WorldWideScience

Sample records for animal drug availability

  1. Regulatory framework for the availability and use of animal drugs in the United States.

    Science.gov (United States)

    Modric, Sanja

    2013-09-01

    The goal of this article is to help practitioners understand the regulatory framework and basis for the approval of new animal drugs, the terminology and specific meaning of terms related to drug approval, and the marketing and use of veterinary drugs in companion animal practice. Understanding the differences between approved versus unapproved drugs and their use helps practitioners make the appropriate clinical decisions on their patients' treatment. Only when buying approved animal drugs can clinicians be assured of product safety, effectiveness, and manufacturing to the strict standards for quality, purity, and potency, as well as truthful and complete labeling.

  2. 36 CFR 10.1 - Animals available.

    Science.gov (United States)

    2010-07-01

    ... 36 Parks, Forests, and Public Property 1 2010-07-01 2010-07-01 false Animals available. 10.1 Section 10.1 Parks, Forests, and Public Property NATIONAL PARK SERVICE, DEPARTMENT OF THE INTERIOR DISPOSAL OF CERTAIN WILD ANIMALS § 10.1 Animals available. From time to time there are surplus live...

  3. Animal Drug Safety FAQs

    Science.gov (United States)

    ... and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its ... have a complaints regarding veterinary standard of care issues? Complaints and questions about standard of care issues ...

  4. International Conference on Harmonisation; guidance on the duration of chronic toxicity testing in animals (rodent and nonrodent toxicity testing); availability. Notice. Food and Drug Administration, HHS.

    Science.gov (United States)

    1999-06-25

    The Food and Drug Administration (FDA) is publishing a guidance entitled "S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and is intended to provide guidance on the duration of chronic toxicity testing in rodents and nonrodents as part of the safety evaluation of a drug product. FDA is also noting circumstances in which it may accept durations of chronic toxicity testing in nonrodents that differ from the duration generally recommended by ICH.

  5. 75 FR 1275 - New Animal Drugs; Ractopamine

    Science.gov (United States)

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug...

  6. Personality, Drug Preference, Drug Use, and Drug Availability

    Science.gov (United States)

    Feldman, Marc; Boyer, Bret; Kumar, V. K.; Prout, Maurice

    2011-01-01

    This study examined the relationship between drug preference, drug use, drug availability, and personality among individuals (n = 100) in treatment for substance abuse in an effort to replicate the results of an earlier study (Feldman, Kumar, Angelini, Pekala, & Porter, 2007) designed to test prediction derived from Eysenck's (1957, 1967)…

  7. 76 FR 57906 - New Animal Drugs; Gamithromycin

    Science.gov (United States)

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 New Animal Drugs; Gamithromycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...

  8. 75 FR 79295 - New Animal Drugs; Mupirocin

    Science.gov (United States)

    2010-12-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 New Animal Drugs; Mupirocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal...

  9. Animal models of drug addiction.

    Science.gov (United States)

    García Pardo, María Pilar; Roger Sánchez, Concepción; De la Rubia Ortí, José Enrique; Aguilar Calpe, María Asunción

    2017-01-12

    The development of animal models of drug reward and addiction is an essential factor for progress in understanding the biological basis of this disorder and for the identification of new therapeutic targets. Depending on the component of reward to be studied, one type of animal model or another may be used. There are models of reinforcement based on the primary hedonic effect produced by the consumption of the addictive substance, such as the self-administration (SA) and intracranial self-stimulation (ICSS) paradigms, and there are models based on the component of reward related to associative learning and cognitive ability to make predictions about obtaining reward in the future, such as the conditioned place preference (CPP) paradigm. In recent years these models have incorporated methodological modifications to study extinction, reinstatement and reconsolidation processes, or to model specific aspects of addictive behavior such as motivation to consume drugs, compulsive consumption or drug seeking under punishment situations. There are also models that link different reinforcement components or model voluntary motivation to consume (two-bottle choice, or drinking in the dark tests). In short, innovations in these models allow progress in scientific knowledge regarding the different aspects that lead individuals to consume a drug and develop compulsive consumption, providing a target for future treatments of addiction.

  10. 76 FR 6326 - New Animal Drugs; Masitinib

    Science.gov (United States)

    2011-02-04

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 New Animal Drugs; Masitinib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect conditional approval of an application for a...

  11. 76 FR 17025 - New Animal Drugs; Oxytetracycline

    Science.gov (United States)

    2011-03-28

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated...

  12. Animal models of alcohol and drug dependence

    Directory of Open Access Journals (Sweden)

    Cleopatra S. Planeta

    2013-01-01

    Full Text Available Drug addiction has serious health and social consequences. In the last 50 years, a wide range of techniques have been developed to model specific aspects of drug-taking behaviors and have greatly contributed to the understanding of the neurobiological basis of drug abuse and addiction. In the last two decades, new models have been proposed in an attempt to capture the more genuine aspects of addiction-like behaviors in laboratory animals. The goal of the present review is to provide an overview of the preclinical procedures used to study drug abuse and dependence and describe recent progress that has been made in studying more specific aspects of addictive behavior in animals.

  13. 21 CFR 25.33 - Animal drugs.

    Science.gov (United States)

    2010-04-01

    ... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENVIRONMENTAL IMPACT...) Nonsystemic topical and ophthalmic animal drugs; (4) Drugs for minor species, including wildlife and endangered species, when the drug has been previously approved for use in another or the same species...

  14. 77 FR 735 - New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition

    Science.gov (United States)

    2012-01-06

    ... antimicrobial drugs (not including cephapirin) in cattle, swine, chickens, and turkeys: (1) For disease... cephalosporin drugs in food-producing major animal species (cattle, swine, chickens, and turkeys) including: (1... setting, and cephalosporins contribute 14 percent of the total outpatient antibiotic prescriptions....

  15. Drug use in animal sports

    DEFF Research Database (Denmark)

    Christiansen, Ask Vest

    2015-01-01

    Taking some of the most significant academic works into consideration this chapter describes how the scholarly interest in drug use in gyms rose from studies of competitive bodybuilding to studies of larger segments of the gym population. The challenge of establishing reliable figures for the fre......Taking some of the most significant academic works into consideration this chapter describes how the scholarly interest in drug use in gyms rose from studies of competitive bodybuilding to studies of larger segments of the gym population. The challenge of establishing reliable figures...... of the significant political campaigns and strategies to regulate and counter drug use in gyms....

  16. Approved Animal Drug Products (Green Book)

    Data.gov (United States)

    U.S. Department of Health & Human Services — On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions,...

  17. 9 CFR 318.20 - Use of animal drugs.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Use of animal drugs. 318.20 Section... General § 318.20 Use of animal drugs. Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any...

  18. 76 FR 60721 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin

    Science.gov (United States)

    2011-09-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health,...

  19. 77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin

    Science.gov (United States)

    2012-07-03

    ...The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where...

  20. 77 FR 58021 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2012-09-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 New Animal Drugs for Use in Animal.... SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a... that the animal drug regulations for certain monensin free-choice Type C medicated feeds for...

  1. 75 FR 7555 - New Animal Drugs for Use in Animal Feeds; Bacitracin Zinc; Nicarbazin

    Science.gov (United States)

    2010-02-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Alpharma, Inc. The ANADA provides for...

  2. 75 FR 20917 - New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine

    Science.gov (United States)

    2010-04-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds...: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div....

  3. [Animal drugs quality status and reason analysis].

    Science.gov (United States)

    Ding, Qing; Qiu, Ya-jing; Fang, Ke-hui; Hu, Hao-bin; Wu, Yue

    2015-11-01

    In order to reaction the quality present situation, problems on the current quality of animal sources of drugs are summed up by using test data analysis, literature search and marketing research. This paper can also help the improvement of the quality management, the revision of the relevant department policy system and the improvement of standards.

  4. [New drugs for horses and production animals in 2011].

    Science.gov (United States)

    Emmerich, I U

    2012-10-17

    In 2011, three newly developed active pharmaceutical ingredients for horses and food producing animals were released on the German market for veterinary drug products. Two of these new products represent different drug classes of antibiotics, the polypeptide antibiotic Bacitracin (Bacivet™) and the macrolide antibiotic Clorsulon (Levatum®). The third product represents an anticestodal antiparasitic (Tildipirosin, Zuprevo®). Furthermore, three established veterinary active pharmaceutical ingredients were modified to allow their application for additional species. Thus the nonsteroidal anti-inflammatory drug sodium salicylate is now additionally authorised for turkeys and both the macrolide antibiotic Tilmicosin and the anticoccidial drug Toltrazuril are currently available for sheep. Additionally, two veterinary drugs with a new formulation as well as a veterinary drug for horses and food producing animals with a resourceful new combination of active pharmaceutical ingredients have recently been released.

  5. Availability of online educational content concerning topics of animal welfare.

    Science.gov (United States)

    Petervary, Nicolette; Allen, Tim; Stokes, William S; Banks, Ron E

    2016-05-01

    Animal welfare is an important area of study for professionals in fields of animal care and use, and many turn to self-learning resources to gain a better understanding of topics in this area. We assessed the state of these self-learning resources by evaluating open access, freely available resources on the internet with respect to their content and the reliability of their information. We categorized content using a modified list of the topics described in the American College of Animal Welfare's Role Delineation Document, and we identified subject areas that are underrepresented among freely available resources. We identified that the field needs more content describing practical information on subtopics of animal transportation, humane education and economic issues in animal welfare. We also suggest a targeted approach to improve and increase particular aspects of content that concerns the impacts of human, animal and environment interactions on animal welfare. We recommend that veterinary societies place more emphasis on welfare policies in their websites. Additionally, the field of animal welfare would benefit from more available and authoritative information on certain species and uses of animals that are presently underrepresented.

  6. 76 FR 78149 - Oral Dosage Form New Animal Drugs; Estriol

    Science.gov (United States)

    2011-12-16

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...

  7. 76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

    Science.gov (United States)

    2011-04-05

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...

  8. 77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

    Science.gov (United States)

    2012-01-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal...

  9. 77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

    Science.gov (United States)

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Phenylpropanolamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...

  10. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... applications for new animal drug products containing medically important antimicrobial new animal drugs for use... recommends that the use of medically important antimicrobial drugs be limited to uses in animals that are... Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI......

  11. 75 FR 9334 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline

    Science.gov (United States)

    2010-03-02

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM Alliance Nutrition, Inc. The supplemental NADA provides for use...

  12. 77 FR 22667 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Science.gov (United States)

    2012-04-17

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to...

  13. 78 FR 76059 - New Animal Drugs for Use in Animal Feeds; Bambermycins

    Science.gov (United States)

    2013-12-16

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Food and Drug Administration (FDA) is amending the animal drug regulations to remove dairy replacement...-8108, email: amey.adams@fda.hhs.gov . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal...

  14. Animal models in drug development for MRSA.

    Science.gov (United States)

    Marra, Andrea

    2014-01-01

    One of the foremost challenges of drug discovery in any therapeutic area is that of solidifying the correlation between in vitro activity and clinical efficacy. Between these is the confirmation that affecting a particular target in vivo will lead to a therapeutic benefit. In antibacterial drug discovery, there is a key advantage from the start, since the targets are bacteria-therefore, it is simple to ascertain in vitro whether a drug has the desired effect, i.e., bacterial cell inhibition or killing, and to understand the mechanism by which that occurs. The downstream criteria, whether a compound reaches the infection site and achieves appropriately high levels to affect bacterial viability, can be evaluated in animal models of infection. In this way animal models of infection can be a highly valuable and predictive bridge between in vitro drug discovery and early clinical evaluation.The Gram-positive pathogen Staphylococcus aureus causes a wide variety of infections in humans (Archer, Clin Infect Dis 26:1179-1181, 1998) and has been said to be able to infect every tissue type. Fortunately, over the years a great deal of effort has been expended toward developing infection models in rodents using this organism, with good success. This chapter will describe the advantages, methods, and outcome measurements of the rodent models most used in drug discovery for S. aureus. Mouse models will be the focus of this chapter, as they are the most economical and thus most commonly used, but a rat infection model is included as well.

  15. Animal Migraine Models for Drug Development

    DEFF Research Database (Denmark)

    Jansen-Olesen, Inger; Tfelt-Hansen, Peer; Olesen, Jes

    2013-01-01

    Migraine is number seven in WHO's list of all diseases causing disability and the third most costly neurological disorder in Europe. Acute attacks are treatable by highly selective drugs such as the triptans but there is still a huge unmet therapeutic need. Unfortunately, drug development...... for headache has almost come to a standstill partly because of a lack of valid animal models. Here we review previous models with emphasis on optimal characteristics of a future model. In addition to selection of animal species, the method of induction of migraine-like changes and the method of recording...... responses elicited by such measures are crucial. The most naturalistic way of inducing attacks is by infusion of endogenous signaling molecules that are known to cause migraine in patients. The most valid response is recording of neural activity in the trigeminal system. The most useful headache related...

  16. 77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

    Science.gov (United States)

    2012-07-27

    ... addressing the judicious use of medically important antimicrobial drugs in food-producing animals (Ref. 2... information about the extent of antimicrobial drug use in food-producing animals. Specifically, the Agency is... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales...

  17. 76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

    Science.gov (United States)

    2011-08-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 524 New Animal Drugs; Change of Sponsor; Moxidectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor...

  18. 76 FR 40808 - Oral Dosage Form New Animal Drugs; Amprolium

    Science.gov (United States)

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new...

  19. 75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

    Science.gov (United States)

    2010-11-01

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new...

  20. 77 FR 32010 - New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol

    Science.gov (United States)

    2012-05-31

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, and 558 New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol AGENCY: Food and Drug Administration, HHS. ] ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

  1. 21 CFR 500.46 - Hexachlorophene in animal drugs.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Hexachlorophene in animal drugs. 500.46 Section 500.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Specific Administrative Rulings and Decisions §...

  2. Animal Farm: Considerations in Animal Gastrointestinal Physiology and Relevance to Drug Delivery in Humans.

    Science.gov (United States)

    Hatton, Grace B; Yadav, Vipul; Basit, Abdul W; Merchant, Hamid A

    2015-09-01

    "All animals are equal, but some are more equal than others" was the illustrious quote derived from British writer George Orwell's famed work, Animal Farm. Extending beyond the remit of political allegory, however, this statement would appear to hold true for the selection of appropriate animal models to simulate human physiology in preclinical studies. There remain definite gaps in our current knowledge with respect to animal physiology, notably those of intra- and inter-species differences in gastrointestinal (GI) function, which may affect oral drug delivery and absorption. Factors such as cost and availability have often influenced the choice of animal species without clear justification for their similarity to humans, and lack of standardization in techniques employed in past studies using various animals may also have contributed to the generation of contradictory results. As it stands, attempts to identify a single animal species as appropriately representative of human physiology and which may able to adequately simulate human in vivo conditions are limited. In this review, we have compiled and critically reviewed data from numerous studies of GI anatomy and physiology of various animal species commonly used in drug delivery modeling, commenting on the appropriateness of these animals for in vivo comparison and extrapolation to humans.

  3. [New drugs for small animals in 2014].

    Science.gov (United States)

    Emmerich, I U

    2015-01-01

    In 2014, six active pharmaceutical ingredients were released on the German market for small animals. Those are the ektoparasiticide of the isoxazoline group afoxolaner (NexGard®) and fluralaner (Bravecto®) and the neonicotinoid dinotefuran (Vectra 3D, Vectra Felis), the antidiabetic protamine zinc insulin of human origin (ProZinc®), the antifungal agent ketoconazole (Fugazid®) as well as the cytostatic drug oclacitinib (Apoquel®). Two substances were authorized for an additional species. The antiparasiticide eprinomectin and the antibiotic clindamycin were also authorized for use in cats. In addition, two active pharmaceutical ingredients, which were approved 2014 for use in human medicine and are of potential interest to veterinary medicine, are discussed. These are the antihypertensive drug riociguat and the urological substance mirabegron.

  4. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Science.gov (United States)

    2013-12-12

    ... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines... antimicrobial drugs intended for use in food-producing animals, as well as data on antimicrobial resistance... Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With...

  5. 76 FR 76894 - New Animal Drugs for Use in Animal Feeds; Tilmicosin

    Science.gov (United States)

    2011-12-09

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... DRUGS FOR USE IN ANIMAL FEEDS 0 1. The authority citation for 21 CFR part 558 continues to read as... antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an...

  6. 76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction

    Science.gov (United States)

    2011-03-24

    ... Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR... and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal...

  7. Probiotics and minerals availability in organic animal farming

    Directory of Open Access Journals (Sweden)

    ŞARA A.

    2008-12-01

    Full Text Available The human and animal health represents one of the most important challenges in EU countries andacceding countries. The alternative solutions adopted in order to improve animal health within organic farming(the use of organic mineral and probiotic supplements are the main issue of this paper. A review of the role ofthe selenium and yeast based probiotics (Saccharomyces cerevisiae used in organic livestock feeding ispresented. The benefits of using organic selenium compared to inorganic forms of selenium in livestock feedingwithin organic farming conditions are emphasized. The synergy between organic selenium and vitamin E inlivestock is also reviewed. A short history of the probiotics and a brief definition of these products is presentedin the second section of this paper. Some of the results of the research performed by authors in this field arepresented.

  8. Animal models for testing anti-prion drugs.

    Science.gov (United States)

    Fernández-Borges, Natalia; Elezgarai, Saioa R; Eraña, Hasier; Castilla, Joaquín

    2013-01-01

    Prion diseases belong to a group of fatal infectious diseases with no effective therapies available. Throughout the last 35 years, less than 50 different drugs have been tested in different experimental animal models without hopeful results. An important limitation when searching for new drugs is the existence of appropriate models of the disease. The three different possible origins of prion diseases require the existence of different animal models for testing anti-prion compounds. Wild type, over-expressing transgenic mice and other more sophisticated animal models have been used to evaluate a diversity of compounds which some of them were previously tested in different in vitro experimental models. The complexity of prion diseases will require more pre-screening studies, reliable sporadic (or spontaneous) animal models and accurate chemical modifications of the selected compounds before having an effective therapy against human prion diseases. This review is intended to put on display the more relevant animal models that have been used in the search of new antiprion therapies and describe some possible procedures when handling chemical compounds presumed to have anti-prion activity prior to testing them in animal models.

  9. 75 FR 68972 - New Animal Drugs; Change of Sponsor's Name

    Science.gov (United States)

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor's Name... (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from North American Nutrition Companies, Inc., to Provimi North America, Inc. DATES: This rule is effective November 10,...

  10. Acute liver failure: a critical appraisal of available animal models.

    Science.gov (United States)

    Bélanger, Mireille; Butterworth, Roger F

    2005-12-01

    The availability of adequate experimental models of acute liver failure (ALF) is of prime importance to provide a better understanding of this condition and allow the development and testing of new therapeutic approaches for patients with ALF. However, the numerous etiologies and complications of ALF contribute to the complexity of this condition and render the development of an ideal experimental model of ALF more difficult than expected. Instead, a number of different models that may be used for the study of specific aspects of ALF have been developed. The most common approaches used to induce ALFin experimental animals are surgical procedures, toxic liver injury,or a combination of both. Despite the high prevalence of viral hepatitis worldwide, very few satisfactory viral models of ALF are available. Established and newly developed models of ALF are reviewed.

  11. 21 CFR 201.115 - New drugs or new animal drugs.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false New drugs or new animal drugs. 201.115 Section 201.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Exemptions From Adequate Directions for Use § 201.115 New drugs or new...

  12. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  13. Restrictions in Availability of Drugs Used for Suicide

    DEFF Research Database (Denmark)

    Nordentoft, Merete

    2007-01-01

    Availability of drugs with high lethality has been hypothesized to increase the risk of self-poisoning suicides. A literature search concerning deliberate self-poisoning and the effect of restricting access to drugs was conducted, and the effect of restrictions in availability of barbiturates, tr...

  14. 75 FR 76259 - Oral Dosage Form New Animal Drugs; Tylosin

    Science.gov (United States)

    2010-12-08

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Tylosin... drug application (ANADA) filed by Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble... for use of PHARMASIN (tylosin tartrate) Soluble in medicated drinking water for chickens,...

  15. 76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

    Science.gov (United States)

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Tylosin... drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The ANADA provides for use of tylosin..., Dublin 24, Ireland, filed ANADA 200-455 for use of TYLOMED-WS (tylosin tartrate), a water soluble...

  16. 75 FR 15610 - New Animal Drugs for Use in Animal Feeds

    Science.gov (United States)

    2010-03-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2009,...

  17. 77 FR 14272 - New Animal Drugs for Use in Animal Feeds

    Science.gov (United States)

    2012-03-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2011,...

  18. 75 FR 81455 - New Animal Drugs; Deslorelin

    Science.gov (United States)

    2010-12-28

    ...)(2) of this section. (c) Conditions of use--(1) Horses and ponies--(i) Amount. One implant per mare... ponies intended for human consumption. Federal law restricts this drug to use by or on the order of...

  19. Subcutaneous implants for long-acting drug therapy in laboratory animals may generate unintended drug reservoirs

    Directory of Open Access Journals (Sweden)

    Michael Guarnieri

    2014-01-01

    Full Text Available Background: Long-acting therapy in laboratory animals offers advantages over the current practice of 2-3 daily drug injections. Yet little is known about the disintegration of biodegradable drug implants in rodents. Objective: Compare bioavailability of buprenorphine with the biodegradation of lipid-encapsulated subcutaneous drug pellets. Methods: Pharmacokinetic and histopathology studies were conducted in BALB/c female mice implanted with cholesterol-buprenorphine drug pellets. Results: Drug levels are below the level of detection (0.5 ng/mL plasma within 4-5 days of implant. However, necroscopy revealed that interstitial tissues begin to seal implants within a week. Visual inspection of the implant site revealed no evidence of inflammation or edema associated with the cholesterol-drug residue. Chemical analyses demonstrated that the residues contained 10-13% of the initial opiate dose for at least two weeks post implant. Discussion: The results demonstrate that biodegradable scaffolds can become sequestered in the subcutaneous space. Conclusion: Drug implants can retain significant and unintended reservoirs of drugs.

  20. 75 FR 79383 - Unapproved Animal Drugs

    Science.gov (United States)

    2010-12-20

    ... enforcement priorities and for making decisions as to whether to take action against an illegally marketed... marketed products that lack approval or other legal marketing status. Such strategies may include...) is soliciting comments from stakeholders on strategies to address the prevalence of animal...

  1. Animal models of social contact and drug self-administration.

    Science.gov (United States)

    Strickland, Justin C; Smith, Mark A

    2015-09-01

    Social learning theories of drug abuse propose that individuals imitate drug use behaviors modeled by social peers, and that these behaviors are selectively reinforced and/or punished depending on group norms. Historically, animal models of social influence have focused on distal factors (i.e., those factors outside the drug-taking context) in drug self-administration studies. Recently, several investigators have developed novel models, or significantly modified existing models, to examine the role of proximal factors (i.e., those factors that are immediately present at the time of drug taking) on measures of drug self-administration. Studies using these newer models have revealed several important conclusions regarding the effects of social learning on drug abuse: 1) the presence of a social partner influences drug self-administration, 2) the behavior of a social partner determines whether social contact will increase or decrease drug intake, and 3) social partners can model and imitate specific patterns of drug self-administration. These findings are congruent with those obtained in the human laboratory, providing support for the cross-species generality and validity of these preclinical models. This mini-review describes in detail some of the preclinical animal models used to study social contact and drug self-administration to guide future research on social learning and drug abuse.

  2. 76 FR 2807 - New Animal Drugs; Change of Sponsor

    Science.gov (United States)

    2011-01-18

    ... from Biopure Corp. to OPK Biotech, LLC. DATES: This rule is effective January 18, 2011. FOR FURTHER... Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141. There is no change in drug labeler code... addition, OPK Biotech, LLC, is not currently listed in the animal drug regulations as a sponsor of...

  3. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Science.gov (United States)

    2013-12-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United...

  4. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... medicated article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and approved conditions of use for... NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this time, the tolerances for residues of... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 Animal Drugs, Feeds, and...

  5. 75 FR 5887 - New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin

    Science.gov (United States)

    2010-02-05

    ... new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The NADA provides for use of single-ingredient Type A medicated articles containing ractopamine..., A Division of Eli Lilly ] & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141-...

  6. 76 FR 58277 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-09-20

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Public Meeting; Request... comments. The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Generic Drug... on the Internet at...

  7. 21 CFR 514.80 - Records and reports concerning experience with approved new animal drugs.

    Science.gov (United States)

    2010-04-01

    ... the new animal drug (or abstracts of them) including clinical trials on safety and effectiveness... approved new animal drugs. 514.80 Section 514.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL...

  8. Impact of Marine Drugs on Animal Reproductive Processes

    Directory of Open Access Journals (Sweden)

    Elisabetta Tosti

    2009-11-01

    Full Text Available The discovery and description of bioactive substances from natural sources has been a research topic for the last 50 years. In this respect, marine animals have been used to extract many new compounds exerting different actions. Reproduction is a complex process whose main steps are the production and maturation of gametes, their activation, the fertilisation and the beginning of development. In the literature it has been shown that many substances extracted from marine organisms may have profound influence on the reproductive behaviour, function and reproductive strategies and survival of species. However, despite the central importance of reproduction and thus the maintenance of species, there are still few studies on how reproductive mechanisms are impacted by marine bioactive drugs. At present, studies in either marine and terrestrial animals have been particularly important in identifying what specific fine reproductive mechanisms are affected by marine-derived substances. In this review we describe the main steps of the biology of reproduction and the impact of substances from marine environment and organisms on the reproductive processes.

  9. 78 FR 27859 - New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor

    Science.gov (United States)

    2013-05-13

    ... sponsor for a new animal drug application (NADA) from Land O'Lakes Purina Feed LLC to Purina Nutrition LLC... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 558 New Animal Drugs; Change of Sponsor.... SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect...

  10. 77 FR 72359 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Public Meeting; Request... comments. The Food and Drug Administration (FDA) is announcing the following meeting: Animal Generic Drug... Animal Generic Drug User Fee Act (AGDUFA II). Date and Time: The meeting will be held on December...

  11. 75 FR 45636 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Rates and Payment Procedures... generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for...

  12. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Rates and Payment Procedures... generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013, which was signed by the President on June...

  13. 78 FR 79299 - New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction

    Science.gov (United States)

    2013-12-30

    ... December 16, 2013 (78 FR 76059). The document amended the animal drug regulations to remove dairy..., Silver Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In the FR Doc. 2013-29810, appearing on page 76059 in the Federal Register of Monday, December 16, 2013 (78 FR 76059), the...

  14. 77 FR 4228 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2012-01-27

    ... drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for approval of free-choice feeds for growing cattle on pasture or in dry lot (stocker... Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 95-735 that provides for use...

  15. 77 FR 24138 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Science.gov (United States)

    2012-04-23

    ... drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for... Ave., Suite 300, Greensboro, NC 27408, filed a supplement to NADA 139-472 for DENAGARD (tiamulin.... The supplemental NADA is approved as of January 6, 2012, and the regulations in 21 CFR 558.4 and...

  16. 76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2011-12-21

    ... drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA revises a manufacturing specification for monensin free-choice Type C medicated feed for growing... 46285, filed a supplement to NADA 95-735 that provides for use of RUMENSIN 90 (monensin, USP) Type...

  17. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. Final rule.

    Science.gov (United States)

    2016-08-31

    The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

  18. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

    Science.gov (United States)

    2013-08-23

    ... of NADA 098-371 for use of nicarbazin, penicillin, and roxarsone in 3-way, combination drug Type C... ``Penicillin 2.4 to 50 and roxarsone 22.7 to 45.4''. Sec. 558.460 0 7. In Sec. 558.460, remove and...

  19. Impulsivity in Animal Models for Drug Abuse Disorders

    OpenAIRE

    Jentsch, J. David

    2008-01-01

    Different conceptual frameworks have been generated to explain substance abuse; of relevance to this article, dysfunction of impulse control systems that are required for avoiding or stopping drug-seeking and –taking may play a key role in addiction. This review summarizes work in animal models that explains the pervasive association between impulse control and substance abuse. It further underscores the concept that impulse control may be a critical target for pharmacological intervention in...

  20. The Two Faces of Social Interaction Reward in Animal Models of Drug Dependence.

    Science.gov (United States)

    El Rawas, Rana; Saria, Alois

    2016-03-01

    Drug dependence is a serious health and social problem. Social factors can modify vulnerability to developing drug dependence, acting as risk factors or protective factors. Whereas stress and peer environment that encourage substance use may increase drug taking, strong attachments between family members and peer environment that do not experience drug use may protect against drug taking and, ultimately, drug dependence. The rewarding effects of drug abuse and social interaction can be evaluated using animal models. In this review we focus on evaluating social interaction reward in the conditioned place preference paradigm. We give an overview of how social interaction, if made available within the drug context, may facilitate, promote and interact with the drug's effects. However, social interaction, if offered alternatively outside the drug context, may have pronounced protective effects against drug abuse and relapse. We also address the importance of the weight difference parameter between the social partners in determining the positive or "agonistic" versus the hostile or "antagonistic" social interaction. We conclude that understanding social interaction reward and its subsequent effects on drug reward is sorely needed for therapeutic interventions against drug dependence.

  1. 78 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables

    Science.gov (United States)

    2013-09-26

    ... antimicrobial new animal drugs approved for use in food-producing animals by amending section 512(l) of the FD&C... sponsors of antimicrobial new animal drugs approved for use in food-producing animals, and further provides... Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals......

  2. Drug policy: making effective drugs available without bankrupting the healthcare system.

    Science.gov (United States)

    Laupacis, Andreas; Anderson, Geoffrey; O'Brien, Bernie

    2002-01-01

    To the extent possible, drug policy should be based upon good quality evidence. This must extend beyond the traditional focus on efficacy and safety in carefully selected patients, to evidence about real-world effectiveness, cost-effectiveness and safety of drugs. This paper will consider methods of improving the quality of the evidence currently available, and the implications of requiring that evidence. Historically, there has been a direct link between research evidence and policy at the level of licensing - drugs are only made available after they have been shown to be safe and efficacious in well-designed and independently assessed research studies. We propose that this reliance on evidence be logically extended to cover the formulary inclusion and post-marketing surveillance aspects of modern prescription drug policy. More specifically we propose that the decision to initially list a drug on a benefit formulary be based on evidence from relevant head-to-head comparisons and well-designed cost-effectiveness analyses. This evidence would be produced by industry in cooperation with independent peer-reviewed funding agencies. Drugs could only be added to a formulary if they met specific predetermined criteria, and drugs could be removed as superior alternatives became available. The provincial governments are monopsony buyers of medicines, and they wield the power to determine public payer "market access'for medicines. This power (within and across provinces) could be used more effectively to negotiate price in the context of reimbursement. The effect of different methods of influencing prescribing (e.g., 'limited access?) upon drug utilization and patient outcomes should be rigorously assessed, including the randomization of groups of patients or communities to different strategies. We also propose that all drugs on the formulary would be subject to a well-designed post-marketing surveillance program. This program would build on the existing passive reporting of

  3. 21 CFR 516.125 - Investigational use of minor species new animal drugs to support indexing.

    Science.gov (United States)

    2010-04-01

    ... drugs to support indexing. 516.125 Section 516.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Species § 516.125 Investigational use of minor species new animal drugs to support indexing. (a) The... Investigational Exemption for a New Animal Drug for Index Listing” and each request for indexing shall be...

  4. 75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Science.gov (United States)

    2010-05-12

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  5. 76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Science.gov (United States)

    2011-12-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

  6. The Two Faces of Social Interaction Reward in Animal Models of Drug Dependence

    Science.gov (United States)

    Rawas, Rana El

    2016-01-01

    Drug dependence is a serious health and social problem. Social factors can modify vulnerability to developing drug dependence, acting as risk factors or protective factors. Whereas stress and peer environment that encourage substance use may increase drug taking, strong attachments between family members and peer environment that do not experience drug use may protect against drug taking and, ultimately, drug dependence. The rewarding effects of drug abuse and social interaction can be evaluated using animal models. In this review we focus on evaluating social interaction reward in the conditioned place preference paradigm. We give an overview of how social interaction, if made available within the drug context, may facilitate, promote and interact with the drug’s effects. However, social interaction, if offered alternatively outside the drug context, may have pronounced protective effects against drug abuse and relapse. We also address the importance of the weight difference parameter between the social partners in determining the positive or “agonistic” versus the hostile or “antagonistic” social interaction. We conclude that understanding social interaction reward and its subsequent effects on drug reward is sorely needed for therapeutic interventions against drug dependence. PMID:26088685

  7. 77 FR 45624 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ..., under Tools and Resources click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create ADUFA...--Create an Animal Drug User Cover Sheet, transmit it to FDA, and print a copy. After logging into...

  8. Animal versus human oral drug bioavailability: do they correlate?

    Science.gov (United States)

    Musther, Helen; Olivares-Morales, Andrés; Hatley, Oliver J D; Liu, Bo; Rostami Hodjegan, Amin

    2014-06-16

    Oral bioavailability is a key consideration in development of drug products, and the use of preclinical species in predicting bioavailability in human has long been debated. In order to clarify whether any correlation between human and animal bioavailability exist, an extensive analysis of the published literature data was conducted. Due to the complex nature of bioavailability calculations inclusion criteria were applied to ensure integrity of the data. A database of 184 compounds was assembled. Linear regression for the reported compounds indicated no strong or predictive correlations to human data for all species, individually and combined. The lack of correlation in this extended dataset highlights that animal bioavailability is not quantitatively predictive of bioavailability in human. Although qualitative (high/low bioavailability) indications might be possible, models taking into account species-specific factors that may affect bioavailability are recommended for developing quantitative prediction.

  9. Animal models of skin disease for drug discovery

    Science.gov (United States)

    Avci, Pinar; Sadasivam, Magesh; Gupta, Asheesh; De Melo, Wanessa CMA; Huang, Ying-Ying; Yin, Rui; Rakkiyappan, Chandran; Kumar, Raj; Otufowora, Ayodeji; Nyame, Theodore; Hamblin, Michael R

    2013-01-01

    Introduction Discovery of novel drugs, treatments, and testing of consumer products in the field of dermatology is a multi-billion dollar business. Due to the distressing nature of many dermatological diseases, and the enormous consumer demand for products to reverse the effects of skin photodamage, aging, and hair loss, this is a very active field. Areas covered In this paper, we will cover the use of animal models that have been reported to recapitulate to a greater or lesser extent the features of human dermatological disease. There has been a remarkable increase in the number and variety of transgenic mouse models in recent years, and the basic strategy for constructing them is outlined. Expert opinion Inflammatory and autoimmune skin diseases are all represented by a range of mouse models both transgenic and normal. Skin cancer is mainly studied in mice and fish. Wound healing is studied in a wider range of animal species, and skin infections such as acne and leprosy also have been studied in animal models. Moving to the more consumer-oriented area of dermatology, there are models for studying the harmful effect of sunlight on the skin, and testing of sunscreens, and several different animal models of hair loss or alopecia. PMID:23293893

  10. Why animal studies are still being used in drug development. An innovation system perspective

    NARCIS (Netherlands)

    Kooijman, M.

    2013-01-01

    In Europe alone, 3.6 million animals per year are used for drug development. Animal studies are worldwide the gold standard to evaluate the safety, efficacy and quality of drugs before these drugs are tested in humans. Nevertheless the value of animal studies to predict risks for humans has never be

  11. 77 FR 28252 - Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole...

    Science.gov (United States)

    2012-05-14

    ...The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group,...

  12. 77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

    Science.gov (United States)

    2012-09-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales and... antimicrobial new animal drugs. The Agency is taking this action in response to requests for an extension to... use in food-producing animals. The Agency has received requests for a 60-day extension of the...

  13. Sex differences in exercise and drug addiction: A mini review of animal studies

    Directory of Open Access Journals (Sweden)

    Yuehui Zhou

    2014-09-01

    Full Text Available Growing literature has demonstrated that exercise may be an effective prevention and treatment option for drug addiction. In the past few years, many studies have suggested that there were sex differences in all phases of drug addiction. However, very limited research has investigated sex differences in the effectiveness of exercise intervention in drug addiction and rehabilitation. In this mini review, we summarize the effect of sex on the results of using exercise to prevent and treat drug addiction. The studies we consider span various animal models and use multiple types of exercise to examine the effectiveness of exercise on the neurobiological mechanism of exercise rehabilitation. We believe that exercise as an adjuvant intervention strategy can be applied better in drug addiction prevention and recovery.

  14. 21 CFR 500.27 - Methylene blue-containing drugs for use in animals.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Methylene blue-containing drugs for use in animals... Decisions § 500.27 Methylene blue-containing drugs for use in animals. (a) New information requires a re- evaluation of the status of drugs containing methylene blue (tetramethylthionine chloride) for oral use...

  15. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Science.gov (United States)

    2011-01-20

    ... Animal Drugs; Oxytetracycline and Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin... that provides for veterinary prescription use of HEXASOL (oxytetracycline and flunixin...

  16. 76 FR 22713 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

    Science.gov (United States)

    2011-04-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine; Correction AGENCY: Food and Drug Administration, HHS....

  17. 76 FR 37814 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs...

    Science.gov (United States)

    2011-06-28

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed... FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug... appropriate, and other forms of information technology. New Animal Drugs for Investigational Uses--21 CFR...

  18. 75 FR 73103 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User...

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed... FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration... appropriate, and other forms of information technology. Animal Drug User Fee Cover Sheet; FDA Form 3546...

  19. Drug discovery of antimicrobial photosensitizers using animal models.

    Science.gov (United States)

    Sharma, Sulbha K; Dai, Tianhong; Kharkwal, Gitika B; Huang, Ying-Ying; Huang, Liyi; De Arce, Vida J Bil; Tegos, George P; Hamblin, Michael R

    2011-01-01

    Antimicrobial photodynamic therapy (aPDT) is an emerging alternative to antibiotics motivated by growing problems with multi-drug resistant pathogens. aPDT uses non-toxic dyes or photosensitizers (PS) in combination with harmless visible of the correct wavelength to be absorbed by the PS. The excited state PS can form a long-lived triplet state that can interact with molecular oxygen to produce reactive oxygen species such as singlet oxygen and hydroxyl radical that kill the microbial cells. To obtain effective PS for treatment of infections it is necessary to use cationic PS with positive charges that are able to bind to and penetrate different classes of microbial cells. Other drug design criteria require PS with high absorption coefficients in the red/near infra-red regions of the spectrum where light penetration into tissue is maximum, high photostability to minimize photobleaching, and devising compounds that will selectively bind to microbial cells rather than host mammalian cells. Several molecular classes fulfill many of these requirements including phenothiazinium dyes, cationic tetrapyrroles such as porphyrins, phthalocyanines and bacteriochlorins, cationic fullerenes and cationic derivatives of other known PS. Larger structures such as conjugates between PS and cationic polymers, cationic nanoparticles and cationic liposomes that contain PS are also effective. In order to demonstrate in vivo efficacy it is necessary to use animal models of localized infections in which both PS and light can be effectively delivered into the infected area. This review will cover a range of mouse models we have developed using bioluminescent pathogens and a sensitive low light imaging system to non-invasively monitor the progress of the infection in real time. Effective aPDT has been demonstrated in acute lethal infections and chronic biofilm infections; in infections caused by Gram-positive, Gram-negative bacteria and fungi; in infections in wounds, third degree burns

  20. Substitute of animals in drug research: An approach towards fulfillment of 4R′s

    Directory of Open Access Journals (Sweden)

    T Arora

    2011-01-01

    Full Text Available The preclinical studies for drug screening involve the use of animals which is very time consuming and expensive and at times leads to suffering of the used organism. Animal right activists around the world are increasingly opposing the use of animals. This has forced the researchers to find ways to not only decrease the time involved in drug screening procedures but also decrease the number of animals used and also increase the humane care of animals. To fulfill this goal a number of new in vitro techniques have been devised which are called ′Alternatives′ or ′Substitutes′ for use of animals in research involving drugs. These ′Alternatives′ are defined as the adjuncts which help to decrease the use as well as the number of animals in biomedical research. Russell and Burch have defined these alternatives by three R′s - Reduction, Refinement and Replacement. These alternative strategies include physico-chemical methods and techniques utilizing tissue culture, microbiological system, stem cells, DNA chips, micro fluidics, computer analysis models, epidemiological surveys and plant-tissue based materials. The advantages of these alternatives include the decrease in the number of animals used, ability to obtain the results quickly, reduction in the costs and flexibility to control the variables of the experiment. However these techniques are not glittering gold and have their own shortcomings. The disadvantages include the lack of an appropriate alternative to study the whole animal′s metabolic response, inability to study transplant models and idiosyncratic responses and inability to study the body′s handling of drugs and its subsequent metabolites. None-the-less these aalternative methods to certain extent help to reduce the number of animals required for research. But such alternatives cannot eliminate the need for animals in research completely. Even though no animal model is a complete set of replica for a process within a

  1. 78 FR 24154 - Notice of Availability of a National Animal Health Laboratory Network Reorganization Concept Paper

    Science.gov (United States)

    2013-04-24

    ... Network Reorganization Concept Paper AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION... Plant Health Inspection Service is making available a concept paper that describes a revised structure... paper we are making available for comment presents a structure we believe will give the NAHLN...

