WorldWideScience

Sample records for animal drug availability

  1. 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 elk...

  2. 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)…

  3. Animal models of drug addiction.

    Science.gov (United States)

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

    2017-09-29

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

  4. 75 FR 81455 - New Animal Drugs; Deslorelin

    Science.gov (United States)

    2010-12-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 [Docket No. FDA-2010-N-0002] New Animal Drugs; Deslorelin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  5. 75 FR 1275 - New Animal Drugs; Ractopamine

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2009-N-0665] New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

  6. 76 FR 6326 - New Animal Drugs; Masitinib

    Science.gov (United States)

    2011-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 [Docket No. FDA-2011-N-0003] New Animal Drugs; Masitinib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

  7. 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 FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.33 Animal drugs. The classes of actions listed in this section are...

  8. 75 FR 79295 - New Animal Drugs; Mupirocin

    Science.gov (United States)

    2010-12-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 [Docket No. FDA-2010-N-0002] 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...

  9. Electronic Animal Drug Product Listing Directory

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Electronic Animal Drug Product Listing Directory is a directory of all animal drug products that have been listed electronically since June 1, 2009, to comply...

  10. 78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

    Science.gov (United States)

    2013-08-23

    ... 558 [Docket No. FDA-2013-N-0839] New Animal Drugs; Withdrawal of Approval of New Animal Drug...: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request...

  11. 75 FR 79383 - Unapproved Animal Drugs

    Science.gov (United States)

    2010-12-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0528] Unapproved Animal Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on...

  12. 77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food

    Science.gov (United States)

    2012-12-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2012-N-1067] RIN 0910-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food AGENCY: Food and Drug Administration, HHS. ACTION...

  13. 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,...

  14. 9 CFR 318.20 - Use of animal drugs.

    Science.gov (United States)

    2010-01-01

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

  15. Compounding and Extralabel Use of Drugs in Exotic Animal Medicine.

    Science.gov (United States)

    Powers, Lauren V; Davidson, Gigi

    2018-05-01

    Extralabel drug use is the use of a Food and Drug Administration (FDA)-approved drug in a manner different from what is stipulated on the approved label. Compounding is the process of preparing a medication in a manner not indicated on the label to create a formulation specifically tailored to the needs of an individual patient. Extralabel drug use and compounding are vital aspects of safe and effective drug delivery to patients in exotic animal practice. There are few FDA-approved drugs for exotic animal species, and many approved drugs for other species are not available in suitable formulations for use in exotic animals. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. 76 FR 17025 - New Animal Drugs; Oxytetracycline

    Science.gov (United States)

    2011-03-28

    ... [Docket No. FDA-2011-N-0003] New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS... Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder... use of PENNOX 343 (oxytetracycline HCl) Soluble Powder for control of American and European foulbrood...

  17. Availability and usage of new antibacterial drugs in Europe.

    Science.gov (United States)

    Ziv, G

    1980-05-15

    The present-day availability and usage of established and new antibacterial drugs approved for clinical and therapeutic purposes in food-producing animals and poultry in the United States and Europe were compared. Presently, 42 such drugs are approved in Europe, 13 of which were approved since Dec 31, 1974. In the United States, 17 such drugs are currently approved, only four were approved since Dec 31, 1974. Most drug products approved in Europe contain two or more antibacterial agents, whereas most of the products approved in the United States are single drug entities. Drugs approved in Europe but not in the United States include sulfonamide and trimethoprim combinations, nafcillin, oxacillin, metampicillin, cephoxazole, cephalonium, cephacetrile, cephalexin, gentamicin, rifamycin SV, nifuroquine, tiamulin, chloramphenicol, colistin, and polymyxin B. Pharmacologic and clinical features of several of these drugs are briefly described.

  18. 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. Copyright 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  19. 75 FR 5887 - New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin

    Science.gov (United States)

    2010-02-05

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Elanco...

  20. 76 FR 76894 - New Animal Drugs for Use in Animal Feeds; Tilmicosin

    Science.gov (United States)

    2011-12-09

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Tilmicosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  1. 75 FR 11451 - New Animal Drugs for Use in Animal Feeds; Zilpaterol

    Science.gov (United States)

    2010-03-11

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Zilpaterol 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 three abbreviated new animal drug applications (ANADAs) filed...

  2. 75 FR 9334 - New Animal Drugs for Use in Animal Feeds; Chlortetracycline

    Science.gov (United States)

    2010-03-02

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM...

  3. 75 FR 54019 - New Animal Drugs for Use in Animal Feed; Ractopamine

    Science.gov (United States)

    2010-09-03

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feed; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by...

  4. 75 FR 34361 - New Animal Drugs for Use in Animal Feeds; Florfenicol

    Science.gov (United States)

    2010-06-17

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

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

    Science.gov (United States)

    2012-04-23

    .... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

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

    Science.gov (United States)

    2012-01-27

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  7. 76 FR 79064 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2011-12-21

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by...

  8. 77 FR 22667 - New Animal Drugs for Use in Animal Feeds; Tiamulin

    Science.gov (United States)

    2012-04-17

    .... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Tiamulin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application...

  9. [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.

  10. 77 FR 58021 - New Animal Drugs for Use in Animal Feeds; Monensin

    Science.gov (United States)

    2012-09-19

    ... [Docket No. FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug... amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to... . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug regulations for certain monensin free-choice...

  11. 75 FR 60308 - New Animal Drugs for Use in Animal Feeds; Melengestrol

    Science.gov (United States)

    2010-09-30

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol AGENCY: Food and Drug... amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The...

  12. 78 FR 76059 - New Animal Drugs for Use in Animal Feeds; Bambermycins

    Science.gov (United States)

    2013-12-16

    .... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Bambermycins AGENCY: Food and Drug... amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for....gov . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug regulations for bambermycins...

  13. 75 FR 20917 - New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine

    Science.gov (United States)

    2010-04-22

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Melengestrol, Monensin, and Ractopamine... (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc. The...

  14. 75 FR 7555 - New Animal Drugs for Use in Animal Feeds; Bacitracin Zinc; Nicarbazin

    Science.gov (United States)

    2010-02-22

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Bacitracin Zinc; Nicarbazin AGENCY: Food... amending the animal drug regulations to reflect approval of an original abbreviated new animal drug... generic copy of NADA 141-146, sponsored by Phibro Animal Health, for combination use of BACIFERM...

  15. 76 FR 65109 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin

    Science.gov (United States)

    2011-10-20

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin; Tylosin AGENCY...) 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, Inc. The...

  16. 76 FR 60721 - New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin

    Science.gov (United States)

    2011-09-30

    .... FDA-2011-N-0003] New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin AGENCY: Food and... 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, Inc. The supplemental ANADA...

  17. 75 FR 24394 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2010-05-05

    ... [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations by...

  18. 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...

  19. 76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

    Science.gov (United States)

    2011-09-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  20. 77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

    Science.gov (United States)

    2012-01-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  1. 76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

    Science.gov (United States)

    2011-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  2. 76 FR 40808 - Oral Dosage Form New Animal Drugs; Amprolium

    Science.gov (United States)

    2011-07-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] 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...

  3. 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 § 500.46...

  4. 77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

    Science.gov (United States)

    2012-03-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Pergolide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  5. 75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

    Science.gov (United States)

    2010-11-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

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

    Science.gov (United States)

    2011-12-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

  7. 76 FR 16534 - New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction

    Science.gov (United States)

    2011-03-24

    .... FDA-2010-N-0002] New Animal Drugs for Use in Animal Feeds; Florfenicol; Correction AGENCY: Food and...) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained...

  8. 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 animal...

  9. Animal models of pancreatic cancer for drug research.

    Science.gov (United States)

    Kapischke, Matthias; Pries, Alexandra

    2008-10-01

    The operative and conservative results of therapy in pancreatic ductal adenocarcinoma remain appallingly poor. This underlines the demand for further research for effective anticancer drugs. The various animal models remain the essential method for the determination of efficacy of substances during preclinical phase. Unfortunately, most of these tested substances showed a good efficacy in pancreatic carcinoma in the animal model but were not confirmed during the clinical phase. The available literature in PubMed, Medline, Ovid and secondary literature was searched regarding the available animal models for drug testing against pancreatic cancer. The models were analyzed regarding their pros and cons in anticancer drug testing. The different modifications of the orthotopic model (especially in mice) seem at present to be the best model for anticancer testing in pancreatic carcinoma. The value of genetically engineered animal model (GEM) and syngeneic models is on debate. A good selection of the model concerning the questions supposed to be clarified may improve the comparability of the results of animal experiments compared to clinical trials.

  10. 76 FR 2807 - New Animal Drugs; Change of Sponsor

    Science.gov (United States)

    2011-01-18

    .... FDA-2010-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...., Cambridge, MA 02141 has informed FDA that it has transferred ownership of, and all rights and interest in...

  11. 76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

    Science.gov (United States)

    2011-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 524 [Docket No. FDA-2011-N-0003] New Animal Drugs; Change of Sponsor; Moxidectin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

  12. 77 FR 32010 - New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol

    Science.gov (United States)

    2012-05-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, and 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Altrenogest; Dexamethasone; Florfenicol AGENCY: Food and Drug Administration, HHS. [[Page 32011

  13. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Science.gov (United States)

    2012-04-13

    ... resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' and to set timelines... Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' (GFI 209) and (2) the...

  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

    ... 558 [Docket No. FDA-2010-N-0002] Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran AGENCY...) is amending the animal drug regulations by removing those portions that reflect approval of eight new...

  15. Toxicity studies of drugs and chemicals in animals: An overview

    Directory of Open Access Journals (Sweden)

    S. Saganuwan

    2017-12-01

    Full Text Available Toxicity study is the investigation of either short or long-term toxic effects of a drug or chemical on animals. The toxicity is dose-dependent as asserted by Paracelsus over 500 years ago. However, short-term toxic effect is determined using median lethal dose (LD50 first introduced by Trevan in 1927 and revised many times. Presently there is a growing preponderance of rejection of scientific papers on acute toxicity study, simply because of the belief that in the current hazard and safety as-sessment of drugs and chemicals, LD50 values are no longer used. In view of this, literature search was carried out with a view to investigating the relevance of LD50 in development and assessment of drugs and chemicals. The findings revealed that in the past, many animals had been used for LD50 determination. OECD has reduced the number of test animals to 5–15 and presently it is further re-duced to 2–6. Acute toxicity study is being carried out in medicinal plants research and in the study of patent medicine. Although the application of LD50 has been drastically reduced, it is still applied and accepted in some parts of the world. Moreover, animals on which LD50 tests are conducted, should be allowed to die to see the end effect of the test drug or chemical because euthanisia of test animals may mask some toxicity signs of the test agents. Therefore, toxicity study of drugs and chemicals is a sci-entific process necessary for discovery and development of drugs as well as identification of potential toxicants.

  16. 78 FR 79299 - New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction

    Science.gov (United States)

    2013-12-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2013-N-0002] New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction AGENCY: Food and... amended the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for...

  17. Application of Model Animals in the Study of Drug Toxicology

    Science.gov (United States)

    Song, Yagang; Miao, Mingsan

    2018-01-01

    Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

  18. Animal models for testing anti-prion drugs.

    Science.gov (United States)

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

    2013-01-01

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

  19. Drug and chemical residues in domestic animals.

    Science.gov (United States)

    Mussman, H C

    1975-02-01

    Given the large number of chemical substances that may find their way into the food supply, a system is needed to monitor their presence. The U. S. Department of Agriculture's Meat and Poultry Inspection Program routinely tests for chemical residues in animals coming to slaughter. Pesticides, heavy metals, growth promotants (hormones and hormonelike agents), and antibiotics are included. Samples are taken statistically so that inferences as to national incidence of residues can be drawn. When a problem is identified, a more selective sampling is designed to help follow up on the initial regulatory action. In testing for pesticides, only DDT and dieldrin are found with any frequency and their levels are decreasing; violative residues of any chlorinated hydrocarbon are generally a result of an industrial accident rather than agricultural usage. Analyses for heavy metals have revealed detectable levels of mercury, lead, and others, but none at levels that are considered a health hazard. Of the hormone or hormonelike substances, only diethylstilbestrol has been a residue problem and its future is uncertain. The most extensive monitoring for veterinary drugs is on the antimicrobials, including sulfonamides, streptomycin, and the tetracycline group of antibiotics that constitute the bulk of the violations; their simultaneous use prophylactically and therapeutically has contributed to the problem in certain cases. A strong, well-designed user education program on proper application of pesticides, chemicals, and veterinary drugs appears to be one method of reducing the incidence of unwanted residues.

  20. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Science.gov (United States)

    2013-12-12

    ... Guidance for Industry (GFI) 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food... of certain antimicrobial new animal drug products who are interested in revising conditions of use... Medically Important Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines for stakeholders...

  1. Short history of regulations and approved indications of antimicrobial drugs for food animals in the USA.

    Science.gov (United States)

    Volkova, V V; DeMars, Z

    2017-06-01

    We review historical availability and regulation, and recent indications of antimicrobial drugs for food animals in the USA. We summarize the timeline of introduction of individual antimicrobial drug classes from the 1930s to present, history of regulation of antimicrobial drugs from the 1930s to present and indications of antimicrobial drugs in 1996-2014 for food animals in the USA. The history of antimicrobial drug regulation demonstrates a historical precedent for harmonized regulations of antimicrobials 'for human and other animals' in the USA. © 2016 John Wiley & Sons Ltd.

  2. Can currently available non-animal methods detect pre and ...

    Science.gov (United States)

    Predictive testing to identify and characterise substances for their skin sensitisation potential has historically been based on animal tests such as the Local Lymph Node Assay (LLNA). In recent years, regulations in the cosmetics and chemicals sectors has provided a strong impetus to develop and evaluate non-animal alternative methods. The AOP for skin sensitisation provides a framework to anchor non-animal test methods to key events in the pathway to help identify what tests can be combined together to generate the potency information required for risk assessment. The 3 test methods that have undergone extensive development and validation are the direct peptide reactivity assay (DPRA), the KeratinoSensTM and the human Cell Line Activation Test (h-CLAT). Whilst these methods have been shown to perform relatively well in predicting LLNA results (accuracy ~ 80%), a particular concern that has been raised is their ability to predict chemicals that need to be activated to act as sensitisers (either abiotically on the skin (pre-hapten) or metabolically in the skin (pro-hapten)). The DPRA is a cell free system whereas the other two methods make use of cells that do not fully represent the in vivo metabolic situation. Based on previously published datasets of LLNA data, it has been found that approximately 25% of sensitisers are pre- and/or pro-haptens. This study reviewed an EURL ECVAM dataset of 127 substances for which information was available in the LLNA and the

  3. 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... Provisions § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time...

  4. 76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... . (The Pay.gov payment option is available to you after you submit a cover sheet. Click the ``Pay Now... generic new animal drugs, FDA is assuming that the number of applications that will pay fees in FY 2012... submissions of abbreviated applications for generic new animal drugs is 14.5 per year, which is the average of...

  5. 77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin

    Science.gov (United States)

    2012-09-10

    ... 556 [Docket No. FDA-2012-N-0002] New Animal Drugs; Enrofloxacin; Tylvalosin AGENCY: Food and Drug...Care BAYTRIL 100 Supplement adding 522.812 yes CE \\1\\ LLC, Animal (enrofloxacin) control of bovine... Enrofloxacin. * * * * * (e) * * * (2) * * * (i) Amount--(A) Single-dose therapy: For treatment of bovine...

  6. The use of drugs in food animals: benefits and risks

    National Research Council Canada - National Science Library

    ...; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industries--poultry, dairy, beef, swine, and aquaculture...

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

    African Journals Online (AJOL)

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

  8. Cell and small animal models for phenotypic drug discovery

    Directory of Open Access Journals (Sweden)

    Szabo M

    2017-06-01

    Full Text Available Mihaly Szabo,1 Sara Svensson Akusjärvi,1 Ankur Saxena,1 Jianping Liu,2 Gayathri Chandrasekar,1 Satish S Kitambi1 1Department of Microbiology Tumor, and Cell Biology, 2Department of Biochemistry and Biophysics, Karolinska Institutet, Solna, Sweden Abstract: The phenotype-based drug discovery (PDD approach is re-emerging as an alternative platform for drug discovery. This review provides an overview of the various model systems and technical advances in imaging and image analyses that strengthen the PDD platform. In PDD screens, compounds of therapeutic value are identified based on the phenotypic perturbations produced irrespective of target(s or mechanism of action. In this article, examples of phenotypic changes that can be detected and quantified with relative ease in a cell-based setup are discussed. In addition, a higher order of PDD screening setup using small animal models is also explored. As PDD screens integrate physiology and multiple signaling mechanisms during the screening process, the identified hits have higher biomedical applicability. Taken together, this review highlights the advantages gained by adopting a PDD approach in drug discovery. Such a PDD platform can complement target-based systems that are currently in practice to accelerate drug discovery. Keywords: phenotype, screening, PDD, discovery, zebrafish, drug

  9. 77 FR 14272 - New Animal Drugs for Use in Animal Feeds

    Science.gov (United States)

    2012-03-09

    ... 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, on page 490, in Sec. 558.500, (e)(1)(i) is reinstated to read as...

  10. 75 FR 15610 - New Animal Drugs for Use in Animal Feeds

    Science.gov (United States)

    2010-03-30

    ... 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, in Sec. 558.55, on page 408, at the end of the table to...

  11. 78 FR 17595 - New Animal Drugs; Changes of Sponsor

    Science.gov (United States)

    2013-03-22

    ... RAPINOVET (propofol) Injectable Emulsion. 141-245 TRIBUTAME (embutramide, chloroquine, and lidocaine... DRUGS FOR USE IN ANIMAL FEEDS 0 53. The authority citation for 21 CFR part 558 continues to read as...

  12. Restrictions in Availability of Drugs Used for Suicide

    DEFF Research Database (Denmark)

    Nordentoft, Merete

    2007-01-01

    Availability of drugs with high lethality has been hypothesized to increase the risk of self-poisoning suicides. A literature search concerning deliberate self-poisoning and the effect of restricting access to drugs was conducted, and the effect of restrictions in availability of barbiturates, tr...... in availability of drugs with high case fatality should be a part of suicide prevention strategies.......Availability of drugs with high lethality has been hypothesized to increase the risk of self-poisoning suicides. A literature search concerning deliberate self-poisoning and the effect of restricting access to drugs was conducted, and the effect of restrictions in availability of barbiturates......, tricyclic antidepressants, dextropropoxyphene, and weak analgesics was reviewed. The correlations between method-specific and overall suicide rates and sales figures for barbiturates, dextropropoxyphene, weak analgesics, and tricyclic antidepressants were reviewed. It is concluded that restriction...

  13. FDA-approved drugs that are spermatotoxic in animals and the utility of animal testing for human risk prediction.

    Science.gov (United States)

    Rayburn, Elizabeth R; Gao, Liang; Ding, Jiayi; Ding, Hongxia; Shao, Jun; Li, Haibo

    2018-02-01

    This study reviews FDA-approved drugs that negatively impact spermatozoa in animals, as well as how these findings reflect on observations in human male gametes. The FDA drug warning labels included in the DailyMed database and the peer-reviewed literature in the PubMed database were searched for information to identify single-ingredient, FDA-approved prescription drugs with spermatotoxic effects. A total of 235 unique, single-ingredient, FDA-approved drugs reported to be spermatotoxic in animals were identified in the drug labels. Forty-nine of these had documented negative effects on humans in either the drug label or literature, while 31 had no effect or a positive impact on human sperm. For the other 155 drugs that were spermatotoxic in animals, no human data was available. The current animal models are not very effective for predicting human spermatotoxicity, and there is limited information available about the impact of many drugs on human spermatozoa. New approaches should be designed that more accurately reflect the findings in men, including more studies on human sperm in vitro and studies using other systems (ex vivo tissue culture, xenograft models, in silico studies, etc.). In addition, the present data is often incomplete or reported in a manner that prevents interpretation of their clinical relevance. Changes should be made to the requirements for pre-clinical testing, drug surveillance, and the warning labels of drugs to ensure that the potential risks to human fertility are clearly indicated.

  14. 75 FR 55676 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2010-09-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and...; International Nutrition, Inc., 7706 ``I'' Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd... 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 520 continues to...

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

    International Nuclear Information System (INIS)

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

    2015-01-01

    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

  16. 78 FR 25182 - New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin

    Science.gov (United States)

    2013-04-30

    ... [Docket No. FDA-2013-N-0002] New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and... Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013. FDA...

  17. Availability and affordability of antiglaucoma drugs in Benin city ...

    African Journals Online (AJOL)

    Glaucoma is a leading cause of blindness. Affordability and availability are key factors that determine access to effective treatment. The aim of this study is to investigate the availability and affordability of antiglaucoma medicines in Benin City. A cross sectional survey of the major drug distribution sectors was conducted.

  18. Determining animal drug combinations based on efficacy and safety.

    Science.gov (United States)

    Kratzer, D D; Geng, S

    1986-08-01

    A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

  19. 21 CFR 530.20 - Conditions for permitted extralabel animal and human drug use in food-producing animals.

    Science.gov (United States)

    2010-04-01

    ... consumption: (1) Such use must be accomplished in accordance with an appropriate medical rationale; and (2) If... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Conditions for permitted extralabel animal and human drug use in food-producing animals. 530.20 Section 530.20 Food and Drugs FOOD AND DRUG...

  20. 78 FR 19986 - New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

    Science.gov (United States)

    2013-04-03

    ... 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin AGENCY: Food and............ CE \\1\\ Laboratories, (enrofloxacin) as a generic Ltd., Station Injectable copy of NADA 141- Works... introductory text to paragraph (e)(2) to read as follows: Sec. 522.812 Enrofloxacin. * * * * * (b) Sponsors...

  1. Interactions of Rosiglitazone and Anti.Arrhythmic Drugs in Animal ...

    African Journals Online (AJOL)

    Interactions of Rosiglitazone and Anti.Arrhythmic Drugs in Animal Model. YM Mohammed, EI Mohammed, N Mohiuddin, SS Syeda. Abstract. Background: Diabetes increases the risk of vascular problems by two times compared with a healthy individual, with deposition of fats in blood vessel and this includes cardiovascular ...

  2. 77 FR 45629 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013

    Science.gov (United States)

    2012-08-01

    ..., beginning with the letters ``AG'', from the upper right-hand corner of your completed Animal Generic Drug...] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2013 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2013 generic new animal drug user fees. The Federal Food, Drug...

  3. 75 FR 45632 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ...), beginning with the letters AD, from the upper right-hand corner of your completed Animal Drug User Fee Cover...] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2011 AGENCY: Food and Drug... payment procedures for fiscal year (FY) 2011 animal drug user fees. The Federal Food, Drug, and Cosmetic...

  4. Availability of prescription drugs for bipolar disorder at online pharmacies.

    Science.gov (United States)

    Monteith, Scott; Glenn, Tasha; Bauer, Rita; Conell, Jörn; Bauer, Michael

    2016-03-15

    There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. No evaluation of product quality, packaging or purchasing. Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website

  5. 78 FR 24154 - Notice of Availability of a National Animal Health Laboratory Network Reorganization Concept Paper

    Science.gov (United States)

    2013-04-24

    ...] Notice of Availability of a National Animal Health Laboratory Network Reorganization Concept Paper AGENCY... available a concept paper that describes a revised structure for the National Animal Health Laboratory... biological threats to the nation's food animals. The concept paper we are making available for comment...

  6. Latest animal models for anti-HIV drug discovery.

    Science.gov (United States)

    Sliva, Katja

    2015-02-01

    HIV research is limited by the fact that lentiviruses are highly species specific. The need for appropriate models to promote research has led to the development of many elaborate surrogate animal models. This review looks at the history of animal models for HIV research. Although natural animal lentivirus infections and chimeric viruses such as chimera between HIV and simian immunodeficiency virus and simian-tropic HIV are briefly discussed, the main focus is on small animal models, including the complex design of the 'humanized' mouse. The review also traces the historic evolution and milestones as well as depicting current models and future prospects for HIV research. HIV research is a complex and challenging task that is highly manpower-, money- and time-consuming. Besides factors such as hypervariability and latency, the lack of appropriate animal models that exhibit and recapitulate the entire infectious process of HIV, is one of the reasons behind the failure to eliminate the lentivirus from the human population. This obstacle has led to the exploitation and further development of many sophisticated surrogate animal models for HIV research. While there is no animal model that perfectly mirrors and mimics HIV infections in humans, there are a variety of host species and viruses that complement each other. Combining the insights from each model, and critically comparing the results obtained with data from human clinical trials should help expand our understanding of HIV pathogenesis and drive future drug development.

  7. Increasing availability of illicit drugs among people who inject drugs in Bangkok, Thailand.

    Science.gov (United States)

    Hayashi, Kanna; Nosyk, Bohdan; Ti, Lianping; Suwannawong, Paisan; Kaplan, Karyn; Wood, Evan; Kerr, Thomas

    2013-09-01

    In recent years, the Thai government has strengthened drug law enforcement as a strategy to address a continuing epidemic of illicit drug use. We sought to assess temporal trends in street-level availability of illicit drugs among injection drug users (IDUs) in Bangkok, Thailand. Using univariate statistics and multivariate logistic regression, we assessed changes in the availability of five substances (heroin, methamphetamine, crystal methamphetamine, midazolam, and illicit methadone) between 2009 and 2011 and examined social, structural and individual factors influencing availability among community-recruited samples of IDUs in Bangkok. Availability was measured in three levels: immediate (available in ≤10 min); moderate (available in 10-90 min); and delayed (available in >90 min; our reference category). The analyses included 718 IDUs, including 165 (23.0%) women. Controlling for changes in participant characteristics between assessments, and in a period of constant nominal illicit drug prices, moderate availability of all substances increased significantly between 2009 and 2011, with adjusted odds ratios ranging between 2.36 (illicit methadone) and 4.61 (crystal methamphetamine) (all pdrug suppression efforts, the availability of illicit drugs among IDUs in Bangkok increased significantly between 2009 and 2011. The findings raise concern about the overreliance on drug law enforcement-based approaches and point to the need for greater investment in evidence-based drug policies. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  8. Drug induced acute kidney injury: an experimental animal study

    International Nuclear Information System (INIS)

    Khan, M.W.A.; Khan, B.T.; Qazi, R.A.; Ashraf, M.; Waqar, M.

    2017-01-01

    Objective: To assess the extent of drug induced nephrotoxicity in laboratory animals for determining the role and extent of iatrogenic kidney damage in patients exposed to nephrotoxic drugs in various clinical setups. Study Design: Randomized control trail. Place and Duration of study: Pharmacology department and animal house of Army Medical College from Jan 2011 to Aug 2011. Material and Methods: Thirty six mixed breed rabbits were used in this study. Animals were randomly divided into six groups consisting of six rabbits in each. Groups were named A, B, C, D, E and F. Group A was control group. Group B was given 0.9% normal saline. Group C rabbits were given acute nephrotoxic single dose of amphotericin B deoxycholate. Group D received 0.9% normal saline 10ml/kg followed by amphotericin B infusion. Group E was injected acute nephrotoxic regimen of cyclosporine and amphotericin B infusion. Group F received saline loading along with acute nephrotoxic regimen of cyclosporine and amphotericin B infusion. Results: Biochemical and histopathological analysis showed significant kidney injury in rabbits exposed to acute nephrotoxic doses of amphotericin B and cyclosporine. Toxicity was additive when the two drugs were administered simultaneously. Group of rabbits with saline loading had significantly lesser kidney damage. Conclusion: Iatrogenic acute kidney damage is a major cause of morbidity in experimental animals exposed to such nephrotoxic drugs like amphotericin B and cyclosporine, used either alone or in combination. Clinical studies are recommended to assess the extent of iatrogenic renal damage in patients and its economic burden. Efficient and cost effective protective measure may be adopted in clinical setups against such adverse effects. (author)

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

    Science.gov (United States)

    El Rawas, Rana; Saria, Alois

    2016-03-01

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

  10. 76 FR 50220 - Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye...

    Science.gov (United States)

    2011-08-12

    ... per test from 6 to 3. The Animal Welfare Act (7 U.S.C. 2131 et seq) and the Public Health Service (PHS....niehs.nih.gov/go/167 . 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...

  11. Toxicity studies of drugs and chemicals in animals: An overview

    OpenAIRE

    S. Saganuwan

    2017-01-01

    Toxicity study is the investigation of either short or long-term toxic effects of a drug or chemical on animals. The toxicity is dose-dependent as asserted by Paracelsus over 500 years ago. However, short-term toxic effect is determined using median lethal dose (LD50) first introduced by Trevan in 1927 and revised many times. Presently there is a growing preponderance of rejection of scientific papers on acute toxicity study, simply because of the belief that in the current hazard and safety ...

  12. 21 CFR 516.125 - Investigational use of minor species new animal drugs to support indexing.

    Science.gov (United States)

    2010-04-01

    ... for investigational use only in laboratory animals or for tests in vitro in support of index listing... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Investigational use of minor species new animal... DRUGS FOR MINOR USE AND MINOR SPECIES Index of Legally Marketed Unapproved New Animal Drugs for Minor...

  13. 76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

    Science.gov (United States)

    2011-01-18

    ... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone AGENCY...) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug....O. Box 324-12, Tyler, TX 75703 has informed FDA that it has transferred ownership of, and all rights...

  14. 75 FR 16001 - New Animal Drugs; Removal of Obsolete and Redundant Regulations

    Science.gov (United States)

    2010-03-31

    ... drug-resistant bacteria associated with these animals, was obsolete as FDA had a new strategy and... on any approved new animal drugs, or to cause any approved new animal drug to lose its marketing ability or experience a loss of sales. C. Regulatory Flexibility Analysis The Regulatory Flexibility Act...

  15. Animals on drugs: understanding the role of pharmaceutical companies in the animal-industrial complex.

    Science.gov (United States)

    Twine, Richard

    2013-12-01

    In this paper I revisit previous critiques that I have made of much, though by no means all, bioethical discourse. These pertain to faithfulness to dualistic ontology, a taken-for-granted normative anthropocentrism, and the exclusion of a consideration of how political economy shapes the conditions for bioethical discourse (Twine Medicine, Health Care and Philosophy 8(3):285-295, 2005; International Journal of Sociology of Agriculture and Food 16(3):1-18, 2007, 2010). Part of my argument around bioethical dualist ontology is to critique the assumption of a division between the "medical" (human) and "agricultural" (nonhuman) and to show various ways in which they are interrelated. I deepen this analysis with a focus on transnational pharmaceutical companies, with specific attention to their role in enhancing agricultural production through animal drug administration. I employ the topical case of antibiotics in order to speak to current debates in not only the interdisciplinary field of bioethics but also that of animal studies. More generally, the animal-industrial complex (Twine Journal for Critical Animal Studies 10(1):12-39, 2012) is underlined as a highly relevant bioethical object that deserves more conceptual and empirical attention.

  16. 76 FR 79195 - Animal Drug User Fee Act; Reopening of the Comment Period

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0656] Animal Drug User Fee Act; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS... notice, FDA requested comments on the Animal Drug User Fee Act (ADUFA) program to date and solicited...

