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. Animal Drug Safety FAQs

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  3. 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...

  4. 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)…

  5. 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...

  6. 21 CFR 25.33 - Animal drugs.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Animal drugs. 25.33 Section 25.33 Food and Drugs... CONSIDERATIONS Categorical Exclusions § 25.33 Animal drugs. The classes of actions listed in this section are... use of the drug. Actions to which this categorical exclusion applies may include: (1) An animal...

  7. 76 FR 6326 - New Animal Drugs; Masitinib

    Science.gov (United States)

    2011-02-04

    ... on the date of conditional approval. This new animal drug qualifies for exclusive marketing rights... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 New Animal Drugs; Masitinib AGENCY...) is amending the animal drug regulations to reflect conditional approval of an application for a...

  8. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

    Science.gov (United States)

    2013-08-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin AGENCY: Food... amending the animal drug regulations to reflect the withdrawal of approval of three new animal...

  9. 76 FR 17025 - New Animal Drugs; Oxytetracycline

    Science.gov (United States)

    2011-03-28

    ...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 Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and...

  10. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2011-03-02

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 Animal Drugs, Feeds, and... Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and... DRUGS FOR USE IN ANIMAL FEEDS 0 5. The authority citation for 21 CFR part 558 continues to read...

  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... CFR Part 558 Animal drugs, animal feeds. 0 Therefore, under the Federal Food, Drug, and Cosmetic...

  12. Animal learning and motivation and addictive drugs.

    Science.gov (United States)

    Logan, F A

    1993-08-01

    Highlights of a systematic analysis of the abstracts of over 1700 publications dealing with addictive drugs (primarily alcohol) in the context of animal learning and motivation are summarized under two main headings. The behavioral effects of drugs vary with the nature of the drug, the dosage, and the behavioral baseline; behavioral tolerance frequently results from continued practice in the drug state. The paradigmatic effects show that drugs can function effectively as conditional stimuli, unconditional stimuli, responses, and reinforcers. As a result, drug habits develop their own motivational support, leading to conditioned tolerance and conditioned addiction. It is contended that principles of animal behavior can provide a basis for a theory of human drug use and abuse, but that voluntary control of addictive behavior requires uniquely human cognitive processes.

  13. Drug use in animal sports

    DEFF Research Database (Denmark)

    Møller, Verner

    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...

  14. 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,...

  15. 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 318.20 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... General § 318.20 Use of animal drugs. Animal drug residues are permitted in meat and meat food products...

  16. Advancing drug availability-experiences from Africa.

    Science.gov (United States)

    Powell, Richard A; Kaye, Richard Mugula; Ddungu, Henry; Mwangi-Powell, Faith

    2010-07-01

    International health and drug regulatory authorities acknowledge that analgesics (especially opioids) are insufficiently available for pain management in many countries. In Africa, reported morphine consumption is far below the global mean, with multiple factors hampering opioid supply. Since 2006, the African Palliative Care Association has hosted three regional drug availability workshops across the continent to address this issue. Using an interactive format, the workshops have identified country-specific barriers to opioid and other essential medication accessibility before supporting participants to develop action plans to address recognized impediments. Despite multiple challenges, a number of successes have arisen from the implementation of the plans. However, key issues remain, including the introduction of supportive policy environments, effective educational initiatives, and measures to address supply-chain obstacles impeding drug availability. PMID:20619205

  17. 76 FR 17776 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-31

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 Animal Drugs, Feeds... Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and.... 000010 and 000069''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 12. The authority citation...

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

    Science.gov (United States)

    2010-02-05

    ... 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 an original new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co....

  20. 75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

    Science.gov (United States)

    2010-06-17

    ... 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 approval of a supplemental new animal... requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. 0...

  1. 77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food

    Science.gov (United States)

    2012-12-05

    ... Federal Regulations (21 CFR part 556) (40 FR 13802 at 13942, March 27, 1975). The part 556 regulations... must be non-detectable or below the limit of detection of the approved regulatory method (67 FR 78172...-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food AGENCY: Food...

  2. 75 FR 55676 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-09-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 Animal Drugs, Feeds, and... drugs, Animal feeds. 0 Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority... section. * * * * * PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 5. The authority citation for...

  3. 75 FR 11451 - New Animal Drugs for Use in Animal Feeds; Zilpaterol

    Science.gov (United States)

    2010-03-11

    ... 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 three abbreviated new animal drug applications (ANADAs) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The...

  4. 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... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The...

  5. 77 FR 24138 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Science.gov (United States)

    2012-04-23

    ... 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 Novartis Animal Health US, Inc. The supplemental NADA provides...

  6. 77 FR 4228 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2012-01-27

    ... 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 Elanco Animal Health, A Division of Eli Lilly & Co. The...

  7. 75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

    Science.gov (United States)

    2010-09-03

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feed... Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The...

  8. 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...

  9. 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...

  10. 76 FR 65109 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

    Science.gov (United States)

    2011-10-20

    ... 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 reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy...

  11. 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....

  12. [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.

  13. [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. PMID:27071276

  14. 75 FR 65565 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-10-26

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole...: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing...

  15. 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...

  16. 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...

  17. 75 FR 79383 - Unapproved Animal Drugs

    Science.gov (United States)

    2010-12-20

    ... Contamination With Thallium or Radioactive Cesium; Availability'' (68 FR 5645, February 4, 2003)) and Pancreatic Enzymes (see ``Exocrine Pancreatic Insufficiency Drug Products'' (69 FR 23410, April 28, 2004), ``Exocrine Pancreatic Insufficiency Drug Products for Over-the-Counter Human Use'' (56 FR 32282, July 15, 1991),...

  18. 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.

  19. 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...

  20. Animal models and brain circuits in drug addiction.

    Science.gov (United States)

    Kalivas, Peter W; Peters, Jamie; Knackstedt, Lori

    2006-12-01

    Animal models in the field of addiction are considered to be among the best available models of neuropsychiatric disease. These models have undergone a number of refinements that allow deeper understanding of the circuitry involved in initiating drug seeking and relapse. Notably, the demonstrable involvement of classic corticostriatal habit circuitry and the engagement of prefrontal cortical circuits in extinction training may have relevance to the therapeutic modulation of habit circuitry and drug addiction in humans. PMID:17200461

  1. 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.

  2. 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. PMID:27096187

  3. [New drugs for horses and production animals in 2010].

    Science.gov (United States)

    Emmerich, I U

    2011-01-01

    In 2010, three new active pharmaceutical ingredients were released on the German market for horses and food-producing animals. These were gamithromycin (Zactran®), a new macrolide antibiotic, Monepantel (Zolvix®), a broad spectrum anthelmintic with a novel mechanism, and Pergolide (Prascend®), the first dopamine receptor agonist for animals. Two substances have been approved for additional species. The tetracycline antibiotic doxycycline is now also authorized for turkeys and the nonsteroidal anti-inflammatory drug firocoxib from the group of cyclo-oxygenase-2 (COX-2) inhibitors is now available for horses. Furthermore, four new preparations with an interesting new pharmaceutical form, one drug with a new formulation and two drugs, which are interesting because of other criteria, were added to the market for horses and food producing animals. PMID:22167083

  4. Utility and importance of animal data in drug product labels.

    Science.gov (United States)

    Baldrick, Paul

    2014-08-01

    Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. PMID:24928564

  5. 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...

  6. 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 §...

  7. 76 FR 16533 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 Animal Drugs, Feeds, and Related Products..., 2010 (75 FR 65565) amending the animal drug regulations. The October 26, 2010, final rule amended the... medicated feed. This correction is being made to improve the accuracy of the animal drug regulations....

  8. 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.

  9. 76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

    Science.gov (United States)

    2011-08-09

    .... Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 524 New Animal Drugs; Change of... Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor...

  10. 76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2011-12-21

    ... requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).) * * * * * Dated... 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...

  11. 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...

  12. Conflicts of Interest in the Development of Animal Drugs

    Directory of Open Access Journals (Sweden)

    Michael Guarnieri S

    2016-03-01

    Full Text Available The past 25 years have witnessed remarkable changes in how new drugs are brought to the market. Pharmaceutical companies once took pride in vertical integration. Animal tests, laboratory analyses, and clinical trials were conducted in-house. Even when companies found that many of these services could be done more effectively by contract research organizations, they maintained tight control of their research programs. Academic scientists frequently reported stories about efforts to contact a pharmaceutical company with an idea about a new drug only to be told politely that if the idea were not developed in house, big pharma was not interested.

  13. 77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

    Science.gov (United States)

    2012-03-19

    ... Medicine, 21 CFR part 520 is amended as follows: PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Pergolide..., 2012. FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary Medicine (HFV-114), Food...

  14. 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...

  15. 21 CFR 510.7 - Consignees of new animal drugs for use in the manufacture of animal feed.

    Science.gov (United States)

    2010-04-01

    ... manufacture of animal feed. 510.7 Section 510.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new...

  16. Antibiotics in Animal Feed Contribute to Drug-Resistant Germs

    Science.gov (United States)

    ... medlineplus/news/fullstory_158316.html Antibiotics in Animal Feed Contribute to Drug-Resistant Germs: Study Individual farm ... HealthDay News) -- Use of antibiotics in farm animal feed is helping drive the worldwide increase in antibiotic- ...

  17. 77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

    Science.gov (United States)

    2012-07-27

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales and Distribution Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA or Agency) is soliciting comments regarding...

  18. 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... CONTACT: Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500... of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is...

  19. 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 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration... Nutrition Companies, Inc., to Provimi North America, Inc. DATES: This rule is effective November 10,...

  20. 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.

  1. Animal models of cerebral ischemia for evaluation of drugs.

    Science.gov (United States)

    Gupta, Y K; Briyal, Seema

    2004-10-01

    Stroke is a major cause of death and disability worldwide. The resulting burden on the society continues to grow, with increase in the incidence of stroke. Brain attack is a term introduced to describe the acute presentation of stroke, which emphasizes the need for urgent action to remedy the situation. Though a large number of therapeutic agents like thrombolytics, NMDA receptor antagonists, calcium channel blockers and antioxidants, have been used or being evaluated, there remains a large gap between the benefits by these agents and properties an ideal drug for stroke should offer. In recent years much attention is being paid towards the exploration of herbal preparation, antioxidant agents and combination therapies including COX-2 inhibitors in experimental model of stroke. For better evaluation of the drugs and enhancement of their predictability from animal experimentation to clinical settings, it has been realized that the selection of animal models, the parameters to be evaluated should be critically assessed. Focal and global cerebral ischemia represents diseases that are common in the human population. Understanding the mechanisms of injury and neuroprotection in these diseases is important to learn new target sites to treat ischemia. There are many animal models available to investigate injury mechanisms and neuroprotective strategies. In this article we attempted to summarize commonly explored animal models of focal and global cerebral ischemia and evaluate their advantages and limitations. PMID:15907047

  2. 75 FR 1275 - New Animal Drugs; Ractopamine

    Science.gov (United States)

    2010-01-11

    ... (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for... Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed...

  3. 76 FR 78149 - Oral Dosage Form New Animal Drugs; Estriol

    Science.gov (United States)

    2011-12-16

    ... for Veterinary Medicine, 21 CFR part 520 is amended as follows: ] PART 520--ORAL DOSAGE FORM NEW... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Estriol..., Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rockville,...

  4. 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,...

  5. 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,...

  6. Juvenile animal testing in drug development--is it useful?

    Science.gov (United States)

    Baldrick, Paul

    2010-01-01

    In pharmaceutical drug development, there has been increased interest in the need to perform juvenile animal studies to support the safety of use of new medicines in the pediatric population. Although such studies are not new, the increased interest has been "formalized" in recent regulatory guidelines. As a result, companies are now performing many more studies in juvenile animals, even when there is a lack of robust knowledge of cross-species functional and kinetic differences among juveniles that means extrapolation of any toxicology study finding to an immature human may not be easy or even relevant, especially if performed in the wrong species at the wrong time. It will be shown by presentation of some basic considerations needed in order to perform such testing, that juvenile animal studies are indeed feasible. However, it will also be highlighted that (based on available knowledge) there are currently not enough clear-cut examples to answer the question of whether juvenile animal toxicology studies to support pediatric development (by affecting the performance or design of a pediatric clinical trial or identifying a potential different-from-adult safety risk in clinical use) are truly useful or necessary. PMID:20350578

  7. Animal models of drug addiction: advantages and limitations

    OpenAIRE

    Quertemont, Etienne

    2006-01-01

    Various animal models have been developed to investigate the neurobiological and behavioral mechanisms of drug addiction. The most popular of these animal models include the locomotor sensitization paradigm, the place conditioning procedure and the self-administration technique. With these techniques, it is possible to mimic in rodents the major aspects of human drug addiction. The self-administration procedure is the most widely used and show an excellent natural and predictive validity. In ...

  8. 76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

    Science.gov (United States)

    2011-09-23

    ... to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520--ORAL DOSAGE... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Tylosin... September 23, 2011. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine...

  9. 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...

  10. Acetylsalicylic-acid-containing drugs and nonsteroidal anti-inflammatory drugs available in Canada

    OpenAIRE

    Brigden, M; Smith, R E

    1997-01-01

    A large number of drugs containing acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter in Canada. The possibility of serious side effects and drug interactions is therefore high. The authors have compiled a comprehensive list of products containing these drugs from information supplied by pharmaceutical databases, independent marketing researchers and Health Canada's Drug Directorate. Physicians should ensure that add...

  11. 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...

  12. Animal nutrition and optimized utilization of locally available resources

    International Nuclear Information System (INIS)

    Rice straw is the most abundant among crop residues. Actually, rice straw is the most important roughage in Myanmar for ruminant feeding. Like other fibrous residues, it is a poor quality feed. The major cause of low productivity of livestock in tropical regions is the inadequate and poor quality of feed. The nutritional limitations of rice straw may be overcome by supplementation with concentrates, urea or green forage. Supplementation of rice straw with concentrate would improve the utilization of rice straw. Supplementation of by-product, which may increase intake and/or digestion, and/or utilization of the basal diet are the condition directly related to microbial activity, which is required to optimize rumen digestion. The microbes within the rumen grow efficiently when ammonia nitrogen in the rumen is adequate. In Myanmar, sesame meal is one of the common feed supplements for the draft cattle and crossbred dairy cows fed rice straw. Sesame meal is highly degradable (88.7%) in the rumen. Therefore, degradation of protein is a considerable factor when the protein sources are supplemented. Several processing treatments (heat, tannin, formaldehyde, etc.) have been used to increase the proportion of dietary protein, which is not degraded in the rumen. Protections of highly degradable feed protein by the heat treatment and formaldehyde have already been reported. However, little information is available about the effect of tannin included in tree foliages for the protein protection. Conventionally, tree foliages have been fed together with agricultural by-products, mainly crop-residues, containing low levels of nitrogen to enhance rumen microbial fermentation and hence the animal productivity. Tanniferous trees and shrubs are important in animal production because they can provide significant protein supplements. Forages containing leucocephala, Ziziphus mauritiana, Albizia chinensis, Manihot esculenta, Terminalia oblongata, etc. Tree legume forages offer a cheap

  13. 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...

  14. Overview on available animal models for application in leukemia research

    International Nuclear Information System (INIS)

    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

  15. Drug eluting stents: are human and animal studies comparable?

    OpenAIRE

    Virmani, R; Kolodgie, F D; Farb, A.; Lafont, A

    2003-01-01

    Animal models of stenting probably predict human responses as the stages of healing are remarkably similar. What is characteristically different is the temporal response to healing, which is substantially prolonged in humans. The prevention of restenosis in recent clinical trials of drug eluting stents may represent a near absent or incomplete phase of intimal healing. Continued long term follow up of patients with drug eluting stents for major adverse cardiac events and angiographic restenos...

  16. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... 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 Act of 2008 (AGDUFA), authorizes FDA to collect user fees for...

  17. 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...

  18. 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...

  19. 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...

  20. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ... 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 Act of 2008 (AGDUFA), authorizes FDA to collect user fees for...

  1. 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. PMID:27580511

  2. 76 FR 50220 - Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye...

    Science.gov (United States)

    2011-08-12

    ...) that reduce the maximum number of required animals per test from 6 to 3. The Animal Welfare Act (7 U.S... . References AWA. 2010. Animal Welfare Act. 7 U.S.C. 2131 et seq. Public Law 89- 544. Available: http://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf . CPSC. 2010. Hazardous Substances and...

  3. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when... those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial... of a final guidance entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in...

  4. Abstinence-Conflict Model: Toward an Optimal Animal Model for Screening Medications Promoting Drug Abstinence.

    Science.gov (United States)

    Peck, J A

    2016-01-01

    Drug addiction is a significant health and societal problem for which there is no highly effective long-term behavioral or pharmacological treatment. A rising concern are the use of illegal opiate drugs such as heroin and the misuse of legally available pain relievers that have led to serious deleterious health effects or even death. Therefore, treatment strategies that prolong opiate abstinence should be the primary focus of opiate treatment. Further, because the factors that support abstinence in humans and laboratory animals are similar, several animal models of abstinence and relapse have been developed. Here, we review a few animal models of abstinence and relapse and evaluate their validity and utility in addressing human behavior that leads to long-term drug abstinence. Then, a novel abstinence "conflict" model that more closely mimics human drug-seeking episodes by incorporating negative consequences for drug seeking (as are typical in humans, eg, incarceration and job loss) and while the drug remains readily available is discussed. Additionally, recent research investigating both cocaine and heroin seeking in rats using the animal conflict model is presented and the implications for heroin treatments are examined. Finally, it is argued that the use of animal abstinence/relapse models that more closely approximate human drug addiction, such as the abstinence-conflict model, could lead to a better understanding of the neurobiological and environmental factors that support long-term drug abstinence. In turn, this will lead to the development of more effective environmental and pharmacotherapeutic interventions to treat opiate addiction and addiction to other drugs of abuse. PMID:27055619

  5. 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...

  6. DIFFERENT ANIMAL MODELS FOR DRUGS WITH POTENTIAL ANTIDIABETIC PROPERTIES

    OpenAIRE

    Shah Tanmay A; Shah Nidhi T; Prajapati Parimal M; Bhatt Pratik B; Solanki Anil S

    2011-01-01

    The increasing worldwide incidence of diabetes mellitus in adults constitutes a global public health burden. It is predicted that by 2030, largest number of people with diabetes. Although medicinal plants have been historically used for diabetes treatment throughout the world, few of them have been validated by scientific criteria. In recent times, an outsized multiplicity of animal models has been developed to enhanced understand the pathogenesis of diabetes mellitus and new drugs have been ...

  7. Functional GI disorders: from animal models to drug development

    OpenAIRE

    Mayer, E A; Bradesi, S; Chang, L; Spiegel, B. M. R.; Bueller, J A; Naliboff, B. D.

    2007-01-01

    Despite considerable efforts by academic researchers and by the pharmaceutical industry, the development of novel pharmacological treatments for irritable bowel syndrome (IBS) and other functional gastrointestinal (GI) disorders has been slow and disappointing. The traditional approach to identifying and evaluating novel drugs for these symptom-based syndromes has relied on a fairly standard algorithm using animal models, experimental medicine models and clinical trials. In the current articl...

  8. 76 FR 40229 - Oral Dosage Form New Animal Drugs; Change of Sponsor

    Science.gov (United States)

    2011-07-08

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Change of... Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug... informed FDA that it has transferred ownership of, and all rights and interest in, NADA 092-150 for...