  2. Silymarin protects liver against toxic effects of anti-tuberculosis drugs in experimental animals

    Directory of Open Access Journals (Sweden)

    Izzettin Fikret V

    2008-07-01

    Full Text Available Abstract Background The first line anti-tuberculosis drugs isoniazid (INH, rifampicin (RIF and pyrazinamide (PZA continues to be the effective drugs in the treatment of tuberculosis, however, the use of these drugs is associated with toxic reactions in tissues, particularly in the liver, leading to hepatitis. Silymarin, a standard plant extract with strong antioxidant activity obtained from S. marianum, is known to be an effective agent for liver protection and liver regeneration. The aim of this study was to investigate the protective actions of silymarin against hepatotoxicity caused by different combinations of anti-tuberculosis drugs. Methods Male Wistar albino rats weighing 250–300 g were used to form 6 study groups, each group consisting of 10 rats. Animals were treated with intra-peritoneal injection of isoniazid (50 mg/kg and rifampicin (100 mg/kg; and intra-gastric administration of pyrazinamid (350 mg/kg and silymarin (200 mg/kg. Hepatotoxicity was induced by a combination of drugs with INH+RIF and INH+RIF+PZA. Hepatoprotective effect of silymarin was investigated by co-administration of silymarin together with the drugs. Serum biochemical tests for liver functions and histopathological examination of livers were carried out to demonstrate the protection of liver against anti-tuberculosis drugs by silymarin. Results Treatment of rats with INH+RIF or INH+RIF+PZA induced hepatotoxicity as evidenced by biochemical measurements: serum alanine aminotransferase (ALT, aspartate aminotransferase (AST and alkaline phosphatase (ALP activities and the levels of total bilirubin were elevated, and the levels of albumin and total protein were decreased in drugs-treated animals. Histopathological changes were also observed in livers of animals that received drugs. Simultaneous administration of silymarin significantly decreased the biochemical and histological changes induced by the drugs. Conclusion The active components of silymarin had

  3. Animal models for predicting the efficacy and side effects of antipsychotic drugs

    Directory of Open Access Journals (Sweden)

    Pedro H. Gobira

    2013-01-01

    Full Text Available The use of antipsychotic drugs represents an important approach for the treatment of schizophrenia. However, their efficacy is limited to certain symptoms of this disorder, and they induce serious side effects. As a result, there is a strong demand for the development of new drugs, which depends on reliable animal models for pharmacological characterization. The present review discusses the face, construct, and predictive validity of classical animal models for studying the efficacy and side effects of compounds for the treatment of schizophrenia. These models are based on the properties of antipsychotics to impair the conditioned avoidance response and reverse certain behavioral changes induced by psychotomimetic drugs, such as stereotypies, hyperlocomotion, and deficit in prepulse inhibition of the startle response. Other tests, which are not specific to schizophrenia, may predict drug effects on negative and cognitive symptoms, such as deficits in social interaction and memory impairment. Regarding motor side effects, the catalepsy test predicts the liability of a drug to induce Parkinson-like syndrome, whereas vacuous chewing movements predict the liability to induce dyskinesia after chronic treatment. Despite certain limitations, these models may contribute to the development of more safe and efficacious antipsychotic drugs.

  4. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

  5. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  6. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Science.gov (United States)

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  7. 75 FR 16001 - New Animal Drugs; Removal of Obsolete and Redundant Regulations

    Science.gov (United States)

    2010-03-31

    ... had a new strategy and concept for assessing the safety of antimicrobial new animal drugs, including subtherapeutic use of antimicrobials in animal feed, with regard to their microbiological effects on bacteria of... results of studies on the long-term administration of then-marketed antimicrobial drugs in animal feed...

  8. Cost analysis of antiepileptic drugs available in India

    Directory of Open Access Journals (Sweden)

    Ajay Kumar Shukla

    2016-08-01

    Conclusions: The average percentage price variation of different brands of the same oral antiepileptic drugs in Indian market is very wide. Treatment of epilepsy has a long course with compliance being a key factor for successful treatment. Improved adherence to the treatment can be ensured by decreasing the cost of therapy, by changes in the government policies and regulations and creating awareness among treating physicians for switching to cost effective therapy. [Int J Basic Clin Pharmacol 2016; 5(4.000: 1636-1640

  9. In vivo models for cancer stem cell research: a practical guide for frequently used animal models and available biomarkers.

    Science.gov (United States)

    Skidan, I; Steiniger, S C J

    2014-04-01

    The identification of a rare population of cancer stem cells whose presence in tumors is believed to determine their growth and metastatic activity, has provided a novel approach for targeted anti-cancer therapy. At the in vivo stage of the development of new therapeutic approaches for killing cancer stem cells, the most significant issues are the appropriate choice of rational animal models that offer the option to select animal species, strains and substrains, essential techniques for the inoculation of tumors, and methods of tumor detection in animals. The identification and validation of various types of cancer stem cell markers, which could serve as potential marker(s) of therapeutic efficacy of applied drugs, is a considerable challenge. The aim of this review is to provide a guide for the in vivo study of novel therapeutics that target cancer stem cells. This review describes frequently used mouse solid tumor models and evaluates their usefulness for cancer stem cell research. The classification of existing compounds that are used in today's experimental anti-cancer stem cell therapy and examples of exploratory first-in-human studies using these compounds for selective elimination of cancer stem cells will also be discussed. Finally, this review will examine the current status of available cancer stem cell markers, and highlight several important cancer stem cell properties that are still not well understood, but could influence the anti-cancer drug development process.

  10. 75 FR 65642 - Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride...

    Science.gov (United States)

    2010-10-26

    ...The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these...

  11. Toward a complete dataset of drug-drug interaction information from publicly available sources.

    Science.gov (United States)

    Ayvaz, Serkan; Horn, John; Hassanzadeh, Oktie; Zhu, Qian; Stan, Johann; Tatonetti, Nicholas P; Vilar, Santiago; Brochhausen, Mathias; Samwald, Matthias; Rastegar-Mojarad, Majid; Dumontier, Michel; Boyce, Richard D

    2015-06-01

    Although potential drug-drug interactions (PDDIs) are a significant source of preventable drug-related harm, there is currently no single complete source of PDDI information. In the current study, all publically available sources of PDDI information that could be identified using a comprehensive and broad search were combined into a single dataset. The combined dataset merged fourteen different sources including 5 clinically-oriented information sources, 4 Natural Language Processing (NLP) Corpora, and 5 Bioinformatics/Pharmacovigilance information sources. As a comprehensive PDDI source, the merged dataset might benefit the pharmacovigilance text mining community by making it possible to compare the representativeness of NLP corpora for PDDI text extraction tasks, and specifying elements that can be useful for future PDDI extraction purposes. An analysis of the overlap between and across the data sources showed that there was little overlap. Even comprehensive PDDI lists such as DrugBank, KEGG, and the NDF-RT had less than 50% overlap with each other. Moreover, all of the comprehensive lists had incomplete coverage of two data sources that focus on PDDIs of interest in most clinical settings. Based on this information, we think that systems that provide access to the comprehensive lists, such as APIs into RxNorm, should be careful to inform users that the lists may be incomplete with respect to PDDIs that drug experts suggest clinicians be aware of. In spite of the low degree of overlap, several dozen cases were identified where PDDI information provided in drug product labeling might be augmented by the merged dataset. Moreover, the combined dataset was also shown to improve the performance of an existing PDDI NLP pipeline and a recently published PDDI pharmacovigilance protocol. Future work will focus on improvement of the methods for mapping between PDDI information sources, identifying methods to improve the use of the merged dataset in PDDI NLP algorithms

  12. Flow cytometric determination of osmotic behaviour of animal erythrocytes toward their engineering for drug delivery

    Directory of Open Access Journals (Sweden)

    Kostić Ivana T.

    2015-01-01

    Full Text Available Despite the fact that the methods based on the osmotic properties of the cells are the most widely used for loading of drugs in human and animal erythrocytes, data related to the osmotic properties of erythrocytes derived from animal blood are scarce. This work was performed with an aim to investigate the possibility of use the flow cytometry as a tool for determination the osmotic behaviour of porcine and bovine erythrocytes, and thus facilitate the engineering of erythrocytes from animal blood to be drug carriers. The method of flow cytometry successfully provided the information about bovine and porcine erythrocyte osmotic fragility, and made the initial steps in assessment of erythrocyte shape in a large number of erythrocytes. Although this method is not able to confirm the swelling of pig erythrocytes, it indicated to the differences in pig erythrocytes that had basic hematological parameters inside and outside the reference values. In order to apply/use the porcine and bovine erythrocytes as drug carriers, the method of flow cytometry, confirming the presence of osmotically different fractions of red blood cells, indicated that various amounts of the encapsulated drug in porcine and bovine erythrocytes can be expected.

  13. 78 FR 17595 - New Animal Drugs; Changes of Sponsor

    Science.gov (United States)

    2013-03-22

    ... Drugs; Changes of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The..., chloroquine, and lidocaine) Euthanasia Solution. 200-042 Ketamine Hydrochloride Injection, USP....

  14. Habitat availability does not explain the species richness patterns of European lentic and lotic freshwater animals

    DEFF Research Database (Denmark)

    Dehling, D.M.; Hof, C.; Brandle, M.;

    2010-01-01

    Aim In Europe, the relationships between species richness and latitude differ for lentic (standing water) and lotic (running water) species. Freshwater animals are highly dependent on suitable habitat, and thus the distribution of available habitat should strongly influence large-scale patterns...... of species richness. We tested whether habitat availability can account for the differences in species richness patterns between European lentic and lotic freshwater animals. Location Europe. Methods We compiled occurrence data of 1959 lentic and 2445 lotic species as well as data on the amount of lentic...... and lotic habitats across 25 pre-defined biogeographical regions of European freshwaters. We used the range of elevation of each region as a proxy for habitat diversity. We investigated the relationships between species richness, habitat availability and habitat diversity with univariate and multiple...

  15. 76 FR 45811 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ...Industry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and under Tools and Resources click ``The Animal... Sheet, transmit it to FDA, and print a copy. After logging into your account with your user name...

  16. 75 FR 45632 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ...Industry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources click ``The Animal..., transmit it to FDA, and print a copy. After logging into your account with your user name and...

  17. 75 FR 20268 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol

    Science.gov (United States)

    2010-04-19

    ... change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal Health... and interest in, approved NADA 141-070 for RAPINOVET (propofol), an ] injectable anesthetic, to...

  18. TiO2 nanotubes as animal drug delivery system and in vitro controlled release.

    Science.gov (United States)

    Lai, Shuting; Zhang, Wei; Liu, Fang; Wu, Cui; Zeng, Dongping; Sun, Yongxue; Xu, Yuehua; Fang, Yueping; Zhou, Wuyi

    2013-01-01

    The enrofloxacin hydrochloride (Enro), an anti-inflammatory drug for the animals, was loaded on the TNTs through physical absorption due to the high specific surface area and excellent surface activity of the TiO2 nanotubes. The samples were characterized by XRD, BET, TEM, TG and FTIR. The in vitro controlled release behavior at different temperatures was studied in detail. The results showed that the obtained TNTs were uniform and mainly amorphous crystal phase with a diameter of 10-15 nm and a length of 350-400 nm. By investigating the effect of the hydrothermal reaction process of the obtained TiO2 nanotubes and the drug loading frequency on the loading content of Enro drugs, the results indicated that the increasing loading frequency of the drug was available for the drug loading and the maximum loading content of drug reached to 33.28%. Enro-TNTs performed a better release profile at low temperature than at high temperature in PBS solution. The Higuchi square root models are suitable to explain the in vitro drug release behavior of Enro from Enro-TNTs.

  19. Characteristics and Availability of Different Forms of Phosphorus in Animal Manures

    Directory of Open Access Journals (Sweden)

    YAN Zheng-juan

    2015-02-01

    Full Text Available The rapid development of intensive livestock industry has greatly increased the discharge of animal manure. Reasonable utilization of large amounts of phosphorus(Pin animal manure can not only save the fertilizer resource, but also avoid water pollution from manure due to direct discharge or excess application in farmland. In this study, P contents and fractionation in 76 animal manures were analyzed using Hedley P fractionation method based on the survey for 52 livestock farms, and P mobility and environmental risks in different manures were evaluated as the reference for manure P management. The results showed that there were significant differences in total P content of animal manures. The mean P contents were 22.5, 13.7, 12.9, 9.6 g P·kg-1 and 7.5 g P·kg-1, in which the proportion of organic P in total P were 33.1%, 41.5%, 66.4%, 28.1%and 36.8%in pig, chicken, duck, cattle and sheep manures, respectively. The contents of total and organic P in non-ruminant animal manure(pig, chicken and duck manureswere 1.7~3.0 times and 2.1~3.0 times greater than that in ruminant manure (cattle and sheep manuresand the proportion of organic P in total P in poultry manure was higher than that in other manures. P mineraliza-tion was easier in non-ruminant animal manure with lower C/P ratio(19~29, compared with that in ruminant manure with C/P ratio of 38~45. Manure P was sequentially extracted by deionized water(H2O-P, NaHCO3(NaHCO3-P, NaOH(NaOH-Pand HCl(HCl-P. The pro-portion of H2O-P, NaHCO3-P, NaOH-P, HCl-P and residual-P in total P in ruminant animal manure were 27.8%, 32.8%, 18.1%, 15.2%and 6.1%, respectively, while that were 24.6%, 19.4%, 12.7%, 34.4% and 8.9% in non-ruminant animal manure. The significant differences were in NaHCO3-P and HCl-P between ruminant and non-ruminant animal manures. Ruminant manure had greater proportion of liable P (H2O-P and NaHCO3-Pin total P(>60%, but the characteristics of higher mineralization rate might result in

  20. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Science.gov (United States)

    2010-01-11

    ... Animal Drugs; Florfenicol and Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... veterinary prescription use of a combination injectable solution containing ] florfenicol and flunixin... RESFLOR GOLD (florfenicol and flunixin meglumine), a combination injectable solution, for treatment...

  1. 78 FR 46955 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and... Drug User Cover Sheet, transmit it to FDA, and print a copy. After logging into your account with...

  2. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Science.gov (United States)

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and...

  3. 21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

    Science.gov (United States)

    2010-04-01

    ... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room...

  4. 76 FR 79195 - Animal Generic Drug User Fee Act; Reopening of the Comment Period

    Science.gov (United States)

    2011-12-21

    ... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug Administration (FDA or Agency) is extending to January 15, 2013, the...

  5. 21 CFR 514.12 - Confidentiality of data and information in an investigational new animal drug notice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Confidentiality of data and information in an investigational new animal drug notice. 514.12 Section 514.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL...

  6. Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

    Directory of Open Access Journals (Sweden)

    Zaheer Ud Din Babar

    2007-03-01

    Full Text Available BACKGROUND: Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. METHODS AND FINDINGS: The methodology developed by the World Health Organization (WHO and Health Action International (HAI was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. CONCLUSIONS: The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and

  7. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential... and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... availability of a draft guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' Under...

  8. Recent advances using zebrafish animal models for muscle disease drug discovery

    Science.gov (United States)

    Maves, Lisa

    2015-01-01

    Introduction Animal models have enabled great progress in the discovery and understanding of pharmacological approaches for treating muscle diseases like Duchenne muscular dystrophy. Areas covered With this article, the author provides the reader with a description of the zebrafish animal model, which has been employed to identify and study pharmacological approaches to muscle disease. In particular, the author focuses on how both large-scale chemical screens and targeted drug treatment studies have established zebrafish as an important model for muscle disease drug discovery. Expert opinion There are a number of opportunities arising for the use of zebrafish models for further developing pharmacological approaches to muscle diseases, including studying drug combination therapies and utilizing genome editing to engineer zebrafish muscle disease models. It is the author’s particular belief that the availability of a wide range of zebrafish transgenic strains for labeling immune cell types, combined with live imaging and drug treatment of muscle disease models, should allow for new elegant studies demonstrating how pharmacological approaches might influence inflammation and the immune response in muscle disease. PMID:24931439

  9. [Reduction of animal experiments in experimental drug testing].

    Science.gov (United States)

    Behrensdorf-Nicol, H; Krämer, B

    2014-10-01

    In order to ensure the quality of biomedical products, an experimental test for every single manufactured batch is required for many products. Especially in vaccine testing, animal experiments are traditionally used for this purpose. For example, efficacy is often determined via challenge experiments in laboratory animals. Safety tests of vaccine batches are also mostly performed using laboratory animals. However, many animal experiments have clear inherent disadvantages (low accuracy, questionable transferability to humans, unclear significance). Furthermore, for ethical reasons and animal welfare aspects animal experiments are also seen very critical by the public. Therefore, there is a strong trend towards replacing animal experiments with methods in which no animals are used ("replacement"). If a replacement is not possible, the required animal experiments should be improved in order to minimize the number of animals necessary ("reduction") and to reduce pain and suffering caused by the experiment to a minimum ("refinement"). This "3R concept" is meanwhile firmly established in legislature. In recent years many mandatory animal experiments have been replaced by alternative in vitro methods or improved according to the 3R principles; numerous alternative methods are currently under development. Nevertheless, the process from the development of a new method to its legal implementation takes a long time. Therefore, supplementary regulatory measures to facilitate validation and acceptance of new alternative methods could contribute to a faster and more consequent implementation of the 3R concept in the testing of biomedical products.

  10. Strategies that delay or prevent the timely availability of affordable generic drugs in the United States.

    Science.gov (United States)

    Jones, Gregory H; Carrier, Michael A; Silver, Richard T; Kantarjian, Hagop

    2016-03-17

    High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.

  11. Leishmaniasis:Current status of available drugs and new potential drug targets

    Institute of Scientific and Technical Information of China (English)

    Nisha Singh; Manish Kumar; Rakesh Kumar Singh

    2012-01-01

    The control ofLeishmania infection relies primarily on chemotherapy till date. Resistance to pentavalent antimonials, which have been the recommended drugs to treat cutaneous and visceral leishmaniasis, is now widespread in Indian subcontinents. New drug formulations like amphotericinB, its lipid formulations, and miltefosine have shown great efficacy to treat leishmaniasis but their high cost and therapeutic complications limit their usefulness. In addition, irregular and inappropriate uses of these second line drugs in endemic regions like state of Bihar, India threaten resistance development in the parasite. In context to the limited drug options and unavailability of either preventive or prophylactic candidates, there is a pressing need to develop true antileishmanial drugs to reduce the disease burden of this debilitating endemic disease. Notwithstanding significant progress of leishmanial research during last few decades, identification and characterization of novel drugs and drug targets are far from satisfactory. This review will initially describe current drug regimens and later will provide an overview on few important biochemical and enzymatic machineries that could be utilized as putative drug targets for generation of true antileishmanial drugs.

  12. 75 FR 12981 - Oral Dosage Form New Animal Drugs; Tetracycline Powder

    Science.gov (United States)

    2010-03-18

    ... a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA... . SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ 08807 filed a supplement to NADA 65-140... animal drug regulations. Approval of this supplemental NADA did not require review of additional...

  13. 77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

    Science.gov (United States)

    2012-11-20

    ... antimicrobial new animal drugs. FDA requests that an applicant accompany NADAs, supplemental NADAs, and requests... associated with this collection of information. \\2\\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the...

  14. Human Food Safety Implications of Variation in Food Animal Drug Metabolism

    Science.gov (United States)

    Lin, Zhoumeng; Vahl, Christopher I.; Riviere, Jim E.

    2016-01-01

    Violative drug residues in animal-derived foods are a global food safety concern. The use of a fixed main metabolite to parent drug (M/D) ratio determined in healthy animals to establish drug tolerances and withdrawal times in diseased animals results in frequent residue violations in food-producing animals. We created a general physiologically based pharmacokinetic model for representative drugs (ceftiofur, enrofloxacin, flunixin, and sulfamethazine) in cattle and swine based on extensive published literature. Simulation results showed that the M/D ratio was not a fixed value, but a time-dependent range. Disease changed M/D ratios substantially and extended withdrawal times; these effects exhibited drug- and species-specificity. These results challenge the interpretation of violative residues based on the use of the M/D ratio to establish tolerances for metabolized drugs. PMID:27302389

  15. Approval of raxibacumab for the treatment of inhalation anthrax under the US Food and Drug Administration Animal rule

    Directory of Open Access Journals (Sweden)

    Chia-Wei eTsai

    2015-12-01

    Full Text Available On December 14, 2012, the FDA approved raxibacumab, the first product developed under Project BioShield to achieve this milestone, and the first biologic product to be approved through the FDA animal efficacy rule (or Animal Rule. Raxibacumab is approved for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibiotic drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. The approval of Raxibacumab illustrates many of the challenges that product developers may encounter when pursuing approval under the Animal Rule and highlights a number of important regulatory and policy issues.

  16. Animal models of drug relapse and craving: From drug priming-induced reinstatement to incubation of craving after voluntary abstinence.

    Science.gov (United States)

    Venniro, Marco; Caprioli, Daniele; Shaham, Yavin

    2016-01-01

    High rates of relapse to drug use during abstinence is a defining feature of drug addiction. In abstinent drug users, drug relapse is often precipitated by acute exposure to the self-administered drug, drug-associated cues, stress, as well as by short-term and protracted withdrawal symptoms. In this review, we discuss different animal models that have been used to study behavioral and neuropharmacological mechanisms of these relapse-related phenomena. In the first part, we discuss relapse models in which abstinence is achieved through extinction training, including the established reinstatement model, as well as the reacquisition and resurgence models. In the second part, we discuss recent animal models in which drug relapse is assessed after either forced abstinence (e.g., the incubation of drug craving model) or voluntary (self-imposed) abstinence achieved either by introducing adverse consequences to ongoing drug self-administration (e.g., punishment) or by an alternative nondrug reward using a discrete choice (drug vs. palatable food) procedure. We conclude by briefly discussing the potential implications of the recent developments of animal models of drug relapse after voluntary abstinence to the development of medications for relapse prevention.

  17. 78 FR 44432 - New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

    Science.gov (United States)

    2013-07-24

    ... sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health..., NADA 099-667 for IMPOSIL (iron dextran complex) Injection and NADA 110-399 for GLEPTOSIL...

  18. Analysis of price variation amongst different formulations of anxiolytic drugs available in Indian market

    Directory of Open Access Journals (Sweden)

    Vihang S. Chawan

    2016-06-01

    Conclusions: There is a wide variation in the price of different brands of anxiolytic drugs available in Indian market. Government of India should reduce the pricing of drugs by bringing them under drug pricing control order (DPCO. [Int J Res Med Sci 2016; 4(6.000: 2398-2401

  19. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Science.gov (United States)

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... appropriate for them to use a drug product. The guidance provides recommendations to industry involved...

  20. 21 CFR 511.1 - New animal drugs for investigational use exempt from section 512(a) of the act.

    Science.gov (United States)

    2010-04-01

    ... investigational animals in clinical trials. Not for use in humans. Edible products of investigational animals are... 21 Food and Drugs 6 2010-04-01 2010-04-01 false New animal drugs for investigational use exempt..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW...

  1. Food availability and animal space use both determine cache density of Eurasian red squirrels.

    Directory of Open Access Journals (Sweden)

    Ke Rong

    Full Text Available Scatter hoarders are not able to defend their caches. A longer hoarding distance combined with lower cache density can reduce cache losses but increase the costs of hoarding and retrieving. Scatter hoarders arrange their cache density to achieve an optimal balance between hoarding costs and main cache losses. We conducted systematic cache sampling investigations to estimate the effects of food availability on cache patterns of Eurasian red squirrels (Sciurus vulgaris. This study was conducted over a five-year period at two sample plots in a Korean pine (Pinus koraiensis-dominated forest with contrasting seed production patterns. During these investigations, the locations of nest trees were treated as indicators of squirrel space use to explore how space use affected cache pattern. The squirrels selectively hoarded heavier pine seeds farther away from seed-bearing trees. The heaviest seeds were placed in caches around nest trees regardless of the nest tree location, and this placement was not in response to decreased food availability. The cache density declined with the hoarding distance. Cache density was lower at sites with lower seed production and during poor seed years. During seed mast years, the cache density around nest trees was higher and invariant. The pine seeds were dispersed over a larger distance when seed availability was lower. Our results suggest that 1 animal space use is an important factor that affects food hoarding distance and associated cache densities, 2 animals employ different hoarding strategies based on food availability, and 3 seed dispersal outside the original stand is stimulated in poor seed years.

  2. 21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

    Science.gov (United States)

    2010-04-01

    ... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A...

  3. 78 FR 70062 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

    Science.gov (United States)

    2013-11-22

    ...; Carbarsone; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) for roxarsone or... longer manufactured or marketed: NADA 007-891 for 3-NITRO (roxarsone) Type A medicated article, NADA...

  4. 75 FR 10413 - New Animal Drug Applications; Confirmation of Effective Date

    Science.gov (United States)

    2010-03-08

    ... of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date... animal drug products. This document confirms the effective date of the direct final rule....

  5. Effect of the surfactant on the availability of piroxicam as a poorly hydrosoluble drug from suppositories.

    Science.gov (United States)

    Dal Zorro, M; Franceschinis, E; Punchina, A; Realdon, N

    2012-01-01

    The use of surfactants in suppository formulations has been suggested to improve availability of poorly soluble drugs. In the present study, different kinds of surfactants have been investigated to clarify the influence on piroxicam release from suppositories formulated with both lipophilic and hydrophilic bases. Two hydrophilic glucose-derivate surfactants, and a polyoxylglyceride amphiphilic surfactant, all with high HLB values, were investigated for their use in improving drug availability. The two glucose derivate surfactants reduced drug availability from both lipophilic suppositories and hydrophilic formulations, according to longer disintegration times and drug micellization. The more complex surfactant, a lauroyl macrogolglyceride, showed an increase in piroxicam availability from lipophilic suppositories at the higher tested concentrations (15% and 20%). Otherwise, when used in hydrophilic formulations, it was less effective in promoting drug release and even reduced drug availability.

  6. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary.

  7. Chronic Neuroinflammation in Alzheimer’s Disease: New Perspectives on Animal Models and Promising Candidate Drugs

    Directory of Open Access Journals (Sweden)

    Christopher Millington

    2014-01-01

    Full Text Available Chronic neuroinflammation is now considered one of the major factors in the pathogenesis of Alzheimer’s disease (AD. However, the most widely used transgenic AD models (overexpressing mutated forms of amyloid precursor protein, presenilin, and/or tau do not demonstrate the degree of inflammation, neurodegeneration (particularly of the cholinergic system, and cognitive decline that is comparable with the human disease. Hence a more suitable animal model is needed to more closely mimic the resulting cognitive decline and memory loss in humans in order to investigate the effects of neuroinflammation on neurodegeneration. One of these models is the glial fibrillary acidic protein-interleukin 6 (GFAP-IL6 mouse, in which chronic neuroinflammation triggered constitutive expression of the cytokine interleukin-6 (IL-6 in astrocytes. These transgenic mice show substantial and progressive neurodegeneration as well as a decline in motor skills and cognitive function, starting from 6 months of age. This animal model could serve as an excellent tool for drug discovery and validation in vivo. In this review, we have also selected three potential anti-inflammatory drugs, curcumin, apigenin, and tenilsetam, as candidate drugs, which could be tested in this model.

  8. The Use of Animal Models for Cancer Chemoprevention Drug Development

    OpenAIRE

    2010-01-01

    Animal models currently are used to assess the efficacy of potential chemopreventive agents, including synthetic chemicals, chemical agents obtained from natural products and natural product mixtures. The observations made in these models as well as other data are then used to prioritize agents to determine which are qualified to progress to clinical chemoprevention trials. Organ specific animal models are employed to determine which agents or classes of agents are likely to be the most effec...

  9. Availability of information about airborne hazardous releases from animal feeding operations.

    Directory of Open Access Journals (Sweden)

    Tyler J S Smith

    Full Text Available INTRODUCTION: Air from animal feeding operations (AFOs has been shown to transport numerous contaminants of public health concern. While federal statutes like the Emergency Planning and Community Right-to-Know Act (EPCRA generally require that facilities report hazardous releases, AFOs have been exempted from most of these requirements by the U.S. Environmental Protection Agency (EPA. We assessed the availability of information about AFO airborne hazardous releases following these exemptions. METHODS: We submitted public records requests to 7 states overlapping with or adjacent to the Chesapeake Bay watershed for reports of hazardous releases made by AFOs under EPCRA. From the records received, we calculated the proportion of AFOs in each state for which ≥1 reports were available. We also determined the availability of specific types of information required under EPCRA. The numbers of AFOs permitted under the Clean Water Act (CWA or analogous state laws, as determined from permitting databases obtained from states, were used as denominators. RESULTS: We received both EPCRA reports and permitting databases from 4 of 7 states. Across these 4 states, the mean proportion of AFOs for which ≥1 EPCRA reports were available was 15% (range: 2-33%. The mean proportions of AFOs for which the name or identity of the substance released, ≥1 estimates of quantity released, and information about nearby population density and sensitive populations were available were 15% (range: 2-33%, 8% (range: 0-22%, and 14% (range: 2-8%, respectively. DISCUSSION: These results suggest that information about the airborne hazardous releases of a large majority of AFOs is not available under federal law in the states that we investigated. While the results cannot be attributed to specific factors by this method, attention to multiple factors, including revision of the EPA's exemptions, may increase the availability of information relevant to the health of populations

  10. 77 FR 60301 - New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin

    Science.gov (United States)

    2012-10-03

    ...; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Milling 558.625 Hy-Ty Premix Corp., Vigorena (tylosin Feeds, Springfield, phosphate). MN 56087....

  11. Can you shrinkwrap a cow? Protections available for the intellectual property of the animal breeding industry.

    Science.gov (United States)

    Ogden, E R; Weigel, K

    2007-12-01

    There are currently four main intellectual property protection statutory schemes available: copyright, trade secret, trademark and patent. Each of these protects a different aspect of intellectual property, which leaves gaps of protection when an innovation does not fit squarely within the boundaries of the statutes. Contracts allow the industry to tailor the protection desired. One very common approach is to license the product via contract. Licences allow intellectual property owners to retain ownership and give permission to others to use the product. Although there are several types of licences, the most common is the field of use licence, which limits the licensee's use of the product. This often leads to price discrimination where various levels of restriction are offered at corresponding prices. The more rights retained by the owner, the more restricted the buyer is and the lower the purchase price allowing customers to choose the level of restriction they are willing to accept. Therefore, the different uses and needs of various customers can be accounted for and reflected in the price. The animal breeding industry is currently struggling to protect their innovations falling into these statutory gaps. The protection for animal breeding industry innovations is most likely through contract law rather than traditional intellectual property law. By taking advantage of the unique nature of contracts, industry will be able to tailor protection and pricing to best suit the variety of customers and uses for the products sold.

  12. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2011-03-02

    ... Moines, IA 50322. BANMINTH Premix (pyrantel tartrate). Truow Nutrition, Inc., 1590 Todd Farm Dr., Elgin... Five NADAs by Truow Nutrition, Inc. NADA No. product 21 CFR section affected (sponsor drug Previous... Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to...

  13. Consumer judgement and risk perception on availability of over-the-counter-drugs.

    NARCIS (Netherlands)

    Brabers, A.E.M.; Dijk, L. van; Bouvy, M.L.; Jong, J.D. de

    2011-01-01

    Background: Over-the-counter (OTC)-drugs are available without a doctor’s prescription. Whereas this is convenient for consumers, it also makes consumers responsible for appropriate and safe use. European countries differ considerably when it comes to the availability of OTC-drugs. In the Netherland

  14. 78 FR 22 - New Animal Drugs; Meloxicam; Nicarbazin

    Science.gov (United States)

    2013-01-02

    ... chickens, turkeys, and laying hens. It is used in drinking water as follows: * * * * * PART 558--NEW ANIMAL.... treatment for coccidiosis. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or.... Do not feed to laying hens in production. Nicarbazin as provided by No. 066104; bacitracin...

  15. 75 FR 54492 - Oral Dosage Form New Animal Drugs; Tiamulin

    Science.gov (United States)

    2010-09-08

    ... application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides for use of an..., filed a supplement to NADA 140-916 for DENAGARD (tiamulin) Liquid Concentrate administered in drinking... NADA provides for use of a 12.5 percent tiamulin concentrate solution. The supplemental NADA...

  16. Condicionamiento de preferencia de lugar: un modelo animal para evaluar las propiedades motivacionales de las drogas (Conditioned place preference: an animal model of motivational properties of drugs

    Directory of Open Access Journals (Sweden)

    Concepción Roger Sánchez

    2016-08-01

    Full Text Available This article investigated the Conditioned Place Preference (CPP technique as a useful model for studying the motivational properties of drugs of abuse. The background of the technique is presented. Methodological issues that need to be considered when designing a study using CPP are discussed. These issues include the different types of apparatus available, the different phases of the protocol and its possible variations, the type of design (biased vs unbiased, and the need to consider time effects. We discuss data interpretation issues, such what the animal learns, the presentation of the dependent variable, the influence of novelty, state-dependent learning, latent inhibition, the motor and cognitive effects of drugs, and comparison with data from the drug self-administration model. The main applications, advantages, and limitations of the technique are presented. We offer some proposals to address the main criticisms of this model.

  17. 78 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam

    Science.gov (United States)

    2013-01-28

    ...; Meloxicam AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The... Accord Meloxicam Original 522.1367 yes......... CE\\1\\ Healthcare, Injection. approval as a Inc., 1009... 522.1367 yes......... CE\\1\\ Laboratories, (meloxicam) approval as a Ltd., Station Solution for...

  18. 78 FR 19986 - New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

    Science.gov (United States)

    2013-04-03

    ...; Enrofloxacin; Tilmicosin; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, technical... Huvepharma AD, TYLOVET 100 Original approval 558.355 yes......... CE \\1\\ 5th Floor, 3A (tylosin as a generic... follows: Sec. 558.355 Monensin. * * * * * (f) * * * (3) * * * (ii) * * * (b) * * * Tylosin provided by...

  19. 75 FR 11451 - New Animal Drugs for Use in Animal Feeds; Zilpaterol

    Science.gov (United States)

    2010-03-11

    ..., monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated... Liquid Premix, RUMENSIN, and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles...

  20. 76 FR 78150 - Ophthalmic and Topical Dosage Form New Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate...

    Science.gov (United States)

    2011-12-16

    ... Animal Drugs; Hydrocortisone Aceponate, Miconazole Nitrate, and Gentamicin Sulfate Otic Suspension AGENCY... hydrocortisone aceponate, miconazole nitrate, and gentamicin sulfate suspension for the treatment of otitis... of EASOTIC (hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate) Suspension for...

  1. 75 FR 38699 - Implantation or Injectable Dosage Form New Animal Drugs; Propofol

    Science.gov (United States)

    2010-07-06

    ... drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for... owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 filed NADA 141-303 that...

  2. 76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

    Science.gov (United States)

    2011-01-18

    ... sponsor for a new animal drug application (NADA) for follicle stimulating hormone from Ausa International... transferred ownership of, and all rights and interest in, NADA 141-014 for SUPER-OV (follicle...

  3. 76 FR 79064 - New Animal Drugs; Change of Sponsor; Zinc Gluconate

    Science.gov (United States)

    2011-12-21

    ... new animal drug application (NADA) for zinc gluconate injectable solution from Technology Transfer... it has transferred ownership of, and all rights and interest in, NADA 141-217 for NEUTERSOL...

  4. Availability of P and K in ash from thermal gasification of animal manure

    Energy Technology Data Exchange (ETDEWEB)

    Rubaek, G.H.; Soerensen, Peter [Danish Inst. of Agricultural Sciences, Dept. of Agroecology, Tjele (Denmark); Stoholm, P. [Danish Fluid Bed Technology (Denmark)

    2006-08-15

    In areas like Denmark where the livestock density is regulated on the basis of manure N content, surplus phosphorus is becoming a key environmental problem, which has to be solved in order to avoid increasing P losses to surface waters in the future. Combustion of animal manure or its solid fraction and the subsequent export of the ash to nutrient-poor areas could be a solution. However, combustion is difficult due to fouling and corrosion problems, and the ash will only be marketable if the fertiliser value of the remaining P and K is acceptable and if the content of contaminants (heavy metals) is sufficiently low. A combined fast pyrolysis and char gasification technique for treatment of biomass has been developed where organic material such as manure is processed in a fluidised bed reactor at temperatures and around 700 deg. C. After simple separation of a fine textured ash, the cleaned gas is suitable for combustion in a separate unit for energy production. One advantage of this technique is that the temperature can be finely controlled, and temperatures exceeding the melting point of e.g. potassium chloride can be avoided. The low and well-controlled temperature probably also prevents severe reductions in the availability of nutrients in the ash. However, the availability of P and K in the ash remains to be thoroughly tested. (au)

  5. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how ... and distributed as long as FDA's Center for Veterinary Medicine is cited as the corporate author. Animation Animation ...

  6. Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

    OpenAIRE

    Zaheer Ud Din Babar; Mohamed Izham Mohamed Ibrahim; Harpal Singh; Nadeem Irfan Bukahri; Andrew Creese

    2007-01-01

    Editors' Summary Background. The World Health Organization has said that one-third of the people of the world cannot access the medicines they need. An important reason for this problem is that prices are often too high for people or government-funded health systems to afford. In developing countries, most people who need medicines have to pay for them out of their own pockets. Where the cost of drugs is covered by health systems, spending on medicines is a major part of the total healthcare ...

  7. 76 FR 17776 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-31

    ...; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and...., Chaska, MN 55318. G Premix (tylosin phosphate/ sulfamethazine). Abraxis Pharmaceutical Products, Division........ NADA 100-991, McNess Custom 558.625 (010439). Premix L200 (tylosin phosphate). Fort Dodge Animal...

  8. 76 FR 12563 - Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime

    Science.gov (United States)

    2011-03-08

    ... animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary... Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141-321 that provides for... parasites. The NADA is approved as of January 4, 2011, and the regulations in part 520 (21 CFR part 520)...

  9. The Scientific Value of Non-Clinical Animal Studies in Drug Development

    NARCIS (Netherlands)

    van Meer, P.J.K.

    2013-01-01

    Animal studies are considered needed as predictive models to evaluate safety and efficacy of new pharmaceuticals and are required by law. However, the scientific basis of the current paradigm on the predictability of animal studies for the effects of drugs in man is under discussion. Therefore, in t

  10. Is the Physical Availability of Alcohol and Illicit Drugs Related to Neighborhood Rates of Child Maltreatment?

    Science.gov (United States)

    Freisthler, Bridget; Needell, Barbara; Gruenewald, Paul J.

    2005-01-01

    Objective: This study examines how the availability of alcohol and illicit drugs (as measured by alcohol outlet density and police incidents of drug sales and possessions) is related to neighborhood rates of child abuse and neglect, controlling for other neighborhood demographic characteristics. Method: Data from substantiated reports of child…

  11. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

    Science.gov (United States)

    2010-01-11

    ... Animal Drugs; Hyaluronate Sodium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY... NADA provides for a revised human food safety warning for use of hyaluronate sodium injectable solution... for the veterinary prescription use of HYVISC (hyaluronate sodium) Sterile Injection in horses....

  12. 78 FR 78716 - Withdrawal of Approval of New Animal Drug Applications; Roxarsone

    Science.gov (United States)

    2013-12-27

    ... Applications; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and... five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's... requested that FDA withdraw approval of the following five NADAs for roxarsone oral dosage form...

  13. 75 FR 76260 - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

    Science.gov (United States)

    2010-12-08

    ... Animal Drugs; Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food... ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows..., filed a supplement to ANADA 200-061 that provides for veterinary prescription use of FLU-NIX...

  14. 75 FR 13225 - Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

    Science.gov (United States)

    2010-03-19

    ... Animal Drugs; Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food... provides for the use of flunixin meglumine injectable solution in swine. DATES: This rule is effective..., Dublin 24, Ireland, filed ANADA 200-489 that provides for use of FLUNAZINE-S (flunixin...

  15. 21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

    Science.gov (United States)

    2010-04-01

    ... antibiotic, nitrofuran, or sulfonamide not reviewed by the National Academy of Sciences—National Research... of these drugs by that time will be grounds for proceeding to immediately withdraw approval. (3) By... considered as grounds for immediately proceeding to withdraw approval of that drug for use in animal...

  16. 76 FR 27888 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria...

    Science.gov (United States)

    2011-05-13

    ... drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid...-5755, filed NADA 141-322 that provides for the veterinary prescription use of IMPROVEST...

  17. 77 FR 4227 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor Analog...

    Science.gov (United States)

    2012-01-27

    ... drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA extends the slaughter interval for intact male swine injected with..., filed a supplement to NADA 141-322 for IMPROVEST (gonadotropin releasing factor analog-diphtheria...

  18. Resurgence of alcohol seeking produced by discontinuing non-drug reinforcement as an animal model of drug relapse.

    Science.gov (United States)

    Podlesnik, Christopher A; Jimenez-Gomez, Corina; Shahan, Timothy A

    2006-06-01

    Findings from basic behavioral research suggest that simply discontinuing reinforcement for a recently reinforced operant response can cause the recurrence (i.e. resurgence) of a different previously reinforced response. The present experiment examined resurgence as an animal model of drug relapse. Initially, rats pressed levers to self-administer alcohol during baseline conditions. Next, alcohol self-administration was discontinued and non-drug reinforcers (food pellets) were presented contingent on an alternative response (chain pulling). Finally, when the non-drug reinforcer was discontinued, alcohol seeking recurred even though alcohol was still unavailable for lever pressing. These results suggest that simply discontinuing non-drug reinforcement for a behavior may be sufficient to produce relapse to drug seeking. The resurgence procedure could provide a method to examine environmental, pharmacological, and neurobiological factors that lead to relapse following the loss of a non-drug source of reinforcement.

  19. 77 FR 26697 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Change of Sponsor Name and...

    Science.gov (United States)

    2012-05-07

    ... that it has transferred ownership of, and all rights and interest in, abbreviated new animal drug... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 New Animal Drugs; Change of Sponsor... Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the...

  20. 76 FR 65109 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

    Science.gov (United States)

    2011-10-20

    ...; Melengestrol; Monensin; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The... acetate, monensin, and tylosin. DATES: This rule is effective October 20, 2011. FOR FURTHER INFORMATION..., USP), and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles to make...

  1. 75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

    Science.gov (United States)

    2010-09-03

    ... Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed..., USP), and TYLAN (tylosin phosphate) Type A medicated articles to formulate three-way combination drug... containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for...

  2. 75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

    Science.gov (United States)

    2010-06-17

    ... drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for the manufacture of... INFORMATION: Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, filed a supplement to NADA 141-264 for... that provides for the manufacture of Type B medicated swine feeds. The supplemental NADA is approved...