  17. Availability of new drugs and Americans' ability to work.

    Science.gov (United States)

    Lichtenberg, Frank R

    2005-04-01

    The objective of this work was the investigation of the extent to which the introduction of new drugs has increased society's ability to produce goods and services by increasing the number of hours worked per member of the working-age population. Econometric models of ability-to-work measures from data on approximately 200,000 individuals with 47 major chronic conditions observed throughout a 15-year period (1982-1996) were estimated. Under very conservative assumptions, the estimates indicate that the value of the increase in ability to work attributable to new drugs is 2.5 times as great as expenditure on new drugs. The potential of drugs to increase employee productivity should be considered in the design of drug-reimbursement policies. Conversely, policies that broadly reduce the development and utilization of new drugs may ultimately reduce our ability to produce other goods and services.

  18. Drugs to foster kidney regeneration in experimental animals and humans.

    Science.gov (United States)

    Gagliardini, Elena; Benigni, Ariela

    2014-01-01

    The incidence of kidney diseases is increasing worldwide and they are emerging as a major public health problem. Once mostly considered inexorable, renal disease progression can now be halted and lesions can even regress with drugs such as angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II type I receptor blockers, indicating the possibility of kidney repair. The discovery of renal progenitor cells lining the Bowman capsule of adult rat and human kidneys has shed light on the mechanism of repair by ACEi. Parietal progenitors are a reservoir of cells that contribute to podocyte turnover in physiological conditions. In the early phases of renal disease these progenitors migrate chaotically and subsequently proliferate, accumulating in Bowman's space. The abnormal behavior of parietal progenitors is sustained by the activation of CXCR4 receptors in response to an increased production of the chemokine SDF-1 by podocytes activated by the inflammatory environment. Ang II, via the AT1 receptor, also contributes to progenitor cell proliferation. The CXCR4/SDF-1 and Ang II/AT1 receptor pathogenic pathways both pave the way for lesion formation and subsequent sclerosis. ACEi normalize the CXCR4 and AT1 receptor expression on progenitors, limiting their proliferation, concomitant with the regression of hyperplastic lesions in animals, and in a patient with crescentic glomerulopathy. Understanding the molecular and cellular determinants of regeneration triggered by renoprotective drugs will reveal novel pathways that might be challenged or targeted by pharmacological therapy. © 2014 S. Karger AG, Basel.

  19. 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

  20. Drug Interactions between some antiepileptic and certain hypocholesterolaemic drugs in irradiated animals

    International Nuclear Information System (INIS)

    Shaaban, D.M.L.

    2015-01-01

    Drug Interactions between antiepileptic drug such as phenytoin and certain hypercholesterolaemia drug namely rosuvastatin were investigated on several biological parameters. Phenytoin (60 mg/kg i.p) and rosuvastatin (1.25 mg/kg i.p) were given either alone and in combination to normal and irradiated animals to investigate drug interactions between the test drugs. Anticonvulsant activity was evaluated using pentylenetetrazole in a dose (80 mg/kg i.p) in normal and irradiated mice. Brain neurotransmitters (glutamate and GABA) were investigated. Lipid profile (total cholesterol (TC), Triacylglycerol (TG), High density lipoprotein-cholesterol (HDL-C) and low density lipoprotein- cholesterol (LDL-C) were determined. Liver functions such as serum Aspartate amino transferase (AST) and serum alanine amino transferase (ALT) were also estimated. Oxidative stress bio markers namely serum malondialdehyde (MDA), serum nitric oxide (NO) and blood superoxide dismutase activity (SOD) were studied. Histopathological examinations of brain and liver tissues were performed. Administration of phenytoin concurrently with rosuvastatin is not recommended in patients receiving radiotherapy as dangerous side effects on liver functions and lipid profile may occur. The interactions between the two drugs in normal rats improve liver functions and lipid peroxidation. Apart from the action of the combination on total cholesterol, it improves lipid profile pattern. Rosuvastatin administration in combination with phenytoin may have additive anticonvulsant activity.

  1. 75 FR 66304 - New Animal Drugs; Change of Sponsor; Monensin Blocks

    Science.gov (United States)

    2010-10-28

    ... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Monensin Blocks AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... 64116, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 118...

  2. 77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

    Science.gov (United States)

    2012-09-26

    .... FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment... its regulations relating to records and reports for approved antimicrobial new animal drugs. The... obtaining additional data and information about the extent of antimicrobial drug use in food-producing...

  3. 21 CFR 558.15 - Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals.

    Science.gov (United States)

    2010-04-01

    ... use of antibiotics in animal feeds. All persons or firms previously marketing identical, related, or... nitrofuran drugs, if marketing is to continue during the interim. New animal drug entities with antibacterial... assessing the effect of the subtherapeutic use of the drug in feed on the salmonella reservoir in the target...

  4. The Use of Herbal Drugs in Organic Animal Production: The Case of Ethnoveterinary Medicine in Central Anatolia Region

    Directory of Open Access Journals (Sweden)

    Çağrı Çağlar Sinmez

    2017-12-01

    Full Text Available Organic animal production is a natural breeding system in which animal health is protected by giving priority to alternative medicines and treatment as needed by applying appropriate management and feeding methods based on the physiological requirements of animals. Increasing numbers of strains resistant to antibiotics and antiparasitic drugs used in animal breeding have brought about the search for alternative herbal remedies that lead to drug residues in animal products and lead to important health problems in people consuming these products. In this study, it was aimed to evaluate the therapeutic and protective effects of herbal drugs used in organic animal production in ethnoveterinary medicine in the Central Anatolia Region. The material of the study collected as written and declared facts as well as visual data were obtained from animal breeders in the Central Anatolia Region. The results indicated that 30 herbal drugs were used for the treatment of internal diseases, surgical diseases, obstetric and gynecological problems and parasitic diseases in cattle, sheep, horse, poultry, bee, and dog species. Based on the evaluation of the facts that the use of all kinds of synthetic drugs, especially antibiotics, is prohibited or restricted in organic livestock, it can be said that natural herbal drugs instead of artificial substances will provide positive contributions in the protection and treatment of herd health.

  5. 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.

  6. Antitheilerial Chemical Drugs: A Review | Hayat | Bulletin of Animal ...

    African Journals Online (AJOL)

    Synthetic or semi synthetic chemical drugs were used for treatment of Theileria species. These drugs include antimalarial, trypanocides and antibiotics, antiviral, etc. The aim of this study was to over-view chemical drugs tested for treatment of theileriosis. Keywords: Theileria, treatment, chemical drug ...

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

    Science.gov (United States)

    2012-08-01

    .... currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0806] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2013 AGENCY: Food and Drug...

  8. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Science.gov (United States)

    2010-10-25

    ...] Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability AGENCY... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm...

  9. The use of drugs in food animals: benefits and risks

    National Research Council Canada - National Science Library

    .... The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease...

  10. 77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

    Science.gov (United States)

    2012-07-27

    ..., a listing of the target animals, indications, and production classes that are specified on the... in connection with the use of medically important antibiotics in food- producing animals. III... Limited Progress Addressing Antibiotic Use in Animals,'' GAO-11-801, Washington, DC, General Accounting...

  11. [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.

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

    DEFF Research Database (Denmark)

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

    2010-01-01

    Aim In Europe, the relationships between species richness and latitude differ for lentic (standing water) and lotic (running water) species. Freshwater animals are highly dependent on suitable habitat, and thus the distribution of available habitat should strongly influence large-scale patterns...... of species richness. We tested whether habitat availability can account for the differences in species richness patterns between European lentic and lotic freshwater animals. Location Europe. Methods We compiled occurrence data of 1959 lentic and 2445 lotic species as well as data on the amount of lentic...... for previously reported latitudinal patterns in species richness. For lotic species, richness declined with latitude, whereas there was no relationship between habitat availability and latitude. For lentic species, richness showed a hump-shaped relationship with latitude, whereas available habitat increased...

  13. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2013-11-06

    ...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...

  14. 78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N

    Science.gov (United States)

    2013-03-07

    ... Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and...-, 884-, or 1,768-milligram, or 4.42-gram capsules. (3) Conditions of use in dogs--(i) Amount. Administered capsules orally. Capsules containing 221 milligrams of n-butyl chloride are administered to dogs...

  15. 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.

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

    Directory of Open Access Journals (Sweden)

    YAN Zheng-juan

    2015-02-01

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

  17. 77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin...

    Science.gov (United States)

    2012-08-06

    ... Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug..., polymyxin B sulfate, prednisolone acetate) Otic Suspension to Elanco Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. Following these changes of sponsorship, Janssen...

  18. 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.

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

    Science.gov (United States)

    2012-10-02

    .... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0971...

  20. 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 is...

  1. Matrix Metalloproteinases Contribute to Neuronal Dysfunction in Animal Models of Drug Dependence, Alzheimer's Disease, and Epilepsy

    Directory of Open Access Journals (Sweden)

    Hiroyuki Mizoguchi

    2011-01-01

    Full Text Available Matrix metalloproteinases (MMPs and tissue inhibitors of metalloproteinases (TIMPs remodel the pericellular environment by regulating the cleavage of extracellular matrix proteins, cell surface components, neurotransmitter receptors, and growth factors that mediate cell adhesion, synaptogenesis, synaptic plasticity, and long-term potentiation. Interestingly, increased MMP activity and dysregulation of the balance between MMPs and TIMPs have also been implicated in various pathologic conditions. In this paper, we discuss various animal models that suggest that the activation of the gelatinases MMP-2 and MMP-9 is involved in pathogenesis of drug dependence, Alzheimer's disease, and epilepsy.

  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

    ... rights and interest in, abbreviated new animal drug application (ANADA) 200-472 for Fomepizole for... [Docket No. FDA-2012-N-0002] New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Change of.... SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a...

  3. 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 person...

  4. 78 FR 46955 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... courier such as Federal Express or United Parcel Service, the courier may deliver the check and printed... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007] Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2014 AGENCY: Food and Drug...

  5. 75 FR 20268 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol

    Science.gov (United States)

    2010-04-19

    ... 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under... use in dogs and cats--(1) Amount. The drug is administered by intravenous injection as follows: (i) Dogs. For induction of general anesthesia without the use of preanesthetics the dosage is 5.5 to 7.0 mg...

  6. 76 FR 53050 - New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin...

    Science.gov (United States)

    2011-08-25

    ... with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and... in 21 CFR Parts 520 and 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act...) * * * (c) [Reserved] (d) Conditions of use--(1) Dogs--(i) Amount. Administer 2 to 40 mg (up to 120 mg in...

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

    Science.gov (United States)

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

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. 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

  9. 21 CFR 511.1 - New animal drugs for investigational use exempt from section 512(a) of the act.

    Science.gov (United States)

    2010-04-01

    ... in animals used only for laboratory research purposes under this exemption shall use due diligence to... diligence to assure that the new animal drug or animal feed containing a new animal drug will actually be... animal administered any unlicensed experimental veterinary biological product regulated under the viruses...

  10. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  11. Drug availability and health facility usage in a Bamako Initiative and ...

    African Journals Online (AJOL)

    Background: The availability of drugs on a continuous basis is paramount to the success of any health care system. The Bamako Initiative (BI) had provision of essential drugs as one of its key thrusts in order to improve the utilization of health facilities. This study compared the perceived availability of essential drugs and ...

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

    Science.gov (United States)

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

    2007-03-27

    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. 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. 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 affordability, promotion of generic medicines and improved availability

  13. Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia

    Science.gov (United States)

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

    2007-01-01

    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 affordability

  14. 78 FR 21058 - New Animal Drugs; Change of Sponsor

    Science.gov (United States)

    2013-04-09

    ...-803 TASK (dichlovos) Dog Anthelmintic. 35-918 EQUIGARD (dichlovos). 38-200 MEDAMYCIN (oxytetracycline..., under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food...

  15. 76 FR 17776 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications...

    Science.gov (United States)

    2011-03-31

    ...'s Sponsor (established name of drug) drug labeler code) Roche Vitamins, Inc., 45 Waterview Blvd.... Medicator TS-40 Premix (tylosin phosphate/ sulfamethazine). Pegasus Laboratories, Inc., 8809 Ely Rd., NADA... Laboratories, Inc., 100 Nancy Dr., NADA 108-487, DEC Tabs 520.622a (015579). Belle Plaine, MN 56011...

  16. Double-observer line transect surveys with Markov-modulated Poisson process models for animal availability.

    Science.gov (United States)

    Borchers, D L; Langrock, R

    2015-12-01

    We develop maximum likelihood methods for line transect surveys in which animals go undetected at distance zero, either because they are stochastically unavailable while within view or because they are missed when they are available. These incorporate a Markov-modulated Poisson process model for animal availability, allowing more clustered availability events than is possible with Poisson availability models. They include a mark-recapture component arising from the independent-observer survey, leading to more accurate estimation of detection probability given availability. We develop models for situations in which (a) multiple detections of the same individual are possible and (b) some or all of the availability process parameters are estimated from the line transect survey itself, rather than from independent data. We investigate estimator performance by simulation, and compare the multiple-detection estimators with estimators that use only initial detections of individuals, and with a single-observer estimator. Simultaneous estimation of detection function parameters and availability model parameters is shown to be feasible from the line transect survey alone with multiple detections and double-observer data but not with single-observer data. Recording multiple detections of individuals improves estimator precision substantially when estimating the availability model parameters from survey data, and we recommend that these data be gathered. We apply the methods to estimate detection probability from a double-observer survey of North Atlantic minke whales, and find that double-observer data greatly improve estimator precision here too. © 2015 The Authors Biometrics published by Wiley Periodicals, Inc. on behalf of International Biometric Society.

  17. 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 & ...

  18. 76 FR 11330 - Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug...

    Science.gov (United States)

    2011-03-02

    ... Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the.... * * * * * (b) * * * (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses. * * * * * PART 558--NEW...

  19. Animal models of pain and migraine in drug discovery

    DEFF Research Database (Denmark)

    Munro, Gordon; Jansen-Olesen, Inger; Olesen, Jes

    2017-01-01

    of the most commonly used models and methods employed within 'pain and migraine' drug development will be presented. Recent advances within these disciplines suggest that, with the addition of a few extra carefully chosen ancillary models and/or endpoints, the relative value in terms of resources used...

  20. 77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

    Science.gov (United States)

    2012-03-19

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

  1. 76 FR 81806 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Science.gov (United States)

    2011-12-29

    .... FDA-2011-N-0003] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... solution of ivermectin. DATES: This rule is effective December 29, 2011. FOR FURTHER INFORMATION CONTACT... ANADA 200-318 for [[Page 81807

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

    Science.gov (United States)

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

    2012-01-01

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

  3. 75 FR 54017 - New Animal Drugs; Change of Sponsor; Penicillin G Benzathine and Penicillin G Procaine Suspension...

    Science.gov (United States)

    2010-09-03

    ... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Penicillin G Benzathine and Penicillin G... animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from..., Syracuse, NY 13201, has informed FDA that it has transferred ownership of, and all rights and interest in...

  4. 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. Copyright 2009. Published by Elsevier Inc.

  5. 77 FR 60622 - New Animal Drugs; Change of Sponsor's Address; Monensin; Spinosad; Tilmicosin

    Science.gov (United States)

    2012-10-04

    ... swine the sole ration for respiratory disease 21-day period, associated with beginning Actinobacillus... dairy cattle: For 14 days to provide the control of 12.5 milligrams/ bovine respiratory kilogram/head... drug residues least 10 percent of in milk. This drug the animals in the product is not group. approved...

  6. 78 FR 66263 - New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin

    Science.gov (United States)

    2013-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride... transferred ownership of, and all rights and interest in, ANADA 200-555 for LIBREVIA (carprofen) Soft Chewable...

  7. 78 FR 30197 - Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin

    Science.gov (United States)

    2013-05-22

    ...-0002] Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin AGENCY: Food and Drug Administration...- Tallaght, Dublin Oral Drops. 940. 24, Ireland. 200-551........ Putney, Inc., 400 Enrofloxacin Original....812 Enrofloxacin. (a) Specifications. Each tablet contains 22.7, 68.0, or 136.0 milligrams (mg) of...

  8. 76 FR 3488 - Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

    Science.gov (United States)

    2011-01-20

    .... FDA-2010-N-0002] Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin... combination drug injectable solution containing oxytetracycline and flunixin meglumine in cattle. [[Page 3489... veterinary prescription use of HEXASOL (oxytetracycline and flunixin meglumine) Injection for the treatment...

  9. 75 FR 21162 - Certain Other Dosage Form New Animal Drugs; Detomidine

    Science.gov (United States)

    2010-04-23

    .... FDA-2010-N-0002] Certain Other Dosage Form New Animal Drugs; Detomidine AGENCY: Food and Drug... NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation... prescription use of DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of horses. The...

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

    Science.gov (United States)

    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 rodent diets. The only treatment-related changes occurred with vitamin A and peroxide. The typical and high-end doses of gamma irradiation reduced the vitamin A level of the cat diet to 42% and 30% of the untreated value, respectively—levels below recommended allowances for growth and reproduction. Only the higher irradiation dose reduced vitamin A in the rodent diet, and neither dose altered the canine diet. Pasteurization reduced the vitamin A content of the cat diet to 50% of its original level, which was within the recommended level for this species. Irradiation increased the peroxide content of all 3 animal diets: by approximately 11-fold with the typical dose and by 14- to 25-fold with the high-end dose. Therefore gamma irradiation can have profound, selective effects on the vitamin A and peroxide contents of dry diets, and caution is advised when feeding such diets long-term and exclusively to SPF animals, particularly cats. Furthermore, pasteurization (with its fewer deleterious effects) may represent an alternative method of decontaminating diets for rodents, dogs, and cats. PMID:19049256

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

    OpenAIRE

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

    2011-01-01

    Background: Over-the-counter (OTC)-drugs are available without a doctor’s prescription. Whereas this is convenient for consumers, it also makes consumers responsible for appropriate and safe use. European countries differ considerably when it comes to the availability of OTC-drugs. In the Netherlands, the availability of OTC-drugs changed in 2007. A limited number of OTC-drugs can now be sold outside pharmacies and chemistries, mainly in supermarkets. This had led to a discussion on whether c...

  12. The availability and affordability of orphan drugs for rare diseases in China.

    Science.gov (United States)

    Gong, Shiwei; Wang, Yingxiao; Pan, Xiaoyun; Zhang, Liang; Huang, Rui; Chen, Xin; Hu, Juanjuan; Xu, Yi; Jin, Si

    2016-02-27

    Orphan drugs are intended to treat, prevent or diagnose rare diseases. In recent years, China healthcare policy makers and patients have become increasingly concerned about orphan drug issues. However, very few studies have assessed the availability and affordability of orphan drugs for rare diseases in China. The aim of this study was to provide an overview of the availability and affordability of orphan drugs in China and to make suggestions to improve patient access to orphan drugs. Two components of the availability of orphan drugs were examined. Market availability was assessed by the extent to which orphan drugs were marketed in China with a comparison to orphan drugs in international markets, such as the U.S., EU and Japan. We conducted surveys and collected data from 24 tertiary public hospitals in China to measure hospital-level availability of orphan drugs. The affordability of orphan drugs was calculated using hospital dispensary prices and was expressed as days of average daily income required for the cost of a course of treatment. Affordability was also analyzed under the Chinese basic medical insurance system. Orphan drugs approved in the U.S., EU and Japan had 37.8%, 24.6% and 52.4% market availability in China, respectively. Median availability of 31 orphan drugs surveyed at the 24 tertiary public hospitals was 20.8% (very low). Within a periodic treatment course, the average treatment cost of 23 orphan drugs is approximately 4, 843. 5 USD, which equates to 505.6 days of per capita net income for an urban resident with a middle income (187.4 days for a high-income urban resident) or 1,582.8 days's income for a rural resident with a middle income (657.2 days for a high-income rural resident). Except for homoharringtonine, 22 orphan drugs for 14 rare diseases were unaffordable for the most of residents in China. With 5% out-of-pocket expenses, only three generics could be afforded by middle-income residents, whereas seven drugs for high-income urban

  13. An orally available, small-molecule polymerase inhibitor shows efficacy against a lethal morbillivirus infection in a large animal model.

    Science.gov (United States)

    Krumm, Stefanie A; Yan, Dan; Hovingh, Elise S; Evers, Taylor J; Enkirch, Theresa; Reddy, G Prabhakar; Sun, Aiming; Saindane, Manohar T; Arrendale, Richard F; Painter, George; Liotta, Dennis C; Natchus, Michael G; von Messling, Veronika; Plemper, Richard K

    2014-04-16

    Measles virus is a highly infectious morbillivirus responsible for major morbidity and mortality in unvaccinated humans. The related, zoonotic canine distemper virus (CDV) induces morbillivirus disease in ferrets with 100% lethality. We report an orally available, shelf-stable pan-morbillivirus inhibitor that targets the viral RNA polymerase. Prophylactic oral treatment of ferrets infected intranasally with a lethal CDV dose reduced viremia and prolonged survival. Ferrets infected with the same dose of virus that received post-infection treatment at the onset of viremia showed low-grade viral loads, remained asymptomatic, and recovered from infection, whereas control animals succumbed to the disease. Animals that recovered also mounted a robust immune response and were protected against rechallenge with a lethal CDV dose. Drug-resistant viral recombinants were generated and found to be attenuated and transmission-impaired compared to the genetic parent virus. These findings may pioneer a path toward an effective morbillivirus therapy that could aid measles eradication by synergizing with vaccination to close gaps in herd immunity due to vaccine refusal.

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

    NARCIS (Netherlands)

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

    2011-01-01

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

  15. Availability, price and affordability of anti-tuberculosis drugs in Europe: a TBNET survey

    NARCIS (Netherlands)

    Günther, Gunar; Gomez, Gabriela B.; Lange, Christoph; Rupert, Stephan; van Leth, Frank; Andrejak, Claire; Pieridou-Bagatzouni, Despo; Anderson, Aase Bengard; Bojovic, Olivera; Bothamley, Graham; Bruchfeld, Judith; Codecasa, Luigi R.; Danilovits, Manfred; Davidaviciene, Edita; Dalemo, Paulina; Dimopoulos, Giorgos; Duarte, Raquel; Hafizi, Hasan; Horvath, Ildiko; Eyuboglu, Fusun; Ibraim, Elmira; Jankovic, Mateja; Kan, Boris; Kopecka, Emilia; Kruczak, Katarzyna; Kutsyna, Galyna; de lange, Wiel; Leimane, Vaira; Mack, Ulrich; Manzano, Juan Ruiz; Markova, Roumania; McDonald, Colm; McLaughlin, Anne-Marie; Mulliqi, Gjyle; Muylle, Inge; Pesut, Dragica; Polcova, Veronika; Rumetshofer, Rudolf; Rusu, Doina; Skrahina, Alena; Spiric, Nicolina; Solovic, Ivan; Svetina-Sorli, Petra; Vasakova, Martina; Vasankari, Tuula; Viiklepp, Piret; Wirz, Gil; Zakoska, Maja; Zellweger, Jean-Pierre

    2015-01-01

    Data on availability and cost of anti-tuberculosis (TB) drugs in relation to affordability at national level are scarce. We performed a cross-sectional study on availability and cost of anti-TB drugs at major TB-reference centres in 37 European countries. Costs of standardised treatment regimens

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-10-01

    Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices. Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition. Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46 and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47. Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

  17. Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label.

    Science.gov (United States)

    Baldrick, Paul

    2018-01-01

    Juvenile animal testing has become an established part of drug development to support safe clinical use in the human pediatric population and for eventual drug product label use. A review of European Paediatric Investigation Plan decisions showed that from 2007 to mid-2017, 229 drugs had juvenile animal work requested, almost exclusively incorporating general toxicology study designs, in rat (57.5%), dog (8%), mouse (4.5%), monkey (4%), pig (2%), sheep (1%), rabbit (1%), hamster (0.5%), and species not specified (21.5%). A range of therapeutic areas were found, but the most common areas were infectious diseases (15%), endocrinology (13.5%), oncology (13%), neurology (11%), and cardiovascular diseases (10%). Examination of major clinical indications within these therapeutic areas showed some level of consistency in the species of choice for testing and the pediatric age that required support. Examination of juvenile animal study findings presented in product labels raises questions around how useful the data are to allow prescribing the drug to a child. It is hopeful that the new ICH S11 guideline "Nonclinical Safety Testing in Support of Development of Pediatric Medicines" currently in preparation will aid drug developers in clarifying the need for juvenile animal studies as well as in promoting a move away from toxicology studies with a conventional design. This would permit more focused testing to examine identified areas of toxicity or safety concerns and clarify the presentation/interpretation of juvenile animal study findings for proper risk assessment by a drug prescriber.

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

    Science.gov (United States)

    Zucker, Irving

    2017-06-01

    Many drugs with unknown safety profiles are administered to pregnant women, placing their offspring at risk. I assessed whether behavioral outcomes for children exposed during gestation to antidepressants, anxiolytics, anti-seizure, analgesic, anti-nausea and sedative medications can be predicted by more extensive animal studies than are part of the FDA approval process. Human plus rodent data were available for only 8 of 33 CNS-active drugs examined. Similar behavioral and cognitive deficits, including autism and ADHD emerged in human offspring and in animal models of these disorders after exposure to fluoxetine, valproic acid, carbamazepine, phenytoin, phenobarbital and acetaminophen. Rodent data helpful in identifying and predicting adverse effects of prenatal drug exposure in children were first generated many years after drugs were FDA-approved and administered to pregnant women. I recommend that enhanced behavioral testing of rodent offspring exposed to drugs prenatally should begin during preclinical drug evaluation and continue during Phase I clinical trials, with findings communicated to physicians and patients in drug labels. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Antimicrobial drug use in food-producing animals and associated human health risks: what, and how strong, is the evidence?

    Science.gov (United States)

    Hoelzer, Karin; Wong, Nora; Thomas, Joe; Talkington, Kathy; Jungman, Elizabeth; Coukell, Allan

    2017-07-04

    Antimicrobial resistance is a public health threat. Because antimicrobial consumption in food-producing animals contributes to the problem, policies restricting the inappropriate or unnecessary agricultural use of antimicrobial drugs are important. However, this link between agricultural antibiotic use and antibiotic resistance has remained contested by some, with potentially disruptive effects on efforts to move towards the judicious or prudent use of these drugs. The goal of this review is to systematically evaluate the types of evidence available for each step in the causal pathway from antimicrobial use on farms to human public health risk, and to evaluate the strength of evidence within a 'Grades of Recommendations Assessment, Development and Evaluation'(GRADE) framework. The review clearly demonstrates that there is compelling scientific evidence available to support each step in the causal pathway, from antimicrobial use on farms to a public health burden caused by infections with resistant pathogens. Importantly, the pathogen, antimicrobial drug and treatment regimen, and general setting (e.g., feed type) can have significant impacts on how quickly resistance emerges or spreads, for how long resistance may persist after antimicrobial exposures cease, and what public health impacts may be associated with antimicrobial use on farms. Therefore an exact quantification of the public health burden attributable to antimicrobial drug use in animal agriculture compared to other sources remains challenging. Even though more research is needed to close existing data gaps, obtain a better understanding of how antimicrobial drugs are actually used on farms or feedlots, and quantify the risk associated with antimicrobial use in animal agriculture, these findings reinforce the need to act now and restrict antibiotic use in animal agriculture to those instances necessary to ensure the health and well-being of the animals.

  20. [Affordability and availability of drugs for treatment of chronic diseases in the public health care system].

    Science.gov (United States)

    Helfer, Ana Paula; Camargo, Aline Lins; Tavares, Noemia Urruth Leão; Kanavos, Panos; Bertoldi, Andréa Dâmaso

    2012-03-01

    To assess the affordability by workers of drugs used for treatment of chronic diseases, as well as the availability of the reference, similar, or generic forms of these drugs in the public health care system. We employed the methodology recommended by the World Health Organization (WHO) and Health Action International (HAI) for the standardized collection of information on selling prices in the private sector and availability in the public health care system of drugs in six cities in the state of Rio Grande do Sul, Brazil. Data were collected from November 2008 to January 2009. Affordability was estimated as the number of salary days required for a worker receiving the national minimum wage to buy, in a private pharmacy, the amount of medication required for one month of treatment. Availability was assessed by the presence of these drugs in public health care system facilities. Twenty-two public facilities and 30 private pharmacies were studied. Of 21 drugs used for the treatment of seven chronic disorders, only nine were available free of charge in the six cities. Mean availability ranged from 83.3% (São Leopoldo) to 97.6% (Caxias do Sul). Affordability ranged from 0.4 to 10.5 salary days for reference drugs, 0.2 to 8.4 salary days for similar drugs, and 0.3 to 3.8 salary days for generic drugs. The overall availability of the drugs surveyed was higher than the 80% recommended by WHO. However, some treatments were not available, or had limited availability in the public system. Concerning affordability, the number of salary days required to buy these drugs may affect the continuation of drug treatments for chronic diseases.

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

    Directory of Open Access Journals (Sweden)

    Zvyagintseva O.V.

    2015-05-01

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

  2. Mixing pleasures: review of the effects of drugs on sex behavior in humans and animal models.

    Science.gov (United States)

    Frohmader, Karla S; Pitchers, Kyle K; Balfour, Margaret E; Coolen, Lique M

    2010-06-01

    Drugs of abuse act on the brain circuits mediating motivation and reward associated with natural behaviors. There is ample evidence that drugs of abuse impact male and female sexual behavior. First, the current review discusses the effect of drugs of abuse on sexual motivation and performance in male and female humans. In particular, we discuss the effects of commonly abused drugs including psychostimulants, opiates, marijuana/THC, and alcohol. In general, drug use affects sexual motivation, arousal, and performance and is commonly associated with increased sexual risk behaviors. Second, studies on effects of systemic administration of drugs of abuse on sexual behavior in animals are reviewed. These studies analyze the effects on sexual performance and motivation but do not investigate the effects of drugs on risk-taking behavior, creating a disconnect between human and animal studies. For this reason, we discuss two studies that focus on the effects of alcohol and methamphetamine on inhibition of maladaptive sex-seeking behaviors in rodents. Third, this review discusses potential brain areas where drugs of abuse may be exerting their effect on sexual behavior with a focus on the mesolimbic system as the site of action. Finally, we discuss recent studies that have brought to light that sexual experience in turn can affect drug responsiveness, including a sensitized locomotor response to amphetamine in female and male rodents as well as enhanced drug reward in male rats. Copyright 2009 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Claudio ePalmieri

    2011-11-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2006-08-15

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

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

    Directory of Open Access Journals (Sweden)

    Y.J. Mousa

    2017-06-01

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

  6. A New Strategy for Deleting Animal drugs from Traditional Chinese Medicines based on Modified Yimusake Formula.

    Science.gov (United States)

    Wang, Jinghui; Li, Yan; Yang, Yinfeng; Chen, Xuetong; Du, Jian; Zheng, Qiusheng; Liang, Zongsuo; Wang, Yonghua

    2017-05-04

    Traditional Chinese medicine (TCM), such as Uyghur Medicine (UM) has been used in clinical treatment for many years. TCM is featured as multiple targets and complex mechanisms of action, which is normally a combination of medicinal herbs and sometimes even contains certain rare animal medicinal ingredients. A question arises as to whether these animal materials can be removed replaced from TCM applications due to their valuable rare resources or animal ethics. Here, we select a classical UM Yimusake formula, which contains 3 animal drugs and other 8 herbs, and has got wealthy experience and remarkable achievements in treating erectile dysfunction (ED) in China. The active components, drug targets and therapeutic mechanisms have been comprehensively analyzed by systems-pharmacology methods. Additionally, to validate the inhibitory effects of all candidate compounds on their related targets, in vitro experiments, computational analysis and molecular dynamics simulations were performed. The results show that the modified, original and three animal materials display very similar mechanisms for an effective treatment of ED, indicating that it is quite possible to remove these three animal drugs from the original formula while still keep its efficiency. This work provides a new attempt for deleting animal materials from TCM, which should be important for optimization of traditional medicines.

