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... 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...
Feldman, Marc; Boyer, Bret; Kumar, V. K.; Prout, Maurice
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)…
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 New Animal Drugs; Mupirocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 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 regulations to reflect approval of an original new animal...
... similar animal management practices are used; and (5) Drugs intended for use under prescription or... 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...
Cleopatra S. Planeta
Full Text Available Drug addiction has serious health and social consequences. In the last 50 years, a wide range of techniques have been developed to model specific aspects of drug-taking behaviors and have greatly contributed to the understanding of the neurobiological basis of drug abuse and addiction. In the last two decades, new models have been proposed in an attempt to capture the more genuine aspects of addiction-like behaviors in laboratory animals. The goal of the present review is to provide an overview of the preclinical procedures used to study drug abuse and dependence and describe recent progress that has been made in studying more specific aspects of addictive behavior in animals.
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 558 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine; Nicarbazin; Penicillin AGENCY: Food... amending the animal drug regulations to reflect the withdrawal of approval of three new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal... CFR Part 558 Animal drugs, animal feeds. 0 Therefore, under the Federal Food, Drug, and Cosmetic...
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,...
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Use of animal drugs. 318.20 Section 318.20 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE... General § 318.20 Use of animal drugs. Animal drug residues are permitted in meat and meat food products...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs; Ractopamine AGENCY: Food... administering ractopamine hydrochloride Type C medicated feeds as a top dress to cattle fed in confinement for... supplement to NADA 141-221 that provides for use of OPTAFLEXX 45 (ractopamine hydrochloride) Type A...
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 New Animal Drugs; Oxytetracycline... oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for... that provides for use of PENNOX 343 (oxytetracycline HCl) Soluble Powder for control of American...
Brayden, David J; Oudot, Emilie J M; Baird, Alan W
Delivery of biologically active agents to animals is often perceived to be the poor relation of human drug delivery. Yet this field has a long and successful history of species-specific device and formulation development, ranging from simple approaches and devices used in production animals to more sophisticated formulations and approaches for a wide range of species. While several technologies using biodegradable polymers have been successfully marketed in a range of veterinary and human products, the transfer of delivery technologies has not been similarly applied across species. This may be due to a combination of specific technical requirements for use of devices in different species, inter-species pharmacokinetic, pharmacodynamic and physiological differences, and distinct market drivers for drug classes used in companion and food-producing animals. This chapter reviews selected commercialised and research-based parenteral and non-parenteral veterinary drug delivery technologies in selected domestic species. Emphasis is also placed on the impact of endogenous drug transporters on drug distribution characteristics in different species. In vitro models used to investigate carrier-dependent transport are reviewed. Species-specific expression of transporters in several tissues can account for inter-animal or inter-species pharmacokinetic variability, lack of predictability of drug efficacy, and potential drug-drug interactions. PMID:20204584
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co....
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health,...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal... requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. 0...
Powell, Richard A; Kaye, Richard Mugula; Ddungu, Henry; Mwangi-Powell, Faith
International health and drug regulatory authorities acknowledge that analgesics (especially opioids) are insufficiently available for pain management in many countries. In Africa, reported morphine consumption is far below the global mean, with multiple factors hampering opioid supply. Since 2006, the African Palliative Care Association has hosted three regional drug availability workshops across the continent to address this issue. Using an interactive format, the workshops have identified country-specific barriers to opioid and other essential medication accessibility before supporting participants to develop action plans to address recognized impediments. Despite multiple challenges, a number of successes have arisen from the implementation of the plans. However, key issues remain, including the introduction of supportive policy environments, effective educational initiatives, and measures to address supply-chain obstacles impeding drug availability. PMID:20619205
... Federal Regulations (21 CFR part 556) (40 FR 13802 at 13942, March 27, 1975). The part 556 regulations... must be non-detectable or below the limit of detection of the approved regulatory method (67 FR 78172...-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food AGENCY: Food...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, a division of Eli Lilly & Co. The...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The supplemental NADA provides...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds...: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Div....
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy...
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 New Animal Drugs for Use in Animal.... SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to remove a... that the animal drug regulations for certain monensin free-choice Type C medicated feeds for...
Planeta, Cleopatra S.
Drug addiction has serious health and social consequences. In the last 50 years, a wide range of techniques have been developed to model specific aspects of drug-taking behaviors and have greatly contributed to the understanding of the neurobiological basis of drug abuse and addiction. In the last two decades, new models have been proposed in an attempt to capture the more genuine aspects of addiction-like behaviors in laboratory animals. The goal of the present review is to provide an overvi...
Ding, Qing; Qiu, Ya-jing; Fang, Ke-hui; Hu, Hao-bin; Wu, Yue
In order to reaction the quality present situation, problems on the current quality of animal sources of drugs are summed up by using test data analysis, literature search and marketing research. This paper can also help the improvement of the quality management, the revision of the relevant department policy system and the improvement of standards. PMID:27071276
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 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 regulations to reflect approval of an original new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal...
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 556, and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole...: The Food and Drug Administration (FDA) is amending the animal drug regulations by removing...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a tiamulin Type A medicated article that pertain to...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Food and Drug Administration (FDA) is amending the animal drug regulations to remove dairy replacement...-8108, email: firstname.lastname@example.org . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal...
... Contamination With Thallium or Radioactive Cesium; Availability'' (68 FR 5645, February 4, 2003)) and Pancreatic Enzymes (see ``Exocrine Pancreatic Insufficiency Drug Products'' (69 FR 23410, April 28, 2004), ``Exocrine Pancreatic Insufficiency Drug Products for Over-the-Counter Human Use'' (56 FR 32282, July 15, 1991),...
Kalivas, Peter W; Peters, Jamie; Knackstedt, Lori
Animal models in the field of addiction are considered to be among the best available models of neuropsychiatric disease. These models have undergone a number of refinements that allow deeper understanding of the circuitry involved in initiating drug seeking and relapse. Notably, the demonstrable involvement of classic corticostriatal habit circuitry and the engagement of prefrontal cortical circuits in extinction training may have relevance to the therapeutic modulation of habit circuitry and drug addiction in humans. PMID:17200461
Jansen-Olesen, Inger; Tfelt-Hansen, Peer; Olesen, Jes
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...
Emmerich, Ilka Ute
In 2015, four active pharmaceutical ingredients were released on the German market for small animals. These were the calcium-channel blocker Amlodipine (Amodip®), the benzodiazepine Diazepam (Ziapam®), the allylamine antifungal agent Terbinafine (Osurnia®) and the loop diuretic Torasemide (UpCard®). One substance has been authorized for an additional species. The triazole antifungal drug Itraconazole (Fungitraxx®) is now authorized for use in ornamental birds. PMID:27223466
Petervary, Nicolette; Allen, Tim; Stokes, William S; Banks, Ron E
Animal welfare is an important area of study for professionals in fields of animal care and use, and many turn to self-learning resources to gain a better understanding of topics in this area. We assessed the state of these self-learning resources by evaluating open access, freely available resources on the internet with respect to their content and the reliability of their information. We categorized content using a modified list of the topics described in the American College of Animal Welfare's Role Delineation Document, and we identified subject areas that are underrepresented among freely available resources. We identified that the field needs more content describing practical information on subtopics of animal transportation, humane education and economic issues in animal welfare. We also suggest a targeted approach to improve and increase particular aspects of content that concerns the impacts of human, animal and environment interactions on animal welfare. We recommend that veterinary societies place more emphasis on welfare policies in their websites. Additionally, the field of animal welfare would benefit from more available and authoritative information on certain species and uses of animals that are presently underrepresented. PMID:27096187
Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. PMID:24928564
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 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 regulations to reflect approval of an original abbreviated new...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new...
... 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 §...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new...
... requirements. (For selenium see 21 CFR 573.920; for EDDI see 51 FR 11483 (April 3, 1986).) * * * * * Dated... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds... Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new...
... Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR... and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal...
Michael Guarnieri S
Full Text Available The past 25 years have witnessed remarkable changes in how new drugs are brought to the market. Pharmaceutical companies once took pride in vertical integration. Animal tests, laboratory analyses, and clinical trials were conducted in-house. Even when companies found that many of these services could be done more effectively by contract research organizations, they maintained tight control of their research programs. Academic scientists frequently reported stories about efforts to contact a pharmaceutical company with an idea about a new drug only to be told politely that if the idea were not developed in house, big pharma was not interested.
... requested comments on strategies to address the prevalence of animal drug products marketed in the United... legal marketing status. The notice expressed FDA's interest in receiving comments on strategies that... HUMAN SERVICES Food and Drug Administration Unapproved Animal Drugs; Extension of Comment Period...
... manufacture of animal feed. 510.7 Section 510.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS General Provisions § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new...
... human drug use in food-producing animals. 530.20 Section 530.20 Food and Drugs FOOD AND DRUG... Food-Producing Animals § 530.20 Conditions for permitted extralabel animal and human drug use in food... prescribing or dispensing an approved new animal or human drug for an extralabel use in food animals,...
... 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...
... medlineplus/news/fullstory_158316.html Antibiotics in Animal Feed Contribute to Drug-Resistant Germs: Study Individual farm ... HealthDay News) -- Use of antibiotics in farm animal feed is helping drive the worldwide increase in antibiotic- ...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales and Distribution Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration (FDA or Agency) is soliciting comments regarding...
Full Text Available The human and animal health represents one of the most important challenges in EU countries andacceding countries. The alternative solutions adopted in order to improve animal health within organic farming(the use of organic mineral and probiotic supplements are the main issue of this paper. A review of the role ofthe selenium and yeast based probiotics (Saccharomyces cerevisiae used in organic livestock feeding ispresented. The benefits of using organic selenium compared to inorganic forms of selenium in livestock feedingwithin organic farming conditions are emphasized. The synergy between organic selenium and vitamin E inlivestock is also reviewed. A short history of the probiotics and a brief definition of these products is presentedin the second section of this paper. Some of the results of the research performed by authors in this field arepresented.
... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS EXTRALABEL DRUG USE IN ANIMALS Extralabel Use of Human and Animal Drugs in Animals Not Intended for Human Consumption § 530.30 Extralabel drug use in nonfood animals. (a) Because extralabel use of animal and human drugs in nonfood-producing animals does...
Gupta, Y K; Briyal, Seema
Stroke is a major cause of death and disability worldwide. The resulting burden on the society continues to grow, with increase in the incidence of stroke. Brain attack is a term introduced to describe the acute presentation of stroke, which emphasizes the need for urgent action to remedy the situation. Though a large number of therapeutic agents like thrombolytics, NMDA receptor antagonists, calcium channel blockers and antioxidants, have been used or being evaluated, there remains a large gap between the benefits by these agents and properties an ideal drug for stroke should offer. In recent years much attention is being paid towards the exploration of herbal preparation, antioxidant agents and combination therapies including COX-2 inhibitors in experimental model of stroke. For better evaluation of the drugs and enhancement of their predictability from animal experimentation to clinical settings, it has been realized that the selection of animal models, the parameters to be evaluated should be critically assessed. Focal and global cerebral ischemia represents diseases that are common in the human population. Understanding the mechanisms of injury and neuroprotection in these diseases is important to learn new target sites to treat ischemia. There are many animal models available to investigate injury mechanisms and neuroprotective strategies. In this article we attempted to summarize commonly explored animal models of focal and global cerebral ischemia and evaluate their advantages and limitations. PMID:15907047
.... FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and... Veterinary Medicine, 21 CFR part 510 is amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority.... Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine....
... FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug... of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended... Animal Drug Evaluation, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
... INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration... INFORMATION: Biopure Corp., 11 Hurley St., Cambridge, MA 02141 has informed FDA that it has transferred... HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feed... NADAs provide for administering a Type C medicated feed containing ractopamine hydrochloride as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2011,...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2009,...
... use of KINAVET-CA1 (masitinib mesylate) Tablets for the treatment of recurrent (post-surgery) or... and/or chemotherapy except corticosteroids. In accordance with the Federal Food, Drug, and Cosmetic..., Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act...
In pharmaceutical drug development, there has been increased interest in the need to perform juvenile animal studies to support the safety of use of new medicines in the pediatric population. Although such studies are not new, the increased interest has been "formalized" in recent regulatory guidelines. As a result, companies are now performing many more studies in juvenile animals, even when there is a lack of robust knowledge of cross-species functional and kinetic differences among juveniles that means extrapolation of any toxicology study finding to an immature human may not be easy or even relevant, especially if performed in the wrong species at the wrong time. It will be shown by presentation of some basic considerations needed in order to perform such testing, that juvenile animal studies are indeed feasible. However, it will also be highlighted that (based on available knowledge) there are currently not enough clear-cut examples to answer the question of whether juvenile animal toxicology studies to support pediatric development (by affecting the performance or design of a pediatric clinical trial or identifying a potential different-from-adult safety risk in clinical use) are truly useful or necessary. PMID:20350578
Various animal models have been developed to investigate the neurobiological and behavioral mechanisms of drug addiction. The most popular of these animal models include the locomotor sensitization paradigm, the place conditioning procedure and the self-administration technique. With these techniques, it is possible to mimic in rodents the major aspects of human drug addiction. The self-administration procedure is the most widely used and show an excellent natural and predictive validity. In ...
... gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending... application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630...: Authority: 21 U.S.C. 360b. 0 2. Section 522.1014 is added to read as follows: ] Sec. 522.1014...
... the feed of animals. 558.15 Section 558.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUGS FOR USE... similar products except the nitrofuran drugs not the subject of an approved new animal drug...
... medicated article was voluntarily withdrawn (60 FR 37651, July 21, 1995) and approved conditions of use for... NADA 45-738, were removed (60 FR 39847, July 21, 1995). At this time, the tolerances for residues of... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 Animal Drugs, Feeds, and...
Brigden, M; Smith, R E
A large number of drugs containing acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter in Canada. The possibility of serious side effects and drug interactions is therefore high. The authors have compiled a comprehensive list of products containing these drugs from information supplied by pharmaceutical databases, independent marketing researchers and Health Canada's Drug Directorate. Physicians should ensure that add...
Rice straw is the most abundant among crop residues. Actually, rice straw is the most important roughage in Myanmar for ruminant feeding. Like other fibrous residues, it is a poor quality feed. The major cause of low productivity of livestock in tropical regions is the inadequate and poor quality of feed. The nutritional limitations of rice straw may be overcome by supplementation with concentrates, urea or green forage. Supplementation of rice straw with concentrate would improve the utilization of rice straw. Supplementation of by-product, which may increase intake and/or digestion, and/or utilization of the basal diet are the condition directly related to microbial activity, which is required to optimize rumen digestion. The microbes within the rumen grow efficiently when ammonia nitrogen in the rumen is adequate. In Myanmar, sesame meal is one of the common feed supplements for the draft cattle and crossbred dairy cows fed rice straw. Sesame meal is highly degradable (88.7%) in the rumen. Therefore, degradation of protein is a considerable factor when the protein sources are supplemented. Several processing treatments (heat, tannin, formaldehyde, etc.) have been used to increase the proportion of dietary protein, which is not degraded in the rumen. Protections of highly degradable feed protein by the heat treatment and formaldehyde have already been reported. However, little information is available about the effect of tannin included in tree foliages for the protein protection. Conventionally, tree foliages have been fed together with agricultural by-products, mainly crop-residues, containing low levels of nitrogen to enhance rumen microbial fermentation and hence the animal productivity. Tanniferous trees and shrubs are important in animal production because they can provide significant protein supplements. Forages containing leucocephala, Ziziphus mauritiana, Albizia chinensis, Manihot esculenta, Terminalia oblongata, etc. Tree legume forages offer a cheap
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
Virmani, R; Kolodgie, F D; Farb, A.; Lafont, A
Animal models of stenting probably predict human responses as the stages of healing are remarkably similar. What is characteristically different is the temporal response to healing, which is substantially prolonged in humans. The prevention of restenosis in recent clinical trials of drug eluting stents may represent a near absent or incomplete phase of intimal healing. Continued long term follow up of patients with drug eluting stents for major adverse cardiac events and angiographic restenos...
...: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish... to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows: PART 510--NEW ANIMAL.... Bernadette Dunham, Director, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
... March 22, 2013. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV...: email@example.com . SUPPLEMENTARY INFORMATION: Teva Animal Health, Inc., 3915 South 48th Street... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 New...
The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine. PMID:27580511
... concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when... those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial... of a final guidance entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in...
Peck, J A
Drug addiction is a significant health and societal problem for which there is no highly effective long-term behavioral or pharmacological treatment. A rising concern are the use of illegal opiate drugs such as heroin and the misuse of legally available pain relievers that have led to serious deleterious health effects or even death. Therefore, treatment strategies that prolong opiate abstinence should be the primary focus of opiate treatment. Further, because the factors that support abstinence in humans and laboratory animals are similar, several animal models of abstinence and relapse have been developed. Here, we review a few animal models of abstinence and relapse and evaluate their validity and utility in addressing human behavior that leads to long-term drug abstinence. Then, a novel abstinence "conflict" model that more closely mimics human drug-seeking episodes by incorporating negative consequences for drug seeking (as are typical in humans, eg, incarceration and job loss) and while the drug remains readily available is discussed. Additionally, recent research investigating both cocaine and heroin seeking in rats using the animal conflict model is presented and the implications for heroin treatments are examined. Finally, it is argued that the use of animal abstinence/relapse models that more closely approximate human drug addiction, such as the abstinence-conflict model, could lead to a better understanding of the neurobiological and environmental factors that support long-term drug abstinence. In turn, this will lead to the development of more effective environmental and pharmacotherapeutic interventions to treat opiate addiction and addiction to other drugs of abuse. PMID:27055619
... December 16, 2013 (78 FR 76059). The document amended the animal drug regulations to remove dairy..., Silver Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In the FR Doc. 2013-29810, appearing on page 76059 in the Federal Register of Monday, December 16, 2013 (78 FR 76059), the...
Musther, Helen; Olivares-Morales, Andrés; Hatley, Oliver J. D.; Liu, Bo; Rostami Hodjegan, Amin
Oral bioavailability is a key consideration in development of drug products, and the use of preclinical species in predicting bioavailability in human has long been debated. In order to clarify whether any correlation between human and animal bioavailability exist, an extensive analysis of the published literature data was conducted. Due to the complex nature of bioavailability calculations inclusion criteria were applied to ensure integrity of the data. A database of 184 compounds was assemb...
Jentsch, J. David
Different conceptual frameworks have been generated to explain substance abuse; of relevance to this article, dysfunction of impulse control systems that are required for avoiding or stopping drug-seeking and –taking may play a key role in addiction. This review summarizes work in animal models that explains the pervasive association between impulse control and substance abuse. It further underscores the concept that impulse control may be a critical target for pharmacological intervention in...
Mayer, E A; Bradesi, S; Chang, L; Spiegel, B. M. R.; Bueller, J A; Naliboff, B. D.
Despite considerable efforts by academic researchers and by the pharmaceutical industry, the development of novel pharmacological treatments for irritable bowel syndrome (IBS) and other functional gastrointestinal (GI) disorders has been slow and disappointing. The traditional approach to identifying and evaluating novel drugs for these symptom-based syndromes has relied on a fairly standard algorithm using animal models, experimental medicine models and clinical trials. In the current articl...
Shah Tanmay A; Shah Nidhi T; Prajapati Parimal M; Bhatt Pratik B; Solanki Anil S
The increasing worldwide incidence of diabetes mellitus in adults constitutes a global public health burden. It is predicted that by 2030, largest number of people with diabetes. Although medicinal plants have been historically used for diabetes treatment throughout the world, few of them have been validated by scientific criteria. In recent times, an outsized multiplicity of animal models has been developed to enhanced understand the pathogenesis of diabetes mellitus and new drugs have been ...
... food-producing animals. 530.25 Section 530.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... may issue an order prohibiting extralabel use of an approved new animal or human drug in food... an extralabel use of a drug in food-producing animals. Such order shall state that an...
... 21 Food and Drugs 6 2010-04-01 2010-04-01 false General considerations; tolerances for residues of new animal drugs in food. 556.1 Section 556.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... RESIDUES OF NEW ANIMAL DRUGS IN FOOD General Provisions § 556.1 General considerations; tolerances...
Full Text Available The development of efficacious antitumor compounds with minimal toxicity is a hot research topic. Numerous cancer cell targeted agents are evaluated daily in laboratories for their antitumorigenicity at the pre-clinical level, but the process of their introduction into the market is costly and time-consuming. More importantly, even if these new antitumor agents manage to gain approval, clinicians have no former experience with them. Accruing evidence supports the idea that several medications already used to treat pathologies other than cancer display pleiotropic effects, exhibiting multi-level anti-cancer activity and chemosensitizing properties. This review aims to present the anticancer properties of marketed drugs (i.e., metformin and pioglitazone used for the management of diabetes mellitus (DM type II. Mode of action, pre-clinical in vitro and in vivo or clinical data as well as clinical applicability are discussed here. Given the precious multi-year clinical experience with these non-antineoplastic drugs their repurposing in oncology is a challenging alternative that would aid towards the development of therapeutic schemes with less toxicity than those of conventional chemotherapeutic agents. More importantly, harnessing the antitumor function of these agents would save precious time from bench to bedside to aid the fight in the arena of cancer.
Yamamoto, T; Yabuuchi, K; Yamaguchi, T; Nakamichi, M
This paper will review 1) experimental models of drug-seeking behavior and 2) mechanisms underlying the behavior, focusing on cocaine self-administration. After the acquisition of self-administration, vigorous lever-pressing is generally observable after the drug was replaced by saline. This lever-pressing behavior under saline infusion can be considered "drug-seeking behavior". Drug-seeking behavior is reinstated by non-contingent injection of the drug, stress exposure and presentation of drug-associated stimuli even after extinction. This is called a relapse/reinstatement model. Electrophysiological studies showed that the majority of accumbal neurons is tonically inhibited during cocaine self-administration and exhibited phasic increases in firing time-locked to cocaine self-infusion, which might represent the craving state or drive animals to drug-seeking behavior. Voltammetry and microdialysis studies indicated that the timing of drug-seeking responses can be predicted from fluctuations in accumbal extracellular dopamine concentration. Whereas dopamine D2-like agonists reinstated extinguished cocaine-seeking behavior, D1-like agonists prevented the relapse in cocaine-seeking behavior induced by cocaine itself. Given that an AMPA receptor antagonist, but not dopamine antagonist, prevented cocaine-seeking behavior induced by cocaine, glutamate transmission in the nucleus accumbens is thought to be important for expression of craving or drug-seeking behavior. PMID:11233296
... HUMAN SERVICES Food and Drug Administration Animal Generic Drug User Fee Rates and Payment Procedures... experience with a similar user fee program. Based on the previous assumptions, FDA is estimating that it will... generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by...
... Animal Drugs; Oxytetracycline and Flunixin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin... that provides for veterinary prescription use of HEXASOL (oxytetracycline and flunixin...