  9. Animal models for screening anxiolytic-like drugs: a perspective.

    Science.gov (United States)

    Bourin, Michel

    2015-09-01

    Contemporary biological psychiatry uses experimental animal models to increase our understanding of affective disorder pathogenesis. Modern anxiolytic drug discovery mainly targets specific pathways and molecular determinants within a single phenotypic domain. However, greater understanding of the mechanisms of action is possible through animal models. Primarily developed with rats, animal models in anxiety have been adapted with mixed success for mice, easy-to-use mammals with better genetic possibilities than rats. In this review, we focus on the three most common animal models of anxiety in mice used in the screening of anxiolytics. Both conditioned and unconditioned models are described, in order to represent all types of animal models of anxiety. Behavioral studies require careful attention to variable parameters linked to environment, handling, or paradigms; this is also discussed. Finally, we focus on the consequences of re-exposure to the apparatus. Test-retest procedures can provide new answers, but should be intensively studied in order to revalidate the entire paradigm as an animal model of anxiety.

  10. Unexploited Antineoplastic Effects of Commercially Available Anti-Diabetic Drugs

    Directory of Open Access Journals (Sweden)

    Panagiota Papanagnou

    2016-05-01

    Full Text Available The development of efficacious antitumor compounds with minimal toxicity is a hot research topic. Numerous cancer cell targeted agents are evaluated daily in laboratories for their antitumorigenicity at the pre-clinical level, but the process of their introduction into the market is costly and time-consuming. More importantly, even if these new antitumor agents manage to gain approval, clinicians have no former experience with them. Accruing evidence supports the idea that several medications already used to treat pathologies other than cancer display pleiotropic effects, exhibiting multi-level anti-cancer activity and chemosensitizing properties. This review aims to present the anticancer properties of marketed drugs (i.e., metformin and pioglitazone used for the management of diabetes mellitus (DM type II. Mode of action, pre-clinical in vitro and in vivo or clinical data as well as clinical applicability are discussed here. Given the precious multi-year clinical experience with these non-antineoplastic drugs their repurposing in oncology is a challenging alternative that would aid towards the development of therapeutic schemes with less toxicity than those of conventional chemotherapeutic agents. More importantly, harnessing the antitumor function of these agents would save precious time from bench to bedside to aid the fight in the arena of cancer.

  11. 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

  12. Essential drugs in AIDS care: issues of availability and affordability.

    Science.gov (United States)

    Kaur, S R

    1996-01-01

    Several antiretroviral drugs against HIV/AIDS have been developed in recent years. These drugs, reverse transcriptase inhibitors and protease inhibitors, inhibit the reproduction of HIV, but do not eliminate the presence of HIV in the body. The cost of drugs to treat one person with HIV/AIDS easily runs into the thousands of US dollars per year. These new drugs are therefore routinely used in developed countries, but not among the masses in developing countries. Many of the drugs needed to treat the opportunistic infections present during advanced HIV infection and AIDS are also prohibitively expensive for both developing countries and most individuals in those countries. The imposition of World Bank and International Monetary Fund structural adjustment programs together with decreased household purchasing power during the 1990s has led to increased demand for public sector services amid reduced public expenditure. The private sector is increasingly taking over the drug supply in developing countries, driving the cost of drugs out of the range of affordability for the vast majority of the poor. One strategy to contain the cost of drugs is for governments to develop and implement an integrated national drug policy based upon the concept of essential drugs and their rational use. PMID:12292110

  13. 77 FR 9528 - Animal Drugs, Feeds, and Related Products; N-Methyl-2-Pyrrolidone; Correction

    Science.gov (United States)

    2012-02-17

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 500 Animal Drugs, Feeds, and Related Products; N... CFR Part 500 Animal drugs, Animal feeds, Cancer, Labeling, Packaging and containers, Polychlorinated... Register of November 25, 2011 (76 FR 72617), codifying a method of detection for residues of...

  14. 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

  15. [Animal models of drug dependence using the drug self-administration method].

    Science.gov (United States)

    Yamamoto, T; Yabuuchi, K; Yamaguchi, T; Nakamichi, M

    2001-01-01

    This paper will review 1) experimental models of drug-seeking behavior and 2) mechanisms underlying the behavior, focusing on cocaine self-administration. After the acquisition of self-administration, vigorous lever-pressing is generally observable after the drug was replaced by saline. This lever-pressing behavior under saline infusion can be considered "drug-seeking behavior". Drug-seeking behavior is reinstated by non-contingent injection of the drug, stress exposure and presentation of drug-associated stimuli even after extinction. This is called a relapse/reinstatement model. Electrophysiological studies showed that the majority of accumbal neurons is tonically inhibited during cocaine self-administration and exhibited phasic increases in firing time-locked to cocaine self-infusion, which might represent the craving state or drive animals to drug-seeking behavior. Voltammetry and microdialysis studies indicated that the timing of drug-seeking responses can be predicted from fluctuations in accumbal extracellular dopamine concentration. Whereas dopamine D2-like agonists reinstated extinguished cocaine-seeking behavior, D1-like agonists prevented the relapse in cocaine-seeking behavior induced by cocaine itself. Given that an AMPA receptor antagonist, but not dopamine antagonist, prevented cocaine-seeking behavior induced by cocaine, glutamate transmission in the nucleus accumbens is thought to be important for expression of craving or drug-seeking behavior. PMID:11233296

  16. 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.

  17. 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

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

    OpenAIRE

    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 been extensively established. Nowadays, several studies indicate that the value of animal studies is often limited. Pharmaceutical companies and regulatory authorities as well as the public and gover...

  19. 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

  20. 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.

  1. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... HUMAN SERVICES Food and Drug Administration Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft GDUFA IT...

  2. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & ... back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  3. 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...

  4. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... HUMAN SERVICES Food and Drug Administration Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for public comment of the...

  5. 21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Antibiotic, nitrofuran, and sulfonamide drugs in... IN ANIMAL FEEDS General Provisions § 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in the feed... subtherapeutic (increased rate of gain, disease prevention. etc.) uses in animal feed of antibiotic...

  6. 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.

  7. 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...

  8. Unexploited Antineoplastic Effects of Commercially Available Anti-Diabetic Drugs

    Science.gov (United States)

    Papanagnou, Panagiota; Stivarou, Theodora; Tsironi, Maria

    2016-01-01

    The development of efficacious antitumor compounds with minimal toxicity is a hot research topic. Numerous cancer cell targeted agents are evaluated daily in laboratories for their antitumorigenicity at the pre-clinical level, but the process of their introduction into the market is costly and time-consuming. More importantly, even if these new antitumor agents manage to gain approval, clinicians have no former experience with them. Accruing evidence supports the idea that several medications already used to treat pathologies other than cancer display pleiotropic effects, exhibiting multi-level anti-cancer activity and chemosensitizing properties. This review aims to present the anticancer properties of marketed drugs (i.e., metformin and pioglitazone) used for the management of diabetes mellitus (DM) type II. Mode of action, pre-clinical in vitro and in vivo or clinical data as well as clinical applicability are discussed here. Given the precious multi-year clinical experience with these non-antineoplastic drugs their repurposing in oncology is a challenging alternative that would aid towards the development of therapeutic schemes with less toxicity than those of conventional chemotherapeutic agents. More importantly, harnessing the antitumor function of these agents would save precious time from bench to bedside to aid the fight in the arena of cancer. PMID:27164115

  9. Trends in comprehensive service availability in outpatient drug abuse treatment

    OpenAIRE

    Friedmann, Peter D; Lemon, Stephenie C.; Durkin, Elizabeth M.; D’Aunno, Thomas A.

    2003-01-01

    Comprehensive medical and psychosocial services are essential to quality addiction treatment, but their availability declined in the 1980s. To determine whether this downward trend in the availability of comprehensive services continued in the 1990s, we analyzed data from a national panel study of outpatient substance abuse treatment units in 1990, 1995, and 2000. Response rates were greater than 85%. Regarding the availability of comprehensive services, including physical examinations, routi...

  10. 75 FR 38699 - Implantation or Injectable Dosage Form New Animal Drugs; Propofol

    Science.gov (United States)

    2010-07-06

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

  11. 75 FR 9333 - Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin

    Science.gov (United States)

    2010-03-02

    ... supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co... Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a...

  12. A qualitative exploration of prescription opioid injection among street-based drug users in Toronto: behaviours, preferences and drug availability

    Directory of Open Access Journals (Sweden)

    Firestone Michelle

    2008-10-01

    Full Text Available Abstract Background There is evidence of a high prevalence of prescription opioid (PO and crack use among street drug users in Toronto. The purpose of this qualitative study was to describe drug use behaviours and preferences as well as the social and environmental context surrounding the use of these drugs among young and old street-based drug injection drug users (IDUs. Methods In-depth interviews were conducted with 25 PO injectors. Topics covered included drug use history, types of drugs used, how drugs were purchased and transitions to PO use. Interviews were taped and transcribed. Content analysis was conducted to identify themes. Results Five prominent themes emerged from the interviews: 1 Combination of crack and prescription opioids, 2 First injection experience and transition to prescription opioids, 3 Drug preferences and availability, 4 Housing and income and 5 Obtaining drugs. There was consensus that OxyContin and crack were the most commonly available drugs on the streets of Toronto. Drug use preferences and behaviours were influenced by the availability of drugs, the desired effect, ease of administration and expectations around the purity of the drugs. Distinct experiences were observed among younger users as compared to older users. In particular, the initiation of injection drug use and experimentation with POs among younger users was influenced by their experiences on the street, their peers and general curiosity. Conclusion Given the current profile of street-based drug market in Toronto and the emergence of crack and POs as two predominant illicit drug groups, understanding drug use patterns and socio-economic factors among younger and older users in this population has important implications for preventive and therapeutic interventions.

  13. 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...

  14. 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...

  15. 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. PMID:24781726

  16. 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

    regression analyses. Results Species richness increased with habitat availability for lentic species but not for lotic species. Species richness increased with elevational range for lotic species but decreased for lentic species. For both groups, neither habitat availability nor diversity could account......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...

  17. 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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    Monica Lamberti

    2014-01-01

    Full Text Available 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 cardiotoxicity. Actually, some new cytotoxic drugs like trastuzumab and cyclopentenyl cytosine show cardiotoxic effects. In this report we discuss the different mechanisms of cardiotoxicity induced by antiblastic drugs assessed using animal models.

  20. 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.

  1. [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.

  2. [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. PMID:25183445

  3. 77 FR 72356 - Animal Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ... regulated industry agree that dosage characterization is part of the effectiveness technical section of an... applications within 180 days after submission date. Non-manufacturing supplemental new animal drug applications.... Manufacturing supplemental new animal drug applications and reactivations of such supplemental...

  4. 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...

  5. 21 CFR 500.27 - Methylene blue-containing drugs for use in animals.

    Science.gov (United States)

    2010-04-01

    ... an approved new animal drug application (NADA) are deemed to be adulterated under the provisions of... cats or dogs and not the subject of an approved new animal drug application (NADA) may submit an... section 512 of the act. Submission of an NADA will not constitute grounds for continued marketing of...

  6. 75 FR 16346 - Ophthalmic and Topical Dosage Form New Animal Drugs; Orbifloxacin, Mometasone Furoate Monohydrate...

    Science.gov (United States)

    2010-04-01

    ... amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of a suspension containing... Livingston Ave., Roseland, NJ 07068, filed NADA 141-266 that provides for veterinary prescription use...

  7. 21 CFR 556.1 - General considerations; tolerances for residues of new animal drugs in food.

    Science.gov (United States)

    2010-04-01

    ... of analysis in any edible portion of such animals after slaughter or in any food yielded by or... drugs in edible products of food-producing animals treated with such drugs. Consideration of an... in the edible products—in which case a finite tolerance is required; or (2) It is not possible...

  8. 77 FR 3653 - Import Tolerances for Residues of Unapproved New Animal Drugs in Food

    Science.gov (United States)

    2012-01-25

    ... animal drugs where edible portions of animals imported into the United States may contain residues of... section if the Secretary establishes a tolerance for such drug (import tolerance) and any edible portion... approved or conditionally approved for use in the United States, but present in any imported edible...

  9. 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. PMID:26822352

  10. 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.

  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. Animal Husbandry Practices in Rural Bangladesh: Potential Risk Factors for Antimicrobial Drug Resistance and Emerging Diseases

    OpenAIRE

    Roess, Amira A.; Winch, Peter J.; Ali, Nabeel A.; Akhter, Afsana; Afroz, Dilara; El Arifeen, Shams; Darmstadt, Gary L.; Baqui, Abdullah H

    2013-01-01

    Antimicrobial drug administration to household livestock may put humans and animals at risk for acquisition of antimicrobial drug–resistant pathogens. To describe animal husbandry practices, including animal healthcare-seeking and antimicrobial drug use in rural Bangladesh, we conducted semi-structured in-depth interviews with key informants, including female household members (n = 79), village doctors (n = 10), and pharmaceutical representatives, veterinarians, and government officials (n = ...

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

    OpenAIRE

    T Arora; Mehta, A. K.; Joshi, V; Mehta, K D; N Rathor; Mediratta, P. K.; Sharma, K. K.

    2011-01-01

    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 ...

  14. 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...

  15. 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

    Torsades de Pointes (TdP) is a potentially lethal cardiac arrhythmia and a known adverse effect of many drugs secondary to block of the rapidly activating delayed rectifier potassium current (IKr). In animal models antipsychotic drugs have shown reduced pro-arrhythmic potential compared to drugs...

  16. 75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

    Science.gov (United States)

    2010-09-08

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution AGENCY: Food and Drug Administration, HHS...) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken...

  17. 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

  18. Study of variation in prices of oral antiplatelet drugs available in Indian market

    Directory of Open Access Journals (Sweden)

    Abhilasha Rashmi

    2016-06-01

    Conclusions: There is a wide difference in the cost of different brands of oral antiplatelet drugs available in India. The clinicians prescribing these drugs should be aware of these variations in cost to reduce the cost of drug therapy. [Int J Basic Clin Pharmacol 2016; 5(3.000: 810-813

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

    Science.gov (United States)

    2013-04-11

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the......

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

    OpenAIRE

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

    2015-01-01

    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 Ma...

  1. Study of variation in prices of oral antiplatelet drugs available in Indian market

    OpenAIRE

    Abhilasha Rashmi; Sharmada Nerlekar; Kumar Rajeev

    2016-01-01

    Background: Coronary artery disease is one of the most prevalent causes of death and disability in developed and developing countries. There is a wide variation in the prices of oral antiplatelet drugs marketed in India. Thus, a study was planned to find out the variation in cost in the oral antiplatelet drugs available in India either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiplatelet drug by calculating percentage variation i...

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

    OpenAIRE

    Steele, Vernon E.; Lubet, Ronald A.

    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...

  3. Availability of second-line drugs and anti-tuberculosis drug susceptibility testing in China: a situational analysis

    NARCIS (Netherlands)

    G.X. He; S. van den Hof; M.W. Borgdorff; M.J. van der Werf; S.M. Cheng; Y.L. Hu; L.X. Zhang; L.X. Wang

    2010-01-01

    OBJECTIVE: To assess the availability of second-line drugs (SLDs) and the use of drug susceptibility testing (DST) results for the treatment of tuberculosis (TB) in China. DESIGN: Cross-sectional survey in 4675 health care facilities, 1960 of which have a dedicated TB clinic, in 12 provinces in Chin

  4. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...

  5. Effects of Gamma Irradiation and Pasteurization on the Nutritive Composition of Commercially Available Animal Diets

    OpenAIRE

    Caulfield, Catherine D; Cassidy, Joseph P.; Kelly, John P.

    2008-01-01

    Gamma radiation is used to sterilize diets for specific pathogen-free (SPF) animals. Because a gamma-irradiated diet was linked to leukoencephalomyelopathy in SPF cats, we investigated the effects of ‘typical’ (28.9–34.3 kGy) and ‘high-end’ (38.4–48.7 kGy) doses of gamma irradiation and of pasteurization (at 107 °C for 15 min) on the amounts of fat; protein; carbohydrate (and taurine in cat diet); vitamins A, E, B1, B2, B6, and B12; and peroxide in commercially available dry cat, dog, and rod...

  6. 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.

  7. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Science.gov (United States)

    2011-01-20

    ... approval of a new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for... INFORMATION: Norbrook Laboratories, Ltd., Station Works, Newry, BT35 6JP, Northern Ireland, filed NADA...

  8. 76 FR 78815 - Oral Dosage Form New Animal Drugs; Cyclosporine

    Science.gov (United States)

    2011-12-20

    ... (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of... Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-329 that provides for the use of ATOPICA for... allergic dermatitis in cats at least 6 months of age and weighing at least 3 pounds. The NADA is...

  9. 77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

    Science.gov (United States)

    2012-01-26

    ... application (NADA) filed by Novartis Animal Health U.S., Inc. The supplemental NADA provides for veterinary..., Greensboro, NC 27408, filed a supplement to NADA 141-203 that provides for veterinary prescription use of... associated with dental surgery and the addition of a 12-mg size tablet. The supplemental NADA is ]...

  10. 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...

  11. 76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

    Science.gov (United States)

    2011-04-05

    ... application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription... Ave., suite 300, Greensboro, NC 27408, filed NADA 141-320 that provides for the veterinary... associated with orthopedic surgery, ovariohysterectomy, and castration. The NADA is approved as of March...

  12. 77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin

    Science.gov (United States)

    2012-09-10

    ..., Animal (enrofloxacin) control of bovine Health Division, Injectable respiratory disease P.O. Box 390, Solution. (BRD) in beef and non- Shawnee Mission, lactating dairy cattle KS 66201. at high risk of...) Single-dose therapy: For treatment of bovine respiratory disease (BRD), administer 7.5 to 12.5 mg/kg...

  13. 75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

    Science.gov (United States)

    2010-11-01

    ... drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of... Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom, filed NADA 141-314 that provides for... periparturient mares. The NADA is approved as of September 9, 2010, and the regulations in 21 CFR part 520...

  14. 77 FR 32010 - New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol

    Science.gov (United States)

    2012-05-31

    ...; Altrenogest; Dexamethasone; Florfenicol AGENCY: Food and Drug Administration, HHS. ] ACTION: Final rule... approval renders Sec. 516.1215 obsolete. 200-456 Med-Pharmex, Inc., Dexamethasone Original approval of 522... paragraphs (a)(2)(ii) and (a)(3)(iii) to read as follows: Sec. 522.540 Dexamethasone. (a) * * * (2) * * *...

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

    OpenAIRE

    Pedro H. Gobira; Jivago Ropke; Aguiar, Daniele C; Jose A.S. Crippa; Moreira, Fabricio A.

    2013-01-01

    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 ...

  16. 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

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

    OpenAIRE

    Amit Padmakar Date; Harshal M. Mahajan; Amruta V. Dashputra; Rahul R. Bhosale

    2015-01-01

    Background: Diabetes mellitus in early age is on the alarming rise in India, requiring lifelong treatment. There is a wide range of variation in the prices of antidiabetic drugs marketed in India. Hence, we decided to study price variations in the oral antidiabetic drugs available, either singly or in combination, and number of manufacturing companies for each, and to evaluate the difference in cost of different brands of same active drug by calculating percentage variation of cost. Method...

  18. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary ... The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how ...