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

    Science.gov (United States)

    Edery, E G

    2017-05-27

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

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

    Science.gov (United States)

    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 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

  9. Availability of emergency drugs and equipment in general and specialist dental settings in Babol, Iran.

    Science.gov (United States)

    Mehdizadeh, Mohammad; Nosrati, Kamran; Hamzeh, Mahtab

    2014-11-01

    Medical emergencies can frequently happen in dental settings and it is critical to outfit the clinic by emergency drugs and equipment. The aim of this study was to evaluate the emergency drugs and equipment in general and specialist dental settings in Babol, Iran. A questionnaire containing closed ended questions about the available emergency drugs and equipment was used in this descriptive-analytical study. Data were subjected to descriptive analysis using SPSS 18.0 to identify the most frequent drugs and equipment. Chi-square and t-test were used to evaluate the correlation between the variables. p < 0.05 was considered statistically significant. One hundred and twelve dentists answered the questionnaire. The most available drug and equipment were epinephrine (67%) and single use syringe (81.3%) respectively. Significant correlation was found between degree of education and availability of first group of emergency drugs and between sex and possession of second group of emergency equipment (p < 0.05). Degree of availability of emergency drugs and equipment was moderate to low and training about emergencies should be included in the didactic topics of universities and workshops. Information about emergency drug and equipment would help to manage the unwanted emergency situations.

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

    Science.gov (United States)

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

    2009-09-01

    Drug-addicted individuals show 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 drug users. This article reviews this literature, with a particular focus on the effects of chronic cocaine administration, which have been most thoroughly characterized. The potential mechanisms of these effects are described in terms of drug-induced neural alterations in ventral striatal and prefrontal cortical brain systems. Some implications of this research for pharmacological treatment of drug-induced increases in impulsive choice are discussed, along with suggestions for future research in this area.

  11. Modeling the development of drug addiction in male and female animals.

    Science.gov (United States)

    Lynch, Wendy J

    2018-01-01

    An increasing emphasis has been placed on the development and use of animal models of addiction that capture defining features of human drug addiction, including escalation/binge drug use, enhanced motivation for the drug, preference for the drug over other reward options, use despite negative consequences, and enhanced drug-seeking/relapse vulnerability. The need to examine behavior in both males and females has also become apparent given evidence demonstrating that the addiction process occurs differently in males and females. This review discusses the procedures that are used to model features of addiction in animals, as well as factors that influence their development. Individual differences are also discussed, with a particular focus on sex differences. While no one procedure consistently produces all characteristics, different models have been developed to focus on certain characteristics. A history of escalating/binge patterns of use appears to be critical for producing other features characteristic of addiction, including an enhanced motivation for the drug, enhanced drug seeking, and use despite negative consequences. These characteristics tend to emerge over abstinence, and appear to increase rather than decrease in magnitude over time. In females, these characteristics develop sooner during abstinence and/or following less drug exposure as compared to males, and for psychostimulant addiction, may require estradiol. Although preference for the drug over other reward options has been demonstrated in non-human primates, it has been more difficult to establish in rats. Future research is needed to define the parameters that optimally induce each of these features of addiction in the majority of animals. Such models are essential for advancing our understanding of human drug addiction and its treatment in men and women. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. 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

  13. 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.

  14. 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.

  15. Critical overview of all available animal models for abdominal wall hernia research.

    Science.gov (United States)

    Vogels, R R M; Kaufmann, R; van den Hil, L C L; van Steensel, S; Schreinemacher, M H F; Lange, J F; Bouvy, N D

    2017-10-01

    Since the introduction of the first prosthetic mesh for abdominal hernia repair, there has been a search for the "ideal mesh." The use of preclinical or animal models for assessment of necessary characteristics of new and existing meshes is an indispensable part of hernia research. Unfortunately, in our experience there is a lack of consensus among different research groups on which model to use. Therefore, we hypothesized that there is a lack of comparability within published animal research on hernia surgery due to wide range in experimental setup among different research groups. A systematic search of the literature was performed to provide a complete overview of all animal models published between 2000 and 2014. Relevant parameters on model characteristics and outcome measurement were scored on a standardized scoring sheet. Due to the wide range in different animals used, ranging from large animal models like pigs to rodents, we decided to limit the study to 168 articles concerning rat models. Within these rat models, we found wide range of baseline animal characteristics, operation techniques, and outcome measurements. Making reliable comparison of results among these studies is impossible. There is a lack of comparability among experimental hernia research, limiting the impact of this experimental research. We therefore propose the establishment of guidelines for experimental hernia research by the EHS.

  16. 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

    2010-11-01

    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.

  17. 75 FR 26647 - Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution

    Science.gov (United States)

    2010-05-12

    .... FDA-2010-N-0002] Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution... are treated with a topical solution of ivermectin. DATES: This rule is effective May 12, 2010. FOR... ANADA 200-340 for PRIVERMECTIN (ivermectin), a topical solution used on cattle to control infestations...

  18. 76 FR 37814 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs...

    Science.gov (United States)

    2011-06-28

    ... laboratory studies with good laboratory practices, (4) name and address of each clinical investigator, (5... assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected... technology. New Animal Drugs for Investigational Uses--21 CFR Part 511 (OMB Control Number 0910-0117...

  19. 77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin

    Science.gov (United States)

    2012-12-31

    ..., and 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam... (enrofloxacin) adding treatment and Health Division, Injectable control of swine P.O. Box 390, Solution... Enrofloxacin. * * * * * (e) * * * (3) * * * (ii) Indications for use. For the treatment and control of swine...

  20. 76 FR 22610 - Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin

    Science.gov (United States)

    2011-04-22

    .... FDA-2011-N-0003] Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin AGENCY: Food... the indications for use of enrofloxacin solution in cattle, as a single injection, for the treatment... supplement to NADA 141-068 for BAYTRIL 100 (enrofloxacin), an injectable solution. The supplemental NADA...

  1. 78 FR 52852 - New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol

    Science.gov (United States)

    2013-08-27

    ..., 556, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol..., (enrofloxacin) approval as a Inc., 3200 Flavored generic copy Northline Ave., Antibacterial of NADA 140- suite...) to read as follows: Sec. 520.812 Enrofloxacin. (a) Specifications. Each tablet contains: (1) 22.7, 68...

  2. 78 FR 52536 - Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin...

    Science.gov (United States)

    2013-08-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. [email protected] . SUPPLEMENTARY INFORMATION: Phibro Animal Health Corp., 65 Challenger Rd., 3d Floor... Diethylcarbamazine Citrate Capsules used in dogs for the prevention of heartworm disease because the product is no...

  3. 76 FR 16533 - Certain Other Dosage Form New Animal Drugs; Detomidine; Correction

    Science.gov (United States)

    2011-03-24

    .... FDA-2010-N-0002] Certain Other Dosage Form New Animal Drugs; Detomidine; Correction AGENCY: Food and... paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal... conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to...

  4. Experimental protocols for behavioral imaging: seeing animal models of drug abuse in a new light.

    Science.gov (United States)

    Aarons, Alexandra R; Talan, Amanda; Schiffer, Wynne K

    2012-01-01

    Behavioral neuroimaging is a rapidly evolving discipline that represents a marriage between the fields of behavioral neuroscience and preclinical molecular imaging. This union highlights the changing role of imaging in translational research. Techniques developed for humans are now widely applied in the study of animal models of brain disorders such as drug addiction. Small animal or preclinical imaging allows us to interrogate core features of addiction from both behavioral and biological endpoints. Snapshots of brain activity allow us to better understand changes in brain function and behavior associated with initial drug exposure, the emergence of drug escalation, and repeated bouts of drug withdrawal and relapse. Here we review the development and validation of new behavioral imaging paradigms and several clinically relevant radiotracers used to capture dynamic molecular events in behaving animals. We will discuss ways in which behavioral imaging protocols can be optimized to increase throughput and quantitative methods. Finally, we discuss our experience with the practical aspects of behavioral neuroimaging, so investigators can utilize effective animal models to better understand the addicted brain and behavior.

  5. 77 FR 3653 - Import Tolerances for Residues of Unapproved New Animal Drugs in Food

    Science.gov (United States)

    2012-01-25

    ... find a safe import tolerance. It could look at toxicity and residue data and build in a conservative... drugs covered by import tolerances are manufactured under good manufacturing practices (GMP)-like... resistant bacteria in or on the target animal and the potential impact on human health. C. International...

  6. 75 FR 38699 - Implantation or Injectable Dosage Form New Animal Drugs; Propofol

    Science.gov (United States)

    2010-07-06

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

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

    Science.gov (United States)

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

    2016-01-01

    Accumulated research supports the idea that exercise could be an option of potential prevention and treatment for drug addiction. During the past few years, there has been increased interest in investigating of sex differences in exercise and drug addiction. This demonstrates that sex-specific exercise intervention strategies may be important for preventing and treating drug addiction in men and women. However, little is known about how and why sex differences are found when doing exercise-induced interventions for drug addiction. In this review, we included both animal and human that pulled subjects from a varied age demographic, as well as neurobiological mechanisms that may highlight the sex-related differences in these potential to assess the impact of sex-specific roles in drug addiction and exercise therapies. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Sex differences in drug addiction and response to exercise intervention: from human to animal studies

    Science.gov (United States)

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

    2015-01-01

    Accumulated research supports the idea that exercise could be an option of potential prevention and treatment for drug addiction. During the past few years, there has been increased interest in investigating of sex differences in exercise and drug addiction. This demonstrates that sex-specific exercise intervention strategies may be important for preventing and treating drug addiction in men and women. However, little is known about how and why sex differences are found when doing exercise-induced interventions for drug addiction. In this review, we included both animal and human that pulled subjects from a varied age demographic, as well as neurobiological mechanisms that may highlight the sex-related differences in these potential to assess the impact of sex-specific roles in drug addiction and exercise therapies. PMID:26182835

  9. Can currently available non-animal methods detect pre and pro-haptens? (QSAR2016)

    Science.gov (United States)

    Predictive testing to identify and characterise substances for their skin sensitisation potential has historically been based on animal tests such as the Local Lymph Node Assay (LLNA). In recent years, regulations in the cosmetics and chemicals sectors has provided a strong impe...

  10. Critical overview of all available animal models for abdominal wall hernia research

    NARCIS (Netherlands)

    Vogels, R.R.M.; R. Kaufmann (Ruth); L.C.L. van den Hil (Leontine); van Steensel, S.; M.H.F. Schreinemacher (Marc H.F.); J.F. Lange (Johan); N.D. Kannekens-Bouvy (Nicole)

    2017-01-01

    textabstractPurpose: Since the introduction of the first prosthetic mesh for abdominal hernia repair, there has been a search for the “ideal mesh.” The use of preclinical or animal models for assessment of necessary characteristics of new and existing meshes is an indispensable part of hernia

  11. Illicit Internet availability of drugs subject to recall and patient safety consequences.

    Science.gov (United States)

    Mackey, Tim K; Aung, Phyo; Liang, Bryan A

    2015-12-01

    Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. The World Wide Web. After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal "no prescription" marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site's compliance status with external monitoring bodies. Number of recalled drugs marketed as available for purchase on the Internet. We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website alibaba.com primarily as active pharmaceutical ingredient. Despite efforts in several countries to restrict access to these drugs or permanently remove

  12. Animals

    International Nuclear Information System (INIS)

    Skuterud, L.; Strand, P.; Howard, B.J.

    1997-01-01

    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)

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

    Science.gov (United States)

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

    2015-09-01

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

  14. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Science.gov (United States)

    2010-12-03

    ...] Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers... Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human...

  15. Microscopic identification of the remnant hair or feather of five animal drug components in Shenrongbian pill

    Directory of Open Access Journals (Sweden)

    Tingguo Kang

    2012-06-01

    Full Text Available A comparative study was performed to identify the microscopic characteristics of hair or feather in the five animal drug components contained in Shenrongbian pill. Penis et Testis Canis is 40±0.07 in the medulla index, with long circular, banana or triangular circular shaped medulla cells arranged in one line or network, and the hair cuticle is in imbrication (d, m and flat wave (p shape. Penis et Testis Equi is 66±0.10 in the medulla index, with ellipse, spindle or long strip-shaped medulla cells arranged in network, and the hair cuticle is in flat wave shape. Penis et Testis Bovis is 67±0.05 in the medulla index, with rectangle, spindle or polygon-shaped medulla cells arranged in ladder or network form, and the hair cuticle is in flat wave shape. Penis et Testis Mustelae is 29±0.05 in the medulla index, with ellipse-like, square-like or circular shaped medulla cells arranged in one line generally, and the hair cuticle is in acuminate (d, m, imbrication (m,p and slightly flat wave (p shape. Musculus et Bonis Passeris is 24±0.05 in the medulla index, with bamboo joint-shaped barbs and unclear medulla cells, without hair cuticle.

  16. A Study on Animal Drugs in Khaqani’s Divan

    Directory of Open Access Journals (Sweden)

    S Mahdavifar

    2014-02-01

    Full Text Available Difficulty and strangeness are the adjectives which have been ascribed to Khaqani’s Daivan for a long time. A notable part of such difficulties originates from the extensive cultural background on which the poet has based different themes, images and novel expressions. His strange manner in poetry is so that, for staying away from widely-used expressions, he has linked various kinds of knowledge with his poetic competence and created valuable and high poetry. His outstanding talent in using language and the delicacy he showed in using such kinds of knowledge all cause his words not to be strictly scientific and non-literary. Medical statements are one part of his cultural background used by the poet prominently in composing his poems. Due to the presence of great physicians such as Zakariaye Razi, Majusi Ahwazi, Abu Ali Sina, Ismail Jurjani etc. medicine developed a lot in his time. Moreover, the literary milieu of his time required our poet to be a knowledgeable person, especially due to the presence of prominent rivals such as Abul’ala Ganjavi and others. This article aims to investigate animal drugs as a part of such medical knowledge.

  17. Non-Clinical Models for Neurodegenerative Diseases: Therapeutic Approach and Drug Validation in Animal Models

    Directory of Open Access Journals (Sweden)

    Caridad Ivette Fernandez

    2017-12-01

    Full Text Available In 2016, 19.8% of the Cuban population was aged 60 or over. As a result, age-associated degenerative diseases and other diseases have become priority targets from a prophylactic, diagnostic and therapeutic perspective. As a result, the Cuban biomedical scientific community has addressed its basic, preclinical and epidemiological research in order to rise up to the challenge. A firm step in this direction has been the international congress “State of the art in non-clinical models for neurodegenerative diseases” which has brought together preclinical and clinical researchers, technicians and regulatory staff members from different countries to review the state of the art in neurodegenerations, find unifying ideas, objectives and collaborations or partnership. The objective is to expose the perspectives of new biotechnological products from Cuba and other countries from the diagnostic, therapeutic and neuroprotective point of view. It is crucial, therefore, that the irreplaceable role of laboratory animals in achieving these objectives is understood but they must be used in rational, adequate and ethical manner. We expose the current development trends in this field, being of common interest to the work directed to the search for potential drugs, diagnostic tools and the promotion of changes in lifestyle as a preventive projection.

  18. Sex differences in drug addiction: a review of animal and human studies.

    Science.gov (United States)

    Fattore, Liana; Altea, Silvia; Fratta, Walter

    2008-01-01

    Addiction research has historically neglected research on women, and most studies have been conducted on men only, with the concluding results generalized to the female population. The role of sex differences in vulnerability to drug abuse, their repercussions on prevention and treatment strategies all require detailed studies, as does the progression from recreational drug use to dependence. This review synthesizes evidence of gender differences in drug addiction, with particular emphasis on women's health and implications. We first reviewed behavioral studies showing sex differences in the preference for and self-administration of licit (i.e., alcohol and nicotine) and illicit (i.e., cocaine, amphetamine, heroin and cannabis) substances as revealed by animal models of addiction. Clinical studies demonstrating differences between men and women in craving, drug use, abstinence and relapse will then be examined. For both animal and human studies, the effects of hormones and estrous/menstrual cycle will be reviewed. Finally, neurobiological factors underlying gender differences in vulnerability to drug addiction (i.e., brain morphology and neurotransmission) and need for gender-specific detoxification treatments will be discussed.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    DEFF Research Database (Denmark)

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

    2003-01-01

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

  1. 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, Gerrit

    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

  2. Animator

    Science.gov (United States)

    Tech Directions, 2008

    2008-01-01

    Art and animation work is the most significant part of electronic game development, but is also found in television commercials, computer programs, the Internet, comic books, and in just about every visual media imaginable. It is the part of the project that makes an abstract design idea concrete and visible. Animators create the motion of life in…

  3. Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity

    Directory of Open Access Journals (Sweden)

    Elisa Passini

    2017-09-01

    Full Text Available Early prediction of cardiotoxicity is critical for drug development. Current animal models raise ethical and translational questions, and have limited accuracy in clinical risk prediction. Human-based computer models constitute a fast, cheap and potentially effective alternative to experimental assays, also facilitating translation to human. Key challenges include consideration of inter-cellular variability in drug responses and integration of computational and experimental methods in safety pharmacology. Our aim is to evaluate the ability of in silico drug trials in populations of human action potential (AP models to predict clinical risk of drug-induced arrhythmias based on ion channel information, and to compare simulation results against experimental assays commonly used for drug testing. A control population of 1,213 human ventricular AP models in agreement with experimental recordings was constructed. In silico drug trials were performed for 62 reference compounds at multiple concentrations, using pore-block drug models (IC50/Hill coefficient. Drug-induced changes in AP biomarkers were quantified, together with occurrence of repolarization/depolarization abnormalities. Simulation results were used to predict clinical risk based on reports of Torsade de Pointes arrhythmias, and further evaluated in a subset of compounds through comparison with electrocardiograms from rabbit wedge preparations and Ca2+-transient recordings in human induced pluripotent stem cell-derived cardiomyocytes (hiPS-CMs. Drug-induced changes in silico vary in magnitude depending on the specific ionic profile of each model in the population, thus allowing to identify cell sub-populations at higher risk of developing abnormal AP phenotypes. Models with low repolarization reserve (increased Ca2+/late Na+ currents and Na+/Ca2+-exchanger, reduced Na+/K+-pump are highly vulnerable to drug-induced repolarization abnormalities, while those with reduced inward current density

  4. Determination of drug residues by CLAR-MS/MS in animal tissues

    International Nuclear Information System (INIS)

    Brenes Jimenez, Jose Eduardo

    2009-01-01

    Produced food of animal origin, present the possibility of occurrence of any contact with substances that have negative effects on the health of people who consume them. The use of drugs in veterinary medicine is one of the possible sources of such waste; so, the conditions for the analysis of some classes of antibiotics in animal tissues are based on the study. Costa Rica and the countries that are export destination, have regulation and programs for control before to be distributed in local markets, or post if it is received any complaint of pollution. The high resolution liquid chromatography coupled to mass spectrometers (CLAR-MS/MS) allows the analysis of analytes monitored, according to the specifications required by the legislation. The cases of two laboratories in Costa Rica are presented as the only ones who have the ability to perform the analysis of drug residues CLAR-MS/MS. (author) [es

  5. How good are publicly available web services that predict bioactivity profiles for drug repurposing?

    Science.gov (United States)

    Murtazalieva, K A; Druzhilovskiy, D S; Goel, R K; Sastry, G N; Poroikov, V V

    2017-10-01

    Drug repurposing provides a non-laborious and less expensive way for finding new human medicines. Computational assessment of bioactivity profiles shed light on the hidden pharmacological potential of the launched drugs. Currently, several freely available computational tools are available via the Internet, which predict multitarget profiles of drug-like compounds. They are based on chemical similarity assessment (ChemProt, SuperPred, SEA, SwissTargetPrediction and TargetHunter) or machine learning methods (ChemProt and PASS). To compare their performance, this study has created two evaluation sets, consisting of (1) 50 well-known repositioned drugs and (2) 12 drugs recently patented for new indications. In the first set, sensitivity values varied from 0.64 (TarPred) to 1.00 (PASS Online) for the initial indications and from 0.64 (TarPred) to 0.98 (PASS Online) for the repurposed indications. In the second set, sensitivity values varied from 0.08 (SuperPred) to 1.00 (PASS Online) for the initial indications and from 0.00 (SuperPred) to 1.00 (PASS Online) for the repurposed indications. Thus, this analysis demonstrated that the performance of machine learning methods surpassed those of chemical similarity assessments, particularly in the case of novel repurposed indications.

  6. 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

  7. 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 ...

  8. 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.

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

    Science.gov (United States)

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

    2011-01-01

    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 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. LINKED ARTICLES This article is part of a themed issue on Translational Neuropharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.164.issue-4 PMID:21480864

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

    Science.gov (United States)

    Rajamuthiah, Rajmohan; Fuchs, Beth Burgwyn; Jayamani, Elamparithi; Kim, Younghoon; Larkins-Ford, Jonah; Conery, Annie; Ausubel, Frederick M; Mylonakis, Eleftherios

    2014-01-01

    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.

  11. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... 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 ...

  12. Laboratory and greenhouse assessment of plant availability of organic N in animal manure

    NARCIS (Netherlands)

    Antil, R.S.; Janssen, B.H.; Lantinga, E.A.

    2009-01-01

    Laboratory data (thermal fractionation, pepsin extraction, C:No ratio) of dung and manure were mutually compared and contrasted with plant-availability of organic N (No) as found in a greenhouse experiment according to the double-pot technique. Two types of fresh cow dung (one with a relatively wide

  13. FACTORS INFLUENCING THE BIOLOGICAL AVAILABILITY OF RADIONUCLIDES FOR ANIMALS AND MAN

    Energy Technology Data Exchange (ETDEWEB)

    Comar, C. L.

    1963-04-15

    Factors that govern the biological availability of I/sup 131/ and Sr/sup 90/ from fallout for the human population are reviewed. It is pointed out that fresh milk is the most important contributor of Sr/sup 90/ and I/sup 131/ to the human diet. Suggestions are presented for modifying feeding practices of cattle to reduce the levels of I/sup 131/ and Sr/sup 90/ in milk. (C.H.)

  14. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2012-02-29

    ...] Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY: Food and... the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  15. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Science.gov (United States)

    2011-01-19

    ...] Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products... Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products...

  16. Animal models of female sexual dysfunction: basic considerations on drugs, arousal, motivation and behavior.

    Science.gov (United States)

    Ågmo, Anders

    2014-06-01

    Female sexual dysfunctions are a heterogeneous group of symptoms with unknown but probably varying etiology. Social factors may contribute both to the prevalence and to the origin of these dysfunctions. The present review focuses on female hypoactive sexual desire disorder, sexual arousal disorder and orgasmic disorder. These disorders are generally the most common, according to epidemiological studies, and they can all be considered as disorders of motivation. An incentive motivational model of sexual behavior, applicable to humans as well as to non-human animals, is described and the dysfunctions placed into the context of this model. It is shown that endocrine alterations as well as observable alterations in neurotransmitter activity are unlikely causes of the disorders. A potential role of learning is stressed. Nevertheless, the role of some transmitters in female rodent sexual behavior is analyzed, and compared to data from women, whenever such data are available. The conclusion is that there is no direct coincidence between effects on rodent copulatory behavior and sexual behavior in women. Based on these and other considerations, it is suggested that sexual approach behaviors rather than copulatory reflexes in rodents might be of some relevance for human sexual behavior, and perhaps even for predicting the effects of interventions, perhaps even the effects of drugs. Female copulatory behaviors, including the proceptive behaviors, are less appropriate. The common sexual dysfunctions in women are not problems with the performance of copulatory acts, but with the desire for such acts, by feeling aroused by such acts and experiencing the pleasure expected to be caused by such acts. Finally, it is questioned whether female sexual dysfunctions are appropriate targets for pharmacological treatment. © 2013.

  17. Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

    Science.gov (United States)

    Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

    2017-02-01

    Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

  18. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Science.gov (United States)

    2012-10-09

    ... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...

  19. Consumer available permanent hair dye products cause major allergic immune activation in an animal model

    DEFF Research Database (Denmark)

    Bonefeld, C M; Larsen, J M; Dabelsteen, S

    2010-01-01

    Background p-Phenylenediamine (PPD) and related substances are ingredients of more than two-thirds of oxidative (permanent) hair dyes currently used. Although PPD is a potent skin sensitizer in predictive assays, the extent to which permanent hair dyes sensitize humans has been questioned due...... to the in-use conditions, e.g. the presence of couplers in the hair dye gel and rapid oxidation using a developer. Objectives To study the skin sensitizing potential of permanent hair dyes in mice. Methods Two different permanent hair dye products containing PPD were studied in CBA mice using a modified......-cell proliferation within the draining lymph nodes. Treatment with the mixture induced at least 20% more skin inflammation, cytokine production and CD4+ T-cell activation compared with the colour gel alone. Conclusions Consumer available PPD-containing permanent hair dyes can be potent and rapid immune activators...

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

    International Nuclear Information System (INIS)

    Szwaja, S.

    1978-01-01

    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)

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

    Energy Technology Data Exchange (ETDEWEB)

    Szwaja, S [Uniwersytet Jagiellonski, Krakow (Poland)

    1978-01-01

    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.

  2. Outreach nurses in Harm Reduction projects: improving acceptability and availability of medical care to drug users

    Directory of Open Access Journals (Sweden)

    Dvinskykh, Natalya

    2012-07-01

    Full Text Available BACKGROUND: Injection drug users (IDU remain one of the most vulnerable population segments in Ukraine, with HIV prevalence up to 22% among this group. At the same time, drug users lack access to basic health care and reportedly face stigma and discrimination from medical workers. Harm reduction projects in Ukraine partially address this problem by providing regular HIV and STI testing for their clients, and by referring them to medical institutions, where IDU can get free treatment for STI, TB, and ARV therapy for HIV. However, issues of acceptability and availability of medical care for drug users are far from being resolved. METHODS: During 2011, the new approach of ‘outreach nurses’ was piloted by All Ukrainian Harm Reduction Association (UHRA with support from ICF “International HIV/AIDS Alliance in Ukraine”. The aim of the project was to bring medical services closer to IDU by integrating work of medical professionals into a comprehensive package of Harm Reduction project services. The project employed fifteen nurses from five regions of Ukraine. During the project, nurses provided basic medical services, consultations on health improvement issues and referrals. The services were provided at the places convenient for clients: syringe exchange points, community centers, mobile clinics, and at home. RESULTS: The services of the project were well accepted by the clients. From June till December 2011 the project reached 1703 unique clients, with a total of 4525 visits (300 visits per nurse on average. For comparison, in the HR projects that employed surgeons, on average there were 58 visits per doctor (from 30 to 93 during the same period of time. CONCLUSIONS: To improve access to medical care for the drug using population Harm Reduction projects should consider including work of ‘outreach nurses’ to the package of services they provide.

  3. 78 FR 78366 - Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... increases FDA's authorities and responsibilities to address issues such as drug shortages, drug supply chain... and describes new standards and processes affecting drug and biologics approvals, drug supply chain... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD...

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

    Directory of Open Access Journals (Sweden)

    Varsha Bangalee

    2016-12-01

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

  5. 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.

  6. Using ICR and SCID mice as animal models for smallpox to assess antiviral drug efficacy.

    Science.gov (United States)

    Titova, Ksenya A; Sergeev, Alexander A; Zamedyanskaya, Alena S; Galahova, Darya O; Kabanov, Alexey S; Morozova, Anastasia A; Bulychev, Leonid E; Sergeev, Artemiy A; Glotova, Tanyana I; Shishkina, Larisa N; Taranov, Oleg S; Omigov, Vladimir V; Zavjalov, Evgenii L; Agafonov, Alexander P; Sergeev, Alexander N

    2015-09-01

    The possibility of using immunocompetent ICR mice and immunodeficient SCID mice as model animals for smallpox to assess antiviral drug efficacy was investigated. Clinical signs of the disease did not appear following intranasal (i.n.) challenge of mice with strain Ind-3a of variola virus (VARV), even when using the highest possible dose of the virus (5.2 log10 p.f.u.). The 50 % infective doses (ID50) of VARV, estimated by the virus presence or absence in the lungs 3 and 4 days post-infection, were 2.7 ± 0.4 log10 p.f.u. for ICR mice and 3.5 ± 0.7 log10 p.f.u. for SCID mice. After i.n. challenge of ICR and SCID mice with VARV 30 and 50 ID50, respectively, steady reproduction of the virus occurred only in the respiratory tract (lungs and nose). Pathological inflammatory destructive changes were revealed in the respiratory tract and the primary target cells for VARV (macrophages and epithelial cells) in mice, similar to those in humans and cynomolgus macaques. The use of mice to assess antiviral efficacies of NIOCH-14 and ST-246 demonstrated the compliance of results with those described in scientific literature, which opens up the prospect of their use as an animal model for smallpox to develop anti-smallpox drugs intended for humans.

  7. 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

  8. The role of progestins in the behavioral effects of cocaine and other drugs of abuse: human and animal research.

    Science.gov (United States)

    Anker, Justin J; Carroll, Marilyn E

    2010-11-01

    This review summarizes findings from human and animal research investigating the influence of progesterone and its metabolites allopreganolone and pregnanolone (progestins) on the effects of cocaine and other drugs of abuse. Since a majority of these studies have used cocaine, this will be the primary focus; however, the influence of progestins on other drugs of abuse will also be discussed. Collectively, findings from these studies support a role for progestins in (1) attenuating the subjective and physiological effects of cocaine in humans, (2) blocking the reinforcing and other behavioral effects of cocaine in animal models of drug abuse, and (3) influencing behavioral responses to other drugs of abuse such as alcohol and nicotine in animals. Administration of several drugs of abuse in both human and nonhuman animals significantly increased progestin levels, and this is explained in terms of progestins acting as homeostatic regulators that decrease and normalize heightened stress and reward responses which lead to increased drug craving and relapse. The findings discussed here highlight the complexity of progestin-drug interactions, and they suggest a possible use for these agents in understanding the etiology of and developing treatments for drug abuse. Copyright © 2010 Elsevier Ltd. All rights reserved.

