WorldWideScience

Sample records for research including drug

  1. Hallucinogens and Dissociative Drugs, Including LSD, PCP, Ketamine, Dextromethorphan. National Institute on Drug Abuse Research Report Series.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

    Research is developing a clearer picture of the dangers of mind-altering drugs. The goal of this report is to present the latest information to providers to help them strengthen their prevention and treatment efforts. A description is presented of dissociative drugs, and consideration is given as to why people take hallucinogens. The physical…

  2. Drug delivery device including electrolytic pump

    KAUST Repository

    Foulds, Ian G.; Buttner, Ulrich; Yi, Ying

    2016-01-01

    Systems and methods are provided for a drug delivery device and use of the device for drug delivery. In various aspects, the drug delivery device combines a “solid drug in reservoir” (SDR) system with an electrolytic pump. In various aspects an improved electrolytic pump is provided including, in particular, an improved electrolytic pump for use with a drug delivery device, for example an implantable drug delivery device. A catalytic reformer can be incorporated in a periodically pulsed electrolytic pump to provide stable pumping performance and reduced actuation cycle.

  3. Drug delivery device including electrolytic pump

    KAUST Repository

    Foulds, Ian G.

    2016-03-31

    Systems and methods are provided for a drug delivery device and use of the device for drug delivery. In various aspects, the drug delivery device combines a “solid drug in reservoir” (SDR) system with an electrolytic pump. In various aspects an improved electrolytic pump is provided including, in particular, an improved electrolytic pump for use with a drug delivery device, for example an implantable drug delivery device. A catalytic reformer can be incorporated in a periodically pulsed electrolytic pump to provide stable pumping performance and reduced actuation cycle.

  4. Biomedical HIV Prevention Including Pre-exposure Prophylaxis and Opiate Agonist Therapy for Women Who Inject Drugs: State of Research and Future Directions.

    Science.gov (United States)

    Page, Kimberly; Tsui, Judith; Maher, Lisa; Choopanya, Kachit; Vanichseni, Suphak; Mock, Philip A; Celum, Connie; Martin, Michael

    2015-06-01

    Women who inject drugs (WWID) are at higher risk of HIV compared with their male counterparts as a result of multiple factors, including biological, behavioral, and sociostructural factors, yet comparatively little effort has been invested in testing and delivering prevention methods that directly target this group. In this article, we discuss the need for expanded prevention interventions for WWID, focusing on 2 safe, effective, and approved, yet underutilized biomedical prevention methods: opiate agonist therapy (OAT) and oral pre-exposure prophylaxis (PrEP). Although both interventions are well researched, they have not been well examined in the context of gender. We discuss the drivers of women injectors' higher HIV risk, review the effectiveness of OAT and PrEP interventions among women, and explain why these new HIV prevention tools should be prioritized for WWID. There is substantial potential for impact of OAT and PrEP programs for WWID in the context of broader gender-responsive HIV prevention initiatives. Although awaiting efficacy data on other biomedical approaches in the HIV prevention research "pipeline," we propose that the scale-up and implementation of these proven, safe, and effective interventions are needed now.

  5. Dendrimers in drug research

    DEFF Research Database (Denmark)

    Boas, Ulrik; Heegaard, Peter M. H.

    2004-01-01

    and in vivo cytotoxicity, as well as biopermeability, biostability and immunogenicity. The review deals with numerous applications of dendrimers as tools for efficient multivalent presentation of biological ligands in biospecific recognition, inhibition and targeting. Dendrimers may be used as drugs...... for antibacterial and antiviral treatment and have found use as antitumor agents. The review highlights the use of dendrimers as drug or gene delivery devices in e.g. anticancer therapy, and the design of different host-guest binding motifs directed towards medical applications is described. Other specific examples...

  6. Antiviral Drug Research Proposal Activity

    Directory of Open Access Journals (Sweden)

    Lisa Injaian

    2011-03-01

    Full Text Available The development of antiviral drugs provides an excellent example of how basic and clinical research must be used together in order to achieve the final goal of treating disease. A Research Oriented Learning Activity was designed to help students to better understand how basic and clinical research can be combined toward a common goal. Through this project students gained a better understanding of the process of scientific research and increased their information literacy in the field of virology. The students worked as teams to research the many aspects involved in the antiviral drug design process, with each student becoming an "expert" in one aspect of the project. The Antiviral Drug Research Proposal (ADRP culminated with students presenting their proposals to their peers and local virologists in a poster session. Assessment data showed increased student awareness and knowledge of the research process and the steps involved in the development of antiviral drugs as a result of this activity.

  7. Including Everyone in Research: The Burton Street Research Group

    Science.gov (United States)

    Abell, Simon; Ashmore, Jackie; Wilson, Dorothy; Beart, Suzie; Brownley, Peter; Butcher, Adam; Clarke, Zara; Combes, Helen; Francis, Errol; Hayes, Stefan; Hemmingham, Ian; Hicks, Kerry; Ibraham, Amina; Kenyon, Elinor; Lee, Darren; McClimens, Alex; Collins, Michelle; Newton, John; Wilson, Dorothy

    2007-01-01

    In our paper we talk about what it is like to be a group of people with and without learning disabilities researching together. We describe the process of starting and maintaining the research group and reflect on the obstacles that we have come across, and the rewards such research has brought us. Lastly we put forward some ideas about the role…

  8. A perspective of nanotechnology in hypersensitivity reactions including drug allergy.

    Science.gov (United States)

    Montañez, Maria Isabel; Ruiz-Sanchez, Antonio J; Perez-Inestrosa, Ezequiel

    2010-08-01

    We provide an overview of the application of the concepts of nanoscience and nanotechnology as a novel scientific approach to the area of nanomedicine related to the domain of the immune system. Particular emphasis will be paid to studies on drug allergy reactions. Several well defined chemical structures arranged in the dimension of the nanoscale are currently being studied for biomedical purposes. By interacting with the immune system, some of these show promising applications as vaccines, diagnostic tools and activators/effectors of the immune response. Even a brief listing of some key applications of nanostructured materials shows how broad and intense this area of nanomedicine is. As a result of the development of nanoscience and nanotechnology applied to medicine, new approaches can be envisioned for problems related to the modulation of the immune response, as well as in immunodiagnosis, and to design new tools to solve related medical challenges. Nanoparticles offer unique advantages with which to exploit new properties and for materials to play a major role in new diagnostic techniques and therapies. Fullerene-C60 and multivalent functionalized gold nanoparticles of various sizes have led to new tools and opened up new ways to study and interact with the immune system. Some of the most versatile nanostructures are dendrimers. In their interaction with the immune system they can naturally occurring macromolecules, taking advantage of the fact that dendrimers can be synthesized into nanosized structures. Their multivalence can be successfully exploited in vaccines and diagnostic tests for allergic reactions.

  9. Center for Drug Evaluation and Research

    Data.gov (United States)

    Federal Laboratory Consortium — The Center for Drug Evaluation and Research(CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the...

  10. Drugs and Crime: The Relationship of Drug Use and Concomitant Criminal Behavior. Research Issues 17.

    Science.gov (United States)

    Austin, Gregory A., Ed.; Lettieri, Dan J., Ed.

    This volume of abstracts of major research and theoretical studies dealing with the relationship between drug use, criminal behavior and the law is concerned with criminal acts other than the possession of, or trafficking in, illicit drugs. Included are 107 selected studies categorized into seven major topic areas: Reviews and Theories, Drug Use…

  11. Interviewing Objects: Including Educational Technologies as Qualitative Research Participants

    Science.gov (United States)

    Adams, Catherine A.; Thompson, Terrie Lynn

    2011-01-01

    This article argues the importance of including significant technologies-in-use as key qualitative research participants when studying today's digitally enhanced learning environments. We gather a set of eight heuristics to assist qualitative researchers in "interviewing" technologies-in-use (or other relevant objects), drawing on concrete…

  12. Microfluidic cell culture systems for drug research.

    Science.gov (United States)

    Wu, Min-Hsien; Huang, Song-Bin; Lee, Gwo-Bin

    2010-04-21

    In pharmaceutical research, an adequate cell-based assay scheme to efficiently screen and to validate potential drug candidates in the initial stage of drug discovery is crucial. In order to better predict the clinical response to drug compounds, a cell culture model that is faithful to in vivo behavior is required. With the recent advances in microfluidic technology, the utilization of a microfluidic-based cell culture has several advantages, making it a promising alternative to the conventional cell culture methods. This review starts with a comprehensive discussion on the general process for drug discovery and development, the role of cell culture in drug research, and the characteristics of the cell culture formats commonly used in current microfluidic-based, cell-culture practices. Due to the significant differences in several physical phenomena between microscale and macroscale devices, microfluidic technology provides unique functionality, which is not previously possible by using traditional techniques. In a subsequent section, the niches for using microfluidic-based cell culture systems for drug research are discussed. Moreover, some critical issues such as cell immobilization, medium pumping or gradient generation in microfluidic-based, cell-culture systems are also reviewed. Finally, some practical applications of microfluidic-based, cell-culture systems in drug research particularly those pertaining to drug toxicity testing and those with a high-throughput capability are highlighted.

  13. Drug utilization research and risk management

    NARCIS (Netherlands)

    Mazzaglia, Giampiero; Mol, Peter G. M.; Elseviers, Monique; Wettermark, Björn; Almarsdóttir, Anna Birna; Andersen, Morten; Benko, Ria; Bennie, Marion; Eriksson, Irene; Godman, Brian; Krska, Janet; Poluzzi, Elisabetta; Taxis, Katja; Vlahovic-Palcevski, Vera; Stichele, Robert Vander

    2016-01-01

    Good risk management requires continuous evaluation and improvement of planned activities. The evaluation impact of risk management activities requires robust study designs and carefully selected outcome measures. Key learnings and caveats from drug utilization research should be applied to the

  14. Advances in drug metabolism and pharmacogenetics research in Australia.

    Science.gov (United States)

    Mackenzie, Peter I; Somogyi, Andrew A; Miners, John O

    2017-02-01

    Metabolism facilitates the elimination, detoxification and excretion in urine or bile (as biotransformation products) of a myriad of structurally diverse drugs and other chemicals. The metabolism of drugs, non-drug xenobiotics and many endogenous compounds is catalyzed by families of drug metabolizing enzymes (DMEs). These include the hemoprotein-containing cytochromes P450, which function predominantly as monooxygenases, and conjugation enzymes that transfer a sugar, sulfate, acetate or glutathione moiety to substrates containing a suitable acceptor functional group. Drug and chemical metabolism, especially the enzymes that catalyse these reactions, has been the research focus of several groups in Australia for over four decades. In this review, we highlight the role of recent and current drug metabolism research in Australia, including elucidation of the structure and function of enzymes from the various DME families, factors that modulate enzyme activity in humans (e.g. drug-drug interactions, gene expression and genetic polymorphism) and the application of in vitro approaches for the prediction of drug metabolism parameters in humans, along with the broader pharmacological/clinical pharmacological and toxicological significance of drug metabolism and DMEs and their relevance to drug discovery and development, and to clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Targeting molecular networks for drug research

    Directory of Open Access Journals (Sweden)

    José Pedro Pinto

    2014-06-01

    Full Text Available The study of molecular networks has recently moved into the limelight of biomedical research. While it has certainly provided us with plenty of new insights into cellular mechanisms, the challenge now is how to modify or even restructure these networks. This is especially true for human diseases, which can be regarded as manifestations of distorted states of molecular networks. Of the possible interventions for altering networks, the use of drugs is presently the most feasible. In this mini-review, we present and discuss some exemplary approaches of how analysis of molecular interaction networks can contribute to pharmacology (e.g., by identifying new drug targets or prediction of drug side effects, as well as listing pointers to relevant resources and software to guide future research. We also outline recent progress in the use of drugs for in vitro reprogramming of cells, which constitutes an example par excellence for altering molecular interaction networks with drugs.

  16. A Comprehensive List of Items to be Included on a Pediatric Drug Monograph.

    Science.gov (United States)

    Kelly, Lauren E; Ito, Shinya; Woods, David; Nunn, Anthony J; Taketomo, Carol; de Hoog, Matthijs; Offringa, Martin

    2017-01-01

    Children require special considerations for drug prescribing. Drug information summarized in a formulary containing drug monographs is essential for safe and effective prescribing. Currently, little is known about the information needs of those who prescribe and administer medicines to children. Our primary objective was to identify a list of important and relevant items to be included in a pediatric drug monograph. Following the establishment of an expert steering committee and an environmental scan of adult and pediatric formulary monograph items, 46 participants from 25 countries were invited to complete a 2-round Delphi survey. Questions regarding source of prescribing information and importance of items were recorded. An international consensus meeting to vote on and finalize the items list with the steering committee followed. Pediatric formularies are most commonly the first resource consulted for information on medication used in children by 31 Delphi participants. After the Delphi rounds, 116 items were identified to be included in a comprehensive pediatric drug monograph, including general information, adverse drug reactions, dosages, precautions, drug-drug interactions, formulation, and drug properties. Health care providers identified 116 monograph items as important for prescribing medicines for children by an international consensus-based process. This information will assist in setting standards for the creation of new pediatric drug monographs for international application and for those involved in pediatric formulary development.

  17. Qualitative Methods in Drug Utilization Research

    DEFF Research Database (Denmark)

    Almarsdóttir, Anna Birna; Bastholm Rahmner, Pia

    2016-01-01

    Qualitative research methods derive from the social sciences. Their use in drug utilization research is increasingly widespread, especially in understanding patient and prescriber perspectives. The main focus in qualitative research is exploration of a given phenomenon in order to get a wider...... understanding of why and how it appears. Qualitative research methods build on various theoretical underpinnings/schools of thought. The same validity and quality criteria cannot be used for both qualitative and quantitative methods....

  18. [Data-mining characteristics of adverse drug reactions and pharmacovi-gilance of Chinese patent drugs including Aconitum herbs].

    Science.gov (United States)

    Zhang, Xiao-Meng; Li, Fan; Zhang, Bing; Chen, Xiao-Fen; Piao, Jing-Zhu

    2018-01-01

    The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication

  19. Diterpenes: Advances in Neurobiological Drug Research.

    Science.gov (United States)

    Islam, Md Torequl; da Silva, Claucenira Bandeira; de Alencar, Marcus Vinícius Oliveira Barros; Paz, Márcia Fernanda Correia Jardim; Almeida, Fernanda Regina de Castro; Melo-Cavalcante, Ana Amélia de Carvalho

    2016-06-01

    A significant number of studies have been performed with diterpene effect on the brain. Our study aims to make a systematic revision on them. The initial purpose of this review was to screen diterpenes with neurological activity, in particular those that have already been studied and published in different journals (databases until August 2015). The second purpose was to make an action-wise discussion as results viewed on them by taking into drug discovery and development account. Diterpenes considered in this review were selected on the basis of updated information on them and having sufficient information on their screenings. We identified several examples of diterpenes having an interest in further study. We have included the possible sources of them as observed in evidence, their known molecular neurobiological mechanisms, and the active constituents responsible for such activities with the doses and test systems. Results suggest diterpenes to have neurobiological activities like neuro-protection, anti-epileptic, anxiolytic, anti-Alzheimer's disease, anti-Parkinson's disease, anti-cerebral ischemia, anti-neuropathic pain, anti-neuro-inflammatory, and many more. In conclusion, diterpenes may be the prominent candidates in neurobiological drug research. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  20. The role of chemical engineering in medicinal research including Alzheimer's.

    Science.gov (United States)

    Kontogeorgis, Georgios M

    2015-01-01

    Various disciplines of chemical engineering, especially thermodynamics and kinetics, play an important role in medicinal research and this has been particularly recognized during the last 10-15 years (von Stockar and van der Wielen, J Biotechnol 59:25, 1997; Prausnitz, Fluid Phase Equilib 53:439, 1989; Prausnitz, Pure Appl Chem 79:1435, 2007; Dey and Prausnitz, Ind Eng Chem Res 50:3, 2011; Prausnitz, J Chem Thermodynamics 35:21, 2003; Tsivintzelis et al. AIChE J 55:756, 2009). It is expected that during the twenty-first century chemical engineering and especially thermodynamics can contribute as significantly to the life sciences development as it has been done with the oil and gas and chemical sectors in the twentieth century. Moreover, it has during the recent years recognized that thermodynamics can help in understanding diseases like human cataract, sickle-cell anemia, Creuzfeldt-Jacob ("mad cow" disease), and Alzheimer's which are connected to "protein aggregation." Several articles in the Perspectives section of prominent chemical engineering journals have addressed this issue (Hall, AIChE J 54:1956, 2008; Vekilov, AIChE J 54:2508, 2008). This work reviews recent applications of thermodynamics (and other areas of chemical engineering) first in drug development and then in the understanding of the mechanism of Alzheimer's and similar diseases.

  1. 43 CFR 43.215 - What must I include in my drug-free awareness program?

    Science.gov (United States)

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false What must I include in my drug-free awareness program? 43.215 Section 43.215 Public Lands: Interior Office of the Secretary of the Interior GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for Recipients Other Than Individuals § 43.215 What must I...

  2. 29 CFR 1472.215 - What must I include in my drug-free awareness program?

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 4 2010-07-01 2010-07-01 false What must I include in my drug-free awareness program? 1472.215 Section 1472.215 Labor Regulations Relating to Labor (Continued) FEDERAL MEDIATION AND CONCILIATION SERVICE GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Requirements for Recipients Other Than Individuals § 1472.215...

  3. Lung MRI for experimental drug research

    International Nuclear Information System (INIS)

    Beckmann, Nicolau; Cannet, Catherine; Karmouty-Quintana, Harry; Tigani, Bruno; Zurbruegg, Stefan; Ble, Francois-Xavier; Cremillieux, Yannick; Trifilieff, Alexandre

    2007-01-01

    Current techniques to evaluate the efficacy of potential treatments for airways diseases in preclinical models are generally invasive and terminal. In the past few years, the flexibility of magnetic resonance imaging (MRI) to obtain anatomical and functional information of the lung has been explored with the scope of developing a non-invasive approach for the routine testing of drugs in models of airways diseases in small rodents. With MRI, the disease progression can be followed in the same animal. Thus, a significant reduction in the number of animals used for experimentation is achieved, as well as minimal interference with their well-being and physiological status. In addition, under certain circumstances the duration of the observation period after disease onset can be shortened since the technique is able to detect changes before these are reflected in parameters of inflammation determined using invasive procedures. The objective of this article is to briefly address MRI techniques that are being used in experimental lung research, with special emphasis on applications. Following an introduction on proton techniques and MRI of hyperpolarized gases, the attention is shifted to the MRI analysis of several aspects of lung disease models, including inflammation, ventilation, emphysema, fibrosis and sensory nerve activation. The next subject concerns the use of MRI in pharmacological studies within the context of experimental lung research. A final discussion points towards advantages and limitations of MRI in this area

  4. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

  5. Drugs and Minorities. Research Issues 21.

    Science.gov (United States)

    Austin, Gregory A., Ed.; And Others

    This volume contains summaries of the latest research focusing on the issue of the extent of drug use and abuse among racial and ethnic minorities and the factors influencing it. Taken into consideration are age and sex differences among users, narcotics addiction, socioeconomic influences, cultural factors, racial factors, demographic factors,…

  6. Drugs and Pregnancy: The Effects of Nonmedical Use of Drugs on Pregnancy, Childbirth, and Neonates. National Institute on Drug Abuse Research Issues 5.

    Science.gov (United States)

    Ferguson, Patricia, Ed.; And Others

    The National Institute on Drug Abuse presents this report as the fifth in a series intended to summarize the empirical research findings and major theoretical approaches relating to the the issues of drug use and abuse. Included in this volume are summaries of the major research findings concerning the effects of nonmedical drug use on pregnancy.…

  7. How do researchers categorize drugs, and how do drug users categorize them?

    Science.gov (United States)

    Lee, Juliet P; Antin, Tamar M J

    2012-01-01

    This paper considers drug classifications and terms widely used in US survey research, and compares these to classifications and terms used by drug users. We begin with a critical review of drug classification systems, including those oriented to public policy and health services as well as survey research. We then consider the results of a pile sort exercise we conducted with 76 respondents within a mixed method study of Southeast Asian American adolescent and young adult drug users in urban Northern California, USA. We included the pile sort to clarify how respondents handled specific terms which we understood to be related to Ecstasy and methamphetamines. Results of the pile sort were analyzed using graphic layout algorithms as well as content analysis of pile labels. Similar to the national surveys, our respondents consistently differentiated Ecstasy terms from methamphetamine terms. We found high agreement between some specific local terms ( thizz , crystal ) and popular drug terms, while other terms thought to be mainstream ( crank , speed ) were reported as unknown by many respondents. In labeling piles, respondents created taxonomies based on consumption method (in particular, pill ) as well as the social contexts of use. We conclude by proposing that divergences between drug terms utilized in survey research and those used by drug users may reflect two opposing tendencies: the tendency of survey researchers to utilize standardized language that constructs persons and experiences as relatively homogeneous, varying only within measurable degrees, and the tendency of drug users to utilize specialized language (argot) that reflects their understandings of their experiences as hybrid and diverse. The findings problematize the validity of drug terms and categories used in survey research.

  8. Energy secretary's priorities include San Francisco area research projects

    CERN Multimedia

    Widener, A

    2003-01-01

    "Bay Area research labs got a big boost Monday when the Secretary of Energy unveiled his priorities for major research projects his agency hopes to fund over the next two decades. Among the agency's 28 top priorities are a major computer expansion and an experiment examining the expanding universe that could be housed at Lawrence Berkeley Lab and a powerful X-ray laser planned for the Stanford Linear Accelerator Center" (1 page).

  9. Including People with Intellectual Disabilities in Qualitative Research

    Science.gov (United States)

    Hall, Sarah A.

    2013-01-01

    The voice of people with intellectual disabilities (ID) is needed in the literature to best understand their unique experiences and perspectives. Researchers face challenges in conducting interviews with people with ID who are limited in conceptual and verbal language skills. It can also be difficult to obtain participants with ID because of…

  10. Methodological challenges when doing research that includes ethnic minorities

    DEFF Research Database (Denmark)

    Morville, Anne-Le; Erlandsson, Lena-Karin

    2016-01-01

    minorities are included. Method: A thorough literature search yielded 21 articles obtained from the scientific databases PubMed, Cinahl, Web of Science and PsychInfo. Analysis followed Arksey and O’Malley’s framework for scoping reviews, applying content analysis. Results: The results showed methodological...

  11. PET IMAGING STUDIES IN DRUG ABUSE RESEARCH.

    Energy Technology Data Exchange (ETDEWEB)

    Fowler, J.S.; Volkow, N.D.; Ding, Y.S.; Logan, J.; Wang, G.J.

    2001-01-29

    There is overwhelming evidence that addiction is a disease of the brain (Leshner, 1997). Yet public perception that addiction is a reflection of moral weakness or a lack of willpower persists. The insidious consequence of this perception is that we lose sight of the fact that there are enormous medical consequences of addiction including the fact that a large fraction of the total deaths from cancer and heart disease are caused by smoking addiction. Ironically the medical school that educates physicians in addiction medicine and the cancer hospital that has a smoking cessation clinic are vanishingly rare and efforts at harm reduction are frequently met with a public indignation. Meanwhile the number of people addicted to substances is enormous and increasing particularly the addictions to cigarettes and alcohol. It is particularly tragic that addiction usually begins in adolescence and becomes a chronic relapsing problem and there are basically no completely effective treatments. Clearly we need to understand how drugs of abuse affect the brain and we need to be creative in using this information to develop effective treatments. Imaging technologies have played a major role in the conceptualization of addiction as a disease of the brain (Fowler et al., 1998a; Fowler et al., 1999a). New knowledge has been driven by advances in radiotracer design and chemistry and positron emission tomography (PET) instrumentation and the integration of these scientific tools with the tools of biochemistry, pharmacology and medicine. This topic cuts across the medical specialties of neurology, psychiatry, cancer and heart disease because of the high medical, social and economic toll that drugs of abuse, including and especially the legal drugs, cigarettes and alcohol, take on society. In this chapter we will begin by highlighting the important role that chemistry has played in making it possible to quantitatively image the movement of drugs as well as their effects on the human brain

  12. Multi-target drugs: the trend of drug research and development.

    Science.gov (United States)

    Lu, Jin-Jian; Pan, Wei; Hu, Yuan-Jia; Wang, Yi-Tao

    2012-01-01

    Summarizing the status of drugs in the market and examining the trend of drug research and development is important in drug discovery. In this study, we compared the drug targets and the market sales of the new molecular entities approved by the U.S. Food and Drug Administration from January 2000 to December 2009. Two networks, namely, the target-target and drug-drug networks, have been set up using the network analysis tools. The multi-target drugs have much more potential, as shown by the network visualization and the market trends. We discussed the possible reasons and proposed the rational strategies for drug research and development in the future.

  13. GSI research and development programme 1992 (including programme budget)

    International Nuclear Information System (INIS)

    1992-01-01

    The main points on UNILAC will be preparatory experiments on the synthesis of the element 110 and the study of e + e 1 - pair generation for heavy ion impacts on the Coulomb barrier. Experiments on beam fragmentation, to generate and apply radioactive beams and for producing mesons and antiprotons below the threshold will be to the fore at SIS. The central detector of the 4 π detector for exclusive particle production studies will also be set to work. Up to now, the electron cooling and storage experiments have shown, in the main, how heavy ion beams such as 20 Ne, 40 Ar, 86 Kr, 136 Xe and 209 Bi are stored and can be cooled with electron beams to the highest phase space densities (Δ p/p ≅ 10 -6 , ε ≅ 0.3 π mm x mrad). The cooling experiments will be continued, particularly in order to research the conditions for beam condensation. In a series of experiments, electron-ion and laser-ion interaction processes such as radiation capture, dielectric recombination and laser-induced transitions are examined. Spectroscopy experiments on hydrogen- and helium-like heavy atoms to examined QED effects are being started. (orig.) [de

  14. Nonhuman primate positron emission tomography neuroimaging in drug abuse research.

    Science.gov (United States)

    Howell, Leonard Lee; Murnane, Kevin Sean

    2011-05-01

    Positron emission tomography (PET) neuroimaging in nonhuman primates has led to significant advances in our current understanding of the neurobiology and treatment of stimulant addiction in humans. PET neuroimaging has defined the in vivo biodistribution and pharmacokinetics of abused drugs and related these findings to the time course of behavioral effects associated with their addictive properties. With novel radiotracers and enhanced resolution, PET neuroimaging techniques have also characterized in vivo drug interactions with specific protein targets in the brain, including neurotransmitter receptors and transporters. In vivo determinations of cerebral blood flow and metabolism have localized brain circuits implicated in the effects of abused drugs and drug-associated stimuli. Moreover, determinations of the predisposing factors to chronic drug use and long-term neurobiological consequences of chronic drug use, such as potential neurotoxicity, have led to novel insights regarding the pathology and treatment of drug addiction. However, similar approaches clearly need to be extended to drug classes other than stimulants. Although dopaminergic systems have been extensively studied, other neurotransmitter systems known to play a critical role in the pharmacological effects of abused drugs have been largely ignored in nonhuman primate PET neuroimaging. Finally, the study of brain activation with PET neuroimaging has been replaced in humans mostly by functional magnetic resonance imaging (fMRI). There has been some success in implementing pharmacological fMRI in awake nonhuman primates. Nevertheless, the unique versatility of PET imaging will continue to complement the systems-level strengths of fMRI, especially in the context of nonhuman primate drug abuse research.

  15. Gore offers to help drug companies pursue research.

    Science.gov (United States)

    1996-03-08

    A meeting convened between Vice President Al Gore and executives of leading pharmaceutical companies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceutical companies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process.

  16. Applicability of bioanalysis of multiple analytes in drug discovery and development: review of select case studies including assay development considerations.

    Science.gov (United States)

    Srinivas, Nuggehally R

    2006-05-01

    The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval. Although the bioanalytical procedure(s) originally developed during the discovery stage may not necessarily be fit to support the drug development scenario, they may be suitably modified and validated, as deemed necessary. Several reviews have appeared over the years describing analytical approaches including various techniques, detection systems, automation tools that are available for an effective separation, enhanced selectivity and sensitivity for quantitation of many analytes. The intention of this review is to cover various key areas where analytical method development becomes necessary during different stages of drug discovery research and development process. The key areas covered in this article with relevant case studies include: (a) simultaneous assay for parent compound and metabolites that are purported to display pharmacological activity; (b) bioanalytical procedures for determination of multiple drugs in combating a disease; (c) analytical measurement of chirality aspects in the pharmacokinetics, metabolism and biotransformation investigations; (d) drug monitoring for therapeutic benefits and/or occupational hazard; (e) analysis of drugs from complex and/or less frequently used matrices; (f) analytical determination during in vitro experiments (metabolism and permeability related) and in situ intestinal perfusion experiments; (g) determination of a major metabolite as a surrogate for the parent molecule; (h) analytical approaches for universal determination of CYP450 probe substrates and metabolites; (i) analytical applicability to prodrug evaluations-simultaneous determination of prodrug, parent and metabolites; (j) quantitative determination of parent compound and/or phase II metabolite(s) via direct or indirect approaches; (k) applicability in analysis of multiple compounds in select

  17. Ethnographic research in immigrant-specific drug abuse recovery houses.

    Science.gov (United States)

    Pagano, Anna; Lee, Juliet P; García, Victor; Recarte, Carlos

    2018-01-01

    Access to study populations is a major concern for drug use and treatment researchers. Spaces related to drug use and treatment have varying levels of researcher accessibility based on several issues, including legality, public versus private settings, and insider/outsider status. Ethnographic research methods are indispensable for gaining and maintaining access to hidden or "hard-to-reach" populations. Here, we discuss our long-term ethnographic research on drug abuse recovery houses created by and for Latino migrants and immigrants in Northern California. We take our field work experiences as a case study to examine the problem of researcher access and how ethnographic strategies can be successfully applied to address it, focusing especially on issues of entrée, building rapport, and navigating field-specific challenges related to legality, public/private settings, and insider/outsider status. We conclude that continued funding support for ethnography is essential for promoting health disparities research focused on diverse populations in recovery from substance use disorders.

  18. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

  19. Health Services Research for Drug and Alcohol Treatment and Prevention.

    Science.gov (United States)

    McCarty, Dennis; Roman, Paul M; Sorensen, James; Weisner, Constance

    2009-01-01

    Health services research is a multidisciplinary field that examines ways to organize, manage, finance, and deliver high-quality care. This specialty within substance abuse research developed from policy analyses and needs assessments that shaped federal policy and promoted system development in the 1970s. After the authorization of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA), patient information systems supported studies of treatment processes and outcomes. Health services research grew substantially in the 1990s when NIAAA and NIDA moved into the National Institutes of Health and legislation allocated 15% of their research portfolio to services research. The next decade will emphasize research on quality of care, adoption and use of evidence-based practices (including medication), financing reforms and integration of substance abuse treatment with primary care and mental health services.

  20. Plant natural products research in tuberculosis drug discovery and ...

    African Journals Online (AJOL)

    Plant natural products research in tuberculosis drug discovery and development: A situation report ... African Journal of Biotechnology ... tuberculosis (XDR-TB), call for the development of new anti-tuberculosis drugs to combat this disease.

  1. 13 CFR 147.215 - What must I include in my drug-free awareness program?

    Science.gov (United States)

    2010-01-01

    ..., rehabilitation, and employee assistance programs; and (d) The penalties that you may impose upon them for drug...-free awareness program? 147.215 Section 147.215 Business Credit and Assistance SMALL BUSINESS... establish an ongoing drug-free awareness program to inform employees about— (a) The dangers of drug abuse in...

  2. The ethics of HIV research with people who inject drugs in Africa: a desk review.

    Science.gov (United States)

    Mamotte, Nicole

    2012-03-01

    Injecting drug use is a growing problem in Africa and a growing risk factor for contracting HIV in the region. It is imperative that HIV research includes injecting drug users so that they too are able to benefit from safe and effective behavioural interventions and biomedical HIV prevention and treatment products. This article relates a critical review of the findings of a desk review of previously published literature. The article examines injecting drug use in relation to HIV-related risk and research in Kenya, Mauritius, Nigeria, South Africa and Tanzania. The ethical challenges of including people who inject drugs in HIV research in Africa are also presented. The review found injecting drug use to be on the increase in all the countries reviewed. HIV-risk behaviour among people who inject drugs, such as needle-sharing and higher-risk sexual behaviour, was also found to be widespread. Furthermore, criminalisation of drug use and strict anti-drug laws are common in the countries reviewed, while harm-reduction programmes for people who inject drugs were found to be limited. The review identified a number of ethical challenges to the involvement of people who inject drugs in HIV research in Africa. This includes the illegal status and stigma surrounding injecting drug use, which may complicate participant recruitment, enrolment and retention. In addition, a lack of funding for supportive programmes to help injecting drug users may hinder the provision of appropriate standards of prevention and care and treatment for those who seroconvert.

  3. 21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

    Science.gov (United States)

    2010-04-01

    ... to human research subjects during the course of a research project intended to obtain basic research... labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for...

  4. Research Highlights: Helping Adolescents Resist Drugs

    National Research Council Canada - National Science Library

    2000-01-01

    Project ALERT departs boldly from prevention models of the 196Os and 197Os, which emphasized informing adolescents about the long-term consequences of drug use or building their decisionmaking skills...

  5. 76 FR 45268 - Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop

    Science.gov (United States)

    2011-07-28

    ...] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop AGENCY... Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and..., and to gain additional insight from, professional societies, patient advocates, industry, consumer...

  6. Drug Delivery Research: The Invention Cycle.

    Science.gov (United States)

    Park, Kinam

    2016-07-05

    Controlled drug delivery systems have been successful in introducing improved formulations for better use of existing drugs and novel delivery of biologicals. The initial success of producing many oral products and some injectable depot formulations, however, reached a plateau, and the progress over the past three decades has been slow. This is likely due to the difficulties of formulating hydrophilic, high molecular weight drugs, such as proteins and nucleic acids, for targeting specific cells, month-long sustained delivery, and pulsatile release. Since the approaches that have served well for delivery of small molecules are not applicable to large molecules, it is time to develop new methods for biologicals. The process of developing future drug delivery systems, termed as the invention cycle, is proposed, and it starts with clearly defining the problems for developing certain formulations. Once the problems are well-defined, creative imagination examines all potential options and selects the best answer and alternatives. Then, innovation takes over to generate unique solutions for developing new formulations that resolve the previously identified problems. Ultimately, the new delivery systems will have to go through a translational process to produce the final formulations for clinical use. The invention cycle also emphasizes examining the reasons for success of certain formulations, not just the reasons for failure of many systems. Implementation of the new invention cycle requires new mechanisms of funding the younger generation of scientists and a new way of identifying their achievements, thereby releasing them from the burden of short-termism.

  7. Drug knowledge bases and their applications in biomedical informatics research.

    Science.gov (United States)

    Zhu, Yongjun; Elemento, Olivier; Pathak, Jyotishman; Wang, Fei

    2018-01-03

    Recent advances in biomedical research have generated a large volume of drug-related data. To effectively handle this flood of data, many initiatives have been taken to help researchers make good use of them. As the results of these initiatives, many drug knowledge bases have been constructed. They range from simple ones with specific focuses to comprehensive ones that contain information on almost every aspect of a drug. These curated drug knowledge bases have made significant contributions to the development of efficient and effective health information technologies for better health-care service delivery. Understanding and comparing existing drug knowledge bases and how they are applied in various biomedical studies will help us recognize the state of the art and design better knowledge bases in the future. In addition, researchers can get insights on novel applications of the drug knowledge bases through a review of successful use cases. In this study, we provide a review of existing popular drug knowledge bases and their applications in drug-related studies. We discuss challenges in constructing and using drug knowledge bases as well as future research directions toward a better ecosystem of drug knowledge bases. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. DNA sequence analyses of blended herbal products including synthetic cannabinoids as designer drugs.

    Science.gov (United States)

    Ogata, Jun; Uchiyama, Nahoko; Kikura-Hanajiri, Ruri; Goda, Yukihiro

    2013-04-10

    In recent years, various herbal products adulterated with synthetic cannabinoids have been distributed worldwide via the Internet. These herbal products are mostly sold as incense, and advertised as not for human consumption. Although their labels indicate that they contain mixtures of several potentially psychoactive plants, and numerous studies have reported that they contain a variety of synthetic cannabinoids, their exact botanical contents are not always clear. In this study, we investigated the origins of botanical materials in 62 Spice-like herbal products distributed on the illegal drug market in Japan, by DNA sequence analyses and BLAST searches. The nucleotide sequences of four regions were analyzed to identify the origins of each plant species in the herbal mixtures. The sequences of "Damiana" (Turnera diffusa) and Lamiaceae herbs (Mellissa, Mentha and Thymus) were frequently detected in a number of products. However, the sequences of other plant species indicated on the packaging labels were not detected. In a few products, DNA fragments of potent psychotropic plants were found, including marijuana (Cannabis sativa), "Diviner's Sage" (Salvia divinorum) and "Kratom" (Mitragyna speciosa). Their active constituents were also confirmed using gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS), although these plant names were never indicated on the labels. Most plant species identified in the products were different from the plants indicated on the labels. The plant materials would be used mainly as diluents for the psychoactive synthetic compounds, because no reliable psychoactive effects have been reported for most of the identified plants, with the exception of the psychotropic plants named above. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  9. Future Challenges and Opportunities in Online Prescription Drug Promotion Research

    Science.gov (United States)

    Southwell, Brian G.; Rupert, Douglas J.

    2016-01-01

    Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. PMID:26927597

  10. Beyond 'Doing Gender': Incorporating Race, Class, Place, and Life Transitions into Feminist Drug Research.

    Science.gov (United States)

    Miller, Jody; Carbone-Lopez, Kristin

    2015-05-01

    This essay draws from our research with US rural women methamphetamine users in 2009 to offer strategies for "revisioning" the drug use(r) field to better understand the impact of gender on drug use and drug market participation. We highlight the insights and limitations of a popular strategy in feminist research that conceptualizes gender as performance- commonly referred to as "doing gender"-using illustrations from our research. We encourage scholars to move beyond a primarily normative orientation in studying gender, and investigate gendered organizational features of social life including their intersections with other aspects of social inequality such as those of race, class, and place. In addition, we suggest that feminist scholars can integrate gender in a rigorous way into theoretical perspectives that are typically inattentive to its import, as a means of challenging, enriching, and refining research on drug use, drug users, and drug market participation.

  11. In silico studies in drug research against neurodegenerative diseases.

    Science.gov (United States)

    Makhouri, Farahnaz Rezaei; Ghasemi, Jahan B

    2017-08-22

    Neurodegenerative diseases such as Alzheimer's disease (AD), progressive neurodegenerative forms of Huntington's disease, Parkinson's disease (PD), amyotrophic lateral sclerosis, spinal cerebellar ataxias, and spinal and bulbar muscular atrophy are described by slow and selective dysfunction and degeneration of neurons and axons in the central nervous system (CNS). Computer-aided or in silico design methods have matured into powerful tools for reducing the number of ligands that should be screened in experimental assays. In the present review, the authors provide a basic background about neurodegenerative diseases and in silico techniques in the drug research. Furthermore, they review the various in silico studies reported against various targets in neurodegenerative diseases, including homology modeling, molecular docking, virtual high-throughput screening, quantitative structure activity relationship (QSAR), hologram quantitative structure activity relationship (HQSAR), 3D pharmacophore mapping, proteochemometrics modeling (PCM), fingerprints, fragment-based drug discovery, Monte Carlo simulation, molecular dynamic (MD) simulation, quantum-mechanical methods for drug design, support vector machines, and machine learning approaches. Neurodegenerative diseases have a multifactorial pathoetiological origin, so scientists have become persuaded that a multi-target therapeutic strategy aimed at the simultaneous targeting of multiple proteins (and therefore etiologies) involved in the development of a disease is recommended in future. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  12. Studies in youth, drug and alcohol consumption at the Centre for Alcohol and Drug Research

    DEFF Research Database (Denmark)

    Kolind, Torsten; Demant, Jakob Johan; Hunt, Geoffrey

    2013-01-01

    or providing genuine contribution to the sociological analysis and understanding of youth cultures. From the mid-00 s and forward however, a range of analytical tools were developed at Centre for Alcohol and Drug Research (CRF) in order to understand the relationship between youth, drug and alcohol use......Background: During the 90 s and especially in the beginning of the 00 s research in youth, drug and alcohol consumption increased markedly in Denmark. Much of this research was applied and placed in a dilemma between reproducing existing social problem characterizations of youthful behaviors...... and to move beyond the applied perspective into a more social science analytical approach. Aim: The article investigates the relationship developments between drug and alcohol research and youth research in Denmark in general, with a special focus on research conducted at CRF. Specifically, we will focus...

  13. The evolution of drug design at Merck Research Laboratories.

    Science.gov (United States)

    Brown, Frank K; Sherer, Edward C; Johnson, Scott A; Holloway, M Katharine; Sherborne, Bradley S

    2017-03-01

    On October 5, 1981, Fortune magazine published a cover article entitled the "Next Industrial Revolution: Designing Drugs by Computer at Merck". With a 40+ year investment, we have been in the drug design business longer than most. During its history, the Merck drug design group has had several names, but it has always been in the "design" business, with the ultimate goal to provide an actionable hypothesis that could be tested experimentally. Often the result was a small molecule but it could just as easily be a peptide, biologic, predictive model, reaction, process, etc. To this end, the concept of design is now front and center in all aspects of discovery, safety assessment and early clinical development. At present, the Merck design group includes computational chemistry, protein structure determination, and cheminformatics. By bringing these groups together under one umbrella, we were able to align activities and capabilities across multiple research sites and departments. This alignment from 2010 to 2016 resulted in an 80% expansion in the size of the department, reflecting the increase in impact due to a significant emphasis across the organization to "design first" along the entire drug discovery path from lead identification (LID) to first in human (FIH) dosing. One of the major advantages of this alignment has been the ability to access all of the data and create an adaptive approach to the overall LID to FIH pathway for any modality, significantly increasing the quality of candidates and their probability of success. In this perspective, we will discuss how we crafted a new strategy, defined the appropriate phenotype for group members, developed the right skillsets, and identified metrics for success in order to drive continuous improvement. We will not focus on the tactical implementation, only giving specific examples as appropriate.

