinary services and where food animal... the event of a discrepancy between the primary reviewer's scoring and the panel poll results, the...

  15. From “One Health” to “One Communication”: The Contribution of Communication in Veterinary Medicine to Public Health

    Directory of Open Access Journals (Sweden)

    Micaela Cipolla

    2015-07-01

    Full Text Available Despite the fact that health communication is a discipline developed only recently, its importance in human medicine is well recognized. However, it is less considered in veterinary medicine, even if it has the potential to improve public health because of the role of veterinary medicine in public health. For this reason, an One Health approach is useful for communication as well. This approach leads to a “One Communication” concept, which is the result of the synergy in communicative efforts both in human and in veterinary medicine. Our analysis explores the potential of communication in several veterinary fields: institutions, food safety, companion animal and food-producing animal practice, pharmacology and drugs, wildlife fauna and environment. In almost all the areas of veterinary activity communication can contribute to human health. It takes many forms and use several channels, and this variety of communicative opportunities represent a challenge for veterinarians. For this reason, the communication course should be included in the curricula of Veterinary Medicine Schools. As One Health, One Communication is a strategy for expanding collaborations in health communication and it will enhance public health.

  16. Mathematical modeling and simulation in animal health - Part II: principles, methods, applications, and value of physiologically based pharmacokinetic modeling in veterinary medicine and food safety assessment.

    Science.gov (United States)

    Lin, Z; Gehring, R; Mochel, J P; Lavé, T; Riviere, J E

    2016-10-01

    This review provides a tutorial for individuals interested in quantitative veterinary pharmacology and toxicology and offers a basis for establishing guidelines for physiologically based pharmacokinetic (PBPK) model development and application in veterinary medicine. This is important as the application of PBPK modeling in veterinary medicine has evolved over the past two decades. PBPK models can be used to predict drug tissue residues and withdrawal times in food-producing animals, to estimate chemical concentrations at the site of action and target organ toxicity to aid risk assessment of environmental contaminants and/or drugs in both domestic animals and wildlife, as well as to help design therapeutic regimens for veterinary drugs. This review provides a comprehensive summary of PBPK modeling principles, model development methodology, and the current applications in veterinary medicine, with a focus on predictions of drug tissue residues and withdrawal times in food-producing animals. The advantages and disadvantages of PBPK modeling compared to other pharmacokinetic modeling approaches (i.e., classical compartmental/noncompartmental modeling, nonlinear mixed-effects modeling, and interspecies allometric scaling) are further presented. The review finally discusses contemporary challenges and our perspectives on model documentation, evaluation criteria, quality improvement, and offers solutions to increase model acceptance and applications in veterinary pharmacology and toxicology. © 2016 John Wiley & Sons Ltd.

  17. Drug: D08248 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available [veterinary] (TN) ... C19H21NO3. HCl D08248.gif ... Analgesic ... DG01586 ... Opioid receptor antagonist Other ... DG01718 ... Drugs... for addictive disorder ... DG01717 ... Drugs for opioid dependence ATC code: V03AB02 Chemical group: DG0

  18. Veterinary Fusarioses within the United States.

    Science.gov (United States)

    O'Donnell, Kerry; Sutton, Deanna A; Wiederhold, Nathan; Robert, Vincent A R G; Crous, Pedro W; Geiser, David M

    2016-11-01

    Multilocus DNA sequence data were used to assess the genetic diversity and evolutionary relationships of 67 Fusarium strains from veterinary sources, most of which were from the United States. Molecular phylogenetic analyses revealed that the strains comprised 23 phylogenetically distinct species, all but two of which were previously known to infect humans, distributed among eight species complexes. The majority of the veterinary isolates (47/67 = 70.1%) were nested within the Fusarium solani species complex (FSSC), and these included 8 phylospecies and 33 unique 3-locus sequence types (STs). Three of the FSSC species (Fusarium falciforme, Fusarium keratoplasticum, and Fusarium sp. FSSC 12) accounted for four-fifths of the veterinary strains (38/47) and STs (27/33) within this clade. Most of the F. falciforme strains (12/15) were recovered from equine keratitis infections; however, strains of F. keratoplasticum and Fusarium sp. FSSC 12 were mostly (25/27) isolated from marine vertebrates and invertebrates. Our sampling suggests that the Fusarium incarnatum-equiseti species complex (FIESC), with eight mycoses-associated species, may represent the second most important clade of veterinary relevance within Fusarium Six of the multilocus STs within the FSSC (3+4-eee, 1-b, 12-a, 12-b, 12-f, and 12-h) and one each within the FIESC (1-a) and the Fusarium oxysporum species complex (ST-33) were widespread geographically, including three STs with transoceanic disjunctions. In conclusion, fusaria associated with veterinary mycoses are phylogenetically diverse and typically can only be identified to the species level using DNA sequence data from portions of one or more informative genes. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  19. The Veterinary Clinical Trials Network - a Pragmatic Approach to Filling the Evidence Gaps for Veterinary Practice

    Directory of Open Access Journals (Sweden)

    Hannah Doit

    2017-04-01

    Full Text Available Including current published evidence is vital as part of evidence-based decision making in veterinary practice. Sometimes there is no published evidence which is relevant or applicable to the clinical situation.This can be either because it refers to patients with experimentally induced conditions, from a referral population or who lack the co-morbities often seen outside of the experimental context. The Veterinary Clinical Trials Network is unique. It is a rapidly expanding network of veterinary practices, with whom we are working to establish methods for running prospective, pragmatic, practical clinical trials in veterinary practice.Data is extracted from the patient record using an XML Schema. The data extracted is already captured by the Practice Management Software (PMS system as part of the consultation, no extra information is required, and the extraction method is automated. This improves participation as it minimises the time input required from vets and vet nurses. Other data is obtained directly from owners of the animals involved.By working with a large number of first opinion veterinary practices we are able to include enough patients to ensure that our trials are suitably powered, and the participants will be representative of the wider vet-visiting pet population. The research generated from this clinical trials network will help strengthen the evidence base to aid decision making by veterinary practitioners.

  20. Examining why ethics is taught to veterinary students: a qualitative study of veterinary educators' perspectives.

    Science.gov (United States)

    Magalhães-Sant'Ana, Manuel; Lassen, Jesper; Millar, Kate M; Sandøe, Peter; Olsson, I Anna S

    2014-01-01

    Although it is widely agreed that veterinary students need to be introduced to ethics, there is limited empirical research investigating the reasons why veterinary ethics is being taught. This study presents the first extensive investigation into the reasons for teaching veterinary ethics and reports data collected in semi-structured interviews with educators involved in teaching undergraduate veterinary ethics at three European schools: the University of Copenhagen, the University of Nottingham, and the Technical University of Lisbon (curricular year 2010-2011). The content of the interview transcripts were analyzed using Toulmin's argumentative model. Ten objectives in teaching veterinary ethics were identified, which can be grouped into four overarching themes: ethical awareness, ethical knowledge, ethical skills, and individual and professional qualities. These objectives include recognizing values and ethical viewpoints, identifying norms and regulations, developing skills of communication and decision making, and contributing to a professional identity. Whereas many of the objectives complement each other, there is tension between the view that ethics teaching should promote knowledge of professional rules and the view that ethics teaching should emphasize critical reasoning skills. The wide range of objectives and the possible tensions between them highlight the challenges faced by educators as they attempt to prioritize among these goals of ethics teaching within a crowded veterinary curriculum.

  1. Microscope use in clinical veterinary practice and potential implications for veterinary school curricula.

    Science.gov (United States)

    Stewart, Sherry M; Dowers, Kristy L; Cerda, Jacey R; Schoenfeld-Tacher, Regina M; Kogan, Lori R

    2014-01-01

    Microscopy (skill of using a microscope) and the concepts of cytology (study of cells) and histology (study of tissues) are most often taught in professional veterinary medicine programs through the traditional method of glass slides and light microscopes. Several limiting factors in veterinary training programs are encouraging educators to explore innovative options for teaching microscopy skills and the concepts of cytology and histology. An anonymous online survey was administered through the Colorado Veterinary Medical Association to Colorado veterinarians working in private practice. It was designed to assess their current usage of microscopes for cytological and histological evaluation of specimens and their perceptions of microscope use in their veterinary education. The first part of the survey was answered by 183 veterinarians, with 104 indicating they had an onsite diagnostic lab. Analysis pertaining to the use of the microscope in practice and in veterinary programs was conducted on this subset. Most respondents felt the amount of time spent in the curriculum using a microscope was just right for basic microscope use and using the microscope for viewing and learning about normal and abnormal histological sections and clinical cytology. Participants felt more emphasis could be placed on clinical and diagnostic cytology. Study results suggest that practicing veterinarians frequently use microscopes for a wide variety of cytological diagnostics. However, only two respondents indicated they prepared samples for histological evaluation. Veterinary schools should consider these results against the backdrop of pressure to implement innovative teaching techniques to meet the changing needs of the profession.

  2. The role of veterinary team effectiveness in job satisfaction and burnout in companion animal veterinary clinics.

    Science.gov (United States)

    Moore, Irene C; Coe, Jason B; Adams, Cindy L; Conlon, Peter D; Sargeant, Jan M

    2014-09-01

    To determine the role of veterinary team effectiveness regarding job satisfaction and burnout in companion animal veterinary practice. Cross-sectional observational study. 48 companion animal veterinary health-care teams. 274 team members participated in an online survey. Overall job satisfaction was evaluated with a 1-item measure, and the 3 dimensions of burnout (exhaustion, cynicism, and professional efficacy) were measured with the Maslach Burnout Inventory-General Survey. Team effectiveness was assessed with a survey developed for this study. Demographic and team effectiveness factors (coordinated team environment, toxic team environment, team engagement, and individual engagement) associated with job satisfaction and burnout were evaluated. Overall mean job satisfaction score was 5.46 of 7 (median, 6.00); veterinary technicians and kennel attendants had the lowest scores. According to the Maslach survey results, 22.4% of participants were in the high-risk category for exhaustion, 23.2% were in the high-risk category for cynicism, and 9.3% were in the high-risk category for professional efficacy. A coordinated team environment was associated with increased professional efficacy and decreased cynicism. A toxic team environment was negatively associated with job satisfaction and positively associated with exhaustion and cynicism. Individual engagement was positively associated with job satisfaction and professional efficacy and negatively associated with exhaustion and cynicism. Results suggested the effectiveness of a veterinary team can significantly influence individual team members' job satisfaction and burnout. Practices should pay specific attention to the effectiveness with which their veterinary team operates.

  3. Estudio de bioequivalencia: formulaciones genéricas y comerciales de estaduvine, lamiduvine, zidovudine e indinavir en pacientes cubanos infectados con VIH Bioequivalence study: generic and trade formulations of stavudine, lamivudine, zidovudine and indinavir in Cuban HIV-infected subjects

    Directory of Open Access Journals (Sweden)

    Alicia Tarinas Reyes

    2006-08-01

    bioequivalence of each antiretroviral drug (test and reference formulations was determined in 13 or 14subjects by means of a randomizedcrossover blind study with a wash-outperiod of ten days. Methods: The plasma concentrations were monitored over a period of 12 h after drug administration using a validated HPLC method. The pharmacokinetic parameters were determined by using WinNolin Professional software, Version 2.1. The comparison of the pharmacokinetic parameters was made at 95 % confidence interval using the NCSS 2000 and PASS 2000 trial software (paired t-test, null hypothesis.The bioequivalence study was conducted by the EqivTest software of statistical solutions. ANOVA was utilized with 90 % confidence interval. Results: The present study showed that no significant differences were observed in the means of AUC0-12, AUC0-¥, C max, and T max of both formulations of stavudine, lamivudine zidovudine, and indinavir. It wasconcluded that the studied pharmacokinetic parameters are withinthe established range. The ranges for Cmax, AUC0-12, and AUC0-¥ were 80-125 %, whereasthe range for Cmax of zidovudine was 70-143 %. Conclusion: These results prove that the Cuban generic antiretroviralsare bioequivalent to their respective innovatory products in terms ofthe rate and extent of absorption

  4. Effect of the Wetting Agent Sodium Lauryl Sulfate on the Pharmacokinetics of Alectinib: Results From a Bioequivalence Study in Healthy Subjects.