  9. Residues of carcinogenic animal drugs in food: difficulties in evaluation of human safety.

    Science.gov (United States)

    Somogyi, A

    1979-01-01

    The indisputable need to intensify animal production in order to provide an adequate food supply for the world population involves the use of substances that are highly potent pharmacologically and toxicologically. The history of regulatory action with regard to such additives is similar to that for other substances: first, no regulation; next, an over-reaction; and now decisions based on judicious evaluation of scientific facts. One factor that differentiates the chemicals used in animal production from other food additives is that both the parent compounds and their metabolites appear in edible products, posing problems both for the analytical detection and safety evaluation of such residues. It would be unrealistic to propose 'zero' tolerances for these additives, even if they are carcinogenic. The benefits gained from drugs that cure and prevent infections and parasitic diseases in food-producing animals, and the fact that analytical methods can now detect very small quantities make the presence of low levels of these substances in food unobjectionable.

  10. Experimental psychiatric illness and drug abuse models: from human to animal, an overview.

    Science.gov (United States)

    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 of any psychiatric disorder, models do exist for many elements of each disease state or stage. In many cases, the development of certain models is essentially restricted to the human clinical laboratory domain for the purpose of maximizing validity, whereas the use of in vitro models may best represent an adjunctive, well-controlled means to model specific signaling mechanisms associated with psychiatric disease states. The data generated by preclinical models are only as valid as the model itself, and the development and refinement of animal models for human psychiatric disorders continues to be an important challenge. Collaborative relationships between basic neuroscience and clinical modeling could greatly benefit the development of new and better models, in addition to facilitating medications development.

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

    Science.gov (United States)

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

    2016-09-13

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

  12. Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

    Science.gov (United States)

    Liang, Bryan A; Mackey, Tim K

    2012-02-09

    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. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.

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

    Directory of Open Access Journals (Sweden)

    Alvaro Llorente-Berzal

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

    Science.gov (United States)

    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, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

  15. Non-steroidal anti-inflammatory drugs vs. paracetamol: drug availability, patient's preference and knowledge of toxicity

    International Nuclear Information System (INIS)

    Zamir, Q.; Nadeem, A.

    2017-01-01

    Self-medication is a common practice which is influenced by level of education, society factors and health care facilities availability. In our region, Pakistan, it is very common and awareness regarding prescription implementation needs to be ensured. Hence the current study highlights the preference, availability and knowledge of toxicity of non-steroidal anti-inflammatory medications and paracetamol in Pakistan. Method: It was a Descriptive, cross sectional, conducted in Rawalpindi and Islamabad, Pakistan from May to august 2012. A total of 1000 questionnaires comprising of 21 questions were distributed to the persons with age groups from 18 years to 40 years. Non-probability convenience sampling technique was used for results deduction. Data was analysed using descriptive statistics. Results: The most commonly used medicine was Mefenamic acid (n=191, 40.8 percent). Paracetamol was second on the priority list (n=146, 31.3 percent). About 178 out of 467(38.1 percent) used these medications for headache. Very few responders knew about the toxic doses of the medicines they used. Only 52 (11 percent) were aware of the raised bleeding tendency being the most common side effect of acetylsalicylic acid and 129 (28 percent) were aware of liver damage by paracetamol toxicity. Conclusion: In Pakistan, common people take NSAIDs and Paracetamol without prescription and majority of them are unaware of the side effects of these medicines. This is the reason it is important to make the general public aware of the problems they may face if they misuse or over use the drugs without the prescription. (author)

  16. Mapping the availability, price, and affordability of antiepileptic drugs in 46 countries.

    Science.gov (United States)

    Cameron, Alexandra; Bansal, Amit; Dua, Tarun; Hill, Suzanne R; Moshe, Solomon L; Mantel-Teeuwisse, Aukje K; Saxena, Shekhar

    2012-06-01

    In low- and middle-income countries (LMICs), a large proportion of people with epilepsy do not receive treatment. An analysis of the availability, price, and affordability of antiepileptic drugs (AEDs) was conducted to evaluate whether these factors contribute to the treatment gap. Data for five AEDs (phenytoin, carbamazepine, valproic acid, phenobarbital, and diazepam) were obtained from facility-based surveys conducted in 46 countries using the World Health Organization/Health Action International (WHO/HAI) methodology. Outcome measures were percentage availability, ratios of local prices to international reference prices, and number of days' wages needed by the lowest-paid unskilled government worker to purchase treatment. Prices were adjusted for inflation/deflation and purchasing power parity. The average availability of generic AEDs in the public sector was Private sector availability of generic oral AEDs ranged from 42.2% for phenytoin to 69.6% for phenobarbital. Public sector patient prices for generic carbamazepine and phenytoin were 4.95 and 17.50 times higher than international reference prices, respectively, whereas private sector patient prices were 11.27 and 24.77 times higher, respectively. For both medicines, originator brand prices were about 30 times higher. The highest prices were observed in the lowest income countries. The lowest-paid government worker would need wages from 1-2.6 days' to purchase a month's supply of phenytoin, whereas carbamazepine would cost 2.7-16.2 days' wages. Despite its widespread use in LMICs, WHO/HAI survey data for phenobarbital was only available from a small number of countries. In LMICs, availability and affordability of AEDs are poor and may be acting as a barrier to accessing treatment for epilepsy. Ensuring a consistent supply of AEDs at an affordable price should be a priority. Wiley Periodicals, Inc. © 2012 International League Against Epilepsy.

  17. Animation of Antimicrobial Resistance

    Medline Plus

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

  18. Animation of Antimicrobial Resistance

    Medline Plus

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

  19. Establishment of a novel whole animal HTS technology platform for melioidosis drug discovery.

    Science.gov (United States)

    Lakshmanan, Umayal; Yap, Amelia; Fulwood, Justina; Yichun, Li; Hoon, Sim Siew; Lim, Jolander; Ting, Audrey; Sem, Xiao Hui; Kreisberg, Jason F; Tan, Patrick; Tan, Gladys; Flotow, Horst

    2014-01-01

    Melioidosis is a serious emerging endemic infectious disease caused by Burkholderia pseudomallei, a gram-negative pathogen. Septicemic melioidosis has a mortality rate of 50% even with treatment. Like other gram-negative bacteria, B. pseudomallei is resistant to a number of antibiotics and multi-drug resistant B. pseudomallei is beginning to be encountered in hospitals. There is a clear medical need to develop new treatment options to manage this disease. We used Burkholderia thailandensis (a BSL-2 class organism) to infect Caenorhabditis elegans and set up a surrogate whole animal infection model of melioidosis that we could run in a 384 microtitre plate and establish a whole animal HTS assay. We have optimized and validated this assay in a fluorescence-based format that can be run on our automated screening platforms. This assay has now been used to screen over 300,000 compounds from our small molecule library and we are in the process of characterizing the hits obtained and select compounds for further studies. We have thus established a biologically relevant assay technology platform to screen for antibacterial compounds and used this platform to identify new compounds that may find application in treating melioidosis infections.

  20. Effect of administration method, animal weight and age on the intranasal delivery of drugs to the brain.

    Science.gov (United States)

    Krishnan, Jishnu K S; Arun, Peethambaran; Chembukave, Bhadra; Appu, Abhilash P; Vijayakumar, Nivetha; Moffett, John R; Puthillathu, Narayanan; Namboodiri, Aryan M A

    2017-07-15

    The intranasal route of administration has proven to be an effective method for bypassing the blood brain barrier and avoiding first pass hepatic metabolism when targeting drugs to the brain. Most small molecules gain rapid access to CNS parenchyma when administered intranasally. However, bioavailability is affected by various factors ranging from the molecular weight of the drug to the mode of intranasal delivery. We examined the effects of animal posture, intranasal application method and animal weight and age on the delivery of radiolabeled pralidoxime ( 3 H-2-PAM) to the brain of rats. We found that using upright vs. supine posture did not significantly affect 3 H-2-PAM concentrations in different brain regions. Older animals with higher weights required increased doses to achieve the same drug concentration throughout the brain when compared to young animals with lower body weights. The use of an intranasal aerosol propelled delivery device mainly increased bioavailability in the olfactory bulbs, but did not reliably increase delivery of the drug to various other brain regions, and in some regions of the brain delivered less of the drug than simple pipette administration. In view of the emerging interest in the use of intranasal delivery of drugs to combat cognitive decline in old age, we tested effectiveness in very old rats and found the method to be as effective in the older rats. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Innovations: Alcohol & drug abuse: Narcotics on the net: the availability of Web sites selling controlled substances.

    Science.gov (United States)

    Forman, Robert F

    2006-01-01

    The Internet is not only a vital medium for communication, entertainment, and commerce, but it is also an outlet for illicit drug sales. Although the U.S. Controlled Substances Act regulates access to certain drugs by requiring prescriptions, unique characteristics of the Internet create significant challenges for the enforcement of U.S. drug policies. In the late 1990s "no prescription Web sites" (NPWs) began to emerge, which allow persons to purchase drugs, such as opiates, without a prescription. Given the likely role of NPWs in increasing prescription drug abuse, health care professionals must develop and disseminate strategies for helping patients who are affected by these Web sites.

  2. 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)

    Salminen, E.

    2002-01-01

    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.)

  3. 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. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. Distribution of Animal Drugs among Curd, Whey, and Milk Protein Fractions in Spiked Skim Milk and Whey.

    Science.gov (United States)

    Shappell, Nancy W; Shelver, Weilin L; Lupton, Sara J; Fanaselle, Wendy; Van Doren, Jane M; Hakk, Heldur

    2017-02-01

    It is important to understand the partitioning of drugs in processed milk and milk products, when drugs are present in raw milk, in order to estimate the potential consumer exposure. Radioisotopically labeled erythromycin, ivermectin, ketoprofen, oxytetracycline, penicillin G, sulfadimethoxine, and thiabendazole were used to evaluate the distribution of animal drugs among rennet curd, whey, and protein fractions from skim cow milk. Our previous work reported the distribution of these same drugs between skim and fat fractions of milk. Drug distribution between curd and whey was significantly correlated (R 2 = 0.70) to the drug's lipophilicity (log P), with improved correlation using log D (R 2 = 0.95). Distribution of drugs was concentration independent over the range tested (20-2000 nM). With the exception of thiabendazole and ivermectin, more drug was associated with whey protein than casein on a nmol/g protein basis (oxytetracycline experiment not performed). These results provide insights into the distribution of animal drug residues, if present in cow milk, among milk fractions, with possible extrapolation to milk products.

  5. Benchmarking therapeutic drug monitoring software: a review of available computer tools.

    Science.gov (United States)

    Fuchs, Aline; Csajka, Chantal; Thoma, Yann; Buclin, Thierry; Widmer, Nicolas

    2013-01-01

    Therapeutic drug monitoring (TDM) aims to optimize treatments by individualizing dosage regimens based on the measurement of blood concentrations. Dosage individualization to maintain concentrations within a target range requires pharmacokinetic and clinical capabilities. Bayesian calculations currently represent the gold standard TDM approach but require computation assistance. In recent decades computer programs have been developed to assist clinicians in this assignment. The aim of this survey was to assess and compare computer tools designed to support TDM clinical activities. The literature and the Internet were searched to identify software. All programs were tested on personal computers. Each program was scored against a standardized grid covering pharmacokinetic relevance, user friendliness, computing aspects, interfacing and storage. A weighting factor was applied to each criterion of the grid to account for its relative importance. To assess the robustness of the software, six representative clinical vignettes were processed through each of them. Altogether, 12 software tools were identified, tested and ranked, representing a comprehensive review of the available software. Numbers of drugs handled by the software vary widely (from two to 180), and eight programs offer users the possibility of adding new drug models based on population pharmacokinetic analyses. Bayesian computation to predict dosage adaptation from blood concentration (a posteriori adjustment) is performed by ten tools, while nine are also able to propose a priori dosage regimens, based only on individual patient covariates such as age, sex and bodyweight. Among those applying Bayesian calculation, MM-USC*PACK© uses the non-parametric approach. The top two programs emerging from this benchmark were MwPharm© and TCIWorks. Most other programs evaluated had good potential while being less sophisticated or less user friendly. Programs vary in complexity and might not fit all healthcare

  6. 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

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

    Science.gov (United States)

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

    2016-10-01

    Beside typical human trypanosomes responsible of sleeping sickness in Africa and Chagas disease in Latin America, there is a growing number of reported atypical human infections due to Trypanosoma evansi, a livestock parasite, or Trypanosoma lewisi, a rat parasite, especially in Asia. Drugs available for the treatment of T. brucei ssp. in humans are obviously of choice for the control of T. evansi because it is derived from T. brucei. However, concerning T. lewisi, there is an urgent need to determine the efficacy of trypanocidal drugs for the treatment in humans. In a recent study, pentamidine and fexinidazole were shown to have the best efficacy against one stock of T. lewisi in rats. In the present study suramin, pentamidine, eflornitine, nifurtimox, benznidazole and fexinidazole, were evaluated at low and high doses, in single day administration to normal rats experimentally infected with a stock of T. lewisi recently isolated in Thailand. Because none of these treatments was efficient, a trial was made with the most promising trypanocide identified in a previous study, fexinidazole 100mg/kg, in 5 daily administrations. Results observed were unclear. To confirm the efficacy of fexinidazole, a mixed infection protocol was set up in cyclophosphamide immunosuppressed rats. Animals were infected successively by T. lewisi and T. evansi, and received 10 daily PO administrations of 200mg/kg fexinidazole. Drastic effects were observed against T. evansi which was cleared from the rat's blood within 24 to 48h; however, the treatment did not affect T. lewisi which remained in high number in the blood until the end of the experiment. This mixed infection/treatment protocol clearly demonstrated the efficacy of fexinidazole against T. evansi and its inefficacy against T. lewisi. Since animal trypanocides were also recently shown to be inefficient, other protocols as well as other T. lewisi stocks should be investigated in further studies. Copyright © 2016. Published by

  8. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0090] Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability... familiar and less familiar approaches. As more experience is obtained with the less familiar designs...

  9. 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 an...

  10. Competing pressures on populations: long-term dynamics of food availability, food quality, disease, stress and animal abundance.

    Science.gov (United States)

    Chapman, Colin A; Schoof, Valérie A M; Bonnell, Tyler R; Gogarten, Jan F; Calmé, Sophie

    2015-05-26

    Despite strong links between sociality and fitness that ultimately affect the size of animal populations, the particular social and ecological factors that lead to endangerment are not well understood. Here, we synthesize approximately 25 years of data and present new analyses that highlight dynamics in forest composition, food availability, the nutritional quality of food, disease, physiological stress and population size of endangered folivorous red colobus monkeys (Procolobus rufomitratus). There is a decline in the quality of leaves 15 and 30 years following two previous studies in an undisturbed area of forest. The consumption of a low-quality diet in one month was associated with higher glucocorticoid levels in the subsequent month and stress levels in groups living in degraded forest fragments where diet was poor was more than twice those in forest groups. In contrast, forest composition has changed and when red colobus food availability was weighted by the protein-to-fibre ratio, which we have shown positively predicts folivore biomass, there was an increase in the availability of high-quality trees. Despite these changing social and ecological factors, the abundance of red colobus has remained stable, possibly through a combination of increasing group size and behavioural flexibility. © 2015 The Author(s) Published by the Royal Society. All rights reserved.

  11. 78 FR 78367 - Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment

    Science.gov (United States)

    2013-12-26

    ... biologics approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft PDUFA V... . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration....gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to...

  12. Has the increase in the availability of generic drugs lowered the ...

    African Journals Online (AJOL)

    Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31e53.46) and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10e8.47).

  13. A cross-sectional study of the availability and pharmacist's knowledge of nano-pharmaceutical drugs in Palestinian hospitals.

    Science.gov (United States)

    Assali, Mohyeddin; Shakaa, Ali; Abu-Hejleh, Sabaa; Abu-Omar, Reham; Karajeh, Nareman; Ajory, Nawal; Zyoud, Saed; Sweileh, Waleed

    2018-04-05

    Nanomedicine is the medical application of nanomaterials that may have an infinite size with the range less than 100 nm. This science has provided solutions to many of the current limitations in the diagnosis and treatment of diseases. Therefore, the pharmacist's knowledge and awareness of nano-pharmaceutical drugs will increase their availability in the market, and will improve the patient's compliance to their drug therapy. This study aimed to determine the availability of nano-pharmaceutical drugs in Palestinian hospitals and evaluate the extent of pharmacist's knowledge about them. A cross-sectional study design questionnaire was used to determine the availability of nano-pharmaceutical drugs based on the database of the ministry of health in the Palestinian hospitals (governmental, private and non- governmental organizations). Moreover, the knowledge of these nano-pharmaceutical drugs among pharmacists working in Palestinian hospitals was assessed based on developed questionnaire from the literature of the pharmaceutical formulations and nano-formulations. The variables were analyzed using Statistical Package for Social Sciences (SPSS 22). Fifty six pharmacists from 27 hospitals in the West bank completed the survey. The results regarding the availability of nano-pharmaceutical drugs indicated only eight available in hospitals with a frequency range 0-39.3%. Moreover, pharmacist's knowledge in the pharmaceutical formulations was better than that in nano-formulations. The availability of nano-pharmaceutical drugs in Palestinian hospitals was not adequate due to the lack of various nano-pharmaceutical drugs. The knowledge among pharmacists regarding nano-pharmaceutical drugs should be improved by providing courses in nanomedicine during the undergraduate pharmacy programs.

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

    Science.gov (United States)

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

    2017-04-01

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

  15. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... search Popular ... produced a nine-minute animation explaining how antimicrobial resistance both emerges and proliferates among bacteria. Over time, the use of antimicrobial drugs will ...

  16. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... bacteria. Over time, the use of antimicrobial drugs will result in the development of resistant strains of ... and other key audiences. We hope this animation will make the concept more understandable to non-scientists ...

  17. Animation of Antimicrobial Resistance

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    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

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

    Science.gov (United States)

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

    2016-10-02

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

  19. 75 FR 35044 - Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension

    Science.gov (United States)

    2010-06-21

    ...] Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension AGENCY... Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable... of NOROCILLIN (penicillin G procaine) Injectable Suspension by intramuscular injection in cattle...

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

    Science.gov (United States)

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

  1. 76 FR 72617 - Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone

    Science.gov (United States)

    2011-11-25

    ... (NMP), is a carcinogen. As required by section 512(d)(1)(I) of the Federal Food, Drug, and Cosmetic Act... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 500, 522, and...-Pyrrolidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug...

  2. The drug situation in Europe: an overview of data available on illicit drugs and new psychoactive substances from European monitoring in 2015.

    Science.gov (United States)

    Mounteney, Jane; Griffiths, Paul; Sedefov, Roumen; Noor, Andre; Vicente, Julián; Simon, Roland

    2016-01-01

    A central task for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is to produce an annual report of the latest data available on drug demand and drug supply in Europe. This paper is intended to facilitate a better understanding of, and easier access to, the main quantitative European level data sets available in 2015. The European reporting system formally covers all 28 European Union (EU) Member States, Norway and Turkey and incorporates multiple indicators alongside an early warning system (EWS) on uncontrolled new psychoactive substances (NPS). While epidemiological information is based largely on registries, surveys and other routine data reported annually, the EWS collects case-based data on an ongoing basis. The 2015 reporting exercise is centred primarily on a set of standardized reporting tools. The most recent data provided by European countries are presented, including data on drug use, drug-related morbidity and mortality, treatment demand, drug markets and new psychoactive substances, with data tables provided and methodological information. A number of key results are highlighted for illustrative purposes. Drug prevalence estimates from national surveys since 2012 (last year prevalence of use among the 15-34 age band) range from 0.4% in Turkey to 22.1% in France for cannabis, from 0.2% in Greece and Romania to 4.2% in the United Kingdom for cocaine, from 0.1% in Italy and Turkey to 3% in the Czech Republic and the United Kingdom for ecstasy, and from 0.1% or less in Romania, Italy and Portugal to 2.5% in Estonia for amphetamine. Declining trends in new HIV detections among people who inject drugs are illustrated, in addition to presentation of a breakdown of NPS reported to the EU early warning system, which have risen exponentially from fewer than 20 a year between 2005 and 2008, to 101 reported in 2014. Structured information is now available on patterns and trends in drug consumption in Europe, which permits triangulation of

  3. 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. Copyright © 2010 Elsevier Ltd. All rights reserved.

  4. Medication assisted treatment in US drug courts: results from a nationwide survey of availability, barriers and attitudes.

    Science.gov (United States)

    Matusow, Harlan; Dickman, Samuel L; Rich, Josiah D; Fong, Chunki; Dumont, Dora M; Hardin, Carolyn; Marlowe, Douglas; Rosenblum, Andrew

    2013-01-01

    Drug treatment courts are an increasingly important tool in reducing the census of those incarcerated for non-violent drug offenses; medication assisted treatment (MAT) is proven to be an effective treatment for opioid addiction. However, little is known about the availability of and barriers to MAT provision for opioid-addicted people under drug court jurisdiction. Using an online survey, we assessed availability, barriers, and need for MAT (especially agonist medication) for opioid addiction in drug courts. Ninety-eight percent reported opioid-addicted participants, and 47% offered agonist medication (56% for all MAT including naltrexone). Barriers included cost and court policy. Responses revealed significant uncertainty, especially among non-MAT providing courts. Political, judicial and administrative opposition appear to affect MAT's inconsistent use and availability in drug court settings. These data suggest that a substantial, targeted educational initiative is needed to increase awareness of the treatment and criminal justice benefits of MAT in the drug courts. Copyright © 2013 Elsevier Inc. All rights reserved.

  5. 75 FR 34452 - Center for Drug Evaluation and Research Data Standards Plan; Availability for Comment

    Science.gov (United States)

    2010-06-17

    ... comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane... sources. This wealth of data holds great potential to advance CDER's regulatory and scientific work, but... improvements requires careful analysis, advanced planning, project management, expert input, and effective...

  6. 78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

    Science.gov (United States)

    2013-07-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0812... so that safe and effective products can get to market sooner. It is aligned with the objectives of... as captured in the FDA Safety and Innovation Act. The CDER Data Standards Strategy supersedes version...

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

    Science.gov (United States)

    Mitsumori, K

    1993-01-01

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

  8. 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

  9. Animal Models of Seizures and Epilepsy: Past, Present, and Future Role for the Discovery of Antiseizure Drugs.

    Science.gov (United States)

    Löscher, Wolfgang

    2017-07-01

    The identification of potential therapeutic agents for the treatment of epilepsy requires the use of seizure models. Except for some early treatments, including bromides and phenobarbital, the antiseizure activity of all clinically used drugs was, for the most part, defined by acute seizure models in rodents using the maximal electroshock and subcutaneous pentylenetetrazole seizure tests and the electrically kindled rat. Unfortunately, the clinical evidence to date would suggest that none of these models, albeit useful, are likely to identify those therapeutics that will effectively manage patients with drug resistant seizures. Over the last 30 years, a number of animal models have been developed that display varying degrees of pharmacoresistance, such as the phenytoin- or lamotrigine-resistant kindled rat, the 6-Hz mouse model of partial seizures, the intrahippocampal kainate model in mice, or rats in which spontaneous recurrent seizures develops after inducing status epilepticus by chemical or electrical stimulation. As such, these models can be used to study mechanisms of drug resistance and may provide a unique opportunity for identifying a truly novel antiseizure drug (ASD), but thus far clinical evidence for this hope is lacking. Although animal models of drug resistant seizures are now included in ASD discovery approaches such as the ETSP (epilepsy therapy screening program), it is important to note that no single model has been validated for use to identify potential compounds for as yet drug resistant seizures, but rather a battery of such models should be employed, thus enhancing the sensitivity to discover novel, highly effective ASDs. The present review describes the previous and current approaches used in the search for new ASDs and offers some insight into future directions incorporating new and emerging animal models of therapy resistance.

  10. Sedative and Analgesic Drugs Online: A Content Analysis of the Supply and Demand Information Available in Thailand.

    Science.gov (United States)

    Pinyopornpanish, Kanokporn; Jiraporncharoen, Wichuda; Thaikla, Kanittha; Yoonut, Kulyapa; Angkurawaranon, Chaisiri

    2018-03-21

    Evidence from other countries has suggested that many controlled drugs are also offered online, even though it is illegal to sell these drugs without a license. To evaluate the current contents related to the supply and demand of sedatives and analgesic drugs available online in Thailand, with a particular focus on Facebook. A team of reviewers manually searched for data by entering keywords related to analgesic drugs and sedatives. The contents of the website were screened for supply and demand-related information. A total of 5,352 websites were found publicly available. The number of websites and Facebook pages containing the information potentially related to the supply and demand of analgesic drugs and sedatives was limited. Nine websites sold sedatives, and six websites sold analgesics directly. Fourteen Facebook pages were found, including 7 sedative pages and 7 analgesic pages. Within one year, the three remaining active pages multiplied in the number of followers by three- to nine-fold. The most popular Facebook page had over 2,900 followers. Both the internet and social media contain sites and pages where sedatives and analgesics are illegally advertised. These websites are searchable through common search engines. Although the number of websites is limited, the number of followers on these Facebook pages does suggest a growing number of people who are interested in such pages. Our study emphasized the importance of monitoring and developing potential plans relative to the online marketing of prescription drugs in Thailand.

  11. Local Delivery System of Immune Modulating Drug for Unresectable Adenocarcinoma: In Vitro Experimental Study and In Vivo Animal Study

    International Nuclear Information System (INIS)

    Lee, Don Haeng; Kang, Sung-Gwon; Jeong, Seok; Yoon, Chang Jin; Choi, Jung-Ah; Byun, Ju Nam; Park, Jae Hyung; Lee, Kyu Back

    2006-01-01

    The purpose of the study was to evaluate the efficacy and safety of a developed drug delivery system containing OK-432 through in vitro and animal study. An OK-432-impregnated polycarbonate/polyurethane stent membrane was used to develop a drug delivery system (DDS) enabling the locoregional release of OK-432. Polyethyleneglycol was used as a detergent and porosity generator. The stability of OK-432 in solvent, releasing kinetics of drug, and cytotoxicity of the DDS were evaluated. OK-432-impregnated DDS was implanted in mice in which a human adenocarcinoma cell line was injected and grown in their back. Flow cytometry and enzyme-linked immunosorbent assay were used for quantifying the amount of drug. OK-432 exposed to phosphate-buffered saline and OK-432 exposed to N,N-dimethylacetamide showed similar results on dot graphs and histograms. However, OK-432 exposed to tetrahydrofurane showed different dot graphs and histograms, which means that the antigenicity of the drug was changed. The release rate of OK-432 was maintained at a constant level for 6 weeks. The local delivery of OK-432 was found to have an antitumor effect on a human adenocarcinoma cell line in an animal study, but no effect on this cell line in in vitro cell culture. Histologic examination showed minimal inflammatory reaction in surrounding tissue. Our study shows that local treatment using this OK-432 release system is safe and effective in reducing adenocarcinoma in a mouse model

  12. 78 FR 44432 - New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

    Science.gov (United States)

    2013-07-24

    ... for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co..., NADA 141-337 for RECUVYRA (fentanyl) Transdermal Solution to Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, [[Page 44433

  13. 75 FR 9333 - Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin

    Science.gov (United States)

    2010-03-02

    ... (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides a...: [email protected] . SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 140-929 for MICOTIL...

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

    Science.gov (United States)

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

    2017-04-01

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

  15. Chemotext: A Publicly Available Web Server for Mining Drug-Target-Disease Relationships in PubMed.

    Science.gov (United States)

    Capuzzi, Stephen J; Thornton, Thomas E; Liu, Kammy; Baker, Nancy; Lam, Wai In; O'Banion, Colin P; Muratov, Eugene N; Pozefsky, Diane; Tropsha, Alexander

    2018-02-26

    Elucidation of the mechanistic relationships between drugs, their targets, and diseases is at the core of modern drug discovery research. Thousands of studies relevant to the drug-target-disease (DTD) triangle have been published and annotated in the Medline/PubMed database. Mining this database affords rapid identification of all published studies that confirm connections between vertices of this triangle or enable new inferences of such connections. To this end, we describe the development of Chemotext, a publicly available Web server that mines the entire compendium of published literature in PubMed annotated by Medline Subject Heading (MeSH) terms. The goal of Chemotext is to identify all known DTD relationships and infer missing links between vertices of the DTD triangle. As a proof-of-concept, we show that Chemotext could be instrumental in generating new drug repurposing hypotheses or annotating clinical outcomes pathways for known drugs. The Chemotext Web server is freely available at http://chemotext.mml.unc.edu .

  16. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Pin it Email Print The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how antimicrobial resistance both emerges and proliferates among bacteria. Over time, the use of antimicrobial drugs will result in ...

  17. 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

  18. 75 FR 54492 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic...

    Science.gov (United States)

    2010-09-08

    ... Ophthalmic Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment... acetate ophthalmic solution. This action is being taken to comply with the Federal Food, Drug, and... GENTOCIN DURAFILM (gentamicin sulfate and betamethasone acetate) Ophthalmic Solution, sponsored by Intervet...

  19. 75 FR 75175 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User...

    Science.gov (United States)

    2010-12-02

    ... exceed cost... 0 1 0 2 0 740(d)(1)(C) Free choice feeds.. 2 1 2 2 4 740(d)(1)(D) Minor use or minor 52 1... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0603... Fee Waivers and Reductions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  20. 77 FR 22789 - Withdrawal of Approval of Part of a New Animal Drug Application; Tiamulin

    Science.gov (United States)

    2012-04-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0262... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of... to the production indications for use of increased rate of weight gain and improved feed efficiency...

  1. 75 FR 1021 - Certain Other Dosage Form New Animal Drugs; Sevoflurane

    Science.gov (United States)

    2010-01-08

    ... Halocarbon Products Corp. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs. DATES... anesthetic, in dogs. Halocarbon Products Corp.'s Sevoflurane is approved as a generic copy of SEVOFLO... Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs...

  2. Human In Silico Drug Trials Demonstrate Higher Accuracy than Animal Models in Predicting Clinical Pro-Arrhythmic Cardiotoxicity.