  3. International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; availability. Notice.

    Science.gov (United States)

    2012-11-20

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

  4. Cost analysis study of oral antidiabetic drugs available in Indian market

    Directory of Open Access Journals (Sweden)

    Nisharani B Jadhav, Manisha S Bhosale, Charles V Adhav

    2013-01-01

    Full Text Available There exists a wide range of variation in the prices of drugs marketed in India and other countries of the world. Very few studies have been conducted to reveal such price variations in the open market. Aim & Objectives: To evaluate the cost of oral anti-diabetics of different generic classes and different brand names of one compound, To evaluate the difference in cost of different brands for the same active drug by calculating percentage variation of cost. Methods: Cost of a particular drug being manufactured by different companies, in the same strength, number and dosage form was compared. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and the percentage variation in price was calculated. Results: In Single drug therapy, among sulfonylurea group of drugs, Glimepiride (1 mg shows maximum price variation of 655.38%, while Glipizide (10mg shows variation of 38.88%. In Biguanides & Thizolidinediones groups of drugs, Metformin (500 mg & Pioglitazone (15 mg show maximum price variation of 308.33% & 542% respectively. In α-glucosidases inhibitor group of drugs, Miglitol shows maximum price variation of 135.50 %. In combination therapies, Glipizide & Metformin combination shows the maximum variation up to 399.04 %. Conclusion: The average percentage price variation of different brands of the same drug manufactured in India is very wide and the appraisal and management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative personal and economic consequences

  5. Systematic review of available evidence on 11 high-priced inpatient orphan drugs

    NARCIS (Netherlands)

    T.A. Kanters (Tim A.); C. de Sonneville (Caroline); W.K. Redekop (Ken); L. van Hakkaart-van Roijen (Leona)

    2013-01-01

    markdownabstract__Abstract__ __Background__: Attention for Evidence Based Medicine (EBM) is growing, but evidence for orphan drugs is argued to be limited and inferior. This study systematically reviews the available evidence on clinical effectiveness, costeffectiveness and budget impact for orph

  6. COST ANALYSIS OF LONG ESTABLISHED AND NEWER ORAL ANTIEPILEPTIC DRUGS AVAILABLE IN THE INDIAN MARKET

    Directory of Open Access Journals (Sweden)

    Phatak Abhishek M, Hotwani Jitendra H, Deshmukhkiran R, Panchal Sagar S, Naik Madhura S

    2015-10-01

    Full Text Available Background: Large number of pharmaceutical companies manufactures antiepileptic drugs in India. The price variations among the marketed drugs are wide. Aims: The present study was aimed to find the cost of different oral antiepileptic drugs available in Indian market as monotherapy, combination therapy and number of manufacturing companies for each, to evaluate difference in cost of different brands of same dosage of same active drug by calculating percentage variation of cost. Methods and Materials: Cost of a drug being manufactured by different companies, in the same strength and dosage forms was obtained from “Indian Drug Review” Vol. XXI, Issue No.4, 2014 and “Current Index of Medical Specialties” July-October 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in price was calculated. Results: The percentage price variation noted of long-established drugs was – Phenytoin (50mg: 140%, Carbamazepine (100mg: 1033%, Phenobarbital (30mg : 730%, Valproic acid (300mg : 420%. Newer drugs –Levetiracetam (250mg: 75%, Lamotrigine (25mg: 66%, Topiramate (50mg: 108%, Zonisamide (100mg: 19%. Combination drugs – Phenobarbital + Phenytoin (30+100 mg: 354.55%. Conclusion: The percentage price variation of different brands of the same commonly used long-established oral antiepileptic drug manufactured in India is very wide. The formulation or brand of Antiepileptic drugs (AED’s should preferably not be changed since variations in bioavailability or different pharmacokinetic profiles may increase the potential for reduced effect or excessive side effects. Hence, manufacturing companies should aim to decrease the price variation while maintaining the therapeutic efficacy.

  7. Novel in vivo imaging analysis of an inner ear drug delivery system: Drug availability in inner ear following different dose of systemic drug injections.

    Science.gov (United States)

    Kanzaki, Sho; Watanabe, Kotaro; Fujioka, Masato; Shibata, Shinsuke; Nakamura, Masaya; Okano, Hirotaka James; Okano, Hideyuki; Ogawa, Kaoru

    2015-12-01

    Systemic application of drugs is commonly used in clinical situations. Some of these drugs are ototoxic. Since there are few studies on in vivo monitoring of drug delivery dynamics, the time course or bioavailability of drugs in the inner ear of live animals following systemic drug application remains unknown. For instance, it is unknown whether the volume of a drug delivered systemically correlates with its inner ear pharmacokinetics. We previously established a new in vivo imaging system to monitor drug delivery in live mice. In the present study, we used this system to compare drug concentration in the inner ear over time after systemic drug injections. We used transgenic GFAP-Luc mice that harbor a firefly luciferase gene expression cassette regulated by 12 kb of murine GFAP promoter and human beta-globin intron 2. Luciferin delivered into the inner ear of these mice reacts with luciferase, and the resulting signals are detected in GFAP-expressing cells in the cochlear nerve. Thus, we assessed in the inner ear the intensity and duration of luciferin/luciferase signals after systemic injections of different volumes of luciferin. An IVIS(®) imaging system was used to observe signals, and these signals were compared to the drug dynamics of luciferin delivered through subcutaneous (sc) injections. The volume of sc-injected drug correlated significantly with photon counts measured in the inner ear. Photons were detected almost immediately after injection, peaking 20 min after injection. Drug concentration did not affect inner ear signals. Luciferin injected systemically appeared in the inner ear between highest and lowest concentration. Drug volume is an important parameter to know if the inner ear requires a higher level of the drug. We observed that it is the volume of a drug-not its concentration-that is the important factor. Indeed, the more volume of a drug injected systemically increased the concentration of that drug in the inner ear. This study provides a

  8. Risk mitigation for children exposed to drugs during gestation: A critical role for animal preclinical behavioral testing.

    Science.gov (United States)

    Zucker, Irving

    2017-03-16

    Many drugs with unknown safety profiles are administered to pregnant women, placing their offspring at risk. I assessed whether behavioral outcomes for children exposed during gestation to antidepressants, anxiolytics, anti-seizure, analgesic, anti-nausea and sedative medications can be predicted by more extensive animal studies than are part of the FDA approval process. Human plus rodent data were available for only 8 of 33 CNS-active drugs examined. Similar behavioral and cognitive deficits, including autism and ADHD emerged in human offspring and in animal models of these disorders after exposure to fluoxetine, valproic acid, carbamazepine, phenytoin, phenobarbital and acetaminophen. Rodent data helpful in identifying and predicting adverse effects of prenatal drug exposure in children were first generated many years after drugs were FDA-approved and administered to pregnant women. I recommend that enhanced behavioral testing of rodent offspring exposed to drugs prenatally should begin during preclinical drug evaluation and continue during Phase I clinical trials, with findings communicated to physicians and patients in drug labels.

  9. 76 FR 50220 - Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye...

    Science.gov (United States)

    2011-08-12

    ... Institutional Animal Care and Use Committee. In light of this policy and regulations, most in vivo ocular safety..., mailing address, phone, fax, e-mail, and sponsoring organization, if applicable). NICEATM will post...

  10. CHANGING METABOLIC FUNCTIONS IN EXPERIMENTAL ANIMALS AFTER INTRODUCTION OF THE XENOBIOTIC, IMMUNOTROPIC DRUG AND PROBIOTIC

    Directory of Open Access Journals (Sweden)

    Zvyagintseva O.V.

    2015-05-01

    Full Text Available The aim of the study was to evaluate in vivo changes in metabolic and barrier function of the resistance factors (activity of enzymes of neutrophils, the efficiency of phagocytosis, some biochemical parameters (concentration of ceruloplasmin and haptoglobin and proliferate activity in vitro cells after introduction of copper sulfate, probiotics and immunostimulant "Fungidol" the experimental animals. Material and methods. The in vivo experiments were performed on 6-month-old male rats of Wistar line. Identified the following groups: group 1 - control animals, which were intraperitoneally injected with saline (n = 5; group 2 - animals that were administered saline per os and 48 hours a solution of copper sulphate intraperitoneally (n = 5; group 3 - animals, which were injected with immunotropic drug "Fungidol" per os and 48 hours a solution of copper sulphate intraperitoneally (n = 5; group 4 animals, which were injected with a solution of probiotics per os and 48 hours a solution of copper sulphate intraperitoneally (n = 5. As a probiotic used capsules firm Yogurt that contains active Lactobacillus acidophilus, Lactobacillus rhamnosus, Streptococcus thermophillus, Lactobacillus bulgaricus. The concentration of haptoglobin and ceruloplasmin were determined spectrophotometrically. Oxygen-dependent metabolism of neutrophils was investigated by microscopy according to their ability to absorb nitroblue tetrazolium (NBT-test and restore it to deformazione in the form of granules blue color under the influence of superoxide anion, which is formed in the NADP-oxidase reaction, initiating the process of stimulation of phagocytosis (NBT-test. To determine the barrier function of phagocytic cells by light microscopy to evaluate the activity of phagocytosis of neutrophilic granulocytes with subsequent determination of phagocytic index, phagocytic number and the index of completeness of phagocytosis. As a microbial agent used is a suspension culture of

  11. Streptococcus suis, an emerging drug-resistant animal and human pathogen

    Directory of Open Access Journals (Sweden)

    Claudio ePalmieri

    2011-11-01

    Full Text Available Streptococcus suis, a major porcine pathogen, has been receiving growing attention not only for its role in severe and increasingly reported infections in humans, but also for its involvement in drug resistance. Recent studies and the analysis of sequenced genomes have been providing important insights into the S. suis resistome, and have resulted in the identification of resistance determinants for tetracyclines, macrolides, aminoglycosides, chloramphenicol, antifolate drugs, streptothricin, and cadmium salts. Resistance gene-carrying genetic elements described so far include integrative and conjugative elements, transposons, genomic islands, phages, and chimeric elements. Some of these elements are similar to those reported in major streptococcal pathogens such as Streptococcus pyogenes, Streptococcus pneumoniae, and Streptococcus agalactiae and share the same chromosomal insertion sites. The available information strongly suggests that S. suis is an important antibiotic resistance reservoir that can contribute to the spread of resistance genes to the above-mentioned streptococci. S. suis is thus a paradigmatic example of possible intersections between animal and human resistomes.

  12. RISKS ASSOCIATED WITH THE PRESENCE OF ANTIMICROBIAL DRUG RESIDUES IN MEAT PRODUCTS AND PRODUCTS OF ANIMAL SLAUGHTER

    Directory of Open Access Journals (Sweden)

    D. S. Bataeva

    2016-01-01

    Full Text Available The risks associated with the presence of antimicrobial drug residues in meat and products of animal slaughter were determined. One of them is the emergence of antimicrobial resistance in pathogenic and conditionally pathogenic microorganisms isolated from meat and products of animal slaughter. It was established that Escherichia coli, Salmonella and Pseudomonas were resistant to ampicillin, tetracycline, tylosin and cephalolexin. However, Listeria monocytogenes did not have resistance to these antibiotics. It was also established that when entering an animal body, antimicrobials were accumulated mostly in liver and kidneys of an animal followed by meat and, to the least degree, in fat. It was found that up to 65% of the tested samples were contaminated with antimicrobials to a greater or lesser degree.

  13. Molecular and pharmacokinetic properties of 222 commercially available oral drugs in humans.

    Science.gov (United States)

    Sakaeda, T; Okamura, N; Nagata, S; Yagami, T; Horinouchi, M; Okumura, K; Yamashita, F; Hashida, M

    2001-08-01

    This study was performed to determine the exclusion criteria that differentiate poorly absorbed drugs from good drug candidates, and to accelerate drug development by exclusion of unnecessary assessment. The molecular and pharmacokinetic properties of 222 commercially available oral drugs were tabulated and their correlations were analyzed. The exclusion criteria obtained were 1) a molecular weight of more than 500, and 2) a ClogP value of more than 5. Exceptions to molecular weight criteria were compounds with a sugar moiety, high atomic weight, and large cyclic structure. It was also suggested that being a substrate for MDRI (P-glycoprotein) does not always result in poor bioavailability, and that drug development by chemical modification of a seed or lead compound with quantitative structure activity relationship analysis can result in lower bioavailability, higher bound fraction and lower urinary excretion, which would hamper later development processes and might result in considerable drug-drug interaction. The criteria should be adjusted according to the pharmacological profiles of the agents in question and depending on the estimated profit, but ignoring these criteria may result in a significant waste of time and money during drug development.

  14. Cannabidiol, among other cannabinoid drugs, modulates prepulse inhibition of startle in the SHR animal model: implications for schizophrenia pharmacotherapy

    Directory of Open Access Journals (Sweden)

    Fernanda Fiel Peres

    2016-09-01

    Full Text Available Schizophrenia is a severe psychiatric disorder that involves positive, negative and cognitive symptoms. Prepulse inhibition of startle reflex (PPI is a paradigm that assesses the sensorimotor gating functioning and is impaired in schizophrenia patients as well as in animal models of this disorder. Recent data point to the participation of the endocannabinoid system in the pathophysiology and pharmacotherapy of schizophrenia. Here, we focus on the effects of cannabinoid drugs on the PPI deficit of animal models of schizophrenia, with greater focus on the SHR (Spontaneously Hypertensive Rats strain, and on the future prospects resulting from these findings.

  15. Subsidizing the distribution channel: Donor funding to improve the availability of malaria drugs

    OpenAIRE

    Taylor, TA; W. Xiao

    2014-01-01

    ©2014 INFORMS. In countries that bear the heaviest burden of malaria, most patients seek medicine for the disease in the private sector. Because the availability and affordability of recommended malaria drugs provided by the private-sector distribution channel is poor, donors (e.g., the Global Fund) are devoting substantial resources to fund subsidies that encourage the channel to improve access to these drugs. A key question for a donor is whether it should subsidize the purchases and/or the...

  16. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Small Entities Compliance Guide... Animal Drugs for Minor Uses or Minor Species.'' This small entities compliance guide (SECG) aids industry... Animal Drugs for Minor Uses or Minor Species.'' This SECG aids industry in complying with...

  17. Current available strategies to mitigate greenhouse gas emissions in livestock systems: an animal welfare perspective.

    Science.gov (United States)

    Llonch, P; Haskell, M J; Dewhurst, R J; Turner, S P

    2017-02-01

    Livestock production is a major contributor to greenhouse gas (GHG) emissions, so will play a significant role in the mitigation effort. Recent literature highlights different strategies to mitigate GHG emissions in the livestock sector. Animal welfare is a criterion of sustainability and any strategy designed to reduce the carbon footprint of livestock production should consider animal welfare amongst other sustainability metrics. We discuss and tabulate the likely relationships and trade-offs between the GHG mitigation potential of mitigation strategies and their welfare consequences, focusing on ruminant species and on cattle in particular. The major livestock GHG mitigation strategies were classified according to their mitigation approach as reducing total emissions (inhibiting methane production in the rumen), or reducing emissions intensity (Ei; reducing CH4 per output unit without directly targeting methanogenesis). Strategies classified as antimethanogenic included chemical inhibitors, electron acceptors (i.e. nitrates), ionophores (i.e. Monensin) and dietary lipids. Increasing diet digestibility, intensive housing, improving health and welfare, increasing reproductive efficiency and breeding for higher productivity were categorized as strategies that reduce Ei. Strategies that increase productivity are very promising ways to reduce the livestock carbon footprint, though in intensive systems this is likely to be achieved at the cost of welfare. Other strategies can effectively reduce GHG emissions whilst simultaneously improving animal welfare (e.g. feed supplementation or improving health). These win-win strategies should be strongly supported as they address both environmental and ethical sustainability. In order to identify the most cost-effective measures for improving environmental sustainability of livestock production, the consequences of current and future strategies for animal welfare must be scrutinized and contrasted against their effectiveness

  18. Renal failure caused by chemicals, foods, plants, animal venoms, and misuse of drugs. An overview.

    Science.gov (United States)

    Abuelo, J G

    1990-03-01

    Nephrotoxicity caused by contrast media and drugs is a frequent cause of renal failure in medical practice. However, there are only sporadic cases of renal failure caused by chemicals, foods, plants, animal venoms, and misused or illegal drugs, and standard medical textbooks are limited in the coverage given to the subject. This review provides a referenced compilation of these lesser-known nephrotoxins and gives an overview of renal failure caused by substances other than properly used medications.

  19. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry...

  20. Drug residues in animal tissues and their regulatory significance--the Canadian point of view.

    Science.gov (United States)

    Campbell, D J

    1978-09-01

    Today it is almost impossible to produce food of animal origin which is free from traces of drugs or chemicals. In Canada the problem of drug residues is controlled by a method of assessment of human safety which involves many factors. The toxicity of the drug in laboratory animals or, if possible, in man, is established and a no-effect dose is then estimated. These studies require oral administration of the drug and include acute, subacute, and teratogenicity studies. Depending on these results, chronic reproductive or carcinogenicity studies may be required before a no-effect dose can be estimated. Residue studies must encompass data on metabolism, pharmacokinetics, and depletion studies in edible tissues and for products such as milk and eggs. For veterinary drug residues, we must consider the target food animal with its particular metabolism, tissue disposition, and excretion patterns. The analytical method for residue detection must be acceptable and its sensitivity limits suitable for the drug and its major metabolites.

  1. Whole animal automated platform for drug discovery against multi-drug resistant Staphylococcus aureus.

    Directory of Open Access Journals (Sweden)

    Rajmohan Rajamuthiah

    Full Text Available Staphylococcus aureus, the leading cause of hospital-acquired infections in the United States, is also pathogenic to the model nematode Caenorhabditis elegans. The C. elegans-S. aureus infection model was previously carried out on solid agar plates where the bacteriovorous C. elegans feeds on a lawn of S. aureus. However, agar-based assays are not amenable to large scale screens for antibacterial compounds. We have developed a high throughput liquid screening assay that uses robotic instrumentation to dispense a precise amount of methicillin resistant S. aureus (MRSA and worms in 384-well assay plates, followed by automated microscopy and image analysis. In validation of the liquid assay, an MRSA cell wall defective mutant, MW2ΔtarO, which is attenuated for killing in the agar-based assay, was found to be less virulent in the liquid assay. This robust assay with a Z'-factor consistently greater than 0.5 was utilized to screen the Biomol 4 compound library consisting of 640 small molecules with well characterized bioactivities. As proof of principle, 27 of the 30 clinically used antibiotics present in the library conferred increased C. elegans survival and were identified as hits in the screen. Surprisingly, the antihelminthic drug closantel was also identified as a hit in the screen. In further studies, we confirmed the anti-staphylococcal activity of closantel against vancomycin-resistant S. aureus isolates and other Gram-positive bacteria. The liquid C. elegans-S. aureus assay described here allows screening for anti-staphylococcal compounds that are not toxic to the host.

  2. Automated high-content live animal drug screening using C. elegans expressing the aggregation prone serpin α1-antitrypsin Z.

    Directory of Open Access Journals (Sweden)

    Sager J Gosai

    Full Text Available The development of preclinical models amenable to live animal bioactive compound screening is an attractive approach to discovering effective pharmacological therapies for disorders caused by misfolded and aggregation-prone proteins. In general, however, live animal drug screening is labor and resource intensive, and has been hampered by the lack of robust assay designs and high throughput work-flows. Based on their small size, tissue transparency and ease of cultivation, the use of C. elegans should obviate many of the technical impediments associated with live animal drug screening. Moreover, their genetic tractability and accomplished record for providing insights into the molecular and cellular basis of human disease, should make C. elegans an ideal model system for in vivo drug discovery campaigns. The goal of this study was to determine whether C. elegans could be adapted to high-throughput and high-content drug screening strategies analogous to those developed for cell-based systems. Using transgenic animals expressing fluorescently-tagged proteins, we first developed a high-quality, high-throughput work-flow utilizing an automated fluorescence microscopy platform with integrated image acquisition and data analysis modules to qualitatively assess different biological processes including, growth, tissue development, cell viability and autophagy. We next adapted this technology to conduct a small molecule screen and identified compounds that altered the intracellular accumulation of the human aggregation prone mutant that causes liver disease in α1-antitrypsin deficiency. This study provides powerful validation for advancement in preclinical drug discovery campaigns by screening live C. elegans modeling α1-antitrypsin deficiency and other complex disease phenotypes on high-content imaging platforms.

  3. Ocular pharmacoscintigraphic and aqueous humoral drug availability of ganciclovir-loaded mucoadhesive nanoparticles in rabbits

    NARCIS (Netherlands)

    Akhter, Sohail; Ramazani, Farshad; Ahmad, Mohammad Zaki; Ahmad, Farjam Jalees; Rahman, Ziyaur; Bhatnagar, Aseem; Storm, Gert

    2013-01-01

    The present report describes the improved ocular retention and aqueous humoral drug availability of ganciclovir (GCV) when administered via topical instillation of different kind of nanoparticles onto the rabbit eye. GCV was loaded into PLGA nanoparticles, chitosan-coated nanoparticles and chitosan-

  4. Sex differences in drug addiction and response to exercise intervention: From human to animal studies.

    Science.gov (United States)

    Zhou, Yuehui; Zhao, Min; Zhou, Chenglin; Li, Rena

    2016-01-01

    Accumulated research supports the idea that exercise could be an option of potential prevention and treatment for drug addiction. During the past few years, there has been increased interest in investigating of sex differences in exercise and drug addiction. This demonstrates that sex-specific exercise intervention strategies may be important for preventing and treating drug addiction in men and women. However, little is known about how and why sex differences are found when doing exercise-induced interventions for drug addiction. In this review, we included both animal and human that pulled subjects from a varied age demographic, as well as neurobiological mechanisms that may highlight the sex-related differences in these potential to assess the impact of sex-specific roles in drug addiction and exercise therapies.

  5. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFee.... Background Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three different kinds of user fees: (1.... Contact your bank or financial institution regarding the amount of the fees that need to be paid...

  6. 77 FR 3653 - Import Tolerances for Residues of Unapproved New Animal Drugs in Food

    Science.gov (United States)

    2012-01-25

    ... this paragraph, `relevant international organization' means the Codex Alimentarius Commission or other...) Food Standards Program (Codex MRL), provided that the Codex Alimentarius Commission has established a... Codex Alimentarius Commission has established a permanent Codex MRL for a new animal drug, the...

  7. 76 FR 17927 - Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin...

    Science.gov (United States)

    2011-03-31

    ...; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY.......... (016968) (tylosin phosphate/ sulfamethazine). Abraxis Pharmaceutical Products, NADA 100-840 522.1081... McNess Custom Premix L200..... (010439) (tylosin phosphate) Fort Dodge Animal Health, Division...

  8. 78 FR 63870 - New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and...

    Science.gov (United States)

    2013-10-25

    ..., ANADA 200-348 for ECOMECTIN (ivermectin) Topical Solution to SmartVet USA, Inc., 22201 West Innovation... Approved During July 2013 New Animal drug 21 CFR NADA/ANADA Sponsor product name Action Section FOIA...) in lactating dairy cows. 141-349 Zoetis Inc., DRAXXIN 25 Original approval 522.2630 Yes............

  9. 78 FR 70566 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at... 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... approval of NADA 008-019, and all supplements and amendments thereto, is hereby withdrawn. Elsewhere...

  10. 75 FR 4692 - Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

    Science.gov (United States)

    2010-01-29

    ... reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of ceftiofur... Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA...

  11. 78 FR 70496 - Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid

    Science.gov (United States)

    2013-11-26

    ... approval of a new animal drug application (NADA) for an arsanilic acid Type A medicated article at the.... Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO-GEN... gave notice that approval of NADA 008-019, and all supplements and amendments thereto, is...

  12. 75 FR 71016 - Intramammary Dosage Form New Animal Drugs; Cloxacillin Benzathine

    Science.gov (United States)

    2010-11-22

    ... approval of a supplementary new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc... Highway, St. Joseph, MO 64506-2002 has filed a supplement to NADA 55-058 for DRY-CLOX (cloxacillin benzathine) Intramammary Infusion for dry dairy cattle. The supplemental NADA provides for various...

  13. 75 FR 59610 - Implantation and Injectable Dosage Form New Animal Drugs; Firocoxib

    Science.gov (United States)

    2010-09-28

    ... original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary...: Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 filed NADA 141-313 that provides for... inflammation associated with osteoarthritis. The NADA is approved as of August 20, 2010, and the...

  14. 75 FR 62468 - Implantation and Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

    Science.gov (United States)

    2010-10-12

    ... regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of..., Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141 235 for EXCEDE...

  15. 76 FR 72619 - Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin

    Science.gov (United States)

    2011-11-25

    ... reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for addition of a warning statement against the use of eprinomectin topical solution... supplement to NADA 141-079 for EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle, a topical...

  16. 75 FR 60307 - Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine

    Science.gov (United States)

    2010-09-30

    ... supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA provides for... INFORMATION: Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed a supplement to NADA 141-267 for DEXDOMITOR (dexmedetomidine hydrochloride). The supplemental NADA provides for veterinary prescription use...

  17. 75 FR 63085 - Certain Other Dosage Form New Animal Drugs; Progesterone Intravaginal Inserts

    Science.gov (United States)

    2010-10-14

    ... supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of progesterone intravaginal inserts and dinoprost tromethamine by injection... St., New York, NY 10017 filed a supplement to NADA 141-200 that provides for use of EAZI-BREED...

  18. 78 FR 52430 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

    Science.gov (United States)

    2013-08-23

    ... Animal Drug Applications; Quali- Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin... (pyrantel tartrate), NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC...

  19. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs for.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... guidance for industry entitled ``Influenza: Development of Drugs for Treatment and/or...

  20. Regulation of reverse cholesterol transport - a comprehensive appraisal of available animal studies

    Directory of Open Access Journals (Sweden)

    Annema Wijtske

    2012-03-01

    Full Text Available Abstract Plasma levels of high density lipoprotein (HDL cholesterol are strongly inversely correlated to the risk of atherosclerotic cardiovascular disease. A major recognized functional property of HDL particles is to elicit cholesterol efflux and consequently mediate reverse cholesterol transport (RCT. The recent introduction of a surrogate method aiming at determining specifically RCT from the macrophage compartment has facilitated research on the different components and pathways relevant for RCT. The current review provides a comprehensive overview of studies carried out on macrophage-specific RCT including a quick reference guide of available data. Knowledge and insights gained on the regulation of the RCT pathway are summarized. A discussion of methodological issues as well as of the respective relevance of specific pathways for RCT is also included.

  1. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Cosmetics Tobacco Products Animal & ... antimicrobial resistance both emerges and proliferates among bacteria. Over time, the use of antimicrobial drugs will result in the development ...

  2. Effect of drugs of abuse on social behaviour: a review of animal models.

    Science.gov (United States)

    Blanco-Gandía, Maria C; Mateos-García, Ana; García-Pardo, Maria P; Montagud-Romero, Sandra; Rodríguez-Arias, Marta; Miñarro, José; Aguilar, María A

    2015-09-01

    Social behaviour is disturbed in many substance abuse and psychiatric disorders. Given the consensus that social behaviours of lower mammals may help to understand some human emotional reactions, the aim of the present work was to provide an up-to-date review of studies on the changes in social behaviour induced by drugs of abuse. Various animal models have been used to study the relationship between drugs of abuse and social behaviour. Herein, we describe the effects of different substances of abuse on the three most commonly used animal models of social behaviour: the social play test, the social interaction test and the resident-intruder paradigm. The first is the most widely used test to assess adolescent behaviour in rodents, the second is generally used to evaluate a wide repertoire of behaviours in adulthood and the latter is specific to aggressive behaviour. Throughout the review we will explore the most relevant studies carried out to date to evaluate the effects of alcohol, cocaine, opioids, 3,4-methylenedioxymethamphetamine (MDMA), cannabinoids, nicotine and other drugs of abuse on these three paradigms, taking into account the influence of different variables, such as social history, age and type of exposure. Drugs of diverse pharmacological classes induce alterations in social behaviour, although they can be contrasting depending on several factors (drug, individual differences and environmental conditions). Ethanol and nicotine increase social interaction at low doses but reduce it at high doses. Psychostimulants, MDMA and cannabinoids reduce social interaction, whereas opiates increase it. Ethanol and psychostimulants enhance aggression, whereas MDMA, opiates, cannabinoids and nicotine reduce it. Prenatal drug exposure alters social behaviour, whereas drug withdrawal decreases sociability and enhances aggression. As a whole, this evidence has improved our understanding of the social dimension of drug addiction.

  3. 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

    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...... on animal species, age-group and diagnostic grouping; >90% of the total amount of antimicrobials sold on prescription was used for pigs. In 2001, sales of 96,500 kg of antimicrobials were reported....

  4. 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

    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. PMID:27433102

  5. Development of PPAR-agonist GW0742 as antidiabetic drug: study in animals

    Directory of Open Access Journals (Sweden)

    Niu HS

    2015-10-01

    Full Text Available Ho-Shan Niu,1 Po-Ming Ku,2,3 Chiang-Shan Niu,1 Juei-Tang Cheng,3,4 Kung-Shing Lee5–71Department of Nursing, Tzu Chi College of Technology, Hualien City, 2Department of Cardiology, 3Department of Medical Research, Chi-Mei Medical Center, Yong Kang, Tainan City, 4Institute of Medical Sciences, Chang Jung Christian University, Guiren, Tainan City, 5Department of Surgery, Division of Neurosurgery, Pingtung Hospital, 6Department of Surgery, Kaohsiung Medical University, 7School of Medicine, Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung City, TaiwanBackground: The development of new drugs for the treatment of diabetes mellitus (DM is critically important. Insulin resistance (IR is one of the main problems associated with type-2 DM (T2DM seen in clinics. GW0742, a selective peroxisome proliferator-activated receptor (PPAR-δ agonist, has been shown to ameliorate metabolic abnormalities including IR in skeletal muscle in mice fed high-fructose corn syrup. However, the influence of GW0742 on systemic insulin sensitivity has still not been elucidated. Therefore, it is important to investigate the effect of GW0742 on systemic IR in diabetic rats for the development of new drugs.Methods: The present study used a T2DM animal model to compare the effect of GW0742 on IR using homeostasis model assessment-IR (HOMA-IR and hyperinsulinemic euglycemic clamping. Additionally, the insulinotropic action of GW0742 was investigated in type-1 DM (T1DM rats. Changes in the protein expression of glucose transporter 4 (GLUT4 and phosphoenolpyruvate carboxykinase (PEPCK in skeletal muscle and in liver, respectively, were also identified by Western blots.Results: GW0742 attenuated the increased HOMA-IR in diabetic rats fed a fructose-rich diet. This action was blocked by GSK0660 at the dose sufficient to inhibit PPAR-δ. Improvement of IR by GW0742 was also characterized in diabetic rats using hyperinsulinemic euglycemic clamping. Additionally, an

  6. Animals

    Energy Technology Data Exchange (ETDEWEB)

    Skuterud, L.; Strand, P. [Norwegian Radiation Protection Authority (Norway); Howard, B.J. [Inst. of Terrestrial Ecology (United Kingdom)

    1997-10-01

    The radionuclides of most concern with respect to contamination of animals after a nuclear accident are radioiodine, radiocaesium and radiostrontium (ICRP 30, 1979). Of the other significant anthropogenic radionuclides likely to be released in most accidents, only small proportions of that ingested will be absorbed in an animals gut, and the main animal products, milk and meat, will not normally be contaminated to a significant extent. Animal products will mostly be contaminated as a result of ingestion of contaminated feed and possibly, but to a much lesser extent, from inhalation (for radioiodine only). Direct external contamination of animals is of little or no consequence in human food production. Radioiodine and radiostrontium are important with respect to contamination of milk; radiocaesium contaminates both milk and meat. The physical and chemical form of a radionuclide can influence its absorption in the animal gut. For example, following the Chernobyl accident radiocaesium incorporated into vegetation by root uptake was more readily absorbed than that associated with the original deposit. The transfer of radiocaesium and radiostrontium to animals will be presented both as transfer coefficients and aggregated transfer coefficients. For most animal meat products, only radiocaesium is important as other radionuclides do not significantly contaminate muscle. Farm animal products are the most important foodstuff determining radiocaesium intake by the average consumer in the Nordic countries. The major potential source of radioiodine and radiostrontium to humans is milk and milk products. Of the different species, the smaller animals have the highest transfer of radiocaesium from fodder to meat and milk. (EG). 68 refs.

  7. Animal models to guide clinical drug development in ADHD: lost in translation?

    Science.gov (United States)

    Wickens, Jeffery R; Hyland, Brian I; Tripp, Gail

    2011-10-01

    We review strategies for developing animal models for examining and selecting compounds with potential therapeutic benefit in attention-deficit hyperactivity disorder (ADHD). ADHD is a behavioural disorder of unknown aetiology and pathophysiology. Current understanding suggests that genetic factors play an important role in the aetiology of ADHD. The involvement of dopaminergic and noradrenergic systems in the pathophysiology of ADHD is probable. We review the clinical features of ADHD including inattention, hyperactivity and impulsivity and how these are operationalized for laboratory study. Measures of temporal discounting (but not premature responding) appear to predict known drug effects well (treatment validity). Open-field measures of overactivity commonly used do not have treatment validity in human populations. A number of animal models have been proposed that simulate the symptoms of ADHD. The most commonly used are the spontaneously hypertensive rat (SHR) and the 6-hydroxydopamine-lesioned (6-OHDA) animals. To date, however, the SHR lacks treatment validity, and the effects of drugs on symptoms of impulsivity and inattention have not been studied extensively in 6-OHDA-lesioned animals. At the present stage of development, there are no in vivo models of proven effectiveness for examining and selecting compounds with potential therapeutic benefit in ADHD. However, temporal discounting is an emerging theme in theories of ADHD, and there is good evidence of increased value of delayed reward following treatment with stimulant drugs. Therefore, operant behaviour paradigms that measure the effects of drugs in situations of delayed reinforcement, whether in normal rats or selected models, show promise for the future.

  8. New Animal Model Could Boost Research on AIDS Drugs and Vaccines | Poster

    Science.gov (United States)

    By Frank Blanchard, Staff Writer, and Jeff Lifson, Guest Writer In a research milestone reported in the June 20 issue of the journal Science, scientists have developed a minimally modified version of HIV-1, the virus that causes AIDS in infected humans, that is capable of causing progressive infection and AIDS in monkeys. The advance should help create more authentic animal models of the disease and provide a potentially invaluable approach for faster and better preclinical evaluation of new drugs and vaccines.

  9. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... shortages, drug supply chain, safety, security, and drug innovation. As generic drugs account for more than... approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft GDUFA IT plan... the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,...

  10. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pulmonary Tuberculosis... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft... guidance for industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose...

  11. Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents).

    Science.gov (United States)

    Brent, Robert L

    2004-04-01

    Toxicology studies using animals and in vitro cellular or tissue preparations have been used to study the toxic effects and mechanism of action of drugs and chemicals and to determine the effective and safe dose of drugs in humans and the risk of toxicity from chemical exposures. Studies in pregnant animals are used to determine the risk of birth defects and other reproductive effects. There is no question that whole animal teratology studies are helpful in raising concerns about the reproductive effects of drugs and chemicals, but negative animal studies do not guarantee that these agents are free from reproductive effects. There are examples in which drug testing was negative in animals (rat and mouse) but was teratogenic in the human (thalidomide), and there are examples in which a drug was teratogenic in an animal model but not in the human (diflunisal). Testing in animals could be improved if animal dosing using the mg/kg basis were abandoned and drugs and chemicals were administered to achieve pharmacokinetically equivalent serum levels in the animal and the human. Because most human teratogens have been discovered by alert physicians or epidemiology studies, not animal studies, animal studies play a minor role in discovering teratogens. In vitro studies play an even less important role, although they are helpful in describing the cellular or tissue effects of the drugs or chemicals. One cannot determine the magnitude of human risks from these in vitro studies. Performing toxicology studies on adult animals is performed by pharmaceutical companies, chemical companies, the Food and Drug Administration, many laboratories at the National Institutes of Health, and scientific investigators in laboratories throughout the world. Although a vast amount of animal toxicology studies are performed on pregnant animals and numerous toxicology studies are performed on adult animals, there is a paucity of animal studies using newborn, infant, and juvenile animals. This

  12. Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-12-01

    Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  13. Varsity Medical Ethics Debate 2015: should nootropic drugs be available under prescription on the NHS?

    Science.gov (United States)

    Thorley, Emma; Kang, Isaac; D'Costa, Stephanie; Vlazaki, Myrto; Ayeko, Olaoluwa; Arbe-Barnes, Edward H; Swerner, Casey B

    2016-09-13

    The 2015 Varsity Medical Ethics debate convened upon the motion: "This house believes nootropic drugs should be available under prescription". This annual debate between students from the Universities of Oxford and Cambridge, now in its seventh year, provided the starting point for arguments on the subject. The present article brings together and extends many of the arguments put forward during the debate. We explore the current usage of nootropic drugs, their safety and whether it would be beneficial to individuals and society as a whole for them to be available under prescription. The Varsity Medical Debate was first held in 2008 with the aim of allowing students to engage in discussion about ethics and policy within healthcare. The event is held annually and it is hoped that this will allow future leaders to voice a perspective on the arguments behind topics that will feature heavily in future healthcare and science policy. This year the Oxford University Medical Society at the Oxford Union hosted the debate.

  14. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this....regulations.gov . To receive ``Guidance for Industry and Food and Drug Administration Staff; Blood...

  15. Animals

    Institute of Scientific and Technical Information of China (English)

    杨光

    2000-01-01

    The largest animal ever to live on the earth is the blue whale(蓝鲸)It weighs about 80 tons--more than 24 elephants. It is more than 30 metres long. A newborn baby whale weighs as much as a big elephant.

  16. Applications of animal models of infectious arthritis in drug discovery: a focus on alphaviral disease.

    Science.gov (United States)

    Herrero, Lara; Nelson, Michelle; Bettadapura, Jayaram; Gahan, Michelle E; Mahalingam, Suresh

    2011-06-01

    Animal models, which mimic human disease, are invaluable tools for understanding the mechanisms of disease pathogenesis and development of treatment strategies. In particular, animal models play important roles in the area of infectious arthritis. Alphaviruses, including Ross River virus (RRV), o'nyong-nyong virus, chikungunya virus (CHIKV), mayaro virus, Semliki Forest virus and sindbis virus, are globally distributed and cause transient illness characterized by fever, rash, myalgia, arthralgia and arthritis in humans. Severe forms of the disease result in chronic incapacitating arthralgia and arthritis. The mechanisms of how these viruses cause musculoskeletal disease are ill defined. In recent years, the use of a mouse model for RRV-induced disease has assisted in unraveling the pathobiology of infection and in discovering novel drugs to ameliorate disease. RRV as an infection model has the potential to provide key insights into such disease processes, particularly as many viruses, other than alphaviruses, are known to cause infectious arthritides. The emergence and outbreak of CHIKV in many parts of the world has necessitated the need to develop animal models of CHIKV disease. The development of non-human primate models of CHIKV disease has given insights into viral tropism and disease pathogenesis and facilitated the development of new treatment strategies. This review highlights the application of animal models of alphaviral diseases in the fundamental understanding of the mechanisms that contribute to disease and for defining the role that the immune response may have on disease pathogenesis, with the view of providing the foundation for new treatments.

  17. ANIMALS

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Mammals(哺乳动物)Mammals are the world's most dominant(最占优势的)animal.They are extremely(非常)diverse(多种多样的)creatures(生物,动物)that include(包括)the biggest ever animal (the blue whale鲸,which eats up to 6 tons every day),the smallest(leaf-nosed bat小蹄蝠) and the laziest(sloth树獭,who spends 80% of their time sleeping).There are over 4,600 kinds of mammals and they live in very different environments(环境)—oceans(海洋),rivers,the jungle(丛林),deserts,and plains(平原).

  18. Laser-assisted drug delivery in dermatology: from animal models to clinical practice.

    Science.gov (United States)

    Ali, Faisal R; Al-Niaimi, Firas

    2016-02-01

    Topical medicaments are the mainstay of the dermatologists' therapeutic arsenal. Laser-assisted drug delivery enhances the ability of topically applied medicaments to penetrate the skin. We discuss the mechanisms of laser-assisted drug delivery and animal models that have informed clinical practice. We review clinical studies that have employed laser-assisted drug delivery for a range of indications to date including non-melanoma skin cancer, vitiligo, scarring, vaccination, local anaesthesia, analgesia, viral warts, infantile haemangiomas and cosmetic uses. Studies thus far suggest that laser pre-treatment improves transepidermal absorption of topical agents and allows for a much deeper penetration of drugs than is possible with topical medicaments alone. This may allow more efficacious action of current treatments, such that conventional duration of treatment can be shortened or lower concentrations of active agents be used, potentially obviating side effects of treatment. The prospect of using laser technologies to facilitate transdermal vaccination and as an adjunct for inflammatory dermatoses and cosmetic indications remains in its infancy. As larger trials are published, involving greater numbers of patients and utilising various laser and topical medicament parameters, we will enhance our understanding of this nascent modality of treatment delivery.

  19. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971; Formerly Docket FDA-2008-N-0041; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... the draft guidance for industry entitled ``Acute Otitis Media--Developing Antimicrobial Drugs...

  20. 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 i

  1. Situations and Countermeasures on Veterinary drug residues and Detection to Animal Material Food of Entry-Exit Trade

    Institute of Scientific and Technical Information of China (English)

    Hua; YU; Yanbin; QI; Yubao; YAN; Jianqiang; YE; Hua; WU; Diqin; CHEN; Yang; FEI

    2013-01-01

    With the people’s lives improving,the demands of livestock products on the import and export aspects were growing. Veterinary drug residues as the important factor which might influence animal products safety has become a major concern. In this paper,the status quo and inspection of the veterinary drug residue and the corresponding control measures were put forward.

  2. Drug: D06799 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available icine in Japan [BR:br08304] Crude Drugs Drugs for Qi Sedative drugs D06799 Longgu; Fossilized mammal bones Crude drugs [BR:br08305] Animals Mammals D06799 Longgu PubChem: 47208450 ...

  3. Drug: D06750 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available cine in Japan [BR:br08304] Crude Drugs Drugs for external use Drugs for external use D06750 Toad venom Crude drugs [BR:br08305] Animals Amphibians D06750 Toad venom PubChem: 47208401 ...