    Science.gov (United States)

    Morcos, Peter N; Parrott, Neil; Banken, Ludger; Timpe, Carsten; Lindenberg, Marc; Guerini, Elena; Dall, Georgina; Bogman, Katrijn; Sturm, Carolina; Zeaiter, Ali; Martin-Facklam, Meret; Phipps, Alex

    2017-05-01

    The anaplastic lymphoma kinase (ALK) inhibitor alectinib is an effective treatment for ALK-positive non-small-cell lung cancer. This bioequivalence study evaluated the in vivo performance of test 3 formulations with the reduced wetting agent sodium lauryl sulfate (SLS) content. This randomized, 4-period, 4-sequence, crossover study compared alectinib (600 mg) as 25%, 12.5%, and 3% SLS hard capsule formulations with the reference 50% SLS clinical formulation in healthy subjects under fasted conditions (n = 49), and following a high-fat meal (n = 48). Geometric mean ratios and 90% confidence intervals (CIs) for C max , AUC 0-last , and AUC 0-∞ of alectinib, its major active metabolite, M4, and alectinib plus M4 were determined for the test formulations versus the reference formulation. Bioequivalence was concluded if the 90%CIs were within the 80% to 125% boundaries. The 25% SLS formulation demonstrated bioequivalence to the reference 50% SLS formulation for C max , AUC 0-last , and AUC 0-∞ of alectinib, M4, and alectinib plus M4 under both fasted and fed conditions. Further reductions in SLS content (12.5% and 3% SLS) did not meet the bioequivalence criteria. Cross-group comparisons showed an approximately 3-fold positive food effect. Reducing SLS to 25% resulted in a formulation that is bioequivalent to the current 50% SLS formulation used in alectinib pivotal trials. © 2016, The American College of Clinical Pharmacology.

  5. Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

    Science.gov (United States)

    Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

    2016-07-01

    Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. [Bioequivalence of dermatological topical medicines:the Brazilian scenario and the challenges for health surveillance].

    Science.gov (United States)

    Soares, Kelen Carine Costa; Moraes, Marcelo Vogler; Gelfuso, Guilherme Martins; Gratieri, Taís

    2015-11-01

    The comparative evaluation required for the registration of generic topical medicines in Brazil is conducted by means of a pharmaceutical equivalence study, which merely assesses the physical/chemical and microbiological parameters of the formulations. At the international level, clinical or pharmacodynamic studies are now being required to prove the efficacy and safety of semisolid topical generic formulations. This work presents a comparison of the different requirements for the registration of topical formulations, taking into consideration the various regulatory authorities, and presents a survey of topical medicines registered in Brazil prior to 2013. The survey revealed that in comparison with the USA there were many more copies of these formulations registered in Brazil. This fact, together with the large number of studies in the literature showing the lack of bioequivalence of topical medication, is clear proof of the major importance of the need to realign Brazilian legislation with respect to the technical requirements for the registration of generic and similar medication for dermatological topical application in Brazil.

  7. Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products.

    Science.gov (United States)

    Saito, Ken-Ichi; Inoue, Yutaka; Ikegami, Yoji; Nanbo, Izumi; Onozuka, Mari; Sano, Kazumi; Yoshida, Hisahiro; Sakamoto, Toshihiro; Tatebayashi, Emi; Fujita, Ken-Ichi; Sasaki, Yasutsuna; Kitazawa, Takaki

    2016-11-01

    To investigate bioequivalence among generic and brand-name irinotecan products. Products of Yakult and Daiichi-Sankyo (brand-name products), Sandoz, Nippon Kayaku, Taiho, and Sawai were compared with respect to their composition and antitumor activity. High-performance liquid chromatography demonstrated that related substances were within the acceptable range. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay revealed significant differences in cytotoxicity for four cancer cell lines among the products. The concentration of the active compound SN-38 was highest in Yakult's product (23.82 ng/ml) and lowest in Daiichi-Sankyo's product (8.96 ng/ml). MTT assay data were correlated with the SN-38 concentration, suggesting that it influenced differences in cytocidal activity among products. However, the SN-38 concentration was far lower than that of irinotecan (20 mg/ml), suggesting a negligible clinical effect. Metabolism of irinotecan to SN-38 or open-ring forms did not differ significantly among the products. The generic products showed equivalent efficacy and safety to the brand-name products. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  8. Controlled release veterinary drug delivery: biological and pharmaceutical considerations

    National Research Council Canada - National Science Library

    Rathbone, Michael J; Gurny, Robert

    2000-01-01

    ... terms and conditions apply to its use: Photocopying Single photocopies of single chapters may be made for personal use as allowed by national copyright laws. Permission of the Publisher and pay...

  9. Probing the In Vitro Cytotoxicity of the Veterinary Drug Oxytetracycline

    Science.gov (United States)

    Chi, Zhenxing; Liu, Rutao; You, Hong; Ma, Shanshan; Cui, Hao; Zhang, Qiang

    2014-01-01

    The study investigated the effect of oxytetracycline (OTC) on the anti-oxidative defense system, the structure (hemolysis rate and morphology) and function (ATP enzyme activity) of human red blood cells (hRBCs) to investigate the possible toxic mechanism of OTC to hRBCs. The experimental results indicate that OTC can cause a decline in the function of the antioxidant defense system of hRBCs, resulting in oxidative stress. OTC can bring about morphological changes to hRBCs, and further leads to hemolysis, when the concentration of OTC is over 8×10−5 M (about 164 µg/ml). At a low OTC concentration, below 4×10−5 M (82 µg/ml), OTC can enhance the activity of ATP enzyme of hRBCs, known as hormesis. However, at a high concentration, above 4×10−5 M (about 82 µg/ml), the ATP enzymatic activity was inhibited, affecting the function of hRBCs. The estalished mechanism of toxicity of OTC to hRBCs can facilitate a deeper understanding of the toxicity of OTC in vivo. PMID:25019386

  10. Probing the in vitro cytotoxicity of the veterinary drug oxytetracycline.

    Directory of Open Access Journals (Sweden)

    Zhenxing Chi

    Full Text Available The study investigated the effect of oxytetracycline (OTC on the anti-oxidative defense system, the structure (hemolysis rate and morphology and function (ATP enzyme activity of human red blood cells (hRBCs to investigate the possible toxic mechanism of OTC to hRBCs. The experimental results indicate that OTC can cause a decline in the function of the antioxidant defense system of hRBCs, resulting in oxidative stress. OTC can bring about morphological changes to hRBCs, and further leads to hemolysis, when the concentration of OTC is over 8×10(-5 M (about 164 µg/ml. At a low OTC concentration, below 4×10(-5 M (82 µg/ml, OTC can enhance the activity of ATP enzyme of hRBCs, known as hormesis. However, at a high concentration, above 4×10(-5 M (about 82 µg/ml, the ATP enzymatic activity was inhibited, affecting the function of hRBCs. The estalished mechanism of toxicity of OTC to hRBCs can facilitate a deeper understanding of the toxicity of OTC in vivo.

  11. Leveraging existing data for prioritization of the ecological risks of human and veterinary pharmaceuticals to aquatic organisms

    Science.gov (United States)

    Medicinal innovation has lead to the discovery and use of thousands of human and veterinary drugs. With this comes the potential for unintended effects on non-target organisms exposed to pharmaceuticals inevitably entering the environment. The impracticality of generating whole-o...

  12. 75 FR 15387 - Veterinary Feed Directive

    Science.gov (United States)

    2010-03-29

    ..., drug toxicity, drug residues, antimicrobial resistance, or other reasons may dictate that the use of a... relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is... existed for regulating the distribution of animal drugs, including drugs in animal feed: (1) Over-the...

  13. Quality systems in veterinary diagnostics laboratories.

    Science.gov (United States)

    de Branco, Freitas Maia L M

    2007-01-01

    Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.

  14. Information prescriptions: A tool for veterinary practices

    Directory of Open Access Journals (Sweden)

    L.R. Kogan

    2014-09-01

    Full Text Available The Internet has become a major source of health information and has the potential to offer many benefits for both human and animal health. In order for impact to be positive, however, it is critical that users be able to access reliable, trustworthy information. Although more pet owners are using the Internet to research animal health information than ever before, there remains limited research surrounding their online activities or the ability to influence owners’ online search behaviors. The current study was designed to assess the online behaviors and perceptions of pet owners after receiving either general or topic-specific information prescriptions as part of their veterinary appointment. Results indicate that nearly 60% of clients accessed the suggested websites and nearly all of these clients reported positive feelings about this addition to their veterinary services. These results suggest that offering information prescriptions to clients can facilitate better online searches by clients and positively impact both animal health and client satisfaction.

  15. Financing and organisation of veterinary services.

    Science.gov (United States)

    Gallacher, M; Barcos, L

    2012-08-01

    This paper analyses the different ways of financing official Veterinary Services (VS) and the effects of these choices on the performance of such Services. The links between governance, organisational effectiveness and financing arrangements are seen as particularly important. The paper comments on some of the advantages and disadvantages of financing VS with service fees, as compared to budget transfers from general government revenues. Evidence is presented on the considerable heterogeneity in the size of VS and on the impact of this heterogeneity on organisation and financing. The paper concludes with a stylised case study, which emphasises the importance of collaboration and the division of labour between the official and the private sector of the veterinary profession.

  16. Problems associated with veterinary dental radiography

    International Nuclear Information System (INIS)

    Eisner, E.R.

    1990-01-01

    Veterinarians have been radiographing animal skulls for many years, but sophisticated dentistry was not widely used until the 1970s. Elevated awareness of veterinary dental techniques has led to the need for producing accurate radiographic images of the teeth and periodontal structures. Many problems arise for the clinician who treats small animals who has, before this time, radiographed the skull of dogs and cats solely for the purpose of assessing neoplastic, infectious, or traumatic disease of the mandible, maxilla, or calvarium and now desires to perform dental radiography. This chapter will describe the advantages and disadvantages of some of the more common types of radiographic equipment and supplies, discuss extraoral and intraoral radiographic positioning and technique, identify anatomic landmarks and diagnostic features of intraoral radiography, and offer suggestions concerning the art of using dental radiography in veterinary practice

  17. A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

    Science.gov (United States)

    Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

    2017-02-01

    The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge®, Test) and a marketed counterpart (Viagra®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of Cmax (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUClast (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean Cmax was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUClast and AUC∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

  18. Radiotherapy in veterinary medicine: beginnings and perspectives

    International Nuclear Information System (INIS)

    Fernandes, Marco A.R.; Andrade, Alexandre L.; Luvizoto, Maria C.R.; Piero, Juliana R.; Ciarlini, Luciana D.R.P.

    2010-01-01

    This work presents a brief historical about the use of ionizing radiations in Veterinary Medicine, instructing the physical beginnings and techniques wrapped in the realization of the proceedings of radiotherapy in animals, illustrating some treated cases, highlighting the difficulties and pointing to the perspectives and importance of the acting of the medical physics in this kind of therapeutic still little used in the national scenery. (author)

  19. The responsibilities of veterinary educators in responding to emerging needs in veterinary medicine.

    Science.gov (United States)

    Halliwell, R E W

    2009-08-01

    It is an unfortunate fact that not only has veterinary education failed to adapt in the face of likely future needs, but it has also failed to respond to societal changes that have already taken place and that have affected the requirements for veterinary services and veterinary capability. The responsibility is primarily that of educators, although vision and foresight require a co-ordinated approach involving national and international veterinary organisations. Once it is accepted by all parties that change is essential, the implementation will fail unless there is a unified programme involving the schools and colleges, the accrediting agencies, the licensing authorities, governments, the professional organisations and corporate veterinary medicine. All have a role to play, and any one can readily block progress. A unified approach is an absolute requirement. The developed countries must take a leading role, but the issues are global, and ways must be found to facilitate change in all parts of the world. Disease knows no boundaries, and any strategy is only as strong as its weakest link.

  20. International Veterinary Epilepsy Task Force recommendations for a veterinary epilepsy-specific MRI protocol.

    Science.gov (United States)

    Rusbridge, Clare; Long, Sam; Jovanovik, Jelena; Milne, Marjorie; Berendt, Mette; Bhatti, Sofie F M; De Risio, Luisa; Farqhuar, Robyn G; Fischer, Andrea; Matiasek, Kaspar; Muñana, Karen; Patterson, Edward E; Pakozdy, Akos; Penderis, Jacques; Platt, Simon; Podell, Michael; Potschka, Heidrun; Stein, Veronika M; Tipold, Andrea; Volk, Holger A

    2015-08-28

    Epilepsy is one of the most common chronic neurological diseases in veterinary practice. Magnetic resonance imaging (MRI) is regarded as an important diagnostic test to reach the diagnosis of idiopathic epilepsy. However, given that the diagnosis requires the exclusion of other differentials for seizures, the parameters for MRI examination should allow the detection of subtle lesions which may not be obvious with existing techniques. In addition, there are several differentials for idiopathic epilepsy in humans, for example some focal cortical dysplasias, which may only apparent with special sequences, imaging planes and/or particular techniques used in performing the MRI scan. As a result, there is a need to standardize MRI examination in veterinary patients with techniques that reliably diagnose subtle lesions, identify post-seizure changes, and which will allow for future identification of underlying causes of seizures not yet apparent in the veterinary literature.There is a need for a standardized veterinary epilepsy-specific MRI protocol which will facilitate more detailed examination of areas susceptible to generating and perpetuating seizures, is cost efficient, simple to perform and can be adapted for both low and high field scanners. Standardisation of imaging will improve clinical communication and uniformity of case definition between research studies. A 6-7 sequence epilepsy-specific MRI protocol for veterinary patients is proposed and further advanced MR and functional imaging is reviewed.