Kaur, S R
Several antiretroviral drugs against HIV/AIDS have been developed in recent years. These drugs, reverse transcriptase inhibitors and protease inhibitors, inhibit the reproduction of HIV, but do not eliminate the presence of HIV in the body. The cost of drugs to treat one person with HIV/AIDS easily runs into the thousands of US dollars per year. These new drugs are therefore routinely used in developed countries, but not among the masses in developing countries. Many of the drugs needed to treat the opportunistic infections present during advanced HIV infection and AIDS are also prohibitively expensive for both developing countries and most individuals in those countries. The imposition of World Bank and International Monetary Fund structural adjustment programs together with decreased household purchasing power during the 1990s has led to increased demand for public sector services amid reduced public expenditure. The private sector is increasingly taking over the drug supply in developing countries, driving the cost of drugs out of the range of affordability for the vast majority of the poor. One strategy to contain the cost of drugs is for governments to develop and implement an integrated national drug policy based upon the concept of essential drugs and their rational use. PMID:12292110
Full Text Available The preclinical studies for drug screening involve the use of animals which is very time consuming and expensive and at times leads to suffering of the used organism. Animal right activists around the world are increasingly opposing the use of animals. This has forced the researchers to find ways to not only decrease the time involved in drug screening procedures but also decrease the number of animals used and also increase the humane care of animals. To fulfill this goal a number of new in vitro techniques have been devised which are called ′Alternatives′ or ′Substitutes′ for use of animals in research involving drugs. These ′Alternatives′ are defined as the adjuncts which help to decrease the use as well as the number of animals in biomedical research. Russell and Burch have defined these alternatives by three R′s - Reduction, Refinement and Replacement. These alternative strategies include physico-chemical methods and techniques utilizing tissue culture, microbiological system, stem cells, DNA chips, micro fluidics, computer analysis models, epidemiological surveys and plant-tissue based materials. The advantages of these alternatives include the decrease in the number of animals used, ability to obtain the results quickly, reduction in the costs and flexibility to control the variables of the experiment. However these techniques are not glittering gold and have their own shortcomings. The disadvantages include the lack of an appropriate alternative to study the whole animal′s metabolic response, inability to study transplant models and idiosyncratic responses and inability to study the body′s handling of drugs and its subsequent metabolites. None-the-less these aalternative methods to certain extent help to reduce the number of animals required for research. But such alternatives cannot eliminate the need for animals in research completely. Even though no animal model is a complete set of replica for a process within a
In Europe alone, 3.6 million animals per year are used for drug development. Animal studies are worldwide the gold standard to evaluate the safety, efficacy and quality of drugs before these drugs are tested in humans. Nevertheless the value of animal studies to predict risks for humans has never been extensively established. Nowadays, several studies indicate that the value of animal studies is often limited. Pharmaceutical companies and regulatory authorities as well as the public and gover...
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
Pedro H. Gobira
Full Text Available The use of antipsychotic drugs represents an important approach for the treatment of schizophrenia. However, their efficacy is limited to certain symptoms of this disorder, and they induce serious side effects. As a result, there is a strong demand for the development of new drugs, which depends on reliable animal models for pharmacological characterization. The present review discusses the face, construct, and predictive validity of classical animal models for studying the efficacy and side effects of compounds for the treatment of schizophrenia. These models are based on the properties of antipsychotics to impair the conditioned avoidance response and reverse certain behavioral changes induced by psychotomimetic drugs, such as stereotypies, hyperlocomotion, and deficit in prepulse inhibition of the startle response. Other tests, which are not specific to schizophrenia, may predict drug effects on negative and cognitive symptoms, such as deficits in social interaction and memory impairment. Regarding motor side effects, the catalepsy test predicts the liability of a drug to induce Parkinson-like syndrome, whereas vacuous chewing movements predict the liability to induce dyskinesia after chronic treatment. Despite certain limitations, these models may contribute to the development of more safe and efficacious antipsychotic drugs.
.... Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl... Veterinary Medicine, 21 CFR part 510 is amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority..., Office of New Animal Drug Evaluation, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
... September 20, 2011 (76 FR 58279). In that notice, FDA requested comments on the Animal Drug User Fee Act... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Animal Drug User Fee Act; Reopening of the Comment...
Kostić Ivana T.
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.
Marchant, Nathan J.; Li, Xuan; Shaham, Yavin
Drug craving and relapse to drug use during abstinence are defining features of addiction. Evidence indicates that drug craving and relapse in humans are often provoked by acute exposure to the self-administered drug, drug-associated cues, or stress. During the last two decades, this clinical scenario has been primarily studied at the preclinical level using the classical reinstatement model. However, a single preclinical model cannot capture the complicated nature of human drug relapse. Ther...
Dehling, D.M.; Hof, C.; Brandle, M.;
species richness. We tested whether habitat availability can account for the differences in species richness patterns between European lentic and lotic freshwater animals. Location Europe. Methods We compiled occurrence data of 1959 lentic and 2445 lotic species as well as data on the amount of lentic and......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...... latitude. Main conclusions Habitat availability and diversity are poor predictors of species richness of the European freshwater fauna across large scales. Our results indicate that the distributions of European freshwater animals are probably not in equilibrium and may still be influenced by history...
... Animal Drugs; Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate AGENCY: Food and Drug... NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid... releasing factor-diphtheria toxoid conjugate) Sterile Solution for Injection for temporary...
Ayvaz, Serkan; Horn, John; Hassanzadeh, Oktie; Zhu, Qian; Stan, Johann; Tatonetti, Nicholas P; Vilar, Santiago; Brochhausen, Mathias; Samwald, Matthias; Rastegar-Mojarad, Majid; Dumontier, Michel; Boyce, Richard D
Although potential drug-drug interactions (PDDIs) are a significant source of preventable drug-related harm, there is currently no single complete source of PDDI information. In the current study, all publically available sources of PDDI information that could be identified using a comprehensive and broad search were combined into a single dataset. The combined dataset merged fourteen different sources including 5 clinically-oriented information sources, 4 Natural Language Processing (NLP) Corpora, and 5 Bioinformatics/Pharmacovigilance information sources. As a comprehensive PDDI source, the merged dataset might benefit the pharmacovigilance text mining community by making it possible to compare the representativeness of NLP corpora for PDDI text extraction tasks, and specifying elements that can be useful for future PDDI extraction purposes. An analysis of the overlap between and across the data sources showed that there was little overlap. Even comprehensive PDDI lists such as DrugBank, KEGG, and the NDF-RT had less than 50% overlap with each other. Moreover, all of the comprehensive lists had incomplete coverage of two data sources that focus on PDDIs of interest in most clinical settings. Based on this information, we think that systems that provide access to the comprehensive lists, such as APIs into RxNorm, should be careful to inform users that the lists may be incomplete with respect to PDDIs that drug experts suggest clinicians be aware of. In spite of the low degree of overlap, several dozen cases were identified where PDDI information provided in drug product labeling might be augmented by the merged dataset. Moreover, the combined dataset was also shown to improve the performance of an existing PDDI NLP pipeline and a recently published PDDI pharmacovigilance protocol. Future work will focus on improvement of the methods for mapping between PDDI information sources, identifying methods to improve the use of the merged dataset in PDDI NLP algorithms
Hočevar, Andreja; Kovač Šebart, Mojca; Mažgon, Jasna
According to the European Monitoring Centre for Drugs and Drugs Addiction, preventive programmes and interventions should aim to address drug use in specific settings, such as schools. There are no available data about drug use in schools, especially in an international context; therefore, this study attempted to collect data on the availability and use of drugs in schools and in vicinities close to schools, from students attending Slovenian primary schools. The research study consists of a r...
Papanagnou, Panagiota; Stivarou, Theodora; Tsironi, Maria
The development of efficacious antitumor compounds with minimal toxicity is a hot research topic. Numerous cancer cell targeted agents are evaluated daily in laboratories for their antitumorigenicity at the pre-clinical level, but the process of their introduction into the market is costly and time-consuming. More importantly, even if these new antitumor agents manage to gain approval, clinicians have no former experience with them. Accruing evidence supports the idea that several medications already used to treat pathologies other than cancer display pleiotropic effects, exhibiting multi-level anti-cancer activity and chemosensitizing properties. This review aims to present the anticancer properties of marketed drugs (i.e., metformin and pioglitazone) used for the management of diabetes mellitus (DM) type II. Mode of action, pre-clinical in vitro and in vivo or clinical data as well as clinical applicability are discussed here. Given the precious multi-year clinical experience with these non-antineoplastic drugs their repurposing in oncology is a challenging alternative that would aid towards the development of therapeutic schemes with less toxicity than those of conventional chemotherapeutic agents. More importantly, harnessing the antitumor function of these agents would save precious time from bench to bedside to aid the fight in the arena of cancer. PMID:27164115
Friedmann, Peter D; Lemon, Stephenie C.; Durkin, Elizabeth M.; D’Aunno, Thomas A.
Comprehensive medical and psychosocial services are essential to quality addiction treatment, but their availability declined in the 1980s. To determine whether this downward trend in the availability of comprehensive services continued in the 1990s, we analyzed data from a national panel study of outpatient substance abuse treatment units in 1990, 1995, and 2000. Response rates were greater than 85%. Regarding the availability of comprehensive services, including physical examinations, routi...
Full Text Available Abstract Background There is evidence of a high prevalence of prescription opioid (PO and crack use among street drug users in Toronto. The purpose of this qualitative study was to describe drug use behaviours and preferences as well as the social and environmental context surrounding the use of these drugs among young and old street-based drug injection drug users (IDUs. Methods In-depth interviews were conducted with 25 PO injectors. Topics covered included drug use history, types of drugs used, how drugs were purchased and transitions to PO use. Interviews were taped and transcribed. Content analysis was conducted to identify themes. Results Five prominent themes emerged from the interviews: 1 Combination of crack and prescription opioids, 2 First injection experience and transition to prescription opioids, 3 Drug preferences and availability, 4 Housing and income and 5 Obtaining drugs. There was consensus that OxyContin and crack were the most commonly available drugs on the streets of Toronto. Drug use preferences and behaviours were influenced by the availability of drugs, the desired effect, ease of administration and expectations around the purity of the drugs. Distinct experiences were observed among younger users as compared to older users. In particular, the initiation of injection drug use and experimentation with POs among younger users was influenced by their experiences on the street, their peers and general curiosity. Conclusion Given the current profile of street-based drug market in Toronto and the emergence of crack and POs as two predominant illicit drug groups, understanding drug use patterns and socio-economic factors among younger and older users in this population has important implications for preventive and therapeutic interventions.
... 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...
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.
Marchant, Nathan J; Li, Xuan; Shaham, Yavin
Drug craving and relapse to drug use during abstinence are defining features of addiction. Evidence indicates that drug craving and relapse in humans are often provoked by acute exposure to the self-administered drug, drug-associated cues, or stress. During the last two decades, this clinical scenario has been primarily studied at the preclinical level using the classical reinstatement model. However, a single preclinical model cannot capture the complicated nature of human drug relapse. Therefore, more recently, we and others have developed several other models to study different facets of human drug relapse. In this review, we introduce and discuss recent findings from these other relapse models, including incubation of drug craving, reacquisition and resurgence models, and punishment-based and conflict-based relapse models. PMID:23374536
... regulated industry agree that dosage characterization is part of the effectiveness technical section of an... applications within 180 days after submission date. Non-manufacturing supplemental new animal drug applications.... Manufacturing supplemental new animal drug applications and reactivations of such supplemental...
... Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276... Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL... Dunham, Director, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
Behrensdorf-Nicol, H; Krämer, B
In order to ensure the quality of biomedical products, an experimental test for every single manufactured batch is required for many products. Especially in vaccine testing, animal experiments are traditionally used for this purpose. For example, efficacy is often determined via challenge experiments in laboratory animals. Safety tests of vaccine batches are also mostly performed using laboratory animals. However, many animal experiments have clear inherent disadvantages (low accuracy, questionable transferability to humans, unclear significance). Furthermore, for ethical reasons and animal welfare aspects animal experiments are also seen very critical by the public. Therefore, there is a strong trend towards replacing animal experiments with methods in which no animals are used ("replacement"). If a replacement is not possible, the required animal experiments should be improved in order to minimize the number of animals necessary ("reduction") and to reduce pain and suffering caused by the experiment to a minimum ("refinement"). This "3R concept" is meanwhile firmly established in legislature. In recent years many mandatory animal experiments have been replaced by alternative in vitro methods or improved according to the 3R principles; numerous alternative methods are currently under development. Nevertheless, the process from the development of a new method to its legal implementation takes a long time. Therefore, supplementary regulatory measures to facilitate validation and acceptance of new alternative methods could contribute to a faster and more consequent implementation of the 3R concept in the testing of biomedical products. PMID:25183445
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.
Zaheer Ud Din Babar
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
Venniro, Marco; Caprioli, Daniele; Shaham, Yavin
High rates of relapse to drug use during abstinence is a defining feature of drug addiction. In abstinent drug users, drug relapse is often precipitated by acute exposure to the self-administered drug, drug-associated cues, stress, as well as by short-term and protracted withdrawal symptoms. In this review, we discuss different animal models that have been used to study behavioral and neuropharmacological mechanisms of these relapse-related phenomena. In the first part, we discuss relapse models in which abstinence is achieved through extinction training, including the established reinstatement model, as well as the reacquisition and resurgence models. In the second part, we discuss recent animal models in which drug relapse is assessed after either forced abstinence (e.g., the incubation of drug craving model) or voluntary (self-imposed) abstinence achieved either by introducing adverse consequences to ongoing drug self-administration (e.g., punishment) or by an alternative nondrug reward using a discrete choice (drug vs. palatable food) procedure. We conclude by briefly discussing the potential implications of the recent developments of animal models of drug relapse after voluntary abstinence to the development of medications for relapse prevention. PMID:26822352
Jones, Gregory H; Carrier, Michael A; Silver, Richard T; Kantarjian, Hagop
High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented. PMID:26817958
Roess, Amira A.; Winch, Peter J.; Ali, Nabeel A.; Akhter, Afsana; Afroz, Dilara; El Arifeen, Shams; Darmstadt, Gary L.; Baqui, Abdullah H
Antimicrobial drug administration to household livestock may put humans and animals at risk for acquisition of antimicrobial drug–resistant pathogens. To describe animal husbandry practices, including animal healthcare-seeking and antimicrobial drug use in rural Bangladesh, we conducted semi-structured in-depth interviews with key informants, including female household members (n = 79), village doctors (n = 10), and pharmaceutical representatives, veterinarians, and government officials (n = ...
T Arora; Mehta, A. K.; Joshi, V; Mehta, K D; N Rathor; Mediratta, P. K.; Sharma, K. K.
The preclinical studies for drug screening involve the use of animals which is very time consuming and expensive and at times leads to suffering of the used organism. Animal right activists around the world are increasingly opposing the use of animals. This has forced the researchers to find ways to not only decrease the time involved in drug screening procedures but also decrease the number of animals used and also increase the humane care of animals. To fulfill this goal a number of new in ...
... 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...
Mow, Tomas; Frederiksen, Kristen; Thomsen, Morten B.
Torsades de Pointes (TdP) is a potentially lethal cardiac arrhythmia and a known adverse effect of many drugs secondary to block of the rapidly activating delayed rectifier potassium current (IKr). In animal models antipsychotic drugs have shown reduced pro-arrhythmic potential compared to drugs...
... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Ophthalmic Solution AGENCY: Food and Drug Administration, HHS...) for gentamicin sulfate and betamethasone acetate ophthalmic solution. This action is being taken...
... CONTACT: Lisa M. Troutman, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500... of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended...: March 14, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
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 & ...
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the......
Vihang S. Chawan
Conclusions: There is a wide variation in the price of different brands of anxiolytic drugs available in Indian market. Government of India should reduce the pricing of drugs by bringing them under drug pricing control order (DPCO. [Int J Res Med Sci 2016; 4(6.000: 2398-2401
Conclusions: There is a wide difference in the cost of different brands of oral antiplatelet drugs available in India. The clinicians prescribing these drugs should be aware of these variations in cost to reduce the cost of drug therapy. [Int J Basic Clin Pharmacol 2016; 5(3.000: 810-813
Steele, Vernon E.; Lubet, Ronald A.
Animal models currently are used to assess the efficacy of potential chemopreventive agents, including synthetic chemicals, chemical agents obtained from natural products and natural product mixtures. The observations made in these models as well as other data are then used to prioritize agents to determine which are qualified to progress to clinical chemoprevention trials. Organ specific animal models are employed to determine which agents or classes of agents are likely to be the most effec...
Phatak Abhishek M, Hotwani Jitendra H, Deshmukhkiran R, Panchal Sagar S, Naik Madhura S
Background: Large number of pharmaceutical companies manufactures antiepileptic drugs in India. The price variations among the marketed drugs are wide. Aims: The present study was aimed to find the cost of different oral antiepileptic drugs available in Indian market as monotherapy, combination therapy and number of manufacturing companies for each, to evaluate difference in cost of different brands of same dosage of same active drug by calculating percentage variation of cost. Methods and Ma...
Abhilasha Rashmi; Sharmada Nerlekar; Kumar Rajeev
Background: Coronary artery disease is one of the most prevalent causes of death and disability in developed and developing countries. There is a wide variation in the prices of oral antiplatelet drugs marketed in India. Thus, a study was planned to find out the variation in cost in the oral antiplatelet drugs available in India either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiplatelet drug by calculating percentage variation i...
G.X. He; S. van den Hof; M.W. Borgdorff; M.J. van der Werf; S.M. Cheng; Y.L. Hu; L.X. Zhang; L.X. Wang
OBJECTIVE: To assess the availability of second-line drugs (SLDs) and the use of drug susceptibility testing (DST) results for the treatment of tuberculosis (TB) in China. DESIGN: Cross-sectional survey in 4675 health care facilities, 1960 of which have a dedicated TB clinic, in 12 provinces in Chin
Caulfield, Catherine D; Cassidy, Joseph P.; Kelly, John P.
Gamma radiation is used to sterilize diets for specific pathogen-free (SPF) animals. Because a gamma-irradiated diet was linked to leukoencephalomyelopathy in SPF cats, we investigated the effects of ‘typical’ (28.9–34.3 kGy) and ‘high-end’ (38.4–48.7 kGy) doses of gamma irradiation and of pasteurization (at 107 °C for 15 min) on the amounts of fat; protein; carbohydrate (and taurine in cat diet); vitamins A, E, B1, B2, B6, and B12; and peroxide in commercially available dry cat, dog, and rod...
Full Text Available ... Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary ... The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how ...
Full Text Available ... The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) produced a nine-minute animation explaining how ... and distributed as long as FDA's Center for Veterinary Medicine is cited as the corporate author. Animation Animation ...
...; Sulfadiazine and Pyrimethamine Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... change of sponsor for sulfadiazine and pyrimethamine oral suspension from Animal Health Pharmaceuticals... REBALANCE (sulfadiazine and pyrimethamine) Antiprotozoal Oral Suspension to Pegasus Laboratories, Inc.,...
Pedro H. Gobira; Jivago Ropke; Aguiar, Daniele C; Jose A.S. Crippa; Moreira, Fabricio A.
The use of antipsychotic drugs represents an important approach for the treatment of schizophrenia. However, their efficacy is limited to certain symptoms of this disorder, and they induce serious side effects. As a result, there is a strong demand for the development of new drugs, which depends on reliable animal models for pharmacological characterization. The present review discusses the face, construct, and predictive validity of classical animal models for studying the efficacy and side ...
... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 New Animal Drugs; Change of Sponsor... Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... that it has transferred ownership of, and all rights and interest in, abbreviated new animal...
... in swine feed was voluntarily withdrawn by a letter dated November 12, 1973. The Agency acknowledged... that anyone claiming to hold an approved NADA for arsanilate sodium in swine feed submit evidence to... of December 18, 1986 (51 FR 45346), FDA proposed to remove Sec. 558.20 Drugs used in medicated...
...; Altrenogest; Dexamethasone; Florfenicol AGENCY: Food and Drug Administration, HHS. ] ACTION: Final rule... approval renders Sec. 516.1215 obsolete. 200-456 Med-Pharmex, Inc., Dexamethasone Original approval of 522... paragraphs (a)(2)(ii) and (a)(3)(iii) to read as follows: Sec. 522.540 Dexamethasone. (a) * * * (2) * * *...
Elisabetta Tosti; Francesco Silvestre
The discovery and description of bioactive substances from natural sources has been a research topic for the last 50 years. In this respect, marine animals have been used to extract many new compounds exerting different actions. Reproduction is a complex process whose main steps are the production and maturation of gametes, their activation, the fertilisation and the beginning of development. In the literature it has been shown that many substances extracted from marine organisms may have pro...
Tyler J S Smith
Full Text Available INTRODUCTION: Air from animal feeding operations (AFOs has been shown to transport numerous contaminants of public health concern. While federal statutes like the Emergency Planning and Community Right-to-Know Act (EPCRA generally require that facilities report hazardous releases, AFOs have been exempted from most of these requirements by the U.S. Environmental Protection Agency (EPA. We assessed the availability of information about AFO airborne hazardous releases following these exemptions. METHODS: We submitted public records requests to 7 states overlapping with or adjacent to the Chesapeake Bay watershed for reports of hazardous releases made by AFOs under EPCRA. From the records received, we calculated the proportion of AFOs in each state for which ≥1 reports were available. We also determined the availability of specific types of information required under EPCRA. The numbers of AFOs permitted under the Clean Water Act (CWA or analogous state laws, as determined from permitting databases obtained from states, were used as denominators. RESULTS: We received both EPCRA reports and permitting databases from 4 of 7 states. Across these 4 states, the mean proportion of AFOs for which ≥1 EPCRA reports were available was 15% (range: 2-33%. The mean proportions of AFOs for which the name or identity of the substance released, ≥1 estimates of quantity released, and information about nearby population density and sensitive populations were available were 15% (range: 2-33%, 8% (range: 0-22%, and 14% (range: 2-8%, respectively. DISCUSSION: These results suggest that information about the airborne hazardous releases of a large majority of AFOs is not available under federal law in the states that we investigated. While the results cannot be attributed to specific factors by this method, attention to multiple factors, including revision of the EPA's exemptions, may increase the availability of information relevant to the health of populations
Carroll, Marilyn E; Anker, Justin J
Increasing evidence indicates the presence of sex differences in many aspects of drug abuse. Most studies reveal that females exceed males during the initiation, escalation, extinction, and reinstatement (relapse) of drug-seeking behavior, but males are more sensitive than females to the aversive effects of drugs such as drug withdrawal. Findings from human and animal research indicate that circulating levels of ovarian steroid hormones account for these sex differences. Estrogen (E) facilitates drug-seeking behavior, while progesterone (P) and its metabolite, allopregnanalone (ALLO), counteract the effects of E and reduce drug seeking. Estrogen and P influence other behaviors that are affiliated with drug abuse such as drug-induced locomotor sensitization and conditioned place preference. The enhanced vulnerability to drug seeking in females vs. males is also additive with the other risk factors for drug abuse (e.g., adolescence, sweet preference, novelty reactivity, and impulsivity). Finally, treatment studies using behavioral or pharmacological interventions, including P and ALLO, also indicate that females show greater treatment effectiveness during several phases of the addiction process. The neurobiological basis of sex differences in drug abuse appears to be genetic and involves the influence of ovarian hormones and their metabolites, the hypothalamic pituitary adrenal (HPA) axis, dopamine (DA), and gamma-hydroxy-butyric acid (GABA). Overall, sex and hormonal status along with other biological risk factors account for a continuum of addiction-prone and -resistant animal models that are valuable for studying drug abuse prevention and treatment strategies. PMID:19818789
Sharma, Sulbha K.; Dai, Tianhong; Gitika B Kharkwal; Huang, Ying-Ying; Huang, Liyi; Bil De Arce, Vida J.; Tegos, George P.; Hamblin, Michael R.