  19. Sex differences and ovarian hormones in animal models of drug dependence.

    Science.gov (United States)

    Carroll, Marilyn E; Anker, Justin J

    2010-06-01

    Increasing evidence indicates the presence of sex differences in many aspects of drug abuse. Most studies reveal that females exceed males during the initiation, escalation, extinction, and reinstatement (relapse) of drug-seeking behavior, but males are more sensitive than females to the aversive effects of drugs such as drug withdrawal. Findings from human and animal research indicate that circulating levels of ovarian steroid hormones account for these sex differences. Estrogen (E) facilitates drug-seeking behavior, while progesterone (P) and its metabolite, allopregnanalone (ALLO), counteract the effects of E and reduce drug seeking. Estrogen and P influence other behaviors that are affiliated with drug abuse such as drug-induced locomotor sensitization and conditioned place preference. The enhanced vulnerability to drug seeking in females vs. males is also additive with the other risk factors for drug abuse (e.g., adolescence, sweet preference, novelty reactivity, and impulsivity). Finally, treatment studies using behavioral or pharmacological interventions, including P and ALLO, also indicate that females show greater treatment effectiveness during several phases of the addiction process. The neurobiological basis of sex differences in drug abuse appears to be genetic and involves the influence of ovarian hormones and their metabolites, the hypothalamic pituitary adrenal (HPA) axis, dopamine (DA), and gamma-hydroxy-butyric acid (GABA). Overall, sex and hormonal status along with other biological risk factors account for a continuum of addiction-prone and -resistant animal models that are valuable for studying drug abuse prevention and treatment strategies. PMID:19818789

  20. 77 FR 4225 - Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron, and Praziquantel

    Science.gov (United States)

    2012-01-27

    ... approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides..., filed NADA 141-333 that provides for the veterinary prescription use of SENTINEL SPECTRUM (milbemycin... of age and older. The NADA is approved as of December 8, 2011, and 21 CFR part 520 is amended...

  1. 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)...

  2. 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...

  3. 77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

    Science.gov (United States)

    2012-09-26

    ... notice of proposed rulemaking that published July 27, 2012 (77 FR 44177) is extended. Submit written or... . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 27, 2012 (77 FR 44177), FDA published... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales...

  4. 76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

    Science.gov (United States)

    2011-01-18

    ...; Follicle Stimulating Hormone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The... sponsor for a new animal drug application (NADA) for follicle stimulating hormone from Ausa International... hormone) to Therio, Inc., 8801 Anderson Ave., Manhattan, KS 66503. Accordingly, the Agency is amending...

  5. 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...

  6. 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...

  7. 75 FR 26646 - Oral Dosage Form New Animal Drugs; Orbifloxacin Suspension

    Science.gov (United States)

    2010-05-12

    ... redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520--ORAL... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs... of an oral suspension containing orbifloxacin for the treatment of various bacterial infections...

  8. 76 FR 79195 - Animal Generic Drug User Fee Act; Reopening of the Comment Period

    Science.gov (United States)

    2011-12-21

    ...The Food and Drug Administration (FDA or Agency) is extending to January 15, 2013, the comment period for the notice of public meeting; request for public comments, published in the Federal Register of September 20, 2011 (76 FR 58277). In that notice, FDA requested comments on the Animal Generic Drug User Fee Act (AGDUFA) program to date and solicited suggestions regarding the features FDA......

  9. 77 FR 3598 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray

    Science.gov (United States)

    2012-01-25

    ... Animal Drugs; Gentamicin and Betamethasone Spray AGENCY: Food and Drug Administration, HHS. ACTION: Final... betamethasone valerate topical spray in dogs. DATES: This rule is effective January 25, 2012. FOR FURTHER... 200-416 that provides for veterinary prescription use of Gentamicin Topical Spray (gentamicin...

  10. 75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Science.gov (United States)

    2010-05-12

    ... parasites that were approved for the pioneer product with 3 years of marketing exclusivity (69 FR 501... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New... part 524 is amended as follows: PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 1....

  11. 76 FR 57907 - Tolerances for Residues of New Animal Drugs in Food; Progesterone

    Science.gov (United States)

    2011-09-19

    ... values in the current guidance document, ``Guideline for Establishing a Safe Concentration'' (59 FR 37499... HUMAN SERVICES Food and Drug Administration 21 CFR Part 556 Tolerances for Residues of New Animal Drugs... the allowable incremental increase for residues of progesterone in edible tissues of cattle and...

  12. 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…

  13. Effects of chronic administration of drugs of abuse on impulsive choice (delay discounting) in animal models

    OpenAIRE

    Setlow, Barry; Mendez, Ian A.; Mitchell, Marci R; Simon, Nicholas W.

    2009-01-01

    Drug addicted individuals demonstrate high levels of impulsive choice, characterized by preference for small immediate over larger but delayed rewards. Although the causal relationship between chronic drug use and elevated impulsive choice in humans has been unclear, a small but growing body of literature over the past decade has shown that chronic drug administration in animal models can cause increases in impulsive choice, suggesting that a similar causal relationship may exist in human dru...

  14. 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

  15. 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

  16. 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. PMID:23227566

  17. 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

  18. 78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

    Science.gov (United States)

    2013-07-15

    ...The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards Strategy--Action Plan (version 1.0). This action is being taken to ensure that all interested stakeholders are aware that the data standards program documents are available and is intended to......

  19. 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.

  20. 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)

  1. Cognitive enhancers for facilitating drug cue extinction: insights from animal models.

    Science.gov (United States)

    Nic Dhonnchadha, Bríd Áine; Kantak, Kathleen M

    2011-08-01

    Given the success of cue exposure (extinction) therapy combined with a cognitive enhancer for reducing anxiety, it is anticipated that this approach will prove more efficacious than exposure therapy alone in preventing relapse in individuals with substance use disorders. Several factors may undermine the efficacy of exposure therapy for substance use disorders, but we suspect that neurocognitive impairments associated with chronic drug use are an important contributing factor. Numerous insights on these issues are gained from research using animal models of addiction. In this review, the relationship between brain sites whose learning, memory and executive functions are impaired by chronic drug use and brain sites that are important for effective drug cue extinction learning is explored first. This is followed by an overview of animal research showing improved treatment outcome for drug addiction (e.g. alcohol, amphetamine, cocaine, heroin) when explicit extinction training is conducted in combination with acute dosing of a cognitive-enhancing drug. The mechanism by which cognitive enhancers are thought to exert their benefits is by facilitating consolidation of drug cue extinction memory after activation of glutamatergic receptors. Based on the encouraging work in animals, factors that may be important for the treatment of drug addiction are considered. PMID:21295059

  2. Experimental Psychiatric Illness and Drug Abuse Models: From Human to Animal, an Overview

    OpenAIRE

    Edwards, Scott; Koob, George F.

    2012-01-01

    Preclinical animal models have supported much of the recent rapid expansion of neuroscience research and have facilitated critical discoveries that undoubtedly benefit patients suffering from psychiatric disorders. This overview serves as an introduction for the following chapters describing both in vivo and in vitro preclinical models of psychiatric disease components and briefly describes models related to drug dependence and affective disorders. Although there are no perfect animal models ...

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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...

  8. 77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

    Science.gov (United States)

    2012-10-03

    ... (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the... approval of the NADA and ANADAs listed in table 1 of this document because the products are no longer manufactured or marketed. Table 1--NADA and ANADAs for Which Withdrawal of Approval Has Been Requested...

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

    Science.gov (United States)

    2013-11-26

    ... Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for an arsanilic acid Type A...., P.O. Box 34384, Charlotte, NC 28234 has requested that FDA withdraw approval of NADA 008-019 for PRO... given that approval of NADA 008-019, and all supplements and amendments thereto, is hereby...

  10. 77 FR 4226 - Implantation or Injectable Dosage Form New Animal Drugs; Danofloxacin

    Science.gov (United States)

    2012-01-27

    ... supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for an... INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141-207 for ADVOCIN (danofloxacin mesylate) Injectable Solution. The supplemental NADA provides for an...

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

    Science.gov (United States)

    2010-01-11

    ... a supplemental new animal drug application (NADA) filed by Anika Therapeutics, Inc. The supplemental NADA provides for a revised human food safety warning for use of hyaluronate sodium injectable solution... Therapeutics, Inc., 236 W. Cummings Park, Woburn, MA 01801, filed a supplement to NADA 122-578 that...

  12. 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...

  13. 75 FR 54018 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Science.gov (United States)

    2010-09-03

    ... approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA...., Roseland, NJ 07068, filed a supplement to NADA 141-299 that provides for use of RESFLOR GOLD (florfenicol... BRD pathogens for which the use of this product is approved. The supplemental NADA is approved as...

  14. 75 FR 4692 - Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone...

    Science.gov (United States)

    2010-01-29

    ... regulations to reflect approval of a new animal drug application (NADA) filed by Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the... INFORMATION: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium, filed NADA 141-298...

  15. 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...

  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. 76 FR 22610 - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

    Science.gov (United States)

    2011-04-22

    ... supplemental new animal drug application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA provides..., Shawnee Mission, KS 66201, filed a supplement to NADA 141-068 for BAYTRIL 100 (enrofloxacin), an injectable solution. The supplemental NADA provides for the addition of Mycoplasma bovis to the pathogens...

  18. 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...

  19. 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...

  20. 76 FR 72617 - Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone

    Science.gov (United States)

    2011-11-25

    ... reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides... Blvd., Bldg. 500, Duluth, GA 30096-4640 filed NADA 141-327 that provides for veterinary prescription... control of internal and external parasites of cattle on pasture with persistent effectiveness. The NADA...

  1. 75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

    Science.gov (United States)

    2010-01-11

    ... approval of an original new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for... INFORMATION: Intervet, Inc., 56 Livingston Ave., Roseland, NJ 07068, filed NADA 141-299 that provides for use... Histophilus somni, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle. The NADA...

  2. 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...

  3. 77 FR 29216 - New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin

    Science.gov (United States)

    2012-05-17

    ... Forest, IL 000409 60045 * * * * * (2) * * * Drug labeler code Firm name and address * * * * * 000409 Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045. * * * * * PART 520--ORAL DOSAGE FORM NEW ANIMAL... generic copy of Forest, IL sodium) Sterile NADA 140-338. 60045. Powder. 200-455....... Cross...

  4. 76 FR 79064 - New Animal Drugs; Change of Sponsor; Zinc Gluconate

    Science.gov (United States)

    2011-12-21

    ..., Inc., to Ark Sciences, Inc. DATES: This rule is effective December 21, 2011. FOR FURTHER INFORMATION... gluconate) Injectable Solution to Ark Sciences, Inc., 1101 East 33rd St., suite B304, Baltimore, MD 21218.... In addition, Ark Sciences, Inc., is not currently listed in the animal drug regulations as a...

  5. 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-

  6. A qualitative exploration of prescription opioid injection among street-based drug users in Toronto: behaviours, preferences and drug availability

    OpenAIRE

    Firestone Michelle; Fischer Benedikt

    2008-01-01

    Abstract Background There is evidence of a high prevalence of prescription opioid (PO) and crack use among street drug users in Toronto. The purpose of this qualitative study was to describe drug use behaviours and preferences as well as the social and environmental context surrounding the use of these drugs among young and old street-based drug injection drug users (IDUs). Methods In-depth interviews were conducted with 25 PO injectors. Topics covered included drug use history, types of drug...

  7. 75 FR 79320 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

    Science.gov (United States)

    2010-12-20

    ... test animals approach, reflects the original intent of the regulation. (See, e.g., 52 FR 49572 at 49575..., 1987, final rule (52 FR 49572 at 49586), suggests that an emphasis on no significant increase in the... HUMAN SERVICES Food and Drug Administration 21 CFR Part 500 Animal Drugs, Feeds, and Related...

  8. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how ... efforts are underway in both veterinary and human medicine to preserve the effectiveness of these drugs. One ...

  9. 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

  10. 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....

  11. Increasing the number of drugs available over the counter: arguments for and against.

    OpenAIRE

    Bradley, C. P.; Bond, C.

    1995-01-01

    Many drugs previously restricted to prescription only status are being reclassified as pharmacy only status and hence are becoming available over the counter to patients. A general practitioner should make enquiries about a patient's self-medication practices before deciding on treatment for the patient. Over-the-counter medicines are considered safe and their increased use indicates that patients are taking greater responsibility for their own health and possibly taking some of the financial...

  12. 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

  13. 75 FR 34452 - Center for Drug Evaluation and Research Data Standards Plan; Availability for Comment

    Science.gov (United States)

    2010-06-17

    ... HUMAN SERVICES Food and Drug Administration Center for Drug Evaluation and Research Data Standards Plan... development of a comprehensive data standards program in the Center for Drug Evaluation and Research (CDER... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  14. 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.

  15. Removing obstacles in neuroscience drug discovery: The future path for animal models

    OpenAIRE

    Markou, Athina; Chiamulera, Christian; GEYER, Mark A; Tricklebank, Mark; Steckler, Thomas

    2008-01-01

    Despite great advances in basic neuroscience knowledge, the improved understanding of brain functioning has not yet led to the introduction of truly novel pharmacological approaches to the treatment of central nervous system disorders. This situation has been partly attributed to the difficulty of predicting efficacy in patients based on results from preclinical studies. To address these issues, this review critically discusses the traditional role of animal models in drug discovery, the diff...

  16. 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.

  17. Using mitochondrial sirtuins as drug targets: disease implications and available compounds.

    Science.gov (United States)

    Gertz, Melanie; Steegborn, Clemens

    2016-08-01

    Sirtuins are an evolutionary conserved family of NAD(+)-dependent protein lysine deacylases. Mammals have seven Sirtuin isoforms, Sirt1-7. They contribute to regulation of metabolism, stress responses, and aging processes, and are considered therapeutic targets for metabolic and aging-related diseases. While initial studies were focused on Sirt1 and 2, recent progress on the mitochondrial Sirtuins Sirt3, 4, and 5 has stimulated research and drug development for these isoforms. Here we review the roles of Sirtuins in regulating mitochondrial functions, with a focus on the mitochondrially located isoforms, and on their contributions to disease pathologies. We further summarize the compounds available for modulating the activity of these Sirtuins, again with a focus on mitochondrial isoforms, and we describe recent results important for the further improvement of compounds. This overview illustrates the potential of mitochondrial Sirtuins as drug targets and summarizes the status, progress, and challenges in developing small molecule compounds modulating their activity. PMID:27007507

  18. Treatment of bifurcation lesions with drug-coated balloons: A review of currently available scientific data.

    Science.gov (United States)

    Cortese, Bernardo; Piraino, Davide; Buccheri, Dario; Alfonso, Fernando

    2016-10-01

    Bifurcation lesion management still represents a challenge for interventional cardiologists and currently there is a number of different approaches/techniques involving coronary stents. The use of a drug-coated balloon for native coronary vessel management is emerging as an alternative treatment, although in selected patient populations only. In particular, this technology has been tested for the treatment of bifurcations, both for the main vessel and the side branches. Several studies have evaluated this treatment as an alternative or as a therapeutic option complementary to stents, with conflicting and debatable results. However, the perspective of leaving lower metallic burden in this type of lesions is highly appealing and should be deeply investigated. We review here the currently available scientific data and future perspectives on drug-coated balloon use for bifurcation lesions. PMID:27390995

  19. Animals

    International Nuclear Information System (INIS)

    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)

  20. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... En Español Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, ... Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of ...

  1. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is intended to assist sponsors in the clinical development of drugs and therapeutic biological products for the treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both......

  2. Comparison of infliximab drug measurement across three commercially available ELISA kits.

    Science.gov (United States)

    Lee, Monique Wei Meng; Connor, Susan; Ng, Watson; Toong, Catherine Mei-Ling

    2016-10-01

    The monitoring of infliximab drug levels aids in the management of several autoimmune diseases, notably inflammatory bowel disease. Several commercial kits are now available and approved by the Therapeutic Goods Administration (TGA) for the measurement of infliximab levels, but there have been limited verification or comparison studies to date. Finding an assay that most accurately measures infliximab is essential for optimal drug titration and patient management. We performed this study to compare the performance of the Grifols Promonitor, Theradiag Lisatracker and R-Biopharm Ridascreen enzyme linked immunosorbent assay (ELISA) kits. Preparations of serum containing known concentrations of infliximab were assayed using each kit, including in the presence of interference from anti-infliximab antibodies, autoantibodies and other biological agents. The Lisatracker kit provided the most accurate determination of infliximab drug levels, however it yielded false positive results at low concentrations of infliximab. The average coefficients of variation (CVs) for the kits were 8% for Lisatracker, 5% for Ridascreen and 11% for Grifols. Infliximab measurements across all kits were affected by interference from antibodies to infliximab (ATI). This study identified the Lisatracker kit as the most accurate in quantifying infliximab levels, although it was limited by false positive results at low concentrations of infliximab as well as interference from ATI. This has important implications for the monitoring and management of patients receiving infliximab therapy. PMID:27567230

  3. 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.

  4. 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 ...

  5. 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

    2016-01-01

    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. PMID:27624701

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

    OpenAIRE

    Vihang S. Chawan; Sagar V. Badwane; Kalpesh V. Gawand; Maheshi U. Chhaya

    2016-01-01

    Background: Cost of drug therapy is a very serious issue for people belonging to lower economic status in India. A single drug is manufactured by various pharmaceutical companies and sold under different brand names. The prices of these drugs vary in the Indian market. Anxiety is a symptom of many psychiatric disorders and surgical conditions for which anxiolytic drugs are commonly prescribed. This study was planned to study the price variation amongst the different brands of anxiolytic drugs...

  7. Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

    OpenAIRE

    Liang, Bryan A.; Mackey, Tim K.

    2012-01-01

    Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, includi...

  8. In vitro and in vivo drug disposition of cilengitide in animals and human

    OpenAIRE

    Dolgos, Hugues; Freisleben, Achim; Wimmer, Elmar; Scheible, Holger; Krätzer, Friedrich; Yamagata, Tetsuo; Gallemann, Dieter; Fluck, Markus

    2016-01-01

    Abstract Cilengitide is very low permeable (1.0 nm/sec) stable cyclic pentapeptide containing an Arg‐Gly‐Asp motif responsible for selective binding to αvβ3 and αvβ5 integrins administered intravenously (i.v.). In vivo studies in the mouse and Cynomolgus monkeys showed the major component in plasma was unchanged drug (>85%). These results, together with the absence of metabolism in vitro and in animals, indicate minimal metabolism in both species. The excretion of [14C]‐cilengitide showed pro...

  9. Motor reactivity of animals exposed to ionizing radiation and treated with psychotropic drugs

    International Nuclear Information System (INIS)

    The influence of ionizing radiation on motor reactivity of animals and the influence of selected psychotropic drugs (fenactil, haloperidol, relanium) on the changes invoked by ionizing radiation were studied experimentally in rats whose motor reactivity was assessed on the basis of conditional reflexes. In unirradiated rats, fenactil and haloperidol, but not relanium, disordered positive conditional reactions. Roentgen irradiation of the rats with a single dose on the whole body caused a drop in positive conditional reactions. Relanium and fenactil enhanced psychomotor activity of rats after exposure to ionizing radiation. (author)

  10. 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. PMID:26694489

  11. 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.