  4. New insights into the use of currently available non-steroidal anti-inflammatory drugs

    Directory of Open Access Journals (Sweden)

    Brune K

    2015-02-01

    Full Text Available Kay Brune,1 Paola Patrignani2 1Department of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; 2Department of Neuroscience, Imaging and Clinical Sciences, Center of Excellence on Aging, G d’Annunzio University, Chieti, Italy Abstract: Non-steroidal anti-inflammatory drugs (NSAIDs, which act via inhibition of the cyclooxygenase (COX isozymes, were discovered more than 100 years ago. They remain a key component of the pharmacological management of acute and chronic pain. The COX-1 and COX-2 isozymes have different biological functions; analgesic activity is primarily (although not exclusively associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2. All available NSAIDs, including acetaminophen and aspirin, are associated with potential side effects, particularly gastrointestinal and cardiovascular effects, related to their relative selectivity for COX-1 and COX-2. Since all NSAIDs exert their therapeutic activity through inhibition of the COX isozymes, strategies are needed to reduce the risks associated with NSAIDs while achieving sufficient pain relief. A better understanding of the inhibitory activity and COX-1/COX-2 selectivity of an NSAID at therapeutic doses, based on pharmacokinetic and pharmacodynamic properties (eg, inhibitory dose, absorption, plasma versus tissue distribution, and elimination, and the impact on drug tolerability and safety can guide the selection of appropriate NSAIDs for pain management. For example, many NSAIDs with moderate to high selectivity for COX-2 versus COX-1 can be administered at doses that maximize efficacy (~80% inhibition of COX-2 while minimizing COX-1 inhibition and associated side effects, such as gastrointestinal toxicity. Acidic NSAIDs with favorable tissue distribution and short plasma half-lives can additionally be dosed to provide near-constant analgesia while

  5. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... affecting drug and biologics approvals, drug supply chain, and other topics related to human pharmaceuticals... http://www.regulations.gov . Submit written comments to the Division of Dockets Management (HFA-305... http://www.regulations.gov or written comments to the Division of Dockets Management (see...

  6. Cost analysis of different brands of antianginal drugs available in India

    Directory of Open Access Journals (Sweden)

    L. Akila

    2015-10-01

    Conclusions: To increase the benefit to the patient and reduce drug in compliance, doctors should be trained to be familiar from internship period itself about the brand names of cost-effective drugs with good safety profile for a long period. [Int J Basic Clin Pharmacol 2015; 4(5.000: 860-863

  7. 78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin...

    Science.gov (United States)

    2013-03-25

    ... Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide AGENCY: Food and Drug Administration, HHS....

  8. International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice.

    Science.gov (United States)

    2003-11-14

    The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3B(R) Impurities in New Drug Products.'' The revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug products produced by chemically synthesized new drug substances not previously registered in a country, region, or member State. The revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance complements the ICH guidance entitled "Q3A(R) Impurities in New Drug Substances.''

  9. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Skip to common links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration ... Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet ...

  10. Unanticipated Effects of New Drug Availability on Antiretroviral Durability: Implications for Comparative Effectiveness Research.

    Science.gov (United States)

    Eaton, Ellen F; Tamhane, Ashutosh R; Burkholder, Greer A; Willig, James H; Saag, Michael S; Mugavero, Michael J

    2016-04-01

    Background.  Durability of antiretroviral (ARV) therapy is associated with improved human immunodeficiency virus (HIV) outcomes. Data on ARV regimen durability in recent years and clinical settings are lacking. Methods.  This retrospective follow-up study included treatment-naive HIV-infected patients initiating ARV therapy between January 2007 and December 2012 in a university-affiliated HIV clinic in the Southeastern United States. Outcome of interest was durability (time to discontinuation) of the initial regimen. Durability was evaluated using Kaplan-Meier survival analyses. Cox proportional hazard analyses was used to evaluate the association among durability and sociodemographic, clinical, and regimen-level factors. Results.  Overall, 546 patients were analyzed. Median durability of all regimens was 39.5 months (95% confidence interval, 34.1-44.4). Commonly prescribed regimens were emtricitabine and tenofovir with efavirenz (51%; median duration = 40.1 months) and with raltegravir (14%; 47.8 months). Overall, 67% of patients had an undetectable viral load at the time of regimen cessation. Discontinuation was less likely with an integrase strand transfer inhibitor (adjusted hazards ratio [aHR] = 0.35, P = .001) or protease inhibitor-based regimen (aHR = 0.45, P = .006) and more likely with a higher pill burden (aHR = 2.25, P = .003) and a later treatment era (aHR = 1.64, P new drug availability and provider preference. Medication durability must be interpreted carefully in the context of a dynamic treatment landscape.

  11. Study of variation in price of various antidiabetic drugs available in Indian market

    Directory of Open Access Journals (Sweden)

    Amit Padmakar Date

    2015-02-01

    Conclusion: The average percentage price variation of different brands of the same oral antidiabetic drug manufactured in India is very wide. The appropriate changes in the government policy, sensitizing the prescribers about cost of therapy and proper management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative economic consequences. [Int J Basic Clin Pharmacol 2015; 4(1.000: 36-40

  12. ucb L059, a novel anti-convulsant drug: pharmacological profile in animals.

    Science.gov (United States)

    Gower, A J; Noyer, M; Verloes, R; Gobert, J; Wülfert, E

    1992-11-10

    The anticonvulsant activity of ucb L059 ((S)-alpha-ethyl-2-oxo-pyrrolidine acetamide) was evaluated in a range of animal models. ucb L059 was active after oral and intraperitoneal administration in both rats and mice, with a unique profile of action incorporating features in common with several different types of antiepileptic drugs. The compound was active, with ED50 values generally within the range of 5.0-30.0 mg/kg, in inhibiting audiogenic seizures, electrically induced convulsions and convulsions induced chemically by pentylenetetrazole (PTZ), bicuculline, picrotoxin and N-methyl-D-aspartate (NMDA). ucb L059 retarded the development of PTZ-induced kindling in mice and reduced PTZ-induced EEG spike wave discharge in rats. The R enantiomer, ucb L060, had low intrinsic anticonvulsant activity, showing the stereospecificity of action of the molecule although the actual mechanism of action remains unknown. Neurotoxicity, evaluated with an Irwin-type observation test, the rotarod test and open-field exploration, was minimal, with only mild sedation being observed, even at doses 50-100 times higher than the anticonvulsant doses; at pharmacologically active doses, the animals appeared calm but slightly more active. ucb L059 thus presents as an orally active, safe, broad-spectrum anticonvulsant agent, with potential antiepileptogenic and anti-absence actions.

  13. Annular phased array transducer for preclinical testing of anti-cancer drug efficacy on small animals.

    Science.gov (United States)

    Kujawska, Tamara; Secomski, Wojciech; Byra, Michał; Postema, Michiel; Nowicki, Andrzej

    2017-04-01

    A technique using pulsed High Intensity Focused Ultrasound (HIFU) to destroy deep-seated solid tumors is a promising noninvasive therapeutic approach. A main purpose of this study was to design and test a HIFU transducer suitable for preclinical studies of efficacy of tested, anti-cancer drugs, activated by HIFU beams, in the treatment of a variety of solid tumors implanted to various organs of small animals at the depth of the order of 1-2cm under the skin. To allow focusing of the beam, generated by such transducer, within treated tissue at different depths, a spherical, 2-MHz, 29-mm diameter annular phased array transducer was designed and built. To prove its potential for preclinical studies on small animals, multiple thermal lesions were induced in a pork loin ex vivo by heating beams of the same: 6W, or 12W, or 18W acoustic power and 25mm, 30mm, and 35mm focal lengths. Time delay for each annulus was controlled electronically to provide beam focusing within tissue at the depths of 10mm, 15mm, and 20mm. The exposure time required to induce local necrosis was determined at different depths using thermocouples. Location and extent of thermal lesions determined from numerical simulations were compared with those measured using ultrasound and magnetic resonance imaging techniques and verified by a digital caliper after cutting the tested tissue samples. Quantitative analysis of the results showed that the location and extent of necrotic lesions on the magnetic resonance images are consistent with those predicted numerically and measured by caliper. The edges of lesions were clearly outlined although on ultrasound images they were fuzzy. This allows to conclude that the use of the transducer designed offers an effective noninvasive tool not only to induce local necrotic lesions within treated tissue without damaging the surrounding tissue structures but also to test various chemotherapeutics activated by the HIFU beams in preclinical studies on small animals.

  14. Advances in small animal mesentery models for in vivo flow cytometry, dynamic microscopy, and drug screening

    Institute of Scientific and Technical Information of China (English)

    Ekaterina I Galanzha; Vladimir P Zharov; Philips Classic

    2007-01-01

    Using animal mesentery with intravital optical microscopy is a well-established experimental model for studying blood and lymph microcirculation in vivo.Recent advances in cell biology and optical techniques provide the basis for extending this model for new applications, which should generate significantly improved experimental data. This review summarizes the achievements in this specific area, including in vivo label-free blood and lymph photothermal flow cytometry,super-sensitive fluorescence image cytometry, light scattering and speckle flow cytometry, microvessel dynamic microscopy, infrared (IR) angiography, and high-speed imaging of individual cells in fast flow. The capabilities of these techniques, using the rat mesentery model, were demonstrated in various studies; e.g., realtime quantitative detection of circulating and migrating individual blood and cancer cells, studies on vascular dynamics with a focus on lymphatics under normal conditions and under different interventions (e.g. lasers,drugs, nicotine), assessment of lymphatic disturbances from experimental lymphedema, monitoring cell traffic between blood and lymph systems, and highspeed imaging of cell transient deformability in flow.In particular, the obtained results demonstrated that individual cell transportation in living organisms depends on cell type (e.g., normal blood or leukemic cells), the cell's functional state (e.g., live, apoptotic, or necrotic),and the functional status of the organism. Possible future applications, including in vivo early diagnosis and prevention of disease, monitoring immune response and apoptosis, chemo- and radio-sensitivity tests, and drug screening, are also discussed.

  15. Engineering Macaca fascicularis cytochrome P450 2C20 to reduce animal testing for new drugs.

    Science.gov (United States)

    Rua, Francesco; Sadeghi, Sheila J; Castrignanò, Silvia; Di Nardo, Giovanna; Gilardi, Gianfranco

    2012-12-01

    In order to develop in vitro methods as an alternative to P450 animal testing in the drug discovery process, two main requisites are necessary: 1) gathering of data on animal homologues of the human P450 enzymes, currently very limited, and 2) bypassing the requirement for both the P450 reductase and the expensive cofactor NADPH. In this work, P450 2C20 from Macaca fascicularis, homologue of the human P450 2C8 has been taken as a model system to develop such an alternative in vitro method by two different approaches. In the first approach called "molecular Lego", a soluble self-sufficient chimera was generated by fusing the P450 2C20 domain with the reductase domain of cytochrome P450 BM3 from Bacillus megaterium (P450 2C20/BMR). In the second approach, the need for the redox partner and also NADPH were both obviated by the direct immobilization of the P450 2C20 on glassy carbon and gold electrodes. Both systems were then compared to those obtained from the reconstituted P450 2C20 monooxygenase in presence of the human P450 reductase and NADPH using paclitaxel and amodiaquine, two typical drug substrates of the human P450 2C8. The K(M) values calculated for the 2C20 and 2C20/BMR in solution and for 2C20 immobilized on electrodes modified with gold nanoparticles were 1.9 ± 0.2, 5.9 ± 2.3, 3.0 ± 0.5 μM for paclitaxel and 1.2 ± 0.2, 1.6±0.2 and 1.4 ± 0.2 μM for amodiaquine, respectively. The data obtained not only show that the engineering of M. fascicularis did not affect its catalytic properties but also are consistent with K(M) values measured for the microsomal human P450 2C8 and therefore show the feasibility of developing alternative in vitro animal tests.

  16. Predicting adverse drug reactions using publicly available PubChem BioAssay data.

    Science.gov (United States)

    Pouliot, Y; Chiang, A P; Butte, A J

    2011-07-01

    Adverse drug reactions (ADRs) can have severe consequences, and therefore the ability to predict ADRs prior to market introduction of a drug is desirable. Computational approaches applied to preclinical data could be one way to inform drug labeling and marketing with respect to potential ADRs. Based on the premise that some of the molecular actors of ADRs involve interactions that are detectable in large, and increasingly public, compound screening campaigns, we generated logistic regression models that correlate postmarketing ADRs with screening data from the PubChem BioAssay database. These models analyze ADRs at the level of organ systems, using the system organ classes (SOCs). Of the 19 SOCs under consideration, nine were found to be significantly correlated with preclinical screening data. With regard to six of the eight established drugs for which we could retropredict SOC-specific ADRs, prior knowledge was found that supports these predictions. We conclude this paper by predicting that SOC-specific ADRs will be associated with three unapproved or recently introduced drugs.

  17. Zoonotic trypanosomes in South East Asia: Attempts to control Trypanosoma lewisi using human and animal trypanocidal drugs.

    Science.gov (United States)

    Desquesnes, Marc; Yangtara, Sarawut; Kunphukhieo, Pawinee; Jittapalapong, Sathaporn; Herder, Stéphane

    2016-10-01

    Beside typical human trypanosomes responsible of sleeping sickness in Africa and Chagas disease in Latin America, there is a growing number of reported atypical human infections due to Trypanosoma evansi, a livestock parasite, or Trypanosoma lewisi, a rat parasite, especially in Asia. Drugs available for the treatment of T. brucei ssp. in humans are obviously of choice for the control of T. evansi because it is derived from T. brucei. However, concerning T. lewisi, there is an urgent need to determine the efficacy of trypanocidal drugs for the treatment in humans. In a recent study, pentamidine and fexinidazole were shown to have the best efficacy against one stock of T. lewisi in rats. In the present study suramin, pentamidine, eflornitine, nifurtimox, benznidazole and fexinidazole, were evaluated at low and high doses, in single day administration to normal rats experimentally infected with a stock of T. lewisi recently isolated in Thailand. Because none of these treatments was efficient, a trial was made with the most promising trypanocide identified in a previous study, fexinidazole 100mg/kg, in 5 daily administrations. Results observed were unclear. To confirm the efficacy of fexinidazole, a mixed infection protocol was set up in cyclophosphamide immunosuppressed rats. Animals were infected successively by T. lewisi and T. evansi, and received 10 daily PO administrations of 200mg/kg fexinidazole. Drastic effects were observed against T. evansi which was cleared from the rat's blood within 24 to 48h; however, the treatment did not affect T. lewisi which remained in high number in the blood until the end of the experiment. This mixed infection/treatment protocol clearly demonstrated the efficacy of fexinidazole against T. evansi and its inefficacy against T. lewisi. Since animal trypanocides were also recently shown to be inefficient, other protocols as well as other T. lewisi stocks should be investigated in further studies.

  18. Searching the Internet for drug-related web sites: analysis of online available information on ecstasy (MDMA).

    Science.gov (United States)

    Deluca, Paolo; Schifano, Fabrizio

    2007-01-01

    Although the Internet is a growing source of information on MDMA/ecstasy, no studies so far have investigated the level and quality of ecstasy information available to the typical Web user. In the present study, 280 Web sites were identified and analyzed; 50.4% had an anti-drug approach, 16.2% a harm reduction approach, and 24.8% a pro-drug approach. MDMA pro-drug Web sites appeared significantly earlier in the search engines' results list than both anti-drug and harm reduction Web sites (F (3; 159) = 3.288; p = .022). This study represents the first systematic analysis of information available online on ecstasy. Implications for further research are discussed.

  19. 21 CFR 510.106 - Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Labeling of antibiotic and antibiotic-containing... ANIMAL DRUGS Specific Administrative Rulings and Decisions § 510.106 Labeling of antibiotic and antibiotic-containing drugs intended for use in milk-producing animals. Whenever the labeling of...

  20. INVESTIGATION ON EFFECT OF DRUG DOSING REGIMENTS ON DRUG DELIVERY IN SOLID TUMOR VIA LUMPED PARAMETER MODELING AND ANIMAL EXPERIMENTS

    Institute of Scientific and Technical Information of China (English)

    GAO Ci-xiu; XU Shi-xiong; JIANG Yu-ping; TU Jiang-long

    2009-01-01

    This work aims to investigate the effects of dosing regiments on drug delivery in solid tumors and to validate them with experiments on rats.The lumped parameter models of pharmacokinetics and of drug delivery in tumor were developed to simulate time courses of average drug concentration(Ct)of tumor interstitium in two types of dosing regiments(i.e.,single-shot and triple-shot ones).The two regiments were performed via antitumor drug,hydroxycamptothecin(HCPT),on rats,to measure the drug concentration in the tumor.The simulations of the drug concentration in the tumor of the two dosing regiments were conducted and compared with the experimental data on rats.The coefficients in the models were investigated.It is concluded that the triple-shot method is more effective than that of single-shot injection.The present lumped-parameter model is quantitatively competent for drug delivery in solid tumor.

  1. International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.

    Science.gov (United States)

    1998-09-24

    The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin, and outlines data that should be submitted in marketing applications.

  2. New insights into the use of currently available non-steroidal anti-inflammatory drugs

    OpenAIRE

    Brune K; Patrignani P

    2015-01-01

    Kay Brune,1 Paola Patrignani2 1Department of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; 2Department of Neuroscience, Imaging and Clinical Sciences, Center of Excellence on Aging, G d’Annunzio University, Chieti, Italy Abstract: Non-steroidal anti-inflammatory drugs (NSAIDs), which act via inhibition of the cyclooxygenase (COX) isozymes, were discovered more than 100 years ago. They remain a key compon...

  3. Incidence of Exposure of Patients in the United States to Multiple Drugs for Which Pharmacogenomic Guidelines Are Available

    Science.gov (United States)

    Xu, Hong; Blagec, Kathrin; Empey, Philip E.; Malone, Daniel C.; Ahmed, Seid Mussa; Ryan, Patrick; Hofer, Sebastian; Boyce, Richard D.

    2016-01-01

    Pre-emptive pharmacogenomic (PGx) testing of a panel of genes may be easier to implement and more cost-effective than reactive pharmacogenomic testing if a sufficient number of medications are covered by a single test and future medication exposure can be anticipated. We analysed the incidence of exposure of individual patients in the United States to multiple drugs for which pharmacogenomic guidelines are available (PGx drugs) within a selected four-year period (2009–2012) in order to identify and quantify the incidence of pharmacotherapy in a nation-wide patient population that could be impacted by pre-emptive PGx testing based on currently available clinical guidelines. In total, 73 024 095 patient records from private insurance, Medicare Supplemental and Medicaid were included. Patients enrolled in Medicare Supplemental age > = 65 or Medicaid age 40–64 had the highest incidence of PGx drug use, with approximately half of the patients receiving at least one PGx drug during the 4 year period and one fourth to one third of patients receiving two or more PGx drugs. These data suggest that exposure to multiple PGx drugs is common and that it may be beneficial to implement wide-scale pre-emptive genomic testing. Future work should therefore concentrate on investigating the cost-effectiveness of multiplexed pre-emptive testing strategies. PMID:27764192

  4. The virtue of translational PKPD modeling in drug discovery: selecting the right clinical candidate while sparing animal lives.

    Science.gov (United States)

    Bueters, Tjerk; Ploeger, Bart A; Visser, Sandra A G

    2013-09-01

    Translational pharmacokinetic-pharmacodynamic (PKPD) modeling has been fully implemented at AstraZeneca's drug discovery unit for central nervous system and pain indications to facilitate timely progression of the right compound to clinical studies, simultaneously assuring essential preclinical efficacy and safety knowledge. This review illustrates the impact of a translational PKPD paradigm with examples from drug discovery programs. Paradoxically, laboratory animal use decreased owing to better understanding of in vitro-in vivo relationships, optimized in vivo study designs, meta-analyses and hypothesis testing using simulations. From an ethical and effectivity perspective, we advocate that translational PKPD approaches should be implemented more broadly in drug discovery.

  5. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.

    Science.gov (United States)

    2003-02-11

    The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3A(R) Impurities in New Drug Substances." The revised guidance, which updates a guidance on the same topic published in the Federal Register of January 4, 1996 (the 1996 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance clarifies the 1996 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a country, region, or member State.

  6. International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice.

    Science.gov (United States)

    2001-11-07

    The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.

  7. Effect of Antimicrobial Use in Agricultural Animals on Drug-resistant Foodborne Campylobacteriosis in Humans: A Systematic Literature Review.

    Science.gov (United States)

    McCrackin, M A; Helke, Kristi L; Galloway, Ashley M; Poole, Ann Z; Salgado, Cassandra D; Marriott, Bernadette P

    2016-10-02

    Controversy continues concerning antimicrobial use in food animals and its relationship to drug-resistant infections in humans. We systematically reviewed published literature for evidence of a relationship between antimicrobial use in agricultural animals and drug-resistant foodborne campylobacteriosis in humans. Based on publications from the United States (U.S.), Canada and Denmark from 2010 to July 2014, 195 articles were retained for abstract review, 50 met study criteria for full article review with 36 retained for which data are presented. Two publications reported increase in macrolide resistance of Campylobacter coli isolated from feces of swine receiving macrolides in feed, and one of these described similar findings for tetracyclines and fluoroquinolones. A study in growing turkeys demonstrated increased macrolide resistance associated with therapeutic dosing with Tylan® in drinking water. One publication linked tetracycline-resistant C. jejuni clone SA in raw cow's milk to a foodborne outbreak in humans. No studies that identified farm antimicrobial use also traced antimicrobial-resistant Campylobacter from farm to fork. Recent literature confirms that on farm antibiotic selection pressure can increase colonization of animals with drug-resistant Campylobacter spp. but is inadequately detailed to establish a causal relationship between use of antimicrobials in agricultural animals and prevalence of drug-resistant foodborne campylobacteriosis in humans.

  8. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ... new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The supplemental NADA provides... 6JP, Northern Ireland, filed a supplement to NADA 065-010 for use of NOROCILLIN (penicillin G procaine... supplemental NADA is approved as of April 23, 2010. In accordance with the freedom of information provisions...

  9. Distribution of animal drugs between skim milk and milk fat fractions in spiked whole milk: Understanding the potential impact on commercial milk products

    Science.gov (United States)

    Seven animal drugs [penicillin G (PENG), sulfadimethoxine (SDMX), oxytetracycline (OTET), erythromycin (ERY), ketoprofen (KETO), thiabendazole (THIA) and ivermectin (IVR)] were used to evaluate drug distribution between milk fat and skim milk fractions of cow milk. Greater than 90% of radioactivity...

  10. In vivo animal demonstration of the effect of vasoactive drugs using /sup 195m/Au and gamma camera techniques

    Energy Technology Data Exchange (ETDEWEB)

    Bourgeois, P.; Bourgeois, F.; Lupo, P.; Vooren, J.P. van; Clercx, C.

    1987-08-01

    /sup 195m/Au, an ultrashort lived (physical half life = 30.5 s), generator produced, radionuclide, has been used in an animal model to study, by gamma camera techniques, the peripheral effects of the vasoactive drugs norepinephrine and sodium nitroprusside systemically administered or epinephrine intraarterially injected, at various concentrations. According to the results obtained by the analysis of time on the proximal and distal parts of the limbs, the well known hemodynamic changes induced by these drugs, vascoconstriction (resulting in a decrease of the distal acitvity recorded), or vasodilatation (shortening the time of radioactivity appearance), could be observed. It is concluded that gamma camera techniques using the ultrashort lived radionuclide /sup 195m/Au allow the in vivo study of the effects of vasoactive drugs in an animal model and potentially in clinical situations.

  11. 77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin...

    Science.gov (United States)

    2012-08-06

    ... applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA... Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285....

  12. Changes in patterns of drug injection concurrent with a sustained reduction in the availability of heroin in Australia.

    Science.gov (United States)

    Topp, Libby; Day, Carolyn; Degenhardt, Louisa

    2003-06-05

    Between 1996 and 2000, heroin was the drug most frequently injected in Australia, and viable heroin markets existed in six of Australia's eight jurisdictions. In 2001, there was a dramatic and sustained reduction in the availability of heroin that was accompanied by a substantial increase in its price, and a 14% decline in the average purity of seizures analysed by forensic laboratories. The shortage of heroin constitutes a unique natural experiment within which to examine the impact of supply reduction. This paper reviews one important correlate of the shortage, namely changes in patterns of illicit drug injection. A number of studies have consistently suggested that between 2000 and 2001, there was a sizeable decrease in both prevalence and frequency of heroin injection among injecting drug users. These changes were accompanied by increased prevalence and frequency of stimulant injection. Cocaine was favoured in NSW, the sole jurisdiction in which a cocaine market was established prior to the heroin shortage; whereas methamphetamine predominated in other jurisdictions. Some data suggest that, at least in the short-term, some drug injectors left the market altogether subsequent to the reduced heroin availability. However, the findings that (1) some former heroin users switched their drug preference to a stimulant; and (2) subsequently attributed this change to the reduced availability of heroin, suggests that reducing the supply of one drug may serve to increase the use of others. Given the differential harms associated with the use of stimulants and opiates, this possibility has grave implications for Australia, where the intervention and treatment system is designed primarily to accommodate opiate use and dependence.

  13. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ...; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Notice.../ANADA No. Trade name (drug) Applicant 100-556 Vigorena Feeds Hy-Ty Springfield Milling Premix...

  14. Sex differences in exercise and drug addiction: A mini review of animal studies

    OpenAIRE

    Yuehui Zhou; Chenglin Zhou; Rena Li

    2014-01-01

    Growing literature has demonstrated that exercise may be an effective prevention and treatment option for drug addiction. In the past few years, many studies have suggested that there were sex differences in all phases of drug addiction. However, very limited research has investigated sex differences in the effectiveness of exercise intervention in drug addiction and rehabilitation. In this mini review, we summarize the effect of sex on the results of using exercise to prevent and treat drug ...

  15. 75 FR 54018 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Science.gov (United States)

    2010-09-03

    ... Drugs; Florfenicol and Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY... containing florfenicol and flunixin meglumine is an approved treatment. DATES: This rule is effective... flunixin meglumine), a combination drug injectable solution. The supplement adds M. bovis to the...

  16. Cannabidiol, among Other Cannabinoid Drugs, Modulates Prepulse Inhibition of Startle in the SHR Animal Model: Implications for Schizophrenia Pharmacotherapy

    Science.gov (United States)

    Peres, Fernanda F.; Levin, Raquel; Almeida, Valéria; Zuardi, Antonio W.; Hallak, Jaime E.; Crippa, José A.; Abilio, Vanessa C.

    2016-01-01

    Schizophrenia is a severe psychiatric disorder that involves positive, negative and cognitive symptoms. Prepulse inhibition of startle reflex (PPI) is a paradigm that assesses the sensorimotor gating functioning and is impaired in schizophrenia patients as well as in animal models of this disorder. Recent data point to the participation of the endocannabinoid system in the pathophysiology and pharmacotherapy of schizophrenia. Here, we focus on the effects of cannabinoid drugs on the PPI deficit of animal models of schizophrenia, with greater focus on the SHR (Spontaneously Hypertensive Rats) strain, and on the future prospects resulting from these findings. PMID:27667973

  17. RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE, ROSIGLITAZONE AND SITAGLIPTIN – APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS

    Directory of Open Access Journals (Sweden)

    Hitesh P Inamdar et al

    2012-09-01

    Full Text Available A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-diabetic drugs Metformin hydrochloride (MT, Rosiglitazone (RT and Sitagliptin (ST. The separation was achieved on ACE 3 150 mm X 4.6mm, 3.5µm column using gradient method. The mobile phase at a flow rate of 1.5 mL min−1 consisted of 10 mM sodium hexane sulphonate monohydrate and 10 mM Potassium dihydrogen phosphate buffer with acetonitrile and methanol in Gradient ratio. The UV detection was carried out at 210 nm. The forced degradation for these drug substances were performed under Acid, Base, Oxidative, Photolytic and Thermal stress conditions. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

  18. Overview of the animal health drug development and registration process: an industry perspective.

    Science.gov (United States)

    Hunter, Robert P; Shryock, Thomas R; Cox, Brian R; Butler, Roger M; Hammelman, Jason E

    2011-05-01

    Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.

  19. Robustness testing in the determination of seven drugs in animal muscle by liquid chromatography–tandem mass spectrometry

    OpenAIRE

    Oca Casado, Mª Leticia; Rubio Martínez, Laura; Ortiz Fernández, Mª Cruz; Sarabia Peinador, Luis Antonio; García, I.

    2016-01-01

    In this work, the robustness of the sample preparation procedure for the determination of six tranquilizers (xylazine, azaperone, propionylpromazine, chlorpromazine, haloperidol, and azaperol) and a beta-blocker (carazolol) in animal muscle by LC/MS–MS was assessed through the experimental design methodology. A 2III7 − 4 fractional factorial design was performed to evaluate the influence of seven variables on the final concentration of the seven drugs in the samples, in accordance with what i...

  20. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products ...

  1. 77 FR 55413 - New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin

    Science.gov (United States)

    2012-09-10

    ... Gonadotropin; Naloxone; Oxymorphone; Oxytocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.... Painters Dr., Chadds Ford, PA 19317. 046-822 VETOCIN (oxytocin) United Vaccines, A Harlan...

  2. Impact of Animated Spokes-Characters in Print Direct-to-Consumer Prescription Drug Advertising: An Elaboration Likelihood Model Approach.

    Science.gov (United States)

    Bhutada, Nilesh S; Rollins, Brent L; Perri, Matthew

    2017-04-01

    A randomized, posttest-only online survey study of adult U.S. consumers determined the advertising effectiveness (attitude toward ad, brand, company, spokes-characters, attention paid to the ad, drug inquiry intention, and perceived product risk) of animated spokes-characters in print direct-to-consumer (DTC) advertising of prescription drugs and the moderating effects of consumers' involvement. Consumers' responses (n = 490) were recorded for animated versus nonanimated (human) spokes-characters in a fictitious DTC ad. Guided by the elaboration likelihood model, data were analyzed using a 2 (spokes-character type: animated/human) × 2 (involvement: high/low) factorial multivariate analysis of covariance (MANCOVA). The MANCOVA indicated significant main effects of spokes-character type and involvement on the dependent variables after controlling for covariate effects. Of the several ad effectiveness variables, consumers only differed on their attitude toward the spokes-characters between the two spokes-character types (specifically, more favorable attitudes toward the human spokes-character). Apart from perceived product risk, high-involvement consumers reacted more favorably to the remaining ad effectiveness variables compared to the low-involvement consumers, and exhibited significantly stronger drug inquiry intentions during their next doctor visit. Further, the moderating effect of consumers' involvement was not observed (nonsignificant interaction effect between spokes-character type and involvement).

  3. The botanical origin of kratom (Mitragyna speciosa; Rubiaceae) available as abused drugs in the Japanese markets.

    Science.gov (United States)

    Maruyama, Takuro; Kawamura, Maiko; Kikura-Hanajiri, Ruri; Takayama, Hiromitsu; Goda, Yukihiro

    2009-07-01

    Kratom is the leaves of Mitragyna speciosa (Rubiaceae). Recently, kratom has been sold in street shops or on the Internet in Japan for the purpose of abuse due to its opium-like effects. In this study, we investigated the botanical origin of the commercial kratom products using the internal transcribed spacer (ITS) sequence analysis of rDNA in preparation for future regulation of this product. In addition, a previously reported method to authenticate the plant, utilizing polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) was applied to the same products in order to estimate the method's accuracy and utility. The ITS sequence analysis of the commercial kratoms revealed that most of them were derived from M. speciosa or closely related plants, while the others were made from the same tribe plant as M. speciosa. The reported PCR-RFLP method could clearly distinguish kratoms from the other psychoactive plants available in the Japanese markets and also from related plants. The authentication method is considered to be useful for the practical regulation of the plant due to its wide range of application, high accuracy and simplicity.

  4. Animal products, diseases and drugs: a plea for better integration between agricultural sciences, human nutrition and human pharmacology

    Directory of Open Access Journals (Sweden)

    Haug Anna

    2011-01-01

    Full Text Available Abstract Eicosanoids are major players in the pathogenesis of several common diseases, with either overproduction or imbalance (e.g. between thromboxanes and prostacyclins often leading to worsening of disease symptoms. Both the total rate of eicosanoid production and the balance between eicosanoids with opposite effects are strongly dependent on dietary factors, such as the daily intakes of various eicosanoid precursor fatty acids, and also on the intakes of several antioxidant nutrients including selenium and sulphur amino acids. Even though the underlying biochemical mechanisms have been thoroughly studied for more than 30 years, neither the agricultural sector nor medical practitioners have shown much interest in making practical use of the abundant high-quality research data now available. In this article, we discuss some specific examples of the interactions between diet and drugs in the pathogenesis and therapy of various common diseases. We also discuss, using common pain conditions and cancer as specific examples, how a better integration between agricultural science, nutrition and pharmacology could lead to improved treatment for important diseases (with improved overall therapeutic effect at the same time as negative side effects and therapy costs can be strongly reduced. It is shown how an unnaturally high omega-6/omega-3 fatty acid concentration ratio in meat, offal and eggs (because the omega-6/omega-3 ratio of the animal diet is unnaturally high directly leads to exacerbation of pain conditions, cardiovascular disease and probably most cancers. It should be technologically easy and fairly inexpensive to produce poultry and pork meat with much more long-chain omega-3 fatty acids and less arachidonic acid than now, at the same time as they could also have a similar selenium concentration as is common in marine fish. The health economic benefits of such products for society as a whole must be expected vastly to outweigh the direct

  5. 78 FR 57057 - Oral Dosage Form New Animal Drugs; Amprolium; Meloxicam

    Science.gov (United States)

    2013-09-17

    ...; Meloxicam AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug........... Ceva Sante MELOXIDYL Original approval 520.1350 Yes....... CE \\1\\. Animale, 10 (meloxicam) Oral as a....1367 Meloxicam. (a) Specifications--(1) Each milliliter of suspension contains 0.5 milligrams...

  6. Recurrence of adverse drug reactions following inappropriate re-prescription: better documentation, availability of information and monitoring are needed.

    Science.gov (United States)

    van der Linden, Carolien M J; Jansen, Paul A F; van Marum, Rob J; Grouls, René J E; Korsten, Erik H M; Egberts, Antoine C G

    2010-07-01

    Adverse drug reactions (ADRs) are a common, and often preventable, cause of hospital admission, especially in the elderly, and can occur during hospitalization. In this current opinion article, we present three cases of recurrence of a serious ADR due to re-prescription of a withdrawn medication that highlight the need for a system to prevent the undesirable re-prescription of medications withdrawn because of an ADR. In addition, we describe an electronic system that could help prevent undesirable re-prescription following an ADR. Such a system should document ADRs systematically at the patient level, make this information available to relevant healthcare providers and the patient, and flag re-prescription of the offending drug. The effectiveness and cost effectiveness of such a system would need to be determined.

  7. The effect of physico-chemical properties of the drug on the pharmaceutical availability of piroxicam from pellets.

    Science.gov (United States)

    Pieszczek, Barbara; Jachowicz, Renata

    2010-06-01

    The aim of this study was to develop the formulation of pellets with solid dispersions of piroxicam, and determine the effect of physico-chemical properties of the drug on pharmaceutical availability from solid dispersions and pellets. Two types of piroxicam, varying in crystal size, were used in this study. Presence of the amorphous form in solid dispersions depended on the method of their formulation, and type of piroxicam used. Based on the results of piroxicam release rate from pellets, it was established that the extrusion and spheronization process caused change in the drug release profile in comparison to powder systems, because during the pelletization process, the amorphous form of the piroxicam present in the solid dispersion recrystallizes, and a low-solubility type forms. Better results were obtained using the method, where microcrystalline cellulose cores were coated with solid dispersion.

  8. Animal model of undernutrition for the evaluation of drug pharmacokinetics Modelo de desnutrición animal para la evaluación de estudios de farmacocinética

    OpenAIRE

    M. Merino-Sanjuán; A. Catalán-Latorre; A. Nácher; S. Miralles-Arnau; N. V. Jiménez-Torres

    2011-01-01

    Background: Protein energy malnutrition is a public health problem affecting a great number of people. Pathophysiological imbalances in malnourished individuals have a profound impact on drug pharmacokinetics. Objective: To develop an animal model of undernutrition using male Wistar rats to be used to assess, in further studies, the impact of nutritional status on the oral bioavailability and pharmacokinetics of drugs. Desing: Animals were randomly assigned to one of two groups and fed differ...

  9. 78 FR 52536 - Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin...

    Science.gov (United States)

    2013-08-23

    ...; Diethylcarbamazine; Nicarbazin; Penicillin; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice... withdraw approval of NADA 098-371 for use of nicarbazin, penicillin, and roxarsone in 3-way,...

  10. 77 FR 72356 - Animal Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ..., Center for Veterinary Medicine (HFV- 10), Food and Drug Administration, 7519 Standish Pl., Rockville, MD... 2014 Base Revenue \\1\\ 21,600,000 One-Time Information Technology (IT) Funding 2,000,000 Total...

  11. 75 FR 16346 - Ophthalmic and Topical Dosage Form New Animal Drugs; Orbifloxacin, Mometasone Furoate Monohydrate...

    Science.gov (United States)

    2010-04-01

    ... bacteria (coagulase-positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis). The NADA is... aeruginosa, and Enterococcus faecalis). (3) Limitations. Federal law restricts this drug to use by or on...

  12. 75 FR 55810 - Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol, Lincomycin, Pyrantel...

    Science.gov (United States)

    2010-09-14

    ...; Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate and Sulfamethazine AGENCY: Food and Drug..., NE 68127 Feed Service Co., NADA 138-342 TYLAN 5 Sec. 558.630 Inc., 303 Lundin Sulfa-G Premix...

  13. 75 FR 4692 - Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone...

    Science.gov (United States)

    2010-01-29

    ... strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). The NADA is... (Staphylococcus pseudintermedius). (3) Limitations. Federal law restricts this drug to use by or on the order of...

  14. 78 FR 73697 - New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of...

    Science.gov (United States)

    2013-12-09

    ...; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor AGENCY: Food and Drug... interest in, NADA 141-255 for PEROX-AID (hydrogen peroxide) 35% Solution to Western Chemical, Inc.,...

  15. What is animal experimentation telling us about new drug treatments of status epilepticus?

    Science.gov (United States)

    Nehlig, Astrid

    2007-01-01

    Basic research is mostly focused on the consequences of status epilepticus (SE) in terms of neuronal loss, behavior, epileptogenesis or disease-modifying effects such as preventing epilepsy or reducing seizure severity. Among the drugs tested, several were able to trigger neuroprotection but only a few had disease-modifying effects. At this point, many data are still missing, namely which drugs could efficiently stop SE or which mechanisms of action should be searched for to prevent the harmful consequences of SE.

  16. Novelty Seeking and Drug Addiction in Humans and Animals: From Behavior to Molecules.

    Science.gov (United States)

    Wingo, Taylor; Nesil, Tanseli; Choi, Jung-Seok; Li, Ming D

    2016-09-01

    Global treatment of drug addiction costs society billions of dollars annually, but current psychopharmacological therapies have not been successful at desired rates. The increasing number of individuals suffering from substance abuse has turned attention to what makes some people more vulnerable to drug addiction than others. One personality trait that stands out as a contributing factor is novelty seeking. Novelty seeking, affected by both genetic and environmental factors, is defined as the tendency to desire novel stimuli and environments. It can be measured in humans through questionnaires and in rodents using behavioral tasks. On the behavioral level, both human and rodent studies demonstrate that high novelty seeking can predict the initiation of drug use and a transition to compulsive drug use and create a propensity to relapse. These predictions are valid for several drugs of abuse, such as alcohol, nicotine, cocaine, amphetamine, and opiates. On the molecular level, both novelty seeking and addiction are modulated by the central reward system in the brain. Dopamine is the primary neurotransmitter involved in the overlapping neural substrates of both parameters. In sum, the novelty-seeking trait can be valuable for predicting individual vulnerability to drug addiction and for generating successful treatment for patients with substance abuse disorders.

  17. Development and evaluation of an ITS1 "Touchdown" PCR for assessment of drug efficacy against animal African trypanosomosis.

    Science.gov (United States)

    Tran, Thao; Napier, Grant; Rowan, Tim; Cordel, Claudia; Labuschagne, Michel; Delespaux, Vincent; Van Reet, Nick; Erasmus, Heidi; Joubert, Annesca; Büscher, Philippe

    2014-05-28

    Animal African trypanosomoses (AAT) are caused by flagellated protozoa of the Trypanosoma genus and contribute to considerable losses in animal production in Africa, Latin America and South East Asia. Trypanosoma congolense is considered the economically most important species. Drug resistant T. congolense strains present a threat to the control of AAT and have triggered research into discovery of novel trypanocides. In vivo assessment of trypanocidal efficacy relies on monitoring of treated animals with microscopic parasite detection methods. Since these methods have poor sensitivity, follow-up for up to 100 days after treatment is recommended to increase the chance of detecting recurrent parasitaemia waves. Molecular techniques are more amendable to high throughput processing and are generally more sensitive than microscopic detection, thus bearing the potential of shortening the 100-day follow up period. The study presents a "Touchdown" PCR targeting the internal transcribed spacer 1 of the ribosomal DNA (ITS1 TD PCR) that enables detection and discrimination of different Trypanosoma taxa in a single run due to variations in PCR product sizes. The assay achieves analytical sensitivity of 10 parasites per ml of blood for detection of T. congolense savannah type and T. brucei, and 100 parasites per ml of blood for detection of T. vivax in infected mouse blood. The ITS1 TD PCR was evaluated on cattle experimentally infected with T. congolense during an investigational new veterinary trypanocide drug efficacy study. ITS1 TD PCR demonstrated comparable performance to microscopy in verifying trypanocide treatment success, in which parasite DNA became undetectable in cured animals within two days post-treatment. ITS1 TD PCR detected parasite recrudescence three days earlier than microscopy and had a higher positivity rate than microscopy (84.85% versus 57.58%) in 66 specimens of relapsing animals collected after treatments. Therefore, ITS1 TD PCR provides a useful tool

  18. Effects of antimicrobial use in agricultural animals on drug-resistant foodborne salmonellosis in humans: A systematic literature review.

    Science.gov (United States)

    Helke, Kristi L; McCrackin, M A; Galloway, Ashley M; Poole, Ann Z; Salgado, Cassandra D; Marriott, Bernadette P

    2017-02-11

    Controversy continues concerning antimicrobial use in food animals and its relationship to drug-resistant infections in humans. We systematically reviewed published literature for evidence of a relationship between antimicrobial use in agricultural animals and drug-resistant meat or dairy-borne non-typhoidal salmonellosis in humans. Based on publications from the United States (U.S.), Canada, and Denmark from January 2010 to July 2014, 858 articles received title and abstract review, 104 met study criteria for full article review with 68 retained for which data are presented. Antibiotic exposure in both cattle and humans found an increased likelihood of Salmonella colonization, whereas in chickens, animals not exposed to antibiotics (organic) were more likely to be Salmonella positive and those that had antibiotic exposure were more likely to harbor antimicrobial resistant Salmonella organisms. In swine literature, only tylosin exposure was examined and no correlation was found among exposure, Salmonella colonization, or antimicrobial resistance. No studies that identified farm antimicrobial use also traced antimicrobial-resistant Salmonella from farm to fork.