Antimicrobial photodynamic therapy (aPDT) is an emerging alternative to antibiotics motivated by growing problems with multi-drug resistant pathogens. aPDT uses non-toxic dyes or photosensitizers (PS) in combination with harmless visible of the correct wavelength to be absorbed by the PS. The excited state PS can form a long-lived triplet state that can interact with molecular oxygen to produce reactive oxygen species such as singlet oxygen and hydroxyl radical that kill the microbial cells. ...
... Animal Drugs; Gentamicin and Betamethasone Spray AGENCY: Food and Drug Administration, HHS. ACTION: Final... betamethasone valerate topical spray in dogs. DATES: This rule is effective January 25, 2012. FOR FURTHER... 200-416 that provides for veterinary prescription use of Gentamicin Topical Spray (gentamicin...
... related application fees and any other fees owed under the Animal Generic Drug User Fee program. II... that this is a reasonable approach after 5 years of experience with this program. The average number of..., Account Name: Food and Drug Administration, Account No.: 75060099, Routing No.: 021030004, Swift...
.... FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food... and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows... Animal Drug Evaluation, Center for Veterinary Medicine. BILLING CODE 4160-01-P...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... part 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New...--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... part 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... part 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation and Injectable Dosage Form New...: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New...--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New... as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 1. The...
... notice of proposed rulemaking that published July 27, 2012 (77 FR 44177) is extended. Submit written or... . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 27, 2012 (77 FR 44177), FDA published... HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 Antimicrobial Animal Drug Sales...
... the Federal Register of August 10, 2001 (66 FR 42167), the Agency published an advance notice of... Effects Abroad of Major Federal Actions,'' of January 4, 1979 (44 FR 1957, January 9, 1979); and 21 CFR 25... Tolerances for Residues of Unapproved New Animal Drugs in Food AGENCY: Food and Drug Administration,...
... values in the current guidance document, ``Guideline for Establishing a Safe Concentration'' (59 FR 37499... HUMAN SERVICES Food and Drug Administration 21 CFR Part 556 Tolerances for Residues of New Animal Drugs... the allowable incremental increase for residues of progesterone in edible tissues of cattle and...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New...--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR part 524...
... parasites that were approved for the pioneer product with 3 years of marketing exclusivity (69 FR 501... HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New... part 524 is amended as follows: PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 1....
Van Meer, P.J.K.
Animal studies are considered needed as predictive models to evaluate safety and efficacy of new pharmaceuticals and are required by law. However, the scientific basis of the current paradigm on the predictability of animal studies for the effects of drugs in man is under discussion. Therefore, in this thesis we evaluated the scientific basis of the current practices and guidelines for the use of animal studies in pharmaceutical development and assessed the consequences and implications for t...
Setlow, Barry; Mendez, Ian A.; Mitchell, Marci R; Simon, Nicholas W.
Drug addicted individuals demonstrate high levels of impulsive choice, characterized by preference for small immediate over larger but delayed rewards. Although the causal relationship between chronic drug use and elevated impulsive choice in humans has been unclear, a small but growing body of literature over the past decade has shown that chronic drug administration in animal models can cause increases in impulsive choice, suggesting that a similar causal relationship may exist in human dru...
... directions for use to avoid adulteration of milk under section 402(a)(2)(c)(ii) of the act. (c) It is the... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Labeling of drugs for use in milk-producing... Administrative Rulings and Decisions § 510.105 Labeling of drugs for use in milk-producing animals. (a) Part...
Amit Padmakar Date; Harshal M. Mahajan; Amruta V. Dashputra; Rahul R. Bhosale
Background: Diabetes mellitus in early age is on the alarming rise in India, requiring lifelong treatment. There is a wide range of variation in the prices of antidiabetic drugs marketed in India. Hence, we decided to study price variations in the oral antidiabetic drugs available, either singly or in combination, and number of manufacturing companies for each, and to evaluate the difference in cost of different brands of same active drug by calculating percentage variation of cost. Method...
Freisthler, Bridget; Needell, Barbara; Gruenewald, Paul J.
Objective: This study examines how the availability of alcohol and illicit drugs (as measured by alcohol outlet density and police incidents of drug sales and possessions) is related to neighborhood rates of child abuse and neglect, controlling for other neighborhood demographic characteristics. Method: Data from substantiated reports of child…
... Network Reorganization Concept Paper AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION... for the National Animal Health Laboratory Network (NAHLN) for public review and comment. The NAHLN is a nationally coordinated network and partnership of Federal, State, and university-...
...-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance... Institutional Animal Care and Use Committee. In light of this policy and regulations, most in vivo ocular safety testing is expected to adhere to the 3-animal procedure described in OECD Test Guideline 405 (OECD,...
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
T.A. Kanters (Tim A.); C. de Sonneville (Caroline); W.K. Redekop (Ken); L. van Hakkaart-van Roijen (Leona)
markdownabstract__Abstract__ __Background__: Attention for Evidence Based Medicine (EBM) is growing, but evidence for orphan drugs is argued to be limited and inferior. This study systematically reviews the available evidence on clinical effectiveness, costeffectiveness and budget impact for orph
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products. PMID:23227566
Nisharani B Jadhav, Manisha S Bhosale, Charles V Adhav
Full Text Available There exists a wide range of variation in the prices of drugs marketed in India and other countries of the world. Very few studies have been conducted to reveal such price variations in the open market. Aim & Objectives: To evaluate the cost of oral anti-diabetics of different generic classes and different brand names of one compound, To evaluate the difference in cost of different brands for the same active drug by calculating percentage variation of cost. Methods: Cost of a particular drug being manufactured by different companies, in the same strength, number and dosage form was compared. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and the percentage variation in price was calculated. Results: In Single drug therapy, among sulfonylurea group of drugs, Glimepiride (1 mg shows maximum price variation of 655.38%, while Glipizide (10mg shows variation of 38.88%. In Biguanides & Thizolidinediones groups of drugs, Metformin (500 mg & Pioglitazone (15 mg show maximum price variation of 308.33% & 542% respectively. In α-glucosidases inhibitor group of drugs, Miglitol shows maximum price variation of 135.50 %. In combination therapies, Glipizide & Metformin combination shows the maximum variation up to 399.04 %. Conclusion: The average percentage price variation of different brands of the same drug manufactured in India is very wide and the appraisal and management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative personal and economic consequences
...The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data Standards Strategy (version 1.0) and the CDER Data Standards Strategy--Action Plan (version 1.0). This action is being taken to ensure that all interested stakeholders are aware that the data standards program documents are available and is intended to......
Phatak Abhishek M, Hotwani Jitendra H, Deshmukhkiran R, Panchal Sagar S, Naik Madhura S
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.
Rubaek, G.H.; Soerensen, Peter [Danish Inst. of Agricultural Sciences, Dept. of Agroecology, Tjele (Denmark); Stoholm, P. [Danish Fluid Bed Technology (Denmark)
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)
Nic Dhonnchadha, Bríd Áine; Kantak, Kathleen M
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
Edwards, Scott; Koob, George F.
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 ...
Sager J Gosai
Full Text Available The development of preclinical models amenable to live animal bioactive compound screening is an attractive approach to discovering effective pharmacological therapies for disorders caused by misfolded and aggregation-prone proteins. In general, however, live animal drug screening is labor and resource intensive, and has been hampered by the lack of robust assay designs and high throughput work-flows. Based on their small size, tissue transparency and ease of cultivation, the use of C. elegans should obviate many of the technical impediments associated with live animal drug screening. Moreover, their genetic tractability and accomplished record for providing insights into the molecular and cellular basis of human disease, should make C. elegans an ideal model system for in vivo drug discovery campaigns. The goal of this study was to determine whether C. elegans could be adapted to high-throughput and high-content drug screening strategies analogous to those developed for cell-based systems. Using transgenic animals expressing fluorescently-tagged proteins, we first developed a high-quality, high-throughput work-flow utilizing an automated fluorescence microscopy platform with integrated image acquisition and data analysis modules to qualitatively assess different biological processes including, growth, tissue development, cell viability and autophagy. We next adapted this technology to conduct a small molecule screen and identified compounds that altered the intracellular accumulation of the human aggregation prone mutant that causes liver disease in α1-antitrypsin deficiency. This study provides powerful validation for advancement in preclinical drug discovery campaigns by screening live C. elegans modeling α1-antitrypsin deficiency and other complex disease phenotypes on high-content imaging platforms.
... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...
... animal drug user fee program. AGDUFA I provides FDA with additional funds to enhance the performance of... review performance goals for certain submissions over 5 years from fiscal year (FY) 2009 through FY 2013. The purpose of establishing these review performance goals was to expedite the review of ANADAs...
...: Purpose 21 CFR Paragraph and Title What information must be reported concerning approved NADAs or ANADAs... experience report. What are the requirements for submission of advertisement and promotional labeling to FDA... pertinent to safety or effectiveness of a new animal drug that has not been previously submitted as part...
... Forest, IL 000409 60045 * * * * * (2) * * * Drug labeler code Firm name and address * * * * * 000409 Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045. * * * * * PART 520--ORAL DOSAGE FORM NEW ANIMAL... generic copy of Forest, IL sodium) Sterile NADA 140-338. 60045. Powder. 200-455....... Cross...
Hybrid cultivars of bermudagrass are a major feed source for ruminants across the Southeastern USA. This 4-yr experiment compared animal and pasture performance of ‘Coastal’ and ‘Tifton 44’ Bermudagrasses [Cynodon dactylon (L.) Pers.] over three canopy heights designated as short (5.8 cm), medium (...
Akhter, Sohail; Ramazani, Farshad; Ahmad, Mohammad Zaki; Ahmad, Farjam Jalees; Rahman, Ziyaur; Bhatnagar, Aseem; Storm, Gert
The present report describes the improved ocular retention and aqueous humoral drug availability of ganciclovir (GCV) when administered via topical instillation of different kind of nanoparticles onto the rabbit eye. GCV was loaded into PLGA nanoparticles, chitosan-coated nanoparticles and chitosan-
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 ...
Blanco-Gandía, Maria C; Mateos-García, Ana; García-Pardo, Maria P; Montagud-Romero, Sandra; Rodríguez-Arias, Marta; Miñarro, José; Aguilar, María A
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. PMID:26221831
..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS NEW ANIMAL DRUG.... (4) Adverse reaction reports, product experience reports, consumer complaints, and other similar data..., distribution, and similar data and information, except that any compilation of such data and...