  14. The evolution of drug design at Merck Research Laboratories

    Science.gov (United States)

    Brown, Frank K.; Sherer, Edward C.; Johnson, Scott A.; Holloway, M. Katharine; Sherborne, Bradley S.

    2017-03-01

    On October 5, 1981, Fortune magazine published a cover article entitled the "Next Industrial Revolution: Designing Drugs by Computer at Merck". With a 40+ year investment, we have been in the drug design business longer than most. During its history, the Merck drug design group has had several names, but it has always been in the "design" business, with the ultimate goal to provide an actionable hypothesis that could be tested experimentally. Often the result was a small molecule but it could just as easily be a peptide, biologic, predictive model, reaction, process, etc. To this end, the concept of design is now front and center in all aspects of discovery, safety assessment and early clinical development. At present, the Merck design group includes computational chemistry, protein structure determination, and cheminformatics. By bringing these groups together under one umbrella, we were able to align activities and capabilities across multiple research sites and departments. This alignment from 2010 to 2016 resulted in an 80% expansion in the size of the department, reflecting the increase in impact due to a significant emphasis across the organization to "design first" along the entire drug discovery path from lead identification (LID) to first in human (FIH) dosing. One of the major advantages of this alignment has been the ability to access all of the data and create an adaptive approach to the overall LID to FIH pathway for any modality, significantly increasing the quality of candidates and their probability of success. In this perspective, we will discuss how we crafted a new strategy, defined the appropriate phenotype for group members, developed the right skillsets, and identified metrics for success in order to drive continuous improvement. We will not focus on the tactical implementation, only giving specific examples as appropriate.

  15. Preparation and its drug release property of radiation-polymerized poly(methyl methacrylate) capsule including potassium chloride

    International Nuclear Information System (INIS)

    Yoshida, Masaru; Kumakura, Minoru; Kaetsu, Isao

    1979-01-01

    Porous flat circular capsules including KCl as a drug were prepared by radiation-induced polymerization of methyl methacrylate at room temperature in the presence of polyethylene glycol No. 600. The porous structure can be controlled by the methyl methacrylate-polyethylene glycol No. 600 composition. The amount of drug released was linearly related to the square root of time. The magnitude of drug release increased roughly in proportional to the water content of capsule, which can be related to porosity in the capsule. (author)

  16. Research Ethics and Commercial Drug Development: When Integrity Threatens Profitability

    Directory of Open Access Journals (Sweden)

    Bélisle Pipon, Jean-Christophe

    2016-05-01

    Full Text Available This case, based on personal experiences and on those found in the literature, highlights the delicate tension faced by drug development companies having to balance research integrity and their profitability.

  17. Mesoporous Silica Molecular Sieve based Nanocarriers: Transpiring Drug Dissolution Research.

    Science.gov (United States)

    Pattnaik, Satyanarayan; Pathak, Kamla

    2017-01-01

    Improvement of oral bioavailability through enhancement of dissolution for poorly soluble drugs has been a very promising approach. Recently, mesoporous silica based molecular sieves have demonstrated excellent properties to enhance the dissolution velocity of poorly water-soluble drugs. Current research in this area is focused on investigating the factors influencing the drug release from these carriers, the kinetics of drug release and manufacturing approaches to scale-up production for commercial manufacture. This comprehensive review provides an overview of different methods adopted for synthesis of mesoporous materials, influence of processing factors on properties of these materials and drug loading methods. The drug release kinetics from mesoporous silica systems, the manufacturability and stability of these formulations are reviewed. Finally, the safety and biocompatibility issues related to these silica based materials are discussed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. Drug research methodology. Volume 2, The identification of drugs of interest in highway safety

    Science.gov (United States)

    1980-03-01

    This report presents findings of a workshop on the identification of drugs that should be the focus of near-term highway safety research. Drugs of interest are those that have a potential to increase the likelihood of traffic crashes and their attend...

  19. Prescription drugs for human use generally recognized as safe and effective and not misbranded: drugs used in research: radioactive drugs for certain research uses; amended reporting requirements

    International Nuclear Information System (INIS)

    Anon.

    1978-01-01

    This amendment revises the reporting requirements for research studies in which radioactive drugs are used. It deletes the requirement for detailed measurements and calculations for each subject in the study; instead, it permits submission of data on a representative subject. The effect will be to decrease the burden in reporting required of the Radioactive Drug Research Committee, but still provide the agency with data to evaluate the risk attributable to radioactive drugs

  20. Open source drug discovery--a new paradigm of collaborative research in tuberculosis drug development.

    Science.gov (United States)

    Bhardwaj, Anshu; Scaria, Vinod; Raghava, Gajendra Pal Singh; Lynn, Andrew Michael; Chandra, Nagasuma; Banerjee, Sulagna; Raghunandanan, Muthukurussi V; Pandey, Vikas; Taneja, Bhupesh; Yadav, Jyoti; Dash, Debasis; Bhattacharya, Jaijit; Misra, Amit; Kumar, Anil; Ramachandran, Srinivasan; Thomas, Zakir; Brahmachari, Samir K

    2011-09-01

    It is being realized that the traditional closed-door and market driven approaches for drug discovery may not be the best suited model for the diseases of the developing world such as tuberculosis and malaria, because most patients suffering from these diseases have poor paying capacity. To ensure that new drugs are created for patients suffering from these diseases, it is necessary to formulate an alternate paradigm of drug discovery process. The current model constrained by limitations for collaboration and for sharing of resources with confidentiality hampers the opportunities for bringing expertise from diverse fields. These limitations hinder the possibilities of lowering the cost of drug discovery. The Open Source Drug Discovery project initiated by Council of Scientific and Industrial Research, India has adopted an open source model to power wide participation across geographical borders. Open Source Drug Discovery emphasizes integrative science through collaboration, open-sharing, taking up multi-faceted approaches and accruing benefits from advances on different fronts of new drug discovery. Because the open source model is based on community participation, it has the potential to self-sustain continuous development by generating a storehouse of alternatives towards continued pursuit for new drug discovery. Since the inventions are community generated, the new chemical entities developed by Open Source Drug Discovery will be taken up for clinical trial in a non-exclusive manner by participation of multiple companies with majority funding from Open Source Drug Discovery. This will ensure availability of drugs through a lower cost community driven drug discovery process for diseases afflicting people with poor paying capacity. Hopefully what LINUX the World Wide Web have done for the information technology, Open Source Drug Discovery will do for drug discovery. Copyright © 2011 Elsevier Ltd. All rights reserved.

  1. Sewage epidemiology and illicit drug research: the development of ethical research guidelines.

    Science.gov (United States)

    Prichard, Jeremy; Hall, Wayne; de Voogt, Pim; Zuccato, Ettore

    2014-02-15

    To discuss the need to develop ethical guidelines for researchers using sewage epidemiology to monitor drug use in the general population and specific precincts, including prisons, schools and workplaces. Describe current applications of sewage epidemiology, identify potential ethical risks associated with this science, and identify key means by which these risks may be mitigated through proportionate ethical guidance that allows this science to be fully developed. A rapidly advancing field of research is sewage epidemiology (SE) - the analysis of wastewater samples to monitor illicit drug use and other substances. Typically this research involves low ethical risks because individual participants cannot be identified and, consequently, review has been waived by human research ethics committees. In the absence of such oversight, ethical research guidelines are recommended for SE teams, peer reviewers and journal editors; guidelines will assist them to mitigate any risks in general population studies and studies of prisons, schools and workplaces. Potential harms include the stigmatisation of participants and, in the prison setting, austere policy responses to SE data that impact negatively upon inmate-participants. The risk of harm can be managed through research planning, awareness of the socio-political context in which results will be interpreted (or, in the case of media, sensationalised) and careful relations with industry partners. Ethical guidelines should be developed in consultation with SE scholars and be periodically amended. They should include publication processes that safeguard scientific rigour and be promulgated through existing research governance structures. Guidelines will assist to promote an ethical research culture among SE teams and scholars involved in the publication process and this will work to protect the reputation of the field. Copyright © 2014 Elsevier B.V. All rights reserved.

  2. Merkel Cell Carcinomas Arising in Autoimmune Disease Affected Patients Treated with Biologic Drugs, Including Anti-TNF.

    Science.gov (United States)

    Rotondo, John Charles; Bononi, Ilaria; Puozzo, Andrea; Govoni, Marcello; Foschi, Valentina; Lanza, Giovanni; Gafà, Roberta; Gaboriaud, Pauline; Touzé, Françoise Antoine; Selvatici, Rita; Martini, Fernanda; Tognon, Mauro

    2017-07-15

    Purpose: The purpose of this investigation was to characterize Merkel cell carcinomas (MCC) arisen in patients affected by autoimmune diseases and treated with biologic drugs. Experimental Design: Serum samples from patients with MCC were analyzed for the presence and titer of antibodies against antigens of the oncogenic Merkel cell polyomavirus (MCPyV). IgG antibodies against the viral oncoproteins large T (LT) and small T (ST) antigens and the viral capsid protein-1 were analyzed by indirect ELISA. Viral antigens were recombinant LT/ST and virus-like particles (VLP), respectively. MCPyV DNA sequences were studied using PCR methods in MCC tissues and in peripheral blood mononuclear cells (PBMC). Immunohistochemical (IHC) analyses were carried out in MCC tissues to reveal MCPyV LT oncoprotein. Results: MCPyV DNA sequences identified in MCC tissues showed 100% homology with the European MKL-1 strain. PBMCs from patients tested MCPyV-negative. Viral DNA loads in the three MCC tissues were in the 0.1 to 30 copy/cell range. IgG antibodies against LT/ST were detected in patients 1 and 3, whereas patient 2 did not react to the MCPyV LT/ST antigen. Sera from the three patients with MCC contained IgG antibodies against MCPyV VP1. MCC tissues tested MCPyV LT-antigen-positive in IHC assays, with strong LT expression with diffuse nuclear localization. Normal tissues tested MCPyV LT-negative when employed as control. Conclusions: We investigated three new MCCs in patients affected by rheumatologic diseases treated with biologic drugs, including TNF. A possible cause-effect relationship between pharmacologic immunosuppressive treatment and MCC onset is suggested. Indeed, MCC is associated with MCPyV LT oncoprotein activity. Clin Cancer Res; 23(14); 3929-34. ©2017 AACR . ©2017 American Association for Cancer Research.

  3. West African Journal of Pharmacology and Drug Research: Editorial ...

    African Journals Online (AJOL)

    Journal Ouest Africain de Pharmacologie et de Recherche sur les Médicaments) Papers on all aspects of drug action and related topics including chemotherapy and toxicology will be considered for publication.

  4. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    Science.gov (United States)

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  5. HIV Model Parameter Estimates from Interruption Trial Data including Drug Efficacy and Reservoir Dynamics

    Science.gov (United States)

    Luo, Rutao; Piovoso, Michael J.; Martinez-Picado, Javier; Zurakowski, Ryan

    2012-01-01

    Mathematical models based on ordinary differential equations (ODE) have had significant impact on understanding HIV disease dynamics and optimizing patient treatment. A model that characterizes the essential disease dynamics can be used for prediction only if the model parameters are identifiable from clinical data. Most previous parameter identification studies for HIV have used sparsely sampled data from the decay phase following the introduction of therapy. In this paper, model parameters are identified from frequently sampled viral-load data taken from ten patients enrolled in the previously published AutoVac HAART interruption study, providing between 69 and 114 viral load measurements from 3–5 phases of viral decay and rebound for each patient. This dataset is considerably larger than those used in previously published parameter estimation studies. Furthermore, the measurements come from two separate experimental conditions, which allows for the direct estimation of drug efficacy and reservoir contribution rates, two parameters that cannot be identified from decay-phase data alone. A Markov-Chain Monte-Carlo method is used to estimate the model parameter values, with initial estimates obtained using nonlinear least-squares methods. The posterior distributions of the parameter estimates are reported and compared for all patients. PMID:22815727

  6. Including adverse drug events in economic evaluations of anti-tumour necrosis factor-α drugs for adult rheumatoid arthritis: a systematic review of economic decision analytic models.

    Science.gov (United States)

    Heather, Eleanor M; Payne, Katherine; Harrison, Mark; Symmons, Deborah P M

    2014-02-01

    Anti-tumour necrosis factor-α drugs (anti-TNFs) have revolutionised the treatment of rheumatoid arthritis (RA). More effective than standard non-biological disease-modifying anti-rheumatic drugs (nbDMARDs), anti-TNFs are also substantially more expensive. Consequently, a number of model-based economic evaluations have been conducted to establish the relative cost-effectiveness of anti-TNFs. However, anti-TNFs are associated with an increased risk of adverse drug events (ADEs) such as serious infections relative to nbDMARDs. Such ADEs will likely impact on both the costs and consequences of anti-TNFs, for example, through hospitalisations and forced withdrawal from treatment. The aim of this review was to identify and critically appraise if, and how, ADEs have been incorporated into model-based cost-effectiveness analyses of anti-TNFs for adult patients with RA. A systematic literature review was performed. Electronic databases (Ovid MEDLINE; Ovid EMBASE; Web of Science; NHS Economic Evaluations Database) were searched for literature published between January 1990 and October 2013 using electronic search strategies. The reference lists of retrieved studies were also hand searched. In addition, the National Institute for Health and Care Excellence technology appraisals were searched to identify economic models used to inform UK healthcare decision making. Only full economic evaluations that had used an economic model to evaluate biological DMARDs (bDMARDs) (including anti-TNFs) for adult patients with RA and had incorporated the direct costs and/or consequences of ADEs were critically appraised. To be included, studies also had to be available as a full text in English. Data extracted included general study characteristics and information concerning the methods used to incorporate ADEs and any associated assumptions made. The extracted data were synthesised using a tabular and narrative format. A total of 43 model-based economic evaluations of bDMARDs for adult RA

  7. Illicit drugs and the media: models of media effects for use in drug policy research.

    Science.gov (United States)

    Lancaster, Kari; Hughes, Caitlin E; Spicer, Bridget; Matthew-Simmons, Francis; Dillon, Paul

    2011-07-01

    Illicit drugs are never far from the media gaze and although identified almost a decade ago as 'a new battleground' for the alcohol and other drug (AOD) field there has been limited research examining the role of the news media and its effects on audiences and policy. This paper draws together media theories from communication literature to examine media functions. We illustrate how each function is relevant for media and drugs research by drawing upon the existing literature examining Australian media coverage during the late 1990s of escalating heroin-related problems and proposed solutions. Media can influence audiences in four key ways: by setting the agenda and defining public interest; framing issues through selection and salience; indirectly shaping individual and community attitudes towards risk; and feeding into political debate and decision making. Each has relevance for the AOD field. For example, media coverage of the escalating heroin-related problems in Australia played a strong role in generating interest in heroin overdoses, framing public discourse in terms of a health and/or criminal issue and affecting political decisions. Implications AND CONCLUSION: Media coverage in relation to illicit drugs can have multifarious effects. Incorporating media communication theories into future research and actions is critical to facilitate understanding of the short- and long-term impacts of media coverage on illicit drugs and the avenues by which the AOD field can mitigate or inform future media debates on illicit drugs. © 2010 Australasian Professional Society on Alcohol and other Drugs.

  8. 41 CFR 105-74.205 - What must I include in my drug-free workplace statement?

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What must I include in my drug-free workplace statement? 105-74.205 Section 105-74.205 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION...

  9. 41 CFR 105-74.215 - What must I include in my drug-free awareness program?

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What must I include in my drug-free awareness program? 105-74.215 Section 105-74.215 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION...

  10. 21 CFR 361.1 - Radioactive drugs for certain research uses.

    Science.gov (United States)

    2010-04-01

    ... Research Committee. A Radioactive Drug Research Committee, composed and approved by the Food and Drug... CFR 20.61. Investigator Chairman, Radioactive Drug Research Committee At any time a proposal is... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Radioactive drugs for certain research uses. 361.1...

  11. Hydrogels synthesised through photoinitiator-free photopolymerisation technique for delivering drugs including a tumour-tracing porphyrin

    International Nuclear Information System (INIS)

    Ng, Loo-Teck; Swami, Salesh; Gordon-Thomson, Clare

    2006-01-01

    Hydrogels were synthesised using the photoinitiator-free photopolymerisation technique involving interactions between donor/acceptor pairs for delivering drugs of different molecular weights including a porphyrin used as a tumour-tracing agent. N-(5-hydroxy) pentylmaleimide, an acceptor, formed hydrogels with N-vinyl-2-pyrrolidinone, 2-hydroxyethyl methacrylate and N-vinylcaprolactum. Glucosamine, an effective H-donor in enhancing polymerisation as shown by Differential Photocalorimetric results, was found unsuitable for hydrogel preparation. Drugs of different molecular weights releasing at the same rate was discussed. The hydrogels were found to have no toxic effects and were biocompatible with a human keratinocyte cell line

  12. A global call for action to include gender in research impact assessment.

    Science.gov (United States)

    Ovseiko, Pavel V; Greenhalgh, Trisha; Adam, Paula; Grant, Jonathan; Hinrichs-Krapels, Saba; Graham, Kathryn E; Valentine, Pamela A; Sued, Omar; Boukhris, Omar F; Al Olaqi, Nada M; Al Rahbi, Idrees S; Dowd, Anne-Maree; Bice, Sara; Heiden, Tamika L; Fischer, Michael D; Dopson, Sue; Norton, Robyn; Pollitt, Alexandra; Wooding, Steven; Balling, Gert V; Jakobsen, Ulla; Kuhlmann, Ellen; Klinge, Ineke; Pololi, Linda H; Jagsi, Reshma; Smith, Helen Lawton; Etzkowitz, Henry; Nielsen, Mathias W; Carrion, Carme; Solans-Domènech, Maite; Vizcaino, Esther; Naing, Lin; Cheok, Quentin H N; Eckelmann, Baerbel; Simuyemba, Moses C; Msiska, Temwa; Declich, Giovanna; Edmunds, Laurel D; Kiparoglou, Vasiliki; Buchan, Alison M J; Williamson, Catherine; Lord, Graham M; Channon, Keith M; Surender, Rebecca; Buchan, Alastair M

    2016-07-19

    Global investment in biomedical research has grown significantly over the last decades, reaching approximately a quarter of a trillion US dollars in 2010. However, not all of this investment is distributed evenly by gender. It follows, arguably, that scarce research resources may not be optimally invested (by either not supporting the best science or by failing to investigate topics that benefit women and men equitably). Women across the world tend to be significantly underrepresented in research both as researchers and research participants, receive less research funding, and appear less frequently than men as authors on research publications. There is also some evidence that women are relatively disadvantaged as the beneficiaries of research, in terms of its health, societal and economic impacts. Historical gender biases may have created a path dependency that means that the research system and the impacts of research are biased towards male researchers and male beneficiaries, making it inherently difficult (though not impossible) to eliminate gender bias. In this commentary, we - a group of scholars and practitioners from Africa, America, Asia and Europe - argue that gender-sensitive research impact assessment could become a force for good in moving science policy and practice towards gender equity. Research impact assessment is the multidisciplinary field of scientific inquiry that examines the research process to maximise scientific, societal and economic returns on investment in research. It encompasses many theoretical and methodological approaches that can be used to investigate gender bias and recommend actions for change to maximise research impact. We offer a set of recommendations to research funders, research institutions and research evaluators who conduct impact assessment on how to include and strengthen analysis of gender equity in research impact assessment and issue a global call for action.

  13. 21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

  14. Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies.

    Science.gov (United States)

    Rios, Dianne; Magasi, Susan; Novak, Catherine; Harniss, Mark

    2016-12-01

    People with disabilities are largely absent from mainstream health research. Exclusion of people with disabilities may be explicit, attributable to poorly justified exclusion criteria, or implicit, attributable to inaccessible study documents, interventions, or research measures. Meanwhile, people with disabilities experience poorer health, greater incidence of chronic conditions, and higher health care expenditure than people without disabilities. We outline our approach to "accessible research design"-research accessible to and inclusive of people with disabilities. We describe a model that includes 3 tiers: universal design, accommodations, and modifications. Through our work on several large-scale research studies, we provide pragmatic examples of accessible research design. Making efforts to include people with disabilities in public health, epidemiological, and outcomes studies will enhance the interpretability of findings for a significant patient population.

  15. Using Photovoice to Include People with Profound and Multiple Learning Disabilities in Inclusive Research

    Science.gov (United States)

    Cluley, Victoria

    2017-01-01

    Background: It is now expected that projects addressing the lives of people with learning disabilities include people with learning disabilities in the research process. In the past, such research often excluded people with learning disabilities, favouring the opinions of family members, carers and professionals. The inclusion of the voices of…

  16. Income inequality, drug-related arrests, and the health of people who inject drugs: Reflections on seventeen years of research.

    Science.gov (United States)

    Friedman, Samuel R; Tempalski, Barbara; Brady, Joanne E; West, Brooke S; Pouget, Enrique R; Williams, Leslie D; Des Jarlais, Don C; Cooper, Hannah L F

    2016-06-01

    This paper reviews and then discusses selected findings from a seventeen year study about the population prevalence of people who inject drugs (PWID) and of HIV prevalence and mortality among PWID in 96 large US metropolitan areas. Unlike most research, this study was conducted with the metropolitan area as the level of analysis. It found that metropolitan area measures of income inequality and of structural racism predicted all of these outcomes, and that rates of arrest for heroin and/or cocaine predicted HIV prevalence and mortality but did not predict changes in PWID population prevalence. Income inequality and measures of structural racism were associated with hard drug arrests or other properties of policing. These findings, whose limitations and implications for further research are discussed, suggest that efforts to respond to HIV and to drug injection should include supra-individual efforts to reduce both income inequality and racism. At a time when major social movements in many countries are trying to reduce inequality, racism and oppression (including reforming drug laws), these macro-social issues in public health should be both addressable and a priority in both research and action. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. Can open-source R&D reinvigorate drug research?

    Science.gov (United States)

    Munos, Bernard

    2006-09-01

    The low number of novel therapeutics approved by the US FDA in recent years continues to cause great concern about productivity and declining innovation. Can open-source drug research and development, using principles pioneered by the highly successful open-source software movement, help revive the industry?

  18. West African Journal of Pharmacology and Drug Research

    African Journals Online (AJOL)

    (Journal Ouest Africain de Pharmacologie de Recherche sur les Medicaments). Papers on all aspects of drug action and related topics including chemotherapy and toxicology will be considered for publication. Vol 31, No 1 (2016). DOWNLOAD FULL TEXT Open Access DOWNLOAD FULL TEXT Subscription or Fee Access ...

  19. [Alternatives to the drug research and development model].

    Science.gov (United States)

    Velásquez, Germán

    2015-03-01

    One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

  20. Isolation and identification of flavonoids, including flavone rotamers, from the herbal drug 'Crataegi folium cum flore' (hawthorn).

    Science.gov (United States)

    Rayyan, S; Fossen, T; Solheim Nateland, H; Andersen, O M

    2005-01-01

    Twelve flavonoids, including seven flavones, four flavonols and one flavanone, were isolated from methanolic extract of the herbal drug 'Crataegi folium cum flore' (hawthorn leaves and flowers) by a combination of CC (over Amberlite XAD-7 and Sephadex LH-20) and preparative HPLC. Their structures, including that of the novel flavonol 8-methoxykaempferol 3-O-(6"-malonyl-beta-glucopyranoside), were elucidated by homo- and heteronuclear NMR and electrospray/MS. The 1H- and 13C-NMR of all compounds, including rotameric pairs of five flavone C-glycosides, were assigned. The presence and relative proportion of each rotamer was shown by various NMR experiments, including two-dimensional nuclear Overhauser and exchange spectroscopy, to depend on solvent, linkage position and structure of the C-glycosyl substituent.

  1. An ethical exploration of barriers to research on controlled drugs

    Science.gov (United States)

    ANDREAE, Michael H; RHODES, Evelyn; BOURGOISE, Tylor; CARTER, George; WHITE, Robert S.; INDYK, Debbie; SACKS, Henry; RHODES, Rosamond

    2016-01-01

    We examine the ethical, social and regulatory barriers that may hamper research on therapeutic potential of certain controversial controlled substances like marijuana, heroin or ketamine. Hazards for individuals and society, and their potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of certain substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may hinder research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns of undue inducement, informed consent, risk to participants, researchers and institutions, justice and liberty germane to the research with illicit and addictive substances. We debate the disparate research stakeholder perspectives and why they are likely to be infected with bias. We propose an empirical research agenda to provide a more evidentiary basis for ethical reasoning. PMID:26982922

  2. Drug repurposing for aging research using model organisms.

    Science.gov (United States)

    Ziehm, Matthias; Kaur, Satwant; Ivanov, Dobril K; Ballester, Pedro J; Marcus, David; Partridge, Linda; Thornton, Janet M

    2017-10-01

    Many increasingly prevalent diseases share a common risk factor: age. However, little is known about pharmaceutical interventions against aging, despite many genes and pathways shown to be important in the aging process and numerous studies demonstrating that genetic interventions can lead to a healthier aging phenotype. An important challenge is to assess the potential to repurpose existing drugs for initial testing on model organisms, where such experiments are possible. To this end, we present a new approach to rank drug-like compounds with known mammalian targets according to their likelihood to modulate aging in the invertebrates Caenorhabditis elegans and Drosophila. Our approach combines information on genetic effects on aging, orthology relationships and sequence conservation, 3D protein structures, drug binding and bioavailability. Overall, we rank 743 different drug-like compounds for their likelihood to modulate aging. We provide various lines of evidence for the successful enrichment of our ranking for compounds modulating aging, despite sparse public data suitable for validation. The top ranked compounds are thus prime candidates for in vivo testing of their effects on lifespan in C. elegans or Drosophila. As such, these compounds are promising as research tools and ultimately a step towards identifying drugs for a healthier human aging. © 2017 The Authors. Aging Cell published by the Anatomical Society and John Wiley & Sons Ltd.

  3. Addiction research centres and the nurturing of creativity. The Centre for Alcohol and Drug Research: social science alcohol and drug research in Denmark.

    Science.gov (United States)

    Pedersen, Mads U; Elmeland, Karen; Frank, Vibeke A

    2011-12-01

    The purpose of this paper is to introduce the social science alcohol and drug research undertaken by the Centre for Alcohol and Drug Research (CRF) and at the same time offer an insight into the development in Danish alcohol and drug research throughout the past 15-20 years. A review of articles, books and reports published by researcher from CRF from the mid-1990s until today and an analysis of the policy-making in the Danish substance use and misuse area. CRF is a result of the discussions surrounding social, health and allocation policy questions since the mid-1980s. Among other things, these discussions led to the formal establishment of the Centre in 1991 under the Aarhus University, the Faculty of Social Science. Since 2001 the Centre has received a permanent basic allocation, which has made it possible to appoint tenured senior researchers; to work under a more long-term research strategy; to function as a milieu for educating PhD students; and to diversify from commissioned research tasks to initiating projects involving more fundamental research. Research at the Centre is today pivoted around four core areas: consumption, policy, prevention and treatment. The emergence, continuation, financing and character of the research taking place at CRF can be linked closely to the specific Danish drug and alcohol discourse and to the division of the responsibility for alcohol and drug research into separate Ministries. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

  4. HOW ADVERSE DRUG-REACTIONS CAN PLAY A ROLE IN INNOVATIVE DRUG RESEARCH - SIMILARITIES IN ADVERSE DRUG REACTION PROFILES OF CAPTOPRIL AND PENICILLAMINE

    NARCIS (Netherlands)

    RIKKEN, F; VOS, R

    1995-01-01

    We describe how adverse drug reactions (ADRs) can play an important role in pharmaceutical research and drug development. Not only do ADRs represent the risks and drawbacks associated with drugs but they can also be related to other knowledge available in pharmaceutical and medical research. We

  5. Nano-enabled drug delivery: a research profile.

    Science.gov (United States)

    Zhou, Xiao; Porter, Alan L; Robinson, Douglas K R; Shim, Min Suk; Guo, Ying

    2014-07-01

    Nano-enabled drug delivery (NEDD) systems are rapidly emerging as a key area for nanotechnology application. Understanding the status and developmental prospects of this area around the world is important to determine research priorities, and to evaluate and direct progress. Global research publication and patent databases provide a reservoir of information that can be tapped to provide intelligence for such needs. Here, we present a process to allow for extraction of NEDD-related information from these databases by involving topical experts. This process incorporates in-depth analysis of NEDD literature review papers to identify key subsystems and major topics. We then use these to structure global analysis of NEDD research topical trends and collaborative patterns, inform future innovation directions. This paper describes the process of how to derive nano-enabled drug delivery-related information from global research and patent databases in an effort to perform comprehensive global analysis of research trends and directions, along with collaborative patterns. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Lifestyle Factors in Hypertension Drug Research: Systematic Analysis of Articles in a Leading Cochrane Report

    Directory of Open Access Journals (Sweden)

    Dan E. Wilson

    2014-01-01

    Full Text Available Established standards for first-line hypertension management include lifestyle modification and behavior change. The degree to which and how lifestyle modification is systematically integrated into studies of first-line drug management for hypertension is of methodological and clinical relevance. This study systematically reviewed the methodology of articles from a recent Cochrane review that had been designed to inform first-line medical treatment of hypertension and was representative of high quality established clinical trials in the field. Source articles (n=34 were systematically reviewed for lifestyle interventions including smoking cessation, diet, weight loss, physical activity and exercise, stress reduction, and moderate alcohol consumption. 54% of articles did not mention lifestyle modification; 46% contained nonspecific descriptions of interventions. We contend that hypertension management research trials (including drug studies need to elucidate the benefits and risks of drug-lifestyle interaction, to support the priority of lifestyle modification, and that lifestyle modification, rather than drugs, is seen by patients and the public as a priority for health professionals. The inclusion of lifestyle modification strategies in research designs for hypertension drug trials could enhance current research, from trial efficacy to clinical outcome effectiveness, and align hypertension best practices of a range of health professionals with evidence-based knowledge translation.

  7. Natural products against cancer: A comprehensive bibliometric study of the research projects, publications, patents and drugs

    Directory of Open Access Journals (Sweden)

    Jian Du

    2014-01-01

    Full Text Available Objectives: To analyze multi-source data including awards, publications, patents and drugs, and try to draw the whole landscape of the research and development community in the area of natural products (NPs against cancer. Materials and Methods: Awards, publications, patents and drugs data from National Institute of Health/Natural Science Foundation of China (NIH/NSFC, PubMed, Derwent Innovation Index and Cortellis were collected. Bibliometric methodologies and technology are used to investigate publications/patents/drugs, their contents and relationships. Results: NIH and NSFC respectively demonstrated a stable and sustained expenditure growth in this area. The number of publications is continuously increasing. Yet the annual patent applications worldwide and FDA drug approvals were little changed or not obviously fluctuated in 2003-2013. USA and several Asia-pacific countries/territories are important contributing powers. We described the evolution of major research topics by those MeSH Major Topics indexed in PubMed with the largest growth range in three intervals, and analyzed hot research topics in the recent 10 years which include NPs or NPs derivatives, cell line/animal model, laboratory technologies and activation mechanisms. Conclusions: China published the most publications and received the most patent applications, but drug discovery performance is no better than USA and Japan. Research on anti-neoplastic structures and compounds originated from Chinese traditional medicine (TCM, medicinal plants, herbal medicine and marine NPs are major research topics in the recent 10 years. There still exits translational gap between basic research and drug discovery. Translational research should be undertaken to strengthen the applicability of NPs.

  8. Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

  9. Drug research methodology. Volume 4, Epidemiology in drugs and highway safety : the study of drug use among drivers and its role in traffic crashes

    Science.gov (United States)

    1980-06-01

    This report presents the findings of a workshop on epidemiology in drugs and highway safety. A cross-disciplinary panel of experts (1) identified methodological issues and constraints present in research to define the nature and magnitude of the drug...

  10. Including mixed methods research in systematic reviews: Examples from qualitative syntheses in TB and malaria control

    Science.gov (United States)

    2012-01-01

    Background Health policy makers now have access to a greater number and variety of systematic reviews to inform different stages in the policy making process, including reviews of qualitative research. The inclusion of mixed methods studies in systematic reviews is increasing, but these studies pose particular challenges to methods of review. This article examines the quality of the reporting of mixed methods and qualitative-only studies. Methods We used two completed systematic reviews to generate a sample of qualitative studies and mixed method studies in order to make an assessment of how the quality of reporting and rigor of qualitative-only studies compares with that of mixed-methods studies. Results Overall, the reporting of qualitative studies in our sample was consistently better when compared with the reporting of mixed methods studies. We found that mixed methods studies are less likely to provide a description of the research conduct or qualitative data analysis procedures and less likely to be judged credible or provide rich data and thick description compared with standalone qualitative studies. Our time-related analysis shows that for both types of study, papers published since 2003 are more likely to report on the study context, describe analysis procedures, and be judged credible and provide rich data. However, the reporting of other aspects of research conduct (i.e. descriptions of the research question, the sampling strategy, and data collection methods) in mixed methods studies does not appear to have improved over time. Conclusions Mixed methods research makes an important contribution to health research in general, and could make a more substantial contribution to systematic reviews. Through our careful analysis of the quality of reporting of mixed methods and qualitative-only research, we have identified areas that deserve more attention in the conduct and reporting of mixed methods research. PMID:22545681

  11. Including mixed methods research in systematic reviews: examples from qualitative syntheses in TB and malaria control.

    Science.gov (United States)

    Atkins, Salla; Launiala, Annika; Kagaha, Alexander; Smith, Helen

    2012-04-30

    Health policy makers now have access to a greater number and variety of systematic reviews to inform different stages in the policy making process, including reviews of qualitative research. The inclusion of mixed methods studies in systematic reviews is increasing, but these studies pose particular challenges to methods of review. This article examines the quality of the reporting of mixed methods and qualitative-only studies. We used two completed systematic reviews to generate a sample of qualitative studies and mixed method studies in order to make an assessment of how the quality of reporting and rigor of qualitative-only studies compares with that of mixed-methods studies. Overall, the reporting of qualitative studies in our sample was consistently better when compared with the reporting of mixed methods studies. We found that mixed methods studies are less likely to provide a description of the research conduct or qualitative data analysis procedures and less likely to be judged credible or provide rich data and thick description compared with standalone qualitative studies. Our time-related analysis shows that for both types of study, papers published since 2003 are more likely to report on the study context, describe analysis procedures, and be judged credible and provide rich data. However, the reporting of other aspects of research conduct (i.e. descriptions of the research question, the sampling strategy, and data collection methods) in mixed methods studies does not appear to have improved over time. Mixed methods research makes an important contribution to health research in general, and could make a more substantial contribution to systematic reviews. Through our careful analysis of the quality of reporting of mixed methods and qualitative-only research, we have identified areas that deserve more attention in the conduct and reporting of mixed methods research.

  12. Research Costs Investigated: A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research.

    Science.gov (United States)

    van Asselt, Thea; Ramaekers, Bram; Corro Ramos, Isaac; Joore, Manuela; Al, Maiwenn; Lesman-Leegte, Ivonne; Postma, Maarten; Vemer, Pepijn; Feenstra, Talitha

    2018-01-01

    The costs of performing research are an important input in value of information (VOI) analyses but are difficult to assess. The aim of this study was to investigate the costs of research, serving two purposes: (1) estimating research costs for use in VOI analyses; and (2) developing a costing tool to support reviewers of grant proposals in assessing whether the proposed budget is realistic. For granted study proposals from the Netherlands Organization for Health Research and Development (ZonMw), type of study, potential cost drivers, proposed budget, and general characteristics were extracted. Regression analysis was conducted in an attempt to generate a 'predicted budget' for certain combinations of cost drivers, for implementation in the costing tool. Of 133 drug-related research grant proposals, 74 were included for complete data extraction. Because an association between cost drivers and budgets was not confirmed, we could not generate a predicted budget based on regression analysis, but only historic reference budgets given certain study characteristics. The costing tool was designed accordingly, i.e. with given selection criteria the tool returns the range of budgets in comparable studies. This range can be used in VOI analysis to estimate whether the expected net benefit of sampling will be positive to decide upon the net value of future research. The absence of association between study characteristics and budgets may indicate inconsistencies in the budgeting or granting process. Nonetheless, the tool generates useful information on historical budgets, and the option to formally relate VOI to budgets. To our knowledge, this is the first attempt at creating such a tool, which can be complemented with new studies being granted, enlarging the underlying database and keeping estimates up to date.

  13. A luciferase-based assay for rapid assessment of drug activity against Mycobacterium tuberculosis including monitoring of macrophage viability.

    Science.gov (United States)

    Larsson, Marie C; Lerm, Maria; Ängeby, Kristian; Nordvall, Michaela; Juréen, Pontus; Schön, Thomas

    2014-11-01

    The intracellular (IC) effect of drugs against Mycobacterium tuberculosis (Mtb) is not well established but increasingly important to consider when combining current and future multidrug regimens into the best possible treatment strategies. For this purpose, we developed an IC model based on a genetically modified Mtb H37Rv strain, expressing the Vibrio harvei luciferase (H37Rv-lux) infecting the human macrophage like cell line THP-1. Cells were infected at a low multiplicity of infection (1:1) and subsequently exposed to isoniazid (INH), ethambutol (EMB), amikacin (AMI) or levofloxacin (LEV) for 5days in a 96-well format. Cell viability was evaluated by Calcein AM and was maintained throughout the experiment. The number of viable H37Rv-lux was determined by luminescence and verified by a colony forming unit analysis. The results were compared to the effects of the same drugs in broth cultures. AMI, EMB and LEV were significantly less effective intracellularly (MIC90: >4mg/L, 8mg/L and 2mg/L, respectively) compared to extracellularly (MIC90: 0.5mg/L for AMI and EMB; 0.25mg/L for LEV). The reverse was the case for INH (IC: 0.064mg/L vs EC: 0.25mg/L). In conclusion, this luciferase based method, in which monitoring of cell viability is included, has the potential to become a useful tool while evaluating the intracellular effects of anti-mycobacterial drugs. Copyright © 2014 Elsevier B.V. All rights reserved.

  14. [Does the public sector have an independent research role in the development of drugs?].

    Science.gov (United States)

    Poulsen, Henrik Enghusen; Grønlykke, Thor Buch

    2003-04-14

    Exclusively private companies do drug development. The State contributes with education of academics and basic research constituting the basis of half of the drugs developed by the private companies. The Danish private drug research amounts to six billion DKK per year, corresponding to the estimated price of the development of one new drug. The development shows a negative tendency. There are doubts about the scientific credibility, the number of new drugs is declining, drug development costs are rising, and the competitiveness in Europe is declining compared with the one of The United States. Continued improvement of Danish drug development can be achieved by stimulation of the public research related to drug development.

  15. `INCLUDING' Partnerships to Build Authentic Research Into K-12 Science Education

    Science.gov (United States)

    Turrin, M.; Lev, E.; Newton, R.; Xu, C.

    2017-12-01

    Opportunities for authentic research experiences have been shown effective for recruiting and retaining students in STEM fields. Meaningful research experiences entail significant time in project design, modeling ethical practice, providing training, instruction, and ongoing guidance. We propose that in order to be sustainable, a new instructional paradigm is needed, one that shifts from being top-weighted in instruction to a distributed weight model. This model relies on partnerships where everyone has buy-in and reaps rewards, establishing broadened networks for support, and adjusting the mentoring model. We use our successful Secondary School Field Research Program as a model for this new paradigm. For over a decade this program has provided authentic geoscience field research for an expanding group of predominantly inner city high school youth from communities underrepresented in the sciences. The program has shifted the balance with returning participants now serving as undergraduate mentors for the high school student `researchers', providing much of the ongoing training, instruction, guidance and feedback needed. But in order to be sustainable and impactful we need to broaden our base. A recent NSF-INCLUDES pilot project has allowed us to expand this model, linking schools, informal education non-profits, other academic institutions, community partners and private funding agencies into geographically organized `clusters'. Starting with a tiered mentoring model with scientists as consultants, teachers as team members, undergraduates as team leaders and high school students as researchers, each cluster will customize its program to reflect the needs and strengths of the team. To be successful each organization must identify how the program fits their organizational goals, the resources they can contribute and what they need back. Widening the partnership base spreads institutional commitments for research scientists, research locations and lab space

  16. A Prospective Research on Self-medication Practices of Drug ...

    African Journals Online (AJOL)

    Preferred Customer

    METHODS: A multi-stage stratified sampling of drug retail outlets in Addis Ababa was employed. ... the drug. Two-thirds of the drug consumers requested drugs by specifically mentioning the name of the drug or category to which it belongs and 20.7% by telling their illness or .... city, and further classified as private, public.

  17. Intervention research in rational use of drugs : a review

    NARCIS (Netherlands)

    Le Grand, A; Van Hogerzeil, H; Haaijer-Ruskamp, FM; LeGrand, A.

    Many studies have been done to document drug use patterns, and indicate that overprescribing, multi-drug prescribing, misuse of drugs, use of unnecessary expensive drugs and overuse of antibiotics and injections are the most common problems of irrational drug use by prescribers as well as consumers.