    Science.gov (United States)

    Passini, Elisa; Britton, Oliver J; Lu, Hua Rong; Rohrbacher, Jutta; Hermans, An N; Gallacher, David J; Greig, Robert J H; Bueno-Orovio, Alfonso; Rodriguez, Blanca

    2017-01-01

    Early prediction of cardiotoxicity is critical for drug development. Current animal models raise ethical and translational questions, and have limited accuracy in clinical risk prediction. Human-based computer models constitute a fast, cheap and potentially effective alternative to experimental assays, also facilitating translation to human. Key challenges include consideration of inter-cellular variability in drug responses and integration of computational and experimental methods in safety pharmacology. Our aim is to evaluate the ability of in silico drug trials in populations of human action potential (AP) models to predict clinical risk of drug-induced arrhythmias based on ion channel information, and to compare simulation results against experimental assays commonly used for drug testing. A control population of 1,213 human ventricular AP models in agreement with experimental recordings was constructed. In silico drug trials were performed for 62 reference compounds at multiple concentrations, using pore-block drug models (IC 50 /Hill coefficient). Drug-induced changes in AP biomarkers were quantified, together with occurrence of repolarization/depolarization abnormalities. Simulation results were used to predict clinical risk based on reports of Torsade de Pointes arrhythmias, and further evaluated in a subset of compounds through comparison with electrocardiograms from rabbit wedge preparations and Ca 2+ -transient recordings in human induced pluripotent stem cell-derived cardiomyocytes (hiPS-CMs). Drug-induced changes in silico vary in magnitude depending on the specific ionic profile of each model in the population, thus allowing to identify cell sub-populations at higher risk of developing abnormal AP phenotypes. Models with low repolarization reserve (increased Ca 2+ /late Na + currents and Na + /Ca 2+ -exchanger, reduced Na + /K + -pump) are highly vulnerable to drug-induced repolarization abnormalities, while those with reduced inward current density

  3. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients' compliance with medication regimen is to refer them to pharmaceutical industry-sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.   Type: Original Research

  4. Evaluation of Patient Assistance Program Eligibility and Availability for Top 200 Brand Name and Generic Drugs in the United States

    Directory of Open Access Journals (Sweden)

    Chin-Fun Chu

    2012-01-01

    Full Text Available One strategy to encourage uninsured and underinsured patients’ compliance with medication regimen is to refer them to pharmaceutical industry–sponsored patient assistance programs (PAPs. In order to receive the requested medications, patients should be qualified based on the program eligibility requirements. The purpose of this study was to examine PAP eligibility criteria for the most commonly dispensed prescriptions in the United States. We identified 136 unique chemical entities in the Top 200 drug list and 111 (82% of these pharmaceutical products were offered by PAPs. Among the available medications, 69 (62% were brand name; 29 (26% were generic, and 13 (12% had both brand name/generic forms. In terms of the availability of types of drugs (brand name vs. generic provided by PAPs, differences in PAP eligibility requirements were found for citizenship (p < 0.001, permanent residency (p < 0.001, and prescription drug coverage (p< 0.001, but not for income limits (p= 0.051. Overall, PAPs could help low-income patients to obtain necessary medications; however, U.S. citizenship/permanent residency and restriction on prescription coverage are more likely to be required for brand name drugs rather than for generics. PAPs also provide some options for the underinsured and those with private insurance or Medicare Part D plan that offers inadequate prescription coverage.

  5. 77 FR 31722 - New Animal Drugs; Change of Sponsor; Estradiol; Estradiol Benzoate and Testosterone Propionate...

    Science.gov (United States)

    2012-05-30

    ..., Division of Eli Lilly & Co. DATES: This rule is effective May 30, 2012. FOR FURTHER INFORMATION CONTACT... this table to Elanco Animal Health, Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis...

  6. Why Are Drugs So Hard to Quit?

    Medline Plus

    Full Text Available ... 1:51 Anti-Drug Vaccine Animation - Duration: 3:39. National Institute on Drug Abuse (NIDA/NIH) 14,153 views 3:39 Animated Infographic: Monitoring the Future 2017 Survey Results - ...

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

    Science.gov (United States)

    2013-07-15

    ... to all interested persons in a timely fashion. The 30-day public docket closed on May 9, 2013. FDA... detained drug, may be incurred if FDA revokes the detention order on appeal. Given the history of...

  8. 76 FR 58277 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-09-20

    ... support for lower-cost alternatives to brand drugs for consumers. Under AGDUFA, FDA agreed to meet review... Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: September 13, 2011. Leslie Kux, Acting Assistant...

  9. 77 FR 72359 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2012-12-05

    ... Parklawn Dr., Element Bldg., Rockville, MD 20857. Comments: Interested persons may submit either written... to brand name drugs for consumers. Under AGDUFA I, FDA agreed to meet review performance goals for...

  10. 77 FR 39390 - Implantation or Injectable Dosage Form New Animal Drugs; Maropitant; Tildipirosin

    Science.gov (United States)

    2012-07-03

    ..., Foods. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the... of use--(1) Dogs--(i) Amount. Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous...

  11. 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.

  12. Drug-botanical interactions: a review of the laboratory, animal, and human data for 8 common botanicals.

    Science.gov (United States)

    Shord, Stacy S; Shah, Kanan; Lukose, Alvina

    2009-09-01

    Many Americans use complementary and alternative medicine (CAM) to prevent or alleviate common illnesses, and these medicines are commonly used by individuals with cancer.These medicines or botanicals share the same metabolic and transport proteins, including cytochrome P450 enzymes (CYP), glucuronosyltransferases (UGTs), and P-glycoprotein (Pgp), with over-the-counter and prescription medicines increasing the likelihood of drug-botanical interactions.This review provides a brief description of the different proteins, such as CYPs, UGTs, and Pgp.The potential effects of drug-botanical interactions on the pharmacokinetics and pharmacodynamics of the drug or botanical and a summary of the more common models used to study drug metabolism are described.The remaining portion of this review summarizes the data extracted from several laboratory, animal, and clinical studies that describe the metabolism, transport, and potential interactions of 8 selected botanicals. The 8 botanicals include black cohosh, Echinacea, garlic, Gingko biloba, green tea, kava, milk thistle, and St John's wort; these botanicals are among some of the more common botanicals taken by individuals with cancer.These examples are included to demonstrate how to interpret the different studies and how to use these data to predict the likelihood of a clinically significant drug-botanical interaction.

  13. Sensitivity, specificity and comparison of three commercially available immunological tests in the diagnosis of Cryptosporidium species in animals.

    Science.gov (United States)

    Danišová, Olga; Halánová, Monika; Valenčáková, Alexandra; Luptáková, Lenka

    The study was conducted to compare the specificity of immunological diagnostic methods used for the diagnosis of Cryptosporidium species capable of causing life-threatening infection in both immunosuppressed and immunocompetent patients. For the detection of Cryptosporidium species in 79 animals with diarrhoea, we used three Copro-antigen tests: RIDASCREEN ® Cryptosporidium test, Cryptosporidium 2nd Generation (ELISA) and RIDA ® QUICK Cryptosporidium. For immunoassays we used positive and negative samples detected by means of polymerase chain reaction and validated by sequencing and nested polymerase chain reaction to confirm the presence six different species of Cryptosporidium species. Prevalence of cryptosporidiosis in the entire group determined by enzyme immunoassay, enzyme linked immunosorbent assay, immuno-chromatographic test and polymerase chain reaction was 34.17%, 27.84%, 6.33% and 27.84%, respectively. Sensitivity of animal samples with enzyme immunoassay, enzyme linked immunosorbent assay, and immuno-chromatographic test was 63.6%, 40.9% and 22.7%, resp., when questionable samples were considered positive, whereas specificity of enzyme immunoassay, enzyme linked immunosorbent assay and immuno-chromatographic test was 75.9%, 78.9% and 100%, respectively. Positive predictive values and negative predictive values were different for all the tests. These differences results are controversial and therefore reliability and reproducibility of immunoassays as the only diagnostic method is questionable. The use of various Cryptosporidium species in diagnosis based on immunological testing and different results obtained by individual tests indicate potential differences in Copro-antigens produced by individual Cryptosporidium species. Copyright © 2017 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.

  14. Amino acid availability from selected animal and plant derived feedstuffs for market size sunshine bass (Morone chrysops X M. saxatilis)

    Science.gov (United States)

    Accurate diet formulations are essential for the commercial production of hybrid striped bass. However, limited information is available regarding nutrient digestibility and amino acid availability of readily-used practical ingredients for different size classes of this taxon. Therefore, two trial...

  15. 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.

  16. 78 FR 73697 - New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of...

    Science.gov (United States)

    2013-12-09

    ... dogs and the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis... sarcoptic mange caused by Sarcoptes scabiei var. canis. 141-254 Bayer HealthCare ADVANTAGE MULTI for... MULTI for Supplemental 524.1146 yes CE.1 3 LLC, Animal Health Dogs (imidacloprid approval for the...

  17. 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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  19. Drug treatment program patients' hepatitis C virus (HCV education needs and their use of available HCV education services

    Directory of Open Access Journals (Sweden)

    Osborne Andrew

    2007-03-01

    Full Text Available Abstract Background In spite of the disproportionate prevalence of hepatitis C virus (HCV infection among drug users, many remain uninformed or misinformed about the virus. Drug treatment programs are important sites of opportunity for providing HCV education to their patients, and many programs do, in fact, offer this education in a variety of formats. Little is known, however, about the level of HCV knowledge among drug treatment program patients, and the extent to which they utilize their programs' HCV education services. Methods Using data collected from patients (N = 280 in 14 U.S. drug treatment programs, we compared patients who reported that they never injected drugs (NIDUs with past or current drug injectors (IDUs concerning their knowledge about HCV, whether they used HCV education opportunities at their programs, and the facilitators and barriers to doing so. All of the programs were participating in a research project that was developing, implementing, and evaluating a staff training to provide HCV support to patients. Results Although IDUs scored higher on an HCV knowledge assessment than NIDUs, there were many gaps in HCV knowledge among both groups of patients. To address these knowledge gaps, all of the programs offered at least one form of HCV education: all offered 1:1 sessions with staff, 12 of the programs offered HCV education in a group format, and 11 of the programs offered this education through pamphlets/books. Only 60% of all of the participating patients used any of their programs' HCV education services, but those who did avail themselves of these HCV education opportunities generally assessed them positively. In all, many patients were unaware that HCV education was offered at their programs through individual sessions with staff, group meetings, and books/pamphlets, (42%, 49%, and 46% of the patients, respectively, and 22% were unaware that any HCV education opportunities existed. Conclusion Efforts especially need

  20. Intrathecal Catheterization and Drug Delivery in Guinea Pigs: A Small-animal Model for Morphine-evoked Granuloma Formation.

    Science.gov (United States)

    Eddinger, Kelly A; Rondon, Eric S; Shubayev, Veronica I; Grafe, Marjorie R; Scadeng, Miriam; Hildebrand, Keith R; Page, Linda M; Malkmus, Shelle A; Steinauer, Joanne J; Yaksh, Tony L

    2016-08-01

    Intrathecal infusion of opioids in dogs, sheep, and humans produces local space-occupying masses. To develop a small-animal model, the authors examined effects of intrathecal catheterization and morphine infusion in guinea pigs. Under isoflurane, polyethylene or polyurethane catheters were advanced from the cisterna magna to the lumbar enlargement. Drugs were delivered as a bolus through the externalized catheter or continuously by subcutaneous minipumps. Hind paw withdrawal to a thermal stimulus was assessed. Spinal histopathology was systematically assessed in a blinded fashion. To assist in determining catheter placement, ex vivo images were obtained using magnetic resonance imaging in several animals. Canine spinal tissue from previous intrathecal morphine studies was analyzed in parallel. (1) Polyethylene (n = 30) and polyurethane (n = 25) catheters were implanted in the lumbar intrathecal space. (2) Bolus intrathecal morphine produced a dose-dependent (20 to 40 μg/10 μl) increase in thermal escape latencies. (3) Absent infusion, a catheter-associated distortion of the spinal cord and a fibrotic investment were noted along the catheter tract (polyethylene > polyurethane). (4) Intrathecal morphine infusion (25 mg/ml/0.5 μl/h for 14 days) resulted in intrathecal masses (fibroblasts, interspersed collagen, lymphocytes, and macrophages) arising from meninges proximal to the catheter tip in both polyethylene- and polyurethane-catheterized animals. This closely resembles mass histopathology from intrathecal morphine canine studies. Continuous intrathecal infusion of morphine leads to pericatheter masses that morphologically resemble those observed in dogs and humans. This small-animal model may be useful for studying spinal drug toxicology in general and the biology of intrathecal granuloma formation in particular.

  1. 78 FR 46958 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2014

    Science.gov (United States)

    2013-08-02

    ... send a check by a courier such as Federal Express or United Parcel Service, the courier may deliver the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0007... of the Treasury notifies FDA of payment. U.S. Bank and the United States Treasury are required to...

  2. 76 FR 45811 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... additional fees. If you prefer to send a check by a courier such as Federal Express (FEDEX) or United Parcel Service (UPS), the courier may deliver the check and printed copy of the cover sheet to: U.S. Bank, Attn... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0548...

  3. 78 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables

    Science.gov (United States)

    2013-09-26

    ... ``mosaic'' effect, has been recognized by the Courts as a legitimate issue of concern in the context of... highlights the public health relevance of these data, and is consistent with the FDA's strategy to promote... marketing drug products in each class during the calendar year. [[Page 59311

  4. 76 FR 17927 - Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin...

    Science.gov (United States)

    2011-03-31

    ... Drug) Labeler Code) Roche Vitamins, Inc., 45 Waterview NADA 093-029 524.520 Blvd., Parsippany, NJ 07054... phosphate/ sulfamethazine). Pegasus Laboratories, Inc., 8809 Ely NADA 102-824 520.1720a Rd., Pensacola, FL 32514. Phenylbutazone Tablets........ (055246) (phenylbutazone) Wendt Laboratories, Inc., 100 Nancy NADA...

  5. 77 FR 4227 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor Analog...

    Science.gov (United States)

    2012-01-27

    ... Factor Analog-Diphtheria Toxoid Conjugate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... extends the slaughter interval for intact male swine injected with gonadotropin releasing factor analog...-322 for IMPROVEST (gonadotropin releasing factor analog-diphtheria toxoid conjugate) Sterile Solution...

  6. 76 FR 27888 - Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria...

    Science.gov (United States)

    2011-05-13

    ... Factor-Diphtheria Toxoid Conjugate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. [[Page... veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid conjugate by subcutaneous... provides for the veterinary prescription use of IMPROVEST (gonadotropin releasing factor-diphtheria toxoid...

  7. 77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

    Science.gov (United States)

    2012-11-20

    ... must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION...

  8. 77 FR 3598 - Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray

    Science.gov (United States)

    2012-01-25

    ... veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs. DATES... Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, (240... prescription use of Gentamicin Topical Spray (gentamicin sulfate and betamethasone valerate) in dogs. Sparhawk...

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

    Science.gov (United States)

    2010-09-28

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

  10. 77 FR 35837 - Conditionally Approved New Animal Drugs for Minor Use and Minor Species; Masitinib

    Science.gov (United States)

    2012-06-15

    .... The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs. DATES... in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. In accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Minor Use and...

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

    Science.gov (United States)

    2010-04-01

    ... posaconazole for the treatment of otitis externa in dogs. DATES: This rule is effective April 1, 2010. FOR... posaconazole) Otic Suspension for the treatment of otitis externa in dogs associated with susceptible strains... statement is required. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C...

  12. 76 FR 12563 - Oral Dosage Form New Animal Drugs; Spinosad and Milbemycin Oxime

    Science.gov (United States)

    2011-03-08

    ... spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the... and milbemycin oxime) Chewable Tablets in dogs for the treatment and prevention of flea infestations... Friday. Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2...

  13. 78 FR 42006 - Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol

    Science.gov (United States)

    2013-07-15

    ... associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. 200.... Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner... control of atopic dermatitis in dogs at least 12 months of age. (3) Limitations. Federal law restricts...

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

    Science.gov (United States)

    2012-02-01

    ..., and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and... use in dogs--(1) Amount. Administer 25 mg per pound of body weight by mouth every 6 hours. (2....600(c) of this chapter. (c) Conditions of use in dogs and cats--(1) Amount. Apply every 3 hours around...

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

    DEFF Research Database (Denmark)

    Aarestrup, Frank Møller

    2005-01-01

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

  16. 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.

  17. Increasing availability of illicit and prescription opioids among people who inject drugs in a Canadian setting, 2010-2014.

    Science.gov (United States)

    Ho, Joel; DeBeck, Kora; Milloy, M-J; Dong, Huiru; Wood, Evan; Kerr, Thomas; Hayashi, Kanna

    2018-01-01

    Nonmedical use of prescription opioid and illicit opioid has been increasing at an alarming rate in North America over the past decade. We sought to examine the temporal trends and correlates of the availability of illicit and prescription opioids among people who inject drugs (PWID) in Vancouver, Canada. Data were derived from three prospective cohort studies of PWID in Vancouver between 2010 and 2014. In semiannual interviews, participants reported the availability of five sets of illicit and prescription opioids: (1) heroin; (2) Percocet (oxycodone/acetaminophen), Vicodin (hydrocodone/acetaminophen), or Demerol (meperidine); (3) Dilaudid (hydromorphone); (4) Morphine; (5) oxycontin/OxyNEO (controlled-release oxycodone). We defined perceived availability as immediate (e.g., available within 10 minutes) versus no availability/available after 10 minutes. The trend and correlation of immediate availability were identified by multivariable generalized estimating equations logistic regression. Among 1584 participants, of which 564 (35.6%) were female, the immediate availability of all illicit and prescribed opioids (except for oxycontin/OxyNEO) increased over time, independent of potential confounders. The Adjusted Odds Ratios of immediate availability associated with every calendar year increase were between 1.09 (95% confidence interval 1.05-1.12) (morphine and Dilaudid) and 1.13 (95% confidence interval 1.09-1.17) (Percocet/Vicodin/Demerol) (all p-values illicit and prescription opioid use among PWID that could potentially increase the risk of overdose.

  18. 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...

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

    International Nuclear Information System (INIS)

    Singh, B.B.; Srinivasan, V.T.; Shenoy, M.A.; George, K.C.; Maniar, H.S.; Rawat, K.P.

    1987-01-01

    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

  20. 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.

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

    Science.gov (United States)

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

  2. 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. PMID:24223797

  3. The changes in drug binding activity of GABA receptor and animal neural-behavior after gamma irradiation

    International Nuclear Information System (INIS)

    Zheng Hui; Zhen Rong; Zhao Naikun; Xue Hong; Wang Zihui

    2004-01-01

    Objective: The purpose of this study was to investigate the effect of irradiation on gamma-aminobutyric-acid receptor (GABA-R) as well as behavioral changes after brain 60 Co γ-irradiation. Methods: The mice were irradiated with gamma rays (20 Gy; 10 Gy and 5 Gy) . The drug binding activity of GABA receptor in brain receptor was measured by fluorescence anisotropy (FA) and equilibrium dissociation constants. The behavioral changes were observed by the locomotor activity test, elevated plus-maze test and hole-board test at 1, 10, 24 and 48 hr after irradiation. Results: 1. The drug binding activity of the GABA receptor was decreased and the equilibrium dissociation constant (K d ) was significantly increased compared with the negative control group 2 hr after irradiation, and a spike value appeared at 24 hr. It showed that the irradiation might damage or decrease the binding activity and the bio-activity of GABA receptor. 2. The animal experiment confirmed that the irradiated animal model showed neural-behavioral changes of anxiety or depression. 3. The decreased binding activity of GABA receptor and changes in behavior of irradiated animal were dependent on radiation intensity. 4. The changes of behavior was similar to the blocked GABA receptor group. It suggests the relationship of radiation and GABA receptor. Conclusion: These results suggest that GABA receptor may be involved in radiation injury. The functional changes of GABA receptor may be an induction factor of behavioral disorder. The article also discussed the effect of anxiety and results obtained from the point of view of GABA receptor system involvement in the changes observed after irradiation. (authors)

  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

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

  5. Assessment of topical non-steroidal anti-inflammatory drugs in animal models.

    Science.gov (United States)

    Hiramatsu, Y; Akita, S; Salamin, P A; Maier, R

    1990-10-01

    Four commercial gel preparations of topical anti-inflammatory agents have been assessed in six animal models commonly used to determine the biological activity of non-steroidal anti-inflammatory agents for systemic administration. Only UV-induced erythema of the skin, adjuvant induced arthritis and the measurement of vascular permeability proved suitable for differentiation of the potency of the four topical agents. Carrageenin-induced paw oedema, the cotton pellet test and the assessment of the pain threshold according to Randall and Selitto were of little value. The effects of the gel preparation of diclofenac (CAS 15307-86-5) diethylammonium (Voltaren Emulgel) were comparable to two preparations containing 1% and 5% active ingredient, respectively. Gel 4 showed low overall activity. The experiments demonstrated that some of the models used for the assessment of anti-inflammatory agent for systemic administration proved suitable for the testing of topical preparations and that percutaneous absorption was insufficient to elicit anti-inflammatory effect in the animals at sites remote from the site of application.

  6. Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

    International Nuclear Information System (INIS)

    Shleien, B.; Schmidt, G.D.; Chiacchierini, R.P.

    1978-01-01

    The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

  7. Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

    Energy Technology Data Exchange (ETDEWEB)

    Shleien, B; Schmidt, G D; Chiacchierini, R P [Food and Drug Administration, Bureau of Radiological Health, Rockville, MD (United States)

    1978-12-01

    The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

  8. Spatial navigation: implications for animal models, drug development and human studies

    Czech Academy of Sciences Publication Activity Database

    Stuchlík, Aleš; Kubík, Štěpán; Vlček, Kamil; Valeš, Karel

    2014-01-01

    Roč. 63, Suppl.1 (2014), S237-S249 ISSN 0862-8408 R&D Projects: GA ČR(CZ) GBP304/12/G069; GA ČR(CZ) GAP303/12/1464; GA MZd(CZ) NT13386; GA MZd(CZ) NT13403; GA ČR(CZ) GA14-03627S Grant - others:Rada Programu interní podpory projektů mezinárodní spolupráce AV ČR(CZ) M200111204; EC(XE) PIR06-GA/2009-256581 Institutional support: RVO:67985823 Keywords : behavior * rat * animal models Subject RIV: FH - Neurology Impact factor: 1.293, year: 2014

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

    Science.gov (United States)

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

    2016-12-01

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

  10. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not misuse drugs. In animal studies, methamphetamine has been shown to increase the amount of HIV in brain cells 1 . Drug use disorder treatment. Since the late ...

  11. Animal experimentation

    OpenAIRE

    Laz, Alak; Cholakova, Tanya Stefanova; Vrablova, Sofia; Arshad, Naverawaheed

    2016-01-01

    Animal experimentation is a crucial part of medical science. One of the ways to define it is any scientific experiment conducted for research purposes that cause any kind of pain or suffering to animals. Over the years, the new discovered drugs or treatments are first applied on animals to test their positive outcomes to be later used by humans. There is a debate about violating ethical considerations by exploiting animals for human benefits. However, different ethical theories have been made...

  12. 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

    ), 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...... on both soils in the second year, and there was no detectable residual effect of the treatments on grass yield and P uptake. In conclusion, untreated ash and solid manures used in this study were not suitable as starter P fertilizer, but could be used to maintain the level of available P in soil......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...

  13. 75 FR 45636 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... . (The Pay.gov payment option is available to you after you submit a cover sheet. Click the ``Pay Now... that the number of applications that will pay fees in FY 2011 will equal 30 percent less than the... average receipts of 14.4 per year over the latest 5 years, including our FY 2010 estimate. Applying a 30...

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

    OpenAIRE

    Desquesnes, M.; Yangtara, S.; Kunphukhieo, P.; Jittapalapong, S.; Herder, Stéphane

    2016-01-01

    Beside typical human trypanosomes responsible of sleeping sickness in Africa and Chagas disease in Latin America, there is a growing number of reported atypical human infections due to Trypanosoma evansi, a livestock parasite, or Trypanosoma lewisi, a rat parasite, especially in Asia. Drugs available for the treatment of T. brucei ssp. in humans are obviously of choice for the control of T. evansi because it is derived from T. brucei. However, concerning T. lewisi, there is an urgent need to ...

  15. 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.

  16. Doxorubicin-loaded QuadraSphere microspheres: plasma pharmacokinetics and intratumoral drug concentration in an animal model of liver cancer.

    Science.gov (United States)

    Lee, Kwang-Hun; Liapi, Eleni A; Cornell, Curt; Reb, Philippe; Buijs, Manon; Vossen, Josephina A; Ventura, Veronica Prieto; Geschwind, Jean-Francois H

    2010-06-01

    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.

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

    International Nuclear Information System (INIS)

    Lee, Kwang-Hun; Liapi, Eleni A.; Cornell, Curt; Reb, Philippe; Buijs, Manon; Vossen, Josephina A.; Ventura, Veronica Prieto; Geschwind, Jean-Francois H.

    2010-01-01

    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.

  18. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin ...

  19. Animal experiment and clinical preliminary application of percutaneous 70% ethanol injection therapy in multi-drug resistant pulmonary tuberculosis

    International Nuclear Information System (INIS)

    Liu Fuquan; Yue Zhendong; Gao Shunyu; Li YanSheng; Wei Guobin; Guo Weiyi; Chen Xijun; Li Baoyu

    2004-01-01

    Objective: To evaluate the clinical value of percutaneous injection of 70% ethanol in the treatment of multidrug resistant pulmonary tuberculosis. Methods: Percutaneous and transcatheter absolute ethanol, 70% ethanol, and 60% meglucamine diatrizoate(or distilled water) injection into the lung (25 cases) and the bronchi (25 cases) of healthy rabbits were performed, respectively.All specimens were studied with pathology. On the base of animals experiment, thirty-five patients with multi-drug resistant pulmonary tuberculosis were treated with percutaneous 70% ethanol injection. Every patient was treated by the same way for 1-3 times. Results: Pathological findings of the specimens of pulmonary tissue showed nonspecific inflammation, necrosis, and fibrosis. The chief pathological changes with percutaneous or transcatheter 70% ethanol injection were slighter than those with absolute ethanol injection. Pathological findings of the specimens of bronchi showed slight mucosal edema, nonspecific inflammation, and focal cytonecrosis. Recovery of the damaged bronchial mucosa occurred within 14-30 days after the treatment. All patients with multi-drug resistant pulmonary tuberculosis were followed up for 6 to 33 months. The sputum bacterial conversion to negative rate was 100% within 6 months after the treatment. Cavity closing, shrinking, and no changing rate were 47.1% (16/34), 50.0% (17/34), and 2.9% (1/34), respectively. Radiographic improvement rate was 94.3 % (33/35). No severe complications and adverse reactions occurred. Conclusion: Percutaneous 70% ethanol injection is safe, effective, and easy to perform in the treatment of multi-drug resistant pulmonary tuberculosis. (authors)

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

    Science.gov (United States)

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

    2009-10-01

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

  1. Availability and cost of major and first-line antiepileptic drugs: a comprehensive evaluation in the capital of Madagascar.

    Science.gov (United States)

    Jost, Jeremy; Raharivelo, Adeline; Ratsimbazafy, Voa; Nizard, Mandy; Auditeau, Emilie; Newton, Charles R; Preux, Pierre-Marie

    2016-01-01

    The prevalence of epilepsy is high in Madagascar (23.5/1000), as is the treatment gap (estimated at 92 %). The health system of the country is underfunded; some AEDs are used, and the national drug policy does not encourage price regulation or the administration of generic agents. We conducted a cross-sectional study to assess the availability and cost of solid oral AED formulations in Antananarivo, capital of Madagascar. Data were gathered from all officially registered pharmacies (according to the drug agency list, updated in 2015) by means of telephone interviews lasting no more than 10 min and conducted by a native Malagasy speaker. With regard to other sources (hospitals, illicit sales) data were obtained at specific visits. The study received ethical approval from the Madagascar Ministry of Health. A total of 91 of 100 pharmacies (the nine not included were because of an inoperative phone number), two of three public hospitals, and two illegal outlets were investigated. Sodium valproate was available in 84.6 % of the pharmacies, while carbamazepine and phenobarbital were available in 68.1 % and 36.3 % of the pharmacies, respectively, but phenytoin was not available in any supply chain. There were more originator brands than generic formulations, with a higher cost (range 20.3-81.1 %, median 40.7 %) compared to the equivalent generic. The public system had only a very limited choice of AED, but offered the lowest costs. Illicit sources were more expensive by 54.3 % for carbamazepine and 62.5 % for phenobarbital. Concerning the annual cost of treatment, the average percentage of the gross national income per capita based on the purchasing power parity was 29.8 %/19.0 % (brand/generic) for sodium valproate, 16.4 %/7.3 % (brand/generic) for carbamazepine, 8.9 %/5.1 % (brand/generic) for phenobarbital. The main sources of AEDs were private pharmacies, but the stocks held were low. The financial burden was still important in the capital of Madagascar

  2. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Skip to common links HHS U.S. Department of Health and Human Services U.S. Food and Drug Administration A to Z Index Follow FDA En Español Search FDA Submit search ... & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet ...

  3. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  4. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S; Kesselheim, Aaron S

    2018-03-19

    To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Observational study. Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated

  5. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S

    2018-01-01

    Abstract Objectives To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Design Observational study. Setting Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Study cohort Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Main outcome measures Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Results Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might

  6. Proposed Food and Drug Administration protective action guides for human food and animal feed: methods and implementation

    International Nuclear Information System (INIS)

    Schmidt, G.D.; Shleien, B.; Chiacchierini, R.P.

    1978-01-01

    The Food and Drug Administration's proposed recommendations to State and local agencies provide guidance on appropriate planning actions necessary for evaluating and preventing radioactive contamination of foods and animal feeds and the control and use of such products should they become contaminated. This presentation will cover the recommendations on implementation of the Preventive and Emergency PAG's. These recommendations include (1) the use of 'Dietary Factors' to obtain PAG's for specific food items from the general guidance, (2) procedures to be used for radionuclide mixtures and other radionuclides, (3) field and laboratory methods for the measurement of the level of contamination in the event of an incident and, (4) protective actions to be implemented by State and local agencies to limit the radiation dose to the public. Specific protective actions which should be considered for implementation when the projected dose exceeds the Preventive PAG are given for application to pasture, milk, fruits and vegetables, and grains. At the Emergency PAG level, the protective action decision is whether condemnation or other disposition is appropriate. (author)

  7. The Modulatory Properties of Chronic Antidepressant Drugs Treatment on the Brain Chemokine – Chemokine Receptor Network: A Molecular Study in an Animal Model of Depression

    Directory of Open Access Journals (Sweden)

    Ewa Trojan

    2017-11-01

    Full Text Available An increasing number of studies indicate that the chemokine system may be the third major communication system of the brain. Therefore, the role of the chemokine system in the development of brain disorders, including depression, has been recently proposed. However, little is known about the impact of the administration of various antidepressant drugs on the brain chemokine – chemokine receptor axis. In the present study, we used an animal model of depression based on the prenatal stress procedure. We determined whether chronic treatment with tianeptine, venlafaxine, or fluoxetine influenced the evoked by prenatal stress procedure changes in the mRNA and protein levels of the homeostatic chemokines, CXCL12 (SDF-1α, CX3CL1 (fractalkine and their receptors, in the hippocampus and frontal cortex. Moreover, the impact of mentioned antidepressants on the TGF-β, a molecular pathway related to fractalkine receptor (CX3CR1, was explored. We found that prenatal stress caused anxiety and depressive-like disturbances in adult offspring rats, which were normalized by chronic antidepressant treatment. Furthermore, we showed the stress-evoked CXCL12 upregulation while CXCR4 downregulation in hippocampus and frontal cortex. CXCR7 expression was enhanced in frontal cortex but not hippocampus. Furthermore, the levels of CX3CL1 and CX3CR1 were diminished by prenatal stress in the both examined brain areas. The mentioned changes were normalized with various potency by chronic administration of tested antidepressants. All drugs in hippocampus, while tianeptine and venlafaxine in frontal cortex normalized the CXCL12 level in prenatally stressed offspring. Moreover, in hippocampus only fluoxetine enhanced CXCR4 level, while fluoxetine and tianeptine diminished CXCR7 level in frontal cortex. Additionally, the diminished by prenatal stress levels of CX3CL1 and CX3CR1 in the both examined brain areas were normalized by chronic tianeptine and partially fluoxetine

  8. 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…

  9. Disponibilidade de medicamentos essenciais em duas regiões de Minas Gerais, Brasil Availability of essential drugs in two regions of Minas Gerais, Brazil

    Directory of Open Access Journals (Sweden)

    Augusto Afonso Guerra Jr

    2004-03-01

    Full Text Available OBJETIVO: Avaliar a disponibilidade de medicamentos essenciais em localidades com índice de desenvolvimento humano OBJECTIVE: To investigate the availability of essential drugs in municipalities with a human development index < 0.699. METHODS: We surveyed 69 institutions, including municipal pharmacies, public clinics, private and philanthropic health units, and commercial pharmacies, in 19 municipalities of the state of Minas Gerais, Brazil. The municipalities were chosen according to the following selection criteria: (1 a human development index (HDI < 0.699 (the HDI for the entire state of Minas Gerais in 1991 in the microregion where the municipality was located; (2 the municipality had to be the seat of government for the microregion where it was located; (3 there had to be at least two eligible institutions (belonging to the public, private, or philanthropic sectors in full functioning in the municipality during the survey period. Health professionals who were directly responsible for stock control and drug dispensation at the institutions surveyed were interviewed. Institutional documents and records were also reviewed. A list of 21 tracer essential drugs, which were selected among the drugs most widely employed in the State of Minas Gerais’ Basic Pharmacy Program, was used to measure availability. The availability of each tracer drug was calculated at the time of the site visit and for the 12-month period immediately before the survey. In addition, the availability of tracer drugs was calculated for each type of institution surveyed. RESULTS: The availability of essential drugs in municipal pharmacies was 52.0%; in public health clinics, 46.9%; and in philanthropic and private health units, 41.0% and 38.1%, respectively. In commercial pharmacies, the availability of essential drugs reached 81.2%. CONCLUSION: The availability of essential drugs in public facilities is low and varies widely, with the result that persons who need such

  10. Emotional valence and context of social influences on drug abuse-related behavior in animal models of social stress and prosocial interaction.