  12. Do animal models provide a valid analogue for human drug lapse and relapse? Comment on Leri and Stewart (2002).

    Science.gov (United States)

    Marlatt, G Alan

    2002-11-01

    Prior research on animal models of drug relapse has demonstrated that passive exposure to an addictive substance following acquisition and extinction of drug self-administration has a "priming effect" on subsequent drug use. The validity of this animal analogue of human relapse can be criticized, however, because most human drug relapses are precipitated by the user's voluntary self-administration of a substance. The results of the present study by F. Leri and J. Stewart (2002) clearly show that if the initial heroin lapse is self-administered by rats, subsequent heroin seeking during the relapse test is significantly greater than if the heroin is externally administered. These results help bridge the gap between animal and human models of drug use and highlight the significance of both behavioral and environmental determinants of relapse. PMID:12498331

  13. Synergy of image analysis for animal and human neuroimaging supports translational research on drug abuse

    Directory of Open Access Journals (Sweden)

    Guido eGerig

    2011-10-01

    Full Text Available The use of structural magnetic resonance imaging (sMRI and diffusion tensor imaging (DTI in animals models of neuropathology is of increasing interest to the neuroscience community. In this work, we present our approach to create optimal translational studies that include both animal and human neuroimaging data within the frameworks of a study of postnatal neuro-development in intra-uterine cocaine exposure. We propose the use of non-invasive neuroimaging to study developmental brain structural and white matter pathway abnormalities via sMRI and DTI, as advanced MR imaging technology is readily available and automated image analysis methodology have recently been transferred from the human to animal imaging setting. For this purpose, we developed a synergistic, parallel approach to imaging and image analysis for the human and the rodent branch of our study. We propose an equivalent design in both the selection of the developmental assessment stage and the neuroimaging setup. This approach brings significant advantages to study neurobiological features of early brain development that are common to animals and humans but also preserve analysis capabilities only possible in animal research. This paper presents the main framework and individual methods for the proposed cross-species study design, as well as preliminary DTI cross-species comparative results in the intra-uterine cocaine exposure study.

  14. 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

    ... sows with obvious reproductive tract abnormalities. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS...., Sheridan, of time of IN 46069. insemination in weaned sows to facilitate a single fixed-time artificial... Division of Eli Type A medicated use in medicated feed FONSI \\2\\ Lilly & Co., Lilly article. for...

  15. Analysis of Antimicrobial Resistance Genes in Multiple Drug Resistant (MDR) Salmonella enterica Isolated from Animals and Humans

    Science.gov (United States)

    Background: Multiple Drug Resistant (MDR) foodborne bacteria are a concern in animal and human health. Identification of resistance genes in foodborne pathogens is necessary to determine similarities of resistance mechanisms in animal, food and human clinical isolates. This information will help us ...

  16. 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

  17. Multi-Drug Resistance Mediated by Class 1 Integrons in Aeromonas Isolated from Farmed Freshwater Animals.

    Science.gov (United States)

    Deng, Yuting; Wu, Yali; Jiang, Lan; Tan, Aiping; Zhang, Ruiquan; Luo, Li

    2016-01-01

    Aeromonas is regarded as an important pathogen of freshwater animals but little is known about the genetics of its antimicrobial resistance in Chinese aquaculture. The aim of this study was to investigate the presence of integrons and characterize multidrug resistant Aeromonas spp. isolated from diseased farmed freshwater animals. These animal samples included fish, ornamental fish, shrimp, turtles, and amphibians which were collected from 64 farms in Guangdong province of South China. One hundred and twelve Aeromonas spp. isolates were examined for antimicrobial resistance phenotypes and the presence of class 1 integron sequences. Twenty-two (19.6%) of these isolates carried a class 1 integron comprising six different gene insertion cassettes including drfA12-orfF-aadA2, drfA12-orfF, aac(6')-II-bla OXA-21 -cat3, catB3, arr-3, and dfrA17. Among these, drfA12-orfF-aadA2 was the dominant gene cassette array (63.6%, 14/22) and this is the first report of aac(6')-II-bla OXA-21 -cat3 in an Aeromonas hydrophila isolate from a Chinese giant salamander (Andrias davidianus). All the integron-positive strains were resistant to more than five agents and 22 contained other resistance genes including bla CTX-M-3, bla TEM-1, aac(6')-Ib-cr, and tetA. All integron-positive isolates also contained mutations in the quinolone resistance determining regions (QRDR). Our investigation demonstrates that freshwater animals can serve as a reservoir for pathogenic Aeromonas strains containing multiple drug-resistance integrons. This data suggests that surveillance for antimicrobial resistance of animal origin and a prudent and responsible use of antimicrobials in aquaculture is necessary in these farms. PMID:27379065

  18. 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.

  19. 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 guidance with labeling recommendations because of concerns that both healthcare providers and patients...

  20. 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.

  1. Extinction of drug- and withdrawal-paired cues in animal models: Relevance to the treatment of addiction

    OpenAIRE

    Myers, Karyn M.; Carlezon, William A

    2010-01-01

    Conditioned drug craving and withdrawal elicited by cues paired with drug use or acute withdrawal are among the many factors contributing to compulsive drug taking. Understanding how to stop these cues from having these effects is a major goal of addiction research. Extinction is a form of learning in which associations between cues and the events they predict are weakened by exposure to the cues in the absence of those events. Evidence from animal models suggests that conditioned responses t...

  2. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary ...

  3. Estimation of internal radiation dose in human based on animal data. Application of methodology in drug metabolism and pharmacokinetics

    International Nuclear Information System (INIS)

    Before conducting human study on radiolabeled drug, internal radiation dose is evaluated based on the animal data. Generally, however, species difference in the elimination process of radioactivity, mostly in the hepatic metabolism, is ignored. The methodology of correction was described for drugs that are eliminated mostly by hepatic metabolism. We showed the validity of using the method where the hepatic clearance in animal and human are constructed by the hepatic blood flow, protein unbound fraction and metabolic rate in vitro, and the internal radiation exposure calculated is corrected by the animal/human ratio of the hepatic clearance. (author)

  4. 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.

    2016-01-01

    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 drugs and combinations. Reduced durability mostly results from a preference for newly approved regimens rather than indicating failing therapy, as indicated by viral suppression observed in a majority of patients (67%) prior to regimen cessation. Durability is influenced by extrinsic factors including new drug availability and provider preference. Medication durability must be interpreted carefully in the context of a dynamic treatment landscape.

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

    Science.gov (United States)

    Brune, Kay; Patrignani, Paola

    2015-01-01

    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 minimizing plasma concentrations to permit recovery of COX-mediated prostaglandin production in the vascular wall and other organs. Each patient's clinical background, including gastrointestinal and cardiovascular risk factors, should be taken into account when selecting appropriate NSAIDs. New methods are emerging to assist

  6. 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).

  7. 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

  8. Influenza vaccines and influenza antiviral drugs in Africa: are they available and do guidelines for their use exist?

    OpenAIRE

    Duque, Jazmin; McMorrow, Meredith L.; Adam L Cohen

    2014-01-01

    Background Influenza viruses cause significant morbidity and mortality in Africa, particularly among high-risk groups, but influenza vaccines and antiviral drugs may not be commonly available and used. The main aim of this study was to determine the availability and use of influenza vaccines and antiviral drugs as well as to describe existing related guidelines and policies in Africa. Methods A self-administered survey was distributed among key influenza experts in 40 African countries. Resul...

  9. Neurodevelopmental Animal Models of Schizophrenia: Role in Novel Drug Discovery and Development

    OpenAIRE

    Wilson, Christina; Alvin V Terry

    2010-01-01

    Schizophrenia is a devastating mental illness that is associated with a lifetime of disability. For patients to successfully function in society, the amelioration of disease symptoms is imperative. The recently published results of two large antipsychotic clinical trials (e.g., CATIE, CUtLASS) clearly exemplified the limitations of currently available treatment options for schizophrenia, and further highlighted the critical need for novel drug discovery and development in this field. One of t...

  10. 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

  11. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Science.gov (United States)

    2010-01-27

    ... abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit... Abuse (NIDA), as described in a Memorandum of Understanding (MOU) of March 8, 1985 (50 FR 9518). When...

  12. Cell-based assays and animal models for GPCR drug screening.

    Science.gov (United States)

    Takakura, Hideo; Hattori, Mitsuru; Tanaka, Miho; Ozawa, Takeaki

    2015-01-01

    The family of G protein-coupled receptors (GPCRs) remains a central focus of basic pharmacology and drug discovery efforts. Convenient methods to assess the efficacy of potentially therapeutic reagents for GPCRs are strongly required for high-throughput screening (HTS) assay. We recently developed a rapid, sensitive, and quantitative method for detecting potential chemicals that act on GPCRs using split luciferase complementation. In principle, this is based on the detection of interactions of GPCR with β-arrestin, which translocates to the activated GPCRs. This method can facilitate the construction of HTS systems in a multi-well plate format. Particularly, the method is compatible with single-cell imaging and animal models and even deeper tissues such as organs, because of its high sensitivity, suggesting that promising candidates from HTS assay can be moved easily to the next phase for additional analysis. This system can contribute to the effective evaluation of potentially therapeutic reagents and expedite the development of new drugs for GPCRs. PMID:25563190

  13. 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.

  14. Finnish expert report on best available techniques in slaughterhouses and installations for the disposal or recycling of animal carcasses and animal waste

    International Nuclear Information System (INIS)

    The aim of this report is to provide information about Finnish slaughterhouses and installations for the disposal or recycling of animal carcasses and animal waste. The Finnish slaughterhouses slaughter mainly pigs, cattle, and poultry. Rendering plants and fur animal feed production plants treat animal derived waste generated in Finland. The slaughterhouses and installations for the disposal or recycling of animal carcasses and animal waste consume a lot of electricity and heat, whereas they can save energy by recovering residual heat in-situ. Slaughtering consumes a lot of water and produces a high amount of wastewater. Wastewater has a high biological oxygen demand (BOD) because it contains a lot of proteins and fat. To minimize the pollution load it is important to avoid blood and fat entering the drainage. All the slaughterhouses and most of the installations for the disposal or recycling of animal carcasses and animal waste discharge their wastewater to the municipal sewer after pre-treatment. The use of boilers to produce hot water and industrial steam is the main source of air emissions. The storage, handling and treatment of by-products and wastes as well as wastewater treatment and singeing are potential sources of foul odours. (orig.)

  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. PMID:22819650

  16. 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

  17. 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...

  18. Interspecies allometric meta-analysis of the comparative pharmacokinetics of 85 drugs across veterinary and laboratory animal species.

    Science.gov (United States)

    Huang, Q; Gehring, R; Tell, L A; Li, M; Riviere, J E

    2015-06-01

    Allometric scaling is widely used for the determination of first dosage regimen and the interpolation or extrapolation of pharmacokinetic parameters across many animal species during drug development. In this article, 85 drugs used in veterinary medicine obtained from the Food Animal Residue Avoidance Databank database were selected for allometric scaling analysis. Outlier species were identified by statistical methods. The results showed that 77% and 88% of drugs displayed significant correlations between total systemic clearance (CL) and volume of distribution at steady status (Vss) vs. body weight (P pharmacokinetic profiles for predicting drug dosages in veterinary species, and to identify those species for which interpolation or extrapolation of pharmacokinetics properties may be problematic. PMID:25333341

  19. Postmarket Drug Safety Information for Patients and Providers

    Science.gov (United States)

    ... Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Drug Safety and Availability Postmarket Drug ...

  20. Automated High-Content Live Animal Drug Screening Using C. elegans Expressing the Aggregation Prone Serpin α1-antitrypsin Z

    OpenAIRE

    Gosai, Sager J.; Joon Hyeok Kwak; Cliff J Luke; Long, Olivia S.; King, Dale E.; Kovatch, Kevin J.; Johnston, Paul A.; Tong Ying Shun; Lazo, John S.; Perlmutter, David H.; Silverman, Gary A.; Pak, Stephen C.

    2010-01-01

    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. elegan...

  1. 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.

  2. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... About FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  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. 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...

  5. 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

    2016-10-01

    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. PMID:26580432

  6. State of the Animal: monitoring animal welfare and health in The Netherlands (0-measurement) : summary, full report is available in Dutch (report 323)

    OpenAIRE

    Leenstra, F.R.; Bergevoet, R.H.M.; Neijenhuis, F.; Hanekamp, W.J.A.; Vermeij, I.; Ipema, A.H.; Jong, A.R.; Verstappen-Boerekamp, J.A.M.

    2010-01-01

    Document over het effect van het dierenwelzijns- en diergezondheidsbeleid van LNV is. Deze eerste rapportage betreft een nulmeting. Bij herhaalde metingen geeft de rapportage inzicht in de ontwikkeling. In 25 meetpunten zijn de resultaten voor beleidsdoelen op het gebied van dierenwelzijn en diergezondheid in beeld gebracht25 measuring points summarise the results of policy measures for animal welfare and health in The Netherlands

  7. Extinction of drug- and withdrawal-paired cues in animal models: relevance to the treatment of addiction.

    Science.gov (United States)

    Myers, Karyn M; Carlezon, William A

    2010-11-01

    Conditioned drug craving and withdrawal elicited by cues paired with drug use or acute withdrawal are among the many factors contributing to compulsive drug taking. Understanding how to stop these cues from having these effects is a major goal of addiction research. Extinction is a form of learning in which associations between cues and the events they predict are weakened by exposure to the cues in the absence of those events. Evidence from animal models suggests that conditioned responses to drug cues can be extinguished, although the degree to which this occurs in humans is controversial. Investigations into the neurobiological substrates of extinction of conditioned drug craving and withdrawal may facilitate the successful use of drug cue extinction within clinical contexts. While this work is still in the early stages, there are indications that extinction of drug- and withdrawal-paired cues shares neural mechanisms with extinction of conditioned fear. Using the fear extinction literature as a template, it is possible to organize the observations on drug cue extinction into a cohesive framework. PMID:20109490

  8. 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....

  9. 77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

    Science.gov (United States)

    2012-05-30

    ...., to Elanco Animal Health, Division of Eli Lilly & Co. DATES: This rule is effective May 30, 2012. FOR... NADAs and ANADAs in this table to Elanco Animal Health, Division of Eli Lilly & Co., Lilly...

  10. Predicting the profile of nutrients available for absorption: from nutrient requirement to animal response and environmental impact.

    Science.gov (United States)

    Dijkstra, J; Kebreab, E; Mills, J A N; Pellikaan, W F; López, S; Bannink, A; France, J

    2007-02-01

    Current feed evaluation systems for dairy cattle aim to match nutrient requirements with nutrient intake at pre-defined production levels. These systems were not developed to address, and are not suitable to predict, the responses to dietary changes in terms of production level and product composition, excretion of nutrients to the environment, and nutrition related disorders. The change from a requirement to a response system to meet the needs of various stakeholders requires prediction of the profile of absorbed nutrients and its subsequent utilisation for various purposes. This contribution examines the challenges to predicting the profile of nutrients available for absorption in dairy cattle and provides guidelines for further improved prediction with regard to animal production responses and environmental pollution.The profile of nutrients available for absorption comprises volatile fatty acids, long-chain fatty acids, amino acids and glucose. Thus the importance of processes in the reticulo-rumen is obvious. Much research into rumen fermentation is aimed at determination of substrate degradation rates. Quantitative knowledge on rates of passage of nutrients out of the rumen is rather limited compared with that on degradation rates, and thus should be an important theme in future research. Current systems largely ignore microbial metabolic variation, and extant mechanistic models of rumen fermentation give only limited attention to explicit representation of microbial metabolic activity. Recent molecular techniques indicate that knowledge on the presence and activity of various microbial species is far from complete. Such techniques may give a wealth of information, but to include such findings in systems predicting the nutrient profile requires close collaboration between molecular scientists and mathematical modellers on interpreting and evaluating quantitative data. Protozoal metabolism is of particular interest here given the paucity of quantitative data

  11. 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 ...

  12. 75 FR 69586 - New Animal Drugs for Minor Use and Minor Species

    Science.gov (United States)

    2010-11-15

    ... that ``drug'' in the context of Sec. 516.20(b)(2) refers to the ``active pharmaceutical ingredient (API... name (and proprietary name, if any) of the active pharmaceutical ingredient of the drug; and the name and address of the source of the active pharmaceutical ingredient of the drug. * * * * *...

  13. 75 FR 69614 - New Animal Drugs for Minor Use and Minor Species

    Science.gov (United States)

    2010-11-15

    ... clarify that ``drug'' in the context of Sec. 516.20(b)(2) refers to the ``active pharmaceutical ingredient...) of the active pharmaceutical ingredient of the drug; and the name and address of the source of the active pharmaceutical ingredient of the drug. * * * * * Dated: November 3, 2010. Leslie Kux,...

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

    Science.gov (United States)

    Gosai, Sager J; Kwak, Joon Hyeok; Luke, Cliff J; Long, Olivia S; King, Dale E; Kovatch, Kevin J; Johnston, Paul A; Shun, Tong Ying; Lazo, John S; Perlmutter, David H; Silverman, Gary A; Pak, Stephen C

    2010-01-01

    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. PMID:21103396

  15. Improving the translation of analgesic drugs to the clinic: animal models of neuropathic pain

    OpenAIRE

    Percie du Sert, N; Rice, A. S. C.

    2014-01-01

    Neuropathic pain remains an area of considerable unmet clinical need. Research based on preclinical animal models has failed to deliver truly novel treatment options, questioning the predictive value of these models. This review addresses the shortcomings of rodent in vivo models commonly used in the field and highlights approaches which could increase their predictivity, including more clinically relevant assays, outcome measures and animal characteristics. The methodological quality of anim...

  16. Animal models of schizophrenia

    OpenAIRE

    Jones, CA; Watson, DJG; Fone, KCF

    2011-01-01

    Developing reliable, predictive animal models for complex psychiatric disorders, such as schizophrenia, is essential to increase our understanding of the neurobiological basis of the disorder and for the development of novel drugs with improved therapeutic efficacy. All available animal models of schizophrenia fit into four different induction categories: developmental, drug-induced, lesion or genetic manipulation, and the best characterized examples of each type are reviewed herein. Most rod...

  17. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) Chinese Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) ... FEAR Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver ...

  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. Innovative Drugs to Treat Depression: Did Animal Models Fail to Be Predictive or Did Clinical Trials Fail to Detect Effects?

    OpenAIRE

    Belzung, Catherine

    2014-01-01

    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 care...

  20. 77 FR 55481 - Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Naloxone...

    Science.gov (United States)

    2012-09-10

    ...; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin AGENCY: Food and Drug Administration, HHS. ACTION... Pharmaceuticals hydrochloride) Inc., 100 Painters Injection. Dr., Chadds Ford, PA 19317. 046-822 VETOCIN...

  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. Efficacy of herbal coded Hepcon on drug induced hepatitis in experimental animals through histopathological and biochemical analysis.

    Science.gov (United States)

    Jamil, Muhammad Saim; Mahmood, Zahid; Saeed, Aftab; Jamil, Amir; Usmanghani, Khan; Asif, Hafiz Muhammad; Sajjad-al-Hassan; Roohi, Mahira

    2013-09-01

    Drug-induced liver injury is the leading cause for more than 50 percent of cases of acute liver failure. This study was conducted on herbo-mineral formulation "Hepcon" to evaluate its hepatoprotective effects in drug induced hepatitis in experimental animals. The liver injury was introduced with over dosage of non steroidal anti-inflammatory drugs (NSAIDs) and carbon tetrachloride (CCl4). The herbo-mineral formulations "Hepcon" consist of Zingiber officinale, Piprum nigrum, Ammonium chloride and Arsenic trioxide (Hartal warqi). The aqueous extraction was administered to experimental animals. Thereafter their LFTs, IgG, and tissue pathology was studied. It was observed on the basis of biochemical and histopathological analysis that animals which were subjected to Hepcon became normal in 60 days whereas those as control group did not showed improvements and most of them died. It was concluded that the efficacy of Hepcon to treat liver injury caused by CCl4 and NSAIDs is very effective, and no side effects were noticed. PMID:24035958

  3. 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

  4. Repurposing an orally available drug for the treatment of geographic atrophy

    OpenAIRE

    Ahmed, Chulbul M.; Biswal, Manas R; Li, Hong; Han, Pingyang; Ildefonso, Cristhian J; Lewin, Alfred S.