  18. Strongyloidiasis Current Status with Emphasis in Diagnosis and Drug Research

    Directory of Open Access Journals (Sweden)

    Tiago Mendes

    2017-01-01

    Full Text Available Strongyloidiasis is a parasitic neglected disease caused by the nematode Strongyloides stercoralis affecting 30 to 100 million people worldwide. Complications, strongly associated with alcoholism, organ transplants, and HTLV-1 virus, often arise due to late diagnosis, frequently leading to patient death. Lack of preemptive diagnosis is not the only difficulty when dealing with this parasite, since there are no gold standard diagnostic techniques, and the ones used have problems associated with sensitivity, resulting in false negatives. Treatment is also an issue as ivermectin and benzimidazoles administration leads to inconsistent cure rates and several side effects. Researching new anti-Strongyloides drugs is a difficult task since S. stercoralis does not develop until the adult stages in Mus musculus (with the exception of SCID mice, the main experimental host model. Fortunately, alternative parasite models can be used, namely, Strongyloides ratti and S. venezuelensis. However, even with these models, there are other complications in finding new drugs, which are associated with specific in vitro assay protocol steps, such as larvae decontamination. In this review, we highlight the challenges associated with new drug search, the compounds tested, and a list of published in vitro assay methodologies. We also point out advances being made in strongyloidiasis diagnosis so far.

  19. Animal models of pancreatic cancer for drug research.

    Science.gov (United States)

    Kapischke, Matthias; Pries, Alexandra

    2008-10-01

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

  20. Analyzing research trends on drug safety using topic modeling.

    Science.gov (United States)

    Zou, Chen

    2018-04-06

    Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extract 50 main topics, and conducted trend analysis to explore the temporal popularity of these topics over years. Expert Opinion/Commentary: We found that 'benefit-risk assessment and communication', 'diabetes' and 'biologic therapy for autoimmune diseases' are the top 3 most published topics. The topics relevant to the use of electronic health records/observational data for safety surveillance are becoming increasingly popular over time. Meanwhile, there is a slight decrease in research on signal detection based on spontaneous reporting, although spontaneous reporting still plays an important role in benefit-risk assessment. The topics related to medical conditions and treatment showed highly dynamic patterns over time.

  1. The Research Progress of Targeted Drug Delivery Systems

    Science.gov (United States)

    Zhan, Jiayin; Ting, Xizi Liang; Zhu, Junjie

    2017-06-01

    Targeted drug delivery system (DDS) means to selectively transport drugs to targeted tissues, organs, and cells through a variety of drugs carrier. It is usually designed to improve the pharmacological and therapeutic properties of conventional drugs and to overcome problems such as limited solubility, drug aggregation, poor bio distribution and lack of selectivity, controlling drug release carrier and to reduce normal tissue damage. With the characteristics of nontoxic and biodegradable, it can increase the retention of drug in lesion site and the permeability, improve the concentration of the drug in lesion site. at present, there are some kinds of DDS using at test phase, such as slow controlled release drug delivery system, targeted drug delivery systems, transdermal drug delivery system, adhesion dosing system and so on. This paper makes a review for DDS.

  2. Including biodiversity in life cycle assessment – State of the art, gaps and research needs

    International Nuclear Information System (INIS)

    Winter, Lisa; Lehmann, Annekatrin; Finogenova, Natalia; Finkbeiner, Matthias

    2017-01-01

    Purpose: For over 20 years the feasibility of including man-made impacts on biodiversity in the context of Life Cycle Assessment (LCA) has been explored. However, a comprehensive biodiversity impact assessment has so far not been performed. The aim of this study is to analyse how biodiversity is currently viewed in LCA, to highlight limitations and gaps and to provide recommendations for further research. Method: Firstly, biodiversity indicators are examined according to the level of biodiversity they assess (genetic, species, ecosystem) and to their usefulness for LCA. Secondly, relevant pressures on biodiversity that should be included in LCA are identified and available models (in and outside of an LCA context) for their assessment are discussed. Thirdly, existing impact assessment models are analysed in order to determine whether and how well pressures are already integrated into LCA. Finally, suggestions on how to include relevant pressures and impacts on biodiversity in LCA are provided and the necessary changes in each LCA phase that must follow are discussed. Results: The analysis of 119 indicators shows that 4% of indicators represent genetic diversity, 40% species diversity and 35% ecosystem diversity. 21% of the indicators consider further biodiversity-related topics. Out of the indicator sample, 42 indicators are deemed useful as impact indicators in LCA. Even though some identified pressures are already included in LCA with regard to their impacts on biodiversity (e.g. land use, carbon dioxide emissions etc.), other proven pressures on biodiversity have not yet been considered (e.g. noise, artificial light). Conclusion: Further research is required to devise new options (e.g. impact assessment models) for integrating biodiversity into LCA. The final goal is to cover all levels of biodiversity and include all missing pressures in LCA. Tentative approaches to achieve this goal are outlined. - Highlights: •Calculating man-made impacts highlights

  3. Research synergy and drug development: Bright stars in neighboring constellations

    Directory of Open Access Journals (Sweden)

    Samet Keserci

    2017-11-01

    Full Text Available Drug discovery and subsequent availability of a new breakthrough therapeutic or ‘cure’ is a compelling example of societal benefit from research advances. These advances are invariably collaborative, involving the contributions of many scientists to a discovery network in which theory and experiment are built upon. To document and understand such scientific advances, data mining of public and commercial data sources coupled with network analysis can be used as a digital methodology to assemble and analyze component events in the history of a therapeutic. This methodology is extensible beyond the history of therapeutics and its use more generally supports (i efficiency in exploring the scientific history of a research advance (ii documenting and understanding collaboration (iii portfolio analysis, planning and optimization (iv communication of the societal value of research. Building upon prior art, we have conducted a case study of five anti-cancer therapeutics to identify the collaborations that resulted in the successful development of these therapeutics both within and across their respective networks. We have linked the work of over 235,000 authors in roughly 106,000 scientific publications that capture the research crucial for the development of these five therapeutics. Applying retrospective citation discovery, we have identified a core set of publications cited in the networks of all five therapeutics and additional intersections in combinations of networks. We have enriched the content of these networks by annotating them with information on research awards from the US National Institutes of Health (NIH. Lastly, we have mapped these awards to their cognate peer review panels, identifying another layer of collaborative scientific activity that influenced the research represented in these networks. Keywords: Information science, Cancer research

  4. Research on drug abuse and addiction treatment in prisons

    OpenAIRE

    Kljajević Srđan

    2017-01-01

    The causes of drug abuse and criminal behavior are closely linked. Not surprisingly, there is a high percentage of prisoners who during sentence execution abuse or are dependent on drugs. Antisocial personality disorder can be considered a common predictor of committing criminal offenses and drug abuse. A review of studies has revealed a high prevalence of inmates who use drugs while serving a sentence. Also, prison environment represents only a new context of the continuum of drug abuse by i...

  5. Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

    OpenAIRE

    Baranowski, Przemysław; Karolewicz, Bożena; Gajda, Maciej; Pluta, Janusz

    2014-01-01

    This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to...

  6. RESEARCH OF CONDITION OF PUBLIC DRUG ASSISTANCE DURING INDEPENDENCE YEARS OF UKRAINE - FORMATION OF PHARMACEUTICAL MARKET

    Directory of Open Access Journals (Sweden)

    V. O. Boryshchuk

    2015-10-01

    Full Text Available The aim of the research was to study the correspondence of existing legislative and regulatory requirements of the pharmaceutical industry development, the analysis of the formation of the Ukrainian pharmaceutical market, the condition of drug assistance according to European requirements and recommendations of the WHO. For the study archival materials, publications in scientific journals, and mass media were used, laws and provisions regulating pharmaceutical activity were studied and a survey among citizens was conducted. Systematic and logical methods, analytical and comparative analysis were applied, and own researches were performed. For 22 years of Ukrainian statehood formation the following institutes were created: Pharmacological College, Pharmacopoeia Committee and State Service for Quality Control of Drugs which were transported to other institutes. Important laws were adopted: the Law of Ukraine «On Medicines», the Law of Ukraine «On small-scale privatization», the Law of Ukraine «On large-scale privatization» and others, which contributed to the formation and development of the pharmaceutical market. In comparison with 1990 the amount of drugstore chains increased two and a half times and in 2013 in the country already worked 15 566 drugstores, including 3 025 in villages. Specific peculiarity of pharmaceutical market formation in Ukraine was the creation of powerful own regional and all-Ukrainian drugstore chains, that is greatly different from such situation in EU countries, where the legislation allows to have only one or two drugstores. As the result of pharmaceutical market formation the drugs nomenclature increased eight times and now makes up more than 20 000 names, including 92.4 % generic drugs. According to publications, Ukraine lacks about 40 % of drug molecules needed for medical treatment, and 30 % of studied drugs are not proved. There is the problem of uncontrollable turnover and drugs consumption in Ukraine

  7. Research synergy and drug development: Bright stars in neighboring constellations.

    Science.gov (United States)

    Keserci, Samet; Livingston, Eric; Wan, Lingtian; Pico, Alexander R; Chacko, George

    2017-11-01

    Drug discovery and subsequent availability of a new breakthrough therapeutic or 'cure' is a compelling example of societal benefit from research advances. These advances are invariably collaborative, involving the contributions of many scientists to a discovery network in which theory and experiment are built upon. To document and understand such scientific advances, data mining of public and commercial data sources coupled with network analysis can be used as a digital methodology to assemble and analyze component events in the history of a therapeutic. This methodology is extensible beyond the history of therapeutics and its use more generally supports (i) efficiency in exploring the scientific history of a research advance (ii) documenting and understanding collaboration (iii) portfolio analysis, planning and optimization (iv) communication of the societal value of research. Building upon prior art, we have conducted a case study of five anti-cancer therapeutics to identify the collaborations that resulted in the successful development of these therapeutics both within and across their respective networks. We have linked the work of over 235,000 authors in roughly 106,000 scientific publications that capture the research crucial for the development of these five therapeutics. Applying retrospective citation discovery, we have identified a core set of publications cited in the networks of all five therapeutics and additional intersections in combinations of networks. We have enriched the content of these networks by annotating them with information on research awards from the US National Institutes of Health (NIH). Lastly, we have mapped these awards to their cognate peer review panels, identifying another layer of collaborative scientific activity that influenced the research represented in these networks.

  8. Interdisciplinary researches for potential developments of drugs and natural products

    Directory of Open Access Journals (Sweden)

    Arunrat Chaveerach

    2017-04-01

    Full Text Available Developments of drugs or natural products from plants are possibly made, simple to use and lower cost than modern drugs. The development processes can be started with studying local wisdom and literature reviews to choose the plants which have long been used in diverse areas, such as foods, traditional medicine, fragrances and seasonings. Then those data will be associated with scientific researches, namely plant collection and identification, phytochemical screening by gas chromatography-mass spectrometry, pharmacological study/review for their functions, and finally safety and efficiency tests in human. For safety testing, in vitro cell toxicity by cell viability assessment and in vitro testing of DNA breaks by the comet assay in human peripheral blood mononuclear cells can be performed. When active chemicals and functions containing plants were chosen with safety and efficacy for human uses, then, the potential medicinal natural products will be produced. Based on these procedures, the producing cost will be cheaper and the products can be evaluated for their clinical properties. Thus, the best and lowest-priced medicines and natural products can be distributed worldwide.

  9. Interdisciplinary researches for potential developments of drugs and natural products

    Institute of Scientific and Technical Information of China (English)

    Arunrat Chaveerach; Runglawan Sudmoon; Tawatchai Tanee

    2017-01-01

    Developments of drugs or natural products from plants are possibly made,simple to use and lower cost than modern drugs.The development processes can be started with studying local wisdom and literature reviews to choose the plants which have long been used in diverse areas,such as foods,traditional medicine,fragrances and seasonings.Then those data will be associated with scientific researches,namely plant collection and identification,phytochemical screening by gas chromatography-mass spectrometry,pharmacological study/review for their functions,and finally safety and efficiency tests in human.For safety testing,in vitro cell toxicity by cell viability assessment and in vitro testing of DNA breaks by the comet assay in human peripheral blood mononuclear cells can be performed.When active chemicals and functions containing plants were chosen with safety and efficacy for human uses,then,the potential medicinal natural products will be produced.Based on these procedures,the producing cost will be cheaper and the products can be evaluated for their clinical properties.Thus,the best and lowest-priced medicines and natural products can be distributed worldwide.

  10. Chemical countermeasures: Dispersants overview of dispersant use (including application) and research issues

    International Nuclear Information System (INIS)

    Butler, J.N.

    1992-01-01

    I will attempt in twenty minutes to summarize the state of research on oil spill dispersants as I perceive it. The expertise I bring to this task includes 20 years of experience with the fate and effects of petroleum in the marine environment, including participation in the 1973 and 1981 NRC studies and three years as chairman of the NRC committee on oil spill dispersants. I More recently I served on a committee of the International Maritime Organization which reviewed the open-quotes Impact of oil and related chemicals and wastes on the marine environment.close quotes That report will be published this year. However, my statements in this paper are not made as a representative of either NRC or IMO. They are my own interpretation of scientific literature cited in the above reviews. Dispersants are chemical formulations, which include surface active agents, designed to decrease the interfacial tension between oil and water. Because the first attempts to disperse oil on a large scale, at the Torrey Canyon spill of 1967, used highly toxic degreasing agents, dispersants have an undeserved reputation for toxicity. In fact, for twenty years dispersant formulations have been developed with an emphasis on reducing their toxicity to marine life. The dispersal of oil in water has been documented in the laboratory by dozens of papers (see references in NRC 1989, pp 70-79), and in the field by dozens of studies (NRC 1989, pp 165- 193). The toxicity of commercial dispersant formulations (NRC 1989, pp 81-123) and dispersed oil (NRC 1989, pp 123-147) has been tested on a wide variety of marine organisms ranging from algae to salmonid fishes. The NRC review has been updated by the IMO/GESAMP (1992) study, but the conclusions remain unchanged

  11. Ophthalmic Drug Dosage Forms: Characterisation and Research Methods

    Directory of Open Access Journals (Sweden)

    Przemysław Baranowski

    2014-01-01

    Full Text Available This paper describes hitherto developed drug forms for topical ocular administration, that is, eye drops, ointments, in situ gels, inserts, multicompartment drug delivery systems, and ophthalmic drug forms with bioadhesive properties. Heretofore, many studies have demonstrated that new and more complex ophthalmic drug forms exhibit advantage over traditional ones and are able to increase the bioavailability of the active substance by, among others, reducing the susceptibility of drug forms to defense mechanisms of the human eye, extending contact time of drug with the cornea, increasing the penetration through the complex anatomical structure of the eye, and providing controlled release of drugs into the eye tissues, which allows reducing the drug application frequency. The rest of the paper describes recommended in vitro and in vivo studies to be performed for various ophthalmic drugs forms in order to assess whether the form is acceptable from the perspective of desired properties and patient’s compliance.

  12. Professional Development for Researchers in Solid Earth Science Evolved to Include Scientific and Educational Content

    Science.gov (United States)

    Eriksson, S. C.; Arrowsmith, R.; Olds, S. E.

    2011-12-01

    Integrated measures of crustal deformation provide valuable insight about tectonic and human-induced processes for scientists and educators alike. UNAVCO in conjunction with EarthScope initiated a series of short courses for researchers to learn the processing and interpretation of data from new technologies such as high precision GPS, Strainmeter, InSar and LiDAR that provide deformation information relevant to many geoscience sub-disciplines. Intensive short courses of a few days and the widespread availability of processed data through large projects such as EarthScope and GEON enable more geoscientists to incorporate these data into diverse projects. Characteristics of the UNAVCO Short Course Series, reaching over 400 participants since 2005, include having short course faculty who have pioneered development of each technology; open web-access to course materials; processing software installed on class-ready computers; no course fees; scholarships for students, post-doctoral fellows, and emerging faculty when needed; formative evaluation of the courses; community-based decisions on topics; and recruitment of participants across relevant geoscience disciplines. In 2009, when EarthScope airborne LiDAR data became available to the public through OpenTopographhy, teaching materials were provided to these researchers to incorporate the latest technologies into teaching. Multiple data sets across technologies have been developed with instructions on how to access the various data sets and incorporate them into geological problem sets. Courses in GPS, airborne LiDAR, strainmeter, and InSAR concentrate on data processing with examples of various geoscience applications. Ground-based LiDAR courses also include data acquisition. Google Earth is used to integrate various forms of data in educational applications. Various types of EarthScope data can now be used by a variety of geoscientists, and the number of scientists who have the skills and tools to use these various

  13. Incentives for orphan drug research and development in the United States.

    Science.gov (United States)

    Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Szeinbach, Sheryl L; Visaria, Jay

    2008-12-16

    The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 +/- 3.3 years (mean +/- standard deviation). The average maximum effective patent and market exclusivity life was 11.7 +/- 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market.

  14. 42 CFR 2a.5 - Contents of application; research projects in which drugs will be administered.

    Science.gov (United States)

    2010-10-01

    ... application; research projects in which drugs will be administered. (a) In addition to the information... drug shall contain: (1) Identification of the drugs to be administered in the research project and a... project will be conducted. (b) An application for an authorization of confidentiality with respect to a...

  15. [Research Progress on Forensic Toxicology of Z-drugs].

    Science.gov (United States)

    Zhang, Yong-zhi; He, Hong-yuan; She, Cai-meng; Lian, Jie

    2015-08-01

    The Z-drugs (zolpidem, zopiclone, and zaleplon), as the innovative hypnotics, have an improvement over the traditional benzodiazepines in the management of insomnia. Z-drugs have significant hypnotic effects by reducing sleep latency and improving sleep quality, though duration of sleep may not be significantly increased. As benzodiazepines, Z-drugs exert their effects through increasing the transmission of γ-aminobutyric acid. Z-drugs overdose are less likely to be fatal, more likely would result in poisoning. Z-drugs can be detected in blood, urine, saliva, and other postmortem specimens through liquid chromatography-mass spectrometry techniques. Zolpidem and zaleplon exhibit significant postmortem redistribution. Z-drugs have improved pharmacokinetic profiles, but incidence of neuropsychiatric sequelae, poisoning, and death may prove to be similar to the other hypnotics. This review focuses on the pharmacology and toxicology of Z-drugs with respect to their adverse effect profile and toxicity and toxicology data in the field of forensic medicine.

  16. Korea's Contribution to Radiological Research Included in Science Citation Index Expanded, 1986-2010

    International Nuclear Information System (INIS)

    Ku, You Jin; Yoon, Dae Young; Lim, Kyoung Ja; Baek, Sora; Seo, Young Lan; Yun, Eun Joo; Choi, Chul Soon; Bae, Sang Hoon; Lee, Hyun; Ju, Young Su

    2012-01-01

    To evaluate scientific papers published by Korean radiologists in the Science Citation Index Expanded (SCIE) radiology journals, between 1986 and 2010. The Institute for Scientific Information Web of Knowledge-Web of Science (SCIE) database was searched for all articles published by Korean radiologists, in SCIE radiology journals, between 1986 and 2010. We performed the analysis by typing 'Korea' and 'radiol' in the address section and selecting the subject area of 'Radiology, Nuclear Medicine, and Medical Imaging' with the use of the general search function of the software. Analyzed parameters included the total number of publications, document types, journals, and institutions. In addition, we analyzed where Korea ranks, compared to other countries, in terms of the number of published articles. All these data were analyzed according to five time periods: 1986-1990, 1991-1995, 1996-2000, 2001-2005, and 2006-2010. Overall, 4974 papers were published by Korean radiologists, in 99 different SCIE journals, between 1986 and 2010, of which 4237 (85.2%) were article-type papers. Of the total 115395 articles, worldwide, published in radiology journals, Korea's share was 3.7%, with an upward trend over time (p < 0.005). The journal with the highest number of articles was the American Journal of Roentgenology (n 565, 13.3%). The institution which produced the highest number of publications was Seoul National University (n = 932, 22.0%). The number of scientific articles published by Korean radiologists in the SCIE radiology journals has increased significantly between 1986 and 2010. Korea was ranked 4th among countries contributing to radiology research during the last 5 years.

  17. Women and tobacco: a call for including gender in tobacco control research, policy and practice.

    Science.gov (United States)

    Amos, Amanda; Greaves, Lorraine; Nichter, Mimi; Bloch, Michele

    2012-03-01

    Female smoking is predicted to double between 2005 and 2025. There have been numerous calls for action on women's tobacco use over the past two decades. In the present work, evidence about female tobacco use, progress, challenges and ways forward for developing gendered tobacco control is reviewed. Literature on girls, women and tobacco was reviewed to identify trends and determinants of tobacco use and exposure, the application of gender analysis, tobacco marketing, the impact of tobacco control on girls and women and ways to address these issues particularly in low-income and middle-income countries. Global female tobacco use is increasingly complex, involving diverse products and factors including tobacco marketing, globalisation and changes in women's status. In high-income countries female smoking is declining but is increasingly concentrated among disadvantaged women. In low-income and middle-income countries the pattern is more complex; in several regions the gap between girls' and boys' smoking is narrow. Gendered analyses and approaches to tobacco control are uncommon, especially in low-income and middle-income countries. Tobacco control has remained largely gender blind, with little recognition of the importance of understanding the context and challenges of girl's and women's smoking and secondhand smoke exposure. There has been little integration of gender considerations in research, policy and programmes. The present work makes a case for gender and diversity analyses in tobacco control to reflect and identify intersecting factors affecting women's tobacco use. This will help animate the WHO Framework Convention on Tobacco Control's concern for gender specificity and women's leadership, and reduce the impact of tobacco on women.

  18. Evaluation of three rapid oral fluid test devices on the screening of multiple drugs of abuse including ketamine.

    Science.gov (United States)

    Tang, Magdalene H Y; Ching, C K; Poon, Simon; Chan, Suzanne S S; Ng, W Y; Lam, M; Wong, C K; Pao, Ronnie; Lau, Angus; Mak, Tony W L

    2018-05-01

    Rapid oral fluid testing (ROFT) devices have been extensively evaluated for their ability to detect common drugs of abuse; however, the performance of such devices on simultaneous screening for ketamine has been scarcely investigated. The present study evaluated three ROFT devices (DrugWipe ® 6S, Ora-Check ® and SalivaScreen ® ) on the detection of ketamine, opiates, methamphetamine, cannabis, cocaine and MDMA. A liquid chromatography tandem mass spectrometry (LCMS) assay was firstly established and validated for confirmation analysis of the six types of drugs and/or their metabolites. In the field test, the three ROFT devices were tested on subjects recruited from substance abuse clinics/rehabilitation centre. Oral fluid was also collected using Quantisal ® for confirmation analysis. A total of 549 samples were collected in the study. LCMS analysis on 491 samples revealed the following drugs: codeine (55%), morphine (49%), heroin (40%), methamphetamine (35%), THC (8%), ketamine (4%) and cocaine (2%). No MDMA-positive cases were observed. Results showed that the overall specificity and accuracy were satisfactory and met the DRUID standard of >80% for all 3 devices. Ora-Check ® had poor sensitivities (ketamine 36%, methamphetamine 63%, opiates 53%, cocaine 60%, THC 0%). DrugWipe ® 6S showed good sensitivities in the methamphetamine (83%) and opiates (93%) tests but performed relatively poorly for ketamine (41%), cocaine (43%) and THC (22%). SalivaScreen ® also demonstrated good sensitivities in the methamphetamine (83%) and opiates (100%) tests, and had the highest sensitivity for ketamine (76%) and cocaine (71%); however, it failed to detect any of the 28 THC-positive cases. The test completion rate (proportion of tests completed with quality control passed) were: 52% (Ora-Check ® ), 78% (SalivaScreen ® ) and 99% (DrugWipe ® 6S). Copyright © 2018 Elsevier B.V. All rights reserved.

  19. Prescription Drugs: Abuse and Addiction. National Institute on Drug Abuse Research Report Series.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

    This publication answers questions about the consequences of abusing commonly prescribed medications including opioids, central nervous system depressants, and stimulants. In addition to offering information on what research says about how certain medications affect the brain and body, this publication also discusses treatment options. It examines…

  20. Who to include in palliative care research? Consequences of different population definitions in palliative care epidemiology.

    NARCIS (Netherlands)

    Borgsteede, S.D.; Deliens, L.; Francke, A.L.; Stalman, W.A.B.; Willems, D.L.; Eijk, T.T.M. van; Wal, G. van der

    2003-01-01

    Object of the study: Epidemiological research into palliative care faces the problem of defining an adequate research population. Subjects in studies are alternately defined as patients receiving 'palliative care' , 'palliative treatment' or 'end of life care'. So far, it is not known how

  1. Research on drug abuse and addiction treatment in prisons

    Directory of Open Access Journals (Sweden)

    Kljajević Srđan

    2017-01-01

    Full Text Available The causes of drug abuse and criminal behavior are closely linked. Not surprisingly, there is a high percentage of prisoners who during sentence execution abuse or are dependent on drugs. Antisocial personality disorder can be considered a common predictor of committing criminal offenses and drug abuse. A review of studies has revealed a high prevalence of inmates who use drugs while serving a sentence. Also, prison environment represents only a new context of the continuum of drug abuse by inmates. There are different theoretical approaches in explaining this phenomenon. Treatment programs based on empirically validated principles that guarantee the effectiveness, may be one strategy for solving the problem of drug abuse in prisons, with multiple positive effects.

  2. Drug-resistant tuberculosis in Mumbai, India: An agenda for operations research

    Science.gov (United States)

    Mistry, Nerges; Tolani, Monica; Osrin, David

    2012-01-01

    Operations research (OR) is well established in India and is also a prominent feature of the global and local agendas for tuberculosis (TB) control. India accounts for a quarter of the global burden of TB and of new cases. Multidrug-resistant TB is a significant problem in Mumbai, India’s most populous city, and there have been recent reports of totally resistant TB. Much thought has been given to the role of OR in addressing programmatic challenges, by both international partnerships and India’s Revised National TB Control Programme. We attempt to summarize the major challenges to TB control in Mumbai, with an emphasis on drug resistance. Specific challenges include diagnosis of TB and defining cure, detecting drug resistant TB, multiple sources of health care in the private, public and informal sectors, co-infection with human immunodeficiency virus (HIV) and a concurrent epidemic of non-communicable diseases, suboptimal prescribing practices, and infection control. We propose a local agenda for OR: modeling the effects of newer technologies, active case detection, and changes in timing of activities, and mapping hotspots and contact networks; modeling the effects of drug control, changing the balance of ambulatory and inpatient care, and adverse drug reactions; modeling the effects of integration of TB and HIV diagnosis and management, and preventive drug therapy; and modeling the effects of initiatives to improve infection control. PMID:24501697

  3. Models of policy-making and their relevance for drug research.

    Science.gov (United States)

    Ritter, Alison; Bammer, Gabriele

    2010-07-01

    Researchers are often frustrated by their inability to influence policy. We describe models of policy-making to provide new insights and a more realistic assessment of research impacts on policy. We describe five prominent models of policy-making and illustrate them with examples from the alcohol and drugs field, before drawing lessons for researchers. Policy-making is a complex and messy process, with different models describing different elements. We start with the incrementalist model, which highlights small amendments to policy, as occurs in school-based drug education. A technical/rational approach then outlines the key steps in a policy process from identification of problems and their causes, through to examination and choice of response options, and subsequent implementation and evaluation. There is a clear role for research, as we illustrate with the introduction of new medications, but this model largely ignores the dominant political aspects of policy-making. Such political aspects include the influence of interest groups, and we describe models about power and pressure groups, as well as advocacy coalitions, and the challenges they pose for researchers. These are illustrated with reference to the alcohol industry, and interest group conflicts in establishing a Medically Supervised Injecting Centre. Finally, we describe the multiple streams framework, which alerts researchers to 'windows of opportunity', and we show how these were effectively exploited in policy for cannabis law reform in Western Australia. Understanding models of policy-making can help researchers maximise the uptake of their work and advance evidence-informed policy.

  4. [Research on compatibility of prescriptions including Ginseng Radix et Rhizoma and Trogopterus Dung based on complex network analysis].

    Science.gov (United States)

    Li, Meng-Wen; Fan, Xin-Sheng; Zhang, Ling-Shan; Wang, Cong-Jun

    2017-09-01

    The applications of prescriptions including Ginseng Radix et Rhizoma and Trogopterus Dung in contemporary literatures from 1949 to 2016 are compiled and the data mining techniques containing scale-free complex network method are utilized to explore its practical characteristics, with comparison between modern and ancient ones. The results indicate that malignant neoplasms, coronary heart disease which present Qi deficiency and blood stasis type are the main diseases treated by prescriptions including Ginseng Radix et Rhizoma and Trogopterus Dung according to the reports during 1949 to 2016. The complex network connection shows that Glycyrrhizae Radixet Rhizoma, Angelicae Sinensis Radix, Astragali Radix, Typhae Pollen, Salviae Miltiorrhizae Radix et Rhizoma are the primary drugs related to Ginseng Radix et Rhizoma and Trogopterus Dung. The next are Paeoniae Radix Alba, Atractylodis Macrocephalae Rhizoma, Persicae Semen, Foria, et al. Carthami Flos, Notoginseng Radix et Rhizoma, Cyperi Rhizoma, Bupleuri Radix are the peripheral ones. Also, Ginseng Radix et Rhizoma-Glycyrrhizae Radixet Rhizoma, Trogopterus Dung-Glycyrrhizae Radixet Rhizoma, Ginseng Radix et Rhizoma-Angelicae Sinensis Radix, Trogopterus Dung-Angelicae Sinensis Radix, Ginseng Radix et Rhizoma-Astragali Radix, Trogopterus Dung-Astragali Radix are the main paired drugs. The paired drugs including Ginseng Radix et Rhizoma-Trogopterus Dung-Glycyrrhizae Radixet Rhizoma, Ginseng Radix et Rhizoma-Trogopterus Dung-Angelicae Sinensis Radix, Ginseng Radix et Rhizoma-Trogopterus Dung-Astragali Radix, Ginseng Radix et Rhizoma-Trogopterus Dung-Typhae Pollen have a higher support degree. The main compatible drugs are different in ancient and modern prescriptions including Ginseng Radix et Rhizoma and Trogopterus Dung. Notoginseng Radix et Rhizoma, Typhae Pollen, Salviae Miltiorrhizae Radix et Rhizoma, Astragali Radix are utilized frequently in modern prescriptions while less used in ancient ones. It is also shown

  5. Drug and alcohol crash risk : traffic safety facts : research note.

    Science.gov (United States)

    2015-02-01

    While the extent of use of alcohol by drivers and the risks posed by alcohol use have been well known for many decades, relatively little has been known about the use of other drugs by drivers and the associated risks. However, drug-impaired driving ...

  6. 77 FR 13131 - Proposed Collection: Comment Request Post-Award Reporting Requirements Including New Research...

    Science.gov (United States)

    2012-03-05

    ... submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title... Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ... information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project...

  7. Setting Global Research Priorities for Developmental Disabilities, Including Intellectual Disabilities and Autism

    Science.gov (United States)

    Tomlinson, M.; Yasamy, M. T.; Emerson, E.; Officer, A.; Richler, D.; Saxena, S.

    2014-01-01

    Objectives: The prevalence of intellectual disabilities (ID) has been estimated at 10.4/1000 worldwide with higher rates among children and adolescents in lower income countries. The objective of this paper is to address research priorities for development disabilities, notably ID and autism, at the global level and to propose the more rational…

  8. Completed Research in Health, Physical Education, Recreation & Dance; Including International Sources. Volume 27. 1985 Edition.

    Science.gov (United States)

    Freedson, Patty S., Ed.

    This compilation lists research completed in the areas of health, physical education, recreation, dance, and allied areas during 1984. The document is arranged in two parts. In the index, references are arranged under the subject headings in alphabetical order. Abstracts of master's and doctor's theses from institutions offering graduate programs…

  9. Performing Drug Safety Research During Pregnancy and Lactation: Biomedical HIV Prevention Research as a Template.

    Science.gov (United States)

    Beigi, Richard H; Noguchi, Lisa; Brown, Gina; Piper, Jeanna; Watts, D Heather

    2016-07-01

    Evidence-based guidance regarding use of nearly all pharmaceuticals by pregnant and lactating women is limited. Models for performing research may assist in filling these knowledge gaps. Internationally, reproductive age women are at high risk of human immunodeficiency virus (HIV) acquisition. Susceptibility to HIV infection may be increased during pregnancy, and risk of maternal-child transmission is increased with incident HIV infection during pregnancy and lactation. A multidisciplinary meeting of experts was convened at the United States National Institutes of Health to consider paradigms for drug research in pregnancy and lactation applicable to HIV prevention. This report summarizes the meeting proceedings and describes a framework for research on candidate HIV prevention agent use during pregnancy and lactation that may also have broader applications to other pharmaceutical products.

  10. Including Media in Field Research and Becoming Part of the Science Media

    Science.gov (United States)

    Pelto, M. S.

    2015-12-01

    There are two primary strategies that I have pursued over the last decade to engage the media, policy makers, and public; after two decades of typical scientific publication methods. An effective method to engage the media with our ongoing 32 year glacier field research program has been to invite media members to join us in the field. From climate videographers to traditional reporters we have had a member of the media with us in nine of the last ten field seasons; two in 2015. The resulting stories have led to several awards for the journalists and an ongoing relationship with our research program. The second part of this science research communication strategy is to have readily available material on specific topics for the media to utilize; this requires social media outreach. The primary outlet media find is the AGU Blog: From a Glacier's Perspective. This blog pubishes two articles a week on a specific glacier's response to climate change. The blog yields on average a media contact on every fourth blog post in 2015. The contacts revolve around specific local glacier information published on the blog. The goal of each blog post is to tell a story about how each glacier is impacted by climate change.

  11. 78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

    Science.gov (United States)

    2013-02-06

    ... utility of the prescription drug labeling as a communication tool and to discuss strategies for making it... the Web site after this document publishes in the Federal Register.) All holders of marketing... before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several...

  12. Research Article Antimalarial Drugs for Pediatrics - Prescribing and ...

    African Journals Online (AJOL)

    Erah

    2011-03-23

    Mar 23, 2011 ... is a need to institute measures to ensure rational prescribing, dispensing and use of antimalarial drugs in pediatrics. ... facilities, strategies to control behaviour in the private sector are ..... changes were implemented in 2006 in.

  13. Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

    Science.gov (United States)

    Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

    2012-05-01

    In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

  14. Laser induced breakdown spectroscopy of the uranium including calcium. Time resolved measurement spectroscopic analysis (Contract research)

    International Nuclear Information System (INIS)

    Akaoka, Katsuaki; Maruyama, Youichiro; Oba, Masaki; Miyabe, Masabumi; Otobe, Haruyoshi; Wakaida, Ikuo

    2010-05-01

    For the remote analysis of low DF TRU (Decontamination Factor Transuranic) fuel, Laser Breakdown Spectroscopy (LIBS) was applied to uranium oxide including a small amount of calcium oxide. The characteristics, such as spectrum intensity and plasma excitation temperature, were measured using time-resolved spectroscopy. As a result, in order to obtain the stable intensity of calcium spectrum for the uranium spectrum, it was found out that the optimum observation delay time of spectrum is 4 microseconds or more after laser irradiation. (author)

  15. South Baltic representative coastal field surveys, including monitoring at the Coastal Research Station in Lubiatowo, Poland

    Science.gov (United States)

    Ostrowski, Rafał; Schönhofer, Jan; Szmytkiewicz, Piotr

    2016-10-01

    The paper contains a brief description of selected investigations carried out in the south Baltic coastal zone, with the particular focus on the history and recent activities conducted at the Coastal Research Station in Lubiatowo (CRS Lubiatowo), Poland. These activities comprise field investigations of nearshore hydrodynamic, lithodynamic, and morphodynamic processes. The study area is a sandy multi-bar shore with a mild slope, much exposed to the impact of waves approaching from NW-NE sector. The shore has a dissipative character which means that the wave energy is subject to gradual dissipation in the nearshore zone and only a small part of this energy is reflected by the shore. Due to the big wind fetch in N-NNE direction, the location of CRS Lubiatowo is favourable to registration of the maximum values of parameters of hydrodynamic and morphodynamic processes which occur in the Baltic during extreme storms.

  16. The role of chemical engineering in medicinal research including Alzheimer’s

    DEFF Research Database (Denmark)

    Kontogeorgis, Georgios M.

    2015-01-01

    Various disciplines of chemical engineering, especially thermodynamics and kinetics, play an important role in medicinal research and this has been particularly recognized during the last 10–15 years (von Stockar and van der Wielen, J Biotechnol 59:25, 1997; Prausnitz, Fluid Phase Equilib 53......:439, 1989; Prausnitz, Pure Appl Chem 79:1435, 2007; Dey and Prausnitz, Ind Eng Chem Res 50:3, 2011; Prausnitz, J Chem Thermodynamics 35:21, 2003; Tsivintzelis et al. AIChE J 55:756, 2009). It is expected that during the twenty-first century chemical engineering and especially thermodynamics can contribute......” disease), and Alzheimer’s which are connected to “protein aggregation.” Several articles in the Perspectives section of prominent chemical engineering journals have addressed this issue (Hall, AIChE J 54:1956, 2008; Vekilov, AIChE J 54:2508, 2008). This work reviews recent applications of thermodynamics...

  17. Visual communication with non-literates: a review of current knowledge including research in northern India.

    Science.gov (United States)

    Moynihan, M; Mukherjee, U

    1981-01-01

    In this article previous research on the perception of visual aids by non-literates in Kenya, Zambia, Ghana, Papua New Guinea, Mexico, as well as among immigrant groups in London and Paris, in Nepal and, by the authors in northern India, is reviewed. Recognition of pictures is affected by the particular culture of each group. In Africa, photos are better understood and liked: in the Indian subcontinent, line drawings are well recognized and appreciated. Recognition can be reduced by inaccurate detail, stylization and perspective. The authors found that overall size could be kept small if the pictures were simple. Complicated pictures, or a group of interrelated pictures, are not usually well recognized. Familiarity, realism and simplicity seem the most important components for a successful picture. Ways of attaching value ("good" or "bad", for example) have not in the past been very successful, but the authors found that a "vocabulary" of fourteen signs were, once explained, well understood. The values of colours in the culture must be understood and utilized. To be successful, visual materials for non-literates must start from the local culture and not come untested from behind a desk in the capital city.

  18. Urine Testing for Drugs of Abuse. NIDA Research Monograph Series 73.

    Science.gov (United States)

    Hawks, Richard L., Ed.; Chiang, C. Nora, Ed.

    In the past 5 years, a growing concern over the use of illicit drugs in the workplace has led to an interest in urinalysis as a way to detect and deter drug use. This monograph provides information that will assist those involved in the planning or implementation of drug testing programs in making informed choices. Articles include: (1)…

  19. Electrodes for high-definition transcutaneous DC stimulation for applications in drug-delivery and electrotherapy, including tDCS

    OpenAIRE

    Minhas, Preet; Bansal, Varun; Patel, Jinal; Ho, Johnson S.; Diaz, Julian; Datta, Abhishek; Bikson, Marom

    2010-01-01

    Transcutaneous electrical stimulation is applied in a range of biomedical applications including Transcranial Direct Current Stimulation (tDCS). tDCS is a non-invasive procedure where a weak direct current (

  20. From research on rare diseases to new orphan drug development

    NARCIS (Netherlands)

    Heemstra, H.E.

    2010-01-01

    Rare diseases have a prevalence of lower than 5 in 10,000 inhabitants and are life-threatening or chronically debilitating. It is estimated that worldwide more than 5000 rare diseases exist, which account for over 55 million patients in the EU and the US together. However, the development of drugs

  1. Non-profit Drug Research and Development at a Crossroads.

    Science.gov (United States)

    Jarosławski, Szymon; Toumi, Mondher; Auquier, Pascal; Dussart, Claude

    2018-02-07

    In wealthy nations, non-profit drug R&D has been proposed to reduce the prices of medicines. We sought to review the ethical and economic issues concerning non-profit drug R&D companies, and the possible impact that their pricing strategy may have on the innovation efforts from for-profit companies targeting the same segment of the pharmaceutical market. There are two possible approaches to pricing drugs developed by non-profit R&D programs: pricing that maximises profits and "affordable" pricing that reflects the cost of manufacturing and distribution, plus a margin that ensures sustainability of the drug supply. Overall, the non-profits face ethical challenges - due to the lack of resources, they are unable to independently commercialize their products on a large scale; however, the antitrust law does not permit them to impose prices on potential licensees. Also, reduced prices for the innovative products may result in drying the for-profit R&D in the area.

  2. A Novel Technique to Follow Consequences of Exogenous Factors, Including Therapeutic Drugs, on Living Human Breast Epithelial Cells

    Science.gov (United States)

    1999-07-01

    and lipid vectors, are being tested. Concurrent with the development of procedures for live - cell imaging , we are examining the distribution of proteins...dimensional matrix. These studies have not yet begun. There are a number of procedures that must be developed and perfected in the live - cell imaging , as...components of the Wnt signaling pathway are too preliminary and require additional research prior to publication. (9) CONCLUSIONS Live cell imaging of

  3. 21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

    Science.gov (United States)

    2010-04-01

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

  4. Low-rank coal research annual report, July 1, 1989--June 30, 1990 including quarterly report, April--June 1990

    Energy Technology Data Exchange (ETDEWEB)

    1990-11-01

    Research programs in the following areas are presented: control technology and coal preparation; advance research and technology development; combustion; liquefaction; and gasification. Sixteen projects are included. Selected items have been processed separately for inclusion in the Energy Science and Technology Database.

  5. Setting priorities for a research agenda to combat drug-resistant tuberculosis in children.

    Science.gov (United States)

    Velayutham, B; Nair, D; Ramalingam, S; Perez-Velez, C M; Becerra, M C; Swaminathan, S

    2015-12-21

    Numerous knowledge gaps hamper the prevention and treatment of childhood drug-resistant tuberculosis (TB). Identifying research priorities is vital to inform and develop strategies to address this neglected problem. To systematically identify and rank research priorities in childhood drug-resistant TB. Adapting the Child Health and Nutrition Research Initiative (CHNRI) methodology, we compiled 53 research questions in four research areas, then classified the questions into three research types. We invited experts in childhood drug-resistant TB to score these questions through an online survey. A total of 81 respondents participated in the survey. The top-ranked research question was to identify the best combination of existing diagnostic tools for early diagnosis. Highly ranked treatment-related questions centred on the reasons for and interventions to improve treatment outcomes, adverse effects of drugs and optimal treatment duration. The prevalence of drug-resistant TB was the highest-ranked question in the epidemiology area. The development type questions that ranked highest focused on interventions for optimal diagnosis, treatment and modalities for treatment delivery. This is the first effort to identify and rank research priorities for childhood drug-resistant TB. The result is a resource to guide research to improve prevention and treatment of drug-resistant TB in children.