  19. Pharmacokinetics of fluconazole in cerebrospinal fluid and serum of rabbits: validation of an animal model used to measure drug concentrations in cerebrospinal fluid.

    Science.gov (United States)

    Madu, A; Cioffe, C; Mian, U; Burroughs, M; Tuomanen, E; Mayers, M; Schwartz, E; Miller, M

    1994-09-01

    Complete concentration-time data describing the pharmacokinetics of fluconazole in the cerebrospinal fluid (CSF) following a single dose are not available for humans or animals. We studied the pharmacokinetics of fluconazole with an indwelling intracisternal needle as described by R.G. Dacey and M.A. Sande (Antimicrob. Agents Chemother. 6:437-441, 1974). To determine whether the presence of an intracisternal needle alters pharmacokinetics in the CSF, we validated this model with uninfected rabbits by measuring pharmacokinetic constants following direct intracisternal and intravenous administration of fluconazole. Following direct injection, there was no alteration of elimination rates in the CSF with increasing sample number or time. Following intravenous administration, the penetration and kinetic constants were the same in individual animals from which multiple CSF samples were obtained as in a composite subject constructed by pooling virgin samples from different animals. The presence of the intracisternal needle did not alter CSF chemistry or leukocyte counts, and erythrocyte contamination was < 0.001%. While drug concentrations were measured by a microbiological assay, we also compared the sensitivity and reproducibility of a high-performance liquid chromatography (HPLC) assay with those of the microbiological assay. Following a single intravenous dose, the maximum concentration of the drug in serum, the time to maximum concentration of the drug in serum, the terminal elimination half-life in the CSF, and the percent penetration by fluconazole were 6.12 micrograms/ml, 1 h, 9.0 h, and 84.3%, respectively. We conclude that the sampling of CSF via an indwelling needle does not alter fluconazole pharmacokinetics, cause inflammation, or alter chemical parameters; that the microbiological assay is at least equivalent in sensitivity and reproducibility to the HPLC assay; and that robust parameters describing the pharmacokinetics of fluconazole are possible with this

  20. Quality of Reporting and Adherence to ARRIVE Guidelines in Animal Studies for Chagas Disease Preclinical Drug Research: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Julián Ernesto Nicolás Gulin

    2015-11-01

    Full Text Available Publication of accurate and detailed descriptions of methods in research articles involving animals is essential for health scientists to accurately interpret published data, evaluate results and replicate findings. Inadequate reporting of key aspects of experimental design may reduce the impact of studies and could act as a barrier to translation of research findings. Reporting of animal use must be as comprehensive as possible in order to take advantage of every study and every animal used. Animal models are essential to understanding and assessing new chemotherapy candidates for Chagas disease pathology, a widespread parasitic disease with few treatment options currently available. A systematic review was carried out to compare ARRIVE guidelines recommendations with information provided in publications of preclinical studies for new anti-Trypanosoma cruzi compounds. A total of 83 publications were reviewed. Before ARRIVE guidelines, 69% of publications failed to report any macroenvironment information, compared to 57% after ARRIVE publication. Similar proportions were observed when evaluating reporting of microenvironmental information (56% vs. 61%. Also, before ARRIVE guidelines publication, only 13% of papers described animal gender, only 18% specified microbiological status and 13% reported randomized treatment assignment, among other essential information missing or incomplete. Unfortunately, publication of ARRIVE guidelines did not seem to enhance reporting quality, compared to papers appeared before ARRIVE publication. Our results suggest that there is a strong need for the scientific community to improve animal use description, animal models employed, transparent reporting and experiment design to facilitate its transfer and application to the affected human population. Full compliance with ARRIVE guidelines, or similar animal research reporting guidelines, would be an excellent start in this direction.

  1. Assessment of anti-arrhythmic activity of antipsychotic drugs in an animal model

    DEFF Research Database (Denmark)

    Mow, Tomas; Frederiksen, Kristen; Thomsen, Morten B.

    2015-01-01

    limited experimental information exists about the effects of α1-adrenergic receptor activity of antipsychotic drugs in pro-arrhythmic models, we have decided to investigate this. In this study we show that four antipsychotic drugs all have high affinity for α1-adrenergic receptor (sertindole>risperidone......>haloperidol>olanzapine) and all block IKr (sertindole>haloperidol>risperidone>olanzapine). In canine Purkinje fibres, α1-adrenergic stimulation prolonged action potential duration; however, the stimulation does not cause afterdepolarizations, even in the presence of dofetilide-induced delayed repolarization. We showed...

  2. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size of Beads in Drug... industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides... guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft...

  3. 77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin

    Science.gov (United States)

    2012-12-31

    ...; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION.... pseudintermedius. 141-346 Abbott OROCAM (meloxicam) Original approval for 529.1350 Yes CE \\1\\ Laboratories... Meloxicam. (a) Specifications. Each milliliter of solution contains 5 milligrams (mg) meloxicam. (b)...

  4. 78 FR 25182 - New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin

    Science.gov (United States)

    2013-04-30

    ...; Lasalocid; Melengestrol; Monensin; and Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... summary NEPA review 200-532 Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.342 yes CE \\1... 139-192. Sophia, Bulgaria. Type A medicated articles. 200-533 Huvepharma AD, 5th TYLOVET 100...

  5. 77 FR 4895 - New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane...

    Science.gov (United States)

    2012-02-01

    ..., Penicillin G, Phenylbutazone, Pyrantel Tartrate, Tylosin Phosphate, and Sulfamethazine AGENCY: Food and Drug..., NJ 08310. NADA 049-890 NORCO T-2 Pre-Pak Norco Mills of (tylosin phosphate). Norfolk, Inc., P.O. Box... procaine). 93257. NADA 095-953 MOORMABOOST TY 4000 ADM Alliance Medicated (tylosin Nutrition,...

  6. 76 FR 11490 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

    Science.gov (United States)

    2011-03-02

    ...; Phenylbutazone; Pyrantel; Tylosin; Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Notice...., Kalona, IA TYLAN Premix 52247. (tylosin phosphate). Triple ``F'', Inc., 10104 NADA 119-062, Cadco- 558...-352, Seeco T-10 Premix 558.625 (053740). Box 1014, Willmar, MN 56201. (tylosin phosphate). Seeco,...

  7. 78 FR 69992 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

    Science.gov (United States)

    2013-11-22

    ... arsenic; drug and for control of overdose or lack of infectious synovitis water may result in caused by... disease (CRD) and air weakness or paralysis sac infection caused of the legs. by M. gallisepticum... for control of overdose or lack of infectious synovitis water may result in caused by...

  8. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ... FDA's Center for Veterinary Medicine. FDA records the official abbreviated application receipt date as...AGDUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV- 10), Food and Drug... the Center for Veterinary Medicine (CVM) at: cvmagdufa@fda.hhs.gov . SUPPLEMENTARY INFORMATION:...

  9. 77 FR 5700 - New Animal Drugs; Change of Sponsor; Chlortetracycline Powder

    Science.gov (United States)

    2012-02-06

    ...: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish... to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as follows: PART 510--NEW..., LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 * * * * * PART 520--ORAL DOSAGE FORM NEW...

  10. Establishing a structured animal model for screening anti-psychological drugs of schizophrenia

    Institute of Scientific and Technical Information of China (English)

    Liang Li; Zhemeng Wu

    2014-01-01

    Although some traditional animal models for studying schizophrenia have been wildly used,many problems remain in their credibility and validity.We propose that structured animal models with the integration of multiple symptom-inducing factors are be better in simulating the symptoms of schizophrenia and represent the new direction of the future ani-mal-model development.In this article,we review previous studies in this line of research and emphasize the importance of combining the behavior paradigm of the structured top-down attentional modulation of prepulse inhibition with multiple path-ogenic factors related to schizophrenia to establish a new model generation,which will be of great significance in investigating both the pathogenesis and the treatment of schizophrenia.

  11. Using magnetic resonance imaging in animal models to guide drug development in multiple sclerosis.

    Science.gov (United States)

    Nathoo, Nabeela; Yong, V Wee; Dunn, Jeff F

    2014-01-01

    Major advances are taking place in the development of therapeutics for multiple sclerosis (MS), with a move past traditional immunomodulatory/immunosuppressive therapies toward medications aimed at promoting remyelination or neuroprotection. With an increase in diversity of MS therapies comes the need to assess the effectiveness of such therapies. Magnetic resonance imaging (MRI) is one of the main tools used to evaluate the effectiveness of MS therapeutics in clinical trials. As all new therapeutics for MS are tested in animal models first, it is logical that MRI be incorporated into preclinical studies assessing therapeutics. Here, we review key papers showing how MR imaging has been combined with a range of animal models to evaluate potential therapeutics for MS. We also advise on how to maximize the potential for incorporating MRI into preclinical studies evaluating possible therapeutics for MS, which should improve the likelihood of discovering new medications for the condition.

  12. CHANGING METABOLIC FUNCTIONS IN EXPERIMENTAL ANIMALS AFTER INTRODUCTION OF THE XENOBIOTIC, IMMUNOTROPIC DRUG AND PROBIOTIC

    OpenAIRE

    Zvyagintseva O.V.; Klimova E.M.; Lavinska O.V.; Lenkevich A.S.

    2015-01-01

    The aim of the study was to evaluate in vivo changes in metabolic and barrier function of the resistance factors (activity of enzymes of neutrophils, the efficiency of phagocytosis), some biochemical parameters (concentration of ceruloplasmin and haptoglobin) and proliferate activity in vitro cells after introduction of copper sulfate, probiotics and immunostimulant "Fungidol" the experimental animals. Material and methods. The in vivo experiments were performed on ...

  13. 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....

  14. Effects of Ayahuasca and its Alkaloids on Drug Dependence: A Systematic Literature Review of Quantitative Studies in Animals and Humans.

    Science.gov (United States)

    Nunes, Amanda A; Dos Santos, Rafael G; Osório, Flávia L; Sanches, Rafael F; Crippa, José Alexandre S; Hallak, Jaime E C

    2016-01-01

    Recently, the anti-addictive potential of ayahuasca, a dimethyltryptamine(DMT)- and β-carboline-rich hallucinogenic beverage traditionally used by indigenous groups of the Northwest Amazon and currently by syncretic churches worldwide, has received increased attention. To better evaluate this topic, we performed a systematic literature review using the PubMed database to find quantitative studies (using statistical analysis) that assessed the effects of ayahuasca or its components in drug-related symptoms or disorders. We found five animal studies (using harmaline, harmine, or ayahuasca) and five observational studies of regular ayahuasca consumers. All animal studies showed improvement of biochemical or behavioral parameters related to drug-induced disorders. Of the five human studies, four reported significant reductions of dependence symptoms or substance use, while one did not report significant results. The mechanisms responsible for the anti-addictive properties of ayahuasca and its alkaloids are not clarified, apparently involving both peripheral MAO-A inhibition by the β-carbolines and central agonism of DMT at 5-HT2A receptors expressed in brain regions related to the regulation of mood and emotions. Although results are promising, controlled studies are needed to replicate these preliminary findings.

  15. 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...

  16. Animal models

    DEFF Research Database (Denmark)

    Gøtze, Jens Peter; Krentz, Andrew

    2014-01-01

    In this issue of Cardiovascular Endocrinology, we are proud to present a broad and dedicated spectrum of reviews on animal models in cardiovascular disease. The reviews cover most aspects of animal models in science from basic differences and similarities between small animals and the human...... pathology, to biomarkers in diagnosis and prognostic evaluation, to drug testing and targeted medicine....

  17. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... current thinking on adaptive design clinical trials for drugs and biologics. It does not create or confer... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides...

  18. Divergent Isoprenoid Biosynthesis Pathways in Staphylococcus Species Constitute a Drug Target for Treating Infections in Companion Animals

    Science.gov (United States)

    Cain, Christine L.; Morris, Daniel O.; Rankin, Shelley C.

    2016-01-01

    ABSTRACT Staphylococcus species are a leading cause of skin and soft tissue infections in humans and animals, and the antibiotics used to treat these infections are often the same. Methicillin- and multidrug-resistant staphylococcal infections are becoming more common in human and veterinary medicine. From a “One Health” perspective, this overlap in antibiotic use and resistance raises concerns over the potential spread of antibiotic resistance genes. Whole-genome sequencing and comparative genomics analysis revealed that Staphylococcus species use divergent pathways to synthesize isoprenoids. Species frequently associated with skin and soft tissue infections in companion animals, including S. schleiferi and S. pseudintermedius, use the nonmevalonate pathway. In contrast, S. aureus, S. epidermidis, and S. lugdunensis use the mevalonate pathway. The antibiotic fosmidomycin, an inhibitor of the nonmevalonate pathway, was effective in killing canine clinical staphylococcal isolates but had no effect on the growth or survival of S. aureus and S. epidermidis. These data identify an essential metabolic pathway in Staphylococcus that differs among members of this genus and suggest that drugs such as fosmidomycin, which targets enzymes in the nonmevalonate pathway, may be an effective treatment for certain staphylococcal infections. IMPORTANCE Drug-resistant Staphylococcus species are a major concern in human and veterinary medicine. There is a need for new antibiotics that exhibit a selective effect in treating infections in companion and livestock animals and that would not be used to treat human bacterial infections. We have identified fosmidomycin as an antibiotic that selectively targets certain Staphylococcus species that are often encountered in skin infections in cats and dogs. These findings expand our understanding of Staphylococcus evolution and may have direct implications for treating staphylococcal infections in veterinary medicine. PMID:27704053

  19. Sex-dependent psychoneuroendocrine effects of THC and MDMA in an animal model of adolescent drug consumption.

    Science.gov (United States)

    Llorente-Berzal, Alvaro; Puighermanal, Emma; Burokas, Aurelijus; Ozaita, Andrés; Maldonado, Rafael; Marco, Eva M; Viveros, Maria-Paz

    2013-01-01

    Ecstasy is a drug that is usually consumed by young people at the weekends and frequently, in combination with cannabis. In the present study we have investigated the long-term effects of administering increasing doses of delta-9-tetrahydrocannabinol [THC; 2.5, 5, 10 mg/kg; i.p.] from postnatal day (pnd) 28 to 45, alone and/or in conjunction with 3,4-methylenedioxymethamphetamine [MDMA; two daily doses of 10 mg/kg every 5 days; s.c.] from pnd 30 to 45, in both male and female Wistar rats. When tested one day after the end of the pharmacological treatment (pnd 46), MDMA administration induced a reduction in directed exploration in the holeboard test and an increase in open-arm exploration in an elevated plus maze. In the long-term, cognitive functions in the novel object test were seen to be disrupted by THC administration to female but not male rats. In the prepulse inhibition test, MDMA-treated animals showed a decrease in prepulse inhibition at the most intense prepulse studied (80 dB), whereas in combination with THC it induced a similar decrease at 75 dB. THC decreased hippocampal Arc expression in both sexes, while in the frontal cortex this reduction was only evident in females. MDMA induced a reduction in ERK1/2 immunoreactivity in the frontal cortex of male but not female animals, and THC decreased prepro-orexin mRNA levels in the hypothalamus of males, although this effect was prevented when the animals also received MDMA. The results presented indicate that adolescent exposure to THC and/or MDMA induces long-term, sex-dependent psychophysiological alterations and they reveal functional interactions between the two drugs.

  20. Use of antimicrobial growth promoters in food animals and Enterococcus faecium resistance to therapeutic antimicrobial drugs in Europe

    DEFF Research Database (Denmark)

    Wegener, Henrik Caspar; Aarestrup, Frank Møller; Jensen, Lars Bogø

    1999-01-01

    Supplementing animal feed with antimicrobial agents to enhance growth has been common practice for more than 30 years and is estimated to constitute more than half the total antimicrobial use worldwide. The potential public health consequences of this use have been debated; however, until recently......, clear evidence of a health risk was not available. Accumulating evidence now indicates that the use of the glycopeptide avoparcin as a growth promoter has created in food animals a major reservoir of Enterococcus faecium, which contains the high level glycopeptide resistance determinant vanA, located...... on the Tn1546 transposon. Furthermore, glycopeptide-resistant strains, as well as resistance determinants, can be transmitted from animals to humans. Two antimicrobial classes expected to provide the future therapeutic options for treatment of infections with vancomycin-resistant enterococci have analogues...

  1. Innovative drugs to treat depression: did animal models fail to be predictive or did clinical trials fail to detect effects?

    Science.gov (United States)

    Belzung, Catherine

    2014-04-01

    Over recent decades, encouraging preclinical evidence using rodent models pointed to innovative pharmacological targets to treat major depressive disorder. However, subsequent clinical trials have failed to show convincing results. Two explanations for these rather disappointing results can be put forward, either animal models of psychiatric disorders have failed to predict the clinical effectiveness of treatments or clinical trials have failed to detect the effects of these new drugs. A careful analysis of the literature reveals that both statements are true. Indeed, in some cases, clinical efficacy has been predicted on the basis of inappropriate animal models, although the contrary is also true, as some clinical trials have not targeted the appropriate dose or clinical population. On the one hand, refinement of animal models requires using species that have better homological validity, designing models that rely on experimental manipulations inducing pathological features, and trying to model subtypes of depression. On the other hand, clinical research should consider carefully the results from preclinical studies, in order to study these compounds at the correct dose, in the appropriate psychiatric nosological entity or symptomatology, in relevant subpopulations of patients characterized by specific biomarkers. To achieve these goals, translational research has to strengthen the dialogue between basic and clinical science.

  2. CIAPIN1 gene silencing enhances chemosensitivity in a drug-resistant animal model in vivo

    Energy Technology Data Exchange (ETDEWEB)

    Wang, X.M.; Gao, S.J.; Guo, X.F.; Sun, W.J. [Department of Oncology, The Second Affiliated Hospital, Harbin Medical University, Harbin (China); Yan, Z.Q. [Department of Breast Surgery, The Second Affiliated Hospital, Harbin Medical University, Harbin (China); Wang, W.X.; Xu, Y.Q.; Lu, D. [Department of Oncology, The Second Affiliated Hospital, Harbin Medical University, Harbin (China)

    2014-03-21

    Overexpression of cytokine-induced apoptosis inhibitor 1 (CIAPIN1) contributes to multidrug resistance (MDR) in breast cancer. This study aimed to evaluate the potential of CIAPIN1 gene silencing by RNA interference (RNAi) as a treatment for drug-resistant breast cancer and to investigate the effect of CIAPIN1 on the drug resistance of breast cancer in vivo. We used lentivirus-vector-based RNAi to knock down CIAPIN1 in nude mice bearing MDR breast cancer tumors and found that lentivirus-vector-mediated silencing of CIAPIN1 could efficiently and significantly inhibit tumor growth when combined with chemotherapy in vivo. Furthermore, Western blot analysis showed that both CIAPIN1 and P-glycoprotein expression were efficiently downregulated, and P53 was upregulated, after RNAi. Therefore, we concluded that lentivirus-vector-mediated RNAi targeting of CIAPIN1 is a potential approach to reverse MDR of breast cancer. In addition, CIAPIN1 may participate in MDR of breast cancer by regulating P-glycoprotein and P53 expression.

  3. An animal model of social instability stress in adolescence and risk for drugs of abuse.

    Science.gov (United States)

    McCormick, Cheryl M

    2010-02-09

    There is increasing evidence that adolescence, like early life, is a sensitive period in which ongoing brain development can be influenced by environmental factors. This review describes our use of social instability as a model of mild adolescent social stress, its effects on social interactions and on hypothalamic-pituitary-adrenal function over the course of the procedure and in response to new stressors. The effects of social instability are sex-specific, with qualitative differences between the sexes on HPA function over the course of the stressor procedure, and with greater effects in males on behaviour observed during the social instability and greater effects in females on behavioural responses to drugs of abuse into adulthood, long after the stress exposure. The results from investigations with this model of adolescent social stress are discussed in relation to those of studies using other stressor procedures. Elevated exposure to glucocorticoids over the course of adolescence confers sex-specific changes in behavioural responses to drugs of abuse, which may be of relevance for understanding risk factors in people.

  4. Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies

    Directory of Open Access Journals (Sweden)

    E.L. Andrade

    Full Text Available This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS, identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle. This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

  5. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... patients who do not abuse drugs. In animal studies, methamphetamine has been shown to increase the amount ... behaviors. NIDA researchers have studied and continue to study the links between drug abuse and HIV/AIDS. ...

  6. Critical review of current animal models of seizures and epilepsy used in the discovery and development of new antiepileptic drugs.

    Science.gov (United States)

    Löscher, Wolfgang

    2011-06-01

    Animal models for seizures and epilepsy have played a fundamental role in advancing our understanding of basic mechanisms underlying ictogenesis and epileptogenesis and have been instrumental in the discovery and preclinical development of novel antiepileptic drugs (AEDs). However, there is growing concern that the efficacy of drug treatment of epilepsy has not substantially improved with the introduction of new AEDs, which, at least in part, may be due to the fact that the same simple screening models, i.e., the maximal electroshock seizure (MES) and s.c. pentylenetetrazole (PTZ) seizure tests, have been used as gatekeepers in AED discovery for >6 decades. It has been argued that these old models may identify only drugs that share characteristics with existing drugs, and are unlikely to have an effect on refractory epilepsies. Indeed, accumulating evidence with several novel AEDs, including levetiracetan, has shown that the MES and PTZ models do not identify all potential AEDs but instead may fail to discover compounds that have great potential efficacy but work through mechanisms not tested by these models. Awareness of the limitations of acute seizure models comes at a critical crossroad. Clearly, preclinical strategies of AED discovery and development need a conceptual shift that is moving away from using models that identify therapies for the symptomatic treatment of epilepsy to those that may be useful for identifying therapies that are more effective in the refractory population and that may ultimately lead to an effective cure in susceptible individuals by interfering with the processes underlying epilepsy. To realize this goal, the molecular mechanisms of the next generation of therapies must necessarily evolve to include targets that contribute to epileptogenesis and pharmacoresistance in relevant epilepsy models.

  7. Characterising and comparing drug-dispensing practices at animal health outlets in the Rift Valley, Kenya: an exploratory analysis (part II).

    Science.gov (United States)

    Higham, L E; Ongeri, W; Asena, K; Thrusfield, M V

    2016-12-01

    A mixed-method study was conducted in the Rift Valley of Kenya to characterise drug-dispensing practices amongst staff at animal health outlets and to explore perceptions of veterinary medicines amongst pastoralists and farmers. Forty structured questionnaires were administered to staff at animal health outlets, including franchise outlets of 'Sidai Africa Ltd.', and two focus group discussions were facilitated to explore the perceptions of local animal health services by a Maasai pastoralist group and a dairy farmer cooperative. Differences were detected in the characteristics of Sidai outlets, agrovets, pharmacies and dukas. A greater proportion of Sidai outlet staff selected drugs based on principles of responsible drug use than staff at other types of outlet, and technical qualifications and training were associated with responsible drug use. Across all outlet types, staff knowledge and training gaps were identified, including in the correct administration of medicines. The majority of drug sales are accompanied by verbal advice to farmers. Members of the Maasai pastoralist group were concerned about accidental self-medication, withdrawal periods, drug residues and the misuse of drugs due to a lack of quality information and advice. The dairy farmer group raised similar concerns, reporting under-dosing as a common mistake amongst farmers. This study concludes that current knowledge, attitudes and practices of many service providers and livestock owners in the sale, purchase and use of veterinary medicines present risks of drug misuse and therefore the emergence of antimicrobial resistance. There is a clear demand from livestock keepers for accessible, affordable and quality animal health services and products in Kenya, and animal health practitioners have the potential to provide increased support to livestock-based livelihoods and act as stewards of our existing portfolio of animal and human medicines.

  8. [Up-to-date drug treatment of disseminated lung cancer--which other drugs are available in addition to conventional cytotoxic agents?].

    Science.gov (United States)

    Koivunen, Jussi; Knuuttila, Aija; Mali, Pekka

    2016-01-01

    In addition to conventional cytotoxic agents, novel drug treatments have in the last few years been introduced for the treatment of non-small cell lung cancer. Whereas some of the novel treatments have brought significant improvement in treatment outcome, the benefit brought about by the treatment has in some cases been quite small in comparison with the costs and adverse effects. In the present review we explore the goals of drug treatments of disseminated lung cancer, assessment of therapeutic benefits as well as most significant research results of novel drug treatments of the lastfew years In addition, we evaluate the effect of the novel drug treatments on Finnish treatment practices.

  9. Effect of commercially available green and black tea beverages on drug-metabolizing enzymes and oxidative stress in Wistar rats.

    Science.gov (United States)

    Yao, Hsien-Tsung; Hsu, Ya-Ru; Lii, Chong-Kuei; Lin, Ai-Hsuan; Chang, Keng-Hao; Yang, Hui-Ting

    2014-08-01

    The effect of commercially available green tea (GT) and black tea (BT) drinks on drug metabolizing enzymes (DME) and oxidative stress in rats was investigated. Male Wistar rats were fed a laboratory chow diet and GT or BT drink for 5 weeks. Control rats received de-ionized water instead of the tea drinks. Rats received the GT and BT drinks treatment for 5 weeks showed a significant increase in hepatic microsomal cytochrome P450 (CYP) 1A1 and CYP1A2, and a significant decrease in CYP2C, CYP2E1 and CYP3A enzyme activities. Results of immunoblot analyses of enzyme protein contents showed the same trend with enzyme activity. Significant increase in UDP-glucuronosyltransferase activity and reduced glutathione content in liver and lungs were observed in rats treated with both tea drinks. A lower lipid peroxide level in lungs was observed in rats treated with GT drink. Electrophoretic mobility shift assay revealed that both tea drinks decreased pregnane X receptor binding to DNA and increased nuclear factor-erythroid 2 p45-related factor 2 binding to DNA. These results suggest that feeding of both tea drinks to rats modulated DME activities and reduced oxidative stress in liver and lungs. GT drink is more effective on reducing oxidative stress than BT drink.

  10. Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme : a survey of e-pharmacies

    NARCIS (Netherlands)

    Lagan, Briege M.; Dolk, Helen; White, Bronagh; Uges, Donald R. A.; Sinclair, M.

    2014-01-01

    PurposeThe increase in online purchasing of medications raises safety concerns regarding teratogenic drugs. The use of the teratogenic drug isotretinoin' for women of childbearing age requires strict adherence to the Pregnancy Prevention Programme (PPP), a risk minimisation measure imposed on prescr

  11. Post-surgical analgesia in rainbow trout: is reduced cardioventilatory activity a sign of improved animal welfare or the adverse effects of an opioid drug?

    Directory of Open Access Journals (Sweden)

    Albin Gräns

    Full Text Available The use of fish models in biomedical research is increasing. Since behavioural and physiological consequences of surgical procedures may affect experimental results, these effects should be defined and, if possible, ameliorated. Thus, the use of post-surgical analgesia should be considered after invasive procedures also in fish, but presently, little information exists on the effects of analgesics in fish. This study assessed the effects of an opioid drug, buprenorphine (0.05 mg/kg IM, on resting ventilation and heart rates during 7 days of postsurgical recovery in rainbow trout (Oncorhynchus mykiss at 10°C by non-invasively recording bioelectric potentials from the fish via electrodes in the water. Baseline ventilation and heart rates were considerably lower compared to previously reported values for rainbow trout at 10°C, possibly due to the non-invasive recording technique. Buprenorphine significantly decreased both ventilation and heart rates further, and the effects were most pronounced at 4-7 days after anaesthesia, surgical procedures and administration of the drug. Somewhat surprisingly, the same effects of buprenorphine were seen in the two control groups that had not been subject to surgery. These results indicate that the reductions in ventilation and heart rates are not caused by an analgesic effect of the drug, but may instead reflect a general sedative effect acting on both behaviour as well as e.g. central control of ventilation in fishes. This resembles what has previously been demonstrated in mammals, although the duration of the drug effect is considerably longer in this ectothermic animal. Thus, before using buprenorphine for postoperative analgesic treatment in fish, these potentially adverse effects need further characterisation.

  12. Effects of Cannabinoid Drugs on the Deficit of Prepulse Inhibition of Startle in an Animal Model of Schizophrenia: the SHR Strain

    Directory of Open Access Journals (Sweden)

    Raquel eLevin

    2014-02-01

    Full Text Available Clinical and neurobiological findings suggest that the cannabinoids and the endocannabinoid system may be implicated in the pathophysiology and treatment of schizophrenia. We described that the Spontaneously Hypertensive Rats (SHR strain presents a schizophrenia behavioral phenotype that is specifically attenuated by antipsychotic drugs, and potentiated by proschizophrenia manipulations. Based on these findings, we have suggested this strain as an animal model of schizophrenia. The aim of this study was to evaluate the effects of cannabinoid drugs on the deficit of prepulse inhibition of startle (PPI, the main paradigm used to study sensorimotor gating impairment related to schizophrenia, presented by the SHR strain. The following drugs were used: 1 WIN55212,2 (cannabinoid agonist, 2 rimonabant (CB1 antagonist, 3 AM404 (anandamide uptake inhibitor, and 4 cannabidiol (indirect CB1/CB2 receptor antagonist, among other effects. Wistar rats (WR and SHRs were treated with vehicle or different doses of WIN55212 (0.3, 1 or 3 mg/kg, rimonabant (0.75, 1.5 or 3 mg/kg, AM404 (1, 5 or 10 mg/kg or cannabidiol (15, 30 or 60 mg/kg. Vehicle-treated SHRs showed a decreased PPI when compared to WRs. This PPI deficit was reversed by 1 mg/kg WIN and 30 mg/kg cannabidiol. Conversely, 0.75 mg/kg rimonabant decreased PPI in SHR strain, whereas AM404 did not modify it. Our results reinforce the role of the endocannabinoid system in the sensorimotor gating impairment related to schizophrenia, and point to cannabinoid drugs as potential therapeutic strategies.

  13. Animal model of undernutrition for the evaluation of drug pharmacokinetics Modelo de desnutrición animal para la evaluación de estudios de farmacocinética

    Directory of Open Access Journals (Sweden)

    M. Merino-Sanjuán

    2011-12-01

    Full Text Available Background: Protein energy malnutrition is a public health problem affecting a great number of people. Pathophysiological imbalances in malnourished individuals have a profound impact on drug pharmacokinetics. Objective: To develop an animal model of undernutrition using male Wistar rats to be used to assess, in further studies, the impact of nutritional status on the oral bioavailability and pharmacokinetics of drugs. Desing: Animals were randomly assigned to one of two groups and fed different diets for 26 days: WN (well-nourished/regular diet, N = 61 and UN (under-nourished/protein-calorie restricted diet, N = 72. Assessment of the animals' nutritional status was performed taking into account serum albumin, total cholesterol level and total body weight. A kinetic model incorporating population kinetic analysis (NONMEM was developed to analyze body weight versus time profiles in the adaptation period following administration of the two aforementioned diets. Results: Serum albumin plasma levels were lower than 2.3 g/dL in 80% (60/72 of malnourished animals at the end of the adaptation period. The range of the total serum cholesterol was similar in both groups at the end of the adaptation period. Total body weight in all cases was less than 230 g for malnourished animals and higher than 240 g for well-nourished animals. The kinetic model assayed was confirmed to be an expansion module characterized by linear weight gain and a decline module characterized by exponential weight loss, where the weight loss rate constant is an exponential function of time. The bootstrap resampling method confirmed the stability of the model eventually selected. Conclusions: The animal model developed in this study is reliable and could be of use in evaluating the impact of nutritional state on the pharmacokinetics of drugs. The proposed mathematical model allows the body weight of animals to be predicted at a given time taking into account the diet followed in the

  14. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

    OpenAIRE

    Davit, Barbara; Braddy, April C.; Conner, Dale P.; Yu, Lawrence X.

    2013-01-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Assoc...

  15. Animation of Antimicrobial Resistance

    Science.gov (United States)

    ... Animal & Veterinary Cosmetics Tobacco Products Animal & ... antimicrobial resistance both emerges and proliferates among bacteria. Over time, the use of antimicrobial drugs will result in the development ...

  16. Drug: D06906 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available ri, or other related species larval exuvia; Standards for non-pharmacopoeial crude drugs Therapeutic category of drugs... in Japan [BR:br08301] 5 Crude drugs and Chinese medicine formulations 51 Crude drugs 510 Crude drugs 5100 Crude drugs...n Japan [BR:br08304] Crude Drugs Diaphoretic drugs Diaphoretic drugs pungent in flavor and cool in property ...D06906 Cicadae periostracum; Cicada slough; Zentai Crude drugs [BR:br08305] Animals Insects D06906 Cicada larva exuvia PubChem: 51091248 ...

  17. Drug: D06721 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available attle family) Oriental bezoar Major component: Bile acid [CPD:C01558] Powdered product: Standards for non-pharmacopoeial crude drugs... Therapeutic category of drugs in Japan [BR:br08301] 5 Crude drugs... and Chinese medicine formulations 51 Crude drugs 510 Crude drugs 5100 Crude drugs D06721 Oriental ...bezoar (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Other drugs Drugs for resuscita...tion D06721 Oriental bezoar Crude drugs [BR:br08305] Animals Mammals D06721 Oriental bezoar PubChem: 47208372 ...

  18. Availability of human induced pluripotent stem cell-derived cardiomyocytes in assessment of drug potential for QT prolongation

    Energy Technology Data Exchange (ETDEWEB)

    Nozaki, Yumiko, E-mail: yumiko-nozaki@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma. Co., Ltd., Suita, Osaka 564-0053 (Japan); Honda, Yayoi, E-mail: yayoi-honda@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma. Co., Ltd., Suita, Osaka 564-0053 (Japan); Tsujimoto, Shinji, E-mail: shinji-tsujimoto@ds-pharma.co.jp [Regenerative and Cellular Medicine Office, Dainippon Sumitomo Pharma. Co., Ltd., Chuo-ku, Tokyo 104-0031 (Japan); Watanabe, Hitoshi, E-mail: hitoshi-1-watanabe@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma. Co., Ltd., Suita, Osaka 564-0053 (Japan); Kunimatsu, Takeshi, E-mail: takeshi-kunimatsu@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma. Co., Ltd., Suita, Osaka 564-0053 (Japan); Funabashi, Hitoshi, E-mail: hitoshi-funabashi@ds-pharma.co.jp [Preclinical Research Laboratories, Dainippon Sumitomo Pharma. Co., Ltd., Suita, Osaka 564-0053 (Japan)

    2014-07-01

    Field potential duration (FPD) in human-induced pluripotent stem cell-derived cardiomyocytes (hiPS-CMs), which can express QT interval in an electrocardiogram, is reported to be a useful tool to predict K{sup +} channel and Ca{sup 2+} channel blocker effects on QT interval. However, there is no report showing that this technique can be used to predict multichannel blocker potential for QT prolongation. The aim of this study is to show that FPD from MEA (Multielectrode array) of hiPS-CMs can detect QT prolongation induced by multichannel blockers. hiPS-CMs were seeded onto MEA and FPD was measured for 2 min every 10 min for 30 min after drug exposure for the vehicle and each drug concentration. I{sub Kr} and I{sub Ks} blockers concentration-dependently prolonged corrected FPD (FPDc), whereas Ca{sup 2+} channel blockers concentration-dependently shortened FPDc. Also, the multichannel blockers Amiodarone, Paroxetine, Terfenadine and Citalopram prolonged FPDc in a concentration dependent manner. Finally, the I{sub Kr} blockers, Terfenadine and Citalopram, which are reported to cause Torsade de Pointes (TdP) in clinical practice, produced early afterdepolarization (EAD). hiPS-CMs using MEA system and FPDc can predict the effects of drug candidates on QT interval. This study also shows that this assay can help detect EAD for drugs with TdP potential. - Highlights: • We focused on hiPS-CMs to replace in vitro assays in preclinical screening studies. • hiPS-CMs FPD is useful as an indicator to predict drug potential for QT prolongation. • MEA assay can help detect EAD for drugs with TdP potentials. • MEA assay in hiPS-CMs is useful for accurately predicting drug TdP risk in humans.

  19. International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice.

    Science.gov (United States)

    2005-10-20

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. The guidance is intended to encourage the assessment of drug effects on the QT/QTc interval as a standard part of drug development and to encourage the early discussion of this assessment with FDA.

  20. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    Science.gov (United States)

    2016-06-23

    The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

  1. Establishment of liver specific glucokinase gene knockout mice:a new animal model for screening anti-diabetic drugs

    Institute of Scientific and Technical Information of China (English)

    Ya-li ZHANG; Xiao-hong TAN; Mei-fang XIAO; Hui LI; Yi-qing Mao; Xiao YANG; Huan-ran TAN

    2004-01-01

    AIM: To characterize the liver-specific role of glucokinase in maintaining glucose homeostasis and to create an animal model for diabetes. METHODS: We performed hepatocyte-specific gene knockout of glucokinase in mice using Cre-loxP gene targeting strategy. First, two directly repeated loxP sequences were inserted to flank the exon 9 and exon 10 of glucokinase in genomic DNA. To achieve this, linearized targeting vector was electroporated into ES cells. Then G418- and Gancyclovir-double-resistant clones were picked and screened by PCR analysis and the positives identified by PCR were confirmed by Southern blot. A targeted clone was selected for microinjection into C57BL/6J blastocysts and implanted into pseudopregnant FVB recipient. Chimeric mice and their offspring were analyzed by Southern blot. Then by intercrossing the Alb-Cre transgenic mice with mice containing a conditional gk allele, we obtained mice with liver-specific glucokinase gene knockout. RESULTS: Among 161 double resistant clones 4 were positive to PCR and Southern blot and only one was used for further experiments. Eventually we generated the liver specific glucokinase knockout mice. These mice showed increased glucose level with age and at the age of 6 weeks fasting blood glucose level was significantly higher than control and they also displayed impaired glucose tolerance. CONCLUSION: Our studies indicate that hepatic glucokinase plays an important role in glucose homeostasis and its deficiencies contribute to the development of diabetes. The liver glucokinase knockout mouse is an ideal animal model for MODY2, and it also can be applied for screening anti-diabetic drugs.

  2. In vitro efficacies of clinically available drugs against growth and viability of an Acanthamoeba castellanii keratitis isolate belonging to the T4 genotype.

    Science.gov (United States)

    Baig, Abdul Mannan; Iqbal, Junaid; Khan, Naveed Ahmed

    2013-08-01

    The effects of clinically available drugs targeting muscarinic cholinergic, adrenergic, dopaminergic, and serotonergic receptors; intracellular calcium levels and/or the function of calcium-dependent biochemical pathways; ion channels; and cellular pumps were tested against a keratitis isolate of Acanthamoeba castellanii belonging to the T4 genotype. In vitro growth inhibition (amoebistatic) assays were performed by incubating A. castellanii with various concentrations of drugs in the growth medium for 48 h at 30°C. To determine amoebicidal effects, amoebae were incubated with drugs in phosphate-buffered saline for 24 h, and viability was determined using trypan blue exclusion staining. For controls, amoebae were incubated with the solvent alone. Of the eight drugs tested, amlodipine, prochlorperazine, and loperamide showed potent amoebicidal effects, as no viable trophozoites were observed (>95% kill rate), while amiodarone, procyclidine, digoxin, and apomorphine exhibited up to 50% amoebicidal effects. In contrast, haloperidol did not affect viability, but all the drugs tested inhibited A. castellanii growth. Importantly, amlodipine, prochlorperazine, and loperamide showed compelling cysticidal effects. The cysticidal effects were irreversible, as cysts treated with the aforementioned drugs did not reemerge as viable amoebae upon inoculation in the growth medium. Except for apomorphine and haloperidol, all the tested drugs blocked trophozoite differentiation into cysts in encystation assays. Given the limited availability of effective drugs to treat amoebal infections, the clinically available drugs tested in this study represent potential agents for managing keratitis and granulomatous amoebic encephalitis caused by Acanthamoeba spp. and possibly against other meningoencephalitis-causing amoebae, such as Balamuthia mandrillaris and Naegleria fowleri.

  3. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

    Science.gov (United States)

    Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

    2013-10-01

    The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed.

  4. The U.S. Food and Drug Administration's Evaluation of the Safety of Animal Clones: A Failure to Recognize the Normativity of Risk Assessment Projects

    Science.gov (United States)

    Meghani, Zahra; de Melo-Martin, Inmaculada

    2009-01-01

    The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to…

  5. 动物源类药物降血糖作用研究进展%Hypoglycemic effect of animal-original drugs:research advances

    Institute of Scientific and Technical Information of China (English)

    杨红; 杨永寿; 孙梓富; 罗建蓉; 李玲; 薛志革; 耿福能; 何苗; 巫秀美

    2016-01-01

    Diabetes,so-called“emaciation-thirst disease”in traditional Chinese medicine(TCM),is a prevalent chronic dis⁃ease with complicated etiology,incurable and multiple complications,as well as extremely high morbidity and mortality. TCM pays at⁃tention to tackling the problem in the treatment of emaciation-thirst disease,and many prescriptions are single animal medicine or con⁃tain animal-original drug;animal-original drugs possess stasis and other unique characteristics and therapeutic effects. Based on the current anti-diabetic drugs,the review gives an in-depth summary and analysis on the single animal-original drugs derived from the complexes of TCM in the treatment of diabetes according to their mechanism of action,with the aim to provide reference for developing new animal-original drugs to treat diabetes.%糖尿病属中医的“消渴症”,是一种病因复杂、无根治手段且并发症多、致残率和病死率都较高的慢性疾病。中药治疗消渴症讲究标本兼治,不少处方含有动物源药物或单方动物药;动物源类药物具有活血祛瘀等独特功效和治疗作用。本文从现有治疗糖尿病的药物出发,对中药复方中治疗消渴证的单味动物源类药物按照作用机制进行总结与分析,以期为开发新型动物源类治疗糖尿病药物提供借鉴。

  6. Glix 13, a New Drug Acting on Glutamatergic Pathways in Children and Animal Models of Autism Spectrum Disorders

    Directory of Open Access Journals (Sweden)

    Annamaria Chiara Santini

    2014-01-01

    Full Text Available Recently standardized diagnostic instruments have been developed in diagnostic and therapeutic procedures for Autism Spectrumv Disorders (ASD. According to the DSM-5 criteria, individuals with ASD must show symptoms from early childhood. These symptoms are communication deficits and restricted, repetitive patterns of behaviour. It was recently described by Bioinformatic analysis that 99 modified genes were associated with human autism. Gene expression patterns in the low-line animals show significant enrichment in autism-associated genes and the NMDA receptor gene family was identified among these. Using ultrasonic vocalizations, it was demonstrated that genetic variation has a direct impact on the expression of social interactions. It has been proposed that specific alleles interact with a social reward process in the adolescent mouse modifying their social interaction and their approach toward each other. In this review we report that the monoclonal antibody-derived tetrapeptide GLYX-13 was found to act as an N-methyl-D-aspartate receptor modulator and possesses the ability to readily cross the blood brain barrier. Treatment with the NMDAR glycine site partial agonist GLYX-13 rescued the deficit in the animal model. Thus, the NMDA receptor has been shown to play a functional role in autism, and GLYX-13 shows promise for the treatment of autism in autistic children.