    2016-01-01

    Purpose Chronic oxidative stress and subacute inflammation have been implicated as causes of age-related macular degeneration (AMD). In this study, we tested whether an orally available 5-OH-tryptamine (5HT) 1a receptor agonist, xaliproden, could protect against retinal pigment epithelium (RPE) cell damage in culture and in a mouse model of geographic atrophy. Methods Paraquat was used to create mitochondrial oxidative stress in ARPE-19 cells, and tumor necrosis factor-α (TNF-α) was used to s...

  5. 76 FR 49649 - Oral Dosage Form New Animal Drugs; Change of Sponsor; Chlortetracycline; Sulfamethazine

    Science.gov (United States)

    2011-08-11

    ...) * * * (4) * * * (iii) * * * (C) * * * For Nos. 000010 and 021930, do not slaughter animals for food within 5 days of treatment. For No. 000010, do not slaughter animals for food within 24 hours of treatment... for use. For the prevention and treatment of bacterial enteritis; as an aid in the reduction of...

  6. Development of an on-animal separation-based sensor for monitoring drug metabolism in freely roaming sheep.

    Science.gov (United States)

    Scott, David E; Willis, Sean D; Gabbert, Seth; Johnson, David; Naylor, Erik; Janle, Elsa M; Krichevsky, Janice E; Lunte, Craig E; Lunte, Susan M

    2015-06-01

    The development of an on-animal separation-based sensor that can be employed for monitoring drug metabolism in a freely roaming sheep is described. The system consists of microdialysis sampling coupled to microchip electrophoresis with electrochemical detection (MD-ME-EC). Separations were accomplished using an all-glass chip with integrated platinum working and reference electrodes. Discrete samples from the microdialysis flow were introduced into the electrophoresis chip using a flow-gated injection approach. Electrochemical detection was accomplished in-channel using a two-electrode isolated potentiostat. Nitrite was separated by microchip electrophoresis using reverse polarity and a run buffer consisting of 50 mM phosphate at pH 7.4. The entire system was under telemetry control. The system was first tested with rats to monitor the production of nitrite following perfusion of nitroglycerin into the subdermal tissue using a linear probe. The data acquired using the on-line MD-ME-EC system were compared to those obtained by off-line analysis using liquid chromatography with electrochemical detection (LC-EC), using a second microdialysis probe implanted parallel to the first probe in the same animal. The MD-ME-EC device was then used on-animal to monitor the subdermal metabolism of nitroglycerin in sheep. The ultimate goal is to use this device to simultaneously monitor drug metabolism and behavior in a freely roaming animal. PMID:25697221

  7. 78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

    Science.gov (United States)

    2013-07-15

    ... regulations for the administrative detention of drugs (78 FR 21085). The docket was intended to ensure that... use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the... be posted to the docket at http://www.regulations.gov . List of Subjects 21 CFR Part 1...

  8. 77 FR 60622 - New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin

    Science.gov (United States)

    2012-10-04

    ...-343 Elanco Animal Health, PULMOTIL 90 Original approval for 558.355 yes CE \\1\\ A Division of Eli...) Supplemental approval 520.2130 yes CE \\1\\ A Division of Eli Chewable Tablets. for use in cats to Lilly &...

  9. Synergy of image analysis for animal and human neuroimaging supports translational research on drug abuse

    OpenAIRE

    MartinAndreasStyner; GuidoGerig; MatthewMcMurray; HongyuAn; JoohwiLee

    2011-01-01

    The use of structural magnetic resonance imaging (sMRI) and diffusion tensor imaging (DTI) in animals models of neuropathology is of increasing interest to the neuroscience community. In this work, we present our approach to create optimal translational studies that include both animal and human neuroimaging data within the frameworks of a study of postnatal neuro-development in intra-uterine cocaine exposure. We propose the use of non-invasive neuroimaging to study developmental brain struct...

  10. Accelerating drug discovery for Alzheimer's disease: best practices for preclinical animal studies

    OpenAIRE

    Shineman, Diana W; Basi, Guriqbal S.; Bizon, Jennifer L.; Colton, Carol A.; Greenberg, Barry D.; Hollister, Beth A; Lincecum, John; Leblanc, Gabrielle G.; Lee, Linda H; Luo, Feng; Morgan, Dave; Morse, Iva; Refolo, Lorenzo M; Riddell, David R; Scearce-Levie, Kimberly

    2011-01-01

    Animal models have contributed significantly to our understanding of the underlying biological mechanisms of Alzheimer's disease (AD). As a result, over 300 interventions have been investigated and reported to mitigate pathological phenotypes or improve behavior in AD animal models or both. To date, however, very few of these findings have resulted in target validation in humans or successful translation to disease-modifying therapies. Challenges in translating preclinical studies to clinical...

  11. The oxytocin system in drug discovery for autism: Animal models and novel therapeutic strategies

    OpenAIRE

    Modi, Meera E.; Young, Larry J.

    2011-01-01

    Animal models and behavioral paradigms are critical for elucidating the neural mechanism involved in complex behaviors, including social cognition. Both genotype and phenotype based models have implicated the neuropeptide oxytocin (OT) in the regulation of social behavior. Based on the findings in animal models, alteration of the OT system has been hypothesized to play a role in the social deficits associated with autism and other neuropsychiatric disorders. While the evidence linking the pep...

  12. No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule

    OpenAIRE

    Campbell, Carrie

    2004-01-01

    This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible. It gives a summary of the history of the enactment of this regulation and outlines its structure and major features. Next, the regulation is analyzed in light of statutory authority, ethics, and practicality. Finally the approval of pyridostigmine bromide under the Animal Efficacy Rule is eval...

  13. 77 FR 18685 - New Animal Drugs for Minor Use and Minor Species

    Science.gov (United States)

    2012-03-28

    ..., and telephone number; the established name (and proprietary name, if any) of the active pharmaceutical ingredient of the drug; and the name and address of the source ] of the active pharmaceutical ingredient...

  14. 77 FR 4895 - New Animal Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane...

    Science.gov (United States)

    2012-02-01

    ... Drugs; Chloramphenicol, Diethylcarbamazine Citrate, Hygromycin B, Methoxyflurane, Neomycin Sulfate... Affiliate of IGI, ane, prednisolone, Inc., Box 209, tetracaine, Harding Hwy., neomycin sulfate). Buena, NJ 08310. NADA 044-655 NEOMYCANE Ophthalmic Evsco Ointment (neomycin Pharmaceuticals, an...

  15. Streptococcus suis, an Emerging Drug-Resistant Animal and Human Pathogen

    OpenAIRE

    Palmieri, Claudio; Varaldo, Pietro E.; Facinelli, Bruna

    2011-01-01

    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,...

  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. PMID:26481371

  17. 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

  18. 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.

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

    DEFF Research Database (Denmark)

    Aarestrup, Frank Møller

    2005-01-01

    countries, which leaves room for considerable reductions in some countries. The emergence of resistant bacteria and resistance genes due to the use of antimicrobial agents are well documented. In Denmark it has been possible to reduce the usage of antimicrobial agents for food animals significantly...

  20. 78 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables

    Science.gov (United States)

    2013-09-26

    ... ``competitive strengths and weaknesses''); Customs & International Trade Newsletter v. U.S. Customs and Border... container size, strength, and dosage form; (2) by quantities distributed domestically and quantities exported; and (3) for each dosage form, a listing of the target animals, indications, and...

  1. Investigations into the effect of immunostimulating drugs on the immune system of irradiated experimental animals

    International Nuclear Information System (INIS)

    In experiments with mice and pigs a sublethal irradiation before vaccination proved to be by far more efficient than an irradiation with the same dose following vaccination. In the irradiated animals a retarded beginning of the immune response compared with the controls was observed. In the experiments with mice positive effects of the adjuvant azimexon and levamisol on the radiation induced immunosuppression was seen. In the experiments with pigs the radiation iduced immunosuppression was completely abolished by addition of incomplete Freund adjuvant to the antigen. Azimexon as adjuvant was efficient both when given before or after exposition. Post-endotoxic serum from BCG-infected animals (BCG/ET) had only a weak effect in animals immunized before exposition. Serum immunoglobulin levels of pigs were stable against irradiation and application of immunomodulating agents. Stimulation effects of the irradiation on the antibody response were observed in mice and pigs if the animals were first immunized and irradiated afterwards. In the irradiated pigs the mitogenic stimulation of T and B cells was depressed. After application of azimexon the stimulation of T cells was significantly increased in irradiated pigs; the impaired B cell stimulation, however, remained unaltered. By using the monoclonal antibody technique functionally distinct subpopulations of peripherals lymphocytes in swine were detected, each showing a different sensibility towards in vivo irradiation. (orig.) With 10 refs., 21 figs

  2. 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...

  3. 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. ...

  4. 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

    , 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...

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

    Science.gov (United States)

    Gulin, Julián Ernesto Nicolás; Rocco, Daniela Marisa; García-Bournissen, Facundo

    2015-11-01

    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. PMID:26587586

  6. 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.

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

    OpenAIRE

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

    2011-01-01

    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 includ...

  8. The age of anxiety: role of animal models of anxiolytic action in drug discovery

    OpenAIRE

    Cryan, John F; Sweeney, Fabian F.

    2012-01-01

    Anxiety disorders are common, serious and a growing health problem worldwide. However, the causative factors, aetiology and underlying mechanisms of anxiety disorders, as for most psychiatric disorders, remain relatively poorly understood. Animal models are an important aid in giving insight into the aetiology, neurobiology and, ultimately, the therapy of human anxiety disorders. The approach, however, is challenged with a number of complexities. In particular, the heterogeneous nature of anx...

  9. Radiosensitization of hypoxic bacterial cells and animal tumours by membrane active drugs and hyperthermia

    International Nuclear Information System (INIS)

    The present report deals with the results on phenothiazine derivatives such as promethazine (PMZ), trimeprazine (TMZ), trifluoperazine (TFP) and prochlorperazine (PCP) and their comparison with that of chlorpromazine (CPZ). Their efficiency in combination with hyperthermia, radiation and other anti-cancer drugs in treating murine tumors has also been presented herein. In addition, results on bacterial cells dealing with their mechanistic aspects are also included. (author). 57 refs., 27 figures, 13 tables

  10. Cognitive Enhancers for Facilitating Drug Cue Extinction: Insights from Animal Models

    OpenAIRE

    Nic Dhonnchadha, Bríd Áine; Kantak, Kathleen M.

    2011-01-01

    Given the success of cue exposure (extinction) therapy combined with a cognitive enhancer for reducing anxiety, it is anticipated that this approach will prove more efficacious than exposure therapy alone in preventing relapse in individuals with substance use disorders. Several factors may undermine the efficacy of exposure therapy for substance use disorders, but we suspect that neurocognitive impairments associated with chronic drug use are an important contributing factor. Numerous insigh...

  11. 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. PMID:27230395

  12. 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

  13. 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.

  14. 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. PMID:24345817

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

    International Nuclear Information System (INIS)

    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

  16. 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.

  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. 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 ...

  19. 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.

  20. 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.

  1. [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.

  2. 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.

  3. Doxorubicin-Loaded QuadraSphere Microspheres: Plasma Pharmacokinetics and Intratumoral Drug Concentration in an Animal Model of Liver Cancer

    International Nuclear Information System (INIS)

    The purpose of this study was to evaluate, in vitro and in vivo, doxorubicin-loaded poly (vinyl alcohol-sodium acrylate) copolymer microspheres [QuadraSphere microspheres (QSMs)] for transcatheter arterial delivery in an animal model of liver cancer. Doxorubicin loading efficiency and release profile were first tested in vitro. In vivo, 15 rabbits, implanted with a Vx-2 tumor in the liver, were divided into three groups of five rabbits each, based on the time of euthanasia. Twenty-five milligrams of QSMs was diluted in 10 ml of a 10 mg/ml doxorubicin solution and 10 ml of nonionic contrast medium for a total volume of 20 ml. One milliliter of a drug-loaded QSM solution containing 5 mg of doxorubicin was injected into the tumor feeding artery. Plasma doxorubicin and doxorubicinol concentrations, and intratumoral and peritumoral doxorubicin tissue concentrations, were measured. Tumor specimens were pathologically evaluated to record tumor necrosis. As a control, one animal was blandly embolized with plain QSMs in each group. In vitro testing of QSM doxorubicin loadability and release over time showed 82-94% doxorubicin loadability within 2 h and 6% release within the first 6 h after loading, followed by a slow release pattern. In vivo, the doxorubicin plasma concentration declined at 40 min. The peak doxorubicin intratumoral concentration was observed at 3 days and remained detectable till the study's end point (7 days). Mean percentage tumor cell death in the doxorubicin QSM group was 90% at 7 days and 60% in the bland QSM embolization group. In conclusion, QSMs can be efficiently loaded with doxorubicin. Initial experiments with doxorubicin-loaded QSMs show a safe pharmacokinetic profile and effective tumor killing in an animal model of liver cancer.

  4. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Science.gov (United States)

    2013-09-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  5. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides sponsors... Evaluation and Research (CBER) with information regarding adaptive design clinical trials when used in drug... design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when...

  6. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... back to top Popular Content Home Latest Recalls Report an Adverse Event MedWatch Safety Alerts News Releases Consumer Updates About FDA Contact FDA Browse by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...

  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. 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...

  9. 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.

  10. 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.

  11. Drug Facts

    Medline Plus

    Full Text Available ... People Drug Abuse Hurts Families Drug Abuse Hurts Kids Drug Abuse Hurts Unborn Children Drug Abuse Hurts ... Children and Teens Stay Drug-Free Talking to Kids About Drugs: What To Say if You Were ...

  12. In Vitro Efficacies of Clinically Available Drugs against Growth and Viability of an Acanthamoeba castellanii Keratitis Isolate Belonging to the T4 Genotype

    OpenAIRE

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

    2013-01-01

    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 ...

  13. 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…

  14. 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. PMID:23821352

  15. [Not Available].

    Science.gov (United States)

    Ibragimova, V S

    1970-01-01

    Scientists from the Eastern countries have a great merit for the enrichment of the range of medicaments, as well as for the scientific development of pharmacology. In this respect, worth of special interest is a manuscript source, dealing with the medicaments of the XIV century and entitled: "Selected Pharmacopeia, dedicated to Badia al Jemal"--Ihtiyarat of Badia, written by Ali Bin Hussein al Ansari, usually known by his nickname Hodja Zayn al Atar. Most of the concepts, found in the cited manuscript, conserve their significance up to the present day, all the more that the drugs listed, their indications, way of preparation and application are thoroughly described. The Ihtiyarat of Badia, containing the description of 1100 drug denominations of vegetable, animal and mineral origin, is not merely a historical document of medieval pharmacology, but might serve as a source for enriching the armamentarium of modern medicine with drugs. PMID:11636551

  16. 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.

  17. Molecular characterisation of blaESBL-harbouring conjugative plasmids identified in multi-drug resistant Escherichia coli isolated from food-producing animals and healthy humans

    Directory of Open Access Journals (Sweden)

    Juan eWang

    2013-07-01

    Full Text Available Background: Extended-spectrum β-lactamse (ESBL-encoding genes are frequently mapped to plasmids, yet few of these structures have been characterized at the molecular level, to date.Methods: Eighty-seven ESBL-producing E. coli were isolated from fecal samples of food-producing animals and healthy humans in Switzerland from 2009 to 2011. Plasmid DNA of all isolates was purified. Broth mating assays were carried out individually for 32 isolates to determine if the ESBL marker could be transferred by conjugation. The plasmid sizes were determined by S1 nuclease pulsed-field gel electrophoresis (PFGE and the plasmids were typed by PCR-based replicon typing. Susceptibility tests by disk diffusion followed with a re-analysis S1-nuclease PFGE and PCR reactions were performed to confirm plasmid transfer. Microarray was performed to detect additional antibiotic resistance markers and multi-locus sequence typing (MLST was also performed in selected donor strains. The phylotypes were identified by triplex PCR.Results: About half (n=46 of the 87 isolates carried small (< 20-kb plasmids. All selected 32 isolates contained large plasmids (ranging in sizes from 20- to 600-kb. Eleven plasmid replicon types were detected. Of these, IncFIA (n=5, IncFIB (n=9 and IncK/B (n=4 were common. Nine isolates demonstrated the ability to transfer their cefotaxime resistance marker at high transfer rates. Plasmid profile re-analysis of these transconjugants identified 16 plasmids. IncFIB and IncI1 were the most prevalent replicon types. Phylogenetic grouping showed that five of the nine donor strains belonged to phylogroup B1. Nine different STs were identified in nine tested donor strains.Conclusions: Characterization of these ESBL-encoding conjugative plasmids extends our understanding on these resistance markers in multi-drug resistant E. coli cultured from healthy human and animal sources.

  18. 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 amount of HIV in brain cells 1 . Drug abuse treatment. Since the late 1980s, research has shown that treating drug abuse is an ...

  19. Neuroleptic drugs revert the contextual fear conditioning deficit presented by spontaneously hypertensive rats: a potential animal model of emotional context processing in schizophrenia?

    Science.gov (United States)

    Calzavara, Mariana Bendlin; Medrano, Wladimir Agostini; Levin, Raquel; Kameda, Sonia Regina; Andersen, Monica Levy; Tufik, Sergio; Silva, Regina Helena; Frussa-Filho, Roberto; Abílio, Vanessa Costhek

    2009-07-01

    Schizophrenia, bipolar disorder, and attention deficit/hyperactivity disorder (ADHD) present abnormalities in emotion processing. A previous study showed that the spontaneously hypertensive rats (SHR), a putative animal model of ADHD, present reduced contextual fear conditioning (CFC). The aim of the present study was to characterize the deficit in CFC presented by SHR. Adult male normotensive Wistar rats and SHR were submitted to the CFC task. Sensitivity of the animals to the shock and the CFC performance after repeated exposure to the task were investigated. Pharmacological characterization consisted in the evaluation of the effects of the following drugs administered previously to the acquisition of the CFC: pentylenetetrazole (anxiogenic) and chlordiazepoxide (anxiolytic); methylphenidate and amphetamine (used for ADHD); lamotrigine, carbamazepine, and valproic acid (mood stabilizers); haloperidol, ziprasidone, risperidone, amisulpride, and clozapine (neuroleptic drugs); metoclopramide and SCH 23390 (dopamine antagonists without antipsychotic properties); and ketamine (a psychotomimmetic). The effects of paradoxical sleep deprivation (that worsens psychotic symptoms) and the performance in a latent inhibition protocol (an animal model of schizophrenia) were also verified. No differences in the sensitivity to the shock were observed. The repeated exposure to the CFC task did not modify the deficit in CFC presented by SHR. Considering pharmacological treatments, only the neuroleptic drugs reversed this deficit. This deficit was potentiated by proschizophrenia manipulations. Finally, a deficit in latent inhibition was also presented by SHR. These findings suggest that the deficit in CFC presented by SHR could be a useful animal model to study abnormalities in emotional context processing related to schizophrenia. PMID:18281713

  20. 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. PMID:27087082

  1. 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 Abuse Hurts Other People Drug Abuse Hurts Families Drug Abuse Hurts Kids Drug Abuse Hurts Unborn ...

  2. Drug Facts

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

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

    OpenAIRE

    Julián Ernesto Nicolás Gulin; Daniela Marisa Rocco; Facundo García-Bournissen

    2015-01-01

    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....

  4. Effects of cannabinoid drugs on the deficit of prepulse inhibition of startle in an animal model of schizophrenia: the SHR strain

    OpenAIRE

    Levin, Raquel; Peres, Fernanda F.; Almeida, Valéria; Calzavara, Mariana B.; Antonio W Zuardi; Hallak, Jaime E. C.; Crippa, José Alexandre S.; Abílio, Vanessa C.

    2014-01-01

    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 th...