  6. Plant natural products research in tuberculosis drug discovery and ...

    African Journals Online (AJOL)

    SAM

    2014-06-04

    Jun 4, 2014 ... Department of Medicinal Chemistry and Quality Control (MCQC), National Institute for Pharmaceutical Research and. Development ..... Anticancer. Cannabis sativa L. ... National Cancer Research Institute (NCI) at Frederick,.

  7. Neuroproteases in peptide neurotransmission and neurodegenerative diseases: applications to drug discovery research.

    Science.gov (United States)

    Hook, Vivian Y H

    2006-01-01

    The nervous system represents a key area for development of novel therapeutic agents for the treatment of neurological and neurodegenerative diseases. Recent research has demonstrated the critical importance of neuroproteases for the production of specific peptide neurotransmitters and for the production of toxic peptides in major neurodegenerative diseases that include Alzheimer, Huntington, and Parkinson diseases. This review illustrates the successful criteria that have allowed identification of proteases responsible for converting protein precursors into active peptide neurotransmitters, consisting of dual cysteine protease and subtilisin-like protease pathways in neuroendocrine cells. These peptide neurotransmitters are critical regulators of neurologic conditions, including analgesia and cognition, and numerous behaviors. Importantly, protease pathways also represent prominent mechanisms in neurodegenerative diseases, especially Alzheimer, Huntington, and Parkinson diseases. Recent studies have identified secretory vesicle cathepsin B as a novel beta-secretase for production of the neurotoxic beta-amyloid (Abeta) peptide of Alzheimer disease. Moreover, inhibition of cathepsin B reduces Abeta peptide levels in brain. These neuroproteases potentially represent new drug targets that should be explored in future pharmaceutical research endeavors for drug discovery.

  8. Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform.

    Science.gov (United States)

    Ries, Nola M; Thompson, Katie A; Lowe, Michael

    2017-09-01

    Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decision-making principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.

  9. Studies and analyses of the management of scientific research and development, including implementation and application at NASA centers

    Science.gov (United States)

    Rubenstein, A. H.

    1975-01-01

    Summary results obtained through the Program of Research on the Management of Research and Development (POMRAD) were presented. The nature of the overall program and the specific projects undertaken were described. Statistical data is also given concerning the papers, publications, people, and major program areas associated with the program. The actual list of papers, names of doctoral and masters theses, and other details of the program are included as appendices.

  10. Free software, Open source software, licenses. A short presentation including a procedure for research software and data dissemination

    OpenAIRE

    Gomez-Diaz , Teresa

    2014-01-01

    4 pages. Spanish version: Software libre, software de código abierto, licencias. Donde se propone un procedimiento de distribución de software y datos de investigación; The main goal of this document is to help the research community to understand the basic concepts of software distribution: Free software, Open source software, licenses. This document also includes a procedure for research software and data dissemination.

  11. Five-year examination of utilization and drug cost outcomes associated with benefit design changes including reference pricing for proton pump inhibitors in a state employee health plan.

    Science.gov (United States)

    Johnson, Jill T; Neill, Kathryn K; Davis, Dwight A

    2011-04-01

    The Arkansas State Employee Benefits Division (EBD) is a self-insured program comprising public school and other state employees, their spouses, and dependents. Previous research published in JMCP (2006) showed drug cost savings of $2.20 per member per month (PMPM; 37.6%) or annualized savings of $3.4 million associated with a benefit design change and coverage of the proton pump inhibitor (PPI) omeprazole over-the-counter (OTC) beginning in March 2004. On May 1, 2005, brand esomeprazole was excluded from coverage, with current users grandfathered for 4 months until September 2005. Reference pricing for PPIs, including esomeprazole but excluding generic omeprazole, was implemented on September 1, 2005, and the beneficiary cost share for all PPIs except generic omeprazole was determined from comparison of the PPI actual price to the $0.90 omeprazole OTC reference price per unit. To examine PPI utilization and drug costs before and after (a) excluding esomeprazole from coverage (with grandfathering current users) and (b) implementing a therapeutic maximum allowable cost (TMAC), or reference-pricing benefit design, for the PPI class in a large state employee health plan with fairly stable enrollment of approximately 127,500 members in 2005 through 2008 and approximately 128,000 members in 2009 Q1. The pharmacy claims database for the EBD was used to examine utilization and cost data for PPIs in a longitudinal analysis for the 61-month period from March 1, 2004, through March 31, 2009. Pharmacy claims data were compared for the period 14 months prior to esomeprazole exclusion (preperiod), 4 months during the esomeprazole exclusion (postperiod 1), and the ensuing 43 months of PPI reference pricing (postperiod 2). PPI cost and utilization data for the intervention group of approximately 127,500 beneficiaries were compared with a group of 122 self-insured employers with a total of nearly 1 million beneficiaries whose pharmacy benefits did not include reference pricing for

  12. RESEARCH ARTICLE Genetic analysis of drug-metabolizing phase ...

    Indian Academy of Sciences (India)

    Navya

    Sorting intolerant from tolerant (SIFT) (http://sift.bii.a-star.edu.sg/) and .... science and technology research projects of Xizang (Tibet) Autonomous Region ..... color schemes, with bright red for very strong LD (LOD > 2, D'= 1), pink red (LOD >.

  13. Inadequate recording of alcohol-drinking, tobacco-smoking and discharge diagnosis in medical in-patients: failure to recognize risks including drug interactions.

    Science.gov (United States)

    Bairstow, B M; Burke, V; Beilin, L J; Deutscher, C

    1993-11-01

    The records of 62 men and 43 women, 14-88 years old, admitted to general medical wards in a public teaching hospital during 1991 were examined for discharge medications and for the recording of alcohol-drinking, tobacco-smoking and discharge diagnosis. Drinking and smoking status was unrecorded in 22.9% and 21.9% of patients respectively. Twenty-four patients had 31 potential drug interactions which were related to the number of drugs prescribed and to drinking alcohol; 10.5% of the patients had interactions involving alcohol and 2.9% tobacco. Six patients received relatively or absolutely contraindicated drugs, including one asthmatic given two beta-blockers. The drugs prescribed indicated that some patients had conditions such as gastro-oesophageal disorders, diabetes and obstructive airways disease which had not been recorded. Inadequate recording of diagnoses, alcohol and smoking status creates risks to patients and may cause opportunities for preventive care to be missed. This study provides the basis for the development of undergraduate and postgraduate education programmes to address these issues and so decrease risks to patients which arise from inadequate recording practices. Incomplete diagnoses also adversely affect hospital funding where this depends on case-mix diagnostic groups. Quality assurance programmes and other strategies are being implemented to improve medical recording and prescribing habits.

  14. The association of antidepressant drug usage with cognitive impairment or dementia, including Alzheimer disease: A systematic review and meta-analysis.

    Science.gov (United States)

    Moraros, John; Nwankwo, Chijioke; Patten, Scott B; Mousseau, Darrell D

    2017-03-01

    To determine if antidepressant drug usage is associated with cognitive impairment or dementia, including Alzheimer disease (AD). We conducted a systematic search of Medline, PubMed, PsycINFO, Web of Science, Embase, CINAHL, and the Cochrane Library. An initial screen by abstracts and titles was performed, and relevant full articles were then reviewed and assessed for their methodologic quality. Crude effect estimates were extracted from the included articles and a pooled estimate was obtained using a random effects model. Five articles were selected from an initial pool of 4,123 articles. Use of antidepressant drugs was associated with a significant twofold increase in the odds of some form of cognitive impairment or dementia (OR = 2.17). Age was identified as a likely modifier of the association between antidepressant use and some form of cognitive impairment or AD/dementia. Studies that included participants with an average age equal to or greater than 65 years showed an increased odds of some form of cognitive impairment with antidepressant drug usage (OR = 1.65), whereas those with participants less than age 65 revealed an even stronger association (OR = 3.25). Antidepressant drug usage is associated with AD/dementia and this is particularly evident if usage begins before age 65. This association may arise due to confounding by depression or depression severity. However, biological mechanisms potentially linking antidepressant exposure to dementia have been described, so an etiological effect of antidepressants is possible. With this confirmation that an association exists, clarification of underlying etiologic pathways requires urgent attention. © 2016 The Authors. Depression and Anxiety published by Wiley Periodicals, Inc.

  15. The association of antidepressant drug usage with cognitive impairment or dementia, including Alzheimer disease: A systematic review and meta‐analysis

    Science.gov (United States)

    Moraros, John; Nwankwo, Chijioke; Patten, Scott B.

    2016-01-01

    1 Objective To determine if antidepressant drug usage is associated with cognitive impairment or dementia, including Alzheimer disease (AD). 2 Method We conducted a systematic search of Medline, PubMed, PsycINFO, Web of Science, Embase, CINAHL, and the Cochrane Library. An initial screen by abstracts and titles was performed, and relevant full articles were then reviewed and assessed for their methodologic quality. Crude effect estimates were extracted from the included articles and a pooled estimate was obtained using a random effects model. 3 Results Five articles were selected from an initial pool of 4,123 articles. Use of antidepressant drugs was associated with a significant twofold increase in the odds of some form of cognitive impairment or dementia (OR = 2.17). Age was identified as a likely modifier of the association between antidepressant use and some form of cognitive impairment or AD/dementia. Studies that included participants with an average age equal to or greater than 65 years showed an increased odds of some form of cognitive impairment with antidepressant drug usage (OR = 1.65), whereas those with participants less than age 65 revealed an even stronger association (OR = 3.25). 4 Conclusions Antidepressant drug usage is associated with AD/dementia and this is particularly evident if usage begins before age 65. This association may arise due to confounding by depression or depression severity. However, biological mechanisms potentially linking antidepressant exposure to dementia have been described, so an etiological effect of antidepressants is possible. With this confirmation that an association exists, clarification of underlying etiologic pathways requires urgent attention. PMID:28029715

  16. Using standardized methods for research on HIV and injecting drug use in developing/transitional countries: case study from the WHO Drug Injection Study Phase II

    Directory of Open Access Journals (Sweden)

    Stimson Gerry V

    2006-03-01

    Full Text Available Abstract Background Successful cross-national research requires methods that are both standardized across sites and adaptable to local conditions. We report on the development and implementation of the methodology underlying the survey component of the WHO Drug Injection Study Phase II – a multi-site study of risk behavior and HIV seroprevalence among Injecting Drug Users (IDUs. Methods Standardized operational guidelines were developed by the Survey Coordinating Center in collaboration with the WHO Project Officer and participating site Investigators. Throughout the duration of the study, survey implementation at the local level was monitored by the Coordinating Center. Surveys were conducted in 12 different cities. Prior rapid assessment conducted in 10 cities provided insight into local context and guided survey implementation. Where possible, subjects were recruited both from drug abuse treatment centers and via street outreach. While emphasis was on IDUs, non-injectors were also recruited in cities with substantial non-injecting use of injectable drugs. A structured interview and HIV counseling/testing were administered. Results Over 5,000 subjects were recruited. Subjects were recruited from both drug treatment and street outreach in 10 cities. Non-injectors were recruited in nine cities. Prior rapid assessment identified suitable recruitment areas, reduced drug users' distrust of survey staff, and revealed site-specific risk behaviors. Centralized survey coordination facilitated local questionnaire modification within a core structure, standardized data collection protocols, uniform database structure, and cross-site analyses. Major site-specific problems included: questionnaire translation difficulties; locating affordable HIV-testing facilities; recruitment from drug treatment due to limited/selective treatment infrastructure; access to specific sub-groups of drug users in the community, particularly females or higher income groups

  17. A new look at lipid-membrane structure in relation to drug research

    DEFF Research Database (Denmark)

    Mouritsen, Ole G.; Jørgensen, Kent

    1998-01-01

    Lipid-bilayer membranes are key objects in drug research in relation to (i) interaction of drugs with membrane-bound receptors, (ii) drug targeting, penetration, and permeation of cell membranes, and (iii) use of liposomes in micro-encapsulation technologies for drug delivery. Rational design...... of new drugs and drug-delivery systems therefore requries insight into the physical properties of lipid-bilayer membranes. This mini-review provides a perspective on the current view of lipid-bilayer structure and dynamics based on information obtained from a variety of recent experimental...... and theoretical studies. Special attention is paid to trans-bilayer structure, lateral molecular organization of the lipid bilayer, lipid-mediated protein assembly, and lipid-bilayer permeability. It is argued that lipids play a major role in lipid membrane-organization and functionality....

  18. Income inequality, drug-related arrests, and the health of people who inject drugs: Reflections on seventeen years of research

    OpenAIRE

    Friedman, Samuel R.; Tempalski, Barbara; Brady, Joanne E.; West, Brooke S.; Pouget, Enrique R.; Williams, Leslie D.; Des Jarlais, Don C.; Cooper, Hannah L.F.

    2016-01-01

    This paper reviews and then discusses selected findings from a seventeen year study about the population prevalence of people who inject drugs (PWID) and of HIV prevalence and mortality among PWID in 96 large US metropolitan areas. Unlike most research, this study was conducted with the metropolitan area as the level of analysis. It found that metropolitan area measures of income inequality and of structural racism predicted all of these outcomes, and that rates of arrest for heroin and/or co...

  19. Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective: the ISPOR Drug Cost Task Force report--Part II.

    Science.gov (United States)

    Garrison, Louis P; Mansley, Edward C; Abbott, Thomas A; Bresnahan, Brian W; Hay, Joel W; Smeeding, James

    2010-01-01

    Major guidelines regarding the application of cost-effectiveness analysis (CEA) have recommended the common and widespread use of the "societal perspective" for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices-Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring drug costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. The societal perspective can be defined by three conditions: 1) the inclusion of time costs, 2) the use of opportunity costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded drug costs have typically used actual acquisition cost rather than the much lower social opportunity costs that would reflect only short-run manufacturing and distribution costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a "limited societal" or "health systems" perspective, using acquisition drug prices while including indirect costs and community preferences. The

  20. West African Journal of Pharmacology and Drug Research ...

    African Journals Online (AJOL)

    Search tips: Search terms are case-insensitive; Common words are ignored; By default only articles containing all terms in the query are returned (i.e., AND is implied); Combine multiple words with OR to find articles containing either term; e.g., education OR research; Use parentheses to create more complex queries; e.g., ...

  1. 78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-09-11

    ...) Modernizing FDA's Clinical Trials/BIMO Programs; (3) What FDA Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects of Clinical Research; (5) Adverse Event Reporting--Science, Regulation, Error, and...

  2. Why Research Design and Methods Is So Crucial to Understanding Drug Use/Abuse: Introduction to the Special Issue.

    Science.gov (United States)

    Scheier, Lawrence M

    2018-06-01

    The collection of articles in this special issue both raise the bar and inspire new thinking with regard to both design and methodology concerns that influence drug use/abuse research. Thematically speaking, the articles focus on issues related to missing data, response formats, strategies for data harmonization, propensity scoring methods as an alternative to randomized control trials, integrative data analysis, statistical corrections to reduce bias from attrition, challenges faced from conducting large-scale evaluations, and employing abductive theory of method as an alternative to the more traditional hypothetico-deductive reasoning. Collectively, these issues are of paramount importance as they provide specific means to improve our investigative tools and refine the logical framework we employ to examine the problem of drug use/abuse. Each of the authors addresses a specific challenge outlining how it affects our current research efforts and then outlines remedies that can advance the field. To their credit, they have included issues that affect both etiology and prevention, thus broadening our horizons as we learn more about developmental processes causally related to drug use/abuse and intervention strategies that can mitigate developmental vulnerability. This is the essential dialogue required to advance our intellectual tool kit and improve the research skills we bring to bear on the important questions facing the field of drug use/abuse. Ultimately, the goal is to increase our ability to identify the causes and consequences of drug use/abuse and find ways to ameliorate these problems as we engage the public health agenda.

  3. Understanding mechanisms of toxicity: Insights from drug discovery research

    International Nuclear Information System (INIS)

    Houck, Keith A.; Kavlock, Robert J.

    2008-01-01

    Toxicology continues to rely heavily on use of animal testing for prediction of potential for toxicity in humans. Where mechanisms of toxicity have been elucidated, for example endocrine disruption by xenoestrogens binding to the estrogen receptor, in vitro assays have been developed as surrogate assays for toxicity prediction. This mechanistic information can be combined with other data such as exposure levels to inform a risk assessment for the chemical. However, there remains a paucity of such mechanistic assays due at least in part to lack of methods to determine specific mechanisms of toxicity for many toxicants. A means to address this deficiency lies in utilization of a vast repertoire of tools developed by the drug discovery industry for interrogating the bioactivity of chemicals. This review describes the application of high-throughput screening assays as experimental tools for profiling chemicals for potential for toxicity and understanding underlying mechanisms. The accessibility of broad panels of assays covering an array of protein families permits evaluation of chemicals for their ability to directly modulate many potential targets of toxicity. In addition, advances in cell-based screening have yielded tools capable of reporting the effects of chemicals on numerous critical cell signaling pathways and cell health parameters. Novel, more complex cellular systems are being used to model mammalian tissues and the consequences of compound treatment. Finally, high-throughput technology is being applied to model organism screens to understand mechanisms of toxicity. However, a number of formidable challenges to these methods remain to be overcome before they are widely applicable. Integration of successful approaches will contribute towards building a systems approach to toxicology that will provide mechanistic understanding of the effects of chemicals on biological systems and aid in rationale risk assessments

  4. CHOICE, PURCHASE AND CONSUMPTION OF DRUGS: SOCIOLOGICAL RESEARCH EXPERIENCE

    Directory of Open Access Journals (Sweden)

    Ольга Викторовна Ткаченко

    2013-09-01

    Full Text Available The results of pharmaceutical market’s sociological research are representing in the paper. Determinate the basic agents influenced on pharmaceuticals choice and purchase such as a doctor, experience of individual, information from advertisement. Physician competency is of secondary importance to advertisement messages. Experience of individual prepotency of the pharmaceuticals choice raises a point of a level attention of pharmaceuticals consumer behavior. We can describe it in a low level both base on respondents self-conception and in accordance with data research of drug’s advertisement and patient package inserts «content-analysis».DOI: http://dx.doi.org/10.12731/2218-7405-2013-6-53

  5. International guidelines for fire protection at nuclear installations including nuclear fuel plants, nuclear fuel stores, teaching reactors, research establishments

    International Nuclear Information System (INIS)

    The guidelines are recommended to designers, constructors, operators and insurers of nuclear fuel plants and other facilities using significant quantities of radioactive materials including research and teaching reactor installations where the reactors generally operate at less than approximately 10 MW(th). Recommendations for elementary precautions against fire risk at nuclear installations are followed by appendices on more specific topics. These cover: fire protection management and organization; precautions against loss during construction alterations and maintenance; basic fire protection for nuclear fuel plants; storage and nuclear fuel; and basic fire protection for research and training establishments. There are numerous illustrations of facilities referred to in the text. (U.K.)

  6. 21 CFR 20.105 - Testing and research conducted by or with funds provided by the Food and Drug Administration.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testing and research conducted by or with funds... Categories of Records § 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. (a) Any list that may be prepared by the Food and Drug Administration of testing and research...

  7. Summary of ARI Research on Drug and Alcohol Abuse

    Science.gov (United States)

    1975-05-01

    8217 values--resentment of authority, rejection of traditional American culture, and generally hedonistic outlook. Users perceived the company-level...with low morale, boredom , and dissatisfaction with job, officers, and the Army. Certain value-attitude profiles among enlisted men, including

  8. Age and impulsive behavior in drug addiction: A review of past research and future directions.

    Science.gov (United States)

    Argyriou, Evangelia; Um, Miji; Carron, Claire; Cyders, Melissa A

    2018-01-01

    Impulsive behavior is implicated in the initiation, maintenance, and relapse of drug-seeking behaviors involved in drug addiction. Research shows that changes in impulsive behavior across the lifespan contribute to drug use and addiction. The goal of this review is to examine existing research on the relationship between impulsive behavior and drug use across the lifespan and to recommend directions for future research. Three domains of impulsive behavior are explored in this review: impulsive behavior-related personality traits, delay discounting, and prepotent response inhibition. First, we present previous research on these three domains of impulsive behavior and drug use across developmental stages. Then, we discuss how changes in impulsive behavior across the lifespan are implicated in the progression of drug use and addiction. Finally, we discuss the relatively limited attention given to middle-to-older adults in the current literature, consider the validity of the measures used to assess impulsive behavior in middle-to-older adulthood, and suggest recommendations for future research. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Drug utilization research in primary health care as exemplified by physicians' quality assessment groups.

    Science.gov (United States)

    von Ferber, L; Luciano, A; Köster, I; Krappweis, J

    1992-11-01

    Drugs in primary health care are often prescribed for nonrational reasons. Drug utilization research investigates the prescription of drugs with an eye to medical, social and economic causes and consequences of the prescribed drug's utilization. The results of this research show distinct differences in drug utilization in different age groups and between men and women. Indication and dosage appear irrational from a textbook point of view. This indicates nonpharmacological causes of drug utilization. To advice successfully changes for the better quality assessment groups of primary health care physicians get information about their established behavior by analysis of their prescriptions. The discussion and the comparisons in the group allow them to recognize their irrational prescribing and the social, psychological and economic reasons behind it. Guidelines for treatment are worked out which take into account the primary health care physician's situation. After a year with 6 meetings of the quality assessment groups the education process is evaluated by another drug utilization analysis on the basis of the physicians prescription. The evaluation shows a remarkable improvement of quality and cost effectiveness of the drug therapy of the participating physicians.

  10. Research on the Pathological Mechanism and Drug Treatment Mechanism of Depression.

    Science.gov (United States)

    Peng, Guo-jiang; Tian, Jun-sheng; Gao, Xiao-xia; Zhou, Yu-zhi; Qin, Xue-mei

    2015-01-01

    Depression is one of the prevalent and persistent psychiatric illnesses. It brings heavy socioeconomic burden such as healthcare expenditures and even higher suicide rates. Despite many hypotheses about its mechanism have been put forward, so far it is still unclear, not to mention the precise and effective diagnostic or therapeutic methods. In this paper, the current conditions of pathological and pharmacological mechanism of depression were reviewed systematically. Firstly, the most recent hypotheses and metabolomics based research including hereditary, neurotransmitter systems, brain derived neurotrophic factor (BDNF), hyperactivity of the hypothalamic pituitary adrenal (HPA) axis and inflammatory as well as metabolomics were summarized. Secondly, the present situation and development on antidepressant drugs at home and abroad were reviewed. Finally, a conclusion and prospect on the pathological and pharmacological mechanism of depression were provided primarily.

  11. Ethical conflicts in public health research and practice: antimicrobial resistance and the ethics of drug development.

    Science.gov (United States)

    Aiello, Allison E; King, Nicholas B; Foxman, B

    2006-11-01

    Since the 1960s, scientists and pharmaceutical representatives have called for the advancement and development of new antimicrobial drugs to combat infectious diseases. In January 2005, Senate Majority Leader Bill Frist (R-TN), MD, introduced a biopreparedness bill that included provisions for patent extensions and tax incentives to stimulate industry research on new antimicrobials. Although government stimulus for private development of new antimicrobials is important, it does not resolve long-standing conflicts of interest between private entities and society. Rising rates of antimicrobial resistance have only exacerbated these conflicts. We used methicillin-resistant Staphylococcus aureus as a case study for reviewing these problems, and we have suggested alternative approaches that may halt the vicious cycle of resistance and obsolescence generated by the current model of antimicrobial production.

  12. Measuring the impact of pharmacoepidemiologic research using altmetrics: A case study of a CNODES drug-safety article.

    Science.gov (United States)

    Gamble, J M; Traynor, Robyn L; Gruzd, Anatoliy; Mai, Philip; Dormuth, Colin R; Sketris, Ingrid S

    2018-03-24

    To provide an overview of altmetrics, including their potential benefits and limitations, how they may be obtained, and their role in assessing pharmacoepidemiologic research impact. Our review was informed by compiling relevant literature identified through searching multiple health research databases (PubMed, Embase, and CIHNAHL) and grey literature sources (websites, blogs, and reports). We demonstrate how pharmacoepidemiologists, in particular, may use altmetrics to understand scholarly impact and knowledge translation by providing a case study of a drug-safety study conducted by the Canadian Network of Observational Drug Effect Studies. A common approach to measuring research impact is the use of citation-based metrics, such as an article's citation count or a journal's impact factor. "Alternative" metrics, or altmetrics, are increasingly supported as a complementary measure of research uptake in the age of social media. Altmetrics are nontraditional indicators that capture a diverse set of traceable, online research-related artifacts including peer-reviewed publications and other research outputs (software, datasets, blogs, videos, posters, policy documents, presentations, social media posts, wiki entries, etc). Compared with traditional citation-based metrics, altmetrics take a more holistic view of research impact, attempting to capture the activity and engagement of both scholarly and nonscholarly communities. Despite the limited theoretical underpinnings, possible commercial influence, potential for gaming and manipulation, and numerous data quality-related issues, altmetrics are promising as a supplement to more traditional citation-based metrics because they can ingest and process a larger set of data points related to the flow and reach of scholarly communication from an expanded pool of stakeholders. Unlike citation-based metrics, altmetrics are not inherently rooted in the research publication process, which includes peer review; it is unclear to

  13. Toward Omics-Based, Systems Biomedicine, and Path and Drug Discovery Methodologies for Depression-Inflammation Research.

    Science.gov (United States)

    Maes, Michael; Nowak, Gabriel; Caso, Javier R; Leza, Juan Carlos; Song, Cai; Kubera, Marta; Klein, Hans; Galecki, Piotr; Noto, Cristiano; Glaab, Enrico; Balling, Rudi; Berk, Michael

    2016-07-01

    Meta-analyses confirm that depression is accompanied by signs of inflammation including increased levels of acute phase proteins, e.g., C-reactive protein, and pro-inflammatory cytokines, e.g., interleukin-6. Supporting the translational significance of this, a meta-analysis showed that anti-inflammatory drugs may have antidepressant effects. Here, we argue that inflammation and depression research needs to get onto a new track. Firstly, the choice of inflammatory biomarkers in depression research was often too selective and did not consider the broader pathways. Secondly, although mild inflammatory responses are present in depression, other immune-related pathways cannot be disregarded as new drug targets, e.g., activation of cell-mediated immunity, oxidative and nitrosative stress (O&NS) pathways, autoimmune responses, bacterial translocation, and activation of the toll-like receptor and neuroprogressive pathways. Thirdly, anti-inflammatory treatments are sometimes used without full understanding of their effects on the broader pathways underpinning depression. Since many of the activated immune-inflammatory pathways in depression actually confer protection against an overzealous inflammatory response, targeting these pathways may result in unpredictable and unwanted results. Furthermore, this paper discusses the required improvements in research strategy, i.e., path and drug discovery processes, omics-based techniques, and systems biomedicine methodologies. Firstly, novel methods should be employed to examine the intracellular networks that control and modulate the immune, O&NS and neuroprogressive pathways using omics-based assays, including genomics, transcriptomics, proteomics, metabolomics, epigenomics, immunoproteomics and metagenomics. Secondly, systems biomedicine analyses are essential to unravel the complex interactions between these cellular networks, pathways, and the multifactorial trigger factors and to delineate new drug targets in the cellular

  14. The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics

    Science.gov (United States)

    Fisher, Celia B.; Yuko, Elizabeth

    2018-01-01

    The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. PMID:26564944

  15. The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.

    Science.gov (United States)

    Fisher, Celia B; Yuko, Elizabeth

    2015-12-01

    The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. © The Author(s) 2015.

  16. Recommendations to bridge rural/urban drug-use(r) research and practice.

    Science.gov (United States)

    Leukefeld, C G; Edwards, R W

    1999-01-01

    This article presents recommendations developed by a group of United States drug-use(r) researchers interested in rural and urban research and practice who met in Lexington, Kentucky, in October 1996. Overall, there was consensus about the importance of better understanding the urban/rural drug and alcohol use/dependency continuum. It was emphasized that drug and alcohol use/dependency are chronic and relapsing disorders. Definitions of rural and urban are most important, and different definitions may be associated with factors that are masked by population density. Specific recommendations are presented in the following areas: Rural Factors, Epidemiology, HIV/AIDS, Treatment and Other Services, Migration, Youth, Protective Factors, Systems Perspective, Measurement, Confidentiality, Criminal Justice, Research, Policy Research, Economic Factors, Service Providers, and Managed Care.

  17. Brain Chemistry and Behaviour: An Update on Neuroscience Research and Its Implications for Understanding Drug Addiction

    Science.gov (United States)

    Robinson, Emma S. J.

    2011-01-01

    Psychiatric disorders such as drug addiction represent one of the biggest challenges to society. This article reviews clinical and basic science research to illustrate how developments in research methodology have enabled neuroscientists to understand more about the brain mechanisms involved in addiction biology. Treating addiction represents a…

  18. «Dallas Buyers Club (2013» clinical research with drugs for the AIDS epidemic 80

    Directory of Open Access Journals (Sweden)

    Marian de HAAN-BOSCH

    2015-07-01

    Full Text Available Dallas Buyers Club (2013, inspired by true events, tells the story of Ron Woodroof, a middle?aged elec? trician from Dallas (Texas, who is diagnosed with AIDS in 1985. With few treatment options, he estab? lishes the Dallas Buyers Club in order to provide unapproved drugs to the AIDS community. This results in constant business travels, disputes with the FDA and problems with the law and the IRS. The article analyzes the buyers’ clubs phenomenon in the US, the drugs cited in the film and the clinical trial with zidovudine shown in the movie. The film could be useful as a teaching tool providing an introduction to the AIDS epidemic, clinical research and drug development, bioethics of human research and the agen? cies that regulate drug approval and their availability. Finally, the article presents a possible guideline for the use of the film in a teaching environment.

  19. Moral Stress, Moral Practice, and Ethical Climate in Community-Based Drug-Use Research: Views From the Front Line.

    Science.gov (United States)

    Fisher, Celia B; True, Gala; Alexander, Leslie; Fried, Adam L

    2013-01-01

    The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections. This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust. As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress. Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research.

  20. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  1. Development of several data bases related to reactor safety research including probabilistic safety assessment and incident analysis at JAERI

    International Nuclear Information System (INIS)

    Kobayashi, Kensuke; Oikawa, Tetsukuni; Watanabe, Norio; Izumi, Fumio; Higuchi, Suminori

    1986-01-01

    Presented are several databases developed at JAERI for reactor safety research including probabilistic safety assessment and incident analysis. First described are the recent developments of the databases such as 1) the component failure rate database, 2) the OECD/NEA/IRS information retrieval system, 3) the nuclear power plant database and so on. Then several issues are discussed referring mostly to the operation of the database (data input and transcoding) and to the retrieval and utilization of the information. Finally, emphasis is given to the increasing role which artifitial intelligence techniques such as natural language treatment and expert systems may play in improving the future capabilities of the databases. (author)

  2. Coffee shops and clinics: the give and take of doing HIV/AIDS research with injecting drug users.

    Science.gov (United States)

    Marsh, A; Loxley, W

    1992-06-01

    We discuss recruiting and interviewing injecting drug users and using research as health promotion in the context of collecting information related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) from a convenience sample of 200 injecting drug users, half in treatment and half not, in 1989 and 1990 in Perth, Western Australia. A variety of recruiting methods were used including advertising, referral by agency staff, 'snowballing' and approaches to personal contacts and others known to inject by the interviewer. Snowballing and personal contacts were the most successful means of recruiting those not in treatment, while advertising was comparatively unsuccessful with this group because of the importance of establishing the credibility of the study and the interviewer among injecting drug users before they will volunteer to be involved. The promotion of behavioural risk reduction among respondents during the interview is detailed. We argue that the traditionally rigid separation between research and intervention is inappropriate in the HIV/AIDS context. When lives are potentially at stake, any contact with injecting drug users, especially those not in treatment (where may receive HIV/AIDS education), must be used as an HIV/AIDS prevention opportunity, and the interview is an ideal opportunity. The employment of research as community intervention is also discussed.

  3. Drug research methodology. Volume 1, The alcohol-highway safety experience and its applicability to other drugs

    Science.gov (United States)

    1980-03-01

    This report presents the findings of a workshop concerning the alcohol and highway safety experience, which includes research efforts to define the drinking-driving problem and societal responses to reduce the increased highway safety risk attributab...

  4. BZP-party pills: a review of research on benzylpiperazine as a recreational drug.

    Science.gov (United States)

    Cohen, Bruce M Z; Butler, Rachael

    2011-03-01

    BZP-party pills are yet another 'designer drug' which mimics the stimulant qualities of amphetamines and MDMA/Ecstasy. As legal markets for the substance have developed in the last decade (especially amongst young people) so has public and governmental concern. This article provides a summary of the available international research on benzylpiperazine (BZP) and its popular use in the compound form known as 'party pills'. Through performing an analysis of the available medical and social scientific literature, the review outlines current knowledge on the compound, the prevalence of usage of BZP-party pills, as well as the associated harms, risks and rationales for use of the drug. Despite moves towards legislative control of BZP-party pills, the evidence presented suggests limited social and health harms associated with the drug, although research on long term effects is a significant gap in the literature. It also remains inconclusive as to whether BZP-party pills act as a 'gateway' to illegal drugs or, conversely, play a role in harm reduction with illegal drug users turning to legal alternatives; there is some evidence for both positions. With increasing controls of BZP-party pills, and with the increasing numbers of 'legal highs' and new designer drugs on the market, we conclude that new legal alternatives will continue to surface to replace the drug in the future. Considering a harm reduction approach to drug taking, it is suggested that policy makers consider the creation of a legal holding category which restricts and regulates the market in legal highs whilst the social and health harms associated with each drug can be thoroughly investigated. Copyright © 2011 Elsevier B.V. All rights reserved.

  5. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations.

    Science.gov (United States)

    Jandoc, Racquel; Burden, Andrea M; Mamdani, Muhammad; Lévesque, Linda E; Cadarette, Suzanne M

    2015-08-01

    To describe the use and reporting of interrupted time series methods in drug utilization research. We completed a systematic search of MEDLINE, Web of Science, and reference lists to identify English language articles through to December 2013 that used interrupted time series methods in drug utilization research. We tabulated the number of studies by publication year and summarized methodological detail. We identified 220 eligible empirical applications since 1984. Only 17 (8%) were published before 2000, and 90 (41%) were published since 2010. Segmented regression was the most commonly applied interrupted time series method (67%). Most studies assessed drug policy changes (51%, n = 112); 22% (n = 48) examined the impact of new evidence, 18% (n = 39) examined safety advisories, and 16% (n = 35) examined quality improvement interventions. Autocorrelation was considered in 66% of studies, 31% reported adjusting for seasonality, and 15% accounted for nonstationarity. Use of interrupted time series methods in drug utilization research has increased, particularly in recent years. Despite methodological recommendations, there is large variation in reporting of analytic methods. Developing methodological and reporting standards for interrupted time series analysis is important to improve its application in drug utilization research, and we provide recommendations for consideration. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  6. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).

    Science.gov (United States)

    Paskiet, Diane; Jenke, Dennis; Ball, Douglas; Houston, Christopher; Norwood, Daniel L; Markovic, Ingrid

    2013-01-01

    The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The collaborative activities of PQRI participants have, in the case of orally inhaled and nasal drug products (OINDPs), resulted in comprehensive and widely-accepted recommendations for leachables assessments to help ensure patient safety with respect to this class of packaged drug products. These recommendations, which include scientifically justified safety thresholds for leachables, represent a significant milestone towards establishing standardized approaches for safety qualification of leachables in OINDP. To build on the success of the OINDP effort, PQRI's Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group was formed to extrapolate the OINDP threshold concepts and best practice recommendations to other dosage forms with high concern for interaction with packaging/delivery systems. This article considers the general aspects of leachables and their safety assessment, introduces the PODP Work Plan and initial study Protocol, discusses the laboratory studies being conducted by the PODP Chemistry Team, outlines the strategy being developed by the PODP Toxicology Team for the safety qualification of PODP leachables, and considers the issues associated with application of the safety thresholds, particularly with respect to large-volume parenterals. Lastly, the unique leachables issues associated with biologics are described. The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia, and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Orally Inhaled and Nasal Drug Products Leachables and Extractables Working Group resulted in a

  7. 76 FR 44593 - Identifying the Center for Drug Evaluation and Research's Science and Research Needs...

    Science.gov (United States)

    2011-07-26

    ... research needs outlined in the report, CDER hopes to stimulate research and foster collaborations with... research needs, CDER hopes to stimulate research and foster collaborations with external partners and... issues across teams, divisions, or offices; and (3) emerging scientific challenges. A comprehensive set...

  8. Development of anti-inflammatory drugs - the research and development process.

    Science.gov (United States)

    Knowles, Richard Graham

    2014-01-01

    The research and development process for novel drugs to treat inflammatory diseases is described, and several current issues and debates relevant to this are raised: the decline in productivity, attrition, challenges and trends in developing anti-inflammatory drugs, the poor clinical predictivity of experimental models of inflammatory diseases, heterogeneity within inflammatory diseases, 'improving on the Beatles' in treating inflammation, and the relationships between big pharma and biotechs. The pharmaceutical research and development community is responding to these challenges in multiple ways which it is hoped will lead to the discovery and development of a new generation of anti-inflammatory medicines. © 2013 Nordic Pharmacological Society. Published by John Wiley & Sons Ltd.

  9. A Research Strategy Case Study of Alcohol and Drug Prevention by Non-Governmental Organizations in Sweden 2003-2009

    Directory of Open Access Journals (Sweden)

    Larsson Madelene

    2011-04-01

    Full Text Available Abstract Background Alcohol and drug prevention is high on the public health agenda in many countries. An increasing trend is the call for evidence-based practice. In Sweden in 2002 an innovative project portfolio including an integrated research and competence-building strategy for non-governmental organisations (NGOs was designed by the National Board of Health and Welfare (NBHW. This research strategy case study is based on this initiative. Methods The embedded case study includes 135 projects in 69 organisations and 14 in-depth process or effect studies. The data in the case study has been compiled using multiple methods - administrative data; interviews and questionnaires to project leaders; focus group discussions and seminars; direct and participatory observations, interviews, and documentation of implementation; consultations with the NBHW and the NGOs; and a literature review. Annual reports have been submitted each year and three bi-national conferences Reflections on preventions have been held. Results A broad range of organisations have been included in the NBHW project portfolio. A minority of the project were run by Alcohol or drug organisations, while a majority has children or adolescents as target groups. In order to develop a trustful partnership between practitioners, national agencies and researchers a series of measures were developed and implemented: meeting with project leaders, project dialogues and consultations, competence strengthening, support to documentation, in-depth studies and national conferences. A common element was that the projects were program-driven and not research-driven interventions. The role of researchers-as-technical advisors was suitable for the fostering of a trustful partnership for research and development. The independence of the NGOs was regarded as important for the momentum in the project implementation. The research strategy also includes elements of participatory research. Conclusions This

  10. Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

    Science.gov (United States)

    Resnik, David B

    2007-10-01

    Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

  11. Transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma: its research progress

    International Nuclear Information System (INIS)

    Zhao Yan; Han Guohong; Bai Wei; Fan Daiming

    2012-01-01

    Transarterial chemoembolization (TACE) has been the main treatment for patients with intermediate-stage hepatocellular carcinoma (HCC). However, the clinical application of TACE is limited due to the technical deficiencies, such as uncontrolled local drug delivery and systemic toxicity. Recently, the new drug-eluting beads (DEB), loading with doxorubicin, have be used in the TACE procedures. This new technique can not only maintain the local drug level for quite a long time and thus get a higher objective response, but also decrease the systemic toxicity. Transarterial chemoembolization with drug-eluting beads (DEB-TACE) have already been widely used abroad, and more related clinical trials are underway to clarify its advantages. This paper aims to make a comprehensive review in the respects of its characteristics and the latest research progress in DEB-TACE. (authors)

  12. A Bibliographic Study of Drug Abuse Research during last 30 years in Iran

    Directory of Open Access Journals (Sweden)

    Afarin Rahimi Movaghar

    2009-05-01

    Full Text Available In the last decades, the produced science has been significantly increased in the field of drug abuse, globally. The objective of this study was to assess the bibliographic aspects of the science produced in Iran on drug abuse in the last 30 years. All scientific papers published from Iran in a 30-year period (1973-2002 in national as well as international scientific journals were assessed for this study. These papers are indexed in the database for Iranian Mental Health Researches, called IranPsych. The total number of 218 papers on drug and drug abuse were found and assessed by six psychiatrists and psychologists with good inter-rater reliability. About half of these papers were published in the last two years. About half of the papers have been published in the Persian medical journals. One-third have been published in international journals. Overall, 449 authors contributed to the 218 published papers from whom 80 percent had only one paper. Half of the papers were written by only 15 authors (3.3 percent. Most of the authors were Medical Doctors and from Medical Universities. None of the researches was received financial support from pharmacologic industries. This study shows that in recent years, the increase in the publication of the researches conducted on drug abuse has been significant. Nevertheless, according to the high prevalence of drug abuse problem in Iran and improvements in the scientific, as well as executive structures, the whole scientific output is insignificant. The findings guide us to a more systematic approach toward training of researchers and promotion of resaerch in this area. Moreover, more active involvement of social scientists and publication of their research findings are recommended.

  13. Antibacterial and antibiotic resistance modifying activity of the extracts from Allanblackia gabonensis, Combretum molle and Gladiolus quartinianus against Gram-negative bacteria including multi-drug resistant phenotypes.