    Science.gov (United States)

    Neisewander, J L; Peartree, N A; Pentkowski, N S

    2012-11-01

    Social factors are important determinants of drug dependence and relapse. We reviewed pre-clinical literature examining the role of social experiences from early life through the development of drug dependence and relapse, emphasizing two aspects of these experiences: (1) whether the social interaction is appetitive or aversive and (2) whether the social interaction occurs within or outside of the drug-taking context. The models reviewed include neonatal care, isolation, social defeat, chronic subordination, and prosocial interactions. We review results from these models in regard to effects on self-administration and conditioned place preference established with alcohol, psychostimulants, and opiates. We suggest that in general, when the interactions occur outside of the drug-taking context, prosocial interactions are protective against drug abuse-related behaviors, whereas social stressors facilitate these behaviors. By contrast, positive or negative social interactions occurring within the drug-taking context may interact with other risk factors to enhance or inhibit these behaviors. Despite differences in the nature and complexity of human social behavior compared to other species, the evolving animal literature provides useful models for understanding social influences on drug abuse-related behavior that will allow for research on the behavioral and biological mechanisms involved. The models have contributed to understanding social influences on initiation and maintenance of drug use, but more research is needed to understand social influences on drug relapse.

  11. Validation of a Commercially Available Enzyme ImmunoAssay for the Determination of Oxytocin in Plasma Samples from Seven Domestic Animal Species

    Directory of Open Access Journals (Sweden)

    Cecile Bienboire-Frosini

    2017-09-01

    Full Text Available The neurohormone oxytocin (OT has a broad range of behavioral effects in mammals. It modulates a multitude of social behaviors, e.g., affiliative and sexual interactions. Consequently, the OT role in various animal species is increasingly explored. However, several issues have been raised regarding the peripheral OT measurement. Indeed, various methods have been described, leading to assay discrepancies and inconsistent results. This highlights the need for a recognized and reliable method to measure peripheral OT. Our aim was to validate a method combining a pre-extraction step, previously demonstrated as essential by several authors, and a commercially available enzyme immunoassay (EIA for OT measurement, using plasma from seven domestic species (cat, dog, horse, cow, pig, sheep, and goat. The Oxytocin EIA kit (EnzoLifeSciences was used to assay the solid-phase extracted samples following the manufacturer's instructions with slight modifications. For all species except dogs and cats, concentration factors were applied to work above the kit's sensitivity (15 pg/ml. To validate the method, the following performance characteristics were evaluated using Validation Samples (VS at various concentrations in each species: extraction efficiency via spiking tests and intra- and inter-assay precision, allowing for the calculation of total errors. Parallelism studies to assess matrix effects could not be performed because of too low basal concentrations. Quantification ranges and associated precision profiles were established to account for the various OT plasma concentrations in each species. According to guidelines for bioanalytical validation of immunoassays, the measurements were sufficiently precise and accurate in each species to achieve a total error ≤30% in each VS sample. In each species, the inter-assay precision after 3 runs was acceptable, except in low concentration samples. The linearity under dilution of dogs and cats' samples was

  12. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Science.gov (United States)

    2011-04-13

    ... Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to... exploration and verification of drug effects under epidemic and pandemic conditions. A draft notice of...

  13. Availability of and access to orphan drugs: an international comparison of pharmaceutical treatments for pulmonary arterial hypertension, Fabry disease, hereditary angioedema and chronic myeloid leukaemia.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom; Schreyögg, Jonas

    2011-01-01

    Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US. Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib. Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and

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

    International Nuclear Information System (INIS)

    Nozaki, Yumiko; Honda, Yayoi; Tsujimoto, Shinji; Watanabe, Hitoshi; Kunimatsu, Takeshi; Funabashi, Hitoshi

    2014-01-01

    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 + channel and Ca 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 Kr and I Ks blockers concentration-dependently prolonged corrected FPD (FPDc), whereas Ca 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 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

  15. 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.

  16. Histological vis-a-vis biochemical assessment on the toxic level and antineoplastic efficacy of a synthetic drug Pt-ATP on experimental animal models.

    Science.gov (United States)

    Pal, Shipra; Sadhu, Arpita Sengupta; Patra, Swarup; Mukherjea, Kalyan K

    2008-11-12

    Cisplatin, a platinum based anticancer drug has played a vital role in the treatment of cancers by chemical agents, but in view of the serious toxicity including nephrotoxicity of cisplatin, various other platinum based drugs have been synthesized and screened to overcome its toxicity. A Pt-ATP compound was prepared in our laboratory hoping to have reduced or no toxicity along with the potentiality of reducing neoplasm growth. A Pt-ATP compound was prepared. It was first screened for its antineoplastic efficacy. Confirming that, subsequent experiments were carried on to test its toxicity on animals, viz. Albino Swiss mice. The animals were randomly divided into four sets--Set I: Erhlich Ascites Carcinoma (EAC) challenged mice; Set II: Normal mice; Set III: Drug treated mice, Set IVA Cisplatin (CDDP) treated mice, Set IV B EAC challenged Cisplatin treated mice. Set I was used to test antineoplasticity of the drug, Set II and Set III for studying drug toxicity and Set IV was treated with CDDP. Set II was used as a control. Animals were sacrificed after 5 days, 10 days 15 days and 20 days of drug administration on the 6th, 11th, 16th and 21st days respectively for Set I, II and III. Set IVA was sacrificed only on the 16th day and Set IV B on 6th and 11th days. For Set I only tumor cell count and packed cell volume (PCV) of tumor cells were recorded. For Set II and III, aspartate aminotransferase (AST), alanine aminotransferase (ALT) assays were done using serum while blood creatinine and creatine were assayed from blood filtrate. For cytotoxicity assessment liver, spleen and kidney tissues were collected and subjected to scanning electron microscopy (SEM) after extensive treatment. Set IV A was only studied for the biochemical parameters viz. aspartate aminotransferase (AST), alanine aminotransferase (ALT) assays were done using serum while blood creatinine and creatine were assayed from blood filtrate. Set IV B was studied for tumor cell count after treatment with

  17. Whole bone testing in small animals: systematic characterization of the mechanical properties of different rodent bones available for rat fracture models.

    Science.gov (United States)

    Prodinger, Peter M; Foehr, Peter; Bürklein, Dominik; Bissinger, Oliver; Pilge, Hakan; Kreutzer, Kilian; von Eisenhart-Rothe, Rüdiger; Tischer, Thomas

    2018-02-14

    Rat fracture models are extensively used to characterize normal and pathological bone healing. Despite, systematic research on inter- and intra-individual differences of common rat bones examined is surprisingly not available. Thus, we studied the biomechanical behaviour and radiological characteristics of the humerus, the tibia and the femur of the male Wistar rat-all of which are potentially available in the experimental situation-to identify useful or detrimental biomechanical properties of each bone and to facilitate sample size calculations. 40 paired femura, tibiae and humeri of male Wistar rats (10-38 weeks, weight between 240 and 720 g) were analysed by DXA, pQCT scan and three-point-bending. Bearing and loading bars of the biomechanical setup were adapted percentually to the bone's length. Subgroups of light (skeletal immature) rats under 400 g (N = 11, 22 specimens of each bone) and heavy (mature) rats over 400 g (N = 9, 18 specimens of each bone) were formed and evaluated separately. Radiologically, neither significant differences between left and right bones, nor a specific side preference was evident. Mean side differences of the BMC were relatively small (1-3% measured by DXA and 2.5-5% by pQCT). Over all, bone mineral content (BMC) assessed by DXA and pQCT (TOT CNT, CORT CNT) showed high correlations between each other (BMC vs. TOT and CORT CNT: R 2  = 0.94-0.99). The load-displacement diagram showed a typical, reproducible curve for each type of bone. Tibiae were the longest bones (mean 41.8 ± 4.12 mm) followed by femurs (mean 38.9 ± 4.12 mm) and humeri (mean 29.88 ± 3.33 mm). Failure loads and stiffness ranged from 175.4 ± 45.23 N / 315.6 ± 63.00 N/mm for the femurs, 124.6 ± 41.13 N / 260.5 ± 59.97 N/mm for the humeri to 117.1 ± 33.94 N / 143.8 ± 36.99 N/mm for the tibiae. Smallest interindividual differences were observed in failure loads of the femurs (CV% 8.6) and tibiae (CV% 10.7) of heavy

  18. Validation of a Commercially Available Enzyme ImmunoAssay for the Determination of Oxytocin in Plasma Samples from Seven Domestic Animal Species.

    Science.gov (United States)

    Bienboire-Frosini, Cecile; Chabaud, Camille; Cozzi, Alessandro; Codecasa, Elisa; Pageat, Patrick

    2017-01-01

    The neurohormone oxytocin (OT) has a broad range of behavioral effects in mammals. It modulates a multitude of social behaviors, e.g., affiliative and sexual interactions. Consequently, the OT role in various animal species is increasingly explored. However, several issues have been raised regarding the peripheral OT measurement. Indeed, various methods have been described, leading to assay discrepancies and inconsistent results. This highlights the need for a recognized and reliable method to measure peripheral OT. Our aim was to validate a method combining a pre-extraction step, previously demonstrated as essential by several authors, and a commercially available enzyme immunoassay (EIA) for OT measurement, using plasma from seven domestic species (cat, dog, horse, cow, pig, sheep, and goat). The Oxytocin EIA kit (EnzoLifeSciences) was used to assay the solid-phase extracted samples following the manufacturer's instructions with slight modifications. For all species except dogs and cats, concentration factors were applied to work above the kit's sensitivity (15 pg/ml). To validate the method, the following performance characteristics were evaluated using Validation Samples (VS) at various concentrations in each species: extraction efficiency via spiking tests and intra- and inter-assay precision, allowing for the calculation of total errors. Parallelism studies to assess matrix effects could not be performed because of too low basal concentrations. Quantification ranges and associated precision profiles were established to account for the various OT plasma concentrations in each species. According to guidelines for bioanalytical validation of immunoassays, the measurements were sufficiently precise and accurate in each species to achieve a total error ≤30% in each VS sample. In each species, the inter-assay precision after 3 runs was acceptable, except in low concentration samples. The linearity under dilution of dogs and cats' samples was verified. Although

  19. Impact of caloric and dietary restriction regimens on markers of health and longevity in humans and animals: a summary of available findings

    Directory of Open Access Journals (Sweden)

    Kabir Mohammad M

    2011-10-01

    Full Text Available Abstract Considerable interest has been shown in the ability of caloric restriction (CR to improve multiple parameters of health and to extend lifespan. CR is the reduction of caloric intake - typically by 20 - 40% of ad libitum consumption - while maintaining adequate nutrient intake. Several alternatives to CR exist. CR combined with exercise (CE consists of both decreased caloric intake and increased caloric expenditure. Alternate-day fasting (ADF consists of two interchanging days; one day, subjects may consume food ad libitum (sometimes equaling twice the normal intake; on the other day, food is reduced or withheld altogether. Dietary restriction (DR - restriction of one or more components of intake (typically macronutrients with minimal to no reduction in total caloric intake - is another alternative to CR. Many religions incorporate one or more forms of food restriction. The following religious fasting periods are featured in this review: 1 Islamic Ramadan; 2 the three principal fasting periods of Greek Orthodox Christianity (Nativity, Lent, and the Assumption; and 3 the Biblical-based Daniel Fast. This review provides a summary of the current state of knowledge related to CR and DR. A specific section is provided that illustrates related work pertaining to religious forms of food restriction. Where available, studies involving both humans and animals are presented. The review includes suggestions for future research pertaining to the topics of discussion.

  20. Distribution of animal drugs among curd, whey, and milk protein fractions in spiked skim milk and whey

    Science.gov (United States)

    It is important to understand the partitioning of drugs in processed milk and milk products, when drugs are present in raw milk, in order to estimate the potential consumer exposure. Radioisotopically labelled erythromycin, ivermectin, ketoprofen, oxytetracycline, penicillin G, sulfadimethoxine, and...

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

    Directory of Open Access Journals (Sweden)

    Anuradha eGhosh

    2012-02-01

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

  2. Drug Facts

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  4. Drug Facts

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  5. Animation of Antimicrobial Resistance

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  6. Impact of caloric and dietary restriction regimens on markers of health and longevity in humans and animals: a summary of available findings.

    Science.gov (United States)

    Trepanowski, John F; Canale, Robert E; Marshall, Kate E; Kabir, Mohammad M; Bloomer, Richard J

    2011-10-07

    Considerable interest has been shown in the ability of caloric restriction (CR) to improve multiple parameters of health and to extend lifespan. CR is the reduction of caloric intake - typically by 20 - 40% of ad libitum consumption - while maintaining adequate nutrient intake. Several alternatives to CR exist. CR combined with exercise (CE) consists of both decreased caloric intake and increased caloric expenditure. Alternate-day fasting (ADF) consists of two interchanging days; one day, subjects may consume food ad libitum (sometimes equaling twice the normal intake); on the other day, food is reduced or withheld altogether. Dietary restriction (DR) - restriction of one or more components of intake (typically macronutrients) with minimal to no reduction in total caloric intake - is another alternative to CR. Many religions incorporate one or more forms of food restriction. The following religious fasting periods are featured in this review: 1) Islamic Ramadan; 2) the three principal fasting periods of Greek Orthodox Christianity (Nativity, Lent, and the Assumption); and 3) the Biblical-based Daniel Fast. This review provides a summary of the current state of knowledge related to CR and DR. A specific section is provided that illustrates related work pertaining to religious forms of food restriction. Where available, studies involving both humans and animals are presented. The review includes suggestions for future research pertaining to the topics of discussion.

  7. Impact of caloric and dietary restriction regimens on markers of health and longevity in humans and animals: a summary of available findings

    Science.gov (United States)

    2011-01-01

    Considerable interest has been shown in the ability of caloric restriction (CR) to improve multiple parameters of health and to extend lifespan. CR is the reduction of caloric intake - typically by 20 - 40% of ad libitum consumption - while maintaining adequate nutrient intake. Several alternatives to CR exist. CR combined with exercise (CE) consists of both decreased caloric intake and increased caloric expenditure. Alternate-day fasting (ADF) consists of two interchanging days; one day, subjects may consume food ad libitum (sometimes equaling twice the normal intake); on the other day, food is reduced or withheld altogether. Dietary restriction (DR) - restriction of one or more components of intake (typically macronutrients) with minimal to no reduction in total caloric intake - is another alternative to CR. Many religions incorporate one or more forms of food restriction. The following religious fasting periods are featured in this review: 1) Islamic Ramadan; 2) the three principal fasting periods of Greek Orthodox Christianity (Nativity, Lent, and the Assumption); and 3) the Biblical-based Daniel Fast. This review provides a summary of the current state of knowledge related to CR and DR. A specific section is provided that illustrates related work pertaining to religious forms of food restriction. Where available, studies involving both humans and animals are presented. The review includes suggestions for future research pertaining to the topics of discussion. PMID:21981968

  8. Determination of the external contamination and cross-contamination by cytotoxic drugs on the surfaces of vials available on the Swiss market.

    Science.gov (United States)

    Fleury-Souverain, Sandrine; Nussbaumer, Susanne; Mattiuzzo, Marc; Bonnabry, Pascal

    2014-04-01

    The external contamination and cross-contamination by cytotoxic drugs on the surface (outside and septum) of 133 vials from various manufacturers and available on the Swiss market were evaluated. All of the tested vials contained one of the following active ingredients: cyclophosphamide, cytarabine, doxorubicin, epirubicin, etoposide phosphate, gemcitabine, ifosfamide, irinotecan, methotrexate or vincristine. The validated wiping liquid chromatography-mass spectrometry method used in this study allowed for the simultaneous determination of these 10 cytotoxic drugs in less than 30 min. External contamination by cytotoxic drugs was detected on 63% of tested vials (outside and septum). The highest contamination level was observed on etoposide phosphate vials with 1896.66 ng of active ingredient on the outside of the vial. Approximately 20% of the contaminated vials had greater than 10 ng of cytotoxic drugs. Chemical contamination on the septum was detected on 38% of the vials. No contamination or very low levels of cytotoxic drugs, less than 1 ng per vial, were detected on the vials protected by plastic shrink-wrap. Traces of cytotoxic drugs different from the active ingredient were detected on 35% of the tested vials. Handling cytotoxic vials with gloves and having a procedure for the decontamination of vials are of the utmost importance for reducing exposure to cytotoxic drugs. Moreover, manufacturers must improve their procedures to provide products free from any contamination.

  9. 75 FR 79320 - Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing...

    Science.gov (United States)

    2010-12-20

    ... carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of ``S o '' and revising the definition of ``S m '' so that it conforms to the clarified definition of S... to induce cancer in man or animals. However, each clause contains an exception, termed the...

  10. A clinical trial comparing the responses of animal tumors receiving heat sensitizing drugs prior to whole body hyperthermia

    International Nuclear Information System (INIS)

    Klein, M.K.; Forsyth, K.; Dewhirst, M.W.; Fuller, D.J.M.

    1984-01-01

    Whole body hyperthermia (WBH) has rarely been found effective in inducing complete tumor responses. Recent in vitro studies showing that heat sensitizion is possible have renewed interest in this field. In this protocol, WBH is induced via a commercially available inductive device and maintained at 42 0 C for thirty minutes. The heat sensitizing drugs, difluoromethylornithine (DFMO) methylglyoxal bis (guanylhydrazone) (MGBG) are administered 48 hours before, in accordance with in vitro studies. Goals of the study include evaluation of normal tissue toxicity and tumor response. Two normal dogs were treated to study acute toxicities before inception of the clinical trial. The gastrointestinal and hematopoietic systems were used to monitor toxicities using systems review and serial bloodwork. These studies and preliminary clinical results of observed tumor regression in dogs with lymphomas are discussed. Consistent changes in all patients included elevations in liver enzymes, creatine phosphokinase (CPK), and white blood cell counts, as well as, decreases in platelet counts. All changes were transient and clinical signs were not associated with them. Tumor volume reductions from 25% to 74% have been documented

  11. 78 FR 14803 - Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications

    Science.gov (United States)

    2013-03-07

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

  12. High-throughput expression of animal venom toxins in Escherichia coli to generate a large library of oxidized disulphide-reticulated peptides for drug discovery.

    Science.gov (United States)

    Turchetto, Jeremy; Sequeira, Ana Filipa; Ramond, Laurie; Peysson, Fanny; Brás, Joana L A; Saez, Natalie J; Duhoo, Yoan; Blémont, Marilyne; Guerreiro, Catarina I P D; Quinton, Loic; De Pauw, Edwin; Gilles, Nicolas; Darbon, Hervé; Fontes, Carlos M G A; Vincentelli, Renaud

    2017-01-17

    Animal venoms are complex molecular cocktails containing a wide range of biologically active disulphide-reticulated peptides that target, with high selectivity and efficacy, a variety of membrane receptors. Disulphide-reticulated peptides have evolved to display improved specificity, low immunogenicity and to show much higher resistance to degradation than linear peptides. These properties make venom peptides attractive candidates for drug development. However, recombinant expression of reticulated peptides containing disulphide bonds is challenging, especially when associated with the production of large libraries of bioactive molecules for drug screening. To date, as an alternative to artificial synthetic chemical libraries, no comprehensive recombinant libraries of natural venom peptides are accessible for high-throughput screening to identify novel therapeutics. In the accompanying paper an efficient system for the expression and purification of oxidized disulphide-reticulated venom peptides in Escherichia coli is described. Here we report the development of a high-throughput automated platform, that could be adapted to the production of other families, to generate the largest ever library of recombinant venom peptides. The peptides were produced in the periplasm of E. coli using redox-active DsbC as a fusion tag, thus allowing the efficient formation of correctly folded disulphide bridges. TEV protease was used to remove fusion tags and recover the animal venom peptides in the native state. Globally, within nine months, out of a total of 4992 synthetic genes encoding a representative diversity of venom peptides, a library containing 2736 recombinant disulphide-reticulated peptides was generated. The data revealed that the animal venom peptides produced in the bacterial host were natively folded and, thus, are putatively biologically active. Overall this study reveals that high-throughput expression of animal venom peptides in E. coli can generate large

  13. Diagnostic imaging of herpes simplex virus encephalitis using a radiolabeled antiviral drug: autoradiographic assessment in an animal model

    International Nuclear Information System (INIS)

    Saito, Y.; Rubenstein, R.; Price, R.W.; Fox, J.J.; Watanabe, K.A.

    1984-01-01

    To develop a new approach to the diagnosis of herpes simplex encephalitis, we used a radiolabeled antiviral drug, 2'-fluoro-5-methyl-1-beta-D-arabinosyluracil labeled with carbon 14 ([14C]FMAU), as a probe for selectively imaging brain infection in a rat model by quantitative autoradiography. A high correlation was found between focal infection, as defined by immunoperoxidase viral antigen staining, and increased regional [14C]FMAU uptake in brain sections. Two potential sources of false-positive imaging were defined: high concentrations of drug in the choroid plexus because of its higher permeability compared with brain, and drug sequestration by proliferating uninfected cell populations. Our results support the soundness of the proposed strategy of using a labeled antiviral drug that is selectively phosphorylated by herpes simplex virus type 1 thymidine kinase in conjunction with scanning methods for human diagnosis, and also define some of the factors that must be taken into account when planning clinical application

  14. The distribution of radiolabelled drug in animals infected with cutaneous leishmaniasis: comparison of free and liposome-bound sodium stibogluconate

    International Nuclear Information System (INIS)

    New, R.R.C.; Chance, M.L.; Critchley, M.

    1982-01-01

    Sodium stibogluconate, labelled with antimony 125, was used to study the altered distribution of drugs, entrapped by positively and negatively charged liposomes, used to treat cutaneous leishmaniasis. (U.K.)

  15. Animation of Antimicrobial Resistance

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  16. Animation of Antimicrobial Resistance

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  17. Drug Facts

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

    International Nuclear Information System (INIS)

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

    2011-01-01

    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 99m Tc-MDP, DMSA, and 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, 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 99 mTc-DMSA SPECT/CT imaging study. We also performed the PET image study using U87MG tumor bearing mice and 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

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

    Science.gov (United States)

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

    2014-08-29

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

  20. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... who use methamphetamine than among HIV patients who do not misuse drugs. In animal studies, methamphetamine has ... risk, trends in HIV/AIDS, and what to do to counter these trends. Online Resources NIDA for ...

  1. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... cells in the brain and cognitive impairment among people who use methamphetamine than among HIV patients who do not misuse drugs. In animal studies, methamphetamine has been shown to increase the ...

  2. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not misuse drugs. In animal studies, methamphetamine has been shown to increase the ... of this virus. Although we currently have medical therapies that greatly extend the lives of people infected ...

  3. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... main content En español Researchers Medical & Health Professionals Patients & Families Parents & Educators Children & Teens Search Connect with ... among people who use methamphetamine than among HIV patients who do not misuse drugs. In animal studies, ...

  4. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not misuse drugs. In animal studies, methamphetamine has been shown to increase the ... groups of young people, guiding the use of technology, the discussion between friends, and the importance of ...

  5. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV patients who do not misuse 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. ...

  6. Multiscale Modeling of Antibody Drug Conjugates: Connecting tissue and cellular distribution to whole animal pharmacokinetics and potential implications for efficacy

    Science.gov (United States)

    Cilliers, Cornelius; Guo, Hans; Liao, Jianshan; Christodolu, Nikolas; Thurber, Greg M.

    2016-01-01

    Antibody drug conjugates exhibit complex pharmacokinetics due to their combination of macromolecular and small molecule properties. These issues range from systemic concerns, such as deconjugation of the small molecule drug during the long antibody circulation time or rapid clearance from non-specific interactions, to local tumor tissue heterogeneity, cell bystander effects, and endosomal escape. Mathematical models can be used to study the impact of these processes on overall distribution in an efficient manner, and several types of models have been used to analyze varying aspects of antibody distribution including physiologically based pharmacokinetic (PBPK) models and tissue-level simulations. However, these processes are quantitative in nature and cannot be handled qualitatively in isolation. For example, free antibody from deconjugation of the small molecule will impact the distribution of conjugated antibodies within the tumor. To incorporate these effects into a unified framework, we have coupled the systemic and organ-level distribution of a PBPK model with the tissue-level detail of a distributed parameter tumor model. We used this mathematical model to analyze new experimental results on the distribution of the clinical antibody drug conjugate Kadcyla in HER2 positive mouse xenografts. This model is able to capture the impact of the drug antibody ratio (DAR) on tumor penetration, the net result of drug deconjugation, and the effect of using unconjugated antibody to drive ADC penetration deeper into the tumor tissue. This modeling approach will provide quantitative and mechanistic support to experimental studies trying to parse the impact of multiple mechanisms of action for these complex drugs. PMID:27287046

  7. Pharmacokinetic evaluation of UK-49,858, a metabolically stable triazole antifungal drug, in animals and humans.

    Science.gov (United States)

    Humphrey, M J; Jevons, S; Tarbit, M H

    1985-11-01

    The pharmacokinetic profile of UK-49,858 (fluconazole), a novel triazole antifungal agent which is being developed for oral and intravenous use, was determined in mice, rats, dogs, and humans. Comparative data following oral and intravenous administration showed that bioavailability was essentially complete in all four species. Peak concentrations in plasma of drug normalized to a 1-mg/kg dose level following oral administration, were relatively high: 0.7, 0.6, 1.1, and 1.4 micrograms/ml in mice, rats, dogs, and humans, respectively. The volumes of distribution ranged between 1.1 liter/kg in mice and 0.7 liter/kg in humans, which are approximate to the values for total body water. Whole body autoradiography studies in mice following intravenous administration of [14C]UK-49,858 demonstrated that the drug was evenly distributed throughout the tissues, including the central nervous system and the gastrointestinal tract. Plasma protein binding was low (11 to 12%) in all species. Marked species differences were observed in elimination half-lives, with mean values of 4.8, 4.0, 14, and 22 h in mice, rats, dogs, and humans, respectively. The major route of elimination of the drug was renal clearance, with about 70% of the dose being excreted unchanged in the urine in each species. Studies with [14C]UK-49,858 on metabolism and excretion (intravenous and oral) in mice and dogs showed that about 90% of the dose was recovered as unchanged drug in urine and feces, confirming the metabolic stability of the drug. This pharmacokinetic profile is markedly different from that of imidazole antifungal drugs and undoubtedly contributes to the excellent efficacy of UK-49,858 in vivo.

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

    International Nuclear Information System (INIS)

    Coulibaly, Kafana

    1972-01-01

    The distribution of 14 C 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) [fr

  9. 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

  10. 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

    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...... 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...... 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...

  11. Analysis of metal and biocides resistance genes in drug resistance and susceptible Salmonella enterica from food animals

    Science.gov (United States)

    Background Generally drug resistant bacteria carry antibiotic resistance genes and heavy metal and biocide resistance genes on large conjugative plasmids. The presence of these metal and biocide resistance genes in susceptible bacteria are not assessed comprehensively. Hence, WGS data of susceptib...

  12. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Science.gov (United States)

    2010-09-02

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0432... Health Act of 2004 (MUMS act) establishes new regulatory procedures that provide incentives intended to... other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major...

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

    Science.gov (United States)

    2012-10-23

    ... Rutherford, NSW 2320, Injectable Anesthetic maintenance of Australia. for Cats and Dogs. anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in dogs and cats. [[Page 64716... Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the...

  14. 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.

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

    International Nuclear Information System (INIS)

    Haradahira, Terushi; Zhang, Ming-Rong; Maeda, Jun; Okauchi, Takashi; Kawabe, Kouichi; Kida, Takayo; Suzuki, Kazutoshi; Suhara, Tetsuya

    2000-01-01

    A positron-emitter labeled radioligand for the glycine-binding site of the N-methyl-D-aspartate (NMDA) receptor, [ 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. [ 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 [ 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 [ 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

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

    Science.gov (United States)

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

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

  17. Drug utilization review of potassium chloride injection formulations available in a private hospital in kuching, sarawak, malaysia.

    Science.gov (United States)

    Melissa, Mohammad Hirman; Azmi, Sarriff

    2013-07-01

    The concentrated potassium chloride injection is a high-alert medication and replacing it with a pre-mixed formulation can reduce the risks associated with its use. The aim of this study was to determine the clinical characteristics of patients receiving different potassium chloride formulations available at a private institution. The study also assessed the effectiveness and safety of pre-mixed formulations in the correction of hypokalaemia. This was a retrospective observational study consisting of 296 cases using concentrated and pre-mixed potassium chloride injections in 2011 in a private hospital in Kuching, Sarawak, Malaysia. There were 135 (45.6%) cases that received concentrated potassium chloride, and 161 (54.4%) cases that received pre-mixed formulations. The patients' clinical characteristics that were significantly related to the utilization of the different formulations were diagnosis (P < 0.001), potassium serum blood concentration (P < 0.05), and fluid overload risk (P < 0.05). The difference observed for the cases that achieved or maintained normokalaemia was statistically insignificant (P = 0.172). Infusion-related adverse effects were seen more in pre-mixes compared to concentrated formulations (6.8% versus 2.2%, P < 0.05). This study provides insight into the utilization of potassium chloride injections at this specific institution. The results support current recommendations to use pre-mixed formulations whenever possible.