Firestone Michelle; Fischer Benedikt
Abstract Background There is evidence of a high prevalence of prescription opioid (PO) and crack use among street drug users in Toronto. The purpose of this qualitative study was to describe drug use behaviours and preferences as well as the social and environmental context surrounding the use of these drugs among young and old street-based drug injection drug users (IDUs). Methods In-depth interviews were conducted with 25 PO injectors. Topics covered included drug use history, types of drug...
Song, Jae-Sang; Park, Su-Jeong; Choi, Jung-Yun; Kim, Jin-Sook; Kang, Myung-Hee; Choi, Bo-Kyung
This study was conducted to determine the residual amount of veterinary drugs such as meloxicam, flunixin, and tulathromycin in animal products (beef, pork, horsemeat, and milk). Veterinary drugs have been widely used in the rearing of livestock to prevent and treat diseases. A total of 152 samples were purchased from markets located in major Korean cities (Seoul, Busan, Incheon, Daegu, Daejeon, Gwangju, Ulsan and Jeju), including Jeju. Veterinary drugs were analyzed by liquid chromatography-tandem mass spectrometry according to the Korean Food Standards Code. The resulting data, which are located within 70-120% of recovery range and less than 20% of relative standard deviations, are in compliance with the criteria of CODEX. A total of five veterinary drugs were detected in 152 samples, giving a detection rate of approximately 3.3%; and no food source violated the guideline values. Our result indicated that most of the veterinary drug residues in animal products were below the maximum residue limits specified in Korea. PMID:27433102
Stege, H.; Bager, Flemming; Jacobsen, Erik;
of drugs for use in animal production is reported on a monthly basis. Pharmacies provided 95% of the total weight antimicrobial compounds used in Denmark in 2001. More than 80% of the antimicrobial compounds reported by pharmacies were sold on prescription to end-users (owners) and included information...... on animal species, age-group and diagnostic grouping; >90% of the total amount of antimicrobials sold on prescription was used for pigs. In 2001, sales of 96,500 kg of antimicrobials were reported....
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
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)
Markou, Athina; Chiamulera, Christian; GEYER, Mark A; Tricklebank, Mark; Steckler, Thomas
Despite great advances in basic neuroscience knowledge, the improved understanding of brain functioning has not yet led to the introduction of truly novel pharmacological approaches to the treatment of central nervous system disorders. This situation has been partly attributed to the difficulty of predicting efficacy in patients based on results from preclinical studies. To address these issues, this review critically discusses the traditional role of animal models in drug discovery, the diff...
By Frank Blanchard, Staff Writer, and Jeff Lifson, Guest Writer In a research milestone reported in the June 20 issue of the journal Science, scientists have developed a minimally modified version of HIV-1, the virus that causes AIDS in infected humans, that is capable of causing progressive infection and AIDS in monkeys. The advance should help create more authentic animal models of the disease and provide a potentially invaluable approach for faster and better preclinical evaluation of new drugs and vaccines.
Ahmed, Syed Masud; Islam, Qazi Shafayetul
In Bangladesh, the National Drug Policy (NDP) 1982 was instrumental in improving the supply of essential drugs of quality at an affordable price, especially in the early years. However, over time, evidence showed that the situation deteriorated in terms of both availability of essential drugs and their rational use. The study examined the current status of the outcome of the NDP objectives in terms of the availability and rational use of drugs in the primary healthcare (PHC) facilities in Ban...
Bradley, C. P.; Bond, C.
Many drugs previously restricted to prescription only status are being reclassified as pharmacy only status and hence are becoming available over the counter to patients. A general practitioner should make enquiries about a patient's self-medication practices before deciding on treatment for the patient. Over-the-counter medicines are considered safe and their increased use indicates that patients are taking greater responsibility for their own health and possibly taking some of the financial...
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)
Full Text Available Abstract Background Ecologic studies have shown a relationship between alcohol outlet densities, illicit drug use and violence. The present study examined this relationship in the City of Houston, Texas, using a sample of 439 census tracts. Neighborhood sociostructural covariates, alcohol outlet density, drug crime density and violent crime data were collected for the year 2000, and analyzed using hierarchical Bayesian models. Model selection was accomplished by applying the Deviance Information Criterion. Results The counts of violent crime in each census tract were modelled as having a conditional Poisson distribution. Four neighbourhood explanatory variables were identified using principal component analysis. The best fitted model was selected as the one considering both unstructured and spatial dependence random effects. The results showed that drug-law violation explained a greater amount of variance in violent crime rates than alcohol outlet densities. The relative risk for drug-law violation was 2.49 and that for alcohol outlet density was 1.16. Of the neighbourhood sociostructural covariates, males of age 15 to 24 showed an effect on violence, with a 16% decrease in relative risk for each increase the size of its standard deviation. Both unstructured heterogeneity random effect and spatial dependence need to be included in the model. Conclusion The analysis presented suggests that activity around illicit drug markets is more strongly associated with violent crime than is alcohol outlet density. Unique among the ecological studies in this field, the present study not only shows the direction and magnitude of impact of neighbourhood sociostructural covariates as well as alcohol and illicit drug activities in a neighbourhood, it also reveals the importance of applying hierarchical Bayesian models in this research field as both spatial dependence and heterogeneity random effects need to be considered simultaneously.
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Although a large number of reports are available on the total and soluble PKN (and other nutrient elements) content of manure biochars, information is lacking to understand the changes in chemical speciation of different elements during pyrolysis. Manure is intrinsically heterogeneous, and is compo...
Gertz, Melanie; Steegborn, Clemens
Sirtuins are an evolutionary conserved family of NAD(+)-dependent protein lysine deacylases. Mammals have seven Sirtuin isoforms, Sirt1-7. They contribute to regulation of metabolism, stress responses, and aging processes, and are considered therapeutic targets for metabolic and aging-related diseases. While initial studies were focused on Sirt1 and 2, recent progress on the mitochondrial Sirtuins Sirt3, 4, and 5 has stimulated research and drug development for these isoforms. Here we review the roles of Sirtuins in regulating mitochondrial functions, with a focus on the mitochondrially located isoforms, and on their contributions to disease pathologies. We further summarize the compounds available for modulating the activity of these Sirtuins, again with a focus on mitochondrial isoforms, and we describe recent results important for the further improvement of compounds. This overview illustrates the potential of mitochondrial Sirtuins as drug targets and summarizes the status, progress, and challenges in developing small molecule compounds modulating their activity. PMID:27007507
Cortese, Bernardo; Piraino, Davide; Buccheri, Dario; Alfonso, Fernando
Bifurcation lesion management still represents a challenge for interventional cardiologists and currently there is a number of different approaches/techniques involving coronary stents. The use of a drug-coated balloon for native coronary vessel management is emerging as an alternative treatment, although in selected patient populations only. In particular, this technology has been tested for the treatment of bifurcations, both for the main vessel and the side branches. Several studies have evaluated this treatment as an alternative or as a therapeutic option complementary to stents, with conflicting and debatable results. However, the perspective of leaving lower metallic burden in this type of lesions is highly appealing and should be deeply investigated. We review here the currently available scientific data and future perspectives on drug-coated balloon use for bifurcation lesions. PMID:27390995
Full Text Available Abstract Plasma levels of high density lipoprotein (HDL cholesterol are strongly inversely correlated to the risk of atherosclerotic cardiovascular disease. A major recognized functional property of HDL particles is to elicit cholesterol efflux and consequently mediate reverse cholesterol transport (RCT. The recent introduction of a surrogate method aiming at determining specifically RCT from the macrophage compartment has facilitated research on the different components and pathways relevant for RCT. The current review provides a comprehensive overview of studies carried out on macrophage-specific RCT including a quick reference guide of available data. Knowledge and insights gained on the regulation of the RCT pathway are summarized. A discussion of methodological issues as well as of the respective relevance of specific pathways for RCT is also included.
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. PMID:24125786
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is intended to assist sponsors in the clinical development of drugs and therapeutic biological products for the treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both......
Hisaka, Akihiro; Nakamura, Mikiko; Tsukihashi, Ayako; Koh, Saori; Suzuki, Hiroshi
In this study, we developed the drug-drug interaction (DDI) method as a new assessment technique of intestinal availability (F(G), the fraction of drug transferred from the intestinal enterocytes into the liver, escaping from intestinal metabolism) based on the clearance theory. This method evaluates F(G) from changes caused by DDIs in the area under the blood concentration-time curve and in the elimination half-life of victim drugs. Application of the DDI method to data from the literature revealed that the mean and S.D. of F(G) values for 20 substrate drugs of CYP3A was 0.56 ± 0.29, whereas that for 8 substrate drugs of CYP2C9, CYP2C19, and CYP2D6 was 0.86 ± 0.11. These results were consistent with the fact that intestinal metabolism is mediated predominantly by CYP3A. The DDI method showed reasonable correlations with the conventional i.v./p.o. method and the grape fruit juice (GFJ) method (coefficients of determination of 0.41 and 0.81, respectively). The i.v./p.o. method was more susceptible to fluctuations in the hepatic blood flow rate compared with the DDI and GFJ methods. The DDI method evaluates F(G) separating from the absorption ratio (F(A)) although it requires approximation of F(A). Since preciseness of approximation of F(A) does not greatly affect the evaluation of F(G) by the DDI method, we proposed a reasonable approximation method of F(A) for the evaluation of F(G) in the DDI method. The DDI method would be applicable to a broad range of situations in which various DDI data are utilizable. PMID:25061161
... for human pharmaceuticals. DATES: Submit either electronic or written comments by February 24, 2014... affecting drug and biologics approvals, drug supply chain, and other topics related to human...
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)
Dolgos, Hugues; Freisleben, Achim; Wimmer, Elmar; Scheible, Holger; Krätzer, Friedrich; Yamagata, Tetsuo; Gallemann, Dieter; Fluck, Markus
Abstract Cilengitide is very low permeable (1.0 nm/sec) stable cyclic pentapeptide containing an Arg‐Gly‐Asp motif responsible for selective binding to αvβ3 and αvβ5 integrins administered intravenously (i.v.). In vivo studies in the mouse and Cynomolgus monkeys showed the major component in plasma was unchanged drug (>85%). These results, together with the absence of metabolism in vitro and in animals, indicate minimal metabolism in both species. The excretion of [14C]‐cilengitide showed pro...
Sørensen, Peter; Thomsen, Ingrid Kaag; Møller, Henrik Bjarne; Kahn, Arab R.; Christensen, Bent Tolstrup
We compared the release of C and N from untreated and anaerobically digested plant biomasses and animal manures. Based on losses of C during the plant biomass (feed) passage in cattle, during anaerobic digestion (AD), and during incubation with soil, the retention of C in soil was estimated. When...... relationship between N release and C retention. The increase in N availability due to AD was equivalent to 10-35% of total N in slurry, but after AD of plant biomass and faeces the N availability increased significantly more....