  1. Prevalence of hazardous exposures in veterinary practice

    Energy Technology Data Exchange (ETDEWEB)

    Wiggins, P.; Schenker, M.B.; Green, R.; Samuels, S.

    1989-01-01

    All female graduates of a major U.S. veterinary school were surveyed by mailed questionnaire to obtain details of work practice and hazard exposure during the most recent year worked and during all pregnancies. Exposure questions were based on previously implicated occupational hazards which included anesthetic gases, radiation, zoonoses, prostaglandins, vaccines, physical trauma, and pesticides. The response rate was 86% (462/537). We found that practice type and pregnancy status were major determinants of hazard exposure within the veterinary profession. Small-animal practitioners reported the highest rates of exposure to anesthetic gas (94%), X-ray (90%), and pesticides (57%). Large-animal practitioners reported greater rates of trauma (64%) and potential exposure to prostaglandins (92%), Brucella abortus vaccine (23%), and carbon monoxide (18%). Potentially hazardous workplace practices or equipment were common. Forty-one percent of respondents who reported taking X-rays did not wear film badges, and 76% reported physically restraining animals for X-ray procedures. Twenty-seven percent of the respondents exposed to anesthetic gases worked at facilities which did not have waste anesthetic gas scavenging systems. Women who worked as veterinarians during a pregnancy attempted to reduce exposures to X-rays, insecticides, and other potentially hazardous exposures. Some potentially hazardous workplace exposures are common in veterinary practice, and measures to educate workers and to reduce these exposures should not await demonstration of adverse health effects.

  2. Use of adenoviral vectors as veterinary vaccines.

    Science.gov (United States)

    Ferreira, T B; Alves, P M; Aunins, J G; Carrondo, M J T

    2005-10-01

    Vaccines are the most effective and inexpensive prophylactic tool in veterinary medicine. Ideally, vaccines should induce a lifelong protective immunity against the target pathogen while not causing clinical or pathological signs of diseases in the vaccinated animals. However, such ideal vaccines are rare in the veterinary field. Many vaccines are either of limited effectiveness or have harmful side effects. In addition, there are still severe diseases with no effective vaccines. A very important criterion for an ideal vaccine in veterinary medicine is low cost; this is especially important in developing countries and even more so for poultry vaccination, where vaccines must sell for a few cents a dose. Traditional approaches include inactivated vaccines, attenuated live vaccines and subunit vaccines. Recently, genetic engineering has been applied to design new, improved vaccines. Adenovirus vectors are highly efficient for gene transfer in a broad spectrum of cell types and species. Moreover, adenoviruses often induce humoral, mucosal and cellular immune responses to antigens encoded by the inserted foreign genes. Thus, adenoviruses have become a vector of choice for delivery and expression of foreign proteins for vaccination. Consequently, the market requirements for adenovirus vaccines are increasing, creating a need for production methodologies of concentrated vectors with warranted purity and efficacy. This review summarizes recent developments and approaches of adenovirus production and purification as the application of these vectors, including successes and failures in clinical applications to date.

  3. Prevalence of hazardous exposures in veterinary practice

    International Nuclear Information System (INIS)

    Wiggins, P.; Schenker, M.B.; Green, R.; Samuels, S.

    1989-01-01

    All female graduates of a major U.S. veterinary school were surveyed by mailed questionnaire to obtain details of work practice and hazard exposure during the most recent year worked and during all pregnancies. Exposure questions were based on previously implicated occupational hazards which included anesthetic gases, radiation, zoonoses, prostaglandins, vaccines, physical trauma, and pesticides. The response rate was 86% (462/537). We found that practice type and pregnancy status were major determinants of hazard exposure within the veterinary profession. Small-animal practitioners reported the highest rates of exposure to anesthetic gas (94%), X-ray (90%), and pesticides (57%). Large-animal practitioners reported greater rates of trauma (64%) and potential exposure to prostaglandins (92%), Brucella abortus vaccine (23%), and carbon monoxide (18%). Potentially hazardous workplace practices or equipment were common. Forty-one percent of respondents who reported taking X-rays did not wear film badges, and 76% reported physically restraining animals for X-ray procedures. Twenty-seven percent of the respondents exposed to anesthetic gases worked at facilities which did not have waste anesthetic gas scavenging systems. Women who worked as veterinarians during a pregnancy attempted to reduce exposures to X-rays, insecticides, and other potentially hazardous exposures. Some potentially hazardous workplace exposures are common in veterinary practice, and measures to educate workers and to reduce these exposures should not await demonstration of adverse health effects

  4. [Marketing in veterinary practice; a theoretical framework].

    Science.gov (United States)

    Schuurmans, A J; Smidts, A

    1990-03-15

    An increase in the number of veterinarians, while at the same time the number of animals has remained constant, has resulted in growing competition. By extending the range of products and by enlarging the veterinarians' scope of activities this competition can be decreased. A marketing-orientation will be helpful in this respect. This article indicates in which way marketing concepts can be used in a veterinary practice. The services of the veterinarian will be looked at by means of the Abell approach. This focuses on the functions performed by the services and examines, per function performed, for whom this might be interesting and which alternatives there might be. Next the concept of market segmentation is filled in for a veterinary practice by means of a hypothetical example. The marketing mix (product, place, price, promotion and personnel) is given considerable attention. The last element of marketing in a veterinary practice that is discussed here is the marketing information system. In a next article the question will be answered how marketing-directed the Dutch veterinarian works nowadays. To find this out research has been done; 166 vets were interviewed by telephone for approximately 40 minutes each.

  5. Curriculum Redesign in Veterinary Medicine: Part I.

    Science.gov (United States)

    Chaney, Kristin P; Macik, Maria L; Turner, Jacqueline S; Korich, Jodi A; Rogers, Kenita S; Fowler, Debra; Scallan, Elizabeth M; Keefe, Lisa M

    Curricular review is considered a necessary component for growth and enhancement of academic programs and requires time, energy, creativity, and persistence from both faculty and administration. At Texas A&M College of Veterinary Medicine & Biomedical Sciences (TAMU), the faculty and administration partnered with the university's Center for Teaching Excellence to create a faculty-driven, data-enhanced curricular redesign process. The 8-step process begins with the formation of a dedicated faculty curriculum design team to drive the redesign process and to support the college curriculum committee. The next steps include defining graduate outcomes and mapping the current curriculum to identify gaps and redundancies across the curriculum. Data are collected from internal and external stakeholders including veterinary students, faculty, alumni, and employers of graduates. Data collected through curriculum mapping and stakeholder engagement substantiate the curriculum redesign. The guidelines, supporting documents, and 8-step process developed at TAMU are provided to assist other veterinary schools in successful curricular redesign. This is the first of a two-part report that provides the background, context, and description of the process for charting the course for curricular change. The process involves defining expected learning outcomes for new graduates, conducting a curriculum mapping exercise, and collecting stakeholder data for curricular evaluation (steps 1-4). The second part of the report describes the development of rubrics that were applied to the graduate learning outcomes (steps 5-8) and engagement of faculty during the implementation phases of data-driven curriculum change.

  6. Characterization of a Murine Model of Bioequivalent Bladder Wound Healing and Repair Following Subtotal Cystectomy

    Directory of Open Access Journals (Sweden)

    Mona Zarifpour

    2017-05-01

    Full Text Available Previous work demonstrated restoration of a bioequivalent bladder within 8 weeks of removing the majority of the bladder (subtotal cystectomy or STC in rats. The goal of the present study was to extend our investigations of bladder repair to the murine model, to harness the power of mouse genetics to delineate the cellular and molecular mechanisms responsible for the observed robust bladder regrowth. Female C57 black mice underwent STC, and at 4, 8, and 12 weeks post-STC, bladder repair and function were assessed via cystometry, ex vivo pharmacologic organ bath studies, and T2-weighted magnetic resonance imaging (MRI. Histology was also performed to measure bladder wall thickness. We observed a time-dependent increase in bladder capacity (BC following STC, such that 8 and 12 weeks post-STC, BC and micturition volumes were indistinguishable from those of age-matched non-STC controls and significantly higher than observed at 4 weeks. MRI studies confirmed that bladder volume was indistinguishable within 3 months (11 weeks post-STC. Additionally, bladders emptied completely at all time points studied (i.e., no increases in residual volume, consistent with functional bladder repair. At 8 and 12 weeks post-STC, there were no significant differences in bladder wall thickness or in the different components (urothelium, lamina propria, or smooth muscle layers of the bladder wall compared with age-matched control animals. The maximal contractile response to pharmacological activation and electrical field stimulation increased over time in isolated tissue strips from repaired bladders but remained lower at all time points compared with controls. We have established and validated a murine model for the study of de novo organ repair that will allow for further mechanistic studies of this phenomenon after, for example, genetic manipulation.

  7. Application of a rapid and sensitive liquid chromatography-tandem mass spectrometry method for determination of bumetanide in human plasma for a bioequivalence study.

    Science.gov (United States)

    Patel, Dinesh S; Sharma, Naveen; Patel, Mukesh C; Patel, Bhavin N; Shrivastav, Pranav S; Sanyal, Mallika

    2012-07-01

    A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of bumetanide in human plasma using tamsulosin as internal standard (IS). The analyte and IS were extracted from 200 μL of human plasma via solid phase extraction and the chromatographic separation was achieved on Peerless Basic C18 (100 mm × 4.6 mm, 3 μm) column under isocratic conditions. Detection of bumetanide and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for bumetanide and IS were m/z 365.2→240.2 and 409.2→228.2 respectively. The method was fully validated as per the US FDA guidelines. The limit of detection and lower limit of quantitation of the method were 0.03 and 0.30 ng/mL respectively with a linear dynamic range of 0.30-200.0 ng/mL for bumetanide. The intra-batch and inter-batch precision (% CV) was ≤6.9% while the mean extraction recovery was >90% across quality control levels. The method is selective in presence of four diuretic drugs and some commonly used medications by healthy volunteers. It was successfully applied to a bioequivalence study of 2mg bumetanide tablet formulation in 10 healthy Indian male subjects under fasting condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 42 incurred samples. Copyright © 2012 Elsevier B.V. All rights reserved.

  8. A simple and sensitive HPLC method for analysis of imipramine in human plasma with UV detection and liquid-liquid extraction: Application in bioequivalence studies.

    Science.gov (United States)

    Rezazadeh, Mahboubeh; Emami, Jaber

    2016-01-01

    High-performance liquid chromatography (HPLC) methods employing ultraviolet (UV) detector are not sufficiently sensitive to measure the low plasma concentrations following single oral dose of imipramine. Therefore, in the present study a simple, rapid and yet sensitive HPLC method with UV detection was developed and validated for quantitation of imipramine in human plasma samples. An efficient liquid-liquid extraction (LLE) of imipramine from plasma with the mixture of hexane/isoamyl alcohol (98:2) and back extraction of the drug in acidic medium concomitant with evaporation of organic phase allowed the use of UV detector to conveniently measure plasma levels of this compound as low level as 3 ng/ml. Separation was achieved on a μ-Bondapak C18 HPLC column using sodium hydrogen phosphate solution (0.01 M)/acetonitrile (60/40 v/v) at pH 3.5 ± 0.1 at 1.5 ml/min. Trimipramine was used as the internal standard for analysis of plasma samples. The retention times for imipramine and trimipramine were 4.3 and 5.2 min, respectively. Calibration curve was linear in the range of 3-40 ng/ml using human plasma with the average extraction recovery of 85 ± 5%. Imipramine was found to be stable in plasma samples with no evidence of degradation during three freeze-thaw cycles and three months storage at -70°C. The current validated method was finally applied in bioequivalence studies of two different imipramine products according to a standard two-way crossover design with a two weeks washout period.

  9. Quantitation of itopride in human serum by high-performance liquid chromatography with fluorescence detection and its application to a bioequivalence study.

    Science.gov (United States)

    Singh, Sonu Sundd; Jain, Manish; Sharma, Kuldeep; Shah, Bhavin; Vyas, Meghna; Thakkar, Purav; Shah, Ruchy; Singh, Shriprakash; Lohray, Brajbhushan

    2005-04-25

    A new method was developed for determination of itopride in human serum by reversed phase high-performance liquid chromatography (HPLC) with fluorescence detection (excitation at 291 nm and emission at 342 nm). The method employed one-step extraction of itopride from serum matrix with a mixture of tert-butyl methyl ether and dichloromethane (70:30, v/v) using etoricoxib as an internal standard. Chromatographic separation was obtained within 12.0 min using a reverse phase YMC-Pack AM ODS column (250 mm x 4.6 mm, 5 microm) and an isocratic mobile phase constituting of a mixture of 0.05% tri-fluoro acetic acid in water and acetonitrile (75:25, v/v) flowing at a flow rate of 1.0 ml/min. The method was linear in the range of 14.0 ng/ml to 1000.0 ng/ml. The lower limit of quantitation (LLOQ) was 14.0 ng/ml. Average recovery of itopride and the internal standard from the biological matrix was more than 66.04 and 64.57%, respectively. The inter-day accuracy of the drug containing serum samples was more than 97.81% with a precision of 2.31-3.68%. The intra-day accuracy was 96.91% or more with a precision of 5.17-9.50%. Serum samples containing itopride were stable for 180.0 days at -70+/-5 degrees C and for 24.0 h at ambient temperature (25+/-5 degrees C). The method was successfully applied to the bioequivalence study of itopride in healthy, male human subjects.