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

    Science.gov (United States)

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

    2016-01-01

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

  19. Excipient-mediated alteration in drug bioavailability in the rat depends on the sex of the animal.

    Science.gov (United States)

    Mai, Yang; Afonso-Pereira, Francisco; Murdan, Sudaxshina; Basit, Abdul W

    2017-09-30

    The pharmaceutical excipient, polyethylene glycol 400 (PEG 400), unexpectedly alters the bioavailability of the BCS class III drug ranitidine in a sex-dependent manner. As ranitidine is a substrate for the efflux transporter P-glycoprotein (P-gp), we hypothesized that the sex-related influence could be due to interactions between PEG 400 and P-gp. In this study, we tested this hypothesis by: i) measuring the influence of PEG 400 on the oral bioavailability of another P-gp substrate (ampicillin) and of a non-P-gp substrate (metformin); and ii) measuring the effect of PEG 400 on drug bioavailability in the presence of a P-gp inhibitor (cyclosporine A) in male and female rats. We found that PEG 400 significantly increased (pbioavailability of ampicillin (the P-gp substrate) in male rats, but not in female ones. In contrast, PEG 400 had no influence on the bioavailability of the non-P-gp substrate, metformin in male or female rats. Inhibition of P-gp by oral pre-treatment with cyclosporine A increased the bioavailability of the P-gp substrates (ampicillin and ranitidine) in males and females (pbioavailability of metformin in either male or female rats. These results prove the hypothesis that the sex-specific effect of PEG 400 on the bioavailability of certain drugs is due to the interaction of PEG 400 with the efflux transporter P-gp. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Synthesis of enantiomerically enriched drug precursors and an insect pheromone via reduction of ketones using commercially available carbonyl reductase screening kit "Chiralscreen® OH".

    Science.gov (United States)

    Nagai, Toshiya; Sakurai, Saki; Natori, Naoki; Hataoka, Manaka; Kinoshita, Takako; Inoue, Hiroyoshi; Hanaya, Kengo; Shoji, Mitsuru; Sugai, Takeshi

    2018-04-01

    Commercially available "Chiralscreen® OH" starter kit containing five types of carbonyl reductases (E001, E007, E031, E039, and E078) was used for the reduction of several aromatic and aliphatic ketones to obtain enantiomerically enriched drug precursors and an insect pheromone. Almost stereochemically pure secondary alcohols, used in the synthesis of drugs such as (R)-rasagiline mesylate, (S)-rivastigmine, (R)-chlorphenesin carbamate, and (R)-mexiletine, and the insect pheromone (4S,5R)-sitophilure, were conveniently obtained. The enzymes worked well with ketones containing at least one non-bulky substituent at the carbonyl group. The diverse stereochemical preference of the above five carbonyl reductases was clarified. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Comparison between two commercially available serological tests and polymerase chain reaction in the diagnosis of Cryptosporidium in animals and diarrhoeic children.

    Science.gov (United States)

    Helmy, Yosra A; Krücken, Jürgen; Nöckler, Karsten; von Samson-Himmelstjerna, Georg; Zessin, Karl-H

    2014-01-01

    For the detection of Cryptosporidium species in 804 animals and 165 diarrhoeic children (tests, the RIDASCREEN® Cryptosporidium test [enzyme immunoassay (EIA)] and the RIDA®QUICK Cryptosporidium/Giardia Combi [immuno-chromatographic test (ICT)] as well as polymerase chain reaction (PCR) were used. Prevalence of Cryptosporidium was 15.0, 19.5 and 32.3% in animals and 2.4, 6.7 and 49.1% in children using EIA, ICT and PCR, respectively.Using PCR as reference method, animal samples sensitivity (Se) of the EIA was 46.5% when questionable samples were considered positive, whereas specificity (Sp) was 100%. Se of the ICT was 60.4% while Sp was 100%. Positive predictive values (PPVs) for both EIA and ICT test were 100%, and negative predictive values (NPVs) for EIA were 79.7 and 84.1% for ICT. For the children samples, the Se of EIA was 5%, Sp was 100%, PPV was 100% and NPV was 52.2%, while the Se of ICT was 13.6%, Sp was 100%, PPV was 100% and NPV was 54.6%.The Kappa score of agreement between PCR and ICT was 67.4%, 54.1% between PCR and EIA and 84.4% between ICT and EIA. Until the second serial dilution of the EIA and ICT test, 9 × 10(3) oocysts/μl of Cryptosporidia was detected, whereas in PCR, they were detected until the sixth serial dilution. Copro-antigen tests were easy to perform and less time-consuming but less sensitive compared to PCR. They obviously are best applicable for screening and epidemiological studies of large numbers of subjects, for batch specimen processing and in isolated or rural areas where reliable tests like PCR are unfeasible. When in children, a single stool sample is used for the diagnosis of clinical cases; better results can be obtained when non-standardized PCR due low specificity is coupled with copro-antigen tests.

  2. 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.

  3. Drug-induced Defibrinogenation as New Treatment Approach of Acute Hearing Loss in an Animal Model for Inner Ear Vascular Impairment.

    Science.gov (United States)

    Weiss, Bernhard G; Bertlich, Mattis; Bettag, Stephan A; Desinger, Hendrik; Ihler, Friedrich; Canis, Martin

    2017-06-01

    Disturbance of cochlear microcirculation is considered to be the final common pathway of various inner ear diseases. Hyperfibrinogenemia causing increased plasma viscosity is a known risk factor for sudden sensorineural hearing loss and may lead to a critical reduction of cochlear blood flow. The aim of this study was to evaluate the effect of a substantial reduction of plasma fibrinogen levels by drug-induced defibrinogenation for the treatment of acute hearing loss in vivo. Acute hearing loss was induced by hyperfibrinogenemia (i.v. injection of 330 mg/kg BW fibrinogen), using a guinea pig animal model. Parameters of cochlear microcirculation and hearing thresholds were quantified by intravital microscopy and evoked response audiometry. After obtaining baseline values, the course of hearing loss and disturbances of microcirculation were investigated under influence of intravenous defibrinogenation therapy (ancrod), corticosteroid, or placebo treatment, using 5 animals/group. Acute hyperfibrinogenemia caused hearing loss from 10 ± 7 to 26 ± 10 dB SPL at baseline. Drug-induced reduction of fibrinogen levels showed a significant increase of cochlear microcirculation (1.6-fold) and recovered hearing threshold (11 ± 6 dB SPL). Placebo or corticosteroid treatment had no effect on hearing loss (35 ± 7 dB SPL and 32 ± 18 dB SPL, respectively). Acute hyperfibrinogenemia resulted in hearing loss. Drug-induced reduction of elevated fibrinogen levels caused an increase in cochlear blood flow and a decrease in hearing thresholds. Placebo or corticosteroid treatment had no effect. Reduction of plasma fibrinogen levels could serve as a clinical treatment option for acute hearing loss.

  4. 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.

  5. Examination of why some community pharmacists do not provide 72-hour emergency prescription drugs to Medicaid patients when prior authorization is not available.

    Science.gov (United States)

    Shepherd, Marvin D

    2013-09-01

    Existing federal law requires that a 72-hour emergency supply of a prescription drug be dispensed to Medicaid patients when prior authorization (PA) is not available and the medication is needed without delay. The pharmacist's role is to contact prescribers and inform them that PA is needed. If the prescriber cannot be reached, the pharmacist can dispense a 72-hour emergency supply. To determine (a) the reasons why some community pharmacy owners/managers, staff pharmacists, and technicians are not compliant with the law; (b) how often the decision is made; and (c) estimate how often pharmacies do not dispense the 72-hour emergency supply when PA is not available. A questionnaire was mailed to selected Texas community pharmacies. The instrument was developed by the researcher and reviewed by the Texas Medicaid Vendor Drug Program staff. The University of Texas, Office of Survey Research collected the data in September and October of 2011 by mail and online. The data were forwarded to the researcher for analyses. A total of 788 identified community pharmacies were mailed a packet containing 3 questionnaires to be completed by the pharmacist-in-charge, a staff pharmacist, and a pharmacy technician. There were 2 mailings of the questionnaire packet and follow-up telephone calls to nonrespondents. A total of 653 questionnaires were completed and returned from 288 community pharmacies (36.7%) out of 788 pharmacies that were mailed the questionnaire packets. A total of 368 (57.5%) completed questionnaires came from chain store pharmacy respondents and 272 (42.5%) questionnaires from independent pharmacy respondents. A total of 21.3% (n = 134) of the respondents indicated that they were not aware of the federal and state requirement to dispense a 72-hour emergency supply of a prescription drug to Medicaid patients when prior authorization (PA) is not available. A greater proportion of the chain store respondents (26.6%) were unaware of the requirement compared with the

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

    Science.gov (United States)

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

    2006-05-01

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

  7. 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)

    Bheekhee, H.; Hulman, B.; Boodoo, A.A.; Ramnauth, R.K.; Lam Heung Yuen, R.; Fakim, R.; Dobee, B.

    2002-01-01

    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)

  8. A brave new beef: The US Food and Drug Administration's review of the safety of cloned animal products.

    Science.gov (United States)

    Solomon, Louis M; Noll, Rebekka C; Mordkoff, David S; Murphy, Patrick; Rolerson, Marcy

    2009-09-01

    To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyzes the risks the FDA considered, and concludes that there is a disconnect between the risks the FDA assessed in these studies and the risks that might arise from cloned food products. The FDA should consider instituting effective tracking mechanisms and other diagnostics that would permit scientists and the public to answer the question of health risks posed by cloned food products.

  9. 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 compliance...

  10. Drug Facts

    Medline Plus

    Full Text Available ... Use and Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

  11. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Kids Drug Use and Unborn Children Drug Use and Your Health Other Effects on ... Someone Find Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids ...

  12. 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.

  13. Gastrointestinal allergy in the experimental animal: The use of radioiodinated serum albumin in the assessment of new drugs

    International Nuclear Information System (INIS)

    Freier, S.

    1980-03-01

    Gastrointestinal allergy, wherein the afflicted subject experiences an allergic reaction to certain proteins in the diet, is estimated to be found in about 0.5% of the population of all ages. It is associated with a considerable morbidity and a not negligible mortality. Several drugs are capable of suppressing allergic reactions, and at least one is somewhat effective in gastrointestinal allergy. The purpose of this investigation was to develop a rat model to assist the study of gastrointestinal allergy and means to prevent it. It was found possible to induce allergic sensitivity in rats to certain proteins by injecting proteins and adjuvants in various regimes. For suckling rats sensitivity could also be established by oral administration of the protein. A hypersensitive gastrointestinal reaction to challenge could be demonstrated by electron microscopy, by light microscopy with the aid of conventional staining techniques, and also by a radionuclide procedure wherein 51 Cr-labelled albumin injected intravenously shortly before the challenge concentrated in the intestinal walls in rough proportion to the severity of the reaction. In suppressing the hypersensitive intestinal reaction, disodium cromoglycate, dexamethazone, aspirin, indomethecan, and ipobrufen were found ineffective; aminophylline gave a slight amelioration

  14. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin it More sharing options ... CVM) produced a nine-minute animation explaining how antimicrobial resistance both emerges and proliferates among bacteria. Over time, ...

  15. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin it More sharing options ... of Animation of Antimicrobial Resistance More in Antimicrobial ... Antimicrobial Resistance Monitoring System About NARMS 2015 NARMS Integrated ...

  16. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Animal & Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin it More sharing ... CVM) produced a nine-minute animation explaining how antimicrobial resistance both emerges and proliferates among bacteria. Over ...

  17. The wake-promoting drug modafinil stimulates specific hypothalamic circuits to promote adaptive stress responses in an animal model of PTSD.

    Science.gov (United States)

    Cohen, S; Ifergane, G; Vainer, E; Matar, M A; Kaplan, Z; Zohar, J; Mathé, A A; Cohen, H

    2016-10-11

    Pharmacotherapeutic intervention during traumatic memory consolidation has been suggested to alleviate or even prevent the development of posttraumatic stress disorder (PTSD). We recently reported that, in a controlled, prospective animal model, depriving rats of sleep following stress exposure prevents the development of a PTSD-like phenotype. Here, we report that administering the wake-promoting drug modafinil to rats in the aftermath of a stressogenic experience has a similar prophylactic effect, as it significantly reduces the prevalence of PTSD-like phenotype. Moreover, we show that the therapeutic value of modafinil appears to stem from its ability to stimulate a specific circuit within the hypothalamus, which ties together the neuropeptide Y, the orexin system and the HPA axis, to promote adaptive stress responses. The study not only confirms the value of sleep prevention and identifies the mechanism of action of a potential prophylactic treatment after traumatic exposure, but also contributes to understanding mechanisms underlying the shift towards adaptive behavioral response.

  18. Access to Experimental Cancer Drugs

    Science.gov (United States)

    An experimental drug has been tested in the lab and with animals and approved for testing in people by the FDA, but can’t yet be advertised, sold, or prescribed. Experimental drugs may be available through clinical trials or expanded access programs - learn more about these programs and how to talk to your doctor.

  19. Animal experimentations: Part I: General considerations

    Directory of Open Access Journals (Sweden)

    T K Pal

    2015-01-01

    Full Text Available All materials, in the form of drugs or devices, which are intended for human use are required to be tested first in suitable animals. Many biological understandings are established on various modes of cruelties on animals. This observational notes guide us to accept or modify or even reject materials for ultimate human use. The science of experiments on animals gives us the remedial solutions to many of our human sufferings. This unique and important discipline is in need of proper understanding for selection of suitable number of animals and its proper care in captivity, and further refinements of code of conducts and ethical issues.

  20. Animal Transports

    Directory of Open Access Journals (Sweden)

    Diana Ludrovcová

    2016-08-01

    Full Text Available Purpose and Originality: The research is aimed to the animal transports issue, from two points of view – first is the animal cruelty and second is the policy and economic consideration. The goal is to acquaint the readers with the transports risks and its cruelty and evaluation of the economic, political aspects for he involved countries. The study is oriented on more points of view, what is rare in works with a similar theme. Method: This paper examines many issues and examinations from different authors and subsequently summarized the findings with authors own knowledge to one expanded unit. Results: Results proves, that livestock transports have negative impact on animal´s health, environment. Number of transported animals is rising every year. Society: Research familiarize the society with the animal transports, cruelty against animals during them, and influence of transports on some countries, their economy, policy. People get better informed and can form their own opinion on this topic. They may start acting, undertaking some steps to improve the present situation, what could help a lot to animals and environment. Limitations / further research: Future research could show progress and improvement of transports, quality of food supply and economics.

  1. Neurodevelopmental Animal Models Reveal the Convergent Role of Neurotransmitter Systems, Inflammation, and Oxidative Stress as Biomarkers of Schizophrenia: Implications for Novel Drug Development.

    Science.gov (United States)

    Möller, M; Swanepoel, T; Harvey, B H

    2015-07-15

    Schizophrenia is a life altering disease with a complex etiology and pathophysiology, and although antipsychotics are valuable in treating the disorder, certain symptoms and/or sufferers remain resistant to treatment. Our poor understanding of the underlying neuropathological mechanisms of schizophrenia hinders the discovery and development of improved pharmacological treatment, so that filling these gaps is of utmost importance for an improved outcome. A vast amount of clinical data has strongly implicated the role of inflammation and oxidative insults in the pathophysiology of schizophrenia. Preclinical studies using animal models are fundamental in our understanding of disease development and pathology as well as the discovery and development of novel treatment options. In particular, social isolation rearing (SIR) and pre- or postnatal inflammation (PPNI) have shown great promise in mimicking the biobehavioral manifestations of schizophrenia. Furthermore, the "dual-hit" hypothesis of schizophrenia states that a first adverse event such as genetic predisposition or a prenatal insult renders an individual susceptible to develop the disease, while a second insult (e.g., postnatal inflammation, environmental adversity, or drug abuse) may be necessary to precipitate the full-blown syndrome. Animal models that emphasize the "dual-hit" hypothesis therefore provide valuable insight into understanding disease progression. In this Review, we will discuss SIR, PPNI, as well as possible "dual-hit" animal models within the context of the redox-immune-inflammatory hypothesis of schizophrenia, correlating such changes with the recognized monoamine and behavioral alterations of schizophrenia. Finally, based on these models, we will review new therapeutic options, especially those targeting immune-inflammatory and redox pathways.

  2. The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

    Science.gov (United States)

    Hong, Haeyeon; Mackey, William C

    2014-08-01

    Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The

  3. 41 CFR 102-41.220 - Is drug paraphernalia forfeited under 21 U.S.C. 863 available for transfer to other Federal...

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Is drug paraphernalia... Management Federal Property Management Regulations System (Continued) FEDERAL MANAGEMENT REGULATION PERSONAL... Personal Property Requiring Special Handling Drug Paraphernalia § 102-41.220 Is drug paraphernalia...

  4. Optical Imaging of Tumor Hypoxia and Evaluation of Efficacy of a Hypoxia-Targeting Drug in Living Animals

    Directory of Open Access Journals (Sweden)

    Hiroshi Harada

    2005-07-01

    Full Text Available Solid tumors containing more hypoxic regions show a more malignant phenotype by increasing the expression of genes encoding angiogenic and metastatic factors. Hypoxia-inducible factor-1 (HIF-1 is a master transcriptional activator of such genes, and thus, imaging and targeting hypoxic tumor cells where HIF-1 is active are important in cancer therapy. In the present study, HIF-1 activity was monitored via an optical in vivo imaging system by using a luciferase reporter gene under the regulation of an artificial HIF-1-dependent promoter, 5HRE. To monitor tumor hypoxia, we isolated a stable reporter-transfectant, HeLa/5HRE-Luc, which expressed more than 100-fold luciferase in response to hypoxic stress, and observed bioluminescence from its xenografts. Immunohistochemical analysis of the xenografts with a hypoxia marker, pimonidazole, confirmed that the luciferase-expressing cells were hypoxic. Evaluation of the efficacy of a hypoxia-targeting prodrug, TOP3, using this optical imaging system revealed that hypoxic cells were significantly diminished by TOP3 treatment. Immunohistochemical analysis of the TOP3-treated xenografts confirmed that hypoxic cells underwent apoptosis and were removed after TOP3 treatment. These results demonstrate that this model system using the 5HRE-luciferase reporter construct provides qualitative information (hypoxic status of solid tumors and enables one to conveniently evaluate the efficacy of cancer therapy on hypoxia in malignant solid tumors.

  5. AVN-322 is a Safe Orally Bio-Available Potent and Highly Selective Antagonist of 5-HT6R with Demonstrated Ability to Improve Impaired Memory in Animal Models.

    Science.gov (United States)

    Ivachtchenko, Alexandre V; Ivanenkov, Yan A; Veselov, Mark S; Okun, I M

    2017-01-01

    In recent years, 5-hydroxytryptamine subtype 6 receptor (5-HT6 receptor, 5- HT6R) has emerged as a promising therapeutic target for the treatment of neuropathological disorders, including Alzheimer's disease (AD) and schizophrenia. 5-HT6 receptors were hypothesized to be implicated in the processes of learning, memory, and cognition with 5-HT6R antagonists being effective in animal models of cognition and memory impairment. Several selective 5-HT6R ligands are currently undergoing clinical trials for treatment of AD. We describe results of preclinical development of a novel and highly selective and potent 5- HT6R antagonist, AVN-322, as a clinical candidate for the treatment of AD to improve concurrent debilitation of memory and cognition in the AD patients, and schizophrenia as a substance with antipsychotic effect. In the manuscript, we present its in vitro and vivo efficacy, ADME, pharmacokinetics in animals and in humans, and toxicity. While having high binding affinity in medium picomolar range, the lead compound demonstrates substantially better selectivity index then the reference drug candidates currently being tested in clinical studies. AVN-322 showed high oral bioavailability and favorable blood-brain barrier (BBB) penetration. In vivo testing revealed its clear cognition enhancing effect. AVN-322 significantly restored both scopolamine- and MK-801-induced cognitive dysfunction and demonstrated antipsychotic potential. Taking into account its good safety profile and favorable pharmacokinetics, AVN-322 can be reasonably considered as a novel drug candidate for the treatment of neurological disorders such as AD and/or schizophrenia. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  6. Hybrid shell engineering of animal cells for immune protections and regulation of drug delivery: towards the design of "artificial organs".

    Directory of Open Access Journals (Sweden)

    Philippe Dandoy

    Full Text Available BACKGROUND: With the progress in medicine, the average human life expectancy is continuously increasing. At the same time, the number of patients who require full organ transplantations is augmenting. Consequently, new strategies for cell transplantation are the subject of great interest. METHODOLOGY/PRINCIPAL FINDINGS: This work reports the design, the synthesis and the characterisation of robust and biocompatible mineralised beads composed of two layers: an alginate-silica composite core and a Ca-alginate layer. The adequate choice of materials was achieved through cytotoxicity LDH release measurement and in vitro inflammatory assay (IL-8 to meet the biocompatibility requirements for medical purpose. The results obtained following this strategy provide a direct proof of the total innocuity of silica and alginate networks for human cells as underscored by the non-activation of immune defenders (THP-1 monocytes. The accessible pore size diameter of the mineralised beads synthesized was estimated between 22 and 30 nm, as required for efficient immuno-isolation without preventing the diffusion of nutrients and metabolites. The model human cells, HepG2, entrapped within these hybrid beads display a high survival rate over more than six weeks according to the measurements of intracellular enzymatic activity, respiration rate, as well as the "de novo" biosynthesis and secretion of albumin out of the beads. CONCLUSIONS/SIGNIFICANCE: The current study shows that active mammalian cells can be protected by a silica-alginate hybrid shell-like system. The functionality of the cell strain can be maintained. Consequently, cells coated with an artificial and a biocompatible mineral shell could respond physiologically within the human body in order to deliver therapeutic agents in a controlled fashion (i.e. insulin, substituting the declining organ functions of the patient.

  7. Prelimbic Stimulation Ameliorates Depressive-Like Behaviors and Increases Regional BDNF Expression in a Novel Drug-Resistant Animal Model of Depression.

    Science.gov (United States)

    Moshe, Hagar; Gal, Ram; Barnea-Ygael, Noam; Gulevsky, Tatiana; Alyagon, Uri; Zangen, Abraham

    2016-01-01

    Approximately one third of all major depression patients fail to respond to conventional pharmacological antidepressants, and brain stimulation methods pose a promising alternative for this population. Recently, based on repeated multifactorial selective inbreeding of rats for depressive-like behaviors, we introduced a novel animal model for MDD. Rats from this Depressive Rat Line (DRL) exhibit inherent depressive-like behaviors, which are correlated with lower levels of brain-derived neurotrophic factor (BDNF) in specific brain regions. In addition, DRL rats do not respond to antidepressant medication but respond to electroconvulsive treatment, and they can thus be utilized to test the effectiveness of brain stimulation on hereditary, medication-resistant depressive-like behaviors. To test the effect of sub-convulsive electrical stimulation (SCES) of the prelimbic cortex, using TMS-like temporal pattern of stimulation, on depressive-like behaviors and regional BDNF levels in DRL rats. SCES sessions were administered daily for 10 days through chronically implanted electrodes. Temporal stimulation parameters were similar to those used in TMS for major depression in human patients. Depressive-like behaviors were assayed after treatment, followed by brain extraction and regional BDNF measurements. SCES normalized both the depressive-like behaviors and the reduced BDNF levels observed in DRL rats. Correlation analyses suggest that changes in specific behaviors are mediated, at least in part, by BDNF expression in reward-related brain regions. Brain stimulation is effective in a drug-resistant, inherited animal model for depression. BDNF alterations in specific regions may mediate different antidepressant effects. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. [Anti-inflammatory, analgesic and anti-pyretic activities of a non-steroidal anti-inflammatory drug, etofenamate, in experimental animals].

    Science.gov (United States)

    Nakamura, H; Motoyoshi, S; Imazu, C; Ishii, K; Yokoyama, Y; Seto, Y; Kadokawa, T; Shimizu, M

    1982-08-01

    Anti-inflammatory, analgesic, and anti-pyretic activities of orally administered etofenamate, the diethylene glycol ester of flufenamic acid, were investigated in experimental animals. Against acetic acid-induced vascular permeability in mice and ultra-violet light-induced erythema in guinea pigs, etofenamate produced a dose related inhibition at doses of 40--320 mg/kg and 5--20 mg/kg, respectively. In rats, felt-pellet-induced granuloma formation and adjuvant-induced arthritis were significantly inhibited by repeated administration of etofenamate at doses of 20 mg/kg/day for 5 days and 40 mg/kg/day for 21 days, respectively. Etofenamate showed an inhibitory activity on the squeak response caused by flexing and extending the silver nitrate-induced arthritic joint in rats; and it produced a dose related anti-writhing activity at doses of 50--300 mg/kg and 10--80 mg/kg in mice and rats, respectively, in the acetic acid-induced writhing test. Etofenamate showed a significant anti-pyretic activity at doses of 0.2 mg/kg or more. These potencies of etofenamate were 0.5 to 1.6 times those of flufenamic acid. In particular, the anti-erythema, anti-arthritis, and anti-pyretic activities of etofenamate were approximately equivalent to or superior to those of flufenamic acid. From these results, it was suggested that etofenamate given orally, like other non-steroidal anti-inflammatory drugs, showed anti-inflammatory, analgesic, and anti-pyretic activities in experimental animals.

  9. Treatment of human and livestock helminth infections in a mobile pastoralist setting at Lake Chad: Attitudes to health and analysis of active pharmaceutical ingredients of locally available anthelminthic drugs.

    Science.gov (United States)

    Greter, Helena; Cowan, Noemi; Ngandolo, Bongo N; Kessely, Hamit; Alfaroukh, Idriss O; Utzinger, Jürg; Keiser, Jennifer; Zinsstag, Jakob

    2017-11-01

    Mobile pastoralists face challenges in accessing quality health care and medication for managing human and animal diseases. We determined livestock disease priorities, health seeking behaviour of people bearing helminthiases and - placing particular emphasis on trematode infections - treatment strategies and outcome satisfaction among mobile pastoralists of four ethnic groups in the Lake Chad area using focus group discussions. People suffering from schistosomiasis were interviewed about symptoms, health seeking behaviour and their satisfaction with respect to the provided treatment. Anthelminthic drugs for human and veterinary use obtained from various health care structures were analysed for active pharmaceutical ingredients (API) and quantity, using high pressure liquid chromatography-UV and liquid chromatography combined with tandem mass spectrometry. Most people suffering from schistosomiasis sought treatment at health care centres. Yet, they also consulted informal providers without medical training. Regarding animal health, self-mediated therapy was common to manage suspected livestock fascioliasis. Self-reported treatment satisfaction for human schistosomiasis and trematodiasis treatment outcome in livestock were low. Mobile pastoralists perceived the purchased drugs to be of low quality. Among 33 products locally sold as anthelminthic drugs for human or veterinary use, 27 contained albendazole or mebendazole, varying between 91% and 159% of the labelled amount. Six products were sold loosely with incomplete information and their API could not be identified. No counterfeit anthelminthic drugs were detected. None of the samples contained praziquantel or triclabendazole, the drugs of choice against schistosomiasis and fascioliasis, respectively. The perceived unsatisfactory treatment outcomes in humans and animals infected with trematodes are most likely due to empiric diagnosis and the resulting use of inadequate therapy for human schistosomiasis and the

  10. Animal Product Safety Information

    Science.gov (United States)

    ... Home Animal & Veterinary Safety & Health Product Safety Information Product Safety Information Share Tweet Linkedin Pin it More ... to report adverse experiences with veterinary drugs. Additional Product Information Questions and Answers: Evanger’s Dog and Cat ...

  11. Assessment of prescription opioid intentional exposures across the rural-urban continuum in the United States using both population and drug availability rates.

    Science.gov (United States)

    Le Lait, Marie-Claire; Martinez, Erin M; Severtson, Stevan G; Lavery, Sarah A; Bucher-Bartelson, Becki; Dart, Richard C

    2014-12-01

    Prescription opioid abuse and misuse are a serious problem in the U.S. today. Several studies have shown that the epidemic disproportionately affects rural areas. This paper uses three different rates to gain a more complete picture of opioid abuse in rural areas. This study examines prescription opioid intentional exposures using opioid classes tracked in the RADARS(®) System Poison Center Program. Intentional exposure rates were calculated adjusting for population and unique recipients of dispensed drug (URDD). These rates were analyzed using time (quarter) and the proportion of a three-digit zip code residing in a rural area as covariates. Additionally, the URDD per population rate was calculated to examine the proportion of the population filling prescriptions for opioids. After adjusting for population, intentional exposure cases significantly increased as the proportion of the population residing in a rural area increased. However, when adjusting for URDD, intentional exposure cases decreased with increasing rural population. The URDD per population increased as the proportion of people residing in a rural area increased. Using both population and URDD adjusted intentional exposure rates gives a more complete picture of opioid abuse in rural areas. Considering product availability can be used to develop opioid abuse prevention strategies and further the education of physicians serving rural areas about this epidemic. Copyright © 2014 John Wiley & Sons, Ltd.

  12. Drug Facts

    Medline Plus

    Full Text Available ... symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen ... to prescription drugs. The addiction slowly took over his life. I need different people around me. To ...

  14. Naturally Occurring Canine Invasive Urinary Bladder Cancer: A Complementary Animal Model to Improve the Success Rate in Human Clinical Trials of New Cancer Drugs

    Directory of Open Access Journals (Sweden)

    Christopher M. Fulkerson

    2017-01-01

    Full Text Available Genomic analyses are defining numerous new targets for cancer therapy. Therapies aimed at specific genetic and epigenetic targets in cancer cells as well as expanded development of immunotherapies are placing increased demands on animal models. Traditional experimental models do not possess the collective features (cancer heterogeneity, molecular complexity, invasion, metastasis, and immune cell response critical to predict success or failure of emerging therapies in humans. There is growing evidence, however, that dogs with specific forms of naturally occurring cancer can serve as highly relevant animal models to complement traditional models. Invasive urinary bladder cancer (invasive urothelial carcinoma (InvUC in dogs, for example, closely mimics the cancer in humans in pathology, molecular features, biological behavior including sites and frequency of distant metastasis, and response to chemotherapy. Genomic analyses are defining further intriguing similarities between InvUC in dogs and that in humans. Multiple canine clinical trials have been completed, and others are in progress with the aim of translating important findings into humans to increase the success rate of human trials, as well as helping pet dogs. Examples of successful targeted therapy studies and the challenges to be met to fully utilize naturally occurring dog models of cancer will be reviewed.

  15. Availability of essential drugs for managing HIV-related pain and symptoms within 120 PEPFAR-funded health facilities in East Africa: a cross-sectional survey with onsite verification.