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

    OpenAIRE

    Raquel eLevin; Fernanda Fiel Peres; Valéria eAlmeida; Mariana Bendlin Calzavara; Antonio Waldo Zuardi; Jaime Eduardo Cecílio Hallak; José Alexandre de Souza Crippa; Vanessa Costhek Abílio

    2014-01-01

    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 th...

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

    OpenAIRE

    LudekZurek; KateKuKanich

    2012-01-01

    In the USA, small animal veterinary hospitals (SAVHs) commonly keep resident cats living permanently as pets within their facilities. Previously, multi-drug resistant (MDR) enterococci were found as a contaminant of multiple surfaces within such veterinary hospitals, and nosocomial infections are a concern. The objectives of this study were to determine whether resident cats carry MDR enterococci and to compare the feline isolates genotypically to those obtained from SAVH surfaces in a previo...

  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 ... on HIV/AIDS and related diseases, counseling and testing services, and referrals for medical and social services. ...

  8. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... abuse and HIV both affect the brain. Research has shown that HIV causes greater injury to cells ... do not abuse drugs. In animal studies, methamphetamine has been shown to increase the amount of HIV ...

  9. 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 ... risky choices that ultimately led to an HIV-positive diagnosis. The "After the Party" PSA tells the ...

  10. The Evaluation of In Vitro Drug Dissolution of Commercially Available Oral Dosage Forms for Itraconazole in Gastrointestinal Simulator With Biorelevant Media.

    Science.gov (United States)

    Matsui, Kazuki; Tsume, Yasuhiro; Amidon, Gregory E; Amidon, Gordon L

    2016-09-01

    The purpose of this study was to assess the feasibility of a multicompartmental in vitro dissolution apparatus, gastrointestinal simulator (GIS), in assessing the drug dissolution of 2 commercially available oral dosage forms for itraconazole (ICZ). The GIS consists of 3 chambers, mimicking the upper gastrointestinal tract. In vitro dissolution of ICZ capsule or oral solution was evaluated in United States Pharmacopeia apparatus II and GIS. To investigate the suitability of fasted state simulated intestinal fluid (FaSSIF) to predict better in vivo, FaSSIF as well as phosphate buffer were used as dissolution media. Area under the dissolved drug amount-time curve (AUDC) was calculated for each dosage form in each apparatus, and the ratios of AUDCoral solution to AUDCcapsule were compared with human pharmacokinetic data. Based on this comparison, GIS with FaSSIF can adequately distinguish the pharmacokinetic profiles of 2 oral dosage forms for ICZ. Additionally, Caco-2 cell transepithelial transport study in combination with GIS revealed that improved drug dissolution by formulations resulted in enhanced permeation of ICZ through cell monolayer, suggesting the observed ICZ concentration in the GIS will directly reflect systemic exposure. These results indicate GIS would be a powerful tool to assess the formulations of ICZ as well as other Biopharmaceutics Classification System class II drug formulations. PMID:27020985

  11. The false-positive responses of analgesic drugs to the intradermal serotonin- and compound 48/80-induced scratches as an animal model of itch.

    Science.gov (United States)

    Ilkaya, Fatih; Yesilyurt, Ozgur; Seyrek, Melik; Gunduz, Ozgur; Ide, Tayfun; Akar, Ahmet; Ulugol, Ahmet; Guzel, Hasan; Dogrul, Ahmet; Ucar, Durmus; Gunaydin, Caner

    2016-01-01

    Intradermal injection of pruritogens such as serotonin, histamine and compound 48/80 into the skin and then, the evaluation of the scratching behavior is the commonly used animal model to advance pruritic research and drug development. However, predictive validity of this model is poorly documented. There is a close interaction between itch and pain sensations with regard to mediation through an anatomically and functionally identical neuronal pathway. One approach is whether the existing animal model of itch differentiates itch or pain to show efficacy of clinically effective analgesic drugs as a back translation. In this study, we explored the effects of different group of analgesic drugs on serotonin and compound 48/80-induced scratching behavior in Balb-C mice. Serotonin (25 μg) and compound 48/80 (100 μg) was injected intradermally in a volume of 50 μl into the rostral part of skin on the back of male mice and scratches were counted for a 30-min observation period. Morphine (1, 3, 10 mg/kg), tramadol (20, 40, 80 mg/kg), cannabinoid agonist CP 55,940 (0.1, 0.3, 1 mg/kg), paracetamol (100, 200, 300 mg/kg) and diclofenac (50, 100, 200 mg/kg) were given intraperitoneally 30 min prior to pruritogen injection. The analgesic drugs dose dependently blocked serotonin and compound 48/80-induced straching behavior with exerting complete inhibition at certain doses. Our data suggests that intradermal pruritogen-induced scratching models may not discriminate pain and itch sensations and give false positive results when standard analgesic drugs are used. PMID:27685776

  12. 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.

  13. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & ... Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products

  14. 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

  15. Drug Facts

    Medline Plus

    Full Text Available ... Health Drug Abuse Hurts Bodies Drug Abuse Hurts Brains Drug Abuse and Mental Health Problems Often Happen Together The Link Between Drug Abuse and HIV/AIDS Recovery & Treatment Drug Treatment Facts Does Drug Treatment Work? Types of Drug Treatment What Is a Relapse? ...

  16. Development of an analytical methodology for the determination of the antiparasitic drug toltrazuril and its two metabolites in surface water, soil and animal manure

    DEFF Research Database (Denmark)

    Olsen, Jesper; Björklund, Erland; Krogh, Kristine A;

    2012-01-01

    phase extraction and selective pressurized liquid extraction with integrated clean-up, the analytical method allows for the determination of these compounds down to 0.06-0.13 ng L(-1) in water, 0.01-0.03 ng g(-1)dw in soil and 0.22-0.51 ng g(-1) dw in manure. The deuterated analog of toltrazuril......This paper presents the development, optimization and validation of a LC-MS/MS methodology to determine the antiparasitic veterinary drug toltrazuril and its two main metabolites, toltrazuril sulfoxide and toltrazuril sulfone, in environmental surface water, soil and animal manure. Using solid...... was used as internal standard, and ensured method accuracy in the range 96-123% for water and 77-110% for soil samples. The developed method can also be applied to simultaneously determine steroid hormones in the solid samples. The antiparasitic drug and its metabolites were found in manure and soil up...

  17. The behavior of chloroquine (a synthesized anti-malaria drug) labeled with 14C in healthy and malarious animals

    International Nuclear Information System (INIS)

    The distribution of 14C labeled chloroquine is identical in healthy and malarious animals. Fixation (by order of intensity) takes place in the liver, spleen, lungs, lacrimal glands, cerebrospinal fluid, bones, thyroid, and intestinal walls. This was confirmed from quantitative studies and demonstrates the traversing of the blood-brain barrier and the intestinal elimination after biliary excretion. Pharmaco-kinetic studies were undertaken with healthy animals and those afflicted with malaria. After a phase, in which the distribution of chloroquine is identical for both types of animal, a more rapid decrease in the blood level is observed with the malarious animals. The leucocytes contained distinctly more of the tracer than the normal or malarious red corpuscles or the blood plasma. Examination of the urinary elimination revealed a mono-exponential function; nevertheless, the urinary elimination was less regular with the malarious rats. This elimination corresponds to the excretion of unchanged chloroquine accompanied by two metabolites. A third metabolite appeared after a delay period. (author)

  18. 77 FR 50591 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

    Science.gov (United States)

    2012-08-22

    ... cancer to the test animals approach (See e.g., 52 FR 49572 at 49575 and 49582). Therefore, FDA has..., 2010, FDA issued a proposed rule (75 FR 79320) to amend its regulations regarding compounds of... Proviso (See 75 FR 79320 at 79321) without requiring the development of a second, alternative, set...

  19. 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.

  20. 76 FR 16290 - Tolerances for Residues of New Animal Drugs in Food; 2-Acetylamino-5-Nitrothiazole; Buquinolate...

    Science.gov (United States)

    2011-03-23

    ...) and as Sec. 556.550 (40 FR 13802 at 13956). 12. Salicylic acid (Sec. 556.590). In 2005, FDA acknowledged the voluntary withdrawal of approval of salicylic acid for use in cattle under NADA 010-481 and...; Prednisolone; Prednisone; Progesterone; Propylparaben; and Salicylic Acid AGENCY: Food and Drug...

  1. A sensitive and semi-quantitative method for determination of multi-drug residues in animal body fluids using multiplex dipstick immunoassay.

    Science.gov (United States)

    Han, Shuaijuan; Zhou, Tianjiao; Yin, Bingjie; He, Pingli

    2016-07-13

    The objective of this research was to develop a multiplex dipstick immunoassay method for the simultaneous determination of multi-veterinary drug residues, such as β-agonists, sulfonamides, and tetracyclines in milk, urine, and serum. The multiplex dipstick assay format was based on an indirect competitive approach: Three test lines (different antigens) and one control line (goat anti-mouse IgG) were located on the strip membrane. Labeled antibodies were freeze-dried in microwells. Samples did not require pretreatment and could be directly analyzed within 10 min. Threshold levels in different sample matrices were visually estimated at 0.3-0.45 ng mL(-1) for clenbuterol; 3-4 ng mL(-1) for sulfadiazine; and 4.5-6 ng mL(-1) for tetracycline, respectively. The linear relationship between the concentrations of veterinary drug residues and the Au nanoparticles plasmon absorbance allowed quantitative determination of these veterinary drug residues. The recoveries of clenbuterol, sulfadiazine and tetracycline in spiked samples ranged from 78.4% to 112.6%, and the relative standard deviations were below 11.2%. Analysis of animal samples suggested that the proposed multiplex dipstick assay method was consistent with the LC-MS/MS method. The percentage of false results was less than or equal to 5%. Thus, the proposed multiplex dipstick assay is inexpensive, easy-to-use, and suitable for the purposes of rapid and comprehensive screening of 3 families of β-agonists, sulfonamides and tetracyclines including 26 drugs in animal body fluids. PMID:27237838

  2. 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......), thermally gasified SS (GAs), thermally gasified poultry manure (GAp), crushed triple super phosphate (TSP) and disodium phosphate (DSP) was used as reference P fertilizer. For application of 20 kg P ha-1 mineral P fertilizer replacement value (RV) in the second year in the sandy soil was 76% and 99% for GA...

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

    OpenAIRE

    Annamaria Chiara Santini; Giovanna Maria Pierantoni; Raffaele Gerlini; Rosamaria Iorio; Yinka Olabinjo; Alfonso Giovane; Marina Di Domenico; Carla Sogos

    2014-01-01

    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 si...

  4. Pharmacological Actions of NGB 2904, a Selective Dopamine D3 Receptor Antagonist, in Animal Models of Drug Addiction

    OpenAIRE

    Xi, Zheng-Xiong; Gardner, Eliot L

    2007-01-01

    As a continuation of our work with SB-277011A, we have examined the effects of another highly elective dopamine (DA) D3 receptor antagonist, N-(4-[4-{2,3-dichlorophenyl}-1-piperazinyl]butyl)-2-fluorenylcarboxamide (NGB 2904), in animal models of addiction. Our results indicate that by systemic administration, NGB 2904 inhibits intravenous cocaine self-administration maintained under a progressive-ratio (PR) reinforcement schedule, cocaine-or cocaine cue–induced reinstatement of cocaine-seekin...

  5. 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.

  6. Form for reporting serious adverse events and product problems with human drug and biological products and devices; availability--FDA. Notice.

    Science.gov (United States)

    1993-06-01

    The Food and Drug Administration (FDA) is announcing the availability of a new form for reporting adverse events and product problems with human drug products, biologic products, medical devices (including in-vitro diagnostics), special nutritional products (dietary supplements, medical foods, infant formulas), and other products regulated by FDA. There are two versions of the form. One version of the form (FDA Form 3500) is available for use by health professionals for voluntary reporting; the other version of the form (FDA Form 3500A) is to be used by user facilities, distributors, and manufacturers for reporting that is required by statute or FDA regulations. The new form will simplify and consolidate the reporting of adverse events and product problems and will enhance agency-wide consistency in the collection of postmarketing data. This notice also responds to written comments the agency received on proposed versions of this form. Copies of both versions of the new form appear at the end of this document. PMID:10171452

  7. Challenges in pre-clinical testing of anti-cancer drugs in cell culture and in animal models

    OpenAIRE

    HogenEsch, Harm; Yu Nikitin, Alexander

    2012-01-01

    Experiments with cultures of human tumor cell lines, xenografts of human tumors into immunodeficient mice, and mouse models of human cancer are important tools in the development and testing of anti-cancer drugs. Tumors are complex structures composed of genetically and phenotypically heterogeneous cancer cells that interact in a reciprocal manner with the stromal microenvironment and the immune system. Modeling the complexity of human cancers in cell culture and in mouse models for preclinic...

  8. 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.

  9. 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.

  10. 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.

  11. 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 ...

  12. Human health risk assessment of multiple contaminants due to consumption of animal-based foods available in the markets of Shanghai, China.

    Science.gov (United States)

    Lei, Bingli; Zhang, Kaiqiong; An, Jing; Zhang, Xinyu; Yu, Yingxin

    2015-03-01

    To assess the health risks due to food consumption, the human daily intake and uptake of organochlorine pesticides, polychlorinated biphenyls, polybrominated diphenyl ethers, polycyclic aromatic hydrocarbons, and toxic trace elements (mercury, chromium, cadmium, lead, and arsenic) were estimated based on the animal-based foods collected from markets in Shanghai, China. The estimated daily intake and uptake considering the contaminant bioaccessibility via single food consumption were 9.4-399 and 4.2-282 ng/kg body weight/day for adults, and 10.8-458 and 4.8-323 ng/kg body weight/day for children, respectively. These values were 0.2-104 and 0.05-58.1, and 0.2-119 and 0.06-66.6 ng/kg body weight/day via multiple food consumption for adults and children, respectively. According to the United States Environmental Protection Agency risk assessment method, the non-cancer and cancer health risks posed by the contaminants were estimated using the hazard quotient and the lifetime cancer risk method, respectively. The results showed that the combined hazard quotient values for multiple contaminants via single or multiple food consumption were below 1, suggesting that the residents in Shanghai would not experience a significant non-cancer health risk. Among the contaminants investigated, the potential non-cancer risk of methylmercury was highest. However, the combined cancer risk posed by multiple contaminants in most foods exceeded the accepted risk level of 10(-6), and inorganic arsenic was the main contributor. The risks caused by polybrominated diphenyl ethers for cancer and non-cancer effects were negligible. The cancer risk of inorganic arsenic is a matter of concern in animal-based foods from Shanghai markets. PMID:25315930

  13. 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.

  14. 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. PMID:26092534

  15. 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.

  16. 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.

  17. 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.

  18. Nanotechnology developments: opportunities for animal health and production

    Directory of Open Access Journals (Sweden)

    Anju Manuja

    2012-01-01

    Full Text Available Nanotechnology has opened up new vistas for applications in molecular biology, biotechnology and almost all the disciplines of veterinary and animal sciences. Excellence in animal health and production can be achieved by translation of this newer technology to create effective services and products for animals. The ability to manufacture and manipulate matter on the nanoscale has offered opportunities for application in diverse areas of animal sciences. Nanosensors, nanovaccines, adjuvants, gene delivery and smart drug delivery methods have the potential to revolutionize animal health and production. There can be numerous applications of the nanomaterials for disease diagnosis, treatment, drug delivery, animal nutrition, animal breeding, reproduction, tissue engineering and value addition to animal products. This paper reviews the recent developments in nanotechnology research and opportunities for application in animal sciences.

  19. Development and field evaluation of animal feed supplementation packages for improving meat and milk production in ruminant livestock using locally available feed resources

    International Nuclear Information System (INIS)

    Molasses is a major by-product of the sugar industry in Mauritius and is still under-utilized for livestock production because of legislation and handling problems. A combination of urea, molasses and other feed ingredients can be used to produce urea-molasses multinutrient blocks (UMMB) that can be fed to livestock as a supplement. The main objective of UMMB supplementation is to provide a constant source of degradable nitrogen throughout the day, to promote growth of rumen microbes in ruminants fed poor quality forage. In Mauritius, studies were undertaken to evaluate the effect of UMMB supplementation on milk production, reproduction parameters and live weight change. Sixty cows were initially involved, 30 receiving UMMB over and above their normal ration and 30 constituting the control group. These studies have shown that UMMB improved milk yield of cows although the animals were already fed a dairy concentrate. Cows that calved resumed ovarian activity slightly earlier in the treatment group (67±32 days) than those in the control group (73±36 days). Body condition was not affected by UMMB supplementation. (author)

  20. Drug Facts

    Medline Plus

    Full Text Available ... Drug Abuse Hurts Other People Drug Abuse Hurts Families Drug Abuse Hurts Kids Drug Abuse Hurts Unborn Children ... a Relapse? Find Treatment/Rehab Resources Friends and Family Can Help Prevent Drug Abuse Help Children and Teens Stay Drug-Free ...

  1. A Validated HPLC/MS Limit Test Method for a Potential Genotoxic Impurity in Cilostazol and its Quantification in the API and in the Commercially Available Drug Product.

    Science.gov (United States)

    Bray, Luigi; Monzani, Luca; Brunoldi, Enrico; Allegrini, Pietro

    2015-01-01

    Cilostazol is a selective inhibitor of type 3 phosphodiesterase. 5-(3-Chloropropyl)-1-cyclohexyl-1H-tetrazole, used as an intermediate in the synthesis of cilostazol, has a primary alkyl chloride group, a well-known alerting function for genotoxic activity. Upon request from a regulatory agency, a limit test in accordance with ICH Q2(R1) added with the accuracy of a recovery test of 5-(4-chlorobutyl)-1-cyclohexyl-1H-tetrazole in cilostazol was developed and validated. The application of the method highlighted the need to optimize the purification process to ensure levels of this potential genotoxic impurity in the final active pharmaceutical ingredient below the established limit. Also, the analytical method was suitable to determine the amount of the impurity in samples of the commercially available drug product, which showed the levels to be above the established threshold of toxicological concern (TTC). PMID:26839820

  2. Investigating the effects of food available and climatic variables on the animal host density of hemorrhagic Fever with renal syndrome in changsha, china.

    Directory of Open Access Journals (Sweden)

    Hong Xiao

    Full Text Available BACKGROUND: The transmission of hemorrhagic fever with renal syndrome (HFRS is influenced by population dynamics of its main host, rodents. It is therefore important to better understand rodents' characteristic in epidemic areas. METHODOLOGY/PRINCIPAL FINDINGS: We examined the potential impact of food available and climatic variability on HFRS rodent host and developed forecasting models. Monthly rodent density of HFRS host and climate data in Changsha from January 2004 to December 2011 were obtained. Monthly normalized difference vegetation index (NDVI and temperature vegetation dryness index (TVDI for rice paddies were extracted from MODIS data. Cross-correlation analysis were carried out to explore correlation between climatic variables and food available with monthly rodent data. We used auto-regressive integrated moving average model with explanatory variables to examine the independent contribution of climatic variables and food supply to rodent density. The results indicated that relative rodent density of HFRS host was significantly correlated with monthly mean temperatures, monthly accumulative precipitation, TVDI and NDVI with lags of 1-6 months. CONCLUSIONS/SIGNIFICANCE: Food available plays a significant role in population fluctuations of HFRS host in Changsha. The model developed in this study has implications for HFRS control and prevention.

  3. 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...