  10. Implementation of Online Veterinary Hospital on Cloud Platform.

    Science.gov (United States)

    Chen, Tzer-Shyong; Chen, Tzer-Long; Chung, Yu-Fang; Huang, Yao-Min; Chen, Tao-Chieh; Wang, Huihui; Wei, Wei

    2016-06-01

    Pet markets involve in great commercial possibilities, which boost thriving development of veterinary hospital businesses. The service tends to intensive competition and diversified channel environment. Information technology is integrated for developing the veterinary hospital cloud service platform. The platform contains not only pet medical services but veterinary hospital management and services. In the study, QR Code andcloud technology are applied to establish the veterinary hospital cloud service platform for pet search by labeling a pet's identification with QR Code. This technology can break the restriction on veterinary hospital inspection in different areas and allows veterinary hospitals receiving the medical records and information through the exclusive QR Code for more effective inspection. As an interactive platform, the veterinary hospital cloud service platform allows pet owners gaining the knowledge of pet diseases and healthcare. Moreover, pet owners can enquire and communicate with veterinarians through the platform. Also, veterinary hospitals can periodically send reminders of relevant points and introduce exclusive marketing information with the platform for promoting the service items and establishing individualized marketing. Consequently, veterinary hospitals can increase the profits by information share and create the best solution in such a competitive veterinary market with industry alliance.

  11. Overview of suspected adverse reactions to veterinary medicinal products reported in South Africa (March 2001 - February 2002 : report

    Directory of Open Access Journals (Sweden)

    V. Naidoo

    2002-07-01

    Full Text Available 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.

  12. Therapeutic potential of stem cells in veterinary practice

    Directory of Open Access Journals (Sweden)

    Nitin E Gade

    Full Text Available Stem cell research acquired great attention during last decade inspite of incredible therapeutic potential of these cells the ethical controversies exists. Stem cells have enormous uses in animal cloning, drug discovery, gene targeting, transgenic production and regenerative therapy. Stem cells are the naïve cells of body which can self-renew and differentiate into other cell types to carry out multiple functions, these properties have been utilized in therapeutic application of stem cells in human and veterinary medicine. The application of stem cells in human medicine is well established and it is commonly used for chronic and accidental injuries. In Veterinary sciences previous studies mostly focused on establishing protocols for isolation and their characterization but with advancement in array of techniques for in vitro studies, stem cells rapidly became a viable tool for regenerative therapy of chronic, debilitating and various unresponsive clinical diseases and disorders. Multipotent adult stem cells have certain advantages over embryonic stem cells like easy isolation and expansion from numerous sources, less immunogenicity and no risk of teratoma formation hence their use is preferred in therapeutics. Adult stem cells have been utilized for treatment of spinal injuries, tendonitis, cartilage defects, osteoarthritis and ligament defects, liver diseases, wounds, cardiac and bone defects in animals. The multi-potential capability of these cells can be better utilized in near future to overcome the challenges faced by the clinicians. This review will emphasize on the therapeutic utilization and success of stem cell therapies in animals. [Vet. World 2012; 5(8.000: 499-507

  13. Methicillin-resistant staphylococcal contamination of cellular phones of personnel in a veterinary teaching hospital

    Directory of Open Access Journals (Sweden)

    Julian Timothy

    2012-07-01

    Full Text Available Abstract Background Hospital-associated infections are an increasing cause of morbidity and mortality in veterinary patients. With the emergence of multi-drug resistant bacteria, these infections can be particularly difficult to eradicate. Sources of hospital-associated infections can include the patients own flora, medical staff and inanimate hospital objects. Cellular phones are becoming an invaluable feature of communication within hospitals, and since they are frequently handled by healthcare personnel, there may be a potential for contamination with various pathogens. The objective of this study was to determine the prevalence of contamination of cellular phones (hospital issued and personal carried by personnel at the Ontario Veterinary College Health Sciences Centre with methicillin-resistant Staphylococcus pseudintermedius (MRSP and methicillin-resistant Staphylococcus aureus (MRSA. Results MRSP was isolated from 1.6% (2/123 and MRSA was isolated from 0.8% (1/123 of cellular phones. Only 21.9% (27/123 of participants in the study indicated that they routinely cleaned their cellular phone. Conclusions Cellular phones in a veterinary teaching hospital can harbour MRSP and MRSA, two opportunistic pathogens of significant concern. While the contamination rate was low, cellular phones could represent a potential source for infection of patients as well as infection of veterinary personnel and other people that might have contact with them. Regardless of the low incidence of contamination of cellular phones found in this study, a disinfection protocol for hospital-issued and personal cellular phones used in veterinary teaching hospitals should be in place to reduce the potential of cross-contamination.

  14. Prevalence and antimicrogram of Staphylococcus intermedius group isolates from veterinary staff, companion animals, and the environment in veterinary hospitals in Korea.

    Science.gov (United States)

    Youn, Jung-Ho; Yoon, Jang Won; Koo, Hye Cheong; Lim, Suk-Kyung; Park, Yong Ho

    2011-03-01

    The Staphylococcus intermedius bacterial group (SIG) includes 3 distinct genetically heterogenous species: S. intermedius, S. pseudintermedius, and S. delphini. This pathogen group is associated with many opportunistic skin and ear infections in companion animals. Human infections with S. intermedius and S. pseudintermedius isolates and the emergence of methicillin-resistant isolates have been recently reported, which emphasizes the importance of nationwide identification of SIG isolate prevalence and antibiotic resistance in veterinary clinics. In the present study, a total of 178 SIG isolates were obtained from veterinary staff (n  =  40), companion animals (n  =  115), and the local environment (n  =  23) in 8 Korean veterinary hospitals. Isolates were differentiated into 167 S. pseudintermedius (93.8%) and 11 S. intermedius (6.2%) isolates; S. delphini isolates were not identified. The most effective antibiotics against these isolates included amoxicillin-clavulanic acid, amikacin, nitrofloxacin, imipenem, and vancomycin; whereas ampicillin, penicillin, tetracycline, erythromycin, and trimethoprim-sulfamethoxazole were not effective. Surprisingly, the 128 SIG isolates (71.9%) displayed multiple drug resistance (MDR) against 3 or more antibiotic classes. Out of 52 SIG isolates carrying the methicillin-resistance gene (mecA), only 34 (65.4%) were oxacillin-resistant, and 49 (94.2%) methicillin-resistant SIG were multidrug resistant. This finding suggests the presence of greater numbers of MDR phenotypes than other isolates (P < 0.05).

  15. Antibiotic prophylaxis in veterinary cancer chemotherapy: A review and recommendations.

    Science.gov (United States)

    Bisson, J L; Argyle, D J; Argyle, S A

    2018-06-12

    Bacterial infection following cancer chemotherapy-induced neutropenia is a serious cause of morbidity and mortality in human and veterinary patients. Antimicrobial prophylaxis is controversial in the human oncology field, as any decreased incidence in bacterial infections is countered by patient adverse effects and increased antimicrobial resistance. Comprehensive guidelines exist to aid human oncologists in prescribing antimicrobial prophylaxis but similar recommendations are not available in veterinary literature. As the veterinarian's role in antimicrobial stewardship is increasingly emphasized, it is vital that veterinary oncologists implement appropriate antimicrobial use. By considering the available human and veterinary literature we present an overview of current clinical practices and are able to suggest recommendations for prophylactic antimicrobial use in veterinary cancer chemotherapy patients. © 2018 The Authors. Veterinary and Comparative Oncology published by John Wiley & Sons Ltd.

  16. Educational programme on radiation protection for veterinary medicine specialists

    International Nuclear Information System (INIS)

    Djuric, G.; Popovic, D.

    1992-01-01

    The education of radiation protection for veterinary medicine specialists on the University of Belgrade is integrated both in regular graduate studies and in postgraduate studies. Within the graduate studies, students attend courses in physics and biophysics and in radiation hygiene. During postgraduate or specialistic veterinary medicine studies, veterinary medicine specialists expand their knowledge in radiation protection through a number of courses on radiation biophysics, radioecology, nuclear instrumentation and environmental protection. (author)

  17. THE APIPHYTOTHERAPY WITH PROACTIVATOR IN THE VETERINARY DERMATOLOGY AND SURGERY

    OpenAIRE

    A. SICEANU; AGRIPINA SAPCALIU; I. RADOI; D. CONDUR; ELIZA CAUIA; CRENGUTA PAVEL

    2008-01-01

    The main objective of this clinical study consisted in evaluation of the therapeutic effects of the propolis extract used in different disorders at company animals, thus being improved the palette of the apitherapeutical products used in veterinary purposes. The experiments were carried out on company animals (two experimental groups) during the 2007-2008 period, in the frame of the Veterinary Medicine Faculty – Bucharest and the University - Spiru Haret, at the veterinary departments: Parasi...

  18. Evidence-based integrative medicine in clinical veterinary oncology.

    Science.gov (United States)

    Raditic, Donna M; Bartges, Joseph W

    2014-09-01

    Integrative medicine is the combined use of complementary and alternative medicine with conventional or traditional Western medicine systems. The demand for integrative veterinary medicine is growing, but evidence-based research on its efficacy is limited. In veterinary clinical oncology, such research could be translated to human medicine, because veterinary patients with spontaneous tumors are valuable translational models for human cancers. An overview of specific herbs, botanics, dietary supplements, and acupuncture evaluated in dogs, in vitro canine cells, and other relevant species both in vivo and in vitro is presented for their potential use as integrative therapies in veterinary clinical oncology. Published by Elsevier Inc.

  19. Veterinary Pharmaceutics: An Opportunity for Interprofessional Education in New Zealand?

    Science.gov (United States)

    McDowell, Arlene; Beard, Rebekah; Brightmore, Anna; Lu, Lisa W; McKay, Amelia; Mistry, Maadhuri; Owen, Kate; Swan, Emma; Young, Jessica

    2017-07-26

    Globally pharmacists are becoming increasingly involved in veterinary medicine; however, little is known about the level of interest for pharmacists playing a larger role in animal treatment in New Zealand. A key stakeholder in any progression of pharmacists becoming more involved in the practice of veterinary pharmacy is the veterinary profession. The aim of this study was to investigate views of veterinarians and veterinary students on the role of pharmacists supporting veterinarians with advice on animal medicines. Open interviews were conducted with veterinarians in Dunedin, New Zealand. Veterinary students at Massey University completed an online survey. Most veterinarians do not have regular communication with pharmacists regarding animal care, but believe it may be beneficial. In order to support veterinarians, pharmacists would need further education in veterinary medicine. Veterinary students believe there is opportunity for collaboration between professions provided that pharmacists have a better working knowledge of animal treatment. Most of the veterinary students surveyed perceive a gap in their knowledge concerning animal medicines, specifically pharmacology and compounding. While there is support for pharmacists contributing to veterinary medicine, particularly in the area of pharmaceutics, this is currently limited in New Zealand due to a lack of specialized education opportunities.

  20. Applications of Metal Additive Manufacturing in Veterinary Orthopedic Surgery

    Science.gov (United States)

    Harrysson, Ola L. A.; Marcellin-Little, Denis J.; Horn, Timothy J.

    2015-03-01

    Veterinary medicine has undergone a rapid increase in specialization over the last three decades. Veterinarians now routinely perform joint replacement, neurosurgery, limb-sparing surgery, interventional radiology, radiation therapy, and other complex medical procedures. Many procedures involve advanced imaging and surgical planning. Evidence-based medicine has also become part of the modus operandi of veterinary clinicians. Modeling and additive manufacturing can provide individualized or customized therapeutic solutions to support the management of companion animals with complex medical problems. The use of metal additive manufacturing is increasing in veterinary orthopedic surgery. This review describes and discusses current and potential applications of metal additive manufacturing in veterinary orthopedic surgery.

  1. Ethical principles for novel therapies in veterinary practice.

    Science.gov (United States)

    Yeates, J W

    2016-02-01

    To present insights to aid decision-making about novel veterinary treatments from regulations concerning animal experimentation and human clinical medical trials. EU Directive 2010/63/EU on the protection of animals used for scientific purposes and EU Regulation 536/2014 on clinical trials on medicinal products for human use were analysed, evaluated and "translated" into relevant principles for veterinary surgeons. A number of principles are relevant, relating to treatment expectations, thresholds and objectives; client consent; minimising harms; personnel; review committees; assessment and publication. These principles should assist veterinary surgeons to make good ethical decisions about novel treatments. © 2015 British Small Animal Veterinary Association.