  7. Drug: D06790 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available herapeutic category of drugs in Japan [BR:br08301] 5 Crude drugs and Chinese medi...cine formulations 51 Crude drugs 510 Crude drugs 5100 Crude drugs D06790 Oyster shell (JP16); Powdered oyste...r shell (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs for Qi Sedative drugs D0...6790 Oyster shell; Powdered oyster shell; Oyster shell Crude drugs [BR:br08305] Animals Mollusks D06790 Oyster shell PubChem: 47208441 ... ...: E00159 Therapeutic category: 5100 Osteridae Oyster shell Major component: Calcium carbonate [CPD:C08129] T

  8. Impact of early life exposure to antiepileptic drugs on neurobehavioral outcomes based on laboratory animal and clinical research.

    Science.gov (United States)

    Bath, Kevin G; Scharfman, Helen E

    2013-03-01

    Epilepsy affects approximately 1% of children under the age of 15, making it a very common neurological disorder in the pediatric population (Russ et al., 2012). In addition, ~0.4-0.8% of all pregnant women have some form of epilepsy (Hauser et al., 1996a,b; Borthen et al., 2009; Krishnamurthy, 2012). Despite the potential deleterious effects of antiepileptic drugs (AEDs) on the developing brain, their use is still required for seizure control in pregnant women (Krishnamurthy, 2012), and they represent the standard approach for treating children with epilepsy (Chu-Shore and Thiele, 2010; Quach et al., 2010; Verrotti et al., 2011). Even when AEDs are effective, there are potential side effects, including cognitive and affective changes or altered sleep and appetite. The consequences of AED exposure in development have been studied extensively (Canger et al., 1999; Modi et al., 2011a,b; Oguni, 2011). Despite intensive study, there is still debate about the long-term consequences of early life AED exposure. Here, we consider the evidence to date that AED exposure, either prenatally or in early postnatal life, has significant adverse effects on the developing brain and incorporate studies of laboratory animals as well as those of patients. We also note the areas of research where greater clarity seems critical in order to make significant advances. A greater understanding of the impact of AEDs on somatic, cognitive and behavioral development has substantial value because it has the potential to inform clinical practice and guide studies aimed at understanding the genetic and molecular bases of comorbid pathologies associated with common treatment regimens. Understanding these effects has the potential to lead to AEDs with fewer side effects. Such advances would expand treatment options, diminish the risk associated with AED exposure in susceptible populations, and improve the quality of life and health outcomes of children with epilepsy and children born to women who

  9. Availability of antidotes and key emergency drugs in tertiary care hospitals of Punjab and assessment of the knowledge of health care professionals in the management of poisoning cases.

    Science.gov (United States)

    Arslan, Naheed; Khiljee, Sonia; Bakhsh, Allah; Ashraf, Muhammad; Maqsood, Iram

    2016-03-01

    This study was conducted to evaluate the availability of antidotes/key emergency drugs in tertiary care hospitals of the Punjab province, and to assess the knowledge of health care professionals in the stocking and administration of antidotes in the proper management of poisoning cases. Seventeen (n=17) tertiary care hospitals of Punjab Pakistan were selected. Two performas (A and B) were designed for 26 antidotes/key emergency drugs and given to the hospital pharmacists and physicians respectively. It was observed that Activated Charcoal, being the universal antidote was found only in 6 hospitals (41%). Digoxin Immune Fab, Edentate Calcium disodium and Glucagon were not available in emergency department of any hospital and even not included in the formulary of any hospital. About 80% pharmacists were aware of the method of preparation of Activated Charcoal and 85% physicians were familiar with its route of administration. Data showed that tertiary care hospitals of Punjab do not stock antidotes according to national drug policy. Moreover the study strongly suggests the development of health care centers and professional by organizing antidote awareness programs, continuous education and record keeping of poisonous cases and availability of emergency drugs around the clock.

  10. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice.

    Science.gov (United States)

    2004-02-05

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (the ICH E2C guidance). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In the Federal Register of May 19, 1997 (62 FR 27470), FDA published the ICH E2C guidance, which recommends a unified standard for the format, content, and reporting frequency for postmarketing periodic safety update reports (PSURs) for drug and biological products. This guidance, an addendum to the ICH E2C guidance, provides additional information on the content and format of PSURs, including clarification of the objectives, general principles, and model for PSURs. This guidance is intended to help harmonize collection and submission of postmarketing clinical safety data.

  11. International Conference on Harmonisation: guidance on Q1D bracketing and matrixing designs for stability testing of new drug substances and products; availability. Notice.

    Science.gov (United States)

    2003-01-16

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is an annex to an ICH guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products" (66 FR 56332, November 7, 2001). It is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in ICH Q1A(R).

  12. International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions; availability. Notice.

    Science.gov (United States)

    2011-08-11

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes recommendations regarding the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. The guidance is intended to create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.

  13. 77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor's Name; Change of Sponsor's...

    Science.gov (United States)

    2012-10-23

    ...., Sheridan, of time of IN 46069. insemination in weaned sows to facilitate a single fixed-time artificial... * * * * * * * JBS United Animal Health II LLC, 322 S. Main St., Sheridan, 051233 IN 46069 * * * * * * * Jurox Pty... United Animal Health II LLC, 322 S. Main St., Sheridan, IN 46069. * * * * * * * 066916 ECO LLC,...

  14. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Science.gov (United States)

    2010-06-29

    ... use of medically important antimicrobial drugs in food-producing animals. In regard to the use of... measures as follows: (1) Limiting medically important antimicrobial drugs to uses in food-producing animals... Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS....

  15. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Science.gov (United States)

    2012-04-13

    ... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals... Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug...

  16. Plant-availability to barley of phosphorus in ash from thermally treated animal manure in comparison to other manure based materials and commercial fertilizer

    DEFF Research Database (Denmark)

    Kuligowski, Ksawery; Poulsen, Tjalfe Gorm; Rubæk, Gitte Holton

    2010-01-01

     kg P ha-1 in both soils had no significant effect on barley DM yield and P uptake. The overall efficiency for liquid fertilizers was much higher than for solid ones and relative effectiveness (RE) of ExL was comparable to RE of DSP. Despite the low P level in soils, the ryegrass crop grew very well......Phosphorus (P) is an essential nutrient and a limited resource, yet excess P is applied to agricultural land and can cause environmental problems in areas with intensive animal farming. In this study, the fertilizing effects of P in several animal manure-based products (including thermal treatment...... (GA) and a corresponding neutralized acid extract of the ash (ExL) in liquid form were the products in focus. Other products in use were: pelletized pig manure biogas residue (PEL), incinerated PEL (IA), anaerobically digested pig slurry (DS), dried ExL, dried fraction of separated pig slurry (SS...

  17. Overview on available animal models for application in leukemia research; Uebersicht ueber vorhandene Tiermodelle, die fuer die Leukaemieforschung angewandt werden koennten

    Energy Technology Data Exchange (ETDEWEB)

    Borkhardt, A.; Sanchez-Garcia, I.; Cobaleda, C.; Hauer, J.

    2015-01-15

    The term ''leukemia'' encompasses a group of diseases with a variable clinical and pathological presentation. Its cellular origin, its biology and the underlying molecular genetic alterations determine the very variable and individual disease phenotype. The focus of this review is to discuss the most important guidelines to be taken into account when we aim at developing an ''ideal'' animal model to study leukemia. The animal model should mimic all the clinical, histological and molecular genetic characteristics of the human phenotype and should be applicable as a clinically predictive model. It should achieve all the requirements to be used as a standardized model adaptive to basic research as well as to pharmaceutical practice. Furthermore it should fulfill all the criteria to investigate environmental risk factors, the role of genomic mutations and be applicable for therapeutic testing. These constraints limit the usefulness of some existing animal models, which are however very valuable for basic research. Hence in this review we will primarily focus on genetically engineered mouse models (GEMMs) to study the most frequent types of childhood leukemia. GEMMs are robust models with relatively low site specific variability and which can, with the help of the latest gene modulating tools be adapted to individual clinical and research questions. Moreover they offer the possibility to restrict oncogene expression to a defined target population and regulate its expression level as well as its timely activity. Until recently it was only possible in individual cases to develop a murin model, which fulfills the above mentioned requirements. Hence the development of new regulatory elements to control targeted oncogene expression should be priority. Tightly controlled and cell specific oncogene expression can then be combined with a knock-in approach and will depict a robust murine model, which enables almost physiologic oncogene

  18. 76 FR 16290 - Tolerances for Residues of New Animal Drugs in Food; 2-Acetylamino-5-Nitrothiazole; Buquinolate...

    Science.gov (United States)

    2011-03-23

    ..., antibiotic/steroid intramammary infusion (28 FR 4948, May 17, 1963). Section 121.1131 was redesignated as 21... combination drug, antibiotic intramammary infusion (30 FR 11952 at 11954, September 18, 1965). Section 121... a combination drug, antibiotic intramammary infusion (29 FR 14624, October 27, 1964). Section...

  19. 78 FR 52535 - Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins...

    Science.gov (United States)

    2013-08-23

    ...; Quali- Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin AGENCY: Food and Drug... feeds, are no longer manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin...

  20. Animal Models in Studies of Cardiotoxicity Side Effects from Antiblastic Drugs in Patients and Occupational Exposed Workers

    OpenAIRE

    Monica Lamberti; Giancarlo Giovane; Garzillo, Elpidio M.; Franca Avino; Antonia Feola; Stefania Porto; Vincenzo Tombolini; Marina Di Domenico

    2014-01-01

    Cardiotoxicity is an important side effect of cytotoxic drugs and may be a risk factor of long-term morbidity for both patients during therapy and also for staff exposed during the phases of manipulation of antiblastic drugs. The mechanism of cardiotoxicity studied in vitro and in vivo essentially concerns the formation of free radicals leading to oxidative stress, with apoptosis of cardiac cells or immunologic reactions, but other mechanisms may play a role in antiblastic-induced cardiotoxic...

  1. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Veterinary Home Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin it ... Veterinary Medicine is cited as the corporate author. Animation Animation of Antimicrobial Resistance (WMV - 19.2MB) 9: ...

  2. Drug Facts

    Medline Plus

    Full Text Available ... The Link Between Drug Use and HIV/AIDS Recovery & Treatment Drug Treatment Facts Does Drug Treatment Work? ... and Family Can Help Find Treatment/Rehab Resources Prevent Drug Use Help Children and Teens Stay Drug- ...

  3. Drug Facts

    Medline Plus

    Full Text Available ... Addiction? Addiction Risk Factors Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use Hurts Other People Drug Use Hurts Families Drug Use Hurts Kids Drug Use Hurts Unborn ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... Use Hurts Unborn Children Drug Use Hurts Your Health Drug Use Hurts Bodies Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  5. International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice.

    Science.gov (United States)

    2003-11-21

    The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled "Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV'' (the Q1F guidance). The second is a revised guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products'' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.

  6. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not abuse drugs. In animal studies, methamphetamine has been shown to increase the ... on HIV/AIDS and related diseases, counseling and testing services, and referrals for medical and social services. ...

  7. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not abuse drugs. In animal studies, methamphetamine has been shown to increase the ... clinical trials, and other research information for health care providers, researchers, people affected by HIV/AIDS, and ...

  8. 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.

  9. Host-feeding patterns of Aedes albopictus (Diptera: Culicidae) in relation to availability of human and domestic animals in suburban landscapes of central North Carolina.

    Science.gov (United States)

    Richards, Stephanie L; Ponnusamy, Loganathan; Unnasch, Thomas R; Hassan, Hassan K; Apperson, Charles S

    2006-05-01

    Aedes albopictus (Skuse) (Diptera: Culicidae) is a major nuisance mosquito and a potential arbovirus vector. The host-feeding patterns of Ae. albopictus were investigated during the 2002 and 2003 mosquito seasons in suburban neighborhoods in Wake County, Raleigh, NC. Hosts of blood-fed Ae. albopictus (n = 1,094) were identified with an indirect enzyme-linked immunosorbent assay, by using antisera made in New Zealand White rabbits to the sera of animals that would commonly occur in peridomestic habitats. Ae. albopictus fed predominantly on mammalian hosts (83%). Common mammalian hosts included humans (24%), cats (21%), and dogs (14%). However, a notable proportion (7%) of bloodmeals also was taken from avian hosts. Some bloodmeals taken from birds were identified to species by a polymerase chain reaction-heteroduplex assay (PCR-HDA). Ae. albopictus fed predominantly on chickens and a northern cardinal. PCR-HDA failed to produce detectable products for 29 (58%) of 50 bloodmeals for which DNA had been amplified, indicating that these mosquitoes took mixed bloodmeals from avian and nonavian hosts. Ae. albopictus preference for humans, dogs, and cats was determined by calculating host-feeding indices for the three host pairs based on the proportion of host specific blood-fed mosquitoes collected in relation to the number of specific hosts per residence as established by a door-to-door survey conducted in 2003. Estimates of the average amount of time that residents and their pets (cats and dogs) spent out of doors were obtained. Host-feeding indices based only on host abundance indicated that Ae. albopictus was more likely to feed on domestic animals. However, when feeding indices were time-weighted, Ae. albopictus fed preferentially upon humans. Ae. albopictus blood feeding on humans was investigated using a STR/PCR-DNA profiling technique that involved amplification of three short tandem repeats loci. Of 40 human bloodmeals, 32 (80%) were from a single human, whereas

  10. 75 FR 79320 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

    Science.gov (United States)

    2010-12-20

    ... corresponding to no ] significant increase in the risk of cancer to the human consumer. However, the definition... cancer to the test animals'' approach currently found in the definitions of S m and S o . Interested... Agency is clarifying the definition of ``S o '' and revising the definition of ``S m '' so that...

  11. 77 FR 50591 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

    Science.gov (United States)

    2012-08-22

    ... cancer in the test animals of 1 in 1 million.'' The rule also clarifies the definition of S m to mean... the definition of ``S o '' and revising the definition of ``S m '' so that it conforms to the clarified definition of S o . Other clarifying and conforming changes are also being made. DATES: This...

  12. A strategy for increasing the brain uptake of a radioligand in animals: use of a drug that inhibits plasma protein binding

    Energy Technology Data Exchange (ETDEWEB)

    Haradahira, Terushi E-mail: terushi@nirs.go.jp; Zhang, Ming-Rong; Maeda, Jun; Okauchi, Takashi; Kawabe, Kouichi; Kida, Takayo; Suzuki, Kazutoshi; Suhara, Tetsuya

    2000-05-01

    A positron-emitter labeled radioligand for the glycine-binding site of the N-methyl-D-aspartate (NMDA) receptor, [{sup 11}C]L-703,717, was examined for its ability to penetrate the brain in animals by simultaneous use with drugs having high-affinity separate binding sites on human serum albumin. [{sup 11}C]L-703,717 has poor blood-brain barrier (BBB) permeability because it binds tightly to plasma proteins. Co-injection of warfarin (50-200 mg/kg), a drug that binds to albumin and resembles L-703,717 in structure, dose-dependently enhanced the penetration by [{sup 11}C]L-703,717 in mice, resulting in a five-fold increase in the brain radioactivity at 1 min after the injection. Drugs structurally unrelated to L-703,717, salicylate, phenol red, and L-tryptophan, were less effective or ineffective in increasing the uptake of [{sup 11}C]L-703,717. These results suggest that the simultaneous use of a drug that inhibits the binding of a radioligand to plasma proteins is a useful way to overcome the poor BBB permeability of the radioligand triggered by its tight binding to plasma proteins. In brain distribution studies in rodents, it was found that, after the increase in brain uptake with warfarin, much of the glycine site antagonist accumulates in the cerebellum but its pharmacological specificity did not match the glycine site of NMDA receptors.

  13. Animal Testing

    Science.gov (United States)

    Moretto, Johnny; Chauffert, Bruno; Bouyer, Florence

    The development of a new anticancer drug is a long, complex and multistep process which is supervised by regulatory authorities from the different countries all around the world [1]. Application of a new drug for admission to the market is supported by preclinical and clinical data, both including the determination of pharmacodynamics, toxicity, antitumour activity, therapeutic index, etc. As preclinical studies are associated with high cost, optimization of animal experiments is crucial for the overall development of a new anticancer agent. Moreover, in vivo efficacy studies remain a determinant panel for advancement of agents to human trials and thus, require cautious design and interpretation from experimental and ethical point of views.

  14. RP-HPLC METHOD FOR SIMULTATANEOUS DETERMINATION OF ATORVASTATIN CALCIUM, OLMESARTAN MEDOXOMIL, CANDESARTAN, HYDROCHLOROTHIAZIDE AND CHLORTHALIDONE – APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS

    Directory of Open Access Journals (Sweden)

    R.A. Mhaske et al.

    2012-03-01

    Full Text Available A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-hypertensive drugs Atorvastatin Calcium, Olmesartan Medoxomil, Candesartan, diuretics Hydrochlorothiazide and Chlorthalidone. The separation was achieved on Cosmosil PAQ (Length 150 mm × Diameter 4.6 mm Particle size 5 μm column with gradient flow. The mobile phase at a flow rate of 1.0 mL min−1 consisted of 0.05 M sodium dihydrogen phosphate buffer and acetonitrile (Gradient ratio. The UV detection was carried out at 220 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

  15. A REVISED RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND PIOGLITAZONE HCl – APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS

    Directory of Open Access Journals (Sweden)

    Hitesh P. Inamdar *,Ashok A. Mhaskeand Shirish P. Sahastrabudhe

    2013-02-01

    Full Text Available A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-diabetic drugs. The separation was achieved on ACE 3 150mm*4.6mm, 3.5µm column with gradient flow. The mobile phase at a flow rate of 1.5 mL min−1 consisted of 10mM sodium hexane sulphonate monohydrate and 10mM Potassium dihydrogen phosphate buffer with acetonitrile and methanol in gradient ratio. The UV detection was carried out at 210 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

  16. RP-HPLC METHOD FOR SIMULTATANEOUS DETERMINATION OF IRBESARTAN, LOSARTAN, HYDRO-CHLOROTHIAZIDE AND CHLORTHALIDONE–APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS

    Directory of Open Access Journals (Sweden)

    R. A. Mhaske et al.

    2012-04-01

    Full Text Available A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-hypertensive drugs Irbesartan, Losartan, diuretics Hydrochlorothiazide and Chlorthalidone. The separation was achieved on Hypersil BDS (Length 250 mm × Diameter 4.6 mm Particle size 5 μm column with gradient flow. The mobile phase at a flow rate of 1.0 mL min−1 consisted of 0.05 M sodium dihydrogen phosphate buffer and acetonitrile (Gradient ratio. The UV detection was carried out at 220 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

  17. RP-HPLC METHOD FOR SIMULTATANEOUS DETERMINATION OF AMLODIPINE BESYLATE, VALSARTAN, TELMISARTAN, HYDROCHLOROTHIAZIDE AND CHLORTHALIDONE: APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTS

    Directory of Open Access Journals (Sweden)

    R. A. Mhaske et al.

    2012-01-01

    Full Text Available A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-hypertensive drugs Amlodipine Besylate, Valsartan, Telmisartan and diuretics Hydrochlorothiazide and Chlorthalidone. The separation was achieved on Cosmosil PAQ (150 mm × 4.6 mm 5 μm column with gradient flow. The mobile phase at a flow rate of 1.0 mL min−1 consisted of 0.05 M sodium dihydrogen phosphate buffer and acetonitrile (Gradient ratio. The UV detection was carried out at 220 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

  18. A bio-ballistic micro-jet for drug injection into animal skin using a Nd:YAG laser

    Science.gov (United States)

    Yoh, J. J.; Jang, H.; Park, M.; Han, T.; Hah, J.

    2016-01-01

    Imaging of the abdominal skin of a guinea pig after injecting a fluorescent probe and biotin via the laser-induced ballistic technique revealed the epidermal and dermal layers which were stained well below 60 \\upmu m underneath the outer layer of the skin. An extensive network of cells was evident in the deeper layer of the stained dermis as the distributed fluorescein isothiocyanate dose was administered by repeated injection using a laser-based micro-jet. We performed optically controlled release of the drug by breaching the guinea pig's skin tissue targeting the region 10-400 \\upmu m beneath the outermost layer. Tissue damage was minimized by reducing the injection volume to approximately 100 nl per pulse. This was done using a micro-jet diameter equal to half of that of a conventional 200 \\upmu m syringe needle. Thus, the optimally controlled delivery of liquid drugs using an irradiated laser pulse was shown to be possible.

  19. In Vitro Research Tools in the Field of Human Immediate Drug Hypersensitivity and Their Present Use in Small Animal Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Lavergne S. Lavergne

    2016-12-01

    Full Text Available Drug hypersensitivity reactions (DHR are immune-mediated idiosyncratic adverse drug events. Type I DHR are often referred to as “immediate” and involve B lymphocyte-secreted IgE that bind to the membrane of basophils and mast cells, inducing their degranulation. This review presents various in vitro tests that were developed in the field of human type I HS and implemented as clinical diagnostic tools in human cases of immediate DHR. The respective strengths and weaknesses of each test will be discussed in parallel of validation data such as specificity and sensitivity whenever available. Some of them have also been used as diagnostic tools in veterinary medicine, but not in cases of immediate DHR. Most of these diagnostic tools can be categorized into humoral and cellular tests. The former tests measure serum concentrations of factors, such as histamine, tryptase, and drug-specific IgE. The latter assays quantify markers of drug-induced basophil activation or drug-specific lymphocyte proliferation. Pharmacogenetic markers have also been investigated in immediate DHR, but not as extensively as in non-immediate ones. Throughout, practical aspects and limitations of the tests, as well as sensitivity and specificity parameters, will be presented. In addition, the experience of veterinary medicine with these diagnostic tools will be summarized. However, to date, none of them has ever been reported in a veterinary case of type I DHR.

  20. Electrochemistry of Canis familiaris cytochrome P450 2D15 with gold nanoparticles: An alternative to animal testing in drug discovery.

    Science.gov (United States)

    Rua, Francesco; Sadeghi, Sheila J; Castrignanò, Silvia; Valetti, Francesca; Gilardi, Gianfranco

    2015-10-01

    This work reports for the first time the direct electron transfer of the Canis familiaris cytochrome P450 2D15 on glassy carbon electrodes to provide an analytical tool as an alternative to P450 animal testing in the drug discovery process. Cytochrome P450 2D15, that corresponds to the human homologue P450 2D6, was recombinantly expressed in Escherichia coli and entrapped on glassy carbon electrodes (GC) either with the cationic polymer polydiallyldimethylammonium chloride (PDDA) or in the presence of gold nanoparticles (AuNPs). Reversible electrochemical signals of P450 2D15 were observed with calculated midpoint potentials (E1/2) of −191 ± 5 and −233 ± 4 mV vs. Ag/AgCl for GC/PDDA/2D15 and GC/AuNPs/2D15, respectively. These experiments were then followed by the electro-catalytic activity of the immobilized enzyme in the presence of metoprolol. The latter drug is a beta-blocker used for the treatment of hypertension and is a specific marker of the human P450 2D6 activity. Electrocatalysis data showed that only in the presence of AuNps the expected α-hydroxy-metoprolol product was present as shown by HPLC. The successful immobilization of the electroactive C. familiaris cytochrome P450 2D15 on electrode surfaces addresses the ever increasing demand of developing alternative in vitromethods for amore detailed study of animal P450 enzymes' metabolism, reducing the number of animals sacrificed in preclinical tests.

  1. Establishment study of the in vivo imaging analysis with small animal imaging modalities (micro-PET and micro-SPECT/CT) for bio-drug development

    Energy Technology Data Exchange (ETDEWEB)

    Jang, Beomsu; Park, Sanghyeon; Park, Jeonghoon; Jo, Sungkee; Jung, Uhee; Kim, Seolwha; Lee, Yunjong; Choi, Daeseong

    2011-01-15

    In this study, we established the image acquisition and analysis procedures of micro-PET, SPECT/CT using the experimental animal (mouse) for the development of imaging assessment method for the bio-drug. We examined the micro-SPECT/CT, PET imaging study using the Siemens Inveon micro-multimodality system (SPECT/CT) and micro-PET with {sup 99m}Tc-MDP, DMSA, and {sup 18}F-FDG. SPECT imaging studies using 3 types of pinhole collimators. 5-MWB collimator was used for SPECT image study. To study whole-body distribution, {sup 99m}Tc-MDP SPECT image study was performed. We obtained the fine distribution image. And the CT images was obtained to provide the anatomical information. And then these two types images are fused. To study specific organ uptake, we examined {sup 99}mTc-DMSA SPECT/CT imaging study. We also performed the PET image study using U87MG tumor bearing mice and {sup 18}F-FDG. The overnight fasting, warming and anesthesia with 2% isoflurane pretreatment enhance the tumor image through reducing the background uptake including brown fat, harderian gland and skeletal muscles. Also we got the governmental approval for use of x-ray generator for CT and radioisotopes as sealed and open source. We prepared the draft of process procedure for the experimental animal imaging facility. These research results can be utilized as a basic image study protocols and data for the image assessment of drugs including biological drug.

  2. 21 CFR 211.173 - Laboratory animals.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Laboratory animals. 211.173 Section 211.173 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Laboratory animals. Animals used in testing components, in-process materials, or drug products for...

  3. Post-surgical analgesia in rainbow trout: is reduced cardioventilatory activity a sign of improved animal welfare or the adverse effects of an opioid drug?

    Science.gov (United States)

    Gräns, Albin; Sandblom, Erik; Kiessling, Anders; Axelsson, Michael

    2014-01-01

    The use of fish models in biomedical research is increasing. Since behavioural and physiological consequences of surgical procedures may affect experimental results, these effects should be defined and, if possible, ameliorated. Thus, the use of post-surgical analgesia should be considered after invasive procedures also in fish, but presently, little information exists on the effects of analgesics in fish. This study assessed the effects of an opioid drug, buprenorphine (0.05 mg/kg IM), on resting ventilation and heart rates during 7 days of postsurgical recovery in rainbow trout (Oncorhynchus mykiss) at 10°C by non-invasively recording bioelectric potentials from the fish via electrodes in the water. Baseline ventilation and heart rates were considerably lower compared to previously reported values for rainbow trout at 10°C, possibly due to the non-invasive recording technique. Buprenorphine significantly decreased both ventilation and heart rates further, and the effects were most pronounced at 4-7 days after anaesthesia, surgical procedures and administration of the drug. Somewhat surprisingly, the same effects of buprenorphine were seen in the two control groups that had not been subject to surgery. These results indicate that the reductions in ventilation and heart rates are not caused by an analgesic effect of the drug, but may instead reflect a general sedative effect acting on both behaviour as well as e.g. central control of ventilation in fishes. This resembles what has previously been demonstrated in mammals, although the duration of the drug effect is considerably longer in this ectothermic animal. Thus, before using buprenorphine for postoperative analgesic treatment in fish, these potentially adverse effects need further characterisation.

  4. [Not Available].

    Science.gov (United States)

    Murray, Clinton K; Bennett, Jason W

    2009-01-01

    Malaria's global impact is expansive and includes the extremes of the healthcare system ranging from international travelers returning to nonendemic regions with tertiary referral medical care to residents in hyperendemic regions without access to medical care. Implementation of prompt and accurate diagnosis is needed to curb the expanding global impact of malaria associated with ever-increasing antimalarial drug resistance. Traditionally, malaria is diagnosed using clinical criteria and/or light microscopy even though both strategies are clearly inadequate in many healthcare settings. Hand held immunochromatographic rapid diagnostic tests (RDTs) have been recognized as an ideal alternative method for diagnosing malaria. Numerous malaria RDTs have been developed and are widely available; however, an assortment of issues related to these products have become apparent. This review provides a summary of RDT including effectiveness and strategies to select the ideal RDT in varying healthcare settings.

  5. A retractable barb needle for drug darts

    Directory of Open Access Journals (Sweden)

    G.L. van Rooyen

    1973-07-01

    Full Text Available The mechanism and action of a new retractable barbneedle for drug darts are described. This dart needle is particularly successful in obviating unnecessary flight reactions andtrauma in darted animals, and facilitates the complete injection of the drug dose before the barb is retracted and the dart is dislogded from the animal. The whole process is completed within a few seconds and the expended dart can usually be retrieved in the immediate vicinity where the animal was darted.

  6. Drug: D09176 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available 91], Beauveria bassiana [TAX:176275] Same as: E00308 Bombycidae Silkworm infected Cordycepitaceae Beauveria bassiana Vuillemin.; Stan...dards for non-pharmacopoeial crude drugs Crude drugs [BR:br08305] Animals Insects D09176 Stiff silkworm PubChem: 96025856 ...

  7. Change in enrollment patterns, patient selection, and clinical outcomes with the availability of drug-eluting stents in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial

    Science.gov (United States)

    Shah, Binita; Srinivas, Vankeepuram S.; Lu, Jiang; Brooks, Maria M.; Bates, Eric R.; Nedeljkovic, Zoran S.; Escobedo, Jorge; Das, Gladwin S.; Lopez, John J.; Feit, Frederick

    2013-01-01

    Background In the BARI 2D trial, patients with type 2 diabetes and stable coronary artery disease were randomized to prompt revascularization versus intensive medical therapy (IMT). This analysis sought to evaluate how the availability of drug-eluting stents (DESs) has changed practice and outcomes. Methods In BARI 2D, 1,605 patients were in the percutaneous coronary intervention (PCI)–intended stratum. As DES became available midway through recruitment, we report clinical outcomes among patients who underwent IMT versus prompt PCI with bare-metal stents (BMSs) or DES up to 4 years. Results In North America, after DES became available, selection for the PCI-intended stratum increased from 73% to 79% (P = .003). Fewer BMS than DES patients had total occlusions treated or underwent rotational atherectomy (5.6% vs 9.7%, P = .02, and 1.2% vs 3.7%, P < .01, respectively). Subsequent revascularization (IMT 39%, BMS 29%, DES 21%, P < .01) and target vessel revascularization (BMS 16.1% vs DES 9.6%, P = .03) were lower with DES. Angina at 2 years tended to be less common with DES (IMT 39%, BMS 37%, DES 29%, P = .04, for 3 groups, P = .07 for DES vs BMS). The composite of death, myocardial infarction, or stroke was IMT 16.0%, BMS 20.5%, DES 17.5%; P = .80. Conclusions When DES became available in North America, patients were more likely to be selected into the PCI-intended stratum. Compared with patients receiving BMS, those receiving DES tended to have less target vessel revascularization and angina. PMID:24016502

  8. 21 CFR 514.11 - Confidentiality of data and information in a new animal drug application file.

    Science.gov (United States)

    2010-04-01

    ... availability for public disclosure of any record in the NADA file shall be handled in accordance with the...) For an NADA approved prior to July 1, 1975, internal agency records that describe such data and.... (a) The Center for Veterinary Medicine may at an appropriate time prior to approval of the...

  9. Transgenic animals and their application in medicine

    Directory of Open Access Journals (Sweden)

    Bagle TR, Kunkulol RR, Baig MS, More SY

    2013-01-01

    Full Text Available Transgenic animals are animals that are genetically altered to have traits that mimic symptoms of specific human pathologies. They provide genetic models of various human diseases which are important in understanding disease and developing new targets. In early 1980 Gordon and co-workers described the first gene addition experiment using the microinjection technology and since then the impact of transgenic technology on basic research has been significant. Within 20 years of its inception, ATryn the first drug approved by USFDA from transgenic animals was developed and it has opened door to drugs from transgenic animals. In addition, they are looked upon as potential future donors for xenotransplantation. With increasing knowledge about the genetics and improvements in the transgenetic technology numerous useful applications like biologically safe new-generation drugs based on human regulatory proteins are being developed.Various aspects of concern in the coming years are the regulatory guidelines, ethical issues and patents related to the use of transgenic animals. This modern medicine is on the threshold of a pharmacological revolution. Use of transgenic animals will provide solutions for drug research, xenotransplantation, clinical trials and will prove to be a new insight in drug development.

  10. Animal Studies of Addictive Behavior

    OpenAIRE

    Vanderschuren, Louk J.M.J.; Ahmed, Serge H.

    2013-01-01

    It is increasingly recognized that studying drug taking in laboratory animals does not equate to studying genuine addiction, characterized by loss of control over drug use. This has inspired recent work aimed at capturing genuine addiction-like behavior in animals. In this work, we summarize empirical evidence for the occurrence of several DSM-IV-like symptoms of addiction in animals after extended drug use. These symptoms include escalation of drug use, neurocognitive deficits, resistance to...

  11. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Science.gov (United States)

    2013-09-13

    ... revising the guidance to reflect advancements in the science and technology of bioanalytical method... to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications...

  12. Towards an animal model of food addiction.

    Science.gov (United States)

    de Jong, Johannes W; Vanderschuren, Louk J M J; Adan, Roger A H

    2012-01-01

    The dramatically increasing prevalence of obesity, associated with potentially life-threatening health problems, including cardiovascular diseases and type II diabetes, poses an enormous public health problem. It has been proposed that the obesity epidemic can be explained by the concept of 'food addiction'. In this review we focus on possible similarities between binge eating disorder (BED), which is highly prevalent in the obese population, and drug addiction. Indeed, both behavioral and neural similarities between addiction and BED have been demonstrated. Behavioral similarities are reflected in the overlap in DSM-IV criteria for drug addiction with the (suggested) criteria for BED and by food addiction-like behavior in animals after prolonged intermittent access to palatable food. Neural similarities include the overlap in brain regions involved in food and drug craving. Decreased dopamine D2 receptor availability in the striatum has been found in animal models of binge eating, after cocaine self-administration in animals as well as in drug addiction and obesity in humans. To further explore the neurobiological basis of food addiction, it is essential to have an animal model to test the addictive potential of palatable food. A recently developed animal model for drug addiction involves three behavioral characteristics that are based on the DSM-IV criteria: i) extremely high motivation to obtain the drug, ii) difficulty in limiting drug seeking even in periods of explicit non-availability, iii) continuation of drug-seeking despite negative consequences. Indeed, it has been shown that a subgroup of rats, after prolonged cocaine self-administration, scores positive on these three criteria. If food possesses addictive properties, then food-addicted rats should also meet these criteria while searching for and consuming food. In this review we discuss evidence from literature regarding food addiction-like behavior. We also suggest future experiments that could

  13. Development of Liposomal Formulation for Delivering Anticancer Drug to Breast Cancer Stem-Cell-Like Cells and its Pharmacokinetics in an Animal Model.

    Science.gov (United States)

    Ahmad, Ajaz; Mondal, Sujan Kumar; Mukhopadhyay, Debabrata; Banerjee, Rajkumar; Alkharfy, Khalid M

    2016-03-07

    The objective of the present study is to develop a liposomal formulation for delivering anticancer drug to breast cancer stem-cell-like cells, ANV-1, and evaluate its pharmacokinetics in an animal model. The anticancer drug ESC8 was used in dexamethasone (Dex)-associated liposome (DX) to form ESC8-entrapped liposome named DXE. ANV-1 cells showed high-level expression of NRP-1. To enhance tumor regression, we additionally adapted to codeliver the NRP-1 shRNA-encoded plasmid using the established DXE liposome. In vivo efficacy of DXE-NRP-1 was carried out in mice bearing ANV-1 cells as xenograft tumors and the extent of tumor growth inhibition was evaluated by tumor-size measurement. A significant difference in tumor volume started to reveal between DXE-NRP-1 group and DXE-Control group. DXE-NRP-1 group showed ∼4 folds and ∼2.5 folds smaller tumor volume than exhibited by untreated and DXE-Control-treated groups, respectively. DXE disposition was evaluated in Sprague-Dawley rats following an intraperitoneal dose (3.67 mg/kg of ESC8 in DXE). The plasma concentrations of ESC8 in the DXE formulation were measured by liquid chromatography mass spectrometry and pharmacokinetic parameters were determined using a noncompartmental analysis. ESC8 had a half-life of 11.01 ± 0.29 h, clearance of 2.10 ± 3.63 L/kg/h, and volume of distribution of 33.42 ± 0.83 L/kg. This suggests that the DXE liposome formulation could be administered once or twice daily for therapeutic efficacy. In overall, we developed a potent liposomal formulation with favorable pharmacokinetic and tumor regressing profile that could sensitize and kill highly aggressive and drug-resistive cancer stem-cell-like cells.

  14. Protective effect of geranylgeranylacetone, an inducer of heat shock protein 70, against drug-induced lung injury/fibrosis in an animal model

    Directory of Open Access Journals (Sweden)

    Hasegawa Yoshinori

    2009-09-01

    Full Text Available Abstract Background To determine whether oral administration of geranylgeranylacetone (GGA, a nontoxic anti-ulcer drug that is an inducer of heat shock protein (HSP 70, protects against drug-induced lung injury/fibrosis in vivo. Methods We used a bleomycin (BLM-induced lung fibrosis model in which mice were treated with oral 600 mg/kg of GGA before and after BLM administration. Inflammation and fibrosis were evaluated by histological scoring, hydroxyproline content in the lung and inflammatory cell count, and quantification by ELISA of macrophage inflammatory protein-2 (MIP-2 in bronchoalveolar lavage fluid. Apoptosis was evaluated by the TUNEL method. The induction of HSP70 in the lung was examined with western blot analysis and its localization was determined by immunohistochemistry. Results We confirmed the presence of inflammation and fibrosis in the BLM-induced lung injury model and induction of HSP70 by oral administration of GGA. GGA prevented apoptosis of cellular constituents of lung tissue, such as epithelial cells, most likely related to the de novo induction of HSP70 in the lungs. GGA-treated mice also showed less fibrosis of the lungs, associated with the findings of suppression of both production of MIP-2 and inflammatory cell accumulation in the injured lung, compared with vehicle-treated mice. Conclusion GGA had a protective effect on drug-induced lung injury/fibrosis. Disease-modifying antirheumatic drugs such as methotrexate, which are indispensable for the treatment of rheumatoid arthritis, often cause interstitial lung diseases, an adverse event that currently cannot be prevented. Clinical use of GGA for drug-induced pulmonary fibrosis might be considered in the future.

  15. A REVIEW ON ANIMAL MODELS OF DEPRESSION

    OpenAIRE

    Madhu Devi* and Ramica Sharma

    2013-01-01

    As described by the world health organization (WHO), depression is the most common and serious disorder leading to suicide. Numbers of synthetic drugs are available for the treatment of this fatal disease, but are associated with serious complications. A wide diversity of animal models has been used to examine antidepressant activity. These range from relatively simple models sensitive to acute treatment, to highly sophisticated models. The number of validated animal models for affective diso...

  16. Translational research challenges: finding the right animal models.

    Science.gov (United States)

    Prabhakar, Sharma

    2012-12-01

    Translation of scientific discoveries into meaningful human applications, particularly novel therapies of human diseases, requires development of suitable animal models. Experimental approaches to test new drugs in preclinical phases often necessitated animal models that not only replicate human disease in etiopathogenesis and pathobiology but also biomarkers development and toxicity prediction. Whereas the transgenic and knockout techniques have revolutionized manipulation of rodents and other species to get greater insights into human disease pathogenesis, we are far from generating ideal animal models of most human disease states. The challenges in using the currently available animal models for translational research, particularly for developing potentially new drugs for human disease, coupled with the difficulties in toxicity prediction have led some researchers to develop a scoring system for translatability. These aspects and the challenges in selecting an animal model among those that are available to study human disease pathobiology and drug development are the topics covered in this detailed review.

  17. Animal Models of Depression and Drug Delivery with Food as an Effective Dosing Method: Evidences from Studies with Celecoxib and Dicholine Succinate

    Directory of Open Access Journals (Sweden)

    João P. Costa-Nunes

    2015-01-01

    Full Text Available Multiple models of human neuropsychiatric pathologies have been generated during the last decades which frequently use chronic dosing. Unfortunately, some drug administration methods may result in undesirable effects creating analysis confounds hampering model validity and preclinical assay outcomes. Here, automated analysis of floating behaviour, a sign of a depressive-like state, revealed that mice, subjected to a three-week intraperitoneal injection regimen, had increased floating. In order to probe an alternative dosing design that would preclude this effect, we studied the efficacy of a low dose of the antidepressant imipramine (7 mg/kg/day delivered via food pellets. Antidepressant action for this treatment was found while no other behavioural effects were observed. We further investigated the potential efficacy of chronic dosing via food pellets by testing the antidepressant activity of new drug candidates, celecoxib (30 mg/kg/day and dicholine succinate (50 mg/kg/day, against standard antidepressants, imipramine (7 mg/kg/day and citalopram (15 mg/kg/day, utilizing the forced swim and tail suspension tests. Antidepressant effects of these compounds were found in both assays. Thus, chronic dosing via food pellets is efficacious in small rodents, even with a low drug dose design, and can prevail against potential confounds in translational research within depression models applicable to adverse chronic invasive pharmacotherapies.

  18. Real-time study of E-cadherin and membrane dynamics in living animals: implications for disease modeling and drug development.