    Science.gov (United States)

    Fankam, Aimé G; Kuiate, Jules R; Kuete, Victor

    2015-06-30

    Bacterial resistance to antibiotics is becoming a serious problem worldwide. The discovery of new and effective antimicrobials and/or resistance modulators is necessary to tackle the spread of resistance or to reverse the multi-drug resistance. We investigated the antibacterial and antibiotic-resistance modifying activities of the methanol extracts from Allanblackia gabonensis, Gladiolus quartinianus and Combretum molle against 29 Gram-negative bacteria including multi-drug resistant (MDR) phenotypes. The broth microdilution method was used to determine the minimal inhibitory concentrations (MIC) and minimal bactericidal concentrations (MBC) of the samples meanwhile the standard phytochemical methods were used for the preliminary phytochemical screening of the plant extracts. Phytochemical analysis showed the presence of alkaloids, flavonoids, phenols and tannins in all studied extracts. Other chemical classes of secondary metabolites were selectively presents. Extracts from A. gabonensis and C. molle displayed a broad spectrum of activity with MICs varying from 16 to 1024 μg/mL against about 72.41% of the tested bacteria. The extract from the fruits of A. gabonensis had the best activity, with MIC values below 100 μg/mL on 37.9% of tested bacteria. Percentages of antibiotic-modulating effects ranging from 67 to 100% were observed against tested MDR bacteria when combining the leaves extract from C. molle (at MIC/2 and MIC/4) with chloramphenicol, kanamycin, streptomycin and tetracycline. The overall results of the present study provide information for the possible use of the studied plant, especially Allanblackia gabonensis and Combretum molle in the control of Gram-negative bacterial infections including MDR species as antibacterials as well as resistance modulators.

  14. Aspects of physicians' attitudes towards the rational use of drugs at a training and research hospital: a survey study.

    Science.gov (United States)

    Filiz Basaran, Nesrin; Akici, Ahmet

    2013-08-01

    The rational use of drugs (RUD) is primarily the responsibility of physicians. The aim of this study was to investigate whether physicians are aware of RUD principles and how they apply them in daily medical practice. A total 136 physicians working at the Kartal Training and Research Hospital in Istanbul were enrolled in the study between February and March 2012. A face-to-face interview was conducted with physicians to assess their knowledge and attitude regarding RUD. A large majority of the physicians declared that consultation time was insufficient (84 %). The data obtained from the survey indicate that 54 % of the enrolled physicians monitored the therapeutic outcome and that 27 % found the information given to the patient to be sufficient. Participating physicians stated that the less known characteristics of the drugs they prescribed were drug interactions, traceability in market, and price. The most preferred reference source was Vademecum (a drug guideline prepared by the private sector). Two major factors contributing to prescribing patterns were "self study" and "observation of teachers" at clinical training. There was a significant difference between internists-surgeons and residents-specialists in the number of prescribed drugs per prescription (p change in managerial practices within the healthcare system. The other, more essential explanation is education; consequently, serious consideration should be given to including effective clinical pharmacotherapy training and RUD courses in the medical education curriculum.

  15. Precision-cut intestinal slices: alternative model for drug transport, metabolism, and toxicology research.

    Science.gov (United States)

    Li, Ming; de Graaf, Inge A M; Groothuis, Geny M M

    2016-01-01

    The absorption, distribution, metabolism, excretion and toxicity (ADME-tox) processes of drugs are of importance and require preclinical investigation intestine in addition to the liver. Various models have been developed for prediction of ADME-tox in the intestine. In this review, precision-cut intestinal slices (PCIS) are discussed and highlighted as model for ADME-tox studies. This review provides an overview of the applications and an update of the most recent research on PCIS as an ex vivo model to study the transport, metabolism and toxicology of drugs and other xenobiotics. The unique features of PCIS and the differences with other models as well as the translational aspects are also discussed. PCIS are a simple, fast, and reliable ex vivo model for drug ADME-tox research. Therefore, PCIS are expected to become an indispensable link in the in vitro-ex vivo-in vivo extrapolation, and a bridge in translation of animal data to the human situation. In the future, this model may be helpful to study the effects of interorgan interactions, intestinal bacteria, excipients and drug formulations on the ADME-tox properties of drugs. The optimization of culture medium and the development of a (cryo)preservation technique require more research.

  16. Use of anonymous Web communities and websites by medical consumers in Japan to research drug information.

    Science.gov (United States)

    Kishimoto, Keiko; Fukushima, Noriko

    2011-01-01

    In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy.

  17. Research Costs Investigated: A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research

    NARCIS (Netherlands)

    T. van Asselt (Thea); B.L.T. Ramaekers (Bram); I. Corro Ramos (Isaac); M.A. Joore (Manuela); M.J. Al (Maiwenn); Lesman-Leegte, I. (Ivonne); M.J. Postma (Maarten); P. Vemer (Pepijn); T.L. Feenstra (Talitha)

    2017-01-01

    textabstractBackground: The costs of performing research are an important input in value of information (VOI) analyses but are difficult to assess. Objective: The aim of this study was to investigate the costs of research, serving two purposes: (1) estimating research costs for use in VOI analyses;

  18. Research Costs Investigated : A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research

    NARCIS (Netherlands)

    van Asselt, Thea; Ramaekers, Bram; Corro Ramos, Isaac; Joore, Manuela; Al, Maiwenn; Lesman-Leegte, Ivonne; Postma, Maarten; Vemer, Pepijn; Feenstra, Talitha

    BACKGROUND: The costs of performing research are an important input in value of information (VOI) analyses but are difficult to assess. OBJECTIVE: The aim of this study was to investigate the costs of research, serving two purposes: (1) estimating research costs for use in VOI analyses; and (2)

  19. Institutional ethical review and ethnographic research involving injection drug users: a case study.

    Science.gov (United States)

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

    Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. A bibliometric study of scientific research conducted on second-generation antipsychotic drugs in Singapore.

    Science.gov (United States)

    López-Muñoz, Francisco; Sim, Kang; Shen, Winston Wu; Huelves, Lorena; Moreno, Raquel; Molina, Juan de Dios; Rubio, Gabriel; Noriega, Concha; Pérez-Nieto, Miguel Ángel; Alamo, Cecilio

    2014-01-01

    A bibliometric study was carried out to ascertain the volume and impact of scientific literature published on second-generation antipsychotic drugs (SGAs) in Singapore from 1997 to 2011. A search of the EMBASE and MEDLINE databases was performed to identify articles originating from Singapore that included the descriptors 'atypic* antipsychotic*', 'second-generation antipsychotic*', 'clozapine', 'risperidone', 'olanzapine', 'ziprasidone', 'quetiapine', 'sertindole', 'aripiprazole', 'paliperidone', 'amisulpride', 'zotepine', 'asenapine', 'iloperidone', 'lurasidone', 'perospirone' and 'blonanserin' in the article titles. Certain bibliometric indicators of production and dispersion (e.g. Price's Law on the increase of scientific literature, and Bradford's Law) were applied, and the participation index of various countries was calculated. The bibliometric data was also correlated with some social and health data from Singapore, such as the total per capita expenditure on health and gross domestic expenditure on research and development. From 1997 to 2011, a total of 51 articles on SGAs in Singapore were published. Our results suggested non-fulfilment of Price's Law (r = 0.0648 after exponential adjustment vs. r = 0.2140 after linear adjustment). The most widely studied drugs were clozapine (21 articles), risperidone (16 articles) and olanzapine (8 articles). Division into Bradford zones yielded a nucleus occupied by the Journal of Clinical Psychopharmacology (6 articles) and the Singapore Medical Journal(4 articles). The analysed material was published in a total of 30 journals, with the majority from six journals. Four of these six journals have an impact factor greater than 2. Publications on SGAs in Singapore are still too few to confirm an exponential growth of scientific literature.

  1. Drug-eluting stents: from bench-top to clinical research

    NARCIS (Netherlands)

    Basalus, Mounir Welson Zakhary

    2013-01-01

    The development of drug-eluting stents (DES) has improved the invasive treatment of obstructive coronary artery disease by reducing both, restenosis rate and need for reinterventions. This success resulted in a widespread utilization of DES in clinical practice and entailed many clinical research

  2. Review on research of suppression male fertility and male contraceptive drug development by natural products.

    Science.gov (United States)

    Bajaj, Vijay Kumar; Gupta, Radhey S

    2013-08-01

    Male contraceptive development in the present scenario is most viable aspect of research due to uncontrolled population growth in the world. In this respect investigators are busy to find out a safe male contraceptive drug. Researchers have started their finding for a suitable drug from natural sources because these are safe and easily acceptable for common man, most of natural sources are plants and their products. In this review 137 plants and their effects on reproduction and reproductive physiology are summarized. Some of them have intense effect on male reproductive system and do not produce any side effects. Reproductive toxicological studies are also important aspects of these kinds of researches, so it is important that drugs are safe and widely acceptable. An ideal male contraceptive can influence semen, testes, hormone level, accessory reproductive organs and general physiology of animals and produced some alterations. Many plants in this review are showing antifertility as well as antispermatogenic effects, so these may be used for further study for contraceptives development but it is important to find out the mechanism of reaction and further laboratory and clinical research on some plants are needed for final male contraceptive drug development. In conclusion this review will help for finding suitable plant products for male contraceptive clinical and laboratory studies.

  3. Alcohol and Other Drug Use: The Connection to Youth Suicide. Abstracts of Selected Research.

    Science.gov (United States)

    Laws, Kathy; Turner, Amy

    This publication provides the reader with an overview of the research done on the connection between the use of alcohol and other drugs and the ideation and/or completion of suicide among adolescents. It also provides information and resources on how to develop a youth suicide prevention program. The introduction gives a brief overview of the…

  4. Cryopreservation of Precision-cut Tissue Slices for Application in Drug Metabolism Research

    NARCIS (Netherlands)

    Graaf, Inge Anne Maria de

    2002-01-01

    The research described in this thesis had two important aims. The first was to determine whether tissue slices could be used as an in vitro tool to predict the in vivo metabolism of new drugs. The second aim was to find a manner to store tissue slices for longer time periods by cryopreservation.

  5. Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology.

    Science.gov (United States)

    Maurer, Hans H

    2018-04-30

    This paper reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers.

  6. Scaling Up Research on Drug Abuse and Addiction Through Social Media Big Data.

    Science.gov (United States)

    Kim, Sunny Jung; Marsch, Lisa A; Hancock, Jeffrey T; Das, Amarendra K

    2017-10-31

    Substance use-related communication for drug use promotion and its prevention is widely prevalent on social media. Social media big data involve naturally occurring communication phenomena that are observable through social media platforms, which can be used in computational or scalable solutions to generate data-driven inferences. Despite the promising potential to utilize social media big data to monitor and treat substance use problems, the characteristics, mechanisms, and outcomes of substance use-related communications on social media are largely unknown. Understanding these aspects can help researchers effectively leverage social media big data and platforms for observation and health communication outreach for people with substance use problems. The objective of this critical review was to determine how social media big data can be used to understand communication and behavioral patterns of problematic use of prescription drugs. We elaborate on theoretical applications, ethical challenges and methodological considerations when using social media big data for research on drug abuse and addiction. Based on a critical review process, we propose a typology with key initiatives to address the knowledge gap in the use of social media for research on prescription drug abuse and addiction. First, we provided a narrative summary of the literature on drug use-related communication on social media. We also examined ethical considerations in the research processes of (1) social media big data mining, (2) subgroup or follow-up investigation, and (3) dissemination of social media data-driven findings. To develop a critical review-based typology, we searched the PubMed database and the entire e-collection theme of "infodemiology and infoveillance" in the Journal of Medical Internet Research / JMIR Publications. Studies that met our inclusion criteria (eg, use of social media data concerning non-medical use of prescription drugs, data informatics-driven findings) were

  7. Addiction research centres and the nurturing of creativity: The Alcohol & Drug Abuse Research Unit at the South African Medical Research Council - strengthening substance abuse research and policy in South Africa.

    Science.gov (United States)

    Parry, Charles; Morojele, Neo; Myers, Bronwyn; Plüddemann, Andreas

    2013-01-01

    The Alcohol and Drug Abuse Research Unit (ADARU) was established at the South African Medical Research Council (MRC) at the beginning of 2001, although its origins lie in the activities of the Centre for Epidemiological Research in Southern Africa and other MRC entities. Initial challenges included attracting external funding, recruiting new staff, developing the skills of junior staff, publishing in international journals and building national and international collaborative networks. ADARU currently comprises a core staff of 33 members who work on 22 projects spanning substance use epidemiology and associated consequences, intervention studies with at-risk populations and services research. A large component of this portfolio focuses on the link between alcohol and other drug use and human immunodeficiency virus (HIV) risk behaviour, with funding from the US Centers for Disease Control and Prevention. Junior staff members are encouraged to develop independent research interests and pursue PhD studies. Research outputs, such as the 20 papers that were published in 2010 and the 35 conference presentations from that year, form an important part of the unit's research translation activities. We engage actively with policy processes at the local, provincial, national and international levels, and have given particular attention to alcohol policy in recent years. The paper includes an analysis of major challenges currently facing the unit and how we are attempting to address them. It ends with some thoughts on what the unit intends doing to enhance the quality of its research, the capacity of its staff and its international standing. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  8. Illegal Drugs Laws: Clearing a 50-Year-Old Obstacle to Research

    Science.gov (United States)

    Nutt, David

    2015-01-01

    The United Nations drug control conventions of 1960 and 1971 and later additions have inadvertently resulted in perhaps the greatest restrictions of medical and life sciences research. These conventions now need to be revised to allow neuroscience to progress unimpeded and to assist in the innovation of treatments for brain disorders. In the meantime, local changes, such as the United Kingdom moving cannabis from Schedule 1 to Schedule 2, should be implemented to allow medical research to develop appropriately. PMID:25625189

  9. Illegal drugs laws: clearing a 50-year-old obstacle to research.

    Directory of Open Access Journals (Sweden)

    David Nutt

    2015-01-01

    Full Text Available The United Nations drug control conventions of 1960 and 1971 and later additions have inadvertently resulted in perhaps the greatest restrictions of medical and life sciences research. These conventions now need to be revised to allow neuroscience to progress unimpeded and to assist in the innovation of treatments for brain disorders. In the meantime, local changes, such as the United Kingdom moving cannabis from Schedule 1 to Schedule 2, should be implemented to allow medical research to develop appropriately.

  10. Illegal drugs laws: clearing a 50-year-old obstacle to research.

    Science.gov (United States)

    Nutt, David

    2015-01-01

    The United Nations drug control conventions of 1960 and 1971 and later additions have inadvertently resulted in perhaps the greatest restrictions of medical and life sciences research. These conventions now need to be revised to allow neuroscience to progress unimpeded and to assist in the innovation of treatments for brain disorders. In the meantime, local changes, such as the United Kingdom moving cannabis from Schedule 1 to Schedule 2, should be implemented to allow medical research to develop appropriately.

  11. Research as an event: a novel approach to promote patient-focused drug development

    Directory of Open Access Journals (Sweden)

    Tsai JH

    2018-05-01

    Full Text Available Jui-Hua Tsai, Ellen Janssen, John FP Bridges Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Abstract: Patient groups are increasingly engaging in research to understand patients’ preferences and incorporate their perspectives into drug development and regulation. Several models of patient engagement have emerged, but there is little guidance on how to partner with patient groups to engage the disease community. Our group has been using an approach to engage patient groups that we call research as an event. Research as an event is a method for researchers to use a community-centered event to engage patients in their own environment at modest incremental cost. It is a pragmatic solution to address the challenges of engaging patients in research to minimize patients’ frustration, decrease the time burden, and limit the overall cost. The community, the event, and the research are the three components that constitute the research as an event framework. The community represents a disease-specific community. The event is a meeting of common interest for patients and other stakeholders, such as a patient advocacy conference. The research describes activities in engaging the community for the purpose of research. Research as an event follows a six-step approach. A case study is used to demonstrate the six steps followed by recommendations for future implementation. Keywords: patients’ perspectives, decision making, drug approval, patient engagement, patient organization, patients’ preference

  12. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers.

    Science.gov (United States)

    Kesselheim, Aaron S; Rome, Benjamin N; Sarpatwari, Ameet; Avorn, Jerry

    2017-02-01

    To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication. Yet the economic impact of such proposals is rarely addressed. We found that for the thirteen FDA-approved drugs that gained supplemental approval for a rare disease indication from 2005 through 2010, the median projected cost of clinical trials leading to approval was $29.8 million. If the exclusivity extension had been in place, the median discounted financial gain to manufacturers would have been $94.6 million. Median net returns would have been $82.4 million, with higher returns for drugs with higher annual sales. Extending market exclusivity would provide substantial compensation to many manufacturers, particularly for top-selling products, far in excess of the cost of conducting these trials. Alternative strategies to incentivize the study of approved drugs for rare diseases may offer similar benefits at a lower cost. Project HOPE—The People-to-People Health Foundation, Inc.

  13. An exploratory research on the role of family in youth's drug addiction.

    Science.gov (United States)

    Masood, Sobia; Us Sahar, Najam

    2014-01-01

    Most of the researches in Pakistan are concerned with the aetiological factors of drug addiction among the youth. However, few studies seek to explore the social aspects of this phenomenon. The present study aimed to explore the role of family, the influence of parental involvement, and communication styles in youth's drug addiction in a qualitative manner. Twenty drug addicts (age range 18-28 years) were taken as a sample from drug rehabilitation centres in Rawalpindi and Islamabad, Pakistan. A structured interview guide was administered comprising questions related to the individual's habits, relationship with family and friends, and modes of communication within the family. Case profiles of the participants were also taken. The rehabilitation centres offered family therapy and the researcher, as a non-participant, observed these sessions as part of the analysis. The demographic information revealed that majority of the participants were poly-substance abusers (80%) and the significant reasons for starting drugs were the company of peers and curiosity. The thematic analysis revealed parental involvement and emotional expressiveness as two major components in family communication. It was found that parents were concerned about their children, but were not assertive in the implementation of family rules. It was also found that the major life decisions of the participants were taken by their parents, which is a characteristic of collectivist Pakistani society.

  14. A practical approach to risk-benefit estimation in pediatric drug research.

    Science.gov (United States)

    Koren, Gideon

    2015-02-01

    One of the most difficult challenges in pediatric drug research is in exposing children to risk, often without a balanced chance of benefits. While the concept of risk is similar in adult research, the adult patient can decide for himself/herself on an acceptable level of risk, whereas children have to accept the decisions of their guardians. This paper attempts to put the complexities of estimating risk in pediatric drug research into their practical perspective, and to familiarize the reader with the way such processes are conducted in different parts of the world. Although there are regional differences, all authorities typically quantify risks of pediatric research in general, and drug research in particular, in three levels: those experienced in day-to-day life; risks slightly above this 'baseline' risk; and risks substantially above 'baseline risk'. Proportionally, the diligence of the ethics process depends on these levels, as well as on the potential benefits (or lack of) to the child involved in the research. Importantly, risk is context dependent, and a particular intervention may be effective or safe in one setting but not in another, based on local experience, staffing levels, and similar variabilities.

  15. Scaling Up Research on Drug Abuse and Addiction Through Social Media Big Data

    Science.gov (United States)

    Marsch, Lisa A; Hancock, Jeffrey T; Das, Amarendra K

    2017-01-01

    Background Substance use–related communication for drug use promotion and its prevention is widely prevalent on social media. Social media big data involve naturally occurring communication phenomena that are observable through social media platforms, which can be used in computational or scalable solutions to generate data-driven inferences. Despite the promising potential to utilize social media big data to monitor and treat substance use problems, the characteristics, mechanisms, and outcomes of substance use–related communications on social media are largely unknown. Understanding these aspects can help researchers effectively leverage social media big data and platforms for observation and health communication outreach for people with substance use problems. Objective The objective of this critical review was to determine how social media big data can be used to understand communication and behavioral patterns of problematic use of prescription drugs. We elaborate on theoretical applications, ethical challenges and methodological considerations when using social media big data for research on drug abuse and addiction. Based on a critical review process, we propose a typology with key initiatives to address the knowledge gap in the use of social media for research on prescription drug abuse and addiction. Methods First, we provided a narrative summary of the literature on drug use–related communication on social media. We also examined ethical considerations in the research processes of (1) social media big data mining, (2) subgroup or follow-up investigation, and (3) dissemination of social media data-driven findings. To develop a critical review-based typology, we searched the PubMed database and the entire e-collection theme of “infodemiology and infoveillance” in the Journal of Medical Internet Research / JMIR Publications. Studies that met our inclusion criteria (eg, use of social media data concerning non-medical use of prescription drugs, data

  16. Conceptualizing ethnicity in alcohol and drug research: Epidemiology meets social theory.

    Science.gov (United States)

    Hunt, Geoffrey; Kolind, Torsten; Antin, Tamar

    2018-01-01

    Since the 1990s, social scientists have rejected notions of ethnicity as something static and discrete, instead highlighting the context-dependent and fluid nature of multiple identities. In spite of these developments, researchers within the substance use fields continue to assess ethnic group categories in ways that suggest little critical reflection in terms of the validity of the measurements themselves, nor the social, bureaucratic, and political decisions shaping standard measures of ethnicity. This paper highlights these considerations, while also acknowledging the role of socially-delineated ethnic categorizations in documenting health inequities and social injustices. We call on researchers in alcohol and drugs research to critically appraise their use of ethnic categorizations, querying how to best measure ethnicity within their own studies in ways that are justified beyond simplified explanations of social convention and that "do no harm" in terms of perpetuating racism and obscuring the roots causes of social and health problems related to alcohol and drugs.

  17. Previniendo el Uso de Drogas entre Ninos y Adolescentes: Una Guia Basada en Investigaciones (Preventing Drug Use among Children and Adolescents: A Research-Based Guide).

    Science.gov (United States)

    Sloboda, Zili; David, Susan L.

    This question and answer guide provides an overview of the research on the origins and pathways of drug abuse, the basic principles derived from effective drug abuse prevention research, and the application of research results to the prevention of drug use among young people. The basic principles derived from drug abuse prevention research are…

  18. Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison.

    Science.gov (United States)

    Sorenson, Corinna

    2010-07-01

    Comparative effectiveness research (CER) has assumed an increasing role in drug coverage and, in some cases, pricing decisions in Europe, as decision-makers seek to obtain better value for money. This issue brief comparatively examines the use of CER across six countries--Denmark, England, France, Germany, the Netherlands, and Sweden. With CER gaining traction in the United States, these international experiences offer insights and potential lessons. Investing in CER can help address the current gap in publicly available, credible, up-to-date, and scientifically based comparative information on the effectiveness of drugs and other health interventions. This information can be used to base coverage and pricing decisions on evidence of value, thereby facilitating access to and public and private investment in the most beneficial new drugs and technologies. In turn, use of CER creates incentives for more efficient, high-quality health care and encourages development of innovative products that offer measurable value to patients.

  19. Designing and recruiting to UK autism spectrum disorder research databases: do they include representative children with valid ASD diagnoses?

    Science.gov (United States)

    Warnell, F; George, B; McConachie, H; Johnson, M; Hardy, R; Parr, J R

    2015-09-04

    (1) Describe how the Autism Spectrum Database-UK (ASD-UK) was established; (2) investigate the representativeness of the first 1000 children and families who participated, compared to those who chose not to; (3) investigate the reliability of the parent-reported Autism Spectrum Disorder (ASD) diagnoses, and present evidence about the validity of diagnoses, that is, whether children recruited actually have an ASD; (4) present evidence about the representativeness of the ASD-UK children and families, by comparing their characteristics with the first 1000 children and families from the regional Database of children with ASD living in the North East (Dasl(n)e), and children and families identified from epidemiological studies. Recruitment through a network of 50 UK child health teams and self-referral. Parents/carers with a child with ASD, aged 2-16 years, completed questionnaires about ASD and some gave professionals' reports about their children. 1000 families registered with ASD-UK in 30 months. Children of families who participated, and of the 208 who chose not to, were found to be very similar on: gender ratio, year of birth, ASD diagnosis and social deprivation score. The reliability of parent-reported ASD diagnoses of children was very high when compared with clinical reports (over 96%); no database child without ASD was identified. A comparison of gender, ASD diagnosis, age at diagnosis, school placement, learning disability, and deprivation score of children and families from ASD-UK with 1084 children and families from Dasl(n)e, and families from population studies, showed that ASD-UK families are representative of families of children with ASD overall. ASD-UK includes families providing parent-reported data about their child and family, who appear to be broadly representative of UK children with ASD. Families continue to join the databases and more than 3000 families can now be contacted by researchers about UK autism research. Published by the BMJ

  20. PBPK Modeling - A Predictive, Eco-Friendly, Bio-Waiver Tool for Drug Research.

    Science.gov (United States)

    De, Baishakhi; Bhandari, Koushik; Mukherjee, Ranjan; Katakam, Prakash; Adiki, Shanta K; Gundamaraju, Rohit; Mitra, Analava

    2017-01-01

    The world has witnessed growing complexities in disease scenario influenced by the drastic changes in host-pathogen- environment triadic relation. Pharmaceutical R&Ds are in constant search of novel therapeutic entities to hasten transition of drug molecules from lab bench to patient bedside. Extensive animal studies and human pharmacokinetics are still the "gold standard" in investigational new drug research and bio-equivalency studies. Apart from cost, time and ethical issues on animal experimentation, burning questions arise relating to ecological disturbances, environmental hazards and biodiversity issues. Grave concerns arises when the adverse outcomes of continued studies on one particular disease on environment gives rise to several other pathogenic agents finally complicating the total scenario. Thus Pharma R&Ds face a challenge to develop bio-waiver protocols. Lead optimization, drug candidate selection with favorable pharmacokinetics and pharmacodynamics, toxicity assessment are vital steps in drug development. Simulation tools like Gastro Plus™, PK Sim®, SimCyp find applications for the purpose. Advanced technologies like organ-on-a chip or human-on-a chip where a 3D representation of human organs and systems can mimic the related processes and activities, thereby linking them to major features of human biology can be successfully incorporated in the drug development tool box. PBPK provides the State of Art to serve as an optional of animal experimentation. PBPK models can successfully bypass bio-equivalency studies, predict bioavailability, drug interactions and on hyphenation with in vitro-in vivo correlation can be extrapolated to humans thus serving as bio-waiver. PBPK can serve as an eco-friendly bio-waiver predictive tool in drug development. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. Korea's Contribution to Radiological Research Included in Science Citation Index Expanded, 1986-2010

    Energy Technology Data Exchange (ETDEWEB)

    Ku, You Jin; Yoon, Dae Young; Lim, Kyoung Ja; Baek, Sora; Seo, Young Lan; Yun, Eun Joo; Choi, Chul Soon; Bae, Sang Hoon [Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul (Korea, Republic of); Lee, Hyun; Ju, Young Su [Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang (Korea, Republic of)

    2012-09-15

    To evaluate scientific papers published by Korean radiologists in the Science Citation Index Expanded (SCIE) radiology journals, between 1986 and 2010. The Institute for Scientific Information Web of Knowledge-Web of Science (SCIE) database was searched for all articles published by Korean radiologists, in SCIE radiology journals, between 1986 and 2010. We performed the analysis by typing 'Korea' and 'radiol' in the address section and selecting the subject area of 'Radiology, Nuclear Medicine, and Medical Imaging' with the use of the general search function of the software. Analyzed parameters included the total number of publications, document types, journals, and institutions. In addition, we analyzed where Korea ranks, compared to other countries, in terms of the number of published articles. All these data were analyzed according to five time periods: 1986-1990, 1991-1995, 1996-2000, 2001-2005, and 2006-2010. Overall, 4974 papers were published by Korean radiologists, in 99 different SCIE journals, between 1986 and 2010, of which 4237 (85.2%) were article-type papers. Of the total 115395 articles, worldwide, published in radiology journals, Korea's share was 3.7%, with an upward trend over time (p < 0.005). The journal with the highest number of articles was the American Journal of Roentgenology (n 565, 13.3%). The institution which produced the highest number of publications was Seoul National University (n = 932, 22.0%). The number of scientific articles published by Korean radiologists in the SCIE radiology journals has increased significantly between 1986 and 2010. Korea was ranked 4th among countries contributing to radiology research during the last 5 years.

  2. Semiconductor technology in protein kinase research and drug discovery: sensing a revolution.

    Science.gov (United States)

    Bhalla, Nikhil; Di Lorenzo, Mirella; Estrela, Pedro; Pula, Giordano

    2017-02-01

    Since the discovery of protein kinase activity in 1954, close to 600 kinases have been discovered that have crucial roles in cell physiology. In several pathological conditions, aberrant protein kinase activity leads to abnormal cell and tissue physiology. Therefore, protein kinase inhibitors are investigated as potential treatments for several diseases, including dementia, diabetes, cancer and autoimmune and cardiovascular disease. Modern semiconductor technology has recently been applied to accelerate the discovery of novel protein kinase inhibitors that could become the standard-of-care drugs of tomorrow. Here, we describe current techniques and novel applications of semiconductor technologies in protein kinase inhibitor drug discovery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Mother-infant consultation during drug treatment: Research and innovative clinical practice

    Directory of Open Access Journals (Sweden)

    Lester Barry M

    2008-02-01

    Full Text Available Abstract Background This paper details a model for consulting with mothers and infants, and drug treatment staff used in a residential drug treatment program and relevant to other treatment settings. The role of parent-infant consultation based on the Neonatal Network Neurobehavioral Scale (NNNS was evaluated. Methods A sequential cohort model was used to assign participants to 1. NNNS consultation versus 2. standard care. The effects of NNNS consultation were evaluated using the Parenting Stress Index and NNNS summary scores. Results Participants in the NNNS consultation condition had significantly less stress overall, and less stress related to infant behavior than participants in standard care. There were no differences in infant behavior on the NNNS Summary scores. Conclusion The implications for NNNS consultation in drug treatment programs is outlined. The importance of prevention/intervention to establish satisfactory mother-infant interaction in recovery programs which include a central parenting component is indicated.

  4. Radioprotective drugs: a synopsis of current research and a proposed research plan for the Federal Emergency Management Agency. Final report

    International Nuclear Information System (INIS)

    Hickman, R.; Anspaugh, L.

    1985-04-01

    FEMA has broad roles in the management of disasters potentially involving substantial amounts of radioactive contamination. These could be either peacetime or wartime disasters. A meeting was held in March 1985 to see if there are any research contributions that FEMA might reasonably make in the area of radioprotective drugs that would substantially enhance its ability to perform its mission. The other federal agencies presently sponsoring research in the field were represented at the meeting. A few selected researchers also participated to provide complementary viewpoints. Activities of a modest scale that FEMA might undertake were identified, as were larger scale activities that might be undertaken in the event of long-term, major funding-level increases for FEMA. 2 refs

  5. THE RESEARCH RESULTS OF TENDER PROCUREMENTS OF THE DRUGS FOR CANCER PATIENTS IN UKRAINE

    Directory of Open Access Journals (Sweden)

    G. L. Panfilova

    2014-02-01

    Full Text Available Introduction. Since 2002, the pharmaceutical care of the cancer patients in Ukraine is carried out centrally by public funds in the framework of the target program "Oncology." In a chronic shortage of funds in the national health care system, as well as taking into account the perspectives of the introduction of the social model of obligatory medical insurance (OMI, enhanced the importance of research on the development of rational mechanisms for the use of public funds, which are sent to drug purchases. Given the high mortality rate among cancer patients, especially in children in Ukraine, these works are of particular socio-economic importance. The aim of work. To study drug purchases that are made for cancer patients in Ukraine in order to identify the main problems and directions of rational scientific basis for the use of public funds in terms of lack of resources in health care, as well as from the perspectives of the introduction of the social model of OMI in Ukraine. Materials and methods. Objects of research: data from the National Cancer Registry, annual plans and registers of public drug procurement Ministry of Ukraine. The paper used data from national legislative and regulatory framework governing the organization of pharmaceutical support cancer patients, standard methods of statistical processing of the dynamics of the clinic-economic analysis. Results and discussion. During 2010-2013 marked increase in the amounts of permanent drug purchases for cancer patients, which is on the growth rate did not meet the dynamics of changes in the relevant during epidemiological indicators. The results integrated ABC/VEN-analysis found no drug purchasing products from the group N and with the status A/V, and the dominance of the number of agents with the status items C/V. The main volume of financial resources was directed to the purchase of drugs from the group E (84.8% - 92.4% and the status of A/E (78,9% -79,8%, as well as drug belonging to

  6. Drug research methodology. Volume 3, The detection and quantitation of drugs of interest in body fluids from drivers

    Science.gov (United States)

    1980-03-01

    This report presents the findings of a workshop on the chemical analysis of human body fluids for drugs of interest in highway safety. A cross-disciplinary panel of experts reviewed the list of drugs of interest developed in a previous workshop and d...

  7. Consensus Statement on Research Definitions for Drug-Resistant Tuberculosis in Children.

    Science.gov (United States)

    Seddon, James A; Perez-Velez, Carlos M; Schaaf, H Simon; Furin, Jennifer J; Marais, Ben J; Tebruegge, Marc; Detjen, Anne; Hesseling, Anneke C; Shah, Sarita; Adams, Lisa V; Starke, Jeffrey R; Swaminathan, Soumya; Becerra, Mercedes C

    2013-06-01

    Few children with drug-resistant (DR) tuberculosis (TB) are identified, diagnosed, and given an appropriate treatment. The few studies that have described this vulnerable population have used inconsistent definitions. The World Health Organization (WHO) definitions used for adults with DR-TB and for children with drug-susceptible TB are not always appropriate for children with DR-TB. The Sentinel Project on Pediatric Drug-Resistant Tuberculosis was formed in 2011 as a network of experts and stakeholders in childhood DR-TB. An early priority was to establish standardized definitions for key parameters in order to facilitate study comparisons and the development of an evidence base to guide future clinical management. This consensus statement proposes standardized definitions to be used in research. In particular, it suggests consistent terminology, as well as definitions for measures of exposure, drug resistance testing, previous episodes and treatment, certainty of diagnosis, site and severity of disease, adverse events, and treatment outcome. © The Author 2013. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society.

  8. Scoping Review on Research on Food conducted in the Faculty of Social Sciences. Including other Institutions in the Norwich Research Park and Beyond

    OpenAIRE

    Howard Wilsher, Stephanie

    2014-01-01

    Executive summary The scoping review was commissioned to examine what research on food has been conducted in the Faculty of Social Sciences (SSF) at the University of East Anglia (UEA) since 2005. The aim of the report is to facilitate collaborative research between SSF and the rest of the Norwich Research Park (NRP), in particular, the Institute of Food Research (IFR). However, it is important to contextualise this beyond the NRP as the Eastern Academic Research Consortium (EARC) provides fu...

  9. Drug Abuse

    Science.gov (United States)

    ... Cocaine Heroin Inhalants Marijuana Prescription drugs, including opioids Drug abuse also plays a role in many major social problems, such as drugged driving, violence, stress, and child abuse. Drug abuse can lead to ...

  10. Including Ideology

    Science.gov (United States)

    Allan, Julie

    2013-01-01

    Ellen Brantlinger's paper, "Using ideology: cases of non-recognition of the politics of research and practice in special education" (Brantlinger, E. 1997. "Using ideology: Cases of nonrecognition of the politics of research and practice in special education." "Review of Educational Research" 67, no. 4: 425-59),…

  11. Reconciling incongruous qualitative and quantitative findings in mixed methods research: exemplars from research with drug using populations.

    Science.gov (United States)

    Wagner, Karla D; Davidson, Peter J; Pollini, Robin A; Strathdee, Steffanie A; Washburn, Rachel; Palinkas, Lawrence A

    2012-01-01

    Mixed methods research is increasingly being promoted in the health sciences as a way to gain more comprehensive understandings of how social processes and individual behaviours shape human health. Mixed methods research most commonly combines qualitative and quantitative data collection and analysis strategies. Often, integrating findings from multiple methods is assumed to confirm or validate the findings from one method with the findings from another, seeking convergence or agreement between methods. Cases in which findings from different methods are congruous are generally thought of as ideal, whilst conflicting findings may, at first glance, appear problematic. However, the latter situation provides the opportunity for a process through which apparently discordant results are reconciled, potentially leading to new emergent understandings of complex social phenomena. This paper presents three case studies drawn from the authors' research on HIV risk amongst injection drug users in which mixed methods studies yielded apparently discrepant results. We use these case studies (involving injection drug users [IDUs] using a Needle/Syringe Exchange Program in Los Angeles, CA, USA; IDUs seeking to purchase needle/syringes at pharmacies in Tijuana, Mexico; and young street-based IDUs in San Francisco, CA, USA) to identify challenges associated with integrating findings from mixed methods projects, summarize lessons learned, and make recommendations for how to more successfully anticipate and manage the integration of findings. Despite the challenges inherent in reconciling apparently conflicting findings from qualitative and quantitative approaches, in keeping with others who have argued in favour of integrating mixed methods findings, we contend that such an undertaking has the potential to yield benefits that emerge only through the struggle to reconcile discrepant results and may provide a sum that is greater than the individual qualitative and quantitative parts

  12. Japan-China Joint Medical Workshop on Drug Discoveries and Therapeutics 2008: The need of Asian pharmaceutical researchers' cooperation.

    Science.gov (United States)

    Nakata, M; Tang, W

    2008-10-01

    The Japan-China Joint Medical Workshop on Drug Discoveries and Therapeutics 2008 (JCMWDDT 2008) was held from September 29 to October 1, 2008 at The University of Tokyo, Tokyo, Japan. JCMWDDT is an international workshop that is mainly organized by Asian editorial members of Drug Discoveries & Therapeutics (http://www.ddtjournal.com/home) for the purpose of promoting research exchanges in the field of drug discovery and therapeutic. This year's JCMWDDT is the second workshop and focused particularly on novel development and technological innovation of anti-influenza agents. The workshop began with an announcement by the Japanese Co-chairperson, Dr. Sekimizu (Department of Microbiology, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Japan; Editorin- Chief of Drug Discoveries & Therapeutics, DDT) followed by a speech by the Chinese Co-chairperson, Dr. Wenfang Xu (School of Pharmaceutical Sciences, Shandong University, Shandong, China; Editor in China Office of DDT), with additional speeches by Dr. Norio Matsuki (The University of Tokyo, Japan; Editor of DDT) and Dr. Guanhua Du (Chinese Academy of Medical Science, China; Editor of DDT). Fifty-nine titles were presented in 6 specialized sessions (Research Advances in Drug Discoveries and Therapeutics, Drug Synthesis/Clinical Therapeutics, Medicinal Chemistry/Natural Products, Anti-influenza Drugs, Anti-infection/antiviral Drugs, Biochemistry/Molecular Biology /Pharmacology) and a poster session (Drug Discov Ther 2008; 2, Suppl; available at http://www.ddtjournal.com/Announce/index.htm). An annual outbreak of avian influenza in Asian countries including China and Japan has sparked fears that the virus will mutate and then cause an epidemic in humans. Therefore, Asian researchers need to work together to control this infection. This year's JCMWDDT helped provide an opportunity to reiterate the crucial role of medicinal chemistry in conquering influenza and created an environment for cooperative

  13. Trafficking Golden Crescent Drugs into Western China: An Analysis and Translation of a Recent Chinese Police Research Article

    Science.gov (United States)

    2011-01-01

    illegal drug exchanges and consumption markets in Xinjiang, and soon this heroin even exceeded the market position of traditional Golden Triangle heroin...tons of the precursor chemical acetic anhydride {cusucmgan; WiW. iff) being smuggled out of the border. • 800,000 tabs of the psychoactive drug ...Trafficking Golden Crescent Drugs into Western China: An Analysis and Translation of a Recent Chinese Police Research Article Dr. Murray Scot

  14. Research on acute and chronic toxity of the experimental drug Аmprolinsyl

    Directory of Open Access Journals (Sweden)

    B. Gutyj

    2017-02-01

    Full Text Available The drug Amprolinsyl is a is a mixture of hydrochloric amprolium (12.5 g and milled fruits of the milk thistle (up to 100 g, designed to prevent and treat protozoonoses in birds, especially when mixed associative invasions occur. The fruits of the milk thistle contain the natural vitamins (A, C, E, B and the minerals (copper, iron, cobalt and other factors that significantly expand and enhance the pharmacological effect of the drug Amprolinsyl. We found that when the drug Amprolinsyl was administered intra gastrically to white rats at a dose of 5000 mg/kg and higher clinical signs of toxicity occurred after 4–5 hours. Damage to motor activity and tremors of individual muscles of these animals was observed. The rats died after 1–4 days. A direct relationship was found between the drug at a specific dosage and the death of rats. After intra gastric administration of the drug Amprolinsyl to white rats clinical signs of toxicity appeared after 5–6 hours at a dose of 4000 mg/kg body weight. These animals attempted to gather in groups and to hide in the bedding. The death of the mice occured in 1–3 days. Thus, LD50 drug of Amprolinsyl following intra gastric administration to white rats (5917 mg/kg and for white mice (5167 mg/kg. After studying the cumulative properties of Amprolinsyl, it was found that the total drug administered in avarage doses was 831 mg/kg, and the cumulative rate – 8.31. Long-term daily intragastric administration of Amprolinsyl over 24 days affected the functional state of the liver and kidneys. The magnitude of weight ratios of lungs, heart and spleen during the research period was the same as in the control group of rats. Significant changes were found only after analyzing the leukocyte profile. A reduction was observed in the number of neutrophils to 54.7% and an increase in the number of lymphocytes to 9.2%. Following prolonged daily administration of increasing doses Amprolinsyl causes a slight degradation of the

  15. Ethical issues in HIV prevention research with people who inject drugs.

    Science.gov (United States)

    Sugarman, Jeremy; Rose, Scott M; Metzger, David

    2014-04-01

    Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research. To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed. The ethical issues encountered during the life cycle of the trial were cataloged by the principal investigator, study coordinator, and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described. Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs, where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned, and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Furthermore, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration. The issues described in this article are necessarily limited to how they manifested themselves within the context of a

  16. Auxiliary variables in multiple imputation in regression with missing X: a warning against including too many in small sample research

    Directory of Open Access Journals (Sweden)

    Hardt Jochen

    2012-12-01

    Full Text Available Abstract Background Multiple imputation is becoming increasingly popular. Theoretical considerations as well as simulation studies have shown that the inclusion of auxiliary variables is generally of benefit. Methods A simulation study of a linear regression with a response Y and two predictors X1 and X2 was performed on data with n = 50, 100 and 200 using complete cases or multiple imputation with 0, 10, 20, 40 and 80 auxiliary variables. Mechanisms of missingness were either 100% MCAR or 50% MAR + 50% MCAR. Auxiliary variables had low (r=.10 vs. moderate correlations (r=.50 with X’s and Y. Results The inclusion of auxiliary variables can improve a multiple imputation model. However, inclusion of too many variables leads to downward bias of regression coefficients and decreases precision. When the correlations are low, inclusion of auxiliary variables is not useful. Conclusion More research on auxiliary variables in multiple imputation should be performed. A preliminary rule of thumb could be that the ratio of variables to cases with complete data should not go below 1 : 3.