  4. Drug: D06799 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available D06799 Crude, Drug Longgu (JP16); Powdered longgu (JP16); Fossilized mammal bones (...56], Strontium [CPD:C13884], Zirconium, Rubidium [CPD:C17061], Potassium [CPD:C00238], Titanium, Aluminum, O...ajor component: Calcium carbonate [CPD:C08129], Calcium biphosphate [CPD:C13556] Therapeutic category of dru...gs in Japan [BR:br08301] 5 Crude drugs and Chinese medicine formulations 51 Crude drugs 510 Crude drugs 5100 Crude dru...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 ...

  5. Orthotopic animal model of pseudomyxoma peritonei: An in vivo model to test anti-angiogenic drug effects.

    Science.gov (United States)

    Dohan, Anthony; Lousquy, Ruben; Eveno, Clarisse; Goere, Diane; Broqueres-You, Dong; Kaci, Rachid; Lehmann-Che, Jacqueline; Launay, Jean-Marie; Soyer, Philippe; Bonnin, Philippe; Pocard, Marc

    2014-07-01

    Pseudomyxoma peritonei (PMP) is an uncommon peritoneal mucinous carcinomatosis confined to the peritoneal cavity. The rarity of PMP in humans makes evaluation of the disease biological features and new therapeutic strategies difficult. Accordingly, there is a need for animal models of PMP. Human PMP tissue was i.p. grafted and grown into nude mice, then constituted into reliable and reproducible orthotopic models. Histological and immunostaining analysis was performed. Bevacizumab was injected twice a week either during tumor growth or after cytoreductive surgery. In vivo imaging of tumor angiogenesis was performed using barium sulfate or isolectin microangiography and Doppler ultrasonography of the superior mesenteric artery. Tumor angiogenesis was confirmed by the presence of tortuous vascular networks with high levels of expression of CD31, vascular endothelial cadherin, and desmin. Doppler ultrasonography of the superior mesenteric artery revealed a twofold increase in blood flow velocity compared with tumor-free mice (P < 0.001). Bevacizumab administration was correlated with the normalization of tumor vascularity when injected during tumor growth and with the stabilization of the histological and hemodynamic findings when injected after cytoreductive surgery. Our PMP models mimic human PMP. Our results confirmed the presence of tumor angiogenesis related to PMP growth. Our murine model allows researchers to actually bench test and evaluate, in preclinical studies, the efficacy of new therapeutic strategies and anti-angiogenic therapies. PMID:24814606

  6. 21 CFR 514.11 - Confidentiality of data and information in a new animal drug application file.

    Science.gov (United States)

    2010-04-01

    ... application file. (a) For purposes of this section the NADA file includes all data and information submitted with or incorporated by reference in the NADA, INAD's incorporated into the NADA, supplemental NADA's... availability for public disclosure of any record in the NADA file shall be handled in accordance with...

  7. Analysis of veterinary drug and pesticide residues in animal feed by high-resolution mass spectrometry: comparison between time-of-flight and Orbitrap.

    Science.gov (United States)

    Gómez-Pérez, María Luz; Romero-González, Roberto; Martínez Vidal, José Luis; Garrido Frenich, Antonia

    2015-01-01

    The use of medium-high-resolution mass spectrometers (M-HRMS) provides many advantages in multi-residue analysis. A comparison between two mass spectrometers, medium-resolution (MRMS) time-of-flight (TOF) and high-resolution (HRMS) Orbitrap, has been carried out for the analysis of toxic compounds in animal feed. More than 300 compounds belonging to several classes of veterinary drugs (VDs) and pesticides have been determined in different animal feed samples using a generic extraction method. The use of a clean-up procedure has been evaluated in both instruments, and several validation parameters have been established, such as the matrix effect, linearity, recovery and sensitivity. Finally, both instruments have been used during the analysis of 18 different feed samples (including chicken, hen, rabbit and horse). Some VDs (sulfadiazine, trimethoprim, robenidine and monensin sodium) and one pesticide (chlorpyrifos) have been identified. In general, better results were obtained using the Orbitrap, such as sensitivity (1-12.5 µg kg(-1)) and recovery values (60-125%). Moreover, this analyser had several software tools, which reduced the time for data processing and were easy to use, performing quick screening for more than 450 compounds in less than 5 min. However, some disadvantages such as the high cost and a decrease in the number of detected compounds at low concentrations must be taken into account.

  8. Molecularly imprinted solid-phase extraction for the determination of ten macrolide drugs residues in animal muscles by liquid chromatography-tandem mass spectrometry.

    Science.gov (United States)

    Song, Xuqin; Zhou, Tong; Liu, Qingying; Zhang, Meiyu; Meng, Chenying; Li, Jiufeng; He, Limin

    2016-10-01

    A simple and sensitive method based on molecularly imprinted solid-phase extraction coupled with liquid chromatography-tandem mass spectrometry was developed for the determination of the residues of ten macrolide drugs in swine, cattle and chicken muscles samples. The molecularly imprinted polymers (MIPs) were synthesized using tylosin as a template and methacrylic acid as a functional monomer. Samples were extracted with sodium borate buffer solution and ethyl acetate, and purified by the MIP cartridge. The results showed that the cartridge exhibited good recognition performance for macrolides, and better purification effect than the traditional solid-phase extraction cartridges. Recoveries of analytes at three spiking levels 1, 5 and 20μgkg(-1) ranged from 60.7% to 100.3% with the relative standard deviations less than 14%. The limits of detection of the method were between 0.1 and 0.4μgkg(-1). The method is useful for the routine monitoring of the residues of macrolide drugs in animal muscles. PMID:27132837

  9. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... 08 Animation of Antimicrobial Resistance (text version) Arabic Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) Chinese Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) French ...

  10. 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.

  11. 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

  12. 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.

  13. 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...

  14. [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.

  15. [Not Available].

    Science.gov (United States)

    Forstner, Christina; Pletz, Mathias W

    2016-02-01

    Infections with multi-drug resistant bacteria are increasing worldwide. Glycopeptides, linezolid, daptomycin and 5th generation cephalosporins ("MRSA-cephalsoporins") are used against severe infections with MRSA, combination partners are rifampin and fosfomycin. Treatment options against VRE-infections are limited to linezolid, daptomycin and tigecyclin. New agents with activity against MRSA and VRE are tedizolid, dalbvancin and oritavancin. For monotherapy of severe infections due to 3MRGN carbapenems are available. Ceftolozane/tazobactam has been licensed by the European Medical Agency and shows good activity against a relevant proportion of ESBL-pathogens. Oral agents such as nitrofurantoin or fosfomycin are used for treatment of uncomplicated cystitis. Colistin shows best in vitro susceptibility against carbapenem-resistant Enterobacteriaceae, followed by fosfomycin and tigecycline. For serious infections with 4MRGN a colistin-based combination treatment with two to three agents is recommended. In such cases a carbapenem as combination partner may be useful. PMID:26949908

  16. Drug Facts

    Medline Plus

    Full Text Available ... Weed, Pot) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Other Drugs of Abuse What ... About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs You can call 1-800- ...

  17. 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...

  18. 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.

  19. [Not Available].

    Science.gov (United States)

    Svensson, Mikael; Nilsson, Fredrik

    2016-01-01

    The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is the government body responsible for deciding whether outpatient drugs are to be included in the pharmaceutical benefits scheme. This paper analyzed all decisions made by TLV between 2005 and 2011 in order to investigate how the cost-effectiveness of a drug and the severity of the disease the drug targets affected the likelihood of subsidy of a drug. We find that TLV places significant weight on both the cost-effectiveness, measured as the cost per Quality-Adjusted Life Year (QALY), and disease severity. We also find that the higher cost per QALY approved for severe diseases is mainly represented by cancer drugs. Drugs targeting severe diseases other than cancer have a similar cost per QALY as for non-severe diseases. PMID:27404777

  20. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Science.gov (United States)

    2012-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  1. 78 FR 20326 - Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food...

    Science.gov (United States)

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration--Human and Animal Food; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft Compliance...

  2. Why Are Drugs So Hard to Quit?

    Medline Plus

    Full Text Available ... Spacebound 1,508,842 views 2:32 Quitting Drugs, Addiction and How to Deal With It - Duration: 23: ... 1,060,280 views 5:19 Mechanism of Drug Addiction in the Brain, Animation. - Duration: 4:16. Alila ...

  3. The cultivation and responsibilities of experimental animal veterinarians under the drug GLP system%GLP体系下实验动物兽医的培养与职责研究

    Institute of Scientific and Technical Information of China (English)

    孙昌华; 冷佳蔚; 祝清芬

    2016-01-01

    随着我国医药工业的迅猛发展,药物非临床研究(GLP)工作也得到了快速发展,同时带动了实验动物科学和动物试验的迅速发展,实验动物的需求量越来越大。熟悉并掌握实验动物的饲养管理,疾病的预防、诊断、治疗及动物伦理福利的实验动物兽医的需求量也越来越大。因此,实验动物兽医在药物安全性评价实验室的重要性逐渐突显出来。下面结合本中心在实验动物兽医培养等方面的心得,探讨一下药物非临床研究体系下实验动物兽医的培养及职责。%With the rapid development of Chinese pharmaceutical industry,pharmaceutical non - clinical research and the work(GLP)also got rapid development,at the same time it led to the rapid development of laboratory animal science and animal experiment,the growing demand of experimental animals. Be familiar with and master experimental animal breeding management,disease prevention,diagnosis,treatment and welfare of laboratory animal veterinarians animal ethics demand is also increasing significantly. Therefore,experimental animal veterinarians in drug safety evaluation gradually high-light the importance of the laboratory. Now combine this center in aspects such as experimental animal and veterinary train-ing experience,explore the drug GLP system functions and the cultivation of experimental animal veterinarian.

  4. 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.

  5. [Not Available].

    Science.gov (United States)

    Thunell, Stig

    2016-01-01

    The attack of acute porphyria Based on in silico evidence of pharmacokinetic, pharmacodynamic, and physiologic properties, have approximately 1 300 medicinal drugs been assessed with regard to the specific risk to carriers of acute porphyria. The classifications have been published in booklet form, together with prophylactic advice to the carriers and suggestions for doctors in charge of their care. The risk-classifications rest on the behavior of the drug in an extended molecular model of the attack of acute porphyria. In this, symptoms are effects of 5-aminolevulinate (ALA) produced in surplus after acceleration of enzyme-deficient heme biosynthesis, taking place during induction of drug-metabolizing cytochromes P450 and triggered by hepatocellular nuclear receptors, activated by the drug. The process is enhanced by glucagon- and sirtuin-dependent molecular processes activated in stress and cellular energy deficit, and enhanced and prolonged by auto-generating ALA. PMID:27622758

  6. Drug Facts

    Medline Plus

    Full Text Available ... text to you. This web site talks about drug abuse, addiction and treatment. Watch Videos Information About Drugs Alcohol ... of the drug. "Max" was addicted to prescription drugs. The addiction slowly took over his life. I need different ...

  7. 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...n [BR:br08301] 7 Agents not mainly for therapeutic purpose 71 Dispensing medicines 712 Ointment bases 7121 Oil bases D04969 White bee...swax (JP16); Wax, white (NF) Crude drugs [BR:br08305] Animals Insects D04969 White beeswax CAS: 8012-89-3 PubChem: 17398240 NIKKAJI: J269.255D ...

  8. 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 ...

  9. Animal models of asthma

    OpenAIRE

    Bates, Jason H.T.; Rincon, Mercedes; Irvin, Charles G.

    2009-01-01

    Studies in animal models form the basis for much of our current understanding of the pathophysiology of asthma, and are central to the preclinical development of drug therapies. No animal model completely recapitulates all features of the human disease, however. Research has focused primarily on ways to generate allergic inflammation by sensitizing and challenging animals with a variety of foreign proteins, leading to an increased understanding of the immunological factors that mediate the in...

  10. Animal Model of Dermatophytosis

    OpenAIRE

    Tsuyoshi Shimamura; Nobuo Kubota; Kazutoshi Shibuya

    2012-01-01

    Dermatophytosis is superficial fungal infection caused by dermatophytes that invade the keratinized tissue of humans and animals. Lesions from dermatophytosis exhibit an inflammatory reaction induced to eliminate the invading fungi by using the host’s normal immune function. Many scientists have attempted to establish an experimental animal model to elucidate the pathogenesis of human dermatophytosis and evaluate drug efficacy. However, current animal models have several issues. In the presen...

  11. 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.

  12. " Animal, trop animal "

    OpenAIRE

    Potestà, Andréa

    2010-01-01

    Dans la tradition philosophique, on trouve plusieurs définitions de l’homme. La célèbre définition aristotélicienne, zoon logon echon (animal doué du langage ou animal rationnel) fournit le paradigme ainsi que la méthode de toutes les définitions successives. Il s’agit d’ajouter au vivant, à l’animal, quelque chose d’autre, quelque chose de plus, qui permette de le caractériser et le fasse entendre comme différent des bêtes. Cette diversité peut être conçue différemment : en tant qu’élévation...

  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. 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

  15. 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.

  16. 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

    of liable P in non-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.%我国规模化养殖业的快速发展导致动物粪肥数量急剧增加,合理利用畜禽粪肥中的大量磷素,不仅可节约磷矿资源,而且避免由于粪肥直接排放和农田过量施用所带来的水体面源污染问题。本研究结合调研工作,采集了52个典型养殖场的76个动物粪肥样品,采用Hedley磷分组方法,系统分析了不同粪肥中磷素含量及其组分特征,评价不同形态磷素在土壤中的移动性及其环境风险,为合理磷素管理提供参考。结果表明:不同动物粪肥的全磷含量差异很大,猪粪、鸡粪、鸭粪、牛粪和羊粪的平均含量分别为22.5、13.7、12.9、9.6 g P·kg-1和7.5 g P·kg-1,其中粪肥中的有机磷占总磷的比例分别为33.1%、41.5%、66.4%、28.1%和36.8%。非反刍动物粪肥(猪粪、鸡粪、鸭粪)中全磷含量和有机磷含量分别为反刍动物粪肥(牛粪和羊粪)中全磷和有机磷含量的1.7~3.0倍和2.1~3.0倍,以鸡鸭粪肥中有机磷占全磷的比例最高;非反刍动物粪肥C/P比(19~29)明显低于反刍动物粪肥C/P比(38~45),其中的磷素更易矿化;依次采用H2O、NaHCO3、NaOH和HCl作为提取剂提取动物粪肥的磷素组分,反刍动物粪肥中H2O-P、NaHCO3-P、NaOH-P、HCl-P和残余态磷分别为总磷的27.8%、32.8%、18.1%、15.2%和6.1%;而非反刍动物粪肥中的各磷素组分的比例分别为24.6%、19.4%、12.7%、34.4%和8.9%;两者主要在NaHCO3-P和HCl

  17. 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.

  18. 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. PMID:23249442

  19. 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.

  20. 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

  1. Analgesic drugs

    OpenAIRE

    Kerec Kos, Mojca

    2015-01-01

    In the management of pain analgesic drugs are chosen regarding the intensity and type of pain. The selection of analgesic drug depends on pharmacokinetic properties of the drug and available pharmaceutical dosage forms. Beside non-opioid analgesics (non-steroidal antiinflammatory drugs, acetaminophen), opioid analgesic drugs have an important role in the treatment of pain. Pri zdravljenju bolečine izberemo analgetik glede na jakost in vrsto bolečine. Na izbiro ustreznega analgetika vplivaj...

  2. 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.

  3. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to Z ... Pin it Email Print The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a ...

  4. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to ... Search FDA Submit search Popular Content Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics ...

  5. Drug Facts

    Medline Plus

    Full Text Available ... Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts Meth (Crank, Ice) Facts Pain ... Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs You can ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... Numbers and Websites Search Share Listen English Español Information about this page Click on the button that ... about drug abuse, addiction and treatment. Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain ...

  7. Drug Facts

    Medline Plus

    Full Text Available Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Cigarette and Tobacco Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana ( ...

  8. Drug Facts

    Medline Plus

    Full Text Available ... People Abuse Alcohol Facts Cigarette and Tobacco Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, ... and treatment. Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs ...

  9. Drug Facts

    Medline Plus

    Full Text Available ... People Abuse Alcohol Facts Cigarette and Tobacco Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana ( ... and treatment. Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs ...

  10. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction and treatment. Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco ... 662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter ...

  11. Drug Facts

    Medline Plus

    Full Text Available ... Bodies Drug Abuse Hurts Brains Drug Abuse and Mental Health Problems Often Happen Together The Link Between ... This Website Tools and Resources | Contact Us | Site Map | Accessibility | Privacy | FOIA (NIH) The National Institute on ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... Search form Search Menu Home Drugs That People Abuse Alcohol Facts Cigarette and Tobacco Facts Cocaine (Coke, ... Pain Medicine (Oxy, Vike) Facts Other Drugs of Abuse What is Addiction? Do You or a Loved ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... Cigarette and Tobacco Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts Meth ( ... treatment. Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs You ...

  14. Animal facilities

    International Nuclear Information System (INIS)

    The animal facilities in the Division are described. They consist of kennels, animal rooms, service areas, and technical areas (examining rooms, operating rooms, pathology labs, x-ray rooms, and 60Co exposure facilities). The computer support facility is also described. The advent of the Conversational Monitor System at Argonne has launched a new effort to set up conversational computing and graphics software for users. The existing LS-11 data acquisition systems have been further enhanced and expanded. The divisional radiation facilities include a number of gamma, neutron, and x-ray radiation sources with accompanying areas for related equipment. There are five 60Co irradiation facilities; a research reactor, Janus, is a source for fission-spectrum neutrons; two other neutron sources in the Chicago area are also available to the staff for cell biology studies. The electron microscope facilities are also described

  15. 21 CFR 510.301 - Records and reports concerning experience with animal feeds bearing or containing new animal...

    Science.gov (United States)

    2010-04-01

    ... animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license... HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS Records and Reports § 510.301 Records and reports concerning experience with animal feeds bearing...

  16. 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...

  17. Leading compounds for the validation of animal models of psychopathology.

    Science.gov (United States)

    Micale, Vincenzo; Kucerova, Jana; Sulcova, Alexandra

    2013-10-01

    Modelling of complex psychiatric disorders, e.g., depression and schizophrenia, in animals is a major challenge, since they are characterized by certain disturbances in functions that are absolutely unique to humans. Furthermore, we still have not identified the genetic and neurobiological mechanisms, nor do we know precisely the circuits in the brain that function abnormally in mood and psychotic disorders. Consequently, the pharmacological treatments used are mostly variations on a theme that was started more than 50 years ago. Thus, progress in novel drug development with improved therapeutic efficacy would benefit greatly from improved animal models. Here, we review the available animal models of depression and schizophrenia and focus on the way that they respond to various types of potential candidate molecules, such as novel antidepressant or antipsychotic drugs, as an index of predictive validity. We conclude that the generation of convincing and useful animal models of mental illnesses could be a bridge to success in drug discovery. PMID:23942897

  18. 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

  19. 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

  20. Amazing Animals

    Science.gov (United States)

    Al-Kuwari, Najat Saad

    2007-01-01

    "Animals" is a three-part lesson plan for young learners with a zoo animal theme. The first lesson is full of activities to describe animals, with Simon Says, guessing games, and learning stations. The second lesson is about desert animals, but other types of animals could be chosen depending on student interest. This lesson teaches…

  1. Clinically Available Medicines Demonstrating Anti-Toxoplasma Activity.

    Science.gov (United States)

    Neville, Andrew J; Zach, Sydney J; Wang, Xiaofang; Larson, Joshua J; Judge, Abigail K; Davis, Lisa A; Vennerstrom, Jonathan L; Davis, Paul H

    2015-12-01

    Toxoplasma gondii is an apicomplexan parasite of humans and other mammals, including livestock and companion animals. While chemotherapeutic regimens, including pyrimethamine and sulfadiazine regimens, ameliorate acute or recrudescent disease such as toxoplasmic encephalitis or ocular toxoplasmosis, these drugs are often toxic to the host. Moreover, no approved options are available to treat infected women who are pregnant. Lastly, no drug regimen has shown the ability to eradicate the chronic stage of infection, which is characterized by chemoresistant intracellular cysts that persist for the life of the host. In an effort to promote additional chemotherapeutic options, we now evaluate clinically available drugs that have shown efficacy in disease models but which lack clinical case reports. Ideally, less-toxic treatments for the acute disease can be identified and developed, with an additional goal of cyst clearance from human and animal hosts. PMID:26392504

  2. 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

  3. Neuroleptic Drugs Revert the Contextual Fear Conditioning Deficit Presented by Spontaneously Hypertensive Rats: A Potential Animal Model of Emotional Context Processing in Schizophrenia?