Ali, Faisal R; Al-Niaimi, Firas
Topical medicaments are the mainstay of the dermatologists' therapeutic arsenal. Laser-assisted drug delivery enhances the ability of topically applied medicaments to penetrate the skin. We discuss the mechanisms of laser-assisted drug delivery and animal models that have informed clinical practice. We review clinical studies that have employed laser-assisted drug delivery for a range of indications to date including non-melanoma skin cancer, vitiligo, scarring, vaccination, local anaesthesia, analgesia, viral warts, infantile haemangiomas and cosmetic uses. Studies thus far suggest that laser pre-treatment improves transepidermal absorption of topical agents and allows for a much deeper penetration of drugs than is possible with topical medicaments alone. This may allow more efficacious action of current treatments, such that conventional duration of treatment can be shortened or lower concentrations of active agents be used, potentially obviating side effects of treatment. The prospect of using laser technologies to facilitate transdermal vaccination and as an adjunct for inflammatory dermatoses and cosmetic indications remains in its infancy. As larger trials are published, involving greater numbers of patients and utilising various laser and topical medicament parameters, we will enhance our understanding of this nascent modality of treatment delivery. PMID:26694489
Marlatt, G Alan
Prior research on animal models of drug relapse has demonstrated that passive exposure to an addictive substance following acquisition and extinction of drug self-administration has a "priming effect" on subsequent drug use. The validity of this animal analogue of human relapse can be criticized, however, because most human drug relapses are precipitated by the user's voluntary self-administration of a substance. The results of the present study by F. Leri and J. Stewart (2002) clearly show that if the initial heroin lapse is self-administered by rats, subsequent heroin seeking during the relapse test is significantly greater than if the heroin is externally administered. These results help bridge the gap between animal and human models of drug use and highlight the significance of both behavioral and environmental determinants of relapse. PMID:12498331
... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this....regulations.gov . To receive ``Guidance for Industry and Food and Drug Administration Staff; Blood...
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.
Liang, Bryan A.; Mackey, Tim K.
Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, includi...
Vihang S. Chawan; Sagar V. Badwane; Kalpesh V. Gawand; Maheshi U. Chhaya
Background: Cost of drug therapy is a very serious issue for people belonging to lower economic status in India. A single drug is manufactured by various pharmaceutical companies and sold under different brand names. The prices of these drugs vary in the Indian market. Anxiety is a symptom of many psychiatric disorders and surgical conditions for which anxiolytic drugs are commonly prescribed. This study was planned to study the price variation amongst the different brands of anxiolytic drugs...
The largest animal ever to live on the earth is the blue whale(蓝鲸)It weighs about 80 tons--more than 24 elephants. It is more than 30 metres long. A newborn baby whale weighs as much as a big elephant.
Stolker, A.A.M.; Brinkman, U.A.T.
After a brief introduction into the field of veterinary drugs and growth-promoting agents, the most important EU regulations and directives for the inspection of food-producing animals and animal products regarding the residue control of these substances are presented and discussed. Main attention i
Background: Multiple Drug Resistant (MDR) foodborne bacteria are a concern in animal and human health. Identification of resistance genes in foodborne pathogens is necessary to determine similarities of resistance mechanisms in animal, food and human clinical isolates. This information will help us ...
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Deng, Yuting; Wu, Yali; Jiang, Lan; Tan, Aiping; Zhang, Ruiquan; Luo, Li
Aeromonas is regarded as an important pathogen of freshwater animals but little is known about the genetics of its antimicrobial resistance in Chinese aquaculture. The aim of this study was to investigate the presence of integrons and characterize multidrug resistant Aeromonas spp. isolated from diseased farmed freshwater animals. These animal samples included fish, ornamental fish, shrimp, turtles, and amphibians which were collected from 64 farms in Guangdong province of South China. One hundred and twelve Aeromonas spp. isolates were examined for antimicrobial resistance phenotypes and the presence of class 1 integron sequences. Twenty-two (19.6%) of these isolates carried a class 1 integron comprising six different gene insertion cassettes including drfA12-orfF-aadA2, drfA12-orfF, aac(6')-II-bla OXA-21 -cat3, catB3, arr-3, and dfrA17. Among these, drfA12-orfF-aadA2 was the dominant gene cassette array (63.6%, 14/22) and this is the first report of aac(6')-II-bla OXA-21 -cat3 in an Aeromonas hydrophila isolate from a Chinese giant salamander (Andrias davidianus). All the integron-positive strains were resistant to more than five agents and 22 contained other resistance genes including bla CTX-M-3, bla TEM-1, aac(6')-Ib-cr, and tetA. All integron-positive isolates also contained mutations in the quinolone resistance determining regions (QRDR). Our investigation demonstrates that freshwater animals can serve as a reservoir for pathogenic Aeromonas strains containing multiple drug-resistance integrons. This data suggests that surveillance for antimicrobial resistance of animal origin and a prudent and responsible use of antimicrobials in aquaculture is necessary in these farms. PMID:27379065
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
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. PMID:26067292
Myers, Karyn M.; Carlezon, William A
Conditioned drug craving and withdrawal elicited by cues paired with drug use or acute withdrawal are among the many factors contributing to compulsive drug taking. Understanding how to stop these cues from having these effects is a major goal of addiction research. Extinction is a form of learning in which associations between cues and the events they predict are weakened by exposure to the cues in the absence of those events. Evidence from animal models suggests that conditioned responses t...
Mammals（哺乳动物）Mammals are the world＇s most dominant（最占优势的）animal.They are extremely（非常）diverse（多种多样的）creatures（生物，动物）that include（包括）the biggest ever animal （the blue whale鲸，which eats up to 6 tons every day）,the smallest（leaf-nosed bat小蹄蝠） and the laziest（sloth树獭，who spends 80% of their time sleeping）.There are over 4,600 kinds of mammals and they live in very different environments（环境）—oceans（海洋）,rivers,the jungle（丛林）,deserts,and plains（平原）.
Before conducting human study on radiolabeled drug, internal radiation dose is evaluated based on the animal data. Generally, however, species difference in the elimination process of radioactivity, mostly in the hepatic metabolism, is ignored. The methodology of correction was described for drugs that are eliminated mostly by hepatic metabolism. We showed the validity of using the method where the hepatic clearance in animal and human are constructed by the hepatic blood flow, protein unbound fraction and metabolic rate in vitro, and the internal radiation exposure calculated is corrected by the animal/human ratio of the hepatic clearance. (author)
Full Text Available ... Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) Chinese Translation - Animation of Antimicrobial Resistance (WMV - 19.2MB) ... by Product Area Product Areas back Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ...
Eaton, Ellen F.; Tamhane, Ashutosh R.; Burkholder, Greer A.; Willig, James H.; Saag, Michael S.; Mugavero, Michael J.
Background. Durability of antiretroviral (ARV) therapy is associated with improved human immunodeficiency virus (HIV) outcomes. Data on ARV regimen durability in recent years and clinical settings are lacking. Methods. This retrospective follow-up study included treatment-naive HIV-infected patients initiating ARV therapy between January 2007 and December 2012 in a university-affiliated HIV clinic in the Southeastern United States. Outcome of interest was durability (time to discontinuation) of the initial regimen. Durability was evaluated using Kaplan-Meier survival analyses. Cox proportional hazard analyses was used to evaluate the association among durability and sociodemographic, clinical, and regimen-level factors. Results. Overall, 546 patients were analyzed. Median durability of all regimens was 39.5 months (95% confidence interval, 34.1–44.4). Commonly prescribed regimens were emtricitabine and tenofovir with efavirenz (51%; median duration = 40.1 months) and with raltegravir (14%; 47.8 months). Overall, 67% of patients had an undetectable viral load at the time of regimen cessation. Discontinuation was less likely with an integrase strand transfer inhibitor (adjusted hazards ratio [aHR] = 0.35, P = .001) or protease inhibitor-based regimen (aHR = 0.45, P = .006) and more likely with a higher pill burden (aHR = 2.25, P = .003) and a later treatment era (aHR = 1.64, P drugs and combinations. Reduced durability mostly results from a preference for newly approved regimens rather than indicating failing therapy, as indicated by viral suppression observed in a majority of patients (67%) prior to regimen cessation. Durability is influenced by extrinsic factors including new drug availability and provider preference. Medication durability must be interpreted carefully in the context of a dynamic treatment landscape.
Brune, Kay; Patrignani, Paola
Non-steroidal anti-inflammatory drugs (NSAIDs), which act via inhibition of the cyclooxygenase (COX) isozymes, were discovered more than 100 years ago. They remain a key component of the pharmacological management of acute and chronic pain. The COX-1 and COX-2 isozymes have different biological functions; analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2. All available NSAIDs, including acetaminophen and aspirin, are associated with potential side effects, particularly gastrointestinal and cardiovascular effects, related to their relative selectivity for COX-1 and COX-2. Since all NSAIDs exert their therapeutic activity through inhibition of the COX isozymes, strategies are needed to reduce the risks associated with NSAIDs while achieving sufficient pain relief. A better understanding of the inhibitory activity and COX-1/COX-2 selectivity of an NSAID at therapeutic doses, based on pharmacokinetic and pharmacodynamic properties (eg, inhibitory dose, absorption, plasma versus tissue distribution, and elimination), and the impact on drug tolerability and safety can guide the selection of appropriate NSAIDs for pain management. For example, many NSAIDs with moderate to high selectivity for COX-2 versus COX-1 can be administered at doses that maximize efficacy (~80% inhibition of COX-2) while minimizing COX-1 inhibition and associated side effects, such as gastrointestinal toxicity. Acidic NSAIDs with favorable tissue distribution and short plasma half-lives can additionally be dosed to provide near-constant analgesia while minimizing plasma concentrations to permit recovery of COX-mediated prostaglandin production in the vascular wall and other organs. Each patient's clinical background, including gastrointestinal and cardiovascular risk factors, should be taken into account when selecting appropriate NSAIDs. New methods are emerging to assist
Wilson, Christina; Alvin V Terry
Schizophrenia is a devastating mental illness that is associated with a lifetime of disability. For patients to successfully function in society, the amelioration of disease symptoms is imperative. The recently published results of two large antipsychotic clinical trials (e.g., CATIE, CUtLASS) clearly exemplified the limitations of currently available treatment options for schizophrenia, and further highlighted the critical need for novel drug discovery and development in this field. One of t...
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
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Duque, Jazmin; McMorrow, Meredith L.; Adam L Cohen
Background Influenza viruses cause significant morbidity and mortality in Africa, particularly among high-risk groups, but influenza vaccines and antiviral drugs may not be commonly available and used. The main aim of this study was to determine the availability and use of influenza vaccines and antiviral drugs as well as to describe existing related guidelines and policies in Africa. Methods A self-administered survey was distributed among key influenza experts in 40 African countries. Resul...
Ekaterina I Galanzha; Vladimir P Zharov; Philips Classic
Using animal mesentery with intravital optical microscopy is a well-established experimental model for studying blood and lymph microcirculation in vivo.Recent advances in cell biology and optical techniques provide the basis for extending this model for new applications, which should generate significantly improved experimental data. This review summarizes the achievements in this specific area, including in vivo label-free blood and lymph photothermal flow cytometry,super-sensitive fluorescence image cytometry, light scattering and speckle flow cytometry, microvessel dynamic microscopy, infrared (IR) angiography, and high-speed imaging of individual cells in fast flow. The capabilities of these techniques, using the rat mesentery model, were demonstrated in various studies; e.g., realtime quantitative detection of circulating and migrating individual blood and cancer cells, studies on vascular dynamics with a focus on lymphatics under normal conditions and under different interventions (e.g. lasers,drugs, nicotine), assessment of lymphatic disturbances from experimental lymphedema, monitoring cell traffic between blood and lymph systems, and highspeed imaging of cell transient deformability in flow.In particular, the obtained results demonstrated that individual cell transportation in living organisms depends on cell type (e.g., normal blood or leukemic cells), the cell's functional state (e.g., live, apoptotic, or necrotic),and the functional status of the organism. Possible future applications, including in vivo early diagnosis and prevention of disease, monitoring immune response and apoptosis, chemo- and radio-sensitivity tests, and drug screening, are also discussed.