  17. National Institute on Drug Abuse International Program: improving opioid use disorder treatment through international research training.

    Science.gov (United States)

    Gust, Steven W; McCormally, Judy

    2018-07-01

    For more than 25 years, the National Institute on Drug Abuse (NIDA) has supported research-training programs, establishing a global research network and expanding the knowledge base on substance use disorders. International research to inform approaches to opioid addiction is particularly important and relevant to the United States, where opioid misuse, addiction, and overdose constitute an emerging public health crisis. This article summarizes the NIDA International Program and illustrates its impact by reviewing recent articles about treatment approaches for opioid use disorders (OUD). Studies in several countries have demonstrated the effectiveness of physician office-based opioid substitution therapies. Other research has demonstrated the effectiveness of different formulations and doses of the opioid antagonist naltrexone, as well as different approaches to providing naloxone to treat opioid overdose. Continuing research into implementation of evidence-based treatment in international settings with limited resources is applicable to US regions that face similar structural, legal, and fiscal constraints. The current review describes international research on OUD treatment and opioid overdose, most coauthored by former NIDA fellows. The findings from outside the United States have important implications for best practices domestically and in other countries that are experiencing increases in OUD prevalence and related overdose deaths.

  18. A review of geographic variation and Geographic Information Systems (GIS) applications in prescription drug use research.

    Science.gov (United States)

    Wangia, Victoria; Shireman, Theresa I

    2013-01-01

    While understanding geography's role in healthcare has been an area of research for over 40 years, the application of geography-based analyses to prescription medication use is limited. The body of literature was reviewed to assess the current state of such studies to demonstrate the scale and scope of projects in order to highlight potential research opportunities. To review systematically how researchers have applied geography-based analyses to medication use data. Empiric, English language research articles were identified through PubMed and bibliographies. Original research articles were independently reviewed as to the medications or classes studied, data sources, measures of medication exposure, geographic units of analysis, geospatial measures, and statistical approaches. From 145 publications matching key search terms, forty publications met the inclusion criteria. Cardiovascular and psychotropic classes accounted for the largest proportion of studies. Prescription drug claims were the primary source, and medication exposure was frequently captured as period prevalence. Medication exposure was documented across a variety of geopolitical units such as countries, provinces, regions, states, and postal codes. Most results were descriptive and formal statistical modeling capitalizing on geospatial techniques was rare. Despite the extensive research on small area variation analysis in healthcare, there are a limited number of studies that have examined geographic variation in medication use. Clearly, there is opportunity to collaborate with geographers and GIS professionals to harness the power of GIS technologies and to strengthen future medication studies by applying more robust geospatial statistical methods. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Computerized clinical decision support systems for therapeutic drug monitoring and dosing: A decision-maker-researcher partnership systematic review

    Directory of Open Access Journals (Sweden)

    Weise-Kelly Lorraine

    2011-08-01

    Full Text Available Abstract Background Some drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing. Methods We conducted a decision-maker-researcher partnership systematic review. Studies from our previous review were included, and new studies were sought until January 2010 in MEDLINE, EMBASE, Evidence-Based Medicine Reviews, and Inspec databases. Randomized controlled trials assessing the effect of a CCDSS on process of care or patient outcomes were selected by pairs of independent reviewers. A study was considered to have a positive effect (i.e., CCDSS showed improvement if at least 50% of the relevant study outcomes were statistically significantly positive. Results Thirty-three randomized controlled trials were identified, assessing the effect of a CCDSS on management of vitamin K antagonists (14, insulin (6, theophylline/aminophylline (4, aminoglycosides (3, digoxin (2, lidocaine (1, or as part of a multifaceted approach (3. Cluster randomization was rarely used (18% and CCDSSs were usually stand-alone systems (76% primarily used by physicians (85%. Overall, 18 of 30 studies (60% showed an improvement in the process of care and 4 of 19 (21% an improvement in patient outcomes. All evaluable studies assessing insulin dosing for glycaemic control showed an improvement. In meta-analysis, CCDSSs for vitamin K antagonist dosing significantly improved time in therapeutic range. Conclusions CCDSSs have potential for improving process of care for therapeutic drug monitoring and dosing, specifically insulin and vitamin K antagonist dosing. However, studies were small and generally of modest quality, and effects on patient outcomes were uncertain, with no convincing

  20. Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs

    DEFF Research Database (Denmark)

    Grebely, Jason; Bruneau, Julie; Lazarus, Jeffrey V

    2017-01-01

    of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network on Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the prevention and management of HCV among PWID. This round table......, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment. This paper...

  1. The innovative use of a large-scale industry biomedical consortium to research the genetic basis of drug induced serious adverse events.

    Science.gov (United States)

    Holden, Arthur L

    2007-01-01

    The International Serious Adverse Event Consortium (SAEC) is a pharmaceutical industry and FDA led international (501 c3 non-profit) consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events (SAEs). As such, it functions with the explicit purpose of enhancing the 'public good'. Its members are (i) organizations engaged principally in the business of discovering, developing and marketing pharmaceutical products, or (ii) a charitable, governmental, or other non-profit organization with an interest in researching the molecular basis of drug response.Drug-induced, rare SAEs present significant health issues for patients; and pose challenges for the safe use of approved drugs and the development of new drugs. Examples of drug-induced, rare SAEs include hepatotoxicity, QT prolongation, rhabdomyolosis, serious skin rashes (e.g. SJS), edema, acute renal failure, acute hypersensitivity, anemias/neutropenias, excessive weigh gain, retinopathy, vasculitis, among others. The rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company or research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is industry, government and health care providers can join forces to make use of a variety of sample and data resources in researching the genetic basis of these events.The purpose of the SAEC is threefold:•To carry out research directed toward the discovery of DNA-variants clinically useful in understanding and predicting the risk of drug induced serious adverse events and similar scientific research.•To ensure the widespread availability of the results of such research to the scientific research community and the public at large for no charge through publication and web-based methods; and•To educate the scientific research and medical

  2. Benchtop-NMR and MRI--a new analytical tool in drug delivery research.

    Science.gov (United States)

    Metz, Hendrik; Mäder, Karsten

    2008-12-08

    During the last years, NMR spectroscopy and NMR imaging (magnetic resonance imaging, MRI) have been increasingly used to monitor drug delivery systems in vitro and in vivo. However, high installation and running costs of the commonly used superconducting magnet technology limits the application range and prevents the further spread of this non-invasive technology. Benchtop-NMR (BT-NMR) relaxometry uses permanent magnets and is much less cost intensive. BT-NMR relaxometry is commonly used in the food and chemical industry, but so far scarcely used in the pharmaceutical field. The paper shows on several examples that the application field of BT-NMR relaxometry can be extended into the field of drug delivery, including the characterisation of emulsions and lipid ingredients (e.g. the amount and physicochemical state of the lipid) and the monitoring of adsorption characteristics (e.g. oil binding of porous ingredients). The most exciting possibilities of BT-NMR technology are linked with the new development of BT-instruments with imaging capability. BT-MRI examples on the monitoring of hydration and swelling of HPMC-based monolayer and double-layer tablets are shown. BT-MRI opens new MRI opportunities for the non-invasive monitoring of drug delivery processes.

  3. Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs

    Directory of Open Access Journals (Sweden)

    Elisa Chilet-Rosell

    2014-12-01

    Full Text Available This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.

  4. Gender bias in clinical research, pharmaceutical marketing, and the prescription of drugs.

    Science.gov (United States)

    Chilet-Rosell, Elisa

    2014-01-01

    This thesis is part of the studies of gender bias in health which together with the paradigm of evidence-based medicine shares the empirical assumption that there are inaccuracies in medical practice, in addition to a lack of rigour and transparency. It worked with the distinction between the concepts of sex and gender and between the concepts of sex-related differences and gender inequalities, in terms of applying a gender perspective in the study design and the subsequent analysis. This PhD review presents the research process conducted in Spain, which can provide an example for future research. Study I described a review of 58 clinical trials (CTs) of etoricoxib to assess its compliance with the Recommendations of Evaluation of Gender Differences in the Clinical Evaluation of Drugs. In Study II, key informants from professions related to different areas in drug development and pharmacovigilance held a working meeting to reach a consensus document on recommendations for the study and evaluation of gender differences in CTs in Spain. In Study III, the websites of the eight best-selling hormone replacement therapy drugs in Spain on Google first page of results were analysed. In Study IV, a logistic regression analysis was performed to compare analgesic prescription by sex in regions with a higher or lower Gender Development Index (GDI) than the Spanish average. Gender biases identified in this thesis limited the legitimacy of medicine, which is not based on the best possible evidence. The results also demonstrate the existence of inequalities between men and women that are not due merely to biological differences, but are gender inequalities stemming from the social differences that exist between both sexes.

  5. Research progress of PARP-1 inhibitors in antitumor drugs and radionuclide markers

    International Nuclear Information System (INIS)

    Zhao Lingzhou; Zhang Huabei

    2011-01-01

    Poly(ADP-ribose)polymerase (PARP) is a new target in the cancer treatment nowadays. PARP not only can repair DNA damage, regulate and control transcription, maintain the stability of intracellular environment and genome, regulate the process of cell survival and death, but also is the main transcription factor in the development of inflammation and the process of cancer. To inhibit PARP activity can reduce the DNA repair function in tumor cells, and increase the sensibility to DNA damage agents, so as to improve the efficacy of radiation therapy and chemotherapy for tumor. A number of studies have suggested that, whether used alone or combination with other chemotherapy drugs, PARP inhibitors show the potential in the anti-tumor therapeutic areas. In this paper, PARP-1 inhibitors were reviewed in antitumor research progress. According to the stage of development , PARP-1 inhibitors are classified. Several representative PARP-1 inhibitors, in clinical trials, with potential clinical value were introduced. Positron emission tomography (PET), uses the main short half-life elementary in human body as tracer, and at the molecular level, achieve the no wound, quantitative and dynamic observation about the different changes of metabolites or drugs in the body. PET is the most advanced contemporary video diagnostic technology, and this paper simply introduce the research progress of PARP-1 inhibitors labeled with radioactive nuclides. (authors)

  6. Chiral drug analysis using mass spectrometric detection relevant to research and practice in clinical and forensic toxicology.

    Science.gov (United States)

    Schwaninger, Andrea E; Meyer, Markus R; Maurer, Hans H

    2012-12-21

    This paper reviews analytical approaches published in 2002-2012 for chiral drug analysis and their relevance in research and practice in the field of clinical and forensic toxicology. Separation systems such as gas chromatography, high performance liquid chromatography, capillary electromigration, and supercritical fluid chromatography, all coupled to mass spectrometry, are discussed. Typical applications are reviewed for relevant chiral analytes such as amphetamines and amphetamine-derived designer drugs, methadone, tramadol, psychotropic and other CNS acting drugs, anticoagulants, cardiovascular drugs, and some other drugs. Usefulness of chiral drug analysis in the interpretation of analytical results in clinical and forensic toxicology is discussed as well. Copyright © 2012 Elsevier B.V. All rights reserved.

  7. Development of a Course-Based Undergraduate Research Experience to Introduce Drug-Receptor Concepts

    Directory of Open Access Journals (Sweden)

    Hollie I. Swanson

    2016-01-01

    Full Text Available Course-based research experiences (CUREs are currently of high interest due to their potential for engaging undergraduate students in authentic research and maintaining their interest in science, technology, engineering, and mathematics (STEM majors. As part of a campus-wide initiative called STEMCats , which is a living learning program offered to freshman STEM majors at the University of Kentucky funded by a grant from Howard Hughes Medical Institute, we have developed a CURE for freshmen interested in pursuing health care careers. Our course, entitled “Drug–Drug Interactions in Breast Cancer,” utilized a semester-long, in-class authentic research project and instructor-led discussions to engage students in a full spectrum of research activities, ranging from developing hypotheses and experimental design to generating original data, collaboratively interpreting results and presenting a poster at a campus-wide symposium. Student's feedback indicated a positive impact on scientific understanding and skills, enhanced teamwork and communication skills, as well as high student engagement, motivation, and STEM belonging. STEM belonging is defined as the extent to which a student may view the STEM fields as places where they belong. The results obtained from this pilot study, while preliminary, will be useful for guiding design revisions and generating appropriate objective evaluations of future pharmacological-based CUREs.

  8. Pushing the accelerator - speeding up drug research with accelerator mass spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Garner, R.C. E-mail: colin.garner@cbams.co.uk; Leong, D

    2000-10-01

    Accelerator mass spectrometry (AMS) is the most sensitive analytical method yet developed for elemental isotope analysis and has a broad range of applications. The measurement of {sup 14}C is of most interest to biomedical researchers but few studies have been reported using AMS in drug discovery and development. For biomedical use, {sup 14}C is incorporated into organic molecules by either radiosynthesis or biosynthetically and the isotope is used as a surrogate for the distribution of the radiolabelled molecule either in animal or human studies. The majority of users of {sup 14}C quantitate the radioactivity using decay counting usually with a liquid scintillation counter (LSC). Our Centre over the past 12 months has been evaluating and validating the use of AMS as an alternative detection method. In vitro spiking studies of human plasma with {sup 14}C-Fluconazole, a prescription antifungal drug has demonstrated an excellent correlation between AMS and LSC (correlation coefficient 0.999). Human Phase I clinical studies have been conducted with radioactive doses ranging from 120 Bq (7000 dpm) to 11 kBq (300 nCi) to provide mass balance, plasma concentration and radioactive metabolite profiling data. Limits of detection of 0.00022 Bq {sup 14}C-labelled drug/ml plasma have been accurately quantitated in a plasma background of 0.0078 Bq/ml (0.013 dpm/ml in a plasma background of 0.47 dpm/ml or 2.72 pMC in a background of 90.19 pMC)

  9. Research of Ultrasound-Mediated Transdermal Drug Delivery System Using Cymbal-Type Piezoelectric Composite Transducer

    Science.gov (United States)

    Huan, Huiting; Gao, Chunming; Liu, Lixian; Sun, Qiming; Zhao, Binxing; Yan, Laijun

    2015-06-01

    Transdermal drug delivery (TDD) implemented by especially low-frequency ultrasound is generally known as sonophoresis or phonophoresis which has drawn considerable wide attention. However, TDD has not yet achieved its full potential as an alternative to conventional drug delivery methods due to its bulky instruments. In this paper, a cymbal-type piezoelectric composite transducer (CPCT) which has advantages over a traditional ultrasound generator in weight, flexibility, and power consumption, is used as a substitute ultrasonicator to realize TDD. First, theoretical research on a CPCT based on the finite element analysis was carried out according to which a series of applicable CPCTs with bandwidths of 20 kHz to 100 kHz were elaborated. Second, a TDD experimental setup was built with previously fabricated CPCTs aimed at the administration of glucose. Finally, the TDD performance of glucose molecule transport in porcine skin was measured in vitro by quantifying the concentration of glucose, and the time variation curves were subsequently obtained. During the experiment, the driving wave form, frequency, and power consumption of the transducers were selected as the main elements which determined the efficacy of glucose delivery. The results indicate that the effectiveness of the CPCT-based delivery is constrained more by the frequency and intensity of ultrasound rather than the driving waveform. The light-weight, flexibility, and low-power consumption of a CPCT can potentially achieve effective TDD.

  10. Compliance revisited: pharmaceutical drug trials in the era of the contract research organization.

    Science.gov (United States)

    Jonvallen, Petra

    2009-12-01

    Over the past decade, the management of clinical trials of pharmaceuticals has become a veritable industry, as evidenced by the emergence and proliferation of contract research organizations (CROs) that co-ordinate and monitor trials. This article focuses on work performed by one CRO involved in the introduction of new software, modelled on industrial production processes, into clinical trial practices. It investigates how this new management technique relates to the work performed in the clinic to ensure that trial participants comply with the protocol. Using an analytical distinction between 'classical' management work and invisible work, the article contextualizes the meaning of compliance in the clinic and suggests that the work involved in producing compliance should be taken into consideration by those concerned with validity of trials, as clinical trials are put under private industrial management. The article builds on participant observation at a Swedish university hospital and interviews the nurses, dieticians, doctors and a software engineer, all part of a team involved in pharmaceutical drug trials on a potential obesity drug.

  11. Factors for incomplete adherence to antiretroviral therapy including drug refill and clinic visits among older adults living with human immunodeficiency virus - cross-sectional study in South Africa.

    Science.gov (United States)

    Barry, Abbie; Ford, Nathan; El-Khatib, Ziad

    2018-03-01

    To assess adherence outcomes to antiretroviral therapy (ART) of recipients ≥50 years in Soweto, South Africa. This was a secondary data analysis for a cross-sectional study at two HIV clinics in Soweto. Data on ART adherence and covariates were gathered through structured interviews with HIV 878 persons living with HIV (PLHIV) receiving ART. Logistic regression analysis was used to assess associations. PLHIV ≥50 years (n = 103) were more likely to miss clinic visits during the last six months than PLHIV aged 25-49 (OR 2.15; 95%CI 1.10-4.18). PLHIV ≥50 years with no or primary-level education were less likely to have missed a clinic visit during the last six months than PLHIV with secondary- or tertiary-level education in the same age category (OR 0.3; 95%CI 0.1-1.1), as were PLHIV who did not disclose their status (OR 0.2; 95%CI 0-1.1). There was no evidence of increased risk for non-adherence to ART pills and drug refill visits among older PLHIV. Missing a clinic visit was more common among older PLHIV who were more financially vulnerable. Further studies are needed to verify these findings and identify new risk factors associated with ART adherence. © 2017 John Wiley & Sons Ltd.

  12. Low-rank coal research. Final technical report, April 1, 1988--June 30, 1989, including quarterly report, April--June 1989

    Energy Technology Data Exchange (ETDEWEB)

    1989-12-31

    This work is a compilation of reports on ongoing research at the University of North Dakota. Topics include: Control Technology and Coal Preparation Research (SO{sub x}/NO{sub x} control, waste management), Advanced Research and Technology Development (turbine combustion phenomena, combustion inorganic transformation, coal/char reactivity, liquefaction reactivity of low-rank coals, gasification ash and slag characterization, fine particulate emissions), Combustion Research (fluidized bed combustion, beneficiation of low-rank coals, combustion characterization of low-rank coal fuels, diesel utilization of low-rank coals), Liquefaction Research (low-rank coal direct liquefaction), and Gasification Research (hydrogen production from low-rank coals, advanced wastewater treatment, mild gasification, color and residual COD removal from Synfuel wastewaters, Great Plains Gasification Plant, gasifier optimization).

  13. Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

    Science.gov (United States)

    Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E

    2017-12-01

    This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Simplifying sample pretreatment: application of dried blood spot (DBS) method to blood samples, including postmortem, for UHPLC-MS/MS analysis of drugs of abuse.

    Science.gov (United States)

    Odoardi, Sara; Anzillotti, Luca; Strano-Rossi, Sabina

    2014-10-01

    The complexity of biological matrices, such as blood, requires the development of suitably selective and reliable sample pretreatment procedures prior to their instrumental analysis. A method has been developed for the analysis of drugs of abuse and their metabolites from different chemical classes (opiates, methadone, fentanyl and analogues, cocaine, amphetamines and amphetamine-like substances, ketamine, LSD) in human blood using dried blood spot (DBS) and subsequent UHPLC-MS/MS analysis. DBS extraction required only 100μL of sample, added with the internal standards and then three droplets (30μL each) of this solution were spotted on the card, let dry for 1h, punched and extracted with methanol with 0.1% of formic acid. The supernatant was evaporated and the residue was then reconstituted in 100μL of water with 0.1% of formic acid and injected in the UHPLC-MS/MS system. The method was validated considering the following parameters: LOD and LOQ, linearity, precision, accuracy, matrix effect and dilution integrity. LODs were 0.05-1ng/mL and LOQs were 0.2-2ng/mL. The method showed satisfactory linearity for all substances, with determination coefficients always higher than 0.99. Intra and inter day precision, accuracy, matrix effect and dilution integrity were acceptable for all the studied substances. The addition of internal standards before DBS extraction and the deposition of a fixed volume of blood on the filter cards ensured the accurate quantification of the analytes. The validated method was then applied to authentic postmortem blood samples. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. RD and D-Programme 2004. Programme for research, development and demonstration of methods for the management and disposal of nuclear waste, including social science research

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-09-01

    SKB (the Swedish Nuclear Fuel and Waste Management Co), which is owned by the companies that operate the Swedish nuclear power plants, has been assigned the task of managing and disposing of the spent nuclear fuel from the reactors. The Nuclear Activities Act requires a programme of comprehensive research and development and other measures that are needed to manage and dispose of nuclear waste in a safe manner and to decommission and dismantle the nuclear power plants. SKB is now presenting RD and D-Programme 2004 in fulfilment of this requirement. The programme describes SKB's plans for the period 2005-2010. The period of immediate concern is 2005-2007. The level of detail for the three subsequent years is naturally lower.The programme provides a basis for designing systems for safe management and disposal of the radioactive waste from the nuclear power plants. SKB's plan is to implement deep disposal of the spent fuel in accordance with the KBS-3 method. In the RD and D-Programme we describe our activities and planning for this line of action and the work that is being conducted on alternative methods. Review of the programme can contribute valuable outside viewpoints. The regulatory authorities and the Government can clarify how they look upon different parts of the programme and stipulate guidelines for the future. Municipalities and other stakeholders can, after studying the programme, offer their viewpoints to SKB, the regulatory authorities or the Government.The goal for the period up to the end of 2008 is to be able to submit permit applications for the encapsulation plant and the deep repository. This RD and D-Programme therefore differs from the preceding ones in that it concentrates on questions relating to technology development for these facilities. The programmes for safety assessment and research on the long-term processes that take place in the deep repository are then linked together with the programmes for technology development. Another new

  16. RD and D-Programme 2004. Programme for research, development and demonstration of methods for the management and disposal of nuclear waste, including social science research

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-09-01

    SKB (the Swedish Nuclear Fuel and Waste Management Co), which is owned by the companies that operate the Swedish nuclear power plants, has been assigned the task of managing and disposing of the spent nuclear fuel from the reactors. The Nuclear Activities Act requires a programme of comprehensive research and development and other measures that are needed to manage and dispose of nuclear waste in a safe manner and to decommission and dismantle the nuclear power plants. SKB is now presenting RD and D-Programme 2004 in fulfilment of this requirement. The programme describes SKB's plans for the period 2005-2010. The period of immediate concern is 2005-2007. The level of detail for the three subsequent years is naturally lower.The programme provides a basis for designing systems for safe management and disposal of the radioactive waste from the nuclear power plants. SKB's plan is to implement deep disposal of the spent fuel in accordance with the KBS-3 method. In the RD and D-Programme we describe our activities and planning for this line of action and the work that is being conducted on alternative methods. Review of the programme can contribute valuable outside viewpoints. The regulatory authorities and the Government can clarify how they look upon different parts of the programme and stipulate guidelines for the future. Municipalities and other stakeholders can, after studying the programme, offer their viewpoints to SKB, the regulatory authorities or the Government.The goal for the period up to the end of 2008 is to be able to submit permit applications for the encapsulation plant and the deep repository. This RD and D-Programme therefore differs from the preceding ones in that it concentrates on questions relating to technology development for these facilities. The programmes for safety assessment and research on the long-term processes that take place in the deep repository are then linked together with the programmes for technology development. Another

  17. RD and D-Programme 2004. Programme for research, development and demonstration of methods for the management and disposal of nuclear waste, including social science research

    International Nuclear Information System (INIS)

    2004-09-01

    SKB (the Swedish Nuclear Fuel and Waste Management Co), which is owned by the companies that operate the Swedish nuclear power plants, has been assigned the task of managing and disposing of the spent nuclear fuel from the reactors. The Nuclear Activities Act requires a programme of comprehensive research and development and other measures that are needed to manage and dispose of nuclear waste in a safe manner and to decommission and dismantle the nuclear power plants. SKB is now presenting RD and D-Programme 2004 in fulfilment of this requirement. The programme describes SKB's plans for the period 2005-2010. The period of immediate concern is 2005-2007. The level of detail for the three subsequent years is naturally lower.The programme provides a basis for designing systems for safe management and disposal of the radioactive waste from the nuclear power plants. SKB's plan is to implement deep disposal of the spent fuel in accordance with the KBS-3 method. In the RD and D-Programme we describe our activities and planning for this line of action and the work that is being conducted on alternative methods. Review of the programme can contribute valuable outside viewpoints. The regulatory authorities and the Government can clarify how they look upon different parts of the programme and stipulate guidelines for the future. Municipalities and other stakeholders can, after studying the programme, offer their viewpoints to SKB, the regulatory authorities or the Government.The goal for the period up to the end of 2008 is to be able to submit permit applications for the encapsulation plant and the deep repository. This RD and D-Programme therefore differs from the preceding ones in that it concentrates on questions relating to technology development for these facilities. The programmes for safety assessment and research on the long-term processes that take place in the deep repository are then linked together with the programmes for technology development. Another new

  18. [Moderation-integrated-balance presupposition of Chinese medicine compound and pharmacological problems in traditional Chinese drug research].

    Science.gov (United States)

    Zhao, Jun-Ning

    2017-03-01

    The moderation-integrated-balance presupposition (MIBP) of Chinese medicine compound was first proposed in this paper based on the review of function characteristics and action principles of Chinese medicine compound. Furthermore, the pharmacological problems of traditional Chinese drug research were discussed in details. The results were of important value in accelerating the transformation of traditional Chinese medicine compound, and constructing the new drug innovation and review system for traditional Chinese medicine. Copyright© by the Chinese Pharmaceutical Association.

  19. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.

    Science.gov (United States)

    Dechartres, Agnes; Trinquart, Ludovic; Atal, Ignacio; Moher, David; Dickersin, Kay; Boutron, Isabelle; Perrodeau, Elodie; Altman, Douglas G; Ravaud, Philippe

    2017-06-08

    Objective  To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades. Design  Mapping of trials included in Cochrane reviews. Data sources  Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data. Data extraction  For each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors. Main outcomes measures  We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively. Results  We analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment. Conclusions  Poor reporting and inadequate methods have decreased over time, especially for sequence generation

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

    Science.gov (United States)

    Anker, Justin J; Carroll, Marilyn E

    2010-11-01

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

  1. Predicting Adolescent Drug Abuse: A Review of Issues, Methods and Correlates. Research Issues 11.

    Science.gov (United States)

    Lettieri, Dan J., Ed.

    Presented are 18 papers on predicting adolescent drug abuse. The papers have the following titles: "Current Issues in the Epidemiology of Drug Abuse as Related to Psychosocial Studies of Adolescent Drug Use"; "The Quest for Interpersonal Predictors of Marihuana Abuse in Adolescents"; "Assessing the Interpersonal Determinants of Adolescent Drug…

  2. Functional genetic research for radiation and drug resistant adenocarcinoma and its application

    Energy Technology Data Exchange (ETDEWEB)

    Kim, In Gyu; Kim, Kug Chan; Jung, Il Lae; Chul, Shin Byung; Kook, Park Hyo; Lee, Hee Min

    2012-01-15

    The work scope of 'Functional genetic research for radiation and drug resistant adenocarcinoma and its application' had contained the research about effect of transgelin(SM22a), neurotensin, metallothionein-1G transgelin-2 genes on the cell death triggered ionizing radiation, cisplatin, MMS, luteolin and H{sub 2}O{sub 2}(toxic agents), which are highly expressed in radiation-induced mutant cells. In this study, to elucidate the role of these proteins in the ionizing radiation (toxic chemicals)-induced cell death, we utilized sensed (or antisense, small interference RNA) cells, which overexpress (or down-regulate) RNAs associated with these proteins biosynthesis, and investigated the effects of these genes on the cytotoxicity caused by ionizing radiation, H{sub 2}O{sub 2} and toxic chemicals. We also investigated the functions of downstream target genes of transgelin such as IGF-1Rβ/PI3K/AKT pathway and transgelin/metallothioneine in A-549 and HepG2 cells because such target genes are able to potentiate the cell-killing or cell protecting effects against radiation.

  3. Functional genetic research for radiation and drug resistant adenocarcinoma and its application

    International Nuclear Information System (INIS)

    Kim, In Gyu; Kim, Kug Chan; Jung, Il Lae; Chul, Shin Byung; Kook, Park Hyo; Lee, Hee Min

    2012-01-01

    The work scope of 'Functional genetic research for radiation and drug resistant adenocarcinoma and its application' had contained the research about effect of transgelin(SM22a), neurotensin, metallothionein-1G transgelin-2 genes on the cell death triggered ionizing radiation, cisplatin, MMS, luteolin and H 2 O 2 (toxic agents), which are highly expressed in radiation-induced mutant cells. In this study, to elucidate the role of these proteins in the ionizing radiation (toxic chemicals)-induced cell death, we utilized sensed (or antisense, small interference RNA) cells, which overexpress (or down-regulate) RNAs associated with these proteins biosynthesis, and investigated the effects of these genes on the cytotoxicity caused by ionizing radiation, H 2 O 2 and toxic chemicals. We also investigated the functions of downstream target genes of transgelin such as IGF-1Rβ/PI3K/AKT pathway and transgelin/metallothioneine in A-549 and HepG2 cells because such target genes are able to potentiate the cell-killing or cell protecting effects against radiation

  4. RHODIOLA ROSEA: STATUS OF RESEARCH AND POSSIBILITIES FOR COSMECEUTICAL AND DERMATOLOGICAL DRUGS PRODUCTION

    Directory of Open Access Journals (Sweden)

    E. F. Stepanova

    2016-01-01

    Full Text Available Rhodiola rosea is one of the most popular adaptogene agents. Apart from adaptogene, it has the whole range of other pharmaceutical properties: antioxidant, nootropic, antidepressant, immunomodulatory, and other. Russian industry manufactures liquid extract of Rhodiola rosea, as well as food BAS based on the Rhodiola rosea, but there are no dosage forms for external use.The purpose of this work is to analyze scientific information about general characteristics of the pharmacological activity and possible use of Rhodiola rosea in external drugs and cosmetics.Methods. The following resources were used for general characteristic of Rhodiola rosea, its pharmacological properties, particularly the usage of Rhodiola rosea in medical and cosmetic practices, as well prospects of its external use: eLIBRARY, PubMed, Cyberleninca, ResearchGate, information from manufacturers and dealers web-pages.Results. Rhodiola drugs are considered prospective agents for depressions therapy, Parkinson disease treatment, memory, attention defects, for arrhythmia prevention, stamina increase, and stress level decrease in sport and space medicine, for acceptability and efficiency improvement of chemo- and radiotherapy, as immunostimulatory agent. Nowadays in the Russian Federation Rhodiola rosea liquid extract is used as a tonic agent and is prescribed for over-fatigue in healthy persons, and for the sick, weakened as the result of a long-term treatment. Literature has sufficient amount of data about possible effect of biologically active substances of Rhodiola rosea at external use: antioxidant and antimicrobial, bleaching, UV-protective, metabolism stimulating.Conclusion. Thus, the data obtained give evidence about the prospect of Rhodiola use in cosmeceutics and prove the experience of its traditional use for withering and fat skin treatment, as well as acne.

  5. Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders' views in South Wales.

    Science.gov (United States)

    Wood, Fiona; Prout, Hayley; Bayer, Antony; Duncan, Donna; Nuttall, Jacqueline; Hood, Kerenza; Butler, Christopher C

    2013-08-09

    Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies. Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes. Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study. Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a

  6. Including Youth with Intellectual Disabilities in Health Promotion Research: Development and Reliability of a Structured Interview to Assess the Correlates of Physical Activity among Youth

    Science.gov (United States)

    Curtin, Carol; Bandini, Linda G.; Must, Aviva; Phillips, Sarah; Maslin, Melissa C. T.; Lo, Charmaine; Gleason, James M.; Fleming, Richard K.; Stanish, Heidi I.

    2016-01-01

    Background: The input of youth with intellectual disabilities in health promotion and health disparities research is essential for understanding their needs and preferences. Regular physical activity (PA) is vital for health and well-being, but levels are low in youth generally, including those with intellectual disabilities. Understanding the…

  7. Improvement of basic food crops in Africa through plant breeding, including the use of induced mutations. Proceedings of a final research co-ordination meeting

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    The Co-ordinated Research Programme (CRP) on Improvement of Basic Food Crops in Africa Through Plant Breeding, Including the Use of Induced Mutations, funded by the Italian Government, was initiated in 1989 in the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture. The primary objective of this CRP was to breed improved varieties of stable food crops of Africa with the main emphasis on the indigenous species and their local cultivars. The fourth and final Research Co-ordination meeting under the CRP was held in Naples, Italy from 30 October - 3 November 1995. This publication includes the reports, conclusions and recommendations made by the participants. We hope that it will be of value to researchers, students and policy makers alike in their endeavour to promote plant breeding and increase food productions in Africa. Refs, figs, tabs.

  8. Improvement of basic food crops in Africa through plant breeding, including the use of induced mutations. Proceedings of a final research co-ordination meeting

    International Nuclear Information System (INIS)

    1997-07-01

    The Co-ordinated Research Programme (CRP) on Improvement of Basic Food Crops in Africa Through Plant Breeding, Including the Use of Induced Mutations, funded by the Italian Government, was initiated in 1989 in the Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture. The primary objective of this CRP was to breed improved varieties of stable food crops of Africa with the main emphasis on the indigenous species and their local cultivars. The fourth and final Research Co-ordination meeting under the CRP was held in Naples, Italy from 30 October - 3 November 1995. This publication includes the reports, conclusions and recommendations made by the participants. We hope that it will be of value to researchers, students and policy makers alike in their endeavour to promote plant breeding and increase food productions in Africa. Refs, figs, tabs

  9. The inflammatory & neurodegenerative (I&ND) hypothesis of depression: leads for future research and new drug developments in depression.

    Science.gov (United States)

    Maes, Michael; Yirmyia, Raz; Noraberg, Jens; Brene, Stefan; Hibbeln, Joe; Perini, Giulia; Kubera, Marta; Bob, Petr; Lerer, Bernard; Maj, Mario

    2009-03-01

    Despite extensive research, the current theories on serotonergic dysfunctions and cortisol hypersecretion do not provide sufficient explanations for the nature of depression. Rational treatments aimed at causal factors of depression are not available yet. With the currently available antidepressant drugs, which mainly target serotonin, less than two thirds of depressed patients achieve remission. There is now evidence that inflammatory and neurodegenerative (I&ND) processes play an important role in depression and that enhanced neurodegeneration in depression may-at least partly-be caused by inflammatory processes. Multiple inflammatory-cytokines, oxygen radical damage, tryptophan catabolites-and neurodegenerative biomarkers have been established in patients with depression and these findings are corroborated by animal models of depression. A number of vulnerability factors may predispose towards depression by enhancing inflammatory reactions, e.g. lower peptidase activities (dipeptidyl-peptidase IV, DPP IV), lower omega-3 polyunsaturated levels and an increased gut permeability (leaky gut). The cytokine hypothesis considers that external, e.g. psychosocial stressors, and internal stressors, e.g. organic inflammatory disorders or conditions, such as the postpartum period, may trigger depression via inflammatory processes. Most if not all antidepressants have specific anti-inflammatory effects, while restoration of decreased neurogenesis, which may be induced by inflammatory processes, may be related to the therapeutic efficacy of antidepressant treatments. Future research to disentangle the complex etiology of depression calls for a powerful paradigm shift, i.e. by means of a high throughput-high quality screening, including functional genetics and genotyping microarrays; established and novel animal and ex vivo-in vitro models for depression, such as new transgenic mouse models and endophenotype-based animal models, specific cell lines, in vivo and ex vivo

  10. A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

    Science.gov (United States)

    Liu, Xiao; Chen, Hsinchun

    2015-12-01

    Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

  11. The impact of the Food and Drug Administration Modernization Act on the recruitment of children for research.

    Science.gov (United States)

    Sharav, Vera Hassner

    2003-01-01

    This article argues that contrary to the claims made by research stakeholders in industry, academia and government, the shift in public policy since the enactment of the Food and Drug Administration Modernization Act (FDAMA) of 1997 and its financial incentives to industry to test drugs on children, has had a deleterious impact on children's dignity, health and welfare. Those lucrative incentives offered an opportunity to accelerate the pace of FDA approval for pediatric drug marketing. FDAMA resulted in a radical shift in federal policy to accommodate an expansion of pediatric trials. Children who are precluded from exercising a human adult's right to informed consent to research are increasingly sought as test subjects even when the trials offer no potential benefit for them. Prior to FDAMA children were protected under federal regulations that prohibited their recruitment for experiments that were not in their best interest. This article discusses eight cases and controversies demonstrating that children have been subjected to experiments that exposed them to pain, discomfort, and serious risks of harm. Babies have died testing a lethal heartburn drug; children have been subjected to "forced dose titration" in antidepressant drug trials that resulted in several suicide attempts. Toddlers are currently being subjected to methylphenidate dose tolerance tests without evidence of any pathological condition. Healthy teenagers are being exposed to antipsychotic drugs known to induce severe pathological side effects in speculative "schizophrenia prevention" experiments.

  12. Evaluating the impact of Mexico's drug policy reforms on people who inject drugs in Tijuana, B.C., Mexico, and San Diego, CA, United States: a binational mixed methods research agenda.

    Science.gov (United States)

    Robertson, Angela M; Garfein, Richard S; Wagner, Karla D; Mehta, Sanjay R; Magis-Rodriguez, Carlos; Cuevas-Mota, Jazmine; Moreno-Zuniga, Patricia Gonzalez; Strathdee, Steffanie A

    2014-02-12

    Policymakers and researchers seek answers to how liberalized drug policies affect people who inject drugs (PWID). In response to concerns about the failing "war on drugs," Mexico recently implemented drug policy reforms that partially decriminalized possession of small amounts of drugs for personal use while promoting drug treatment. Recognizing important epidemiologic, policy, and socioeconomic differences between the United States-where possession of any psychoactive drugs without a prescription remains illegal-and Mexico-where possession of small quantities for personal use was partially decriminalized, we sought to assess changes over time in knowledge, attitudes, behaviors, and infectious disease profiles among PWID in the adjacent border cities of San Diego, CA, USA, and Tijuana, Baja California, Mexico. Based on extensive binational experience and collaboration, from 2012-2014 we initiated two parallel, prospective, mixed methods studies: Proyecto El Cuete IV in Tijuana (n = 785) and the STAHR II Study in San Diego (n = 575). Methods for sampling, recruitment, and data collection were designed to be compatible in both studies. All participants completed quantitative behavioral and geographic assessments and serological testing (HIV in both studies; hepatitis C virus and tuberculosis in STAHR II) at baseline and four semi-annual follow-up visits. Between follow-up assessment visits, subsets of participants completed qualitative interviews to explore contextual factors relating to study aims and other emergent phenomena. Planned analyses include descriptive and inferential statistics for quantitative data, content analysis and other mixed-methods approaches for qualitative data, and phylogenetic analysis of HIV-positive samples to understand cross-border transmission dynamics. Investigators and research staff shared preliminary findings across studies to provide feedback on instruments and insights regarding local phenomena. As a result, recruitment and data

  13. Integrated health outcomes research strategies in drug or medical device development, pre- and postmarketing: time for change.

    Science.gov (United States)

    Badía, Xavier; Guyver, Alice; Magaz, Sol; Bigorra, Juan

    2002-06-01

    The implementation of health outcomes research as a healthcare decision-making tool has expanded rapidly in the last decade. Drugs and medical devices are increasingly being required to demonstrate not only their efficacy and safety characteristics, but also their performance in at least three core dimensions of health outcomes research: clinical effectiveness, patient-reported outcomes and economic outcomes. However, the current integration of health outcomes research lacks coordination and communication and as a result, money and time is being spent on the generation of health outcomes research data which can be both insufficient and fail to satisfy the information demands of all the relevant stakeholders. In response to this, a new paradigm is evolving which involves the implementation of health outcomes research strategies that encompass the development, pre- and postmarketing stages of a drug or medical device.

  14. Research review. Interactions between environmental chemicals and drug biotransformation in man.

    Science.gov (United States)

    Alvares, A P

    1978-01-01

    Many factors influence the metabolism of drugs in man. Besides genetic factors, environmental factors may play a significant role in explaining the variation observed in the rates of drug metabolism between different individuals. Intentional or unintentional exposure to environmental chemicals could enhance or inhibit the activity of hepatic mixed function oxidases that metabolise drugs and other foreign chemicals, as well as endogenous substrates such as steroid hormones. A major source of such exposure may be occupational. Exposure to the heavy metal, lead, has been shown to inhibit drug metabolism; whereas intensive exposure to chlorinated insecticides, and other halogenated hydrocarbons such as polychlorinated biphenyls, has been shown to enhance the metabolism of test drugs such as antipyrine and phenylbutazone. An intentional source of exposure to foreign chemicals is cigarette smoke. Cigarette smoke contains polycyclic hydrocarbons, which are known inducers of hepatic mixed function oxidases. A number of studies have shown that cigarette smoking can alter the pharmacological action and/or the metabolism of some drugs. Pharmacokinetic studies have shown that cigarette smoking decreases the bioavailability of phenacetin and increases dosage requirements of theophylline by enhancing their rate of metabolism. Data, which are not very conclusive, indicate that heavy marijuana use may have an inhibitory effect on metabolism of some drugs and an inducing effect on others such as theophylline. Dietary factors may also play a significant role in the regulation of drug metabolism. Charcoal broiling which introduces polycyclic hydrocarbons into foods has been shown to enhance the metabolism of the test drug, antipyrine, and of such commonly used drugs as phenacetin and theophylline. Such intentional or unintentional exposure to environmental chemicals which may alter the rates of drug metabolism in man indicates the importance of individualisation of drug therapy.