  2. Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products

    Directory of Open Access Journals (Sweden)

    Anke Finnah

    2017-02-01

    Full Text Available Objective: In the present study, the feasibility of a systematic record of clinical study data from marketing authorisation applications for veterinary medicinal products (VMP and benefits of the selected approach were investigated.Background: Drug registration dossiers for veterinary medicinal products contain extensive data from drug studies, which are not easily accessible to assessors.Evidentiary value: Fast access to these data including specific search tools could facilitate a meaningful use of the data and allow assessors for comparison of test and studies from different dossiers.Methods: First, pivotal test parameters and their mutual relationships were identified. Second, a data model was developed and implemented in a relational database management system, including a data entry form and various reports for database searches. Compilation of study data in the database was demonstrated using all available clinical studies involving VMPs containing the anthelmintic drug Praziquantel. By means of descriptive data analysis possibilities of data evaluation including graphical presentation were shown. Suitability of the database to support the performance of meta-analyses was tentatively validated.Results: The data model was designed to cover the specific requirements arising from study data. A total of 308 clinical studies related to 95 VMPs containing Praziquantel (single agent and combination drugs was selected for prototype testing. The relevant data extracted from these studies were appropriately structured and shown to be basically suitable for descriptive data analyses as well as for meta-analyses.Conclusion: The database-supported collection of study data would provide users with easy access to the continuously increasing pool of scientific information held by competent authorities. It enables specific data analyses. Database design allows expanding the data model to all types of studies and classes of drugs registered in veterinary

  3. An introduction to metabolomics and its potential application in veterinary science.

    Science.gov (United States)

    Jones, Oliver A H; Cheung, Victoria L

    2007-10-01

    Metabolomics has been found to be applicable to a wide range of fields, including the study of gene function, toxicology, plant sciences, environmental analysis, clinical diagnostics, nutrition, and the discrimination of organism genotypes. This approach combines high-throughput sample analysis with computer-assisted multivariate pattern-recognition techniques. It is increasingly being deployed in toxico- and pharmacokinetic studies in the pharmaceutical industry, especially during the safety assessment of candidate drugs in human medicine. However, despite the potential of this technique to reduce both costs and the numbers of animals used for research, examples of the application of metabolomics in veterinary research are, thus far, rare. Here we give an introduction to metabolomics and discuss its potential in the field of veterinary science.

  4. A conceptual holding model for veterinary applications

    Directory of Open Access Journals (Sweden)

    Nicola Ferrè

    2014-05-01

    Full Text Available Spatial references are required when geographical information systems (GIS are used for the collection, storage and management of data. In the veterinary domain, the spatial component of a holding (of animals is usually defined by coordinates, and no other relevant information needs to be interpreted or used for manipulation of the data in the GIS environment provided. Users trying to integrate or reuse spatial data organised in such a way, frequently face the problem of data incompatibility and inconsistency. The root of the problem lies in differences with respect to syntax as well as variations in the semantic, spatial and temporal representations of the geographic features. To overcome these problems and to facilitate the inter-operability of different GIS, spatial data must be defined according to a “schema” that includes the definition, acquisition, analysis, access, presentation and transfer of such data between different users and systems. We propose an application “schema” of holdings for GIS applications in the veterinary domain according to the European directive framework (directive 2007/2/EC - INSPIRE. The conceptual model put forward has been developed at two specific levels to produce the essential and the abstract model, respectively. The former establishes the conceptual linkage of the system design to the real world, while the latter describes how the system or software works. The result is an application “schema” that formalises and unifies the information-theoretic foundations of how to spatially represent a holding in order to ensure straightforward information-sharing within the veterinary community.

  5. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg) demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study.

    Science.gov (United States)

    Daher, André; Pitta, Luciana; Santos, Tereza; Barreira, Draurio; Pinto, Douglas

    2015-06-01

    The recommended treatment for latent tuberculosis (TB) infection in adults is a daily dose of isoniazid (INH) 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration "time t" was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients' adherence to the treatment and quality of life.

  6. Using a single tablet daily to treat latent tuberculosis infection in Brazil: bioequivalence of two different isoniazid formulations (300 mg and 100 mg demonstrated by a sensitive and rapid high-performance liquid chromatography-tandem mass spectrometry method in a randomised, crossover study

    Directory of Open Access Journals (Sweden)

    André Daher

    2015-06-01

    Full Text Available The recommended treatment for latent tuberculosis (TB infection in adults is a daily dose of isoniazid (INH 300 mg for six months. In Brazil, INH was formulated as 100 mg tablets. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested a new 300 mg INH formulation. The aim of our study was to compare the bioavailability of the new INH 300 mg formulation and three 100 mg tablets of the reference formulation. We conducted a randomised, single dose, open label, two-phase crossover bioequivalence study in 28 healthy human volunteers. The 90% confidence interval for the INH maximum concentration of drug observed in plasma and area under the plasma concentration vs. time curve from time zero to the last measurable concentration “time t” was 89.61-115.92 and 94.82-119.44, respectively. The main limitation of our study was that neither adherence nor the safety profile of multiple doses was evaluated. To determine the level of INH in human plasma, we developed and validated a sensitive, simple and rapid high-performance liquid chromatography-tandem mass spectrometry method. Our results showed that the new formulation was bioequivalent to the 100 mg reference product. This finding supports the use of a single 300 mg tablet daily strategy to treat latent TB. This new formulation may increase patients’ adherence to the treatment and quality of life.

  7. Gamma rays application in veterinary immunology

    International Nuclear Information System (INIS)

    Bulkhanov, R.U.; Butaev, M.K.; Mirzaev, B.Sh.; Ryasnyanskiy, I.V.; Yuldashev, R.Yu.

    2005-01-01

    Full text: The process based on stimulated action of ionized radiation, change of quality of agricultural goods and row materials, biocides including bactericide action of ionized radiation are among the methods of radiation biotechnology, which can be applied in agriculture. We used the bactericide action of ionized radiation in technological process for creation of fundamentally new preparation possessed by by immunogenic properties and named as 'radio vaccine'. This term is well known and frequently used in scientific papers in the field of applied radiobiology. It is well known that physical (thermal) and chemical actions are used for preparation of vaccine for veterinary. It was noted that this process resulted in destruction of antigenic structure of bacteria cells, with are responsible for immunity creation. The possibility of virulence reduction at constant immunogenic properties of microorganism and keeping its antigenic structure can be achieved by using ionized radiation as one of the factor, which influences on bacteria. Taking into account the necessity of vaccine improvement and increase of quantity of associated vaccine one of the most important problems of veterinary science and particle is creation of vaccines of new generation which are characterized by the ability to form immunity against several diseases of agricultural animals. As a result of many-years investigations using gamma rays radiations in UzSRIV (laboratory of radiobiology) the radiation biotechnology of vaccine preparation was developed. These vaccines are necessary for practical application. Radiation biotechnology allows to prepare high-effective mono-, associated and polyvalent radio vaccines against widespread infection diseases of agricultural animals especially cubs (calves, lambs, young pigs). On the basis of developed radiation biotechnology there were prepared the following vaccines: 'Associated radio vaccine against colibacteriosis and salmonellosis of small horned cattle

  8. Whole-genome sequencing of veterinary pathogens

    DEFF Research Database (Denmark)

    Ronco, Troels

    -electrophoresis and single-locus sequencing has been widely used to characterize such types of veterinary pathogens. However, DNA sequencing techniques have become fast and cost effective in recent years and whole-genome sequencing data provide a much higher discriminative power and reproducibility than any...... genetic background. This indicates that dairy cows can be natural carriers of S. aureus subtypes that in certain cases lead to CM. A group of isolates that mostly belonged to ST151 carried three pathogenicity islands that were primarily found in this group. The prevalence of resistance genes was generally...

  9. 76 FR 80878 - Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan...

    Science.gov (United States)

    2011-12-27

    ... INFORMATION CONTACT: Gary Sherman; National Program Leader, Veterinary Science; National Institute of Food and... of Consultation 3. Rationale for Capping Nominations and State Allocation Method 4. State Allocation... adding section 1415A to the National Agricultural Research, Extension, and Teaching Policy Act of 1997...

  10. 76 FR 5131 - Solicitation of Nomination of Veterinary Shortage Situations for the Veterinary Medicine Loan...

    Science.gov (United States)

    2011-01-28

    ... Science; National Institute of Food and Agriculture; U.S. Department of Agriculture; STOP 2220; 1400... and State Allocation Method 4. State Allocation of Nominations 5. FY 2011 Shortage Situation..., Extension, and Teaching Policy Act of 1997 (NARETPA). This law established a new Veterinary Medicine Loan...

  11. 75 FR 52505 - Fiscal Year 2011 Veterinary Import/Export Services, Veterinary Diagnostic Services, and Export...

    Science.gov (United States)

    2010-08-26

    ... plant and plant product export certification program operations, contact Mr. William E. Thomas, Director...; Birds or poultry, including zoo birds or poultry, receiving nonstandard housing, care, or handling to... diseases of livestock and poultry within the United States. Veterinary diagnostics is the work performed in...

  12. Validação de métodos cromatográficos para a determinação de resíduos de medicamentos veterinários em alimentos Validation of chromatographic methods for the determination of residues of veterinary drugs in foods

    OpenAIRE

    Jonas Augusto Rizzato Paschoal; Susanne Rath; Flavia Pereira da Silva Airoldi; Felix G. R. Reyes

    2008-01-01

    Different agencies that supply validation guidelines worldwide establish almost the same parameters to be evaluated in the validation process of bioanalytical methods. However, they recommend different procedures, as well as establish different acceptance criteria. The present review delineates and discusses the stages involved in the validation procedures of bioanalytical methods designed for determining veterinary residues in food, explaining the main differences in the guidelines establish...

  13. Changes in Veterinary Students' Attitudes Toward the Rural Environment and Rural Veterinary Practice: A Longitudinal Cohort Study.

    Science.gov (United States)

    Hashizume, Cary T; Woloschuk, Wayne; Hecker, Kent G

    2015-01-01

    There is a paucity of research regarding veterinary students' attitudes toward the rural environment and rural veterinary practice and how these attitudes might change over the course of a veterinary medicine program that includes rural clinical experience. Using a 23-item questionnaire, attitudes toward rural lifestyle, rural work-life balance, opportunities for career and skill development in rural veterinary practice, and inter-professional teamwork in the rural environment were assessed at the beginning and completion of a four-year veterinary medicine program. Eighty-six students (74.4% female) were included in this Canadian study over a six-year period. Thirty-one participants (36.1%) were rural students. Overall, students' attitudes toward the rural lifestyle, rural work-life balance, and inter-professional teamwork in rural veterinary practice all significantly decreased (pstudents, rural students had significantly higher rural lifestyle scores at both the beginning (pworking in a rural environment could influence students to exclude rural veterinary practice as a career choice. Rural clinical experiences designed to sustain or increase veterinary student interest in rural practice may not be sufficient to support positive rural attitudes. Given the demand for rural veterinary services in developed countries, the implications of this study may extend beyond Canada.

  14. Balancing knowledge and basic principles in veterinary parasitology - Competencies for future Danish veterinary graduates.

    Science.gov (United States)

    Thamsborg, Stig Milan; Johansen, Maria Vang; Nejsum, Peter; Williams, Andrew R; Mejer, Helena

    2018-03-15

    Veterinary parasitology has always been considered to be relevant and interesting by the Danish veterinary students. Students have to acquaint themselves with many new, small creatures with complicated and varied life cycles and with intricate Latin names that are difficult to pronounce, as only a few parasites have Danish names. In our veterinary curriculum, zoology has disappeared as a discipline, and parasitology has gradually moved from the third year to the beginning of the second year, which implies that, for example, pathology and pharmacology are "unknown fields". The number of contact hours in veterinary parasitology has been gradually cut to 24 lectures (35 min each) and practical exercises (24 h), including 9 h on coprology. The course is taught and examined jointly with bacteriology and virology in a 8-week course. As a comprehensive course, it has become increasingly difficult to get students to acquire enough active knowledge of the most common parasites and an understanding of the basic principles in relation to, for example, transmission and control. Even though information is readily accessible through books and on-line resources, we still believe that a competent clinician should know a range of parasites by heart as an active resource for their work. The dilemma has been tackled (partly) by introducing a veterinary paraclinical refresher course of 18 h (half practicals and half lectures) in the fourth study year. The focus here is on host(herd)-oriented clinical and diagnostic parasitology. The students can also now select a One Health track for six months in which zoonotic parasites are obviously a relevant topic. Copyright © 2018. Published by Elsevier B.V.