Rua, Francesco; Sadeghi, Sheila J; Castrignanò, Silvia; Di Nardo, Giovanna; Gilardi, Gianfranco
In order to develop in vitro methods as an alternative to P450 animal testing in the drug discovery process, two main requisites are necessary: 1) gathering of data on animal homologues of the human P450 enzymes, currently very limited, and 2) bypassing the requirement for both the P450 reductase and the expensive cofactor NADPH. In this work, P450 2C20 from Macaca fascicularis, homologue of the human P450 2C8 has been taken as a model system to develop such an alternative in vitro method by two different approaches. In the first approach called "molecular Lego", a soluble self-sufficient chimera was generated by fusing the P450 2C20 domain with the reductase domain of cytochrome P450 BM3 from Bacillus megaterium (P450 2C20/BMR). In the second approach, the need for the redox partner and also NADPH were both obviated by the direct immobilization of the P450 2C20 on glassy carbon and gold electrodes. Both systems were then compared to those obtained from the reconstituted P450 2C20 monooxygenase in presence of the human P450 reductase and NADPH using paclitaxel and amodiaquine, two typical drug substrates of the human P450 2C8. The K(M) values calculated for the 2C20 and 2C20/BMR in solution and for 2C20 immobilized on electrodes modified with gold nanoparticles were 1.9 ± 0.2, 5.9 ± 2.3, 3.0 ± 0.5 μM for paclitaxel and 1.2 ± 0.2, 1.6±0.2 and 1.4 ± 0.2 μM for amodiaquine, respectively. The data obtained not only show that the engineering of M. fascicularis did not affect its catalytic properties but also are consistent with K(M) values measured for the microsomal human P450 2C8 and therefore show the feasibility of developing alternative in vitro animal tests. PMID:22819650
Conclusions: To increase the benefit to the patient and reduce drug in compliance, doctors should be trained to be familiar from internship period itself about the brand names of cost-effective drugs with good safety profile for a long period. [Int J Basic Clin Pharmacol 2015; 4(5.000: 860-863
... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.'' This... Safety Information--FDA's Communication to the Public.'' This draft guidance updates and revises a...
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.)
... 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...
Huang, Q; Gehring, R; Tell, L A; Li, M; Riviere, J E
Allometric scaling is widely used for the determination of first dosage regimen and the interpolation or extrapolation of pharmacokinetic parameters across many animal species during drug development. In this article, 85 drugs used in veterinary medicine obtained from the Food Animal Residue Avoidance Databank database were selected for allometric scaling analysis. Outlier species were identified by statistical methods. The results showed that 77% and 88% of drugs displayed significant correlations between total systemic clearance (CL) and volume of distribution at steady status (Vss) vs. body weight (P pharmacokinetic profiles for predicting drug dosages in veterinary species, and to identify those species for which interpolation or extrapolation of pharmacokinetics properties may be problematic. PMID:25333341
... Health and Human Services FDA U.S. Food and Drug Administration Protecting and Promoting Your Health A to ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Drug Safety and Availability Postmarket Drug ...
Gosai, Sager J.; Joon Hyeok Kwak; Cliff J Luke; Long, Olivia S.; King, Dale E.; Kovatch, Kevin J.; Johnston, Paul A.; Tong Ying Shun; Lazo, John S.; Perlmutter, David H.; Silverman, Gary A.; Pak, Stephen C.
The development of preclinical models amenable to live animal bioactive compound screening is an attractive approach to discovering effective pharmacological therapies for disorders caused by misfolded and aggregation-prone proteins. In general, however, live animal drug screening is labor and resource intensive, and has been hampered by the lack of robust assay designs and high throughput work-flows. Based on their small size, tissue transparency and ease of cultivation, the use of C. elegan...
Nisharani B Jadhav, Manisha S Bhosale, Charles V Adhav
There exists a wide range of variation in the prices of drugs marketed in India and other countries of the world. Very few studies have been conducted to reveal such price variations in the open market. Aim & Objectives: To evaluate the cost of oral anti-diabetics of different generic classes and different brand names of one compound, To evaluate the difference in cost of different brands for the same active drug by calculating percentage variation of cost. Methods: Cost of a particular drug ...
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L. Akila; R. Jamuna Rani
Background: Ischemic heart disease is the most common cardiovascular disease in developed countries such as United States and Angina pectoris is the most frequent among them. If not managed adequately angina results in significant morbidity and mortality too due to the complications. Antianginal therapy is lifelong. Therefore, analysis of the price of drugs used in ischemic heart disease will help to improve patient compliance. Methods: Prices of various antianginal drugs of different stre...
Amit Padmakar Date
Conclusion: The average percentage price variation of different brands of the same oral antidiabetic drug manufactured in India is very wide. The appropriate changes in the government policy, sensitizing the prescribers about cost of therapy and proper management of marketing drugs should be directed toward maximizing the benefits of therapy and minimizing negative economic consequences. [Int J Basic Clin Pharmacol 2015; 4(1.000: 36-40
GAO Ci-xiu; XU Shi-xiong; JIANG Yu-ping; TU Jiang-long
This work aims to investigate the effects of dosing regiments on drug delivery in solid tumors and to validate them with experiments on rats.The lumped parameter models of pharmacokinetics and of drug delivery in tumor were developed to simulate time courses of average drug concentration(Ct)of tumor interstitium in two types of dosing regiments(i.e.,single-shot and triple-shot ones).The two regiments were performed via antitumor drug,hydroxycamptothecin(HCPT),on rats,to measure the drug concentration in the tumor.The simulations of the drug concentration in the tumor of the two dosing regiments were conducted and compared with the experimental data on rats.The coefficients in the models were investigated.It is concluded that the triple-shot method is more effective than that of single-shot injection.The present lumped-parameter model is quantitatively competent for drug delivery in solid tumor.
Full Text Available ... Trends Alcohol Club Drugs Cocaine Hallucinogens Heroin Inhalants Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Prescription Drugs & Cold ... patients who do not abuse drugs. In animal studies, methamphetamine has been shown to increase the amount ...
Arenas, M Carmen; Aguilar, María A; Montagud-Romero, Sandra; Mateos-García, Ana; Navarro-Francés, Concepción I; Miñarro, José; Rodríguez-Arias, Marta
Novelty seeking (NS), defined as a tendency to pursue novel and intense emotional sensations and experiences, is one of the most relevant individual factors predicting drug use among humans. High novelty seeking (HNS) individuals present an increased risk of drug use compared to low novelty seekers. The NS endophenotype may explain some of the differences observed among individuals exposed to drugs of abuse in adolescence. However, there is little research about the particular response of adolescents to drugs of abuse in function of this endophenotype, and the data that do exist are inconclusive. The present work reviews the literature regarding the influence of NS on psychostimulant reward, with particular focus on adolescent subjects. First, the different animal models of NS and the importance of this endophenotype in adolescence are discussed. Later, studies that have used the most common animal models of reward (self-administration, conditioned place preference paradigms) to evaluate how the NS trait influences the rewarding effects of psychostimulants are reviewed. Finally, possible explanations for the enhanced risk of developing substance dependence among HNS individuals are discussed. In conclusion, the studies referred to in this review show that the HNS trait is associated with: (1) increased initial sensitivity to the rewarding effects of psychostimulants, (2) a higher level of drug craving when the subject is exposed to the environmental cues associated with the drug, and (3) enhanced long-term vulnerability to relapse to drug consumption after prolonged abstinence. PMID:26391743
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...
McCrackin, M A; Helke, Kristi L; Galloway, Ashley M; Poole, Ann Z; Salgado, Cassandra D; Marriott, Bernadette P
Controversy continues concerning antimicrobial use in food animals and its relationship to drug-resistant infections in humans. We systematically reviewed published literature for evidence of a relationship between antimicrobial use in agricultural animals and drug-resistant foodborne campylobacteriosis in humans. Based on publications from the United States (U.S.), Canada and Denmark from 2010 to July 2014, 195 articles were retained for abstract review, 50 met study criteria for full article review with 36 retained for which data are presented. Two publications reported increase in macrolide resistance of Campylobacter coli isolated from feces of swine receiving macrolides in feed, and one of these described similar findings for tetracyclines and fluoroquinolones. A study in growing turkeys demonstrated increased macrolide resistance associated with therapeutic dosing with Tylan® in drinking water. One publication linked tetracycline-resistant C. jejuni clone SA in raw cow's milk to a foodborne outbreak in humans. No studies that identified farm antimicrobial use also traced antimicrobial-resistant Campylobacter from farm to fork. Recent literature confirms that on farm antibiotic selection pressure can increase colonization of animals with drug-resistant Campylobacter spp. but is inadequately detailed to establish a causal relationship between use of antimicrobials in agricultural animals and prevalence of drug-resistant foodborne campylobacteriosis in humans. PMID:26580432
Food animals harboring Multi-Drug Resistant (MDR) Salmonella enterica are a potential source for acquisition of zoonotic pathogens. Plasmids (small, self-replicating, extra-chromosomal DNA) are often associated with antimicrobial resistance and plasmids carrying MDR genes have been found to be a maj...
Fucic, Aleksandra; Stojković, Ranko; Miškov, Snježana; Zeljezic, Davor; Markovic, Darko; Gjergja, Romana; Katic, Jelena; Jazbec, Ana Marija; Bakulic, Tomislav Ivicevic; Demarin, Vida
Antiepileptic drugs (AED) as transplacental agents are known to have adverse effects on fetal development. Genotoxicity of AEDs is still not fully understood. The aim of present study was to investigate the transplacental genotoxicity of valproate on animal model and in 21 mothers and their newborns receiving AED. In both studies, in vivo micronucleus (MN) assay was used. Pregnant dams were exposed to Na-valproate (100mg/kg) on gestational days 12-14. Dams and pups receiving Na-valproate showed a significantly increased MN frequency (5.17 ± 1.17/1000; 5.20 ± 1.48/1000) compared to the control (1.0 ± 0.58/1000; 1.67 ± 1.03/1000). In mother/newborn study a significant increase of MN frequency was detected in newborns of mothers taking AEDs (3.09 ± 0.49/10,000) compared to the referent newborns (1.56 ± 0.22/10,000). The results of this study suggest that AEDs may act as transplacental genotoxins. Launching the mother/newborn cohorts for genotoxicological monitoring may give a significant new insight in health effects of AEDs. PMID:20955786
Leenstra, F.R.; Bergevoet, R.H.M.; Neijenhuis, F.; Hanekamp, W.J.A.; Vermeij, I.; Ipema, A.H.; Jong, A.R.; Verstappen-Boerekamp, J.A.M.
Document over het effect van het dierenwelzijns- en diergezondheidsbeleid van LNV is. Deze eerste rapportage betreft een nulmeting. Bij herhaalde metingen geeft de rapportage inzicht in de ontwikkeling. In 25 meetpunten zijn de resultaten voor beleidsdoelen op het gebied van dierenwelzijn en diergezondheid in beeld gebracht25 measuring points summarise the results of policy measures for animal welfare and health in The Netherlands
Full Text Available ajor component: Calcium carbonate [CPD:C08129], Calcium biphosphate [CPD:C13556] Therapeutic category of drugs... in Japan [BR:br08301] 5 Crude drugs and Chinese medicine formulations 51 Crude drugs 510 Crude drugs 5100 Crude drugs...icine in Japan [BR:br08304] Crude Drugs Drugs for Qi Sedative drugs D06799 Longgu; Fossilized mammal bones Crude drugs [BR:br08305] Animals Mammals D06799 Longgu PubChem: 47208450 ...