    Science.gov (United States)

    Serrels, Alan; Timpson, Paul; Canel, Marta; Schwarz, Juliane P; Carragher, Neil O; Frame, Margaret C; Brunton, Valerie G; Anderson, Kurt I

    2009-04-01

    The ability of tumor cells to invade and metastasize requires deregulation of interactions with adjacent cells and the extracellular matrix. A major challenge of cancer biology is to observe the dynamics of the proteins involved in this process in their functional and physiologic context. Here, for the first time, we have used photobleaching and photoactivation to compare the mobility of cell adhesion and plasma membrane probes in vitro and in tumors grown in mice (in vivo). We find differences between in vitro and in vivo recovery dynamics of two key molecules, the tumor suppressor E-cadherin and the membrane-targeting sequence of H-Ras. Our data show that E-cadherin dynamics are significantly faster in vivo compared with cultured cells, that the ratio of E-cadherin stabilized in cell-cell junctions is significantly higher in vivo, and that E-cadherin mobility correlates with cell migration. Moreover, quantitative imaging has allowed us to assess the effects of therapeutic intervention on E-cadherin dynamics using dasatinib, a clinically approved Src inhibitor, and show clear differences in the efficacy of drug treatment in vivo. Our results show for the first time the utility of photobleaching and photoactivation in the analysis of dynamic biomarkers in living animals. Furthermore, this work highlights critical differences in molecular dynamics in vitro and in vivo, which have important implications for the use of cultured disease models as surrogates for living tissue.

  19. The nonsteroidal antiinflammatory drug piroxicam reverses the onset of depressive-like behavior in 6-OHDA animal model of Parkinson's disease.

    Science.gov (United States)

    Santiago, R M; Tonin, F S; Barbiero, J; Zaminelli, T; Boschen, S L; Andreatini, R; Da Cunha, C; Lima, M M S; Vital, M A B F

    2015-08-06

    Depression is one of the most common psychiatric symptoms in patients with Parkinson's disease (PD). Some authors have reported that depression is characterized by activation of the inflammatory response. Animal models of PD also present with depressive-like behavior, such as increased immobility time in the modified forced swim test and anhedonia-like behavior in the sucrose preference test. Considering the potential neuroprotective effect of nonsteroidal antiinflammatory drugs in neurodegenerative diseases, the objective of the present study was to investigate the effects of piroxicam on depressive-like behavior in male Wistar rats lesioned with 6-hydroxydopamine (6-OHDA) in the substantia nigra (SN). Antidepressant-like effects were observed after prolonged administration of piroxicam for 21days. In the forced swim test, the 6-OHDA+saline group exhibited significant reductions in swimming time and increased immobility time compared with the sham+saline. In the sucrose preference test, the 6-OHDA+piroxicam group exhibited no reduction of sucrose preference compared with the sham+saline, with significant effects of treatment and time and a significant treatment×time interaction. 5-Hydroxytryptamine (5-HT) levels significantly decreased in the hippocampus in the 6-OHDA+saline group and not changed in the 6-OHDA+piroxicam group when compared with the sham+saline on day 21. In conclusion, 21-day treatment with piroxicam reversed the onset of depressive-like behavior and prevented the reduction of hippocampal 5-HT levels.

  20. Optimization of chitosan film as a substitute for animal and human epidermal sheets for in vitro permeation of polar and non polar drugs.

    Science.gov (United States)

    Rana, Vikas; Babita, Kumar; Goyal, Dinesh; Gorea, Rakesh; Tiwary, Ashok

    2004-12-01

    The present investigation is aimed at preparing chitosan films capable of simulating the flux of modal drugs, 5-fluorouracil (5-FU) and indomethacin (INDO), across rat, rabbit and human cadaver epidermal sheets. Application of statistical design revealed that the concentration of chitosan, crosslinking time and concentration of crosslinking agent significantly influenced the in vitro flux of 5-FU and INDO across chitosan films. Multiple linear regression revealed a linear influence of all these active variables on 5-FU and INDO flux. It was deduced from atomic absorption spectroscopic analyses, DSC and IR spectroscopic data that 5% (m/V) sodium tripolyphosphate (NaTPP) produced optimum crosslinking of chitosan films. The in vitro permeation of both 5-FU and INDO across optimized film formulations was found to be comparable to that obtained across rat, rabbit and human epidermal sheets. These results indicate that optimized chitosan films have a potential to be developed as a substitute for animal and human cadaver epidermal sheets for preliminary in vitro permeation studies.

  1. Animal welfare assessment

    Directory of Open Access Journals (Sweden)

    Vučinić Marijana

    2008-01-01

    Full Text Available The paper deals with animal welfare definitions and animal welfare assessment. Animal welfare is a prolonged mental state, resulting from how the animal experiences its environment over time. There are different methods for animal welfare assessment. The four basic criteria for animal welfare assessment are feeding, housing, health and appropriate behavior. Therefore, criteria used to assess animal welfare are not direct measures of the mental state but only parameters that need to be interpreted in terms of welfare. The immediate housing environment and feeding may influence animal welfare either positively, when most of the important requirements are respected, or negatively, when animals are exposed to various stress factors and unpleasant emotions that contribute to animal disease, injuries or inappropriate behavior. Therefore, animal welfare is a unique link between housing conditions, feeding and watering on one side, and animal health status and behavior on the other side.

  2. FARM ANIMAL WELFARE ECONOMICS

    Directory of Open Access Journals (Sweden)

    L.T. CZISZTER

    2013-07-01

    Full Text Available This paper reviews the literature regarding the economics of the farm animal welfare. The following issues are addressed: productions costs and savings of the animal welfare regulations, benefits of improved animal welfare, and consumers’ willingness to pay for animal-friendly products.

  3. A REVIEW ON ANIMAL MODELS OF DEPRESSION

    Directory of Open Access Journals (Sweden)

    Madhu Devi* and Ramica Sharma

    2013-10-01

    Full Text Available As described by the world health organization (WHO, depression is the most common and serious disorder leading to suicide. Numbers of synthetic drugs are available for the treatment of this fatal disease, but are associated with serious complications. A wide diversity of animal models has been used to examine antidepressant activity. These range from relatively simple models sensitive to acute treatment, to highly sophisticated models. The number of validated animal models for affective disorders is large and still growing. A basic understanding of the underlying disease processes in depression is lacking, and therefore, recreating the disease in animal models is not possible. For the animal model of depression, the relevance, reliability and reproducibility in laboratories need to be focused, currently used models of depression attempt to produce quantifiable correlates of human symptoms in experimental animals and the animal modeling remains a potentially important approach towards understanding neurochemical and neurobiological mechanisms in depression. Animal models of depression attempt to represent some aspect of the etiology, symptomatology and treatment of the disorders, in order to facilitate their scientific study. Hence, this review deals with animal models that are beneficial for evaluating the potential of antidepressants. The present review further discusses the ability of currently available animal models for depression to investigate the novel hypothesis.

  4. Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies.

    Science.gov (United States)

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Freitas, C S; Marcon, R; Schwanke, R C; Siqueira, J M; Calixto, J B

    2016-10-24

    This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies. Collectively, improving these aspects will certainly contribute to the robustness of both scientific publications and the translation of new substances to clinical development.

  5. Characteristics and Availability of Different Forms of Phosphorus in Animal Manures%不同动物粪肥的磷素形态特征及有效性分析

    Institute of Scientific and Technical Information of China (English)

    严正娟; 陈硕; 王敏锋; 宋梓玮; 贾伟; 陈清

    2015-01-01

    -ruminant animal manure. Both ruminant and non-ruminant animals have high availability of P in manures. Therefore, the contribution of long-term application non-ruminant animal manure to environmental risk is similar to application of ruminant animal manure with applica-tion of the same amount of P. However, due to the higher P content, the former may contribute to higher environmental risk, compared with latter based on application of the same amount of manure.

  6. Animal Locomotion

    CERN Document Server

    Taylor, Graham K; Tropea, Cameron

    2010-01-01

    This book provides a wide-ranging snapshot of the state-of-the-art in experimental research on the physics of swimming and flying animals. The resulting picture reflects not only upon the questions that are of interest in current pure and applied research, but also upon the experimental techniques that are available to answer them. Doubtless, many new questions will present themselves as the scope and performance of our experimental toolbox develops over the coming years.

  7. Ethics in Animal Experimentation

    Directory of Open Access Journals (Sweden)

    Yusuf Ergun

    2010-08-01

    Full Text Available Experimental animals are frequently used to obtain information for primarily scientific reasons. In the present review, ethics in animal experimentation is examined. At first, the history of animal experimentation and animal rights is outlined. Thereafter, the terms in relation with the topic are defined. Finally, prominent aspects of 3Rs constituting scientific and ethical basis in animal experimentation are underlined. [Archives Medical Review Journal 2010; 19(4.000: 220-235

  8. International Conference on Harmonisation; guidance on data elements for transmission of individual case safety reports; availability. Notice. Food and Drug Administration, HHS.

    Science.gov (United States)

    1998-01-15

    The Food and Drug Administration (FDA) is publishing a guidance entitled "E2B Data Elements for Transmission of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance is intended to facilitate the standardization of the data elements for the transmission of individual case safety reports for both preapproval and postapproval reporting periods.

  9. Animal-derived pharmaceutical proteins.

    Science.gov (United States)

    Redwan, el-Rashdy M

    2009-01-01

    Livestock animals have made a significant contribution to human health and well-being throughout humankind's history. A significant contribution of farm animals to human health are the longstanding use of bovine and porcine for production of insulin (for treatment of diabetes), gelatin (for pharmaceutical and other purposes), as well as horse and sheep antibody against natural venoms, toxins, drugs and microbial peptides. Gelatin being the biggest animal protein consumed in human health, follows with antibodies fragments. The chronic problem of animal-derived therapeutics, especially those of high molecular weight, is the immunogenicity induction in addition to their biosafety. However, the invertebrates and lower vertebrates donate the human being a several crucial emergency saving life small-peptides or their analogs such as Refludan, Prialt, Exendin. Not only, but the farm animals are enormously using as models for novel surgical strategies, testing of biodegradable implants and sources of tissue replacements, such as skin and heart valves. Recently, they are being harnessing as bioreactor for production of biopharmaceutical related products through gene farming with efficiency far greater than any conventional microbial or cell-culture production systems. Only 16 transgenic cows would be covering the worldwide needs from human growth hormone. The transgenic, especially animal, technology would be solving a several biopharmaceutical products disadvantages, such as cost, biosafety, immunogenicity and the availability dimensions.

  10. Carotenoids in Marine Animals

    Directory of Open Access Journals (Sweden)

    Takashi Maoka

    2011-02-01

    Full Text Available Marine animals contain various carotenoids that show structural diversity. These marine animals accumulate carotenoids from foods such as algae and other animals and modify them through metabolic reactions. Many of the carotenoids present in marine animals are metabolites of β-carotene, fucoxanthin, peridinin, diatoxanthin, alloxanthin, and astaxanthin, etc. Carotenoids found in these animals provide the food chain as well as metabolic pathways. In the present review, I will describe marine animal carotenoids from natural product chemistry, metabolism, food chain, and chemosystematic viewpoints, and also describe new structural carotenoids isolated from marine animals over the last decade.

  11. Basic research: Issues with animal experimentations

    Directory of Open Access Journals (Sweden)

    Shyam K Saraf

    2013-01-01

    Full Text Available In vivo studies using the animals are helpful in developing the treatment strategies as they are important link between the successful in vitro testing and safe human use. Various research projects in the field of fixation of fractures, development of newer biomaterials, chemotherapeutic drugs, use of stem cells in nonunion of fractures and cartilage defects etc., have hugely depended on animal experimentation. The employment of animals in experiments is both scientific and ethical issue. There must be reasonable reasons to show that it will significantly advance the present knowledge and lead to improvement in care. The regulatory bodies exist for humane use and care of animals used for experiments e.g., International Council for Laboratory Animal Science, Council for International Organizations of Medical Sciences, International Union of Biological Sciences, International Committee on Laboratory Animals. In India, Indian National Science Academy, Indian Council of Medical Research, National Centre for Laboratory Animal Sciences promote high standards of laboratory animal quality, care and health. The Committee for the Purpose of Control and Supervision on Experiments on Animals guidelines are well defined and is a must read document for any one interested to carry out research with animal facilities.

  12. Animal studies of addictive behavior.

    Science.gov (United States)

    Vanderschuren, Louk J M J; Ahmed, Serge H

    2013-04-01

    It is increasingly recognized that studying drug taking in laboratory animals does not equate to studying genuine addiction, characterized by loss of control over drug use. This has inspired recent work aimed at capturing genuine addiction-like behavior in animals. In this work, we summarize empirical evidence for the occurrence of several DSM-IV-like symptoms of addiction in animals after extended drug use. These symptoms include escalation of drug use, neurocognitive deficits, resistance to extinction, increased motivation for drugs, preference for drugs over nondrug rewards, and resistance to punishment. The fact that addiction-like behavior can occur and be studied in animals gives us the exciting opportunity to investigate the neural and genetic background of drug addiction, which we hope will ultimately lead to the development of more effective treatments for this devastating disorder.

  13. [Alcohol, tobacco and cannabis: Review of teratogenicity studies in animals].

    Science.gov (United States)

    Spézia, F

    2006-10-01

    Despite an intensive national campaign of information, the drugs most frequently consumed by young adults undoubtedly continue to be alcohol, tobacco and cannabis. If the impact of these drugs on the health of the consumers can be evaluated in conjunction with the clinical and epidemiologic data, the consequences on the embryo due to their consumption by the pregnant women can be appreciated thanks to the abundant literature describing their effects in the gravid animal. Taking into account the abundant literature available in multiple animal species, the zero drug recommendation should be widely diffused to pregnant women.

  14. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Science.gov (United States)

    2010-08-06

    ... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug...) information for drug substances that should be submitted to support original new animal drug applications... of information in section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) have...

  15. [Not Available].

    Science.gov (United States)

    Houin, René

    2014-10-01

    Among human parasites, some are also hosted by wild animals which can play a role in their transmission. Different rodents are well known as reservoirs of cutaneous leishmaniasis or of multilocular echinococcosis. But some other groups as fish, can also carry parasites; herrings causes anisakiasis in North Europe, but fresh water fishes do the same for Diphyllobothrium in alpine lakes. Human cases of trichinellosis are rare in countries where veterinary control of pig and horse meat is strict, but cases still occurr with boar meat. All together, the incidence in developped countries is limited, but reducing the prevention would induce re-emergencies of public health importance.

  16. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...

  17. The Nuremberg Code subverts human health and safety by requiring animal modeling

    Directory of Open Access Journals (Sweden)

    Greek Ray

    2012-07-01

    Full Text Available Abstract Background The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations. Discussion We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for models in toxicity testing as an example of the problem with using animal models. Summary We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented.

  18. Animal models of epilepsy for the development of antiepileptogenic and disease-modifying drugs. A comparison of the pharmacology of kindling and post-status epilepticus models of temporal lobe epilepsy.

    Science.gov (United States)

    Löscher, Wolfgang

    2002-06-01

    Control of epilepsy has primarily focused on suppressing seizure activity by antiepileptic drugs (AEDs) after epilepsy has developed. AEDs have greatly improved the lives of people with epilepsy. However, the belief that AEDs, in addition to suppressing seizures, alter the underlying epileptogenic process and, in doing so, the course of the disease and its prognosis, is not supported by the current clinical and experimental data. An intriguing possibility is to control acquired epilepsy by preventing epileptogenesis, the process by which the brain becomes epileptic. A number of AEDs have been evaluated in clinical trials to test whether they prevent epileptogenesis in humans, but to date no drug has been shown to be effective in such trials. Thus, there is a pressing need for drugs that are truly antiepileptogenic to either prevent epilepsy or alter its natural course. For this purpose, animal models of epilepsy are an important prerequisite. There are various animal models with chronic brain dysfunctions thought to reflect the processes underlying human epilepsy. Such chronic models of epilepsy include the kindling model of temporal lobe epilepsy (TLE), post-status models of TLE in which epilepsy develops after a sustained status epilepticus, and genetic models of different types of epilepsy. Currently, the kindling model and post-status models, such as the pilocarpine or kainate models, are the most widely used models for studies on epileptogenic processes and on drug targets by which epilepsy can be prevented or modified. Furthermore, the seizures in these models can be used for testing of antiepileptic drug effects. A comparison of the pharmacology of chronic models with models of acute (reactive or provoked) seizures in previously healthy (non-epileptic) animals, such as the maximal electroshock seizure test, demonstrates that drug testing in chronic models of epilepsy yields data which are more predictive of clinical efficacy and adverse effects, so that

  19. Biotecnologia animal

    Directory of Open Access Journals (Sweden)

    Luiz Lehmann Coutinho

    2010-01-01

    Full Text Available A biotecnologia animal tem fornecido novas ferramentas para os programas de melhoramento e, dessa forma, contribuído para melhorar a eficiência da produção dos produtos de origem animal. No entanto, os avanços têm sido mais lentos do que antecipados, especialmente em razão da dificuldade na identificação dos genes responsáveis pelas características fenotípicas de interesse zootécnico. Três estratégias principais têm sido utilizadas para identificar esses genes - mapeamento de QTL, genes candidatos e sequenciamento de DNA e mRNA - e cada uma tem suas vantagens e limitações. O mapeamento de QTL permite determinar as regiões genômicas que contêm genes, mas o intervalo de confiança do QTL pode ser grande e conter muitos genes. A estratégia de genes candidatos é limitada por causa do conhecimento ainda restrito das funções de todos os genes. Os sequenciamentos de genomas e de sequências expressas podem auxiliar na identificação da posição de genes e de vias metabólicas associadas à característica de interesse. A integração dessas estratégias por meio do desenvolvimento de programas de bioinformática permitirá a identificação de novos genes de interesse zootécnico. Assim, os programas de melhoramento genético se beneficiarão pela inclusão da informação obtida diretamente do DNA na avaliação do mérito genético dos plantéis disponíveis.Animal biotechnology is providing new tools for animal breeding and genetics and thus contributing to advances in production efficiency and quality of animal products. However, the progress is slower than anticipated, mainly because of the difficulty involved in identifying genes that control phenotypic characteristics of importance to the animal industry. Three main strategies: QTL mapping, candidate genes and DNA and mRNA sequencing have been used to identify genes of economic interest to animal breeding and each has advantages and disadvantages. QTL mapping allows

  20. Drug: D04969 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D04969 Crude, Drug White beeswax (JP16); Wax, white (NF); White wax (TN) Apis indic...swax (JP16); Wax, white (NF) Crude drugs [BR:br08305] Animals Insects D04969 White beeswax CAS: 8012-89-3 PubChem: 17398240 NIKKAJI: J269.255D ... ...n [BR:br08301] 7 Agents not mainly for therapeutic purpose 71 Dispensing medicines 712 Ointment bases 7121 Oil bases D04969 White bee

  1. Drug: D06776 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D06776 Crude, Drug Honey (JP16); Honey, purified (NF); Honey (TN) Invert sugar [DR:...rapeutic category: 7149 Apidae Honey Major component: Invert sugar [DR:D06532] Th...medicines 714 Flavorings, deodorants, coloring agents 7149 Others D06776 Honey (JP16); Honey, purified (NF) ... for replenishing Qi D06776 Honey; Honey, purified; Honey Crude drugs [BR:br08305] Animals Insects D06776 Honey; Honey, purified CAS: 8028-66-8 PubChem: 47208427 ...

  2. Animal research

    DEFF Research Database (Denmark)

    Olsson, I.A.S.; Sandøe, Peter

    2012-01-01

    in research is analyzed from the viewpoint of three distinct ethical approaches: contractarianism, utilitarianism, and animal rights view. On a contractarian view, research on animals is only an ethical issue to the extent that other humans as parties to the social contract care about how research animals......This article presents the ethical issues in animal research using a combined approach of ethical theory and analysis of scientific findings with bearing on the ethical analysis. The article opens with a general discussion of the moral acceptability of animal use in research. The use of animals...... are faring. From the utilitarian perspective, the use of sentient animals in research that may harm them is an ethical issue, but harm done to animals can be balanced by benefit generated for humans and other animals. The animal rights view, when thoroughgoing, is abolitionist as regards the use of animals...

  3. [Not Available].

    Science.gov (United States)

    1992-03-25

    Archersstar Sudha Bhuchar, right, launches a video on breast screening for women from ethnic minorities, sponsored by the NHS. The video is available in six languages. Ms Bhuchar is pictured with programme co-ordinator Julietta Patrick.

  4. Places available**

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. TECHNICAL TRAINING Monique Duval tel. 74924 technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: ACCESS 2000 - niveau 1 : 13 & 14.11.03 (2 jours) C++ for Particle Physicists : 17 – 21.11.03 (6 X 3-hour lectures) Programmation automate Schneider TSX Premium – niveau 2 : 18 – 21.11.03 (4 jours) JAVA 2 Enterprise Edition – Part 1 : WEB Applications : 20 & ...

  5. Formulation and profile of pharmaceutical availability from a model oral solid form of a drug of phytochemicals contained in dry Taraxacum officinale extract

    Directory of Open Access Journals (Sweden)

    Marczyński Zbigniew

    2016-12-01

    Full Text Available Introduction: Dandelion (Taraxacum officinale coll., also called the common dandelion grows wild throughout Europe, Asia and the Americas. It is a perennial plant of the family of Asteraceae, having powerful healing properties. The entire plant – flowers, roots and leaves – is the medicinal raw material.

  6. [Not Available].

    Science.gov (United States)

    Nakov, L

    The teaching of Biology at the Medical Faculty in Sofia started in 1918 with Botany and Zoology. Already in the next year, it was radically changed by Metodii Popov: 1. Instead of Botany he introduced General Biology, and instead of Zoology - Parasitology (including a general review of the evolution of non-vertebrate animals) and Comparative Anatomy of the Vertebrates; 2. He adapted the teaching of Biology to the needs of the medical education. Those changes were possible thanks to the considerable medical background of M. Popov - it started in 1911 with suitable specialization and research activities, and continued with the establishment of Department of Biology and the Medical Faculty, and the involvement of medics, besides biologists, in its academic staff. During the past years there have been a lot of changes in the curriculum both in its schedule and contents. Some of them were as a result of the development of the biological science and the integration with the other disciples, but some were forced by the administration. Today the students have 90 hours of lectures and a practical course of 90 hours as well. They have at their disposal textbooks on "Biology", "Parasitology" and "Comparative Anatomy of the Vertebrates", as well as, a "Textbook for the practical Course on Biology". Their knowledge is evaluated during the practical course, at two colloquia, and at a practical and theoretical (oral) exam at the end of the first year of education.

  7. Places available

    CERN Multimedia

    2004-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Places available The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses : Introduction à Outlook : 19.8.2004 (1 journée) Outlook (short course I) : E-mail : 31.8.2004 (2 hours, morning) Outlook (short course II) : Calendar, Tasks and Notes : 31.8.2004 (2 hours, afternoon) Instructor-led WBTechT Study or Follow-up for Microsoft Applications : 7.9.2004 (morning) Outlook (short course III) : Meetings and Delegation : 7.9.2004 (2 hours, afternoon) Introduction ...

  8. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: C++ Programming Level 2 - Traps & Pitfalls:  16 - 19.7.02 (4 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Technical Training Monique Duval Tel.74924 monique.duval@cern.ch

  9. Places available**

    CERN Multimedia

    2004-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. TECHNICAL TRAINING Monique Duval tel. 74924 technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: The JAVA Programming Language Level 1 :9 & 10.1.2004 (2 days) The JAVA Programming Language Level 2 : 11 to 13.1.2004 (3 days) Hands-on Introduction to Python Programming : 16 - 18.2.2004 (3 days - free of charge) CLEAN-2002 : Working in a Cleanroom : 10.3.2004 (afternoon - free of charge) C++ for Particle Physicists : 8 - 12.3.2004...

  10. Places available**

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses : EXCEL 2000 - niveau 1 : 20 & 22.10.03 (2 jours) CLEAN-2002 : Working in a Cleanroom (free of charge) : 23.10.03 (half day) The EDMS-MTF in practice (free of charge) :  28 -  30.10.03 (6 half-day sessions) AutoCAD 2002 - Level 1 : 3, 4, 12, 13.11.03 (4 days) LabVIEW TestStand ver. 3 : 4 & 5.11.03 (2 days) Introduction to Pspice : 4.11.03 p.m. (half-day) Hands-on Introduction to Python Programm...

  11. Places available**

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. TECHNICAL TRAINING Monique Duval Tel. 74924 technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: JAVA 2 Enterprise Edition - Part 1 : WEB Applications : 20 & 21.11.03(2 days) FrontPage 2000 - niveau 1 : 20 & 21.11.03 (2 jours) Oracle 8i : SQL : 3 - 5.12.03 (3 days) Oracle 8i : Programming with PL/SQL : 8 - 10.12.03 (3 days) The JAVA Programming Language - leve...

  12. Places available**

    CERN Document Server

    2004-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.TECHNICAL TRAINING Monique Duval tel. 74924 technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: The JAVA Programming Language Level 1 : 9 & 10.1.2004 (2 days) The JAVA Programming Language Level 2 : 11 to 13.1.2004 (3 days) LabVIEW base 1 : 25 - 27.2.2004 (3 jours) CLEAN-2002 : Working in a Cleanroom : 10.3.2004 (afternoon - free of charge) C++ for Particle Physicists : 8 - 12.3.2004 ( 6 X 4-hour sessions) LabVIEW Basics 1 : 22 - 24.3.20...

  13. Places available**

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. TECHNICAL TRAINING Monique Duval Tel. 74924technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: MATLAB Fundamentals and Programming Techniques (ML01) : 2 & 3.12.03 (2 days) Oracle 8i : SQL : 3 - 5.12.03 (3 days) The EDMS MTF in practice : 5.12.03 (afternoon, free of charge) Modeling Dynamic Systems with Simulink (SL01) : 8 & 9.12.03 (2 days) Signal Processing with MATLAB (SG01) : 11 & 12.12.03 (2 days) The JAVA Programming Language - l...

  14. Places available**

    CERN Multimedia

    2003-01-01

    If you wish to participate in one of the following courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at: http://www.cern.ch/Training/ or fill in an "application for training" form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. TECHNICAL TRAINING Monique Duval tel. 74924 technical.training@cern.ch ** The number of places available may vary. Please check our Web site to find out the current availability. Places are available in the following courses: MATLAB Fundamentals and Programming Techniques (ML01) :2 & 3.12.03 (2 days) Oracle 8i : SQL : 3 - 5.12.03 (3 days) The EDMS MTF in practice : 5.12.03 (afternoon, free of charge) Modeling Dynamic Systems with Simulink (SL01) : 8 & 9.12.03 (2 days) Signal Processing with MATLAB (SG01) : 11 & ...

  15. [Not Available].

    Science.gov (United States)

    Mateus, Christine; Libenciuc, Cristina; Robert, Caroline

    2016-06-01

    ANTI-PD1 ROLE IN TREATMENT OF CUTANEOUS MELANOMA: The treatment of metastatic melanoma dramatically changed over the last years. Two therapeutic revolutions emerged in parallel, targeted anti-BRAF and anti-MEK therapies, for patients BRAFV600 mutated and immunotherapy with immune checkpoint blockers using anti-CTLA-4 then anti-PD1 monoclonal antibodies. Indeed, melanoma immunotherapy was a golden objective for many years but in spite of important efforts using cytokines (interferon, interleukin) and different vaccine approaches no objective improvement of patients 'prognosis was obtained. Ipilimumab, authorized in 2011, was the first drug which showed a benefit of overall survival in patients with metastatic melanoma in spite a low response rate (10-15) and the occurrence of about 25% of serious toxicity. Anti-PD1 appear as a new generation of immune checkpoint blockade with response rates between 30 to 40% of the patients, a proven overall survival benefit as compared with chemotherapy or ipilimumab and less toxicity than ipilimumab. Two molecules, pembrolizumab and nivolumab were recently approved in monotherapy, for metastatic melanoma. Several questions remain unresolved: the respective indications of anti-PD1 and targeted therapies in first line therapy in patients with BRAF mutant melanoma, the benefit of combining immunotherapy with radiotherapy or with targeted therapies, the optimal treatment duration, and the benefit of the anti-PD1 in the adjuvant setting. The combination of ipilimumab and nivolumab, recently approved by the FDA but not yet in Europ, shows an improvement of the objective response rates (50-57%) and progression free survival compared with nivolumab but is associated with an higer incidence of serious adverse events (more than 50%).

  16. Animal models of neurodegenerative diseases

    Directory of Open Access Journals (Sweden)

    Fabiola Mara Ribeiro

    2013-01-01

    Full Text Available The prevalence of neurodegenerative diseases, such as Alzheimer's disease (AD and Parkinson's disease (PD, increases with age, and the number of affected patients is expected to increase worldwide in the next decades. Accurately understanding the etiopathogenic mechanisms of these diseases is a crucial step for developing disease-modifying drugs able to preclude their emergence or at least slow their progression. Animal models contribute to increase the knowledge on the pathophysiology of neurodegenerative diseases. These models reproduce different aspects of a given disease, as well as the histopathological lesions and its main symptoms. The purpose of this review is to present the main animal models for AD, PD, and Huntington's disease.

  17. Disponibilidad de medicamentos esenciales en unidades de primer nivel de la Secretaría de Salud de Tamaulipas, México Availability of essential drugs in Ministry of Health first level healthcare units in Tamaulipas, Mexico

    Directory of Open Access Journals (Sweden)

    Cristela Reséndez

    2000-08-01

    medicamentos en el país, en general, y la disponibilidad de medicamentos esenciales en las unidades de primer nivel, en particular. Dos iniciativas de reciente puesta en marcha permiten ser optimistas al respecto: la descentralización de los servicios de salud para población no asegurada y el Programa de Medicamentos Genéricos Intercambiables, implantado en el ámbito nacional en 1998.OBJECTIVE: To describe the availability of some essential drugs at the primary health care units of the Ministry of Health of Tamaulipas, Mexico. MATERIAL AND METHODS: Between September and October 1998, all first level healthcare units of Tamaulipas' three sanitary jurisdictions were surveyed. Drug availability was assessed. The measurement instrument was a checklist of 56 drugs and 10 different supplies. For each drug and input the absolute number and the proportion of units with this drug or input was calculated. In the units where the drugs were available, the medians were calculated. The median of the total number of drugs available in all units was used as a global indicator. This same exercise was developed for each unit. Comparisons between the availability of these inputs in the units and stockrooms were also done. Stata 5.0 was used for statistical analysis. RESULTS: None of the inspected units had full availability of all checklist drugs. The highest percentage of drug availability was 84% and the lowest was 32%. There was limited availability of antibiotics, antihypertensive, hypoglycemic, and iron deficiency drugs. The availability of oral rehydration salts and contraceptive and vaccine agents was acceptable. CONCLUSIONS: Healthcare organizations must find alternative ways to improve access to drugs nationwide, in general, and availability of essential drugs in first level healthcare units, in particular. Two recent initiatives provide an optimistic outlook: decentralization of health services for the uninsured and the Generic Exchangeable Drugs Program, established nationwide in

  18. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: CLEAN-2002 : Travailler en salle blanche (cours gratuit) : 13.08.2002 (matin) Introduction to the CERN Enginnering Data Management System :  27.8.02  (1 day) The CERN Engineering Data Management System for Advanced Users :  28.8.02  (1 day) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Technical Training Monique Duval Tel.74924 monique.duval@cern.ch    

  19. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Introduction to Databases :  3 - 4.7.01 (2 days) The JAVA programming language Level 2 : 4 - 6.7.01 (3 days) Enterprise JavaBeans :  9 - 11.7.01 (3 days) Design Patterns :  10 - 12.7.01 (3 days) C++ for Particle Physicists :  23 - 27.7.01 (6 3-hour lectures) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : http://www.cern.ch/Training/ or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.

  20. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Introduction to Perl 5 : 2 - 3.7.01 (2 days) Introduction to Databases :  3 - 4.7.01 (2 days) JAVA programming language Level 2 : 4 - 6.7.01 (3 days) Enterprise JavaBeans :  9 - 11.7.01 (3 days) Design Patterns :  10 - 12.7.01 (3 days) C++ for Particle Physicists :  23 - 27.7.01 (6 3-hour lectures) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : http://www.cern.ch/Training/ or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.

  1. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: C++ Programming Level 2 - Traps & Pitfalls:  16 - 19.7.02 (4 days) Frontpage 2000 - level 1 :  22 - 23.7.02  (2 days) Introduction à Windows 2000 au CERN : 24.7.02 (après-midi) CLEAN-2002 : Travailler en salle blanche (cours gratuit) : 13.08.2002 (matin) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Technical Training Monique Duval Tel.74924 monique.duval@cern.ch

  2. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: December 2002   PCAD Schémas - Débutants :  5 & 6.12.02  (2 jours) PCAD PCB - Débutants :  9 - 11.12.02  (3 jours) FrontPage 2000 - level 1:  9 & 10.12.02  (2 days) Introduction à la CAO Cadence (cours gratuit) :  10 & 11.12.02  (2 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Technical Training Monique Duval Tel.74924 monique.duval@cern.ch

  3. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses: Conception de PCB rapides dans le flot Cadence : 11.6.03 (matin) EXCEL 2000 - level 1 : 12 & 13.6.03 (2 days) Introduction to PVSS : 16.6.03 (p.m.) Basic PVSS : 17 - 19.6.03 (3 days) Réalisation de PCB rapides dans le flot Cadence : 17.6.03 (matin) PVSS - JCOP Framework Tutorial : 20.6.03 (1 day) Programmation automate Schneider : Programmation automate Schneider TSX Premium - 2ème niveau : 24 - 27.6.03 (4 jours) - audience : toute personne qui veux maitriser la mise en uvre et la programmation des fonctions spécialisées d'un automate TSX Premium - objectifs : maitriser la mise en uvre et la programmation des fonctions spécialisées d'un automate TSX Premium Cours de sécurité : Etre TSO au CERN : Prochaines sessions : 24, 25 & 27.6.03 - 4, 5 & 7.11.03 (session de 3 jours) ** The number of places available may vary. Please check our Web site to find out the current availability. If you wish to participate in one of these courses, pl...

  4. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth ... 662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter ...

  5. Drug Facts

    Medline Plus

    Full Text Available ... Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts ... Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs ...

  6. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Science.gov (United States)

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION... industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

  7. PLACES AVAILABLES

    CERN Multimedia

    Enseignement Technique; Tél. 74924; monique.duval@cern.ch

    2000-01-01

    Places are available in the following courses: LabView hands-on : 13.11.00 (4 hours) LabView Basics 1 : 14 ­ 16.11.00 (3 days) Nouveautés de WORD : 19 et 20.10.00 (2 jours) ACCESS 1er niveau : 30 ­ 31.10.00 (2 jours) Advanced C programming : 2 ­ 3.11.00 (2 days) Introduction à PowerPoint : 6.11.00 (1 journée) C++ for Particle Physicists : 20 ­ 24.11.00 (12 hours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : http://www.cern.ch/Training/ or fill in an “application for training” form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.

  8. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: Introduction à la CAO CADENCE : 20 & 21.2.02 (2 jours) LabView Basics 1 :  4 - 6.3.02  (3 days) Introduction au VHDL et utilisation du simulateur de CADENCE : 6 & 7.3.02 (2 jours) CLEAN-2002 : Working in a Clean Room :  7.3.2002  (1 day) LabView Base 2 : 11 & 12.3.02 (2 jours) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) LabView Advanced :  13 - 15.3.02 (3 days) Cours sur la migration AutoCAD :   AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisiona...

  9. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: PVSS basics :  18 - 22.2.02 (5 days) Introduction à la CAO CADENCE : 20 & 21.2.02 (2 jours) LabView Basics 1 :  4 - 6.3.02  (3 days) Introduction au VHDL et utilisation du simulateur de CADENCE : 6 & 7.3.02 (2 jours) LabView Base 2 : 11 & 12.3.02 (2 jours) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) LabView Advanced :  13 - 15.3.02 (3 days) Cours sur la migration AutoCAD :   AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO...

  10. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74460

    2001-01-01

    Places are available in the following courses: LabView Base 1 : 27-29.3.01 (3 jours) Contract Follow-up : 9.4.01 (3 heures) Introduction à PowerPoint : 24.4.01 (1 journée) Publier sur le Web : 25-27.4.01 (3 demi-journées) Programmation TSX Premium 2 : 15-16.5.01 (5 jours) LabView Base 2 : 27-29.3.01 (2 jours) Hands-on Object-oriented Analysis, Design & Programming with C++ :  23-27.4.01 (5 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : http://www.cern.ch/Training/ or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.

  11. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: Habilitation électrique : recyclage HT/BT : 11 - 15.3.2002  (2 * 2 heures) PVSS Basics :  8 - 12.4.02  (5 days) ELEC-2002 : Spring Term :  9, 11, 16, 18, 23, 25, 30.4.02 (7 * 2.5 hours) LabVIEW base 1 : 22 - 24.4.02 (3 jours) LabVIEW DSC (F) 25 & 26.4.02 (2 jours) LabVIEW Basics 2 : 13 & 14.5.02 (2 days) LabVIEW DAQ (F) : 15 & 16.5.02 (2 jours) Cours sur la migration AutoCAD :   AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applica...

  12. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel 74924

    2002-01-01

    Places are available in the following courses: LabView hands-on : 21.01.02 (1/2 journée) LabView DAQ hands-on : 21.01.02 (1/2 journée) FileMaker Pro : 22 - 25.1.02 (4 jours) MS-Project 2000 : 24 & 25.01.02 (2 jours) Introduction au PC et à Windows 2000 au CERN : 29 - 30.1.02 (2 jours) LabView Base 1 : 4 - 6.2.02 (3 jours) LabView DAQ (E) : 7 & 8.02.02 (2 days) Hands-on Object-Oriented Design & Programming with Java : 11 - 13.02.02 (3 days) C++ for Particle Physicists : 11 - 15.3.2002 (6 * 3 hour lectures) Cours sur la migration AutoCAD : AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO ...

  13. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: The CERN Engineering Data Management System for Advanced users :  13.6.02  (1 day) The CERN Engineering Data Management System for Local Administrators :  18.6.02  (1 day) AutoCAD 2002 - niveau 2 : 24 - 25.6.02 (2 jours) Frontpage 2000 - niveau 2 : 25 - 26.6.02 (2 jours) Object-oriented Analysis and Design :  2 - 5.7.02  (4 days) C++ Programming Level 2 - Traps & Pitfalls :  16 - 19.7.02  (4 days) C++ for Particle Physicists :  22 - 26.7.02  (6 * 3 hour lectures) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of the...

  14. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: November 2002   Java Programming Language level 1 :  28 & 29.11.02  (2 days) December 2002   LabVIEW - DSC (English) :  2 - 3.12.02  (2 days) FileMaker (Français) :  2 - 5.12.02  (4 jours) PCAD Schémas - Débutants :  5 & 6.12.02  (2 jours) PCAD PCB - Débutants :  9 - 11.12.02  (3 jours) FrontPage 2000 - level 1:  9 & 10.12.02  (2 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt. Technical Training M...

  15. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: November 2002   Hands-on Object-Oriented Design and Programming with C++:  19 - 21.11.02  (3 days)  December 2002   LabVIEW - DSC (English) :  2 - 3.12.02  (2 days) AutoCAD 2002 - niveau 2 :  2 & 3.12.02  (2 jours) FileMaker (Français) :  2 - 5.12.02  (4 jours) PCAD Schémas - Débutants :  5 & 6.12.02  (2 jours) PCAD PCB - Débutants :  9 - 11.12.02  (3 jours) FrontPage 2000 - level 1:  9 & 10.12.02  (2 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisiona...

  16. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Utilisation du simulateur Simplorer : 30.5 - 1.6.01 (3 jours) JAVA programming language level 1: 11-12.6.01 (2 days) LabView hands-on F ou E : 11.6.01 (1/2 journée) Comprehensive VHDL for EPLD/FPGA Design : 11 - 15.6.01 (5 days) Introduction au Langage C : 13 - 15.6.01 (3 jours) LabView Base 1 : 12 - 14.6.01 (3 jours) Habilitation électrique : superviseurs : 2 sessions d'une demi-journée les 12 et 19.6.01 Migration de LabVIEW 5 vers LabVIEW 6i Migration from LabVIEW 5 to LabVIEW 6I :  15.6.01 (1/2 journée/half-day) Introduction to Perl 5 : 2 - 3.7.01 (2 days) JAVA programming language level 2 : 4 - 6.7.01 (3 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : http://www.cern.ch/Training/ or fill in an 'application for training' form available from ...

  17. Places available**

    CERN Document Server

    Places are available in the following courses: Hands-on Introduction to Python Programming: 11-13.08.2003 (3 days) Introduction to the CERN Engineering Data Management System (EDMS): 26.08.2003 (1 day) The CERN Engineering Data Management System (EDMS) for Engineers: 27.08.2003 (1 day) CLEAN-2002 : Travailler en salle blanche : 4.09.2003 (une demi-journée) AutoCAD 2002 - Level 1: 4, 5, 15, 16.09.2003 (2 x 2 days) AutoCAD Mechanical 6 PowerPack : 17, 18, 25, 26.09.2003 et 2, 3.10.2003 (3 x 2 journées, français) AutoCAD 2002 - niveau 1 : 23, 24, 30.09.2003 et 1.10.2003 (2 x 2 journées) Introduction to the CERN Engineering Data Management System (EDMS): 23.09.2003 (1 day) The CERN Engineering Data Management System (EDMS) for Local Administrators: 24-25.09.2003 (2 days) AutoCAD 2002 - niveau 2 : 8 et 10.10.2003 (2 journées) CLEAN-2002: Working in a Cleanroom: 23.10.2003 (half day, p.m.) ** The number of places available may vary. Please check our Web site to find out the current availabili...

  18. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses: Hands-on Introduction to Python Programming: 11-13.08.2003(3 days) Introduction to the CERN Engineering Data Management System (EDMS): 26.08.2003 (1 day) The CERN Engineering Data Management System (EDMS) for Engineers: 27.08.2003 (1 day) CLEAN-2002 : Travailler en salle blanche : 4.09.2003 (une demi-journée) AutoCAD 2002 - Level 1: 4, 5, 15, 16.09.2003 (2 x 2 days) AutoCAD Mechanical 6 PowerPack : 17, 18, 25, 26.09.2003 et 2, 3.10.2003 (3 x 2 journées, français) AutoCAD 2002 - niveau 1 : 23, 24, 30.09.2003 et 1.10.2003 (2 x 2 journées) Introduction to the CERN Engineering Data Management System (EDMS): 23.09.2003 (1 day) The CERN Engineering Data Management System (EDMS) for Local Administrators: 24-25.09.2003 (2 days) AutoCAD 2002 - niveau 2 : 8 et 10.10.2003 (2 journées) CLEAN-2002: Working in a Cleanroom: 23.10.2003 (half day, p.m.) ** The number of places available may vary. Please ch...