  15. Quantitative analysis of valsartan by two-dimensional liquid chromatography (2D-HPLC) and its application in a bioequivalence study in Chinese volunteers
.

    Science.gov (United States)

    Zhang, Min; Deng, Yang; Cai, Hua-Lin; Fang, Ping-Fei; Yan, Miao; Zhang, Bi-Kui; Wu, Yan-Qin

    2017-04-01

    To develop a sensitive, two-dimensional liquid chromatography (2D-LC) method for determination of valsartan, applied to investigate bioequivalence of two valsartan tablets in Chinese volunteers under fasting condition. A full automatic 2D-HPLC system was used to quantify valsartan in human plasma. The analytes were extracted by protein precipitation, using telmisartan as internal standard. The analytical method was applied in a randomized, crossover bioequivalence study of valsartan tablets; the study enrolled 18 Chinese volunteers (12 were men and 6 were women). The subjects received a single 160-mg dose of test or reference preparation with 7-days of washout under fasting state. Plasma samples were collected, pharmacokinetic parameters were obtained and the bioequivalence was evaluated. The calibration range was 9.2 - 4213.8 ng×mL-1. Inter- and intraprecision was less than 7.0%, and accuracies ranged from 99.5 to 103.8%. The extraction recovery for valsartan varied between 89.3 and 97.8%, and the stability in all conditions was excellent. The 90% CI of AUC0→36h and Cmax were 96.5 - 109.4% and 94.2 - 108.6%, respectively. The relative bioavailability was 103.9 ± 15.7%. No gender difference was observed in pharmacokinetic parameters. A sensitive 2D-HPLC method was established for the estimation of valsartan in human plasma and successfully applied in a bioequivalence study of valsartan, which suggests that these two formulations can be assumed to be bioequivalent.
.

  16. Zebrafish: an animal model for research in veterinary medicine.

    Science.gov (United States)

    Nowik, N; Podlasz, P; Jakimiuk, A; Kasica, N; Sienkiewicz, W; Kaleczyc, J

    2015-01-01

    The zebrafish (Danio rerio) has become known as an excellent model organism for studies of vertebrate biology, vertebrate genetics, embryonal development, diseases and drug screening. Nevertheless, there is still lack of detailed reports about usage of the zebrafish as a model in veterinary medicine. Comparing to other vertebrates, they can lay hundreds of eggs at weekly intervals, externally fertilized zebrafish embryos are accessible to observation and manipulation at all stages of their development, which makes possible to simplify the research techniques such as fate mapping, fluorescent tracer time-lapse lineage analysis and single cell transplantation. Although zebrafish are only 2.5 cm long, they are easy to maintain. Intraperitoneal and intracerebroventricular injections, blood sampling and measurement of food intake are possible to be carry out in adult zebrafish. Danio rerio is a useful animal model for neurobiology, developmental biology, drug research, virology, microbiology and genetics. A lot of diseases, for which the zebrafish is a perfect model organism, affect aquatic animals. For a part of them, like those caused by Mycobacterium marinum or Pseudoloma neutrophila, Danio rerio is a natural host, but the zebrafish is also susceptible to the most of fish diseases including Itch, Spring viraemia of carp and Infectious spleen and kidney necrosis. The zebrafish is commonly used in research of bacterial virulence. The zebrafish embryo allows for rapid, non-invasive and real time analysis of bacterial infections in a vertebrate host. Plenty of common pathogens can be examined using zebrafish model: Streptococcus iniae, Vibrio anguillarum or Listeria monocytogenes. The steps are taken to use the zebrafish also in fungal research, especially that dealing with Candida albicans and Cryptococcus neoformans. Although, the zebrafish is used commonly as an animal model to study diseases caused by external agents, it is also useful in studies of metabolic

  17. Reconsidering the lecture in modern veterinary education.

    Science.gov (United States)

    Campanella, Michelangelo; Lygo-Baker, Simon

    2014-01-01

    Those teaching in the higher-education environment are now increasingly meeting with larger cohorts of students. The result is additional pressure on the resources available and on the teacher and learners. Against this backdrop, discussions and reflections took place between a practitioner, within a UK veterinary school, and an educational researcher with extensive experience in observing teaching in veterinary medicine. The result was an examination of the lecture as a method of teaching to consider how to resolve identified challenges. The focus of much of the literature is on technical aspects of teaching and learning, reverting to a range of tips to resolve particular issues recognized in large-group settings. We suggest that while these tips are useful, they will only take a practitioner so far. To be able to make a genuine connection to learners and help them connect directly to the discipline, we need to take account of the emotional aspects of our role as teachers, without which, delivery of knowledge may be undermined.

  18. The preanalytic phase in veterinary clinical pathology.

    Science.gov (United States)

    Braun, Jean-Pierre; Bourgès-Abella, Nathalie; Geffré, Anne; Concordet, Didier; Trumel, Cathy

    2015-03-01

    This article presents the general causes of preanalytic variability with a few examples showing specialists and practitioners that special and improved care should be given to this too often neglected phase. The preanalytic phase of clinical pathology includes all the steps from specimen collection to analysis. It is the phase where most laboratory errors occur in human, and probably also in veterinary clinical pathology. Numerous causes may affect the validity of the results, including technical factors, such as the choice of anticoagulant, the blood vessel sampled, and the duration and conditions of specimen handling. While the latter factors can be defined, influence of biologic and physiologic factors such as feeding and fasting, stress, and biologic and endocrine rhythms can often not be controlled. Nevertheless, as many factors as possible should at least be documented. The importance of the preanalytic phase is often not given the necessary attention, although the validity of the results and consequent clinical decision making and medical management of animal patients would likely be improved if the quality of specimens submitted to the laboratory was optimized. © 2014 American Society for Veterinary Clinical Pathology.

  19. Preferential sampling in veterinary parasitological surveillance

    Directory of Open Access Journals (Sweden)

    Lorenzo Cecconi

    2016-04-01

    Full Text Available In parasitological surveillance of livestock, prevalence surveys are conducted on a sample of farms using several sampling designs. For example, opportunistic surveys or informative sampling designs are very common. Preferential sampling refers to any situation in which the spatial process and the sampling locations are not independent. Most examples of preferential sampling in the spatial statistics literature are in environmental statistics with focus on pollutant monitors, and it has been shown that, if preferential sampling is present and is not accounted for in the statistical modelling and data analysis, statistical inference can be misleading. In this paper, working in the context of veterinary parasitology, we propose and use geostatistical models to predict the continuous and spatially-varying risk of a parasite infection. Specifically, breaking with the common practice in veterinary parasitological surveillance to ignore preferential sampling even though informative or opportunistic samples are very common, we specify a two-stage hierarchical Bayesian model that adjusts for preferential sampling and we apply it to data on Fasciola hepatica infection in sheep farms in Campania region (Southern Italy in the years 2013-2014.

  20. Biosafety and biosecurity in veterinary laboratories

    Energy Technology Data Exchange (ETDEWEB)

    Finley, Melissa R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Astuto-Gribble, Lisa M. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Brass, Van Hildren [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2016-08-01

    Here, with recent outbreaks of MERS-Cov, Anthrax, Nipah, and Highly Pathogenic Avian Influenza, much emphasis has been placed on rapid identification of infectious agents globally. As a result, laboratories are building capacity, conducting more advanced and sophisticated research, increasing laboratory staff, and establishing collections of dangerous pathogens in an attempt to reduce the impact of infectious disease outbreaks and characterize disease causing agents. With this expansion, the global laboratory community has started to focus on laboratory biosafety and biosecurity to prevent the accidental and/or intent ional release o f these agents. Laboratory biosafety and biosecurity systems are used around the world to help mit igate the risks posed by dangerous pathogens in the laboratory. Veterinary laboratories carry unique responsibilities to workers and communities to safely and securely handle disease causing microorganisms. Many microorganisms studied in veterinary laboratories not only infect animals, but also have the potential to infect humans. This paper will discuss the fundamentals of laboratory biosafety and biosecurity.

  1. Views of professionalism: a veterinary institutional perspective.

    Science.gov (United States)

    Roder, C; Whittlestone, K; May, S A

    2012-12-08

    In many western countries, there has been a marked change in the demographic profile of those entering the veterinary profession, with a shift from a predominantly male to a predominantly female intake. There have been parallel changes in society, with greater emphasis on human rights and work-life balance. It is, therefore, timely to consider what constitutes correct professional conduct for the profession, as there is the potential for problems to arise over the interpretation of 'professionalism' due to cultural and generational differences. A cross-section of staff and students within one veterinary institution were invited to take part in a survey exploring their prioritisation of 10 aspects of the professional role. A cluster analysis was performed, and four distinctly different profiles were established according to the views held by the cluster members. Cluster membership was found to significantly correlate to career stage, with altruism and social justice progressively giving way to professional autonomy and dominance. All four clusters in this educational environment prioritised technical and interpersonal competences above all other aspects of the professional role.

  2. 75 FR 31745 - Notice of Request for Approval of an Information Collection; National Veterinary Services...

    Science.gov (United States)

    2010-06-04

    ...] Notice of Request for Approval of an Information Collection; National Veterinary Services Laboratories... collection associated with the National Veterinary Services Laboratories animal health diagnostic system...: For information on request forms associated with the National Veterinary Services Laboratories animal...

  3. 75 FR 57737 - Notice of Request for Approval of an Information Collection; National Veterinary Services...

    Science.gov (United States)

    2010-09-22

    ...] Notice of Request for Approval of an Information Collection; National Veterinary Services Laboratories... Service's intention to request approval of an information collection associated with National Veterinary...' Information Collection Coordinator, at (301) 851-2908. SUPPLEMENTARY INFORMATION: Title: National Veterinary...

  4. 77 FR 77004 - Data Standards for Electronic Interstate Certificates of Veterinary Inspection

    Science.gov (United States)

    2012-12-31

    ...] Data Standards for Electronic Interstate Certificates of Veterinary Inspection AGENCY: Animal and Plant... data standards required to generate an official interstate certificate of veterinary inspection (ICVI... interstate certificate of veterinary inspection (ICVI). The standards were developed with the National...

  5. 75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

    Science.gov (United States)

    2010-10-22

    ...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

  6. [Vigilance for veterinary medicinal products: declarations of adverse reactions in the year 2009].

    Science.gov (United States)

    Müntener, C R; Bruckner, L; Stürer, A; Althaus, F R; Caduff-Janosa, P

    2010-12-01

    During the year 2009, 134 reports of suspected adverse drug reactions (ADRs) to veterinary medicinal products (VMPs) were received (106 in the year 2008). The distribution according to species and drug classes remained in line with previous years. Companion animals were involved in most of the reports (46 % dogs, 19 % cats), followed by cattle or calves (22 %). Antiparasitic drugs made the biggest part with 30 % of the reports, followed by antiinfectives (19 %) and hormones (13 %). Some reactions following their use are specifically discussed. 95 additional enquiries about ADRs of VMPs were received by the Swiss Toxicological Information Centre in Zürich. Most of them concerned dogs or cats and antiparasitics or anti-inflammatory drugs. In the vaccinovigilance program, a total of 1020 reports were received, of which 1000 were related to the vaccination against blue tongue disease. The most frequently reported adverse reactions were aborts, mastitis or alterations of milk quality and they are specifically discussed.

  7. Comparative bioavailability of rifampicin, isoniazid and pyrazinamide from a four drug fixed dose combination with separate formulations at the same dose levels.

    Science.gov (United States)

    Agrawal, Shrutidevi; Singh, Inderjit; Kaur, Kanwal Jit; Bhade, Shantaram R; Kaul, Chaman Lal; Panchagnula, Ramesh

    2004-05-19

    Fixed dose combination (FDC) formulations became popular in the treatment of tuberculosis (TB) because of the better patient compliance, reduced risk of monotherapy and emergence of drug resistance in contrast to treatment with separate formulations of two to four first-line drugs. However, its successful implementation in national programs is limited by probable bioinequivalency of rifampicin if present in FDC form. In this regard, World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) recommend FDCs only of proven bioavailability. Hence, bioequivalence study of four drug FDC tablet was conducted using 22 healthy male volunteers according to WHO recommended protocol to determine bioavailability of rifampicin, isoniazid and pyrazinamide compared to standard separate combination at the same dose level. The study was designed as two period, two treatment crossover experiment with a washout period of 1 week. Bioequivalence of rifampicin was estimated by plasma and urinary method for both rifampicin and its active metabolite, des-acetyl rifampicin whereas isoniazid and pyrazinamide were estimated from plasma. Mean concentration time profiles and all the pharmacokinetic parameters of rifampicin, isoniazid and pyrazinamide from FDC tablet were comparable to individual formulations and passed the bioequivalence test with power of the test above 95%. Further, bioequivalence of both rifampicin and isoniazid shows that in vitro interaction of rifampicin and isoniazid is clinically insignificant. Thus, it was concluded that FDC formulation is bioequivalent for rifampicin, isoniazid and pyrazinamide and ensures the successful treatment of TB without compromising therapeutic efficacy of any of these components of anti-TB therapy.