  15. Consensus Statement on Research Definitions for Drug-Resistant Tuberculosis in Children

    OpenAIRE

    Seddon, James A.; Perez-Velez, Carlos M.; Schaaf, H. Simon; Furin, Jennifer J.; Marais, Ben J.; Tebruegge, Marc; Detjen, Anne; Hesseling, Anneke C.; Shah, Sarita; Adams, Lisa V.; Starke, Jeffrey R.; Swaminathan, Soumya; Becerra, Mercedes C.

    2013-01-01

    Few children with drug-resistant (DR) tuberculosis (TB) are identified, diagnosed, and given an appropriate treatment. The few studies that have described this vulnerable population have used inconsistent definitions. TheWorld Health Organization (WHO) definitions used for adults with DR-TB and for children with drug-susceptible TB are not always appropriate for children with DR-TB. The Sentinel Project on Pediatric Drug-Resistant Tuberculosis was formed in 2011 as a network of experts and st...

  16. 78 FR 16679 - Center for Drug Evaluation and Research Medical Policy Council; Request for Comments

    Science.gov (United States)

    2013-03-18

    ... consistent, predictable communication of medical policy decisions to the public through guidance, notice and... protection, (6) bioresearch monitoring, (7) good clinical practice, (8) counter-terrorism drug development...

  17. Advances in research of targeting delivery and controlled release of drug-loaded nanoparticles

    International Nuclear Information System (INIS)

    Tan Zhonghua

    2003-01-01

    Biochemistry drug, at present, is still the main tool that human struggle to defeat the diseases. So, developing safe and efficacious technique of drug targeting delivery and controlled release is key to enhance curative effect, decrease drug dosage, and lessen its side effect. Drug-loaded nanoparticles, which is formed by conjugate between nanotechnology and modern pharmaceutics, is a new fashioned pharmic delivery carrier. Because of advantages in pharmic targeting transport and controlled or slow release and improving bioavailability, it has been one of developing trend of modern pharmaceutical dosage forms

  18. [Between scientific management and research-action: the problem of overconsumption of drugs in Kasongo (Zaire)].

    Science.gov (United States)

    De Brouwere, V; Van Lerberghe, W; Criel, B; Van Dormael, M

    1996-01-01

    A Primary Health Care (PHC) system may be effective and efficient to the extent that essential drugs are available in health services and financially accessible to the population. In developing countries, besides the difficulties related to supplying health services with adequate amounts of drugs, the control of drug consumption is one of the frequent problems encountered by health authorities. Literature is relatively abundant in the field of rationalization of the diagnosis and drug prescription processes, and also in the field of drug financing mechanisms; publications are however rather scarce when topics related to corruption or drug misappropriation are concerned. The case study submitted hereafter reports a drug overconsumption problem in the health centres (HC) of the Kasongo district (Zaire). Despite the existence of direct control mechanisms as well as indirect ones (monitoring of drug consumption by HC), the problem has been identified belatedly. The district staff then used a step-by-step analysis of the HC drug consumption profiles; this analysis allowed to demonstrate that misappropriation would be the most plausible hypothesis. In order to solve the misappropriation problem-the consequences of which jeopardized the functioning of the very health system-the district staff chose to involve the nurses, in charge of the HC, in the entire problem-solving process. This participative approach, involving different actors as partners, allowed to deepen the situation analysis and to elaborate solutions congruent with PHC principles and acceptable to all concerned.

  19. Development of novel, 384-well high-throughput assay panels for human drug transporters: drug interaction and safety assessment in support of discovery research.

    Science.gov (United States)

    Tang, Huaping; Shen, Ding Ren; Han, Yong-Hae; Kong, Yan; Balimane, Praveen; Marino, Anthony; Gao, Mian; Wu, Sophie; Xie, Dianlin; Soars, Matthew G; O'Connell, Jonathan C; Rodrigues, A David; Zhang, Litao; Cvijic, Mary Ellen

    2013-10-01

    Transporter proteins are known to play a critical role in affecting the overall absorption, distribution, metabolism, and excretion characteristics of drug candidates. In addition to efflux transporters (P-gp, BCRP, MRP2, etc.) that limit absorption, there has been a renewed interest in influx transporters at the renal (OATs, OCTs) and hepatic (OATPs, BSEP, NTCP, etc.) organ level that can cause significant clinical drug-drug interactions (DDIs). Several of these transporters are also critical for hepatobiliary disposition of bilirubin and bile acid/salts, and their inhibition is directly implicated in hepatic toxicities. Regulatory agencies took action to address transporter-mediated DDI with the goal of ensuring drug safety in the clinic and on the market. To meet regulatory requirements, advanced bioassay technology and automation solutions were implemented for high-throughput transporter screening to provide structure-activity relationship within lead optimization. To enhance capacity, several functional assay formats were miniaturized to 384-well throughput including novel fluorescence-based uptake and efflux inhibition assays using high-content image analysis as well as cell-based radioactive uptake and vesicle-based efflux inhibition assays. This high-throughput capability enabled a paradigm shift from studying transporter-related issues in the development space to identifying and dialing out these concerns early on in discovery for enhanced mechanism-based efficacy while circumventing DDIs and transporter toxicities.

  20. Structured evaluation of rodent behavioral tests used in drug discovery research

    Directory of Open Access Journals (Sweden)

    Anders eHånell

    2014-07-01

    Full Text Available A large variety of rodent behavioral tests are currently being used to evaluate traits such as sensory-motor function, social interactions, anxiety-like and depressive-like behavior, substance dependence and various forms of cognitive function. Most behavioral tests have an inherent complexity, and their use requires consideration of several aspects such as the source of motivation in the test, the interaction between experimenter and animal, sources of variability, the sensory modality required by the animal to solve the task as well as costs and required work effort. Of particular importance is a test’s validity because of its influence on the chance of successful translation of preclinical results to clinical settings. High validity may, however, have to be balanced against practical constraints and there are no behavioral tests with optimal characteristics. The design and development of new behavioral tests is therefore an ongoing effort and there are now well over one hundred tests described in the contemporary literature. Some of them are well established following extensive use, while others are novel and still unproven. The task of choosing a behavioral test for a particular project may therefore be daunting and the aim of the present review is to provide a structured way to evaluate rodent behavioral tests aimed at drug discovery research.

  1. How Are Gender Equality and Human Rights Interventions Included in Sexual and Reproductive Health Programmes and Policies: A Systematic Review of Existing Research Foci and Gaps

    Science.gov (United States)

    Khosla, Rajat; Krishnan, Suneeta; George, Asha; Gruskin, Sofia; Amin, Avni

    2016-01-01

    The importance of promoting gender equality and human rights in sexual and reproductive health (SRH) programmes and policies has been affirmed in numerous international and regional agreements, most recently the 2030 Agenda for Sustainable Development. Given the critical role of research to determine what works, we aimed to identify research gaps as part of a broader priority setting exercise on integrating gender equality and human rights approaches in SRH programmes and policies. A systematic literature review of reviews was conducted to examine the question: what do we know about how research in the context of SRH programmes and policies has addressed gender equality and human rights and what are the current gaps in research. We searched three databases for reviews that addressed the research question, were published between 1994–2014, and met methodological standards for systematic reviews, qualitative meta-syntheses and other reviews of relevance to the research question. Additional grey literature was identified based on expert input. Articles were appraised by the primary author and examined by an expert panel. An abstraction and thematic analysis process was used to synthesize findings. Of the 3,073 abstracts identified, 56 articles were reviewed in full and 23 were included along with 10 from the grey literature. The majority focused on interventions addressing gender inequalities; very few reviews explicitly included human rights based interventions. Across both topics, weak study designs and use of intermediate outcome measures limited evidence quality. Further, there was limited evidence on interventions that addressed marginalized groups. Better quality studies, longer-term indicators, and measurement of unintended consequences are needed to better understand the impact of these types of interventions on SRH outcomes. Further efforts are needed to cover research on gender equality and human rights issues as they pertain to a broader set of SRH topics

  2. How Are Gender Equality and Human Rights Interventions Included in Sexual and Reproductive Health Programmes and Policies: A Systematic Review of Existing Research Foci and Gaps.

    Directory of Open Access Journals (Sweden)

    Miriam Hartmann

    Full Text Available The importance of promoting gender equality and human rights in sexual and reproductive health (SRH programmes and policies has been affirmed in numerous international and regional agreements, most recently the 2030 Agenda for Sustainable Development. Given the critical role of research to determine what works, we aimed to identify research gaps as part of a broader priority setting exercise on integrating gender equality and human rights approaches in SRH programmes and policies. A systematic literature review of reviews was conducted to examine the question: what do we know about how research in the context of SRH programmes and policies has addressed gender equality and human rights and what are the current gaps in research. We searched three databases for reviews that addressed the research question, were published between 1994-2014, and met methodological standards for systematic reviews, qualitative meta-syntheses and other reviews of relevance to the research question. Additional grey literature was identified based on expert input. Articles were appraised by the primary author and examined by an expert panel. An abstraction and thematic analysis process was used to synthesize findings. Of the 3,073 abstracts identified, 56 articles were reviewed in full and 23 were included along with 10 from the grey literature. The majority focused on interventions addressing gender inequalities; very few reviews explicitly included human rights based interventions. Across both topics, weak study designs and use of intermediate outcome measures limited evidence quality. Further, there was limited evidence on interventions that addressed marginalized groups. Better quality studies, longer-term indicators, and measurement of unintended consequences are needed to better understand the impact of these types of interventions on SRH outcomes. Further efforts are needed to cover research on gender equality and human rights issues as they pertain to a broader

  3. How Are Gender Equality and Human Rights Interventions Included in Sexual and Reproductive Health Programmes and Policies: A Systematic Review of Existing Research Foci and Gaps.

    Science.gov (United States)

    Hartmann, Miriam; Khosla, Rajat; Krishnan, Suneeta; George, Asha; Gruskin, Sofia; Amin, Avni

    2016-01-01

    The importance of promoting gender equality and human rights in sexual and reproductive health (SRH) programmes and policies has been affirmed in numerous international and regional agreements, most recently the 2030 Agenda for Sustainable Development. Given the critical role of research to determine what works, we aimed to identify research gaps as part of a broader priority setting exercise on integrating gender equality and human rights approaches in SRH programmes and policies. A systematic literature review of reviews was conducted to examine the question: what do we know about how research in the context of SRH programmes and policies has addressed gender equality and human rights and what are the current gaps in research. We searched three databases for reviews that addressed the research question, were published between 1994-2014, and met methodological standards for systematic reviews, qualitative meta-syntheses and other reviews of relevance to the research question. Additional grey literature was identified based on expert input. Articles were appraised by the primary author and examined by an expert panel. An abstraction and thematic analysis process was used to synthesize findings. Of the 3,073 abstracts identified, 56 articles were reviewed in full and 23 were included along with 10 from the grey literature. The majority focused on interventions addressing gender inequalities; very few reviews explicitly included human rights based interventions. Across both topics, weak study designs and use of intermediate outcome measures limited evidence quality. Further, there was limited evidence on interventions that addressed marginalized groups. Better quality studies, longer-term indicators, and measurement of unintended consequences are needed to better understand the impact of these types of interventions on SRH outcomes. Further efforts are needed to cover research on gender equality and human rights issues as they pertain to a broader set of SRH topics

  4. Center for Cancer Research plays key role in first FDA-approved drug for treatment of Merkel cell carcinoma | Center for Cancer Research

    Science.gov (United States)

    The Center for Cancer Research’s ability to rapidly deploy integrated basic and clinical research teams at a single site facilitated the rapid FDA approval of the immunotherapy drug avelumab for metastatic Merkel cell carcinoma, a rare, aggressive form of skin cancer. Learn more...  

  5. Characterization of adolescent prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-related Surveillance (RADARS(®)) System.

    Science.gov (United States)

    Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick

    2013-02-01

    To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS(®)) System. Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all intentional exposures from 2007 through 2009 were used to describe adolescent prescription opioid (oxycodone, fentanyl, hydrocodone, hydromorphone, morphine, methadone, buprenorphine, and tramadol) and stimulant (methylphenidate and amphetamines) exposures. A total of 16,209 intentional adolescent exposures to prescription drugs were identified, 68% to opioids and 32% to stimulants. The mean age was 16.6 years (SD ± 1.7 years). Slightly more than half (52.4%) of drug mentions involved females. The five most frequently misused or abused drugs were hydrocodone (32%), amphetamines (18%), oxycodone (15%), methylphenidate (14%), and tramadol (11%). Of all exposures, 38% were classified as suspected suicidal. Of adolescents who intentionally exposed themselves to prescription drugs, 30% were treated in a health care facility, 2,792 of whom were admitted to the hospital, including 1,293 to the intensive care unit. A total of 17.2% of intentional exposures were associated with no effect, 38.9% minor effects, 23.3% moderate effects, 3.6% major effects, and 0.1% were associated with death. Oxycodone and methadone were associated with the most deaths. No deaths were associated with exposures to stimulants. Prescription drug misuse and abuse poses an important health problem and results in thousands of hospitalizations of adolescents per year. Further work is needed to develop focused interventions and educational programs to prevent prescription drug abuse and misuse by adolescents. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  6. Interaction in the Research Interview and Drug-Related Disclosures among Respondents.

    Science.gov (United States)

    Myers, Vincent

    1979-01-01

    Interviewers and respondents judged interview interactions during a survey of drug-related sentiments. Pronounced variability in interviewer-respondent judgements occurred in unanticipated ways related to gender, role, and ethnicity of participants. Positive interaction yielded different respondent cognitions and reports of illicit drug ingestion…

  7. Muons, soap, and drug delivery - an invitation to enter a new field of research

    Energy Technology Data Exchange (ETDEWEB)

    Roduner, E

    2003-02-01

    Based on a recent report on an avoided-level-crossing {mu}SR study of cosurfactant partitioning in lamellar phase systems, it is proposed that the same technique can be used to determine the partitioning of drug molecules between aqueous environments such as cell fluids and lipid-like environments of a cell membrane, or of polymer or model-lipid based liposomes. The latter serve as drug carriers and play an important role in drug delivery. Understanding the biodistribution of drugs and their partitioning in model systems is essential for the design of drug delivery concepts, but it is often difficult or impossible to obtain such information by conventional methods. It is outlined here how the muon can be used as a novel probe for such investigations.

  8. Article Commentary: Researching Prescription Drug Misuse among First Nations in Canada: Starting from a Health Promotion Framework

    Directory of Open Access Journals (Sweden)

    Colleen Anne Dell

    2012-01-01

    Full Text Available The intentional misuse of psychotropic drugs is recognized as a significant public health concern in Canada, although there is a lack of empirical research detailing this. Even less research has been documented on the misuse of prescription drugs among First Nations in Canada. In the past, Western biomedical and individual-based approaches to researching Indigenous health have been applied, whereas First Nations’ understandings of health are founded on a holistic view of wellbeing. Recognition of this disjuncture, alongside the protective influence of First Nations traditional culture, is foundational to establishing an empirical understanding of and comprehensive response to prescription drug misuse. We propose health promotion as a framework from which to begin to explore this. Our work with a health promotion framework has conveyed its potential to support the consideration of Western and Indigenous worldviews together in an ‘ethical space’, with illustrations provided. Health promotion also allots for the consideration of Canada's colonial history of knowledge production in public health and supports First Nations’ self-determination. Based on this, we recommend three immediate ways in which a health promotion framework can advance research on prescription drug misuse among First Nations in Canada.

  9. Indicators of prescribing quality in drug utilisation research : report of a European meeting (DURQUIM, 13-15 May 2004)

    NARCIS (Netherlands)

    Hoven, JL; Haaijer-Ruskamp, FM; Vander Stichele, RH

    An invitational expert meeting on indicators of prescribing quality was held on 13-15 May 2004, bringing together-from 19 European countries, the US, Canada, and Australia-40 researchers specialized in the development and application of indicators. The meeting was organized by the European Drug

  10. New and investigational antiretroviral drugs for HIV infection: mechanisms of action and early research findings.

    Science.gov (United States)

    Saag, Michael S

    2012-12-01

    Numerous investigational antiretroviral agents are in clinical development. Among them are festinavir (BMS986001), a thymidine analogue similar to stavudine with reduced potential for toxicity; GS-7340, a prodrug of tenofovir that achieves greater intracellular concentrations; MK-1439, a nonnucleoside analogue reverse transcriptase inhibitor (NNRTI) that retains activity against common NNRTI-associated resistance mutations; and albuvirtide, a long-acting parenteral fusion inhibitor. Investigational integrase strand transfer inhibitors (InSTIs) include elvitegravir, recently approved by the US Food and Drug Administration (FDA) as part of a once-daily, single-tablet formulation with cobicistat/tenofovir/emtricitabine; dolutegravir, which maintains some activity against raltegravir- and elvitegravir-resistant mutants; and S/GSK1265744, which also maintains some activity against resistance mutations in the integrase gene and is being developed as a long-lasting parenteral agent. Novel 2-(quinolin-3-yl)acetic acid derivatives (LEDGINs), agents that were originally thought to inhibit the interaction of integrase with its cofactor lens epithelium-derived growth factor p75 (LEDGF/p75), be active against InSTI-resistant mutants and to have additive activity when combined with InSTIs. This article summarizes a presentation by Michael S. Saag, MD, at the IAS-USA live Improving the Management of HCV Disease continuing medical education program held in New York in October 2012.

  11. Skin too thin? The developing utility of zebrafish skin (neuro)pharmacology for CNS drug discovery research.

    Science.gov (United States)

    Nguyen, Michael; Poudel, Manoj K; Stewart, Adam Michael; Kalueff, Allan V

    2013-09-01

    Skin coloration can be affected by many genetic, environmental and pharmacological factors. Zebrafish (Danio rerio) are a useful and versatile model organism in biomedical research due to their genetic tractability, physiological homology to mammals, low cost, reproducibility and high throughput. Zebrafish coloration is mediated by chromatophores - the skin color pigment cells largely controlled by endocrine and neural mechanisms. The characteristic darkening of zebrafish skin is caused by the dispersion (and paling - by aggregation) of melanosomes (pigment-containing organelles), which show high homology to mammalian structures. Various pharmacological agents potently affect zebrafish coloration - the phenotype that often accompanies behavioral effects of the drugs, and may be used for drug discovery. Although zebrafish behavior and skin responses are usually not directly related, they share common regulatory (neural, endocrine) mechanisms, and therefore may be assessed in parallel during psychotropic drug screening. For example, some psychoactive drugs can potently affect zebrafish skin coloration. Can we use this knowledge to refine phenotype-driven psychotropic drug discovery? Here, we present current models using zebrafish skin coloration assays, and discuss how these models may be applied to enhance in vivo CNS drug discovery. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. [Evaporation of selected cytotoxic drugs and permeation of protective gloves--research into the occupational risks of health care personnel handling hazardous cytotoxic drugs (CYTO project)].

    Science.gov (United States)

    Dolezalová, L; Odráska, P; Gorná, L; Prudilová, M; Vejpustková, R; Bláha, L

    2009-01-01

    The CYTO project studies an important aspect of healthcare provision -long-term occupational exposure, both threshold and below-threshold, to chemical agents with carcinogenic and mutagenic properties, with the major focus on antineoplastic drugs.This contribution presents experimental results from the first stages of the project's experimental work, i.e. an evaluation of the physico-chemical characteristics of cytostatic agents (evaporation) and an investigation into protective glove permeation. In co-operation with IUTA (Institut für Energie- und Umwelttechnik e.V., Duisburg, Germany), the vapour pressure of paclitaxel, doxorubicin and dacarbazine was measured following OECD guideline No. 104: Vapour pressure curve--vapour pressure balance. Furthermore, the evaporation of cytostatic drugs was examined in actual laboratory conditions by monitoring the airborne concentration using the passive sampling technique. Besides the evaporation of selected drugs, the permeation of cisplatin, cyclophosphamide, doxorubicin, 5-fluorouracil and paclitaxel through different types of gloves (vinyl, latex, nitrile) was assessed. Although our experiments showed relatively slow evaporation of the evaluated cytostatic drugs (the highest pressure in paclitaxel was 0.024 Pa), equilibrium concentrations may go up to milligrams per cubic metre. Nevertheless, analytical measurements of airborne contamination did not confirm these concentration levels. The glove permeation experiments with cytostatics showed good resistance of nitrile gloves (which were impermeable to all five drugs). Other materials should be avoided while handling cytostatic agents (e.g. maximum permeation of cyclophosphamide through latex was 19 microg/sq cm/hr). Although the volatility of cytostatic agents is low, it cannot be neglected considering the chronic character of exposure. However, in order to estimate actual occupational exposure, future research should focus on the development of sensitive analytical

  13. Addiction research centres and the nurturing of creativity. National institute on alcohol and drugs policies, Brazil.

    Science.gov (United States)

    Laranjeira, Ronaldo; Mitsuhiro, Sandro Sendin

    2012-04-01

    The National Institute of Public Policy for Alcohol and Other Drugs (INPAD) is based at the Federal University of São Paulo, Brazil, and was created to collect scientific evidence regarding epidemiology, develop new therapeutic approaches, study health economics and provide education to subsidize the proper measures to change the Brazilian scenario of alcohol and drug consumption. Policies directed towards the control of alcohol and drugs in Brazil are fragmented, poorly enforced and therefore ineffective. The unregulated market of alcohol in Brazil has contributed to the worsening health of the Brazilian population. Since 1994, INPAD has participated actively in academic debates and discussions about alcohol and drug policies and their effects on the political welfare of the country. Many scientific papers and books have been published on this subject, and the internet and other media have provided excellent opportunities for the dissemination of specialized information to the general population. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  14. Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs.

    Science.gov (United States)

    Grebely, Jason; Bruneau, Julie; Lazarus, Jeffrey V; Dalgard, Olav; Bruggmann, Philip; Treloar, Carla; Hickman, Matthew; Hellard, Margaret; Roberts, Teri; Crooks, Levinia; Midgard, Håvard; Larney, Sarah; Degenhardt, Louisa; Alho, Hannu; Byrne, Jude; Dillon, John F; Feld, Jordan J; Foster, Graham; Goldberg, David; Lloyd, Andrew R; Reimer, Jens; Robaeys, Geert; Torrens, Marta; Wright, Nat; Maremmani, Icro; Norton, Brianna L; Litwin, Alain H; Dore, Gregory J

    2017-09-01

    Globally, it is estimated that 71.1 million people have chronic hepatitis C virus (HCV) infection, including an estimated 7.5 million people who have recently injected drugs (PWID). There is an additional large, but unquantified, burden among those PWID who have ceased injecting. The incidence of HCV infection among current PWID also remains high in many settings. Morbidity and mortality due to liver disease among PWID with HCV infection continues to increase, despite the advent of well-tolerated, simple interferon-free direct-acting antiviral (DAA) HCV regimens with cure rates >95%. As a result of this important clinical breakthrough, there is potential to reverse the rising burden of advanced liver disease with increased treatment and strive for HCV elimination among PWID. Unfortunately, there are many gaps in knowledge that represent barriers to effective prevention and management of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network on Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the prevention and management of HCV among PWID. This round table consisted of a one-day workshop held on 6 September, 2016, in Oslo, Norway, prior to the International Symposium on Hepatitis in Substance Users (INHSU 2016). International experts in drug and alcohol, infectious diseases, and hepatology were brought together to discuss the available scientific evidence, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment. This paper highlights the outcomes of the roundtable discussion focused on future research priorities for enhancing HCV prevention, testing, linkage to care and DAA treatment for PWID as we strive

  15. [Frontiers in Live Bone Imaging Researches. Novel drug discovery by means of intravital bone imaging technology].

    Science.gov (United States)

    Ishii, Masaru

    2015-06-01

    Recent advances in intravital bone imaging technology has enabled us to grasp the real cellular behaviors and functions in vivo , revolutionizing the field of drug discovery for novel therapeutics against intractable bone diseases. In this chapter, I introduce various updated information on pharmacological actions of several antibone resorptive agents, which could only be derived from advanced imaging techniques, and also discuss the future perspectives of this new trend in drug discovery.

  16. Characterization of Multi-Drug Resistant Enterococcus faecalis Isolated from Cephalic Recording Chambers in Research Macaques (Macaca spp.).

    Science.gov (United States)

    Woods, Stephanie E; Lieberman, Mia T; Lebreton, Francois; Trowel, Elise; de la Fuente-Núñez, César; Dzink-Fox, Joanne; Gilmore, Michael S; Fox, James G

    2017-01-01

    Nonhuman primates are commonly used for cognitive neuroscience research and often surgically implanted with cephalic recording chambers for electrophysiological recording. Aerobic bacterial cultures from 25 macaques identified 72 bacterial isolates, including 15 Enterococcus faecalis isolates. The E. faecalis isolates displayed multi-drug resistant phenotypes, with resistance to ciprofloxacin, enrofloxacin, trimethoprim-sulfamethoxazole, tetracycline, chloramphenicol, bacitracin, and erythromycin, as well as high-level aminoglycoside resistance. Multi-locus sequence typing showed that most belonged to two E. faecalis sequence types (ST): ST 4 and ST 55. The genomes of three representative isolates were sequenced to identify genes encoding antimicrobial resistances and other traits. Antimicrobial resistance genes identified included aac(6')-aph(2"), aph(3')-III, str, ant(6)-Ia, tetM, tetS, tetL, ermB, bcrABR, cat, and dfrG, and polymorphisms in parC (S80I) and gyrA (S83I) were observed. These isolates also harbored virulence factors including the cytolysin toxin genes in ST 4 isolates, as well as multiple biofilm-associated genes (esp, agg, ace, SrtA, gelE, ebpABC), hyaluronidases (hylA, hylB), and other survival genes (ElrA, tpx). Crystal violet biofilm assays confirmed that ST 4 isolates produced more biofilm than ST 55 isolates. The abundance of antimicrobial resistance and virulence factor genes in the ST 4 isolates likely relates to the loss of CRISPR-cas. This macaque colony represents a unique model for studying E. faecalis infection associated with indwelling devices, and provides an opportunity to understand the basis of persistence of this pathogen in a healthcare setting.

  17. Characterization of Multi-Drug Resistant Enterococcus faecalis Isolated from Cephalic Recording Chambers in Research Macaques (Macaca spp..

    Directory of Open Access Journals (Sweden)

    Stephanie E Woods

    Full Text Available Nonhuman primates are commonly used for cognitive neuroscience research and often surgically implanted with cephalic recording chambers for electrophysiological recording. Aerobic bacterial cultures from 25 macaques identified 72 bacterial isolates, including 15 Enterococcus faecalis isolates. The E. faecalis isolates displayed multi-drug resistant phenotypes, with resistance to ciprofloxacin, enrofloxacin, trimethoprim-sulfamethoxazole, tetracycline, chloramphenicol, bacitracin, and erythromycin, as well as high-level aminoglycoside resistance. Multi-locus sequence typing showed that most belonged to two E. faecalis sequence types (ST: ST 4 and ST 55. The genomes of three representative isolates were sequenced to identify genes encoding antimicrobial resistances and other traits. Antimicrobial resistance genes identified included aac(6'-aph(2", aph(3'-III, str, ant(6-Ia, tetM, tetS, tetL, ermB, bcrABR, cat, and dfrG, and polymorphisms in parC (S80I and gyrA (S83I were observed. These isolates also harbored virulence factors including the cytolysin toxin genes in ST 4 isolates, as well as multiple biofilm-associated genes (esp, agg, ace, SrtA, gelE, ebpABC, hyaluronidases (hylA, hylB, and other survival genes (ElrA, tpx. Crystal violet biofilm assays confirmed that ST 4 isolates produced more biofilm than ST 55 isolates. The abundance of antimicrobial resistance and virulence factor genes in the ST 4 isolates likely relates to the loss of CRISPR-cas. This macaque colony represents a unique model for studying E. faecalis infection associated with indwelling devices, and provides an opportunity to understand the basis of persistence of this pathogen in a healthcare setting.

  18. Future Challenges and Opportunities in Online Prescription Drug Promotion Research; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

    Directory of Open Access Journals (Sweden)

    Brian G. Southwell

    2016-03-01

    Full Text Available Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions.

  19. Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

    Science.gov (United States)

    Southwell, Brian G; Rupert, Douglas J

    2016-01-16

    Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. © 2016 by Kerman University of Medical Sciences.

  20. Epidemiological methods for research with drug misusers: review of methods for studying prevalence and morbidity

    Directory of Open Access Journals (Sweden)

    Dunn John

    1999-01-01

    Full Text Available Epidemiological studies of drug misusers have until recently relied on two main forms of sampling: probability and convenience. The former has been used when the aim was simply to estimate the prevalence of the condition and the latter when in depth studies of the characteristics, profiles and behaviour of drug users were required, but each method has its limitations. Probability samples become impracticable when the prevalence of the condition is very low, less than 0.5% for example, or when the condition being studied is a clandestine activity such as illicit drug use. When stratified random samples are used, it may be difficult to obtain a truly representative sample, depending on the quality of the information used to develop the stratification strategy. The main limitation of studies using convenience samples is that the results cannot be generalised to the whole population of drug users due to selection bias and a lack of information concerning the sampling frame. New methods have been developed which aim to overcome some of these difficulties, for example, social network analysis, snowball sampling, capture-recapture techniques, privileged access interviewer method and contact tracing. All these methods have been applied to the study of drug misuse. The various methods are described and examples of their use given, drawn from both the Brazilian and international drug misuse literature.

  1. Study sponsorship and the nutrition research agenda: analysis of randomized controlled trials included in systematic reviews of nutrition interventions to address obesity.

    Science.gov (United States)

    Fabbri, Alice; Chartres, Nicholas; Scrinis, Gyorgy; Bero, Lisa A

    2017-05-01

    To categorize the research topics covered by a sample of randomized controlled trials (RCT) included in systematic reviews of nutrition interventions to address obesity; to describe their funding sources; and to explore the association between funding sources and nutrition research topics. Cross-sectional study. RCT included in Cochrane Reviews of nutrition interventions to address obesity and/or overweight. Two hundred and thirteen RCT from seventeen Cochrane Reviews were included. Funding source and authors' conflicts of interest were disclosed in 82·6 and 29·6 % of the studies, respectively. RCT were more likely to test an intervention to manipulate nutrients in the context of reduced energy intake (44·2 % of studies) than food-level (11·3 %) and dietary pattern-level (0·9 %) interventions. Most of the food industry-sponsored studies focused on interventions involving manipulations of specific nutrients (66·7 %). Only 33·1 % of the industry-funded studies addressed dietary behaviours compared with 66·9 % of the non-industry-funded ones (P=0·002). The level of food processing was poorly considered across all funding sources. The predominance of RCT examining nutrient-specific questions could limit the public health relevance of rigorous evidence available for systematic reviews and dietary guidelines.

  2. The entropic brain:A theory of conscious states informed by neuroimaging research with psychedelic drugs

    Directory of Open Access Journals (Sweden)

    Robin Lester Carhart-Harris

    2014-02-01

    Full Text Available Entropy is a dimensionless quantity that is used for measuring uncertainty about the state of a system but it can also imply physical qualities, where high entropy is synonymous with high disorder. Entropy is applied here in the context of states of consciousness and their associated neural dynamics, with a particular focus on the psychedelic state. The psychedelic state is considered an exemplar of a primitive or primary state of consciousness that preceded the development of modern, adult, human, normal waking consciousness. Based on neuroimaging data with psilocybin, a classic psychedelic drug, it is argued that the defining feature of ‘primary states’ is elevated entropy in certain aspects of brain function, such as the repertoire of functional connectivity motifs that form and fragment across time. It is noted that elevated entropy in this sense, is a characteristic of systems exhibiting ‘self-organised criticality’, i.e., a property of systems that gravitate towards a ‘critical’ point in a transition zone between order and disorder in which certain phenomena such as power-law scaling appear. This implies that entropy is suppressed in normal waking consciousness, meaning that the brain operates just below criticality. It is argued that this entropy suppression furnishes consciousness with a constrained quality and associated metacognitive functions, including reality-testing and self-awareness. It is also proposed that entry into primary states depends on a collapse of the normally highly organised activity within the default-mode network (DMN and a decoupling between the DMN and the medial temporal lobes (which are normally significantly coupled. These hypotheses can be tested by examining brain activity and associated cognition in other candidate primary states such as REM sleep and early psychosis and comparing these with non-primary states such as normal waking consciousness and the anaesthetised state.

  3. The entropic brain: a theory of conscious states informed by neuroimaging research with psychedelic drugs

    Science.gov (United States)

    Carhart-Harris, Robin L.; Leech, Robert; Hellyer, Peter J.; Shanahan, Murray; Feilding, Amanda; Tagliazucchi, Enzo; Chialvo, Dante R.; Nutt, David

    2014-01-01

    Entropy is a dimensionless quantity that is used for measuring uncertainty about the state of a system but it can also imply physical qualities, where high entropy is synonymous with high disorder. Entropy is applied here in the context of states of consciousness and their associated neurodynamics, with a particular focus on the psychedelic state. The psychedelic state is considered an exemplar of a primitive or primary state of consciousness that preceded the development of modern, adult, human, normal waking consciousness. Based on neuroimaging data with psilocybin, a classic psychedelic drug, it is argued that the defining feature of “primary states” is elevated entropy in certain aspects of brain function, such as the repertoire of functional connectivity motifs that form and fragment across time. Indeed, since there is a greater repertoire of connectivity motifs in the psychedelic state than in normal waking consciousness, this implies that primary states may exhibit “criticality,” i.e., the property of being poised at a “critical” point in a transition zone between order and disorder where certain phenomena such as power-law scaling appear. Moreover, if primary states are critical, then this suggests that entropy is suppressed in normal waking consciousness, meaning that the brain operates just below criticality. It is argued that this entropy suppression furnishes normal waking consciousness with a constrained quality and associated metacognitive functions, including reality-testing and self-awareness. It is also proposed that entry into primary states depends on a collapse of the normally highly organized activity within the default-mode network (DMN) and a decoupling between the DMN and the medial temporal lobes (which are normally significantly coupled). These hypotheses can be tested by examining brain activity and associated cognition in other candidate primary states such as rapid eye movement (REM) sleep and early psychosis and comparing

  4. Extent, quality and impact of patient and public involvement in antimicrobial drug development research: A systematic review.

    Science.gov (United States)

    Evans, David; Bird, Emma; Gibson, Andy; Grier, Sally; Chin, Teh Li; Stoddart, Margaret; MacGowan, Alasdair

    2018-02-01

    Patient and public involvement (PPI) is increasingly recognized as bringing a range of benefits to clinical and health services research. Recent systematic reviews have identified and synthesized many benefits (eg higher recruitment rates) and some costs (eg extra time need). Much of the literature focuses on PPI in long-term conditions rather than more acute health care in which the majority of microbiological research is undertaken. The aim was to identify the extent, quality and impact of PPI in antimicrobial drug development research. Objectives were to identify any relevant reporting of PPI in antimicrobial research; appraise the quality of reporting on PPI using recognized PPI reporting and critical appraisal tools; and extract and synthesize data on the impact of PPI. A systematic review was undertaken with a search strategy based on four word groups (PPI, patients, antimicrobial drug development and outcomes). Eight online databases were searched. English language publication, publication between 1996 and 2016 and studies describing PPI in antimicrobial drug development research. No studies were found through online searching that met the search strategy and inclusion criteria. One relevant protocol paper with a brief mention of PPI was identified through expert recommendation. Commentary papers recommending PPI were identified through website searching and expert opinion. Despite strong policy guidance encouraging PPI at the international and national levels, and anecdotal accounts of PPI taking place, evidence for the extent, quality and impact of PPI in antimicrobial drug development research has not yet appeared in the peer-reviewed literature. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  5. Improvement of basic food crops in Africa through plant breeding, including the use of induced mutations. Report of the third research co-ordination meeting of FAO/IAEA/ITALY co-ordinated research programme. Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-01

    A Co-ordinated Research Programme, on ``Improvement of basic food corps in Africa through plant breeding including the use of induced mutations``, funded by the Italian Governmnet, was initiated in the Joint Division of the Food and Agriculture Organization and International Atomic Energy Agency, Vienna. The primary objective of this CRP was to breed improved varieties of staple food crops of Africa with main emphasis on the indigenous species and local cultivars. The Third Research Co-ordination Meeting (RCM) under the FAO/IAEA/ITALY Co-ordinated Research Programme was held in Nairobi, Kenya, 20-24 September 1993 in which 24 persons participated and 18 scientific reports were presented. These included reports from 10 Research Contract holders from Africa, 3 Technical Contract holders from Italy and the update on the backstopping of research carried out at the IAEA Laboratories, Seibersdorf. The reports, and conclusions and recommendations made by the participants are presented in this publication. Refs, figs, tabs.

  6. Improvement of basic food crops in Africa through plant breeding, including the use of induced mutations. Report of the third research co-ordination meeting of FAO/IAEA/ITALY co-ordinated research programme. Working material

    International Nuclear Information System (INIS)

    1997-01-01

    A Co-ordinated Research Programme, on ''Improvement of basic food corps in Africa through plant breeding including the use of induced mutations'', funded by the Italian Governmnet, was initiated in the Joint Division of the Food and Agriculture Organization and International Atomic Energy Agency, Vienna. The primary objective of this CRP was to breed improved varieties of staple food crops of Africa with main emphasis on the indigenous species and local cultivars. The Third Research Co-ordination Meeting (RCM) under the FAO/IAEA/ITALY Co-ordinated Research Programme was held in Nairobi, Kenya, 20-24 September 1993 in which 24 persons participated and 18 scientific reports were presented. These included reports from 10 Research Contract holders from Africa, 3 Technical Contract holders from Italy and the update on the backstopping of research carried out at the IAEA Laboratories, Seibersdorf. The reports, and conclusions and recommendations made by the participants are presented in this publication. Refs, figs, tabs

  7. On the Potential Implications of Reports of Fictitious Drug Use for Survey Research on Juvenile Delinquency.

    Science.gov (United States)

    Meldrum, Ryan Charles; Piquero, Alex R

    2015-08-01

    A variety of methodological issues have been raised over self-reports of delinquency and its correlates. In this study, we call attention to the provision of untruthful information and provide an investigation of this issue using a survey item that assesses a respondent's use of a fictitious drug in relation to reports of delinquency and traditional criminological correlates. Bivariate and multivariate analyses were conducted based on data drawn from a probability sample of middle and high school students in Florida. Results show (a) there are important differences on key criminological variables between respondents who report use of a fictitious drug and those who do not; (b) the internal consistency of a variety index of delinquency is particularly sensitive to the inclusion of respondents reporting the use of a fictitious drug; and (c) the effect size of some criminological variables on delinquency may be sensitive to controlling for reports of fictitious drug use. Overall, the inclusion of fictitious drug use items within etiological models may serve as a useful approach to further establishing the reliability and validity of information provided by survey respondents. © The Author(s) 2014.

  8. Addiction research centres and the nurturing of creativity: National Drug Dependence Treatment Centre, India--a profile.

    Science.gov (United States)

    Ray, Rajat; Dhawan, Anju; Chopra, Anita

    2013-10-01

    The National Drug Dependence Treatment Centre (NDDTC) is a part of the All India Institute of Medical Sciences, a premier autonomous medical university in India. This article provides an account of its origin and its contribution to the field of substance use disorder at the national and international levels. Since its establishment, the NDDTC has played a major role in the development of various replicable models of care, the training of post-graduate students of psychiatry, research, policy development and planning. An assessment of the magnitude of drug abuse in India began in the early 1990s and this was followed by a National Survey on Extent, Patterns and Trends of Drug Abuse in 2004. Several models of clinical care have been developed for population subgroups in diverse settings. The centre played an important role in producing data and resource material which helped to scale up opioid substitution treatment in India. A nationwide database on the profile of patients seeking treatment (Drug Abuse Monitoring System) at government drug treatment centres has also been created. The centre has provided valuable inputs for the Government of India's programme planning. Besides clinical studies, research has also focused on pre-clinical studies. Capacity-building is an important priority, with training curricula and resource material being developed for doctors and paramedical staff. Many of these training programmes are conducted in collaboration with other institutions in the country. The NDDTC has received funding from several national and international organizations for research and scientific meetings, and, most recently (2012), it has been designated as a World Health Organization Collaborating Centre on Substance Abuse. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

  9. Research and development of anti-Alzheimer's disease drugs: an update from the perspective of technology flows.

    Science.gov (United States)

    Liu, Kunmeng; Lin, Hui-Heng; Pi, Rongbiao; Mak, Shinghung; Han, Yifan; Hu, Yuanjia

    2018-04-01

    Today, over 20 million people suffer from Alzheimer's disease (AD) worldwide. AD has become a critical issue to human health, especially in aging societies, and therefore it is a research hotspot in the global scientific community. The technology flow method differs from traditional reviews generating an informative overview of the research and development (R&D) landscape in a specific technological area. We need such an updated method to get a general overview of the R&D of anti-AD drugs in light of the dramatic developments in this area in recent years. Areas covered: This study collects patent data from the Integrity database. A total of 399 patents with 821 internal citation pairs in the US from 1978 to 2017 were analyzed. Patent citation network analysis was used to visualize the technology relationship. Expert opinion: For better production of anti-AD drugs, governments should emphasize the multi-target drug design, provide policy support for private companies, and encourage multilateral cooperation. The β-amyloid peptide (Aβ) theory leaves much to be desired; neurotransmitter and tau protein hypotheses are worth further examination. The use of old drugs for new indications is promising, as are traditional herbal medicines.