  19. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: LabView Hands-on (bilingue/bilingual - gratuit/free of charge) : 13.9.02 (a.m.) LabView DAQ Hands-on (bilingue/bilingual - gratuit/free of charge) : 13.9.02 (p.m.) AutoCAD 2002 - niveau 1 : 19, 20, 26, 27.9.02 (4 jours) LabView Base 1 : 23 - 25.9.02 (3 jours) LabView DAQ (E) : 26 - 27.9.02 (2 days) AutoCAD Mechanical 6 PowerPack (F) : 30.9, 1, 2, 9, 10, 11.10.02 (6 jours) CLEAN-2002 : Working in a Cleanroom (free of charge) : 10.10.02 (half-day, p.m.) AutoCAD 2002 - niveau 2 : 14 - 15.10.02 (2 jours) AutoCAD 2002 - Level 1 : 17, 18, 24, 25.10.02 (4 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fill in an 'application for training' form available from your Divisional Secretariat or from your DTO (Divisional Training Of...

  20. Animal Bites

    Science.gov (United States)

    ... or territory. Attacks by pets are more common. Animal bites rarely are life-threatening, but if they become infected, you can develop serious medical problems. To prevent animal bites and complications from bites Never pet, handle, ...

  1. Animal Farm

    Institute of Scientific and Technical Information of China (English)

    徐蓉蓉

    2015-01-01

    This essay first introduce the background of Animal Farm and a brief introduction of the author.Then it discuss three thesis about this novel and briefly discussed about it.At last it give highly review on Animal Farm.

  2. [Not Available].

    Science.gov (United States)

    Blanchard, Elodie; de Lara, Manuel Tunon

    2013-01-01

    Pholcodine is an opioid that has been widely used worldwide since 1950 for the treatment of non-productive cough in children and adults. The results of early preclinical studies but also those of recent clinical trials have shown the antitussive efficacy of pholcodine to be superior to that of codeine, of longer duration, and with an equivalent or safer toxicity profile. Also, there is no risk of addiction. Concern had been raised over a possible cross-sensitisation with neuromuscular blocking agents. While a recent assessment of the available data by the European Medicines Agency (EMA) has confirmed the favourable risk-benefit ratio of pholcodine, further studies are needed to clear this point.

  3. Study on the Isolation ,Identification and Drug Resistance of Enterococcus from Different Animal Sources%不同动物来源肠球菌的分离·鉴定及耐药性研究

    Institute of Scientific and Technical Information of China (English)

    王熙楚; 王世旗; 王波臻; 曹树珠; 周霞

    2012-01-01

    [目的]为动物肠球菌感染机制的研究提供理论依据.[方法]采用常规细菌分离方法从不同动物的肛拭样品中分离肠球菌,利用基于肠球菌保守tuf基因的PCR方法对其进行鉴定,同时采用KB纸片法对分离到的肠球菌进行药敏试验.[结果]共分离到177株细菌,经鉴定确定为肠球菌.药敏试验结果表明,鸡源肠球菌对青霉素的耐药率为80%,牛源肠球菌为46.4%;猪源肠球菌对环丙沙星的耐药率为27.3%,羊源肠球菌为2.8%;鸡源肠球菌对高浓度链霉素的耐药率为62.9%,而羊源未出现耐药菌株.[结论]来源于不同动物的正常菌群肠球菌对某些抗生素表现出不同程度的耐药性.%[ Objective ] The research aimed to provide theoretical basis for studying the infection mechanism of enterococcus from animals. [ Method] Enterococcus were isolated from anus samples of different animals by using conventional bacterial isolation method. And they were identified by PCR based on conservative tuf gene of enterococcus. Drug test on the isolated enterococcus was conducted by using K - B disk diffusion method. [ Result] 177 strains of bacteria were isolated and they were identified as enteroeoccus. The results of drug sensitivity test showed that the drug resistance rate of enterococcus from chicken and cattle to penicillin was 80% and 46.4% respectively. The drug resistance rate of enterococcus from pig and sheep to ciprofloxacin were 27. 3% and 2. 8% respectively. The drug resistance rate of enterococcus from chicken to streptomycin at high concentrations was 62.9% and enterococcus from sheep showed no drug resistance. [ Conclusion ] Enterococcus from normal flora of different animal varieties exhibited resistance to antibiotics to different extent.

  4. A high throughput live transparent animal bioassay to identify non-toxic small molecules or genes that regulate vertebrate fat metabolism for obesity drug development

    Directory of Open Access Journals (Sweden)

    Woollett Laura A

    2008-08-01

    Full Text Available Abstract Background The alarming rise in the obesity epidemic and growing concern for the pathologic consequences of the metabolic syndrome warrant great need for development of obesity-related pharmacotherapeutics. The search for such therapeutics is severely limited by the slow throughput of animal models of obesity. Amenable to placement into a 96 well plate, zebrafish larvae have emerged as one of the highest throughput vertebrate model organisms for performing small molecule screens. A method for visually identifying non-toxic molecular effectors of fat metabolism using a live transparent vertebrate was developed. Given that increased levels of nicotinamide adenine dinucleotide (NAD via deletion of CD38 have been shown to prevent high fat diet induced obesity in mice in a SIRT-1 dependent fashion we explored the possibility of directly applying NAD to zebrafish. Methods Zebrafish larvae were incubated with daily refreshing of nile red containing media starting from a developmental stage of equivalent fat content among siblings (3 days post-fertilization, dpf and continuing with daily refreshing until 7 dpf. Results PPAR activators, beta-adrenergic agonists, SIRT-1 activators, and nicotinic acid treatment all caused predicted changes in fat, cholesterol, and gene expression consistent with a high degree of evolutionary conservation of fat metabolism signal transduction extending from man to zebrafish larvae. All changes in fat content were visually quantifiable in a relative fashion using live zebrafish larvae nile red fluorescence microscopy. Resveratrol treatment caused the greatest and most consistent loss of fat content. The resveratrol tetramer Vaticanol B caused loss of fat equivalent in potency to resveratrol alone. Significantly, the direct administration of NAD decreased fat content in zebrafish. Results from knockdown of a zebrafish G-PCR ortholog previously determined to decrease fat content in C. elegans support that future GPR

  5. Animal models of osteoporosis - necessity and limitations

    Directory of Open Access Journals (Sweden)

    Turner A. Simon

    2001-06-01

    Full Text Available There is a great need to further characterise the available animal models for postmenopausal osteoporosis, for the understanding of the pathogenesis of the disease, investigation of new therapies (e.g. selective estrogen receptor modulators (SERMs and evaluation of prosthetic devices in osteoporotic bone. Animal models that have been used in the past include non-human primates, dogs, cats, rodents, rabbits, guinea pigs and minipigs, all of which have advantages and disadvantages. Sheep are a promising model for various reasons: they are docile, easy to handle and house, relatively inexpensive, available in large numbers, spontaneously ovulate, and the sheep's bones are large enough to evaluate orthopaedic implants. Most animal models have used females and osteoporosis in the male has been largely ignored. Recently, interest in development of appropriate prosthetic devices which would stimulate osseointegration into osteoporotic, appendicular, axial and mandibular bone has intensified. Augmentation of osteopenic lumbar vertebrae with bioactive ceramics (vertebroplasty is another area that will require testing in the appropriate animal model. Using experimental animal models for the study of these different facets of osteoporosis minimizes some of the difficulties associated with studying the disease in humans, namely time and behavioral variability among test subjects. New experimental drug therapies and orthopaedic implants can potentially be tested on large numbers of animals subjected to a level of experimental control impossible in human clinical research.

  6. Drug: D06912 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available nese Medicine in Japan [BR:br08304] Crude Drugs Drugs for blood Drugs for removing blood stasis D06912 *Quercus cortex; Bokusoku Drug...s for external use Drugs for external use D06912 *Quercu

  7. Drug: D06717 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available 0 Crude drugs D06717 Safflower (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs for blood Drugs... for removing blood stasis D06717 *Safflower; Safflower Drugs for external use Drugs

  8. Animal Deliberation

    NARCIS (Netherlands)

    Driessen, C.P.G.

    2014-01-01

    While much has been written on environmental politics on the one hand, and animal ethics and welfare on the other, animal politics, as the interface of the two, is underexamined. There are key political implications in the increase of animal protection laws, the rights of nature, and political parti

  9. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Nouveautés d'EXCEL : 5.11.01 (1/2 journée) Introduction a Windows 2000 au CERN : 6.11.01 (1/2 journée) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) Design Patterns :  7 - 8.11.01 (2 days) The Java programming language Level 1: 8 - 9.11.01 (2 days) Automates et réseaux de terrain : 13 & 14.11.01 (3 jours) Introduction à Windows 2000 au CERN : 12 - 14.11.01 (1/2 journée) Introduction to Windows 2000 at CERN :  14.11.01  (half-day) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to C Programming :  21- 23.11.01 (3 days) Programmation TSX Premium 2 : 26 - 30.11.01 (5 jours) Contract Follow-up (F) : 26.11.01 (1/2 journée) Object-Oriented Analysis and Design :  27 - 30.11.2001  (4 days) Hands-on Object-Oriented Design and Programming with C++ :  11 - 13.12.2...

  10. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses: The CERN EDMS for Local Administrators : 24 & 25.9.03 (2 days, free of charge) HeREF-2003 : Techniques de la réfrigération Hélium cours en français avec support en anglais) : 6 - 10.10.2003 (7 demi-journées) The Java Programming Language Level 1 : 6 - 7.10.2003 (2 days) Java 2 Enterprise Edition - Part 2 : Enterprise JavaBeans : 8 - 10.10.2003 (3 days) FileMaker - niveau 1 : 9 & 10.10.03 (2 jours) EXCEL 2000 - niveau 1 : 20 & 22.10.03 (2 jours) AutoCAD 2002 - niveau 1 : 20, 21, 27, 28.10.03 (4 jours) CLEAN-2002 : Working in a Cleanroom : 23.10.03 (half day, free of charge) AutoCAD 2002 - Level 1 : 3, 4, 12, 13.11.03 (4 days) AutoCAD 2002 - niveau 2 : 10 & 11.11.03 (2 jours) ACCESS 2000 - niveau 1 : 13 & 14.11.03 (2 jours) AutoCAD Mechanical 6 PowerPack (E) : 17, 18, 24, 25.11 & 1, 2.12.03 (6 days) FrontPage 2000 - niveau 1 : 20 & 21.11.03 (2 jours) MAGNE-03 : Magnétisme pour l'électrotechnique : 25 - 27.11.03 (3 jours) ...

  11. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : FrontPage 2000 - niveau 1 : 20 & 21.5.03 (2 jours) PIPES-2003 : Pratique du sertissage de tubes métalliques et multicouches : 21.5.03 (1 jour) Introduction à la CAO Cadence : de la saisie de schéma Concept-HDL au PCB : 20 & 22.5.03 (2 jours) AutoCAD 2002 - niveau 2 : 3 & 4.6.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 5, 6, 12, 13, 26, 27.6.03 (6 jours) EXCEL 2000 - niveau 1 : 10 & 11.6.03 (2 jours) Conception de PCB rapides dans le flot Cadence : 11.6.03 (matin) EXCEL 2000 - level 1 : 12 & 13.6.03 (2 days) PowerPoint 2000 (F) : 17 & 18.6.03 (2 jours) Réalisation de PCB rapides dans le flot Cadence : 17.6.03 (matin) FrontPage 2000 - niveau 2 : 19 & 20.6.03 (2 jours) LabView DSC (langue à décider/language to be defined) : 19 & 20.6.03 EXCEL 2000 - niveau 2 : 24 & 25.6.03 (2 jours) Siemens SIMATIC Training: Introduction to STEP7 : 3 & 4.6.03 (2 days) STEP7 Programming : 16 - 20.6.03 (5 days) Simatic...

  12. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : FrontPage 2000 - niveau 1: 20 & 21.5.03 (2 jours) PIPES-2003 : Pratique du sertissage de tubes métalliques et multicouches: 21.5.03 (1 jour) Introduction à la CAO Cadence: de la saisie de schéma Concept-HDL au PCB : 20 & 22.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (E): 5, 6, 12, 13, 26, 27.6.03 (6 days) EXCEL 2000 - niveau 1: 10 & 11.6.03 (2 jours) Conception de PCB rapides dans le flot Cadence: 11.6.03 (matin) EXCEL 2000 - level 1: 12 & 13.6.03 (2 days) Introduction to PVSS: 16.6.03 (half-day, pm) Basic PVSS: 17 - 19.6.03 (3 days) Réalisation de PCB rapides dans le flot Cadence: 17.6.03 (matin) LabView DSC (language to be defined): 19 & 20.6.03 PVSS - JCOP Framework Tutorial: 20.6.03 (1 day) EXCEL 2000 - niveau 2: 24 & 25.6.03 (2 jours) Siemens SIMATIC Training: Introduction to STEP7: 3 & 4.6.03 (2 days) STEP7 Programming: 16 - 20.6.03 (5 days) Simatic Net Network: 26 & 27.6.03 (2 days) These courses will be given...

  13. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: EXCEL 2000 - niveau 1 : 3 et 4.10.01 (2 jours) Automates et réseaux de terrain : 3 - 4.10.2001 (2 jours) Introduction à Outlook : 5.10.01 (1 journée) C++ for Particle Physicists : 8 - 12.10.01 (6 lectures) Cadence Board Design tools : Upgrading to release 14 : 3 1-day sessions on 9, 10 & 11.10.01 MS-Project 2000 - niveau 1 : 15 - 18.10.01 (4 demi-journées) LabView Base 2 : 18 & 19.10.01 (2 jours) WORD 2000 : importer et manipuler des images : 19.10.01 (1 journée) The CERN Engineering Data Management System for Electronics Design :  30.10.01 (1 day) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) The Java programming language Level 1: 8 - 9.11.01 (2 days) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to XML :  19 - 20.11.01 (2 days) Programming TSX Premium 1 :  19 - 23.11.01  (5 days) Introd...

  14. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Contract Follow-up (F) : 30.10.01 (1/2 journée) The CERN Engineering Data Management System for Electronics Design :  30.10.01 (1 day) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) Nouveautés d'EXCEL : 5.11.01 (1/2 journée) Introduction a Windows 2000 au CERN : 6.11.01 (1/2 journée) The Java programming language Level 1: 8 - 9.11.01 (2 days) LabView Base 1 : 12 - 14.11.01 (3 jours) Automates et réseaux de terrain : 13 & 14.11.01 (2 jours) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to XML :  19 - 20.11.01 (2 days) Programming TSX Premium 1 :  19 - 23.11.01  (5 days) Introduction to C Programming :  21- 23.11.01 (3 days) The Java programming language Level 2:  26 - 28.11.01 (3 days) Programmation TSX Premium 2 : 26 - 30.11.01 (5 jours) Autocad Migration support courses: a detail...

  15. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: MS-Project 2000 - niveau 1 : 15 - 18.10.01 (4 demi-journées) LabView Base 2 : 18 & 19.10.01 (2 jours) WORD 2000 : importer et manipuler des images : 19.10.01 (1 journée) Contract Follow-up (F) : 30.10.01 (1/2 journée) The CERN Engineering Data Management System for Electronics Design :  30.10.01 (1 day) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) The Java programming language Level 1: 8 - 9.11.01 (2 days) LabView Base 1 : 12 - 14.11.01 (3 jours) Automates et réseaux de terrain : 13 & 14.11.01 (2 jours) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to XML :  19 - 20.11.01 (2 days) Programming TSX Premium 1 :  19 - 23.11.01  (5 days) Introduction to C Programming :  21- 23.11.01 (3 days) The Java programming language Level 2:  26 - 28.11.01 (3 days) Programmation TSX Premium 2 : 26 ...

  16. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Cadence Board Design tools : Upgrading to release 14 :  3 1-day sessions on 9, 10 & 11.10.01 MS-Project 2000 - niveau 1 : 15 - 18.10.01 (4 demi-journées) LabView Base 2 : 18 & 19.10.01 (2 jours) WORD 2000 : importer et manipuler des images : 19.10.01 (1 journée) Contract Follow-up (F) :  30.10.01 (1/2 journée) The CERN Engineering Data Management System for Electronics Design :  30.10.01 (1 day) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) The Java programming language Level 1: 8 - 9.11.01 (2 days) LabView Base 1 : 12 - 14.11.01 (3 jours) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to XML :  19 - 20.11.01 (2 days) Programming TSX Premium 1 :  19 - 23.11.01  (5 days) Introduction to C Programming :  21- 23.11.01 (3 days) The Java programming language Level 2:  26 - 28.11.01 (...

  17. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Introduction à Windows 2000 au CERN : 2 sessions de _ journée les 24 et 25.9.01 PROFIBUS : 25 - 26.9.01 (2 jours) PROFIBUS : 27 - 28.9.01 (2 days) EXCEL 2000 - niveau 1 : 3 et 4.10.01 (2 jours) Automates et réseaux de terrain : 3 - 4.10.2001 (2 jours) Introduction à Outlook : 5.10.01 (1 journée) Frontpage 2000 - niveau 1 : 8 et 9.10.01 (2 jours) C++ for Particle Physicists : 8 - 12.10.01 (6 lectures) MS-Project 2000 - niveau 1 : 15 - 18.10.01 (4 demi-journées) Programmation TSX Premium 1 : 15 - 19.10.01 (5 jours) WORD 2000 : importer et manipuler des images : 19.10.01 (1 journée) Programmation TSX Premium 1 : 22 - 26.10.01 (5 jours) UNIX pour non-programmeurs : 5 - 7.11.01 (3 jours) The Java programming language Level 1: 8 - 9.11.01 (2 days) Introduction to PERL 5 :  15 - 16.11.01  (2 days) Introduction to XML :  19 - 20.11.01 (2...

  18. Places available **

    CERN Multimedia

    2003-01-01

    Places are available in the following courses: PIPES-2003 - Pratique du Sertissage de tubes métalliques et multicouches : 26.8.03 (stage pratique) The CERN Engineering Data Management System (EDMS) for Engineers : 27.8.03 (1 day, free of charge) CLEAN-2002 : Travailler en salle blanche : 4.9.03 (une demi-journée, séminaire gratuit) The CERN Engineering Data Management System (EDMS) for Local Administrators : 24 & 25.9.03 (2 days, free of charge) Siemens SIMATIC Training : Programmation STEP7 - niveau 1 : 29 - 2.10.03 (4 jours) - ouverture des inscriptions fin août Programmation STEP7 - niveau 2 : 13 - 17.10.03 (5 jours) - ouverture des inscriptions fin août Réseau Simatic Net : 22 & 23.10.03 (2 jours) - ouverture des inscriptions fin août CLEAN-2002 : Working in a Cleanroom : 23.20.03 (half day, free of charge) These courses will be given in French or Englis...

  19. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses: PIPES-2003 - Pratique du sertissage de tubes métalliques et multicouches :26.8.03(stage pratique) The CERN EDMS for Engineers (free of charge) : 27.8.03 (1 day) CLEAN-2002 : Travailler en salle blanche (séminaire gratuit) : 4.9.03(une demi-journée) The CERN EDMS for Local Administrators (free of charge) : 24 & 25.9.03 (2 days) HeREF-2003 : Techniques de la réfrigération Hélium (cours en français avec support en anglais) : 6 - 10.10.2003 (7 demi-journées) The Java Programming Language Level 1 : 6 - 7.10.2003 (2 days) Java 2 Enterprise Edition - Part 2 : Enterprise JavaBeans : 8 - 10.10.2003 (3 days) FileMaker - niveau 1 : 9 & 10.10.03 (2 jours) EXCEL 2000 - niveau 1 : 20 & 22.10.03 (2 jours) AutoCAD 2002 - niveau 1 : 20, 21, 27, 28.10.03 (4 jours) CLEAN-2002 : Working in a Cleanroom (free of charge) : 23.10.03 (half day) AutoCAD Mechanical 6 PowerPack (E) : 23, 24, 30, 31.10 & 12, 13.11.03 (6 days) AutoCAD 2002 - niveau 2...

  20. PLACES AVAILABLE

    CERN Multimedia

    Enseignement Technique; Tél. 74924; Technical Training; Monique Duval; Tel. 74924

    2000-01-01

    Places are available in the following courses : Premiers pas avec votre PC 12 - 15.9.00 (4 demi-journées) WORD 20, 21 et 26, 27.9.2000 (4 jours) JAVA programming level 1 25 - 26.9.2000 (2 days) Gaz inflammables 1 26.9.2000 (1 journée) Advanced aspects of PERL 5 6.10.2000 (1 day) Initiation au WWW 10 - 12.10.00 (3 demi-journées) WORD : importer et manipuler des images 16.10.2000 (1 journée) FileMaker 17, 18 et 24, 25.10.00 (4 jours) Nouveautés de WORD 19 et 20.10.2000 (2 jours) ACCESS 1er niveau 30 - 31.10.00 (2 jours)Introduction à PowerPoint 6.11.00 (1 journée)Nouveautés d’EXCEL 7.11.2000(4 demi-journées)Excel 13, 14 et 20, 21.11.00 (4 jours) LabView hands-on 13.11.2000(4 hours)LabView Basics 1 14 - 16.11.2000 (3 days) MS-Project 1er niveau 14-17.11.00 (4 demi-journées) If you wish to participate in one of these courses, please discuss with your supervisor and apply elec...

  1. Places available **

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : CLEAN-2002 : Working in a cleanroom (free course, registration required): 11.4.03 (half-day, afternoon, ) LabView Basics 2 : 10 - 11.4.03 (3 days) DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) Oracle iDS Reports : Build Internet Reports : 5 - 9.5.03 (5 days) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03 (6 jours) Formation Siemens SIMATIC /Siemens SIMATIC Training : Introduction à STEP7 /Introduction to STEP7 : 3 & 4.6.03 (2 jours/2 days) Programmation STEP7/STEP7 Programming : 31.3 - 4.4.03 / 16 - 20.6.03 (5 jours/5 days) Réseau Simatic Net /Simatic Net Network : 15 & 16.4.03 / 26 & 27.6.03 These courses will be given in French or English following the requests. Cours de sécurité : Etre TSO au CERN : Prochaines sessions : 24, 25 & 27.6....

  2. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : CLEAN-2002 : Working in a cleanroom (free course, registration required): 11.4.03 (half-day, afternoon, ) LabView Basics 2 : 10 - 11.4.03 (3 days) DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) Oracle iDS Reports : Build Internet Reports : 5 - 9.5.03 (5 days) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03(6 jours) Formation Siemens SIMATIC /Siemens SIMATIC Training : Introduction à STEP7 /Introduction to STEP7 : 3 & 4.6.03 (2 jours/2 days) Programmation STEP7/STEP7 Programming : 31.3 - 4.4.03 / 16 - 20.6.03 (5 jours/5 days) Réseau Simatic Net /Simatic Net Network : 15 & 16.4.03 / 26 & 27.6.03 These courses will be given in French or English following the requests. Cours de sécurité : Etre TSO au CERN : Prochaines sessions : 24, 25 & 27.6...

  3. Places available **

    CERN Multimedia

    2003-01-01

    Des places sont disponibles dans les cours suivants : Places are available in the following courses : DISP-2003 - Spring I Term : Introduction to Digital Signal Processing : 20, 27.2, 6, 13, 20, 27.3, 3.4.03 (7 X 2-hour lectures) AXEL-2003 - Introduction to Accelerators : 24 - 28.2.03 (10 X 1-hour lectures) AutoCAD 2002 - niveau 1 : 24, 25.2 & 3, 4.3.03 (4 jours) Introduction à Windows 2000 au CERN : 25.2.03 (1/2 journée) LabView base 2/LabView Basics 2 : 10 & 11.3.03 (2 jours/2 days) langue à définir/Language to be decided C++ for Particle Physicists : 10 - 14.3.03 (6 X 3-hour lectures) Introduction to PVSS : 10.3.03 (half day, afternoon) Basic PVSS : 11 - 13.3.03 (3 days) LabView avancé /LabView Advanced : 12 - 14.3.03 (3 jours/3days) Langue à définir/language to be decided AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 17, 18, 24 & 25.3.03 (6 jours) PVSS - JCOP Framework Tutorial : 14.3.03 (1 day) CLEAN-2002 : Working in a cleanroom : 2.4.03 (half-day, afternoon, free course, regis...

  4. Places available **

    CERN Multimedia

    2003-01-01

    Des places sont disponibles dans les cours suivants : Places are available in the following courses : C++ for Particle Physicists : 10 - 14.3.03 (6 X 3-hour lectures) Introduction to PVSS : 10.3.03 (half day, afternoon) Basic PVSS : 11 - 13.3.03 (3 days) PVSS - JCOP Framework Tutorial : 14.3.03 (1 day) CLEAN-2002 : Working in a cleanroom : 2.4.03 (half-day, afternoon, free course, registration required) LabView base 1/LabView Basics 1 : 9 - 11.4.03 (3 jours/3 days) Langue à définir/language to be decided DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03 (6 jours) Formation Siemens SIMATIC /Siemens SIMATIC Training : Introduction à STEP7 /Introduction to STEP7 : 11 & 12.3.03 / 3 & 4.6.03 (2 jours/2 days) Programmation STEP7/STEP7 Programming : 31.3 - 4.4.03 / 16...

  5. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : Introduction to PVSS : 10.3.03 (half-day, afternoon) CLEAN-2002 : Working in a cleanroom : 2.4.03 (half-day, afternoon, free course, registration required) LabView Basics 1 : 9 - 11.4.03 (3 days) Language to be decided. DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures). AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03 (6 jours) Siemens SIMATIC Training: Introduction to STEP7 : 3 & 4.6.03 (2 days) STEP7 Programming : 31.3 - 4.4.03 / 16 - 20.6.03 (5 days) Simatic Net Network : 15 & 16.4.03 / 26 & 27.6.03 These courses will be given in French or English following the requests. Cours de sécurité: Etre TSO au CERN : 3 sessions sont programmées pour 2003 : 25, 26 & 28.3.03 - 24, 25 & 27.6.03 - 4, 5 & 7.11.03 (sessions de 3 jours) ** The number o...

  6. Places available **

    CERN Multimedia

    2003-01-01

    Des places sont disponibles dans les cours suivants : Places are available in the following courses : Introduction à Windows 2000 au CERN : 25.2.03 (1/2 journée) LabView base 2/LabView Basics 2 : 10 & 11.3.03 (2 jours/2 days) langue à définir/Language to be decided C++ for Particle Physicists : 10 - 14.3.03 (6 X 3-hour lectures) Introduction to PVSS : 10.3.03 (half day, afternoon) Basic PVSS : 11 - 13.3.03 (3 days) LabView avancé /LabView Advanced : 12 - 14.3.03 (3 jours/3days) Langue à définir/Language to be decided AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 17, 18, 24 & 25.3.03 (6 jours) PVSS - JCOP Framework Tutorial : 14.3.03 (1 day) CLEAN-2002 : Working in a cleanroom : 2.4.03 (half-day, afternoon, free course, registration required) LabView base 1/LabView Basics 1 : 9 - 11.4.03 (3 jours/3 days) Langue à définir/Language to be decided DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (...

  7. Places available **

    CERN Multimedia

    2003-01-01

    Des places sont disponibles dans les cours suivants : Places are available in the following courses : WorldFIP 2003 pour utilisateurs : 11-14.2.03 (4 jours) DISP-2003 ? Spring I Term : Introduction to Digital Signal Processing : 20, 27.2, 6, 13, 20, 27.3, 3.4.03 (7 X 2-hour lectures) AXEL-2003 - Introduction to Accelerators : 24-28.2.03 (10 X 1-hour lectures) AutoCAD 2002 - niveau 1 : 24, 25.2 & 3, 4.3.03 (4 jours) Introduction à Windows 2000 au CERN : 25.2.03 (1/2 journée) LabView base 2/LabView Basics 2 : 10 & 11.3.03 (2 jours/2 days) langue à définir/Language to be decided C++ for Particle Physicists : 10 ? 14.3.03 (6 X 3-hour lectures) Introduction to PVSS : 10.3.03 (half day, afternoon) Basic PVSS : 11 - 13.3.03 (3 days) LabView avancé /LabView Advanced : 12 - 14.3.03 (3 jours/3days) Langue à définir/language to be decided AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 17, 18, 24 & 25.3.03 (6 jours) PVSS - JCOP Framework Tutorial : 14.3.03 (1 day) MAGNE-03 - Magnetism for Technical Ele...

  8. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : CLEAN-2002 : Working in a cleanroom (free course, registration required) : 2.4.03 (half-day, afternoon) LabView base 1/LabView Basics 1 (Langue à définir/ language to be decided) : 9 - 11.4.03 (3 jours/3 days) DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03(6 jours) Formation Siemens SIMATIC /Siemens SIMATIC Training : Introduction à STEP7 /Introduction to STEP7 : 3 & 4.6.03 (2 jours/2 days) Programmation STEP7/STEP7 Programming : 31.3 - 4.4.03 / 16 - 20.6.03 (5 jours/5 days) Réseau Simatic Net /Simatic Net Network : 15 & 16.4.03 / 26 & 27.6.03 These courses will be given in French or English following the requests. Cours de sécurité : Etre TSO au CERN : 3 sessions sont programmées pour 2003 : 25...

  9. Places available**

    CERN Multimedia

    2003-01-01

    Places are available in the following courses : CLEAN-2002 : Working in a cleanroom (free course, registration required): 11.4.03 (half-day, afternoon) LabView Basics 2 : 10 - 11.4.03 (3 days) DISP-2003 - Spring II Term : Advanced Digital Signal Processing : 30.4, 7, 14, 21.5.03 (4 X 2-hour lectures) AutoCAD 2002 - niveau 1 : 29, 30.4 et 7, 8.5.03 (4 jours) Oracle iDS Reports : Build Internet Reports : 5 - 9.5.03 (5 days) AutoCAD 2002 - niveau 2 : 5 & 6.5.03 (2 jours) AutoCAD Mechanical 6 PowerPack (F) : 12, 13, 20, 21, 27 & 28.5.03(6 jours) Formation Siemens SIMATIC /Siemens SIMATIC Training : Introduction à STEP7 /Introduction to STEP7 : 3 & 4.6.03 (2 jours/2 days) Programmation STEP7/STEP7 Programming : 16 - 20.6.03 (5 jours/5 days) Réseau Simatic Net /Simatic Net Network : 15 & 16.4.03 / 26 & 27.6.03 These courses will be given in French or English following the requests. Cours de sécurité : Etre TSO au CERN : Prochaines sessions : 24, 25 & 27.6.03 - 4, 5 & 7....

  10. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: LabView DAQ  (F) : 7 & 8.2.02 (2 jours) Hands-on Object-Oriented Design & Programming with Java :  11 - 13.02.02 (3 days) PVSS basics :  18 - 22.2.02 (5 days) Introduction à Windows 2000 : 18.2.02 (1 demi-journée) Introduction to the CERN Engineering Data Management System :  20.2.02 (1 day) Introduction à la CAO CADENCE : 20 & 21.2.02 (2 jours) The CERN Engineering Data Management System for Advanced users :  21.2.02  (1 day) LabView Basics 1 :  4 - 6.3.02  (3 days) Introduction au VHDL et utilisation du simulateur de CADENCE : 6 & 7.3.02 (2 jours) LabView Base 2 : 11 & 12.3.02 (2 jours) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) LabView Advanced :  13 - 15.3.02 (3 days) Cours sur la migration AutoCAD :   AutoCAD : Mise à...

  11. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: LabVIEW base 1 : 22 - 24.4.02 (3 jours) CLEAN 2002 : working in a cleanroom:  24.4.02  (half-day, pm) LabVIEW DSC (F) 25 & 26.4.02 (2 jours) AutoCAD : Mise à jour AutoCAD r-14 vers 2002 : 25 & 26.4.02 (2 jours) Cotations selon les normes GPS de l'ISO : 29 - 30.4.02 (2 jours) Introduction to the CERN Engineering Data Management System:  7.5.02  (1 day) LabVIEW Basics 2: 13 & 14.5.02 (2 days) AutoCAD Mechanical 6 PowerPack (F) : 13-14, 17, 21, 27-28.5.02 (6 jours) WorldFIP - Généralités : 14.5.2002 (1/2 journée) WorldFIP - Développer avec MicroFIP HANDLER : 14.5 - après-midi, 15.5.02 - matin (1 jour) WorldFIP - FullFIP FDM : FIP Device Manager (F) : 15.5 - après-midi, 16.5.02 - matin (1 jour) LabVIEW DAQ (F) : 15 & 16.5.02 (2 jours) EXCEL 2000 - niveau 2 : 22 & 23.5.02 (2 jours)...

  12. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: The CERN Engineering Data Management System for Advanced users : 16.4.02  (1 day) Migration from AutoCAD 14 towards AutoCAD Mechanical6 PowerPack:  17 - 19.4 and 2 &3.5.02  (5 days) AutoCAD - niveau 1 : 22, 23, 29, 30.4 et 6, 7.5.02 (6 jours) LabVIEW base 1 : 22 - 24.4.02 (3 jours) CLEAN 2002 : working in a cleanroom:  24.4.02  (half-day, pm) LabVIEW DSC (F) 25 & 26.4.02 (2 jours) AutoCAD : Mise à jour AutoCAD r-14 vers 2002 : 25 & 26.4.02 (2 jours) Cotations selon les normes GPS de l'ISO : 29 - 30.4.02 (2 jours) Introduction to the CERN Engineering Data Management System:  7.5.02  (1 day) LabVIEW Basics 2: 13 & 14.5.02 (2 days) AutoCAD Mechanical 6 PowerPack (F) : 13-14, 17, 21, 27-28.5.02 (6 jours) WorldFIP - Généralités : 14.5.2002 (1/2 journée) WorldFIP - Développer avec Micr...

  13. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: Introduction au PC et à Windows 2000 au CERN : 29 - 30.1.02 (2 jours) LabView Base 1 : 4 - 6.2.02 (3 jours) LabView DAQ  (F) : 7 & 8.2.02 (2 jours) Hands-on Object-Oriented Design & Programming with Java :  11 - 13.02.02 (3 days) PVSS basics :  18 - 22.2.02 (5 days) Introduction à Windows 2000 : 18.2.02 (1 demi-journée) Introduction to the CERN Engineering Data Management System :  20.2.02 (1 day) The CERN Engineering Data Management System for Advanced users :  21.2.02  (1 day) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) Cours sur la migration AutoCAD : AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electr...

  14. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) Programming the Web for Control Applications : 11, 12, 18, 19.3.2002  (4 * 2 hour lectures) Habilitation électrique : recyclage HT/BT (Français) : 13 - 14.3.2002 (2 * 2 heures) Introduction à la CAO CADENCE : 19 & 20.3.02 (2 jours) LabVIEW base 1 : 22 - 24.4.02 (3 jours) LabVIEW DSC (F) 25 & 26.4.02 (2 jours) LabVIEW Basics 2 : 13 & 14.5.02 (2 days) LabVIEW DAQ (F) : 15 & 16.5.02 (2 jours) Cours sur la migration AutoCAD :   AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé sur AutoCAD 2002 (5 jours) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that can be found on the Web at : Technical Training or fil...

  15. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: LabVIEW - Basics 1 :  10 - 12.12.01 (3 days) Introduction to XML :  12 & 13.12.01 (2 days) Introduction au PC et Windows 2000 : 12 & 14.12.01 (2 jours) LabVIEW - Basics 2 :  13 - 14.12.01 (2 days) Habilitation électrique : superviseurs : 17.12.2001 (1/2 journée) MS-Project 2000 : 10 & 11.01.02 (2 jours) EXCEL 2000 - niveau 2 : 15 - 16.1.02 (2 jours) Sécurité dans les installations cryogéniques: 15-17.1.2002 (2 demi-journées) C++ Programming Level 2 - Traps and Pitfalls :  15 - 18.1.2002  (4 days) ELEC-2002 Winter Term: Readout and system electronics for Physics  15.1.2002 - 7.2.2002 (8 half- days) Nouveautés de WORD 2000 : 18.1.02 (1/2 journée) LabView hands-on : 21.01.02 (1/2 journée) LabView DAQ hands-on : 21.01.02 (1/2 journée) FileMaker Pro : 22 -...

  16. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2002-01-01

    Places are available in the following courses: LabView hands-on : 21.01.02 (1/2 journée) LabView DAQ hands-on : 21.01.02 (1/2 journée) FileMaker Pro : 22 - 25.1.02 (4 jours) MS-Project 2000 : 22, 24 & 25.01.02 (3 jours) Introduction au PC et à Windows 2000 au CERN : 29 - 30.1.02 (2 jours) LabView Base 1 : 4 - 6.2.02 (3 jours) LabView DAQ  (E) :  7 & 8.02.02 (2 days) Hands-on Object-Oriented Design & Programming with Java :  11 - 13.02.02 (3 days) PVSS basics :  11 - 15.2.02 (5 days) Introduction à Windows 2000 : 18.2.02 (1 demi-journée) Introduction to the CERN Engineering Data Management System :  20.2.02 (1 day) The CERN Engineering Data Management System for Advanced users :  21.2.02  (1 day) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) Cours sur la migration AutoCAD : AutoCAD : Mise à...

  17. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel.74924

    2001-01-01

    Places are available in the following courses: Habilitation électrique : superviseurs : 5.12.01 (1/2 journée) LabVIEW - Basics 1 :  10 - 12.12.01 (3 days) Introduction au PC et Windows 2000 : 12 & 14.12.01 (2 jours) LabVIEW - Basics 2 :  13 - 14.12.01 (2 days) Habilitation électrique : superviseurs : 17.12.2001 (1/2 journée) EXCEL 2000 - niveau 2 : 15 - 16.1.02 (2 jours) Sécurité dans les installations cryogéniques: 15-17.1.2002 (2 demi-journées) C++ Programming Level 2 - Traps and Pitfalls :  15 - 18.1.2002  (4 days) ELEC-2002 Winter Term: Readout and system electronics for Physics  15.1.2002 - 7.2.2002 (8 half- days) Nouveautés de WORD 2000 : 18.1.02 (1/2 journée) LabView hands-on : 21.01.02 (1/2 journée) LabView DAQ hands-on : 21.01.02 (1/2 journée) FileMaker Pro : 22 - 25.1.02 (4 jours) Frontpage...

  18. PLACES AVAILABLE

    CERN Multimedia

    Enseignement Technique; Tel. 74924

    2001-01-01

    Places are available in the following courses: MS-Project 2000 : 10 & 11.01.02 (2 jours) EXCEL 2000 - niveau 2 : 15 - 16.1.02 (2 jours) Sécurité dans les installations cryogéniques: 15-17.1.2002 (2 demi-journées) C++ Programming Level 2 - Traps and Pitfalls :  15 - 18.1.2002  (4 days) ELEC-2002 Winter Term: Readout and system electronics for Physics  15.1.2002 - 7.2.2002 (8 half- days) Nouveautés de WORD 2000 : 18.1.02 (1/2 journée) LabView hands-on : 21.01.02 (1/2 journée) LabView DAQ hands-on : 21.01.02 (1/2 journée) FileMaker Pro : 22 - 25.1.02 (4 jours) MS-Project 2000 : 24 & 25.01.02 (2 jours) Introduction au PC et à Windows 2000 au CERN : 29 - 30.1.02 (2 jours) LabView Base 1 : 4 - 6.2.02 (3 jours) LabView DAQ  (E) :  7 & 8.02.02 (2 days) Hands-on Object-Oriented Design & Programming with Java :&nbs...

  19. PLACES AVAILABLE

    CERN Multimedia

    Monique Duval

    2002-01-01

    Places are available in the following courses: PVSS Basics :  8 - 12.4.02  (5 days) AutoCAD : Mise à jour AutoCAD r-14 vers 2002 : 25 & 26.4.02 (2 jours) ELEC-2002 : Spring Term :  9, 11, 16, 18, 23, 25, 30.4.02 (7 * 2.5 hours) Object-Oriented Analysis & Design: 16 - 19.4.02  (4 days) Migration from AutoCAD 14 towards AutoCAD Mechanical6 PowerPack:  17 - 19.4 and 2 &3.5.02  (5 days) LabVIEW base 1 : 22 - 24.4.02 (3 jours) LabVIEW DSC (F) 25 & 26.4.02 (2 jours) LabVIEW Basics 2 : 13 & 14.5.02 (2 days) EXCEL 2000 - niveau 2 : 22 & 23.5.02 (2 jours) LabVIEW DAQ (F) : 15 & 16.5.02 (2 jours) LabVIEW Basics 1:  3 - 5.6.02  (3 days) LabVIEW DAQ (E):  6 & 7.6.02  (2 days) If you wish to participate in one of these courses, please discuss with your supervisor and apply electronically directly from the course description pages that...

  20. PLACES AVAILABLE

    CERN Multimedia

    Monique DUVAL

    2002-01-01

    Places are available in the following courses: LabView Basics 1 :  4 - 6.3.02  (3 days) CLEAN-2002 : Working in a Clean Room :  7.3.2002  (half day) LabView Base 2 : 11 & 12.3.02 (2 jours) C++ for Particle Physicists :  11 - 15.3.2002  (6 * 3 hour lectures) Programming the Web for Control Applications : 11, 12, 18, 19.3.2002  (4 * 2 hour lectures) Habilitation électrique : recyclage HT/BT (Français) : 13 - 14.3.2002 (2 * 2 heures) LabView Advanced :  13 - 15.3.02 (3 days) Introduction to the CERN Engineering Data Management System (EDMS) :  20.3.2002  (1 day) The CERN (EDMS) for Advanced Users :  21.3.2002  (1 day) LabVIEW DSC : 25 - 26.4.2002 (2 jours) LabVIEW DAQ : 15 - 16.5.2002 (2 jours) Cours sur la migration AutoCAD :   AutoCAD : Mise à jour AutoCAD r-14 vers 2002 (2 jours) AutoCAD Mechanical PowerPack 6 basé ...