  8. Ethno-veterinary control of bovine dermatophilosis and ticks in Zhombe, Njelele and Shamrock resettlement in Zimbabwe.

    Science.gov (United States)

    Ndhlovu, Daud Nyosi; Masika, Patrick J

    2013-02-01

    A structured questionnaire survey was conducted to determine the ethno-veterinary practices and other control methods used by smallholder farmers for the management of bovine dermatophilosis and ticks. A total of 153 farmers were interviewed from Njelele, Zhombe communal and Shamrock resettlement areas. Crop production contributed most to livelihoods (83.2 %) while livestock contributed 9.0 %. Over 90 % of the respondents had attended school up to primary level, with 11.4 % undergoing animal health and husbandry training. Treatment of livestock diseases was practised by 96 % of the farmers, and 49.7 % of these farmers used ethno-veterinary medicines. Across the study sites, dermatophilosis was controlled using the following plants: Cissus quadrangularis (59.7 %), Catunaregam spinosa (10.5 %), Pterocarpus angolensis (10.5 %), Kalanchoe lanceolata (5.3 %), Aloe chabaudii (3.5 %), Cassia abbreviata (1.8 %), Dichrostachys cinerea (1.8 %), Urginea sanguinea (1.8 %), Ximenia caffra (1.8 %) and a plant locally called umfanawembila (1.8 %). Carica papaya and two plants, locally called mugimbura and umdungudungu, were used for tick control, and these were reported once from Njelele communal. Other control methods, besides plants or conventional drugs, were used by 28 % of the farmers for the treatment of dermatophilosis and ticks. Some farmers (14.4 %) claimed that ethno-veterinary medicines performed better than conventional drugs. The study revealed that farmers used ethno-veterinary medical practices for the treatment of dermatophilosis but rarely for tick control.

  9. Sokoto Journal of Veterinary Sciences Babesia caballi infection in a ...

    African Journals Online (AJOL)

    ADEYEYE

    Department of Veterinary Medicine, College of Veterinary Medicine, Michael Okpara University of Agriculture, ... control ticks by regular use of acaricide and timely treatment of affected horses in ... enlarged spleen and liver, pale kidney and oedema in lungs. Babesiosis is usually diagnosed by .... Journal of Animal and Plant.

  10. Comparing Tolerance of Ambiguity in Veterinary and Medical Students.

    Science.gov (United States)

    Hancock, Jason; Hammond, Jennifer A; Roberts, Martin; Mattick, Karen

    Current guidelines suggest that educators in both medical and veterinary professions should do more to ensure that students can tolerate ambiguity. Designing curricula to achieve this requires the ability to measure and understand differences in ambiguity tolerance among and within professional groups. Although scales have been developed to measure tolerance of ambiguity in both medical and veterinary professions, no comparative studies have been reported. We compared the tolerance of ambiguity of medical and veterinary students, hypothesizing that veterinary students would have higher tolerance of ambiguity, given the greater patient diversity and less well-established evidence base underpinning practice. We conducted a secondary analysis of questionnaire data from first- to fourth-year medical and veterinary students. Tolerance of ambiguity scores were calculated and compared using the TAMSAD scale (29 items validated for the medical student population), the TAVS scale (27 items validated for the veterinary student population), and a scale comprising the 22 items common to both scales. Using the TAMSAD and TAVS scales, medical students had a significantly higher mean tolerance of ambiguity score than veterinary students (56.1 vs. 54.1, pambiguity than veterinary students, although this depends on the scale used.

  11. The role of veterinary medical librarians in teaching information literacy.

    Science.gov (United States)

    Dinkelman, Andrea L; Viera, Ann R; Bickett-Weddle, Danelle A

    2011-01-01

    This qualitative study seeks to determine the nature of the instruction librarians provide to veterinary medical students at all 28 United States veterinary colleges. A secondary goal of the study was to determine in what ways and to what extent librarians participated in other instructional activities at their colleges. Over half of the librarians formally taught in one or more courses, predominantly in the first two years of the veterinary curriculum. One presentation per course was most common. Over half of the librarians interviewed stated that evidence-based veterinary medicine was taught at their colleges, and about half of these librarians collaborated with veterinary faculty in this instruction. Many librarians participated in orientation for first-year veterinary students. The librarians also taught instructional sessions for residents, interns, faculty, graduate students, and practicing veterinarians. This study found that librarians teach information literacy skills both formally and informally, but, in general, instruction by librarians was not well integrated into the curriculum. This study advances several recommendations to help veterinary students develop information literacy skills. These include: encourage veterinary faculty and administrators to collaborate more closely with librarians, incorporate a broader array of information literacy skills into assignments, and add a literature evaluation course to the curriculum.

  12. Veterinary Immunology Committee Toolkit Workshop 2010: Progress and plans

    Science.gov (United States)

    The Third Veterinary Immunology Committee (VIC) Toolkit Workshop took place at the Ninth International Veterinary Immunology Symposium (IVIS) in Tokyo, Japan on August 18, 2020. The Workshop built on previous Toolkit Workshops and covered various aspects of reagent development, commercialisation an...

  13. Highlights of the 8th International Veterinary Immunology Symposium

    Science.gov (United States)

    Veterinary immunologists have expanded understanding of the immune systems for our companion animals and developed new vaccines and therapeutics. This manuscript summarizes the highlights of the 8th International Veterinary Immunology Symposium (8 th IVIS) held August 15th-19th, 2007, in Ouro Preto,...

  14. Status and role of radiobiology in veterinary medicine

    International Nuclear Information System (INIS)

    Benova, K.

    2013-01-01

    In this presentation history of radiobiology in University of Veterinary Medicine and Pharmacy in Kosice from 1949 is presented. Scientific and pedagogic programs, role of veterinary physician as well as concept of radiobiology and cooperation are reviewed. Changes in Poecilia reticulata and Artemia franciscana after gamma radiation are presented.

  15. The status and role of radiobiology in veterinary medicine

    International Nuclear Information System (INIS)

    Benova, K.

    2007-01-01

    In this presentation author deals with history of the University of Veterinary Medicine in Kosice as well as with the status and role of radiobiology in veterinary medicine. Some results of gamma irradiation of Pecilia reticulata are presented. Activity levels of cesium-137 in contaminated mushrooms gathered in Slovakia in 2001 are presented.

  16. A Theoretical Framework for Human and Veterinary Medical Ethics Education

    Science.gov (United States)

    Magalhães-Sant'Ana, Manuel

    2016-01-01

    In their practice, physicians and veterinarians need to resort to an array of ethical competences. As a teaching topic, however, there is no accepted gold standard for human medical ethics, and veterinary medical ethics is not yet well established. This paper provides a reflection on the underlying aims of human and veterinary medical ethics…

  17. Quality documentation challenges for veterinary clinical pathology laboratories.

    Science.gov (United States)

    Sacchini, Federico; Freeman, Kathleen P

    2008-05-01

    An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.

  18. Some Observations on Veterinary Undergraduate Training in Surgical Techniques.

    Science.gov (United States)

    Whittick, William G.

    1978-01-01

    The undergraduate surgery course of the Faculty of Veterinary Medicine and Animal Science, Universiti Pertanian Malaysia, is described with focus on its experential method of teaching surgical techniques. Also discussed are the benefits of veterinary school cooperation with a large city Society for the Prevention of Cruelty to Animals (SPCA). (JMD)

  19. Emergency deployment of genetically engineered veterinary vaccines in Europe

    NARCIS (Netherlands)

    Ramezanpour, Bahar; Foucauld, de Jean; Kortekaas, Jeroen

    2016-01-01

    On the 9th of November 2015, preceding the World Veterinary Vaccine Congress, a workshop was held to discuss how veterinary vaccines can be deployed more rapidly to appropriately respond to future epizootics in Europe. Considering their potential and unprecedented suitability for surge

  20. Ethno-veterinary practices amongst livestock farmers in Ngamiland ...

    African Journals Online (AJOL)

    Although the intervention of conventional veterinary medicine is pervasive in Toteng, and many livestock owners are resorting to it, there is evidence, however, of generalized ethno-veterinary knowledge used to treat and prevent livestock diseases. Local farmers and their herders in Ngamiland are not only knowledgeable ...

  1. Sokoto Journal of Veterinary Sciences Epiphyseal plate closure of ...

    African Journals Online (AJOL)

    ADEYEYE

    Nigeria. 2. Department of Veterinary Surgery and Radiology, Faculty of Veterinary Medicine, Usmanu Danfodiyo University. Sokoto, Nigeria ... from three different small ruminant farms with birth record within Sokoto metropolis,. Nigeria. They were ... animals, one of which is the use of epiphyseal plate closure (Choi et al., ...

  2. Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.

    Science.gov (United States)

    Mochel, J P; Tyden, E; Hellmann, K; Vendrig, J C; Şenel, S; Dencker, L; Cristina, R T; Linden, H; Schmerold, I

    2018-06-01

    The European Federation for Pharmaceutical Sciences (EUFEPS) was founded 25 years ago by more than 20 national pharmaceutical societies and faculty members. As a pan-European organization, it brings together pharmaceutical societies as well as academic, industrial and regulatory scientists engaged in drug research and development, drug regulation and education of professionals working in these fields. EUFEPS represents pharmaceutical sciences in Europe and is recognized as such by both the European Commission and the European Medicines Agency. EUFEPS cooperates with the European Federation of Pharmaceutical Industries and other European organizations and maintains global connections with agencies such as the US Food and Drug Administration and the American Association of Pharmaceutical Scientists. EUFEPS has established specified networks forming the basis of its activities. The creation of a Network on Veterinary Medicines is prompted by the manifold problems resulting from the use of veterinary drugs and its inherent interconnections with human medicine, environmental and public health. A long-term goal of this initiative was to expand the spectrum of available therapeutics for use in animals, including the development of innovative delivery systems. © 2017 John Wiley & Sons Ltd.

  3. The advantages of combination therapy on hypertension: development of immediate release perindopril-indapamide tablet and assessment of bioequivalence studies.

    Science.gov (United States)

    Ölçer, A; Ölçer, M; İnce, I; Karasulu, E

    2016-03-01

    Hypertension has a major associated risk for organ damage and mortality, which is further heightened in patients with prior cardiovascular events, comorbid diabetes mellitus, microalbuminuria and renal impairment. Convers Plus tablet including perindopril erbumine (PE), which is an angiotensin converting enzyme (ACE) inhibitor, and indapamide, which is diuretic, was designed as a combined tablet to succes in the treatment of hypertension. Physico-pharmaceutical properties and characterization studies were evaluated in vitro conditions. Later on in vivo study was planned as a cross-designed, randomized, open-labeled, single-dose, single-center study via peroral route in 24 healthy male subjects. In this study, bioequivalence with primary pharmacokinetical target parameters reference (Bipreterax 4/1.25 mg Tablet-S.A.Servier Benelux N.V.) and test (Convers Plus 4/1.25 mg Tablet-ARGESAN Pharmaceutical Company) tablets have been found bioequivalent. The results of pharmacokinetic parameters for perindopril, perindoprilat and indapamide were found as Cmax = 23.179 µg/mL, tmax = 0.729 h, t1/2 = 1.429 h; AUC0-t = 26.998 µgs/mL, AUC0-inf = 27.117 µgs/mL; Cmax = 1.834 µg/mL, tmax = 8.792 h, t1/2 = 40.699 h; AUC0-t = 54.828 µgs/mL, AUC0-inf = 77.113 µgs/mL; Cmax = 18.994 µg/mL, tmax = 3.417 h, t1/2 = 16.626 h and AUC0-t = 385.829 µgs/mL, AUC0-inf = 410.728 µgs/mL respectively. In conclusion, physico-pharmaceutical properties and results of clinical trials show that Convers Plus tablets have been found as bioequivalent for perindopril, perindoprilat and indapamide in terms of AUC and Cmax, in 90% confidence limits.

  4. Drug: D08442 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available icine acetylcholinesterase (AChE) [KO:K01049] ... CAS: 114-26-1 PubChem: 96025128 ChEBI: 34938 ChEMBL: CHEMBL446060 LigandBox: D08442 NIKKAJI: J2.893B ... ... D08442 Drug Propoxur (BAN); Bolfo (TN) ... C11H15NO3 D08442.gif ... Same as: C14334 ... Carbamate veterinary med

  5. Drug: D03771 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D03771 Drug Diaveridine (USAN/INN) ... C13H16N4O2 D03771.gif ... Antiparasitic ... DG01932 ... Antifolate, antiprotoz...oal ... Veterinary medicine dihydrofolate reductase [KO:K13998] ... CAS: 5355-16-8 Pub

  6. Drug: D02534 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D02534 Drug Nitrovin (BAN); Difurazone; Nitrovin (TN) ... C14H12N6O6 D02534.gif ... Same as: C19487 ... veterina...ry medicine ... CAS: 804-36-4 PubChem: 17396705 ChEBI: 82516 ChEMBL: CHEMBL1395447 LigandBox: D02534 NIKKAJI: J4.527F ...