    OpenAIRE

    Calzavara, Mariana Bendlin; Medrano, Wladimir Agostini; Levin, Raquel; Kameda, Sonia Regina; Andersen, Monica Levy; Tufik, Sergio; Silva, Regina Helena; Frussa-Filho, Roberto; Abílio, Vanessa Costhek

    2008-01-01

    Schizophrenia, bipolar disorder, and attention deficit/hyperactivity disorder (ADHD) present abnormalities in emotion processing. A previous study showed that the spontaneously hypertensive rats (SHR), a putative animal model of ADHD, present reduced contextual fear conditioning (CFC). The aim of the present study was to characterize the deficit in CFC presented by SHR. Adult male normotensive Wistar rats and SHR were submitted to the CFC task. Sensitivity of the animals to the shock and the ...

  4. [Not Available].

    Science.gov (United States)

    Schult, Andreas; Friis-Liby, Ingalill

    2016-01-01

    Ascites is a common complication of liver cirrhosis and is associated with a poor prognosis. The main pathophysiology is an increased portal pressure with compensatory activation of neurohumoral systems. A patient history, proper physical exam and adequate examination of ascitic fluid will reveal the aetiology in most cases. Complications such as spontaneous bacterial peritonitis and thrombosis of hepatic vessel should be excluded in cases of first episode of ascites or deterioration of ascites. A moderate salt restriction and treatment with diuretics is the mainstay of treatment. Potentially nephrotoxic drugs such as NSAID and ACE inhibitors should be avoided in patients with cirrhosis. PMID:26978810

  5. [Not Available].

    Science.gov (United States)

    Fatori Popovic, Sandra; Lübbers, Heinz-Theo; von Mandach, Ursula

    2016-01-01

    The aim of this paper is to show aspects of dental treatment in pregnancy. The reader should gain security in the election of the proper drugs for antibiotic therapy and rinsing solutions. Antibiotics as penicillins are the first choice in case of dental infections in pregnancy. In allergic patients, macrolides may be an alternative. Wound and mouth rinsing solutions containing chlorhexidine should be preferred in pregnancy. Ledermix(®) in endodontic treatment should be avoided in the pregnant woman. Solcoseryl(®) can be used for wound healing. Elective dental procedures should be postponed after delivery and after lactation period. PMID:27377565

  6. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 ... Regulatory Information Safety Emergency Preparedness International ...

  7. 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

  8. 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...... 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......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...

  9. Drug Facts

    Medline Plus

    Full Text Available ... Watch Videos Information About Drugs Alcohol Cocaine Heroin Marijuana Meth Pain Medicines Tobacco Other Drugs You can call 1-800-662-HELP (4357) at any time to find drug treatment centers near ... different people around me. To stop using marijuana, "Cristina" is making positive changes in her life. ...

  10. 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.

  11. Food and Drug Administration

    Science.gov (United States)

    ... Drugs @ FDA Device Approvals & Clearances Biologics Products & Establishments Food & Color Additives Animal Drugs @ FDA MedWatch: Adverse Event Reporting Report a Non-Emergency For Industry: Reportable Food Registry Report an Emergency Report Suspected Criminal Activity ...

  12. [Not Available].

    Science.gov (United States)

    Zaiyou, Jian; Li, Meng; Ning, Wang; Guifang, Xu; Jingbo, Yu; Lei, Dai; Yanhong, Shi

    2016-01-01

    The endangered causes of Taxus chinensis var. maireiin the Taihang Mountains are analyzed in three sides in connection with the situation that is resources increasing attenuation.The first is biological factors such as pollination barriers, deeply dormancy seed, cannot vegetative propagation under natural conditions, poor adaptability of seedling to environment and slow growth. The second is environmental factors such as very limited distribution environment and position in community. The third is interference of persons and other animals.According to these factors, we provide three measures to protect Taxus chinensis var. maireiin three sides that protect existing resources, breed subsequent resources and find new pathway of producing taxol. PMID:27513508

  13. 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.

  14. 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

  15. Drug: D06770 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available ommia family) Eucommia bark (dried) Major component: Gutta-percha Therapeutic category of drugs in Japan [BR:br08301] 5 Crude drugs... and Chinese medicine formulations 51 Crude drugs 510 Crude drugs 5100 Crude drugs D0...e Drugs Drugs for Qi Drugs for replenishing Qi D06770 Eucommia bark Crude drugs [BR:br08305] Dicot plants: a

  16. Places available**

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    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 & ...

  17. Molecular Targets Versus Models for New Antiepileptic Drug Discovery

    OpenAIRE

    Rogawski, Michael A.

    2006-01-01

    Animal models have played a key role in the discovery and characterization of all marketed antiepileptic drugs (AED). The conventional wisdom is that the standard animal screening models are becoming obsolete because they fail to identify compounds that act in mechanistically new ways and as a result do not offer therapeutic advantages over presently available agents. In fact, far from only detecting me-too drugs, the models often uncover compounds with distinctive profiles of activity in var...

  18. 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.

  19. 21 CFR 501.18 - Misbranding of animal food.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Misbranding of animal food. 501.18 Section 501.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.18 Misbranding...

  20. 陕西省47种药品的价格和可获得性研究%Study on Prices and Availability of 47 Kinds of Drugs in Shaanxi Province

    Institute of Scientific and Technical Information of China (English)

    闫抗抗; 杨世民; 方宇; 赵君; 刘均

    2013-01-01

    目的:了解药品在陕西省公立医疗卫生机构和零售药店的可获得性,研究陕西省药品价格与国际参考价格的差异.方法:采用世界卫生组织/国际卫生行动组织(WHO/HAI)药品价格标准化调查方法(2008版),于2010年9月对陕西省50所公立医院、36家零售药店47种药品的原研药和最低价格仿制药的价格和可获得性进行调查.结果与结论:调查的47种药品中,公立医院原研药的可获得性很低;公立医院药品的采购价格高于国际参考价;公立医院原研药的零售价格远高于国际参考价,最低价格仿制药价格略低于国际参考价,药品加成率与国家有关规定有出入.政府应提高成本核算技术,药品定价时需与国际参考价格对比,保证价格的制定与国际参考价格具有可比性.应建立政府定价和市场价格监督机制,完善药品价格监控,建立并强化药品定价失真的问责机制,同时,规范药品集中招标采购.%OBJECTIVE: To analyze the availability of drugs in public hospital and retail pharmacy in Shaanxi province, and to study the difference between medicine price of Shaanxi province and international reference prices. METHODS: By using WHO-HAI standard medicine price survey methods (2008 edition), the price and availability of 47 kinds of original drugs and lowest priced generic drugs were investigated in 50 public hospitals and 36 retail pharmacies in Sep. 2010. RESULTS & CONCLUSIONS: These 47 kinds of drugs in Shaanxi province, the availability of originator brand in public hospital is very low; procurement price of medicines in public hospitals is higher than international reference price; sale price of originator brand in public hospitals is far higher than international reference price, the lowest priced generic drugs is slightly lower than international reference price, and the rate of price addition had significant differences according to national regulation. Suggestions: the

  1. [Not Available].

    Science.gov (United States)

    von Arx, Thomas

    2016-01-01

    The objective of apical surgery is to retain teeth with persistent apical pathosis following orthograde root canal treatment if endodontic non-surgical revision is difficult or associated with risks, or is even declined by the patient. Since the most frequent cause of recurrent apical disease is bacterial reinfection from the (remaining) root canal system, the bacteria-tight root-end filling is the most important step in apical surgery. In the early 1990s, mineral trioxide aggregate (MTA) was developed at the Loma Linda University in California/USA. Preclinical studies clearly showed that MTA has a high sealing capability, a good material stability and an excellent biocompatbility. Multiple experimental studies in animals highlighted the mild tissue reactions observed adjacent to this material. Furthermore, histological analysis of the periapical regions demonstrated a frequent deposition of new cementum not only onto the resection plane (cut dentinal surface), but also directly onto MTA. For these reasons, MTA is considered a bioactive material. In 1997 MTA was cleared for clinical use in patients. Multiple prospective clinical and randomized studies have documented high and constant success rates of MTA-treated teeth in apical surgery. A recently published longitudinal study showed that MTA-treated teeth remained stable over five years; hence the high healed rates documented after one year are maintained during long-term observation. PMID:27377433

  2. [Not Available].

    Science.gov (United States)

    Siah, S; Baite, A; Bakkali, H; Atmani, M; Ababou, K; Ihrai, H

    2009-09-30

    Le syndrome de Lyell ou nécrolyse épidermique toxique (NET) est une pathologie très grave des dermatoses bulleuses d'étiologie médicamenteuse. Il se caractérise par une nécrose aiguë de l'épiderme sur toute la hauteur du corps muqueux. L'aspect clinique de la NET est celui d'une brûlure étendue du deuxième degré profond. A ce tableau s'associent constamment des lésions muqueuses et une atteinte multiviscérale qui aggrave le pronostic. Nous rapportons deux cas de NET qui illustrent l'importance d'une prise en charge précoce et multidisciplinaire de ces patients atteints au sein d'un service de réanimation des brûlés, dont les fondements reposent sur l'asepsie rigoureuse, l'apport hydroélectrolytique et nutritionnel, la prévention de l'infection et son traitement par une antibiothérapie adaptée, et un nursing et des soins locaux. L'efficacité supposée des immunoglobulines intraveineuses ne repose que sur des cas isolés et il n'y a pas encore d'études randomisées. PMID:21991170

  3. [Not Available].

    Science.gov (United States)

    Jacqueline, Sophie; Bleton, Jean; Huynh-Charlier, Isabelle; Minchin, Sébastien; Muller, Anne-Laure; Poupon, Joël; Charlier, Philippe

    2016-01-01

    Today, the development of analytic methods brings new scientific insights into the research on the mummification process used by embalmers in ancient Egypt. The application of these techniques of molecular analysis, elementary analysis, botanical analysis and bibliographic analysis of ancient texts allows us to know the composition of mummification balms and material involved in the conservation of the body. Such substances, which are mineral, animal or plant material, played a practical and a symbolic part in the composition of balms used for the preservation of mummified bodies and therefore in the passage to the eternal life after the death. The comparison of analysis results can inform us about changes in embalming techniques depending of the time, the place of mummification, the deceased's social status. However the number of mummies studied is very small compared to the number of bodies that were mummified. Finally the techniques of mummification and making balms were very variable according to practitioners and their modus operandi. Today, using these technic of chemical analysis and medical imaging techniques, we can authenticate and reconstruct the history of museum pieces, as we have done in the unpublished studies conducted in support of literature data previously collected. PMID:27349124

  4. 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 ...

  5. [Not Available].

    Science.gov (United States)

    Valença, Mariana Soares; Possuelo, Lia Gonçalves; Cezar-Vaz, Marta Regina; Silva, Pedro Eduardo Almeida da

    2016-06-01

    The scope of this study was to organize the knowledge produced on tuberculosis in Brazilian prisons in a systematic manner. A comprehensive review was conducted in the Medline and Lilacs databases and the SciELO electronic library using the key words: "Tuberculosis," "Prisons" and "Brazil." Of the 61 records found, 33 were evaluated (28 duplicated records) and 21 included in the review (12 excluded according to the criteria adopted). These studies contribute effectively to improve the knowledge regarding the scale of the disease among inmates, as well as to the choice of screening and diagnostic methods most appropriate to the prison setting. The incidence rates and prevalence of active and latent tuberculosis are presented, in addition to data on the profile of drug and genotype susceptibility of the clinical results. Awareness of the data presented highlights the need to adopt measures aimed at case detection, treatment and follow-up. It is suggested that the new challenges for scientific research should be linked to the development of specific knowledge about dealing with the problem in an environment full of specificities such as a prison. PMID:27383348

  6. Causes, Harm & Control Measures of Veterinary Drugs Residues in Animal Products%畜产品兽药残留的起因、危害及其控制措施

    Institute of Scientific and Technical Information of China (English)

    王芬; 靳胜福; 黄涛

    2013-01-01

    近年来,兽药残留已成为人们普遍关注的社会问题之一.兽药残留不仅危害人体健康,造成环境污染,还影响我国畜牧业的发展和国际化进程.因此,必须采取有效措施,控制和减少兽药的残留.文章主要阐述了兽药残留的起因、危害及其控制措施.%In recent years,veterinary drugs residues have become one of the important social problems of common concern.Veterinary drugs residues not only endanger human health and cause environmental pollution,but also affect the development and the internationalization process of Chinese animal husbandry.Therefore,effective measures must be taken to control and reduce the residues of veterinary drugs.This paper mainly describes the causes.harm and control measures of veterinary drugs residues.

  7. 21 CFR 58.90 - Animal care.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Animal care. 58.90 Section 58.90 Food and Drugs... FOR NONCLINICAL LABORATORY STUDIES Testing Facilities Operation § 58.90 Animal care. (a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b)...

  8. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74460

    2001-01-01

    Places are available in the following courses: Nouveautés de FileMaker : 20 - 23.03.01 (4 matins) Contract Follow-up : 9.4.01 (3 heures) 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.

  9. 76 FR 66073 - Guidance for Industry on What You Need to Know About Administrative Detention of Foods; Availability

    Science.gov (United States)

    2011-10-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on What You Need to Know About.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... intended to provide individuals in the human and animal food industries with an understanding of...

  10. 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...

  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: 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. 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...

  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. 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...

  14. 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...

  15. 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...

  16. 21 CFR 530.21 - Prohibitions for food-producing animals.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Prohibitions for food-producing animals. 530.21... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals § 530.21 Prohibitions...

  17. [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%).

  18. Animal Bites

    Science.gov (United States)

    ... and complications from bites Never pet, handle, or feed unknown animals Leave snakes alone Watch your children closely around animals Vaccinate your cats, ferrets, and dogs against rabies Spay or neuter ...

  19. Animal Bites

    Science.gov (United States)

    Wild animals usually avoid people. They might attack, however, if they feel threatened, are sick, or are protecting their ... or territory. Attacks by pets are more common. Animal bites rarely are life-threatening, but if they ...

  20. 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.

  1. Animal Farm

    Institute of Scientific and Technical Information of China (English)

    徐蓉蓉

    2015-01-01

    This essayfirst 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. 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    

  3. 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

  4. PLACES AVAILABLE

    CERN Multimedia

    TECHNICAL TRAINING; Tel. 74460

    2001-01-01

    Places are available in the following courses: The JAVA programming language level 1: 8 - 9.2.01 (2 days) AutoCAD 2D niveau 1 : 12 - 16.2.01 (5 jours) The JAVA programming language level 2: 19 - 21.2.01 (3 days) C++ for Particle Physicists: 5 - 9.3.01 (20 hrs on 5 days) Contract Follow-up : 12.3.01 (3 heures) The JAVA programming language level 2: 12 - 14.3.01 (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 your Divisional Secretariat or from your DTO (Divisional Training Officer). Applications will be accepted in the order of their receipt.

  5. 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) Contract Follow-up : 11.6.01 (1/2 journée) LabView hands-on : 11.6.01 F ou E (1/2 journée) LabView Base 1 : 12 - 14.6.01 (3 jours) Habilitation électrique : superviseurs: 2 sessions d'une demi-journée les 12 et 19.6.01 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.

  6. 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

  7. 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.

  8. 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.

  9. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Introduction à PowerPoint : 24.4.01 (1 journée) Introduction to Rational Rose: 7 - 8.5.01 (2 days) Programmation TSX Premium 2 : 7 - 11.5.01 (5 jours) EXCEL : 9, 10, 16, 17.5.01 (4 jours) LabView Base 2 : 15 - 16.5.01 (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 : 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.

  10. PLACES AVAILABLE

    CERN Multimedia

    Technical Training; Tel. 74924

    2001-01-01

    Places are available in the following courses: Introduction à PowerPoint : 24.4.01 (1 journée) Programmation TSX Premium 2 : 7 - 11.5.01 (5 jours) EXCEL : 9, 10, 16, 17.5.01 (4 jours) LabView Base 2 :  15 - 16.5.01 (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 : 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. Animal ethics

    OpenAIRE

    Palmer, Clare; Sandøe, Peter

    2011-01-01

    This chapter describes and discusses different views concerning our duties towards animals. First, we explain why it is necessary to engage in thinking about animal ethics and why it is not enough to rely on feelings alone. Secondly, we present and discuss five different kinds of views about the nature of our duties to animals. They are: contractarianism, utilitarianism, the animal rights view, contextual views, and a respect for nature view. Finally, we briefly consider whether it is possibl...

  12. 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...

  13. PLACES AVAILABLE

    CERN Multimedia

    Enseignement Technique; Tél. 74924; Technical Training; Monique Duval; Tel. 74924

    2000-01-01

    Places available 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 aspects of the C language 2 - 3.11.00 2 days Introduction to Oracle SQL and PL/SQL 13 - 17.11.00 5 days C++ for Particle Physicists 20 - 24.11.00 6 lectures Develop PL/SQL Program Units 20 - 22.11.00 3 days Oracle Application Server Develop Web-Based Applications with PL/SQL 27 - 28.11.00 2 days Programmation TSX Premium 1 28.11 - 1.12.00 4 jours Programmation TSX Premium 2 12 - 15.12.00 4 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 : http://www.cern.ch/Training/ or fill in an “application for training” form available from your Divisional Secretariat or from your DTO (Divisional Training Offi...

  14. Drug: D06749 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available drugs 5100 Crude drugs D06749 Nuphar rhizome (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs... for blood Drugs for removing blood stasis D06749 Nuphar rhizome; Nup

  15. Drug: D05431 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available (NF) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Diaphoretic d...rugs Diaphoretic drugs pungent in flavor and cool in property D05431 *Peppermint; Peppermint Drugs for external use Drugs

  16. Drug: D09185 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Stomachic and antidiarrheal drugs Stomachic ...and antidiarrheal drugs D09185 *Myrica Drugs for external use Drugs for external use D09185 *Myrica Crude dr

  17. Drug: D03404 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available drugs D03404 Cardamon (JP16); Cardamom seed (NF) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs... for dampness Drugs for resolving dampness D03404 Cardamon; Cardamom seed; Cardamon Crude drugs [B

  18. Drug: D06767 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available gs D06767 Benincasa seed (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs for blood Drugs... for removing blood stasis D06767 *Benincasa seed Drugs for pus discharge Drugs

  19. Drug: D06772 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Stomachic an...d antidiarrheal drugs Stomachic and antidiarrheal drugs D06772 *Ginseng; Powdered ginseng; Ginseng Drugs for Qi Drugs

  20. Drug: D06803 [KEGG MEDICUS

    Lifescience Database Archive (English)

    Full Text Available 10 Crude drugs 5100 Crude drugs D06803 Nelumbo seed (JP16) Traditional Chinese Medicine in Japan [BR:br08304] Crude Drugs Drugs... for Qi Drugs for replenishing Qi D06803 Nelumbo seed Crude dr