    Science.gov (United States)

    Harding, Richard; Simms, Victoria; Penfold, Suzanne; Downing, Julia; Powell, Richard A; Mwangi-Powell, Faith; Namisango, Eve; Moreland, Scott; Gikaara, Nancy; Atieno, Mackuline; Kataike, Jennifer; Nsubuga, Clare; Munene, Grace; Banga, Geoffrey; Higginson, Irene J

    2014-04-01

    World Health Organization's essential drugs list can control the highly prevalent HIV-related pain and symptoms. Availability of essential medicines directly influences clinicians' ability to effectively manage distressing manifestations of HIV. To determine the availability of pain and symptom controlling drugs in East Africa within President's Emergency Plan for AIDS Relief-funded HIV health care facilities. Directly observed quantitative health facilities' pharmacy stock review. We measured availability, expiration and stock-outs of specified drugs required for routine HIV management, including the World Health Organization pain ladder. A stratified random sample in 120 President's Emergency Plan for AIDS Relief-funded HIV care facilities (referral and district hospitals, health posts/centres and home-based care providers) in Kenya and Uganda. Non-opioid analgesics (73%) and co-trimoxazole (64%) were the most commonly available drugs and morphine (7%) the least. Drug availability was higher in hospitals and lower in health centres, health posts and home-based care facilities. Facilities generally did not use minimum stock levels, and stock-outs were frequently reported. The most common drugs had each been out of stock in the past 6 months in 47% of facilities stocking them. When a minimum stock level was defined, probability of a stock-out in the previous 6 months was 32.6%, compared to 45.5% when there was no defined minimum stock level (χ (2) = 5.07, p = 0.024). The data demonstrate poor essential drug availability, particularly analgesia, limited by facility type. The lack of strong opioids, isoniazid and paediatric formulations is concerning. Inadequate drug availability prevents implementation of simple clinical pain and symptom control protocols, causing unnecessary distress. Research is needed to identify supply chain mechanisms that lead to these problems.

  16. 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.

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

    Science.gov (United States)

    Hu, Yuanan; Cheng, Hefa

    2016-12-01

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

  18. 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

  19. The nonsteroidal antiinflammatory drug piroxicam reverses the onset of depressive-like behavior in 6-OHDA animal model of Parkinson's disease.

    Science.gov (United States)

    Santiago, R M; Tonin, F S; Barbiero, J; Zaminelli, T; Boschen, S L; Andreatini, R; Da Cunha, C; Lima, M M S; Vital, M A B F

    2015-08-06

    Depression is one of the most common psychiatric symptoms in patients with Parkinson's disease (PD). Some authors have reported that depression is characterized by activation of the inflammatory response. Animal models of PD also present with depressive-like behavior, such as increased immobility time in the modified forced swim test and anhedonia-like behavior in the sucrose preference test. Considering the potential neuroprotective effect of nonsteroidal antiinflammatory drugs in neurodegenerative diseases, the objective of the present study was to investigate the effects of piroxicam on depressive-like behavior in male Wistar rats lesioned with 6-hydroxydopamine (6-OHDA) in the substantia nigra (SN). Antidepressant-like effects were observed after prolonged administration of piroxicam for 21days. In the forced swim test, the 6-OHDA+saline group exhibited significant reductions in swimming time and increased immobility time compared with the sham+saline. In the sucrose preference test, the 6-OHDA+piroxicam group exhibited no reduction of sucrose preference compared with the sham+saline, with significant effects of treatment and time and a significant treatment×time interaction. 5-Hydroxytryptamine (5-HT) levels significantly decreased in the hippocampus in the 6-OHDA+saline group and not changed in the 6-OHDA+piroxicam group when compared with the sham+saline on day 21. In conclusion, 21-day treatment with piroxicam reversed the onset of depressive-like behavior and prevented the reduction of hippocampal 5-HT levels. Copyright © 2015 IBRO. Published by Elsevier Ltd. All rights reserved.

  20. Antibiotics in Animal Products

    Science.gov (United States)

    Falcão, Amílcar C.

    The administration of antibiotics to animals to prevent or treat diseases led us to be concerned about the impact of these antibiotics on human health. In fact, animal products could be a potential vehicle to transfer drugs to humans. Using appropri ated mathematical and statistical models, one can predict the kinetic profile of drugs and their metabolites and, consequently, develop preventive procedures regarding drug transmission (i.e., determination of appropriate withdrawal periods). Nevertheless, in the present chapter the mathematical and statistical concepts for data interpretation are strictly given to allow understanding of some basic pharma-cokinetic principles and to illustrate the determination of withdrawal periods

  1. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... Veterinary Safety & Health Antimicrobial Resistance Animation of Antimicrobial Resistance Share Tweet Linkedin Pin it More sharing options ... produced a nine-minute animation explaining how antimicrobial resistance both emerges and proliferates among bacteria. Over time, ...

  2. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... produced material may be copied, reproduced, and distributed as long as FDA's Center for Veterinary Medicine is cited as the corporate author. Animation Animation of Antimicrobial Resistance ( ...

  3. Animal Studies of Addictive Behavior

    Science.gov (United States)

    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 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

  4. Animal facilities

    International Nuclear Information System (INIS)

    Fritz, T.E.; Angerman, J.M.; Keenan, W.G.; Linsley, J.G.; Poole, C.M.; Sallese, A.; Simkins, R.C.; Tolle, D.

    1981-01-01

    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 60 Co 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 60 Co 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

  5. Why Are Drugs So Hard to Quit?

    Medline Plus

    Full Text Available ... NIH) 11,558 views 2:23 Anti-Drug Vaccine Animation - Duration: 3:39. National Institute on Drug ... Language: English Location: United States Restricted Mode: Off History Help Loading... Loading... Loading... About Press Copyright Creators ...

  6. Changes in the pharmacodynamics and pharmacokinetics of psycholeptic drugs in radiation-sickness. Effect of X-ray radiation on pharmacodynamic activity of nitrazepam in animals

    International Nuclear Information System (INIS)

    Szczawinska, K.; Chodera, A.; Wojciak, Z.; Kozaryn, I.

    1975-01-01

    The anticonvulsive effect of nitrazepam was determined in animals exposed to a single 600 R radiation and the exploring activity of the animals was studied after nitrazepam administered during radiation sickness caused by this exposure. On the 1st day after exposure the activity, reducing effect was slightly weaker but on days 3rd and 6th this effect was significantly stronger. The anticonvulsant effect of nitrazepam on the 3rd day after exposure was significantly greater as compared with control animals, but on the 6th day no difference in the power of anticonvulsant activity between the two groups of animals was found. (author)

  7. 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

  8. 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.

  9. Animation of Antimicrobial Resistance

    Medline Plus

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

  10. Animation of Antimicrobial Resistance

    Medline Plus

    Full Text Available ... proliferates among bacteria. Over time, the use of antimicrobial drugs will result in the development of resistant strains ... bacteria, complicating clinician's efforts to select the appropriate ... and human medicine to preserve the effectiveness of these drugs. One ...

  11. Generic Drugs: Questions and Answers

    Science.gov (United States)

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

  12. Animal research

    DEFF Research Database (Denmark)

    Olsson, I.A.S.; Sandøe, Peter

    2012-01-01

    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...... 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...

  13. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... 4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from drugs. But she's afraid ...

  15. Systematic evaluation of commercially available ultra-high performance liquid chromatography columns for drug metabolite profiling: optimization of chromatographic peak capacity.

    Science.gov (United States)

    Dubbelman, Anne-Charlotte; Cuyckens, Filip; Dillen, Lieve; Gross, Gerhard; Hankemeier, Thomas; Vreeken, Rob J

    2014-12-29

    The present study investigated the practical use of modern ultra-high performance liquid chromatography (UHPLC) separation techniques for drug metabolite profiling, aiming to develop a widely applicable, high-throughput, easy-to-use chromatographic method, with a high chromatographic resolution to accommodate simultaneous qualitative and quantitative analysis of small-molecule drugs and metabolites in biological matrices. To this end, first the UHPLC system volume and variance were evaluated. Then, a mixture of 17 drugs and various metabolites (molecular mass of 151-749Da, logP of -1.04 to 6.7), was injected on six sub-2μm particle columns. Five newest generation core shell technology columns were compared and tested against one column packed with porous particles. Two aqueous (pH 2.7 and 6.8) and two organic mobile phases were evaluated, first with the same flow and temperature and subsequently at each column's individual limit of temperature and pressure. The results demonstrated that pre-column dead volume had negligible influence on the peak capacity and shape. In contrast, a decrease in post-column volume of 57% resulted in a substantial (47%) increase in median peak capacity and significantly improved peak shape. When the various combinations of stationary and mobile phases were used at the same flow rate (0.5mL/min) and temperature (45°C), limited differences were observed between the median peak capacities, with a maximum of 26%. At higher flow though (up to 0.9mL/min), a maximum difference of almost 40% in median peak capacity was found between columns. The finally selected combination of solid-core particle column and mobile phase composition was chosen for its selectivity, peak capacity, wide applicability and peak shape. The developed method was applied to rat hepatocyte samples incubated with the drug buspirone and demonstrated to provide a similar chromatographic resolution, but a 6 times higher signal-to-noise ratio than a more traditional UHPLC

  16. Produção de forragem e produção animal em pastagem com duas disponibilidades de forragem associadas ou não à suplementação energética Effects of forage availability and energy supplementation on herbage accumulation rate and animal yield

    Directory of Open Access Journals (Sweden)

    Alcides Pilau

    2005-08-01

    Full Text Available Neste experimento, avaliou-se o efeito de duas disponibilidades de forragem, 1.200 e 1.500 kg/ha de matéria seca (MS, e do uso de suplementação energética sobre a produção de forragem e a produção animal em pastagem de aveia (Avena strigosa Schreb + azevém (Lolium multiflorum Lam. Foram utilizadas 90 novilhas da raça Charolês e suas cruzas com Nelore, com peso vivo (PV de 164 kg no início do pastejo, submetidas às seguintes combinações: DFB - disponibilidade de forragem baixa; DFA - disponibilidade de forragem alta; DFBS - disponibilidade de forragem baixa + suplementação energética; DFAS - disponibilidade de forragem alta + suplementação energética. O suplemento fornecido foi grão de sorgo moído, na proporção de 0,7% do PV. As variáveis estudadas foram produção de forragem (PF, carga animal (CA e ganho de peso vivo por área (GPA. A PF não foi influenciada pelo manejo da pastagem e pela suplementação aos animais. O acúmulo de forragem diário estimado foi de 45,53 kg/ha de MS. A CA na DFA, média de 862 kg/ha de PV, apresentou pouca variação no decorrer do ciclo de pastejo. Em DFAS, DFB e DFBS, a carga animal foi extremamente variável e, a partir de 26/08, foi maior na DFBS. A utilização de 1.200 kg/ha de MS não afetou o GPA, enquanto a suplementação aos animais proporcionou aumento de 59,4% em relação ao uso exclusivo da pastagem.The trial was conducted to evaluate two forage availabilities (1.200 and 1.500 kg/ha of dry matter [DM] and energy supplementation of winter pasture on herbage and animal yields. The pasture was a mixture of oat (Avena strigosa Schreb + Italian ryegrass (Lolium multiflorum Lam. Ninety Charolais and Charolais crossbred Nellore heifers, with initial live weight of 164 kg, were submitted to the following treatments: LFA - low forage availability; HFA - high forage availability; LFAS - low forage availability + supplementation; HFAS - high forage availability + supplementation

  17. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Educators Children & Teens Search Connect with NIDA : Facebook LinkedIn Twitter YouTube Flickr RSS Menu Home Drugs of ... In animal studies, methamphetamine has been shown to increase the amount of HIV in brain cells 1 . ...

  18. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... of abuse and HIV both affect the brain. Research has shown that HIV causes greater injury to cells in the brain and cognitive impairment among people who use methamphetamine than among HIV patients who do not misuse drugs. In animal studies, methamphetamine has been shown to increase the amount ...

  19. Drug: D03867 [KEGG MEDICUS

    Lifescience Database Archive (English)

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

  20. Botanical origin and chemical constituents of commercial Saposhnikoviae radix and its related crude drugs available in Shaanxi and the surrounding regions.

    Science.gov (United States)

    Maruyama, Takuro; Ezaki, Masami; Shiba, Mao; Yamaji, Hiroki; Yoshitomi, Taichi; Kawano, Noriaki; Zhu, Shu; Cheng, Xiao; Yokokura, Tsuguo; Yamamoto, Yutaka; Fuchino, Hiroyuki; Sun, Hang; Komatsu, Katsuko; Kawahara, Nobuo

    2018-01-01

    Saposhnikoviae radix (SR) is described in the Japanese Pharmacopoeia as a crude drug derived from the root of Saposhnikovia divaricata Schischkin (Umbelliferae). According to Flora of China, the root of Peucedanum ledebourielloides K. F. Fu is used as a regional substitute for SR. Therefore, we surveyed the botanical origin of the drug used in China, especially Shaanxi and the surrounding regions, through nucleotide sequence analysis of the internal transcribed spacer region of rDNA. As a result, several samples from Shaanxi () and Shanxi () provinces were identified as Peucedanum ledebourielloides. To prevent this substitute from being distributed as genuine SR, we developed a thin-layer chromatography analysis condition to enable a specific compound of this species to be easily detected. The specific compound was identified as xanthalin, based on 1D- and 2D-NMR and high-resolution mass spectrometry data. The established TLC conditions were as follows-extraction solvent, n-hexane; applied volume, 5 µL; chromatographic support, silica gel; developing solvent, n-hexane:ethyl acetate:acetic acid (20:10:1); developing length, 7 cm; detection, UV (365 nm); R f value, 0.4 (blue fluorescence; xanthalin).

  1. [Not Available].

    Science.gov (United States)

    Lakhoua, Ghozlane; El Aidli, Sihem; Zaïem, Ahmed; Sahnoun, Rim; Kastalli, Sarrah; Loueslati, Mohamed Hedi; Daghfous, Riadh

    2014-01-01

    We describe two cases of fixed drug eruptions induced by pheniramine (1(st) case) and loratadine (2(nd) case). Copyright © 2014 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.

  2. Behavioral measures of tinnitus in laboratory animals.

    Science.gov (United States)

    Turner, Jeremy G

    2007-01-01

    The fact that so little is currently known about the pathophysiology of tinnitus is no doubt partly due to the relatively slow development of an animal model. Not until the work of Jastreboff et al. (1988a, b) did tinnitus researchers have at their disposal a method of determining whether their animals experienced tinnitus. Since then, a variety of additional animal models have been developed. Each of these models will be summarized in this chapter. It is becoming increasingly clear that in order to study tinnitus effectively, researchers need some verification that a drug, noise exposure or other manipulation is causing tinnitus in their animals. As this review will highlight, researchers now have a variety of behavioral options available to them.

  3. Animal derived products may conflict with religious patients' beliefs.

    Science.gov (United States)

    Eriksson, Axelina; Burcharth, Jakob; Rosenberg, Jacob

    2013-12-01

    Implants and drugs with animal and human derived content are widely used in medicine and surgery, but information regarding ingredients is rarely obtainable by health practitioners. A religious perspective concerning the use of animal and human derived drug ingredients has not thoroughly been investigated. The purpose of this study was to clarify which parts of the medical and surgical treatments offered in western world-hospitals that conflicts with believers of major religions. Religious and spiritual leaders of the six largest religions worldwide (18 branches) were contacted. A standardised questionnaire was sent out regarding their position on the use of human and animal derived products in medical and surgical treatments. Of the 18 contacted religious branches, 10 replied representing the 6 largest religions worldwide. Hindus and Sikhs did not approve of the use of bovine or porcine derived products, and Muslims did not accept the use of porcine derived drugs, dressings or implants. Christians (including Jehovah's Witnesses), Jews and Buddhists accepted the use of all animal and human derived products. However, all religions accepted the use of all these products in case of an emergency and only if alternatives were not available. The views here suggest that religious codes conflict with some treatment regimens. It is crucial to obtain informed consent from patients for the use of drugs and implants with animal or human derived content. However, information on the origin of ingredients in drugs is not always available to health practitioners.

  4. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can ...

  5. Drug Facts

    Medline Plus

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

  6. Drug Facts

    Medline Plus

    Full Text Available ... form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts ... addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain ...

  7. Drug Facts

    Medline Plus

    Full Text Available ... Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of ... Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1- ...

  8. Drug Facts

    Medline Plus

    Full Text Available ... Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs ... Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call ...

  9. Drug Facts

    Medline Plus

    Full Text Available ... Nicotine Facts Other Drugs of Abuse What is Addiction? What are some signs and symptoms of someone ... use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted ...

  10. 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 Bath Salts Cocaine Heroin Marijuana ...

  11. Drug Facts

    Medline Plus

    Full Text Available ... Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) ... treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice ( ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I ... The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , the ...

  13. Retinal Cell Degeneration in Animal Models

    Directory of Open Access Journals (Sweden)

    Masayuki Niwa

    2016-01-01

    Full Text Available The aim of this review is to provide an overview of various retinal cell degeneration models in animal induced by chemicals (N-methyl-d-aspartate- and CoCl2-induced, autoimmune (experimental autoimmune encephalomyelitis, mechanical stress (optic nerve crush-induced, light-induced and ischemia (transient retinal ischemia-induced. The target regions, pathology and proposed mechanism of each model are described in a comparative fashion. Animal models of retinal cell degeneration provide insight into the underlying mechanisms of the disease, and will facilitate the development of novel effective therapeutic drugs to treat retinal cell damage.

  14. 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 ...

  15. 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

  16. Animal models

    DEFF Research Database (Denmark)

    Gøtze, Jens Peter; Krentz, Andrew

    2014-01-01

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

  17. Animal Deliberation

    NARCIS (Netherlands)

    Driessen, C.P.G.

    2014-01-01

    While much has been written on environmental politics on the one hand, and animal ethics and welfare on the other, animal politics, as the interface of the two, is underexamined. There are key political implications in the increase of animal protection laws, the rights of nature, and political

  18. Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

    Science.gov (United States)

    Niehaus, Ines; Dintsios, Charalabos-Markos

    2018-03-26

    The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment by contrasting the benefit-risk ratio of EMA and the benefit-harm balance of the HTA jurisdiction. Agreement between market authorization and early benefit assessment is examined by Cohen's kappa (k). 21 of 41 assessments were considered in the analysis. Market authorization is more confirmatory than early benefit assessment because it includes a higher proportion of primary endpoints. The latter implies a primary endpoint to be relevant for the benefit-harm balance in only 67% of cases (0.078). Explorative mortality endpoints reached the highest agreement regarding the mutual consideration for the risk-benefit ratio and the benefit-harm balance (0.000). For explorative morbidity endpoints (-0.600), quality of life (-0.600) and side effects (-0.949) no agreement is ascertainable. To warrant a broader confirmatory basis for decisions supported by HTA, closer inter-institutional cooperation of approval authorities and HTA jurisdictions by means of reliable joint advice for manufacturers regarding endpoint definition would be favorable. Copyright © 2018 Elsevier B.V. All rights reserved.

  19. 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.

  20. 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

    ... with an EC 50 of 3.16 mg L ‚àí1 for toltrazuril [9]. Due to toltrazurils frequent usage ... a LC-MS/MS methodology to determine toltrazuril , toltrazuril sulfoxide and toltrazuril sulfone in ... SPE), and in agricultural soil, animal manure and sediment using pressurized liquid extraction ( PLE ). ...

  1. Avaliação de pastagem diferida de Brachiaria decumbens Stapf. 2. Disponibilidade de forragem e desempenho animal durante a seca Evaluation of a signalgrass (Brachiaria decumbens Stapf postponed pasture. 2. Availability of herbage and animal performance, during the dry season

    Directory of Open Access Journals (Sweden)

    Eduardo Destéfani Guimarães Santos

    2004-02-01

    Full Text Available Verificaram-se as disponibilidades de forragem total, forragem verde e morta e dos componentes folha verde, caule verde, folha seca e caule seco em pastagem diferida de Brachiaria decumbens. A pastagem foi vedada à entrada dos animais de dezembro de 1996 a junho de 1997 e avaliada, sob pastejo contínuo, durante a estação seca, nos meses de julho a outubro de 1997. Também foram estudadas correlações entre características do relvado e ganho de peso de tourinhos Limousin-Nelore com 19 meses e 374 kg de peso. O diferimento da pastagem de Brachiaria decumbens proporcionou disponibilidade média de forragem (DMST de 7.568, forragem verde (DMSV de 3.834 e morta (DMSM de 3.734 kg de matéria seca (MS/ha em julho, antes do período de pastejo. A utilização contínua da pastagem diferida durante o período seco, com lotação animal de 0,75 UA/ha, não afetou a DMST, média de 7.902, e DMSM, média de 4.637 kg/ha, mas afetou a DMSV e a disponibilidade de folhas verdes (DMSFV. A DMSV e a DMSFV apresentaram taxas crescentes em julho e outubro e diminuíram a taxas crescentes em agosto e setembro. No final de setembro, as pastagens apresentaram a menor DMSV, 2.540 kg/ha. A DMSFV e a proporção de folhas verdes no relvado foram maiores no início de agosto, respectivamente, 1.517 kg/ha e 18,5%, e menores no final de setembro, 480 kg/ha e 5,7%, respectivamente. O diferimento da pastagem permitiu a manutenção dos animais e apenas pequeno ganho de peso durante a seca, média de 104 g/dia. Em setembro, os animais nas pastagens perderam peso. O ganho de peso vivo médio diário correlacionou-se linear e negativamente com DMSM e linear e positivamente com as relações [DMSV/DMSM] e [DMSFV/(DMSM + DMSCV], em que DMSCV é a disponibilidade de matéria seca de caule verde. Não foram verificadas correlações entre ganho de peso e as variáveis DMSV, DMSFV, pressão de pastejo e oferta diária de forragem.The availability of herbage, green herbage, dead

  2. 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) All...

  3. 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 of...

  4. A Novel Orally Available Asthma Drug Candidate That Reduces Smooth Muscle Constriction and Inflammation by Targeting GABAA Receptors in the Lung.

    Science.gov (United States)

    Forkuo, Gloria S; Nieman, Amanda N; Kodali, Revathi; Zahn, Nicolas M; Li, Guanguan; Rashid Roni, M S; Stephen, Michael Rajesh; Harris, Ted W; Jahan, Rajwana; Guthrie, Margaret L; Yu, Olivia B; Fisher, Janet L; Yocum, Gene T; Emala, Charles W; Steeber, Douglas A; Stafford, Douglas C; Cook, James M; Arnold, Leggy A

    2018-05-07

    We describe lead compound MIDD0301 for the oral treatment of asthma based on previously developed positive allosteric α 5 β 3 γ 2 selective GABA A receptor (GABA A R) ligands. MIDD0301 relaxed airway smooth muscle at single micromolar concentrations as demonstrated with ex vivo guinea pig tracheal rings. MIDD0301 also attenuated airway hyperresponsiveness (AHR) in an ovalbumin murine model of asthma by oral administration. Reduced numbers of eosinophils and macrophages were observed in mouse bronchoalveolar lavage fluid without changing mucous metaplasia. Importantly, lung cytokine expression of IL-17A, IL-4, and TNF-α were reduced for MIDD0301-treated mice without changing antiinflammatory cytokine IL-10 levels. Automated patch clamp confirmed amplification of GABA induced current mediated by α 1-3,5 β 3 γ 2 GABA A Rs in the presence of MIDD0301. Pharmacodynamically, transmembrane currents of ex vivo CD4 + T cells from asthmatic mice were potentiated by MIDD0301 in the presence of GABA. The number of CD4 + T cells observed in the lung of MIDD0301-treated mice were reduced by an oral treatment of 20 mg/kg b.i.d. for 5 days. A half-life of almost 14 h was demonstrated by pharmacokinetic studies (PK) with no adverse CNS effects when treated mice were subjected to sensorimotor studies using the rotarod. PK studies also confirmed very low brain distribution. In conclusion, MIDD0301 represents a safe and improved oral asthma drug candidate that relaxes airway smooth muscle and attenuates inflammation in the lung leading to a reduction of AHR at a dosage lower than earlier reported GABA A R ligands.

  5. Drug Development Process

    Science.gov (United States)

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

  6. ADVANCES IN ANIMAL WELFARE FOR FREE-LIVING ANIMALS.

    Science.gov (United States)

    2016-04-01

    Over several decades, animal welfare has grown into its own free-standing field of scientific study, from its early beginnings in laboratory animal research to eventually include exhibited animals and farm animals. While it has always been present to some degree, consideration of animal welfare for free-ranging animals has lagged behind, developing as a field of study in the last 20 yr or so. Part of that increase was that animal welfare legislation was finally applied to studies being done on free-ranging animals. But it is the appreciation by the biologists and veterinarians working on wild animals, in which the quality of their results is largely controlled by the quality of the animals they use in their studies, which has resulted in increased attention to the well-being or welfare of the animals that they use. Other important influences driving the recognition of wildlife welfare have been changes in the public's expectations of how wild animals are dealt with, a shift in focus of wildlife professionals from managing animals that can be hunted or angled to include nongame species, the decrease in participation in hunting and fishing by members of the public, and the entry of large numbers of women into fish and wildlife agencies and departments and into veterinary medicine. Technical improvements have allowed the safe capture and handling of large or dangerous animals as immobilization drugs and equipment have been developed. The increasing use of sedating drugs allows for handling of animals with reduced stress and other impacts. A number of topics, such as toe-clipping, branding, defining which taxa can or cannot feel pain, catch-and-release fishing, and more, remain controversial within wildlife science. How we treat the wild animals that we deal with defines who we are as wildlife professionals, and animal welfare concerns and techniques for free-ranging animals will continue to develop and evolve.

  7. 21 CFR 501.100 - Animal food; exemptions from labeling.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food; exemptions from labeling. 501.100... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING Exemptions From Animal Food Labeling Requirements § 501.100 Animal food; exemptions from labeling. (a) The following foods are exempt...

  8. 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 for...

  9. 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

  10. Animal welfare and use of silkworm as a model animal.

    Science.gov (United States)

    Sekimizu, N; Paudel, A; Hamamoto, H

    2012-08-01

    Sacrificing model animals is required for developing effective drugs before being used in human beings. In Japan today, at least 4,210,000 mice and other mammals are sacrificed to a total of 6,140,000 per year for the purpose of medical studies. All the animals treated in Japan, including test animals, are managed under control of "Act on Welfare and Management of Animals". Under the principle of this Act, no person shall kill, injure, or inflict cruelty on animals without due cause. "Animal" addressed in the Act can be defined as a "vertebrate animal". If we can make use of invertebrate animals in testing instead of vertebrate ones, that would be a remarkable solution for the issue of animal welfare. Furthermore, there are numerous advantages of using invertebrate animal models: less space and small equipment are enough for taking care of a large number of animals and thus are cost-effective, they can be easily handled, and many biological processes and genes are conserved between mammals and invertebrates. Today, many invertebrates have been used as animal models, but silkworms have many beneficial traits compared to mammals as well as other insects. In a Genome Pharmaceutical Institute's study, we were able to achieve a lot making use of silkworms as model animals. We would like to suggest that pharmaceutical companies and institutes consider the use of the silkworm as a model animal which is efficacious both for financial value by cost cutting and ethical aspects in animals' welfare.

  11. Drug Facts

    Medline Plus

    Full Text Available ... to main content Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts ... Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... can call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  13. Drug Facts

    Medline Plus

    Full Text Available ... the computer will read the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos ... I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs ... adicción. English Español About the National Institute on Drug Abuse (NIDA) | About This Website Tools and Resources | Contact ...

  15. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  16. Drug Facts

    Medline Plus

    Full Text Available ... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

  17. Animal Models for Tuberculosis in Translational and Precision Medicine

    Directory of Open Access Journals (Sweden)

    Lingjun Zhan

    2017-05-01

    Full Text Available Tuberculosis (TB is a health threat to the global population. Anti-TB drugs and vaccines are key approaches for TB prevention and control. TB animal models are basic tools for developing biomarkers of diagnosis, drugs for therapy, vaccines for prevention and researching pathogenic mechanisms for identification of targets; thus, they serve as the cornerstone of comparative medicine, translational medicine, and precision medicine. In this review, we discuss the current use of TB animal models and their problems, as well as offering perspectives on the future of these models.

  18. [Not Available].

    Science.gov (United States)

    Malmgren, Linnea; Rosén, Johan; Dahlman, Disa; von Wowern, Fredrik

    2016-07-28

    In this case report we illustrate how incorrectly prepared and cooked seeds from white lupin - a common snack among people from parts of the Mediterranean and Middle East - caused an anticholinergic syndrome in a previously healthy man. The symptoms subsided without treatment and the patient was discharged from the hospital in good health. Anticholinergic syndrome results from inhibition of the parasympatic nervous system. The symptoms commonly include dry mouth, confusion, hallucinations, fever, tachycardia, and urine retention. The syndrome may most frequently be provoked by overdose of drugs such as prometazin, hyoscyamin, and biperidin or by ingestion of plants such as belladonna, datura and henbane. The aim of this report is to increase clinicians' awareness of white lupin's anticholinergic effects.

  19. Small animal PET: aspects of performance assessment

    International Nuclear Information System (INIS)

    Weber, Simone; Bauer, Andreas

    2004-01-01

    Dedicated small animal positron emission tomography (PET) systems are increasingly prevalent in industry (e.g. for preclinical drug development) and biological research. Such systems permit researchers to perform animal studies of a longitudinal design characterised by repeated measurements in single animals. With the advent of commercial systems, scanners have become readily available and increasingly popular. As a consequence, technical specifications are becoming more diverse, making scanner systems less broadly applicable. The investigator has, therefore, to make a decision regarding which type of scanner is most suitable for the intended experiments. This decision should be based on gantry characteristics and the physical performance. The first few steps have been taken towards standardisation of the assessment of performance characteristics of dedicated animal PET systems, though such assessment is not yet routinely implemented. In this review, we describe current methods of evaluation of physical performance parameters of small animal PET scanners. Effects of methodologically different approaches on the results are assessed. It is underscored that particular attention has to be paid to spatial resolution, sensitivity, scatter fraction and count rate performance. Differences in performance measurement methods are described with regard to commercially available systems, namely the Concorde MicroPET systems P4 and R4 and the quad-HIDAC. Lastly, consequences of differences in scanner performance parameters are rated with respect to applications of small animal PET. (orig.)

  20. [Not Available].

    Science.gov (United States)

    Mächler, H R

    1994-01-01

    Up to the beginning of modern sleep research, theories about sleep have dominated the scene. With their philosophic background, they must be considered as erroneous by present standards. The history of sleep-inducing drugs has followed its own pathways, which were independent from sleep research. Up to the 19th century, opium and alcohol were used predominantly as hypnotics, later, empirically found chemical compounds were added. Today, new drugs are tested by methods of modern sleep research before they reach the market. Electrophysiology, whose origins are described, formed the basis of electroencephalography (EEG). The history of EEG is an important part of the present exposé. The discovery of rapid eye movements (REM) during sleep has been one of the most important achievements in modern sleep research. It led to a new stage classification - which is still used today - as well as to the discovery of sleep cycles. Subsequently, polysomnography has been increasingly used. Additional methods are actometry and the spectral analysis of the sleep EEG. Research of endogenous sleep substances such as "Delta Sleep Inducing Peptide (DSIP) has been actively pursued in the last 25 years. It is unlikely that one particular endogenous substance underlies sleep regulation. Rather a complex system involving different neurotransmitters must be postulated. Sleep disorders medicine is a new medical discipline which has undergone a rapid development. In the USA more than 1000 "sleep disorders centers" have arisen in the past few years. A description of the new 1990 classification of sleep disorders is provided, and narcolepsy, sleep apnea syndrome and some disturbances of the sleep-wake cycle are briefly characterized.