  7. Drug: D04135 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D04135 Drug Febantel (USAN/INN); Rintal (TN) ... C20H22N4O6S D04135.gif ... Component of Drontal (TN) veter...inary medicine ... CAS: 58306-30-2 PubChem: 47206082 ChEMBL: CHEMBL1080983 LigandBox: D04135 NIKKAJI: J14.650A ...

  8. Drug: D07801 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D07801 Drug Dexamethasone phenylpropionate; Dexafort [veterinary] (TN) ... C31H37FO6 D07801...A:1551] CYP induction: CYP2D6 [HSA:1565] CAS: 1879-72-7 PubChem: 96024498 LigandBox: D07801 NIKKAJI: J199.699A ...

  9. Examining why ethics is taught to veterinary students

    DEFF Research Database (Denmark)

    Magalhães-Sant’Ana, Manuel; Lassen, Jesper; Millar, Kate

    2014-01-01

    Although it is widely agreed that veterinary students need to be introduced to ethics, there is limited empirical research investigating the reasons why veterinary ethics is being taught. This study presents the first extensive investigation into the reasons for teaching veterinary ethics...... and reports data collected in semi-structured interviews with educators involved in teaching undergraduate veterinary ethics at three European schools: the University of Copenhagen, the University of Nottingham, and the Technical University of Lisbon (curricular year 2010–2011). The content of the interview...... transcripts were analyzed using Toulmin's argumentative model. Ten objectives in teaching veterinary ethics were identified, which can be grouped into four overarching themes: ethical awareness, ethical knowledge, ethical skills, and individual and professional qualities. These objectives include recognizing...

  10. Evaluating veterinary practitioner perceptions of communication skills and training.

    Science.gov (United States)

    McDermott, M P; Cobb, M A; Tischler, V A; Robbé, I J; Dean, R S

    2017-03-25

    A survey was conducted among veterinary practitioners in the UK and the USA in 2012/2013. Thematic analysis was used to identify underlying reasons behind answers to questions about the importance of communication skills and the desire to participate in postgraduate communication skills training. Lack of training among more experienced veterinary surgeons, incomplete preparation of younger practitioners and differences in ability to communicate all contribute to gaps in communication competency. Barriers to participating in further communication training include time, cost and doubts in the ability of training to provide value. To help enhance communication ability, communication skills should be assessed in veterinary school applicants, and communication skills training should be more thoroughly integrated into veterinary curricula. Continuing education/professional development in communication should be part of all postgraduate education and should be targeted to learning style preferences and communication needs and challenges through an entire career in practice. British Veterinary Association.

  11. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

    Science.gov (United States)

    Kuribayashi, Ryosuke; Appleton, Scott

    2017-09-01

    Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

  12. What is the veterinary professional identity? Preliminary findings from web-based continuing professional development in veterinary professionalism.

    Science.gov (United States)

    Armitage-Chan, E; Maddison, J; May, S A

    2016-03-26

    Professionalism and professional skills are increasingly being incorporated into veterinary curricula; however, lack of clarity in defining veterinary professionalism presents a potential challenge for directing course outcomes that are of benefit to the veterinary professional. An online continuing education course in veterinary professionalism was designed to address a deficit in postgraduate support in this area; as part of this course, delegates of varying practice backgrounds participated in online discussions reflecting on the implications of professional skills for their clinical practice. The discussions surrounding the role of the veterinary professional and reflecting on strengths and weaknesses in professional skills were analysed using narrative methodology, which provided an understanding of the defining skills and attributes of the veterinary professional, from the perspectives of those involved (i.e. how vets understood their own career identity). The veterinary surgeon was understood to be an interprofessional team member, who makes clinical decisions in the face of competing stakeholder needs and works in a complex environment comprising multiple and diverse challenges (stress, high emotions, financial issues, work-life balance). It was identified that strategies for accepting fallibility, and those necessary for establishing reasonable expectations of professional behaviour and clinical ability, are poorly developed. British Veterinary Association.

  13. World Association for the Advancement of Veterinary Parasitology (WAAVP): the 50th anniversary in 2013--history, achievements, and future perspectives.

    Science.gov (United States)

    Eckert, J

    2013-08-01

    In 2013 the World Association for the Advancement of Veterinary Parasitology (WAAVP) can celebrate its 50th anniversary. At this occasion in this article selected historical data are updated, and the achievements and future perspectives of the WAAVP are discussed. Although the WAAVP is a small association with only a few hundred members, it has been able to develop remarkable activities. Between 1963 and 2011 the WAAVP has organized 23 international scientific congresses, and the 24th conference will take place in Perth, Western Australia, in 2013. These conferences have achieved a high degree of international recognition as indicated by relatively large numbers of participants (up to ~800). Furthermore, the WAAVP has promoted veterinary parasitology in various ways, such as publishing international guidelines (efficacy evaluation of antiparasitic drugs, parasitological methods, standardized nomenclature of animal parasitic diseases "SNOAPAD"), stimulating international discussions on teaching and continued education ("colleges of veterinary parasitology") and by supporting the high quality journal "Veterinary Parasitology" which is the official organ of the WAAVP. In retrospect, the development of the WAAVP can be classified as very successful. New challenges associated with global changes (growth of the world population, urbanization, climate change, new developments in animal and plant production, etc.) will require new efforts in research in various fields, including veterinary parasitology. Future activities of WAAVP may include inter alia: (a) support of international parasitological networks; (b) stimulation of coordinated research aimed at the solution of defined problems; (c) increasing the exposure of WAAVP to parasitology from hitherto neglected regions of the world; (d) strengthening of official links to international organizations (FAO, WHO, etc.); (e) continuation of guideline preparation; and (d) preparation and international distribution of high

  14. Edible vaccines against veterinary parasitic diseases--current status and future prospects.

    Science.gov (United States)

    Jacob, Siju S; Cherian, Susan; Sumithra, T G; Raina, O K; Sankar, M

    2013-04-08

    Protection of domestic animals against parasitic infections remains a major challenge in most of the developing countries, especially in the surge of drug resistant strains. In this circumstance vaccination seems to be the sole practical strategy to combat parasites. Most of the presently available live or killed parasitic vaccines possess many disadvantages. Thus, expression of parasitic antigens has seen a continued interest over the past few decades. However, only a limited success was achieved using bacterial, yeast, insect and mammalian expression systems. This is witnessed by an increasing number of reports on transgenic plant expression of previously reported and new antigens. Oral delivery of plant-made vaccines is particularly attractive due to their exceptional advantages. Moreover, the regulatory burden for veterinary vaccines is less compared to human vaccines. This led to an incredible investment in the field of transgenic plant vaccines for veterinary purpose. Plant based vaccine trials have been conducted to combat various significant parasitic diseases such as fasciolosis, schistosomosis, poultry coccidiosis, porcine cycticercosis and ascariosis. Besides, passive immunization by oral delivery of antibodies expressed in transgenic plants against poultry coccidiosis is an innovative strategy. These trials may pave way to the development of promising edible veterinary vaccines in the near future. As the existing data regarding edible parasitic vaccines are scattered, an attempt has been made to assemble the available literature. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

    Science.gov (United States)

    Ramirez, Elena; Laosa, Olga; Guerra, Pedro; Duque, Blanca; Mosquera, Beatriz; Borobia, Alberto M; Lei, Suhua H; Carcas, Antonio J; Frias, Jesus

    2010-01-01

    AIM The aim of this study was to evaluate the acceptability of 124 bioequivalence (BE) studies with 80 active substances categorized according to the Biopharmaceutics Classification System (BCS) in order to establish if there were different probabilities of proving BE between the different BCS classes. METHODS We evaluated the differences between pharmaceutical products with active substances from different BCS classes in terms of acceptability, number of subjects in the study (n), the point estimates, and intra- and inter-subject coefficients of variation data from BE studies with generic products. RESULTS Out of 124 BE studies 89 (71.77%) were performed with pharmaceutical products containing active substances classified by the BCS. In all BCS classes there were non-bioequivalent pharmaceutical products: 4 out of 26 (15.38%) in class 1, 14 out of 28 (50%) in class 2, 3 out of 22 (13.63%) in class 3 and 1 out of 13 (7.69%) in class 4. When we removed those pharmaceutical products in which intra-subject variability was higher than predicted (2 in class 1 active substances, 9 in class 2 and 2 in class 3) there were still non-BE pharmaceutical products in classes 1, 2 and 3. CONCLUSIONS Comparisons between pharmaceutical products with active substances from the four BCS classes have not allowed us to define differential characteristics of each class in terms of n, inter and intra-subject variability for Cmax or AUC. Despite the usually employed test dissolution methodology proposed as quality control, pharmaceutical products with active substances from the four classes of BCS showed non-BE studies. PMID:21039763

  16. Pharmacokinetics and bioequivalence study of a fixed dose combination of rabeprazole and itopride in healthy Indian volunteers.

    Science.gov (United States)

    Sahoo, Bijay Kumar; Das, Ayan; Agarwal, Sangita; Bhaumik, Uttam; Bose, Anirbandeep; Ghosh, Debotri; Roy, Bikash; Pal, Tapan Kumar

    2009-01-01

    The aim of the present study was to compare the pharmacokinetics of rabeprazole (CAS 117976-89-3) and itopride (CAS 122898-67-3) after oral administration of a rabeprazole (20 mg)-itopride (150 mg) fixed dose combination (FDC) in healthy human volunteers. The bioequivalence of two formulations (test and reference) was determined in 12 healthy Indian male volunteers (age: 25.25 +/- 4.69 years; weight: 60.50 +/- 5.04 kg) in a randomized, single-dose, two-period, two-treatment crossover study. Both formulations were administered orally as a single dose, with the treatments separated by a washout period of 1 week. Rabeprazole and itopride plasma levels were determined by a validated HPLC method using UV detection. The formulations were compared using the pharmacokinetic parameters area under the plasma concentration-time curve (AUC(0-t)), area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) and peak plasma concentration (Cmax). General linear model (GLM) procedures were used in which sources of variation were subject, treatment and period. The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmically transformed AUC(0-infinity) and Cmax values between test and reference formulation. The 90% confidence interval for the ratio of the logarithmically transformed AUC(0-t), AUC(0-infinity) and Cmax were within the bioequivalence limits of 0.8-1.25 and the relative bioavailability of rabeprazole and itopride test and reference formulations was 98.24 and 93.65%, respectively.

  17. Avoiding sexual harassment liability in veterinary practices.

    Science.gov (United States)

    Lacroix, C A; Wilson, J F

    1996-05-15

    Harassment based on gender violates the rule of workplace equality established by Title VII of the Civil Rights Act and enforced by the EEOC. In 1986, the US Supreme Court, in Meritor Savings Bank v Vinson, established the criteria that must be met for a claim of hostile environment sexual harassment to be considered valid. Plaintiffs must show that they were subjected to conduct based on their gender, that it was unwelcome, and that it was severe and pervasive enough to alter their condition of employment, resulting in an abusive working environment. There have been few sexual harassment cases involving veterinary professionals, and it is our goal to help keep the number of filed actions to a minimum. The most effective way to avoid hostile environment sexual harassment claims is to confront the issue openly and to adopt a sexual harassment policy for the practice. When it comes to sexual harassment, an ounce of prevention is unquestionably worth a pound of cure.

  18. New alternatives in veterinary anthelminthic therapy

    Directory of Open Access Journals (Sweden)

    Romeo T. Cristina

    2007-07-01

    Full Text Available Present paper proposes the presentation of antiparasitic boluses, veterinary use specific conditionings with importance in gastro intestinal helminth population control, as a modern alternative to the classic antihelmintic therapy. The active substances are released consecutive to: diffusion, osmotic procesess, to progressive erosion, or through electronic programmed devices. Anthelmintic boluses are classified upon the releasing system in: a anthelmintic sustained release systems: for albendazole (Proftril bolus, morantel tartrate (Paratect flex and bolus ivermectines (Enzec and Alzet, Ivomec SR Bolus, levamisole (Chronominthic bolus, oxfendazol (Synanthic multidose bolus fenbendazole (Panacur Bolus.b anthelmintic programmed periodic release systems: Intra Ruminal Pulse Release Electronic Device (I.R.P.R.E.D and Repidose (Autoworm, Oxfendazole Pulsed Release Bolus.

  19. ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories.

    Science.gov (United States)

    Vap, Linda M; Harr, Kendal E; Arnold, Jill E; Freeman, Kathleen P; Getzy, Karen; Lester, Sally; Friedrichs, Kristen R

    2012-03-01

    In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.

  20. Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.

    Science.gov (United States)

    Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F

    2018-04-01

    The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.