  10. G protein-coupled receptor transmembrane binding pockets and their applications in GPCR research and drug discovery: a survey.

    Science.gov (United States)

    Kratochwil, Nicole A; Gatti-McArthur, Silvia; Hoener, Marius C; Lindemann, Lothar; Christ, Andreas D; Green, Luke G; Guba, Wolfgang; Martin, Rainer E; Malherbe, Pari; Porter, Richard H P; Slack, Jay P; Winnig, Marcel; Dehmlow, Henrietta; Grether, Uwe; Hertel, Cornelia; Narquizian, Robert; Panousis, Constantinos G; Kolczewski, Sabine; Steward, Lucinda

    2011-01-01

    G protein-coupled receptors (GPCRs) share a common architecture consisting of seven transmembrane (TM) domains. Various lines of evidence suggest that this fold provides a generic binding pocket within the TM region for hosting agonists, antagonists, and allosteric modulators. Hence, an automated method was developed that allows a fast analysis and comparison of these generic ligand binding pockets across the entire GPCR family by providing the relevant information for all GPCRs in the same format. This methodology compiles amino acids lining the TM binding pocket including parts of the ECL2 loop in a so-called 1D ligand binding pocket vector and translates these 1D vectors in a second step into 3D receptor pharmacophore models. It aims to support various aspects of GPCR drug discovery in the pharmaceutical industry. Applications of pharmacophore similarity analysis of these 1D LPVs include definition of receptor subfamilies, prediction of species differences within subfamilies in regard to in vitro pharmacology and identification of nearest neighbors for GPCRs of interest to generate starting points for GPCR lead identification programs. These aspects of GPCR research are exemplified in the field of melanopsins, trace amine-associated receptors and somatostatin receptor subtype 5. In addition, it is demonstrated how 3D pharmacophore models of the LPVs can support the prediction of amino acids involved in ligand recognition, the understanding of mutational data in a 3D context and the elucidation of binding modes for GPCR ligands and their evaluation. Furthermore, guidance through 3D receptor pharmacophore modeling for the synthesis of subtype-specific GPCR ligands will be reported. Illustrative examples are taken from the GPCR family class C, metabotropic glutamate receptors 1 and 5 and sweet taste receptors, and from the GPCR class A, e.g. nicotinic acid and 5-hydroxytryptamine 5A receptor. © 2011 Bentham Science Publishers

  11. Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

    Science.gov (United States)

    Gilhooley, Margaret

    2011-01-01

    approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

  12. Double pharmacological challenge on repolarization opens new avenues for drug safety research

    DEFF Research Database (Denmark)

    Thomsen, Morten Bækgaard

    2007-01-01

    pointes (TdP) arrhythmia. Both the pharmaceutical industry and the regulatory bodies are neglecting the available proarrhythmia models. In vitro studies have suggested that combined pharmacological hits on repolarization will produce a superior substrate for in vivo proarrhythmia, compared to the single......-drug assessment. By using consecutive pharmacological challenges, a simple model is proposed, in which combinatorial pharmacology is employed to provoke TdP in the conscious dog. The pharmaceutical industry interested in evaluating the proarrhythmic potential of their present and future drugs now has a simple...

  13. [Fritz hauschild (1908-1974) and drug research in the 'German Democratic Republic' (GDR)].

    Science.gov (United States)

    Meyer, U

    2005-06-01

    The chemist and pharmacologist Fritz Hauschild developed the sympathomimetic agent Pervitin (metamphetamin) in the 1930s. Not only because of the abuse of the stimulant during the Second World War ("pilot's chocolate") it is one of the most controversial substances in drug history. Nearly forgotten are Hauschild's contributions to build up the drug system in the GDR. Although he was a convinced communist, the skilful pharmacologist gave very early warning of the imminent lack of innovation in the GDR pharmaceutical industry. A letter which he addressed to the Minister of Health, Max Sefrin (born 1913), did not lack explicitness.

  14. A systematic review of studies on the faecal microbiota in anorexia nervosa: future research may need to include microbiota from the small intestine.

    Science.gov (United States)

    Schwensen, Hanna Ferløv; Kan, Carol; Treasure, Janet; Høiby, Niels; Sjögren, Magnus

    2018-03-14

    Anorexia nervosa (AN) is a poorly understood and often chronic condition. Deviations in the gut microbiota have been reported to influence the gut-brain axis in other disorders. Therefore, if present in AN, it may impact on symptoms and illness progression. A review of the gut microbiota studies in AN is presented. A literature search on PubMed yielded 27 articles; 14 were selected and based on relevance, 9 articles were included. The findings were interpreted in the larger context of preclinical research and clinical observations. 8 out of 9 included studies analysed microbiota from faeces samples, while the last analysed a protein in plasma produced by the gut. Two studies were longitudinal and included an intervention (i.e., weight restoration), five were cross-sectional, one was a case report, and the last was a case series consisting of three cases. Deviations in abundance, diversity, and microbial composition of the faecal microbiota in AN were found. There are currently only a few studies on the gut microbiota in AN, all done on faeces samples, and not all describe the microbiota at the species level extensively. The Archaeon Methanobrevibacter smithii was increased in participants with a BMI study and specifically in AN patients in three studies. Methanobrevibacter smithii may, if detected, be a benchmark biomarker for future studies. We propose that microbiota samples could also be collected from the small intestine, where a major exchange of nutrients takes place and where the microbiota may have a biological impact on AN.

  15. Gaining Access to Hidden Populations: Strategies for Gaining Cooperation of Drug Sellers/Dealers and Their Families in Ethnographic Research

    Science.gov (United States)

    Dunlap, Eloise; Johnson, Bruce D.

    2009-01-01

    Summary This article examines strategies for gaining the cooperation of drug sellers and their families in order to conduct ethnographic research. The strategies were developed during an eight year study of drug dealers in New York City. A key element in gaining the ability to talk with and observe drug dealers and their family members was the availability of funds to compensate respondents for interviews and other expenses associated with building and maintaining rapport. Access to more successful crack sellers and dealers rested upon the right contacts. The “right contact” is a critical element. Locating a trusted “go-between” was adapted from strategies employed by cocaine sellers to arrange transactions involving large quantities of drugs. Such transactions rely upon a trusted associate of a dealer, the “go-between,” who performs various roles and assumes risks the dealer wishes to avoid. The role of the go-between became important when ethnographers attempted to reach drug dealers for research purposes. Favors and trust are central components in the equation of access to the dealer and his family. Favors are a part of drug dealers' interaction patterns: everyone owes someone else a favor. Such reciprocity norms exist independently of the amount of drugs involved and outlast any particular transaction. Reputations and favors are related. This framework of favors, trust, and reciprocity provides a basis for the ethnographer to gain an introduction to dealers and sellers. The “go-between” is critical because he/she explains the ethnographer's role to the dealer and helps arrange an initial meeting between the ethnographer and the seller. Once the go-between has provided an initial introduction, the ethnographer marshals the communication skills necessary to convince the dealer to allow further contact and conversations. This article examines the ritual of initial conversation within its cultural framework. Developing rapport requires showing

  16. An Analysis of Televised Public Service Advertising. Drug Abuse Information Research Project.

    Science.gov (United States)

    Hanneman, Gerhard J.; And Others

    Government regulations state that broadcasters are obligated to allot program time to matters of public interest, but neither law nor precedent have determined their commitment to present messages on social problems. To determine the amount of public service advertising (PSA) that is broadcast, particularly anti-drug appeals, a content analysis…

  17. 75 FR 34452 - Center for Drug Evaluation and Research Data Standards Plan; Availability for Comment

    Science.gov (United States)

    2010-06-17

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

  18. Anabolic Steroids: A Threat to Body and Mind. National Institute on Drug Abuse Research Report Series.

    Science.gov (United States)

    National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

    This report, based on findings of recent studies on the use of anabolic steroids in the United States, was written to educate the public about these drugs and the dangers of misusing them. It notes that the nonmedical use of anabolic/androgenic steroids among adolescents and young adults is of growing concern, with possibly as many as half a…

  19. New trial evaluates investigational drug for endometrial and breast cancers | Center for Cancer Research

    Science.gov (United States)

    A new clinical trial is testing ONC201, an investigational drug that in laboratory studies has been shown to kill breast and endometrial cancer cells most likely by destroying mitochondria within the tumor cells. Mitochondria are the “powerhouse” of the cell, and blocking its activity may kill tumor cells and shrink tumors in human patients.

  20. Research

    African Journals Online (AJOL)

    abp

    2015-06-24

    Jun 24, 2015 ... related immunosuppression, previous history of TB, and pause in treatment [6]. In Brazil, researchers .... treatment, use of traditional medicines or herbs, history of TB drug side effects and treatment delay). ..... therapy for pulmonary tuberculosis in Lima Ciudad, Peru. International journal of tuberculosis and ...

  1. Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

    Science.gov (United States)

    Schaefer, Christof

    2011-03-01

    Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology. © 2011 The Author. Congenital Anomalies © 2011 Japanese Teratology Society.

  2. Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research.

    Science.gov (United States)

    Orzan, G; Zara, I A; Purcarea, V L

    2012-12-15

    Recent years have seen an "explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer's thoughts and tailor specific marketing messages.

  3. Scaling Up Research on Drug Abuse and Addiction Through Social Media Big Data

    OpenAIRE

    Kim, Sunny Jung; Marsch, Lisa A; Hancock, Jeffrey T; Das, Amarendra K

    2017-01-01

    Background Substance use–related communication for drug use promotion and its prevention is widely prevalent on social media. Social media big data involve naturally occurring communication phenomena that are observable through social media platforms, which can be used in computational or scalable solutions to generate data-driven inferences. Despite the promising potential to utilize social media big data to monitor and treat substance use problems, the characteristics, mechanisms, and outco...

  4. A quest for antipsychotic drug actions in the brain: personal experiences from 50 years of neuropsychiatric research at Karolinska Institutet.

    Science.gov (United States)

    Sedvall, Göran

    2007-09-10

    The exploration of physiological and molecular actions of psychoactive drugs in the brain represents a fundamental approach to the understanding of emerging psychological phenomena. The author gives a personal account of his medical training and research career at Karolinska Institutet over the past 50 years. The paper aims at illustrating how a broad medical education and the integration of basic and clinical neuroscience research is a fruitful ground for the development of new methods and knowledge in this complicated field. Important aspects for an optimal research environment are recruitment of well-educated students, a high intellectual identity of teachers and active researchers, international input and collaboration in addition to good physical resources. In depth exploration of specific signaling pathways as well as an integrative analysis of genes, molecules and systems using multivariate modeling, and bioinformatics, brain mechanisms behind mental phenomena may be understood at a basic level and will ultimately be used for the alleviation and treatment of mental disorders.

  5. Knowledge, attitudes, and practices related to uterotonic drugs during childbirth in Karnataka, India: a qualitative research study.

    Directory of Open Access Journals (Sweden)

    Nitya Nand Deepak

    Full Text Available BACKGROUND AND OBJECTIVES: India has the highest annual number of maternal deaths of any country. As obstetric hemorrhage is the leading cause of maternal death in India, numerous efforts are under way to promote access to skilled attendance at birth and emergency obstetric care. Current initiatives also seek to increase access to active management of the third stage of labor for postpartum hemorrhage prevention, particularly through administration of an uterotonic after delivery. However, prior research suggests widespread inappropriate use of uterotonics at facilities and in communities-for example, without adequate monitoring or referral support for complications. This qualitative study aimed to document health providers' and community members' current knowledge, attitudes, and practices regarding uterotonic use during labor and delivery in India's Karnataka state. METHODS: 140 in-depth interviews were conducted from June to August 2011 in Bagalkot and Hassan districts with physicians, nurses, recently delivered women, mothers-in-law, traditional birth attendants (dais, unlicensed village doctors, and chemists (pharmacists. RESULTS: Many respondents reported use of uterotonics, particularly oxytocin, for labor augmentation in both facility-based and home-based deliveries. The study also identified contextual factors that promote inappropriate uterotonic use, including high value placed on pain during labor; perceived pressure to provide or receive uterotonics early in labor and delivery, perhaps leading to administration of uterotonics despite awareness of risks; and lack of consistent and correct knowledge regarding safe storage, dosing, and administration of oxytocin. CONCLUSIONS: These findings have significant implications for public health programs in a context of widespread and potentially increasing availability of uterotonics. Among other responses, efforts are needed to improve communication between community members and providers

  6. Knowledge, attitudes, and practices related to uterotonic drugs during childbirth in Karnataka, India: a qualitative research study.

    Science.gov (United States)

    Deepak, Nitya Nand; Mirzabagi, Ellie; Koski, Alissa; Tripathi, Vandana

    2013-01-01

    India has the highest annual number of maternal deaths of any country. As obstetric hemorrhage is the leading cause of maternal death in India, numerous efforts are under way to promote access to skilled attendance at birth and emergency obstetric care. Current initiatives also seek to increase access to active management of the third stage of labor for postpartum hemorrhage prevention, particularly through administration of an uterotonic after delivery. However, prior research suggests widespread inappropriate use of uterotonics at facilities and in communities-for example, without adequate monitoring or referral support for complications. This qualitative study aimed to document health providers' and community members' current knowledge, attitudes, and practices regarding uterotonic use during labor and delivery in India's Karnataka state. 140 in-depth interviews were conducted from June to August 2011 in Bagalkot and Hassan districts with physicians, nurses, recently delivered women, mothers-in-law, traditional birth attendants (dais), unlicensed village doctors, and chemists (pharmacists). Many respondents reported use of uterotonics, particularly oxytocin, for labor augmentation in both facility-based and home-based deliveries. The study also identified contextual factors that promote inappropriate uterotonic use, including high value placed on pain during labor; perceived pressure to provide or receive uterotonics early in labor and delivery, perhaps leading to administration of uterotonics despite awareness of risks; and lack of consistent and correct knowledge regarding safe storage, dosing, and administration of oxytocin. These findings have significant implications for public health programs in a context of widespread and potentially increasing availability of uterotonics. Among other responses, efforts are needed to improve communication between community members and providers regarding uterotonic use during labor and delivery and to target training and

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

    Directory of Open Access Journals (Sweden)

    Guido eGerig

    2011-10-01

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

  8. Orphan drugs

    OpenAIRE

    Goločorbin-Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojša; Mikov, Momir

    2013-01-01

    Introduction. Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in ”adopting” them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of ...

  9. A simple, generalizable method for measuring individual research productivity and its use in the long-term analysis of departmental performance, including between-country comparisons.

    Science.gov (United States)

    Wootton, Richard

    2013-01-14

    A simple, generalizable method for measuring research output would be useful in attempts to build research capacity, and in other contexts. A simple indicator of individual research output was developed, based on grant income, publications and numbers of PhD students supervised. The feasibility and utility of the indicator was examined by using it to calculate research output from two similarly-sized research groups in different countries. The same indicator can be used to assess the balance in the research "portfolio" of an individual researcher. Research output scores of 41 staff in Research Department A had a wide range, from zero to 8; the distribution of these scores was highly skewed. Only about 20% of the researchers had well-balanced research outputs, with approximately equal contributions from grants, papers and supervision. Over a five-year period, Department A's total research output rose, while the number of research staff decreased slightly, in other words research productivity (output per head) rose. Total research output from Research Department B, of approximately the same size as A, was similar, but slightly higher than Department A. The proposed indicator is feasible. The output score is dimensionless and can be used for comparisons within and between countries. Modeling can be used to explore the effect on research output of changing the size and composition of a research department. A sensitivity analysis shows that small increases in individual productivity result in relatively greater increases in overall departmental research output. The indicator appears to be potentially useful for capacity building, once the initial step of research priority setting has been completed.

  10. Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

    Science.gov (United States)

    Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

    2010-03-01

    Post-launch drug safety monitoring is essential for the detection of adverse drug signals that may be missed during preclinical trials. Traditional methods of postmarketing surveillance such as spontaneous reporting have intrinsic limitations, many of which can be overcome by the additional application of structured pharmacoepidemiological approaches. However, further improvement in drug safety monitoring requires a shift towards more proactive pharmacoepidemiological methods that can detect adverse drug signals as they occur in the population. To assess the feasibility of using proactive monitoring of an electronic medical record system, in combination with an independent endpoint adjudication committee, to detect adverse events among users of selected drugs. UK General Practice Research Database (GPRD) information was used to detect acute liver disorder associated with the use of amoxicillin/clavulanic acid (hepatotoxic) or low-dose aspirin (acetylsalicylic acid [non-hepatotoxic]). Individuals newly prescribed these drugs between 1 October 2005 and 31 March 2006 were identified. Acute liver disorder cases were assessed using GPRD computer records in combination with case validation by an independent endpoint adjudication committee. Signal generation thresholds were based on the background rate of acute liver disorder in the general population. Over a 6-month period, 8148 patients newly prescribed amoxicillin/clavulanic acid and 5577 patients newly prescribed low-dose aspirin were identified. Within this cohort, searches identified 11 potential liver disorder cases from computerized records: six for amoxicillin/clavulanic acid and five for low-dose aspirin. The independent endpoint adjudication committee refined this to four potential acute liver disorder cases for whom paper-based information was requested for final case assessment. Final case assessments confirmed no cases of acute liver disorder. The time taken for this study was 18 months (6 months for

  11. IDENTIDAD FEMENINA Y CONSUMO DE DROGAS: UN ESTUDIO CUALITATIVO / FEMININE IDENTITY AND DRUG USE: QUALITATIVE RESEARCH

    Directory of Open Access Journals (Sweden)

    Augusto Pérez Gómez* y Marcela Correa Muñoz**

    2011-06-01

    Full Text Available RESUMENEste estudio examina la relación entre identidad femenina (IF y consumo de drogas. Setenta y seis mujeres de tresgrupos de edades (jóvenes, adultas jóvenes y adultas mayores, de tres niveles socioeconómicos (alto, medio y bajo y trescircunstancias de consumo (consumidoras, no consumidoras y ex consumidoras fueron entrevistadas sobre seis aspectos:la definición de ser mujer y las diferencias con ser hombre; la autovaloración femenina; los factores que influyen en laconstrucción de la IF; la evolución de la IF; IF y consumo de drogas; factores protectores y de riesgo.Las entrevistadas consideraron que la mayor parte de los cambios recientes dentro de la sociedad occidental hanmejorado sustancialmente la condición de la mujer, aun cuando algunos de esos cambios también han incrementado suvulnerabilidad y están asociados al notable aumento del consumo de drogas entre las mujeres. Varios de los factoresmencionados no suelen aparecer en los estudios sobre este tema ("mal uso de la libertad", "abandono de responsabilidades","conducta sexual inadecuada" probablemente porque sus autores temen que se les acuse de estar censurando a las mujerescontemporáneas; en este estudio se presentan las percepciones de las mujeres, no las interpretaciones de los autores.ABSTRACTThis study examines the relationship between feminine identity and drug use. Seventy-six women in three ages groups(young, young adults, and mature adults, in three socio-economic levels (upper, medium, low and three drug use conditions(non users, users and ex users were interviewed on six aspects: definition of being a woman; and difference with being amale, women’s self-evaluation, factors influencing the development of FI; FI and drug use; and risk and protective factors.The results showed that the interviewees think that most of the changes that occurred in West society have substantiallyimproved women’s condition; nevertheless, some of those changes have also

  12. Neuromarketing techniques in pharmaceutical drugs advertising. A discussion and agenda for future research

    Science.gov (United States)

    Orzan, G; Zara, IA; Purcarea, VL

    2012-01-01

    Recent years have seen an “explosion" in the abilities of scientists to use neuroscience in new domains. Unfortunately, it is little known and reported on how advertising companies make more effective pharmaceutical drugs commercials. The purpose of this paper is to analyze how neuromarketing techniques may impact the consumer response to pharmaceutical advertising campaigns. The result shows that using neuromarketing methods a pharmaceutical company can better understand the conscious and unconscious consumer’s thoughts and tailor specific marketing messages. PMID:23346245

  13. Towards a 21st-century roadmap for biomedical research and drug discovery: consensus report and recommendations.

    Science.gov (United States)

    Langley, Gillian R; Adcock, Ian M; Busquet, François; Crofton, Kevin M; Csernok, Elena; Giese, Christoph; Heinonen, Tuula; Herrmann, Kathrin; Hofmann-Apitius, Martin; Landesmann, Brigitte; Marshall, Lindsay J; McIvor, Emily; Muotri, Alysson R; Noor, Fozia; Schutte, Katrin; Seidle, Troy; van de Stolpe, Anja; Van Esch, Hilde; Willett, Catherine; Woszczek, Grzegorz

    2017-02-01

    Decades of costly failures in translating drug candidates from preclinical disease models to human therapeutic use warrant reconsideration of the priority placed on animal models in biomedical research. Following an international workshop attended by experts from academia, government institutions, research funding bodies, and the corporate and non-governmental organisation (NGO) sectors, in this consensus report, we analyse, as case studies, five disease areas with major unmet needs for new treatments. In view of the scientifically driven transition towards a human pathways-based paradigm in toxicology, a similar paradigm shift appears to be justified in biomedical research. There is a pressing need for an approach that strategically implements advanced, human biology-based models and tools to understand disease pathways at multiple biological scales. We present recommendations to help achieve this. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Use of genome-wide association studies for cancer research and drug repositioning.

    Directory of Open Access Journals (Sweden)

    Jizhun Zhang

    Full Text Available Although genome-wide association studies have identified many risk loci associated with colorectal cancer, the molecular basis of these associations are still unclear. We aimed to infer biological insights and highlight candidate genes of interest within GWAS risk loci. We used an in silico pipeline based on functional annotation, quantitative trait loci mapping of cis-acting gene, PubMed text-mining, protein-protein interaction studies, genetic overlaps with cancer somatic mutations and knockout mouse phenotypes, and functional enrichment analysis to prioritize the candidate genes at the colorectal cancer risk loci. Based on these analyses, we observed that these genes were the targets of approved therapies for colorectal cancer, and suggested that drugs approved for other indications may be repurposed for the treatment of colorectal cancer. This study highlights the use of publicly available data as a cost effective solution to derive biological insights, and provides an empirical evidence that the molecular basis of colorectal cancer can provide important leads for the discovery of new drugs.

  15. Estimating study costs for use in VOI, a study of dutch publicly funded drug related research

    NARCIS (Netherlands)

    Van Asselt, A.D.; Ramaekers, B.L.; Corro Ramos, I.; Joore, M.A.; Al, M.J.; Lesman-Leegte, I.; Postma, M.J.; Vemer, P.; Feenstra, T.F.

    2016-01-01

    Objectives: To perform value of information (VOI) analyses, an estimate of research costs is needed. However, reference values for such costs are not available. This study aimed to analyze empirical data on research budgets and, by means of a cost tool, provide an overview of costs of several types

  16. Drug Information in Space Medicine

    Science.gov (United States)

    Bayuse, Tina M.

    2009-01-01

    Published drug information is widely available for terrestrial conditions. However, information on dosing, administration, drug interactions, stability, and side effects is scant as it relates to use in Space Medicine. Multinational crews on board the International Space Station present additional challenges for drug information because medication nomenclature, information available for the drug as well as the intended use for the drug is not standard across countries. This presentation will look at unique needs for drug information and how the information is managed in Space Medicine. A review was conducted of the drug information requests submitted to the Johnson Space Center Pharmacy by Space Medicine practitioners, astronaut crewmembers and researchers. The information requested was defined and cataloged. A list of references used was maintained. The wide range of information was identified. Due to the information needs for the medications in the on-board medical kits, the Drug Monograph Project was created. A standard method for answering specific drug information questions was generated and maintained by the Johnson Space Center Pharmacy. The Drug Monograph Project will be presented. Topic-centered requests, including multinational drug information, drug-induced adverse reactions, and medication events due to the environment will be highlighted. Information management of the drug information will be explained. Future considerations for drug information needs will be outlined.

  17. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  18. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  19. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. Intestinal Stem Cells to Advance Drug Development, Precision, and Regenerative Medicine: A Paradigm Shift in Translational Research.

    Science.gov (United States)

    Mochel, Jonathan P; Jergens, Albert E; Kingsbury, Dawn; Kim, Hyun Jung; Martín, Martín G; Allenspach, Karin

    2017-12-12

    Recent advances in our understanding of the intestinal stem cell niche and the role of key signaling pathways on cell growth and maintenance have allowed the development of fully differentiated epithelial cells in 3D organoids. Stem cell-derived organoids carry significant levels of proteins that are natively expressed in the gut and have important roles in drug transport and metabolism. They are, therefore, particularly relevant to study the gastrointestinal (GI) absorption of oral medications. In addition, organoids have the potential to serve as a robust preclinical model for demonstrating the effectiveness of new drugs more rapidly, with more certainty, and at lower costs compared with live animal studies. Importantly, because they are derived from individuals with different genotypes, environmental risk factors and drug sensitivity profiles, organoids are a highly relevant screening system for personalized therapy in both human and veterinary medicine. Lastly, and in the context of patient-specific congenital diseases, orthotopic transplantation of engineered organoids could repair and/or replace damaged epithelial tissues reported in various GI diseases, such as inflammatory bowel disease, cystic fibrosis, and tuft enteropathy. Ongoing translational research on organoids derived from dogs with naturally occurring digestive disorders has the potential to improve the predictability of preclinical models used for optimizing the therapeutic management of severe chronic enteropathies in human patients.

  1. [Threshold value for reimbursement of costs of new drugs: cost-effectiveness research and modelling are essential links].

    Science.gov (United States)

    Frederix, Geert W J; Hövels, Anke M; Severens, Johan L; Raaijmakers, Jan A M; Schellens, Jan H M

    2015-01-01

    There is increasing discussion in the Netherlands about the introduction of a threshold value for the costs per extra year of life when reimbursing costs of new drugs. The Medicines Committee ('Commissie Geneesmiddelen'), a division of the Netherlands National Healthcare Institute ('Zorginstituut Nederland'), advises on reimbursement of costs of new drugs. This advice is based upon the determination of therapeutic value of the drug and the results of economic evaluations. Mathematical models that predict future costs and effectiveness are often used in economic evaluations; these models can vary greatly in transparency and quality due to author assumptions. Standardisation of cost-effectiveness models is one solution to overcome the unwanted variation in quality. Discussions about the introduction of a threshold value can only be meaningful if all involved are adequately informed, and by high quality in cost-effectiveness research and, particularly, economic evaluations. Collaboration and discussion between medical specialists, patients or patient organisations, health economists and policy makers, both in development of methods and in standardisation, are essential to improve the quality of decision making.

  2. Research in Biological and Medical Sciences Including Biochemistry, Communicable Disease and Immunology, Internal Medicine, Nuclear Medicine, Physiology, Psychiatry, Surgery, and Veterinary Medicine. Volume 2

    Science.gov (United States)

    1974-06-30

    therapy (BCP in 4, phenothia- zlne in 1), 5 had "idiopathic galactorrhea" (normal menses , no drug history, normal skull X-ray, no other...balabacensis, female A. minimus are mated after they have taken a blood meal. Oviposition is on the surface of water in paper cups , in preference over...paper cup containing 5% sucrose and held for 7 to 10 days at 270C, 8S% R.H. Fresh sugar pads were provideJ daily. Starting 1-2 hours after

  3. Common single nucleotide variants underlying drug addiction: more than a decade of research.

    Science.gov (United States)

    Bühler, Kora-Mareen; Giné, Elena; Echeverry-Alzate, Victor; Calleja-Conde, Javier; de Fonseca, Fernando Rodriguez; López-Moreno, Jose Antonio

    2015-09-01

    Drug-related phenotypes are common complex and highly heritable traits. In the last few years, candidate gene (CGAS) and genome-wide association studies (GWAS) have identified a huge number of single nucleotide polymorphisms (SNPs) associated with drug use, abuse or dependence, mainly related to alcohol or nicotine. Nevertheless, few of these associations have been replicated in independent studies. The aim of this study was to provide a review of the SNPs that have been most significantly associated with alcohol-, nicotine-, cannabis- and cocaine-related phenotypes in humans between the years of 2000 and 2012. To this end, we selected CGAS, GWAS, family-based association and case-only studies published in peer-reviewed international scientific journals (using the PubMed/MEDLINE and Addiction GWAS Resource databases) in which a significant association was reported. A total of 371 studies fit the search criteria. We then filtered SNPs with at least one replication study and performed meta-analysis of the significance of the associations. SNPs in the alcohol metabolizing genes, in the cholinergic gene cluster CHRNA5-CHRNA3-CHRNB4, and in the DRD2 and ANNK1 genes, are, to date, the most replicated and significant gene variants associated with alcohol- and nicotine-related phenotypes. In the case of cannabis and cocaine, a far fewer number of studies and replications have been reported, indicating either a need for further investigation or that the genetics of cannabis/cocaine addiction are more elusive. This review brings a global state-of-the-art vision of the behavioral genetics of addiction and collaborates on formulation of new hypothesis to guide future work. © 2015 Society for the Study of Addiction.

  4. Application of drug delivery system for boron neutron capture therapy. Basic research toward clinical application

    International Nuclear Information System (INIS)

    Yanagie, Hironobu; Takahashi, Hiroyuki

    2010-01-01

    Tumour cell destruction in boron neutron-capture therapy (BNCT) is due to the nuclear reaction between 10 B and thermal neutrons ( 10 B+ 1 n → 7 Li+ 4 He (α) +2.31 MeV (93.7%)/2.79 MeV (6.3%)). The resulting lithium ions and αparticles are high linear energy transfer (LET) particles which give high biological effect. Their short range in tissue (5-9 μm) restricts radiation damage to those cells in which boron atoms are located at the time of neutron irradiation. BNCT has been applied clinically for the treatment of malignant brain tumors, malignant melanoma, head and neck cancer and hepatoma etc, recently. Sodium borocaptate (Na 2 10 B 12 H 11 SH; BSH) and borono-phenylalanine ( 10 BPA) are currently being used in clinical treatments. To achieve the selective delivery of boron atoms to cancer cells, drug delivery system (DDS) becomes an attractive intelligent technology as targeting and controlled release of drugs. We have firstly reported that 10 B atoms delivered by immunoliposomes are cytotoxic to human pancreatic carcinoma cells (AsPC-1) after thermal neutron irradiation in vitro. The intra-tumoural injection of boronated immunoliposomes can increase the retention of 10 B atoms in tumour cells, causing suppression of tumour growth in vivo following thermal neutron irradiation. We prepared polyethylene-glycol binding liposomes (PEG-liposomes) as an effective 10 B carrier to obviate phagocytosis by reticuloendotherial systems. We had prepared 10 BSH entrapped Water-in-Oil-in-Water (WOW) emulsion. The 10 B concentration in VX-2 tumour after intra-arterial injection of 10 BSH entrapped WOW emulsion was superior to the groups of 10 BSH entrapped conventional Lipiodol mix emulsion. 10 Boron entrapped WOW emulsion is one of the most useful for intra-arterial boron delivery carrier on BNCT to hepatocellular carcinoma. (author)

  5. 78 FR 15953 - Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration...

    Science.gov (United States)

    2013-03-13

    ... enacted in 1992, has provided FDA with the resources and process enhancements to enable a transformation... performance goals and procedures outlined within PDUFA V will require a high degree of leadership, research...

  6. DRUGS IN SPORT

    Directory of Open Access Journals (Sweden)

    David R. Mottram

    2005-12-01

    Full Text Available This new edition includes fresh information regarding drugs use and abuse in sport and the updated worldwide anti-doping laws, and changes to the prohibited and therapeutic use exemption lists. The objectives of the book are to review/discuss the latest information on drugs in sport by considering i actions of drugs and hormones, ii medication and nutritional supplements in sport, iii the latest doping control regulations of the WADA, iv the use of banned therapeutic drugs in sport, v an assessment of the prevalence of drug taking in sport. FEATURES A common, uniform strategy and evidence-based approach to organizing and interpreting the literature is used in all chapters. This textbook is composed of twelve parts with sub-sections in all of them. The topics of the parts are: i An introduction to drugs and their use in sport, ii Drug use and abuse in sport, iii Central nervous system stimulants, iv WADA regulations in relation to drugs used in the treatment of respiratory tract disorders, v Androgenic anabolic steroids, vi Peptide and glycoprotein hormones and sport, vii Blood boosting and sport, viii Drug treatment of inflammation in sports injuries, ix Alcohol, anti-anxiety drugs and sport, x Creatine, xi Doping control and sport, xii Prevalence of drug misuse in sport. Each specific chapter has been systematically developed from the data available in prospective, retrospective, case-control, and cross-sectional studies. The tables and figures are numerous, helpful and very useful. AUDIENCE The book provides a very useful resource for students on sports related courses, coaches and trainers, researchers, nutritionists, exercise physiologists, pharmacologists, healthcare professionals in the fields of sports medicine and those involved in the management and administration side of sport. The readers are going to discover that this is an excellent reference book. Extensively revised new edition of this book is also a first-rate resource for

  7. Exploring drug-target interaction networks of illicit drugs.

    Science.gov (United States)

    Atreya, Ravi V; Sun, Jingchun; Zhao, Zhongming

    2013-01-01

    Drug addiction is a complex and chronic mental disease, which places a large burden on the American healthcare system due to its negative effects on patients and their families. Recently, network pharmacology is emerging as a promising approach to drug discovery by integrating network biology and polypharmacology, allowing for a deeper understanding of molecular mechanisms of drug actions at the systems level. This study seeks to apply this approach for investigation of illicit drugs and their targets in order to elucidate their interaction patterns and potential secondary drugs that can aid future research and clinical care. In this study, we extracted 188 illicit substances and their related information from the DrugBank database. The data process revealed 86 illicit drugs targeting a total of 73 unique human genes, which forms an illicit drug-target network. Compared to the full drug-target network from DrugBank, illicit drugs and their target genes tend to cluster together and form four subnetworks, corresponding to four major medication categories: depressants, stimulants, analgesics, and steroids. External analysis of Anatomical Therapeutic Chemical (ATC) second sublevel classifications confirmed that the illicit drugs have neurological functions or act via mechanisms of stimulants, opioids, and steroids. To further explore other drugs potentially having associations with illicit drugs, we constructed an illicit-extended drug-target network by adding the drugs that have the same target(s) as illicit drugs to the illicit drug-target network. After analyzing the degree and betweenness of the network, we identified hubs and bridge nodes, which might play important roles in the development and treatment of drug addiction. Among them, 49 non-illicit drugs might have potential to be used to treat addiction or have addictive effects, including some results that are supported by previous studies. This study presents the first systematic review of the network

  8. Carbon dioxide and climate. [Appendix includes names and addresses of the Principal Investigators for the research projects funded in FY1991

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    Global climate change is a serious environmental concern, and the US has developed An Action Agenda'' to deal with it. At the heart of the US effort is the US Global Change Research Program (USGCRP), which has been developed by the Committee on Earth and Environmental Sciences (CEES) of the Federal Coordinating Council for Sciences, Engineering, and Technology (FCCSET). The USGCRP will provide the scientific basis for sound policy making on the climate-change issue. The DOE contribution to the USGCRP is the Carbon Dioxide Research Program, which now places particular emphasis on the rapid improvement of the capability to predict global and regional climate change. DOE's Carbon Dioxide Research Program has been addressing the carbon dioxide-climate change connection for more than twelve years and has provided a solid scientific foundation for the USGCRP. The expansion of the DOE effort reflects the increased attention that the Department has placed on the issue and is reflected in the National Energy Strategy (NES) that was released in 1991. This Program Summary describes projects funded by the Carbon Dioxide Research Program during FY 1991 and gives a brief overview of objectives, organization, and accomplishments. The Environmental Sciences Division of the Office of Health and Environmental Research, Office of Energy Research supports a Carbon Dioxide Research Program to determine the scientific linkage between the rise of greenhouse gases in the atmosphere, especially carbon dioxide, and climate and vegetation change. One facet is the Core CO{sub 2} Program, a pioneering program that DOE established more than 10 years ago to understand and predict the ways that fossil-fuel burning could affect atmospheric CO{sub 2} concentration, global climate, and the Earth's biosphere. Major research areas are: global carbon cycle; climate detection and models of climate change; vegetation research; resource analysis; and, information and integration.

  9. The Role of Knowledge Brokers: Lessons from a Community Based Research Study of Cultural Safety in Relation to People Who Use Drugs

    Science.gov (United States)

    McCall, Jane; Mollison, Ashley; Browne, Annette; Parker, Joanne; Pauly, Bernie

    2017-01-01

    The study explored cultural safety as a strategy to address the stigma of substance use in acute care settings. Two research team members took on the role of knowledge brokers (KBs) in order to liaise between the research team and two distinct research advisory groups: one with people who use drugs and the other nurses. The KBs were instrumental…

  10. Cognitive-enhancing drugs in the healthy population: Fundamental drawbacks and researcher roles

    Directory of Open Access Journals (Sweden)

    Tsee Leng Choy

    2015-12-01

    Full Text Available The use of pharmacological cognitive enhancers (PCEs in the healthy population is a controversial topic with numerous and expansive repercussions. By outlining common proponent arguments on the current PCE state of affairs, the definition of normality, and the complex regulation of PCEs, this article addresses why the mainstream use of PCEs in the healthy population is still disadvantageous overall. In this respect, the influence and roles of researchers to the society are emphasized in bringing the focus back to the fundamental issues, which is crucial in deciphering its controversy and avoiding costly societal, research credibility and ethical implications.

  11. Research Perspective: Potential Role of Nitazoxanide in Ovarian Cancer Treatment. Old Drug, New Purpose?

    Directory of Open Access Journals (Sweden)

    Jessie Ehrisman

    2013-09-01

    Full Text Available Among gynecological malignancies epithelial ovarian cancer (EOC is the leading cause of death. Despite improvements in conventional chemotherapy combinations, the overall cure rate has remained mostly stable over the years, and only 10%–15% of patients maintain a complete response following first-line therapy. To improve the efficacy of ovarian cancer chemotherapy it is essential to develop drugs with new mechanisms of action. Compared to normal tissues, protein disulfide isomerase (PDI is overexpressed in ovarian tumors. PDI is a cellular enzyme in the lumen of the endoplasmic reticulum (ER of eukaryotes or the periplasmic region of prokaryotes. This protein catalyzes the formation and breakage of disulphide bonds between cysteine residues in proteins, which affects protein folding. Selective inhibition of PDI activity has been exhibited both in vitro and in vivo anticancer activity in human ovarian cancer models. PDI inhibition caused accumulation of unfolded or misfolded proteins, which led to ER stress and the unfolded protein response (UPR, and in turn resulted in cell death. Nitazoxanide [NTZ: 2-acetyloxy-N-(5-nitro-2-thiazolylbenzamide] is a thiazolide antiparasitic agent with excellent activity against a wide variety of protozoa and helminths. In this article, we propose that NTZ, acting as PDI inhibitor, may be a new and potent addition to the chemotherapeutic strategy against ovarian cancer.

  12. Research Perspective: Potential Role of Nitazoxanide in Ovarian Cancer Treatment. Old Drug, New Purpose?

    Energy Technology Data Exchange (ETDEWEB)

    Di Santo, Nicola, E-mail: nico.disanto@duke.edu; Ehrisman, Jessie [Division of Gynecologic Oncology, Duke University Medical Center, Durham, NC 27710 (United States)

    2013-09-10

    Among gynecological malignancies epithelial ovarian cancer (EOC) is the leading cause of death. Despite improvements in conventional chemotherapy combinations, the overall cure rate has remained mostly stable over the years, and only 10%–15% of patients maintain a complete response following first-line therapy. To improve the efficacy of ovarian cancer chemotherapy it is essential to develop drugs with new mechanisms of action. Compared to normal tissues, protein disulfide isomerase (PDI) is overexpressed in ovarian tumors. PDI is a cellular enzyme in the lumen of the endoplasmic reticulum (ER) of eukaryotes or the periplasmic region of prokaryotes. This protein catalyzes the formation and breakage of disulphide bonds between cysteine residues in proteins, which affects protein folding. Selective inhibition of PDI activity has been exhibited both in vitro and in vivo anticancer activity in human ovarian cancer models. PDI inhibition caused accumulation of unfolded or misfolded proteins, which led to ER stress and the unfolded protein response (UPR), and in turn resulted in cell death. Nitazoxanide [NTZ: 2-acetyloxy-N-(5-nitro-2-thiazolyl)benzamide] is a thiazolide antiparasitic agent with excellent activity against a wide variety of protozoa and helminths. In this article, we propose that NTZ, acting as PDI inhibitor, may be a new and potent addition to the chemotherapeutic strategy against ovarian cancer.

  13. A South African outpatient drug treatment centre | Karassellos ...

    African Journals Online (AJOL)

    The Cape Town Drug Counselling Centre is an outpatient drug treatment ... Management of clients, which includes psychotherapy with an emphasis on ... medical intervention, is described, and proposed areas for further research are outlined.

  14. New Animal Model Could Boost Research on AIDS Drugs and Vaccines | FNLCR

    Science.gov (United States)

    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 i

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

    Science.gov (United States)

    By Frank Blanchard, Staff Writer, and Jeff Lifson, Guest Writer In a research milestone reported in the June 20 issue of the journal Science, scientists have developed a minimally modified version of HIV-1, the virus that causes AIDS in infected humans, that is capable of causing progressive infection and AIDS in monkeys. The advance should help create more authentic animal

  16. A bibliometric review of drug and alcohol research focused on Indigenous peoples of Australia, New Zealand, Canada and the United States.

    Science.gov (United States)

    Clifford, Anton; Shakeshaft, Anthony

    2017-07-01

    Indigenous peoples of Australia, New Zealand, Canada and the United States experience a disproportionately high burden of harms from substance misuse. Research is therefore required to improve our understanding of substance use in Indigenous populations and provide evidence on strategies effective for reducing harmful use. A search of 13 electronic databases for peer-reviewed articles published between 1993 and 2014 focusing on substance use and Indigenous peoples of Australia, New Zealand, Canada and the United States. Relevant abstracts were classified as data or non-data based research. Data-based studies were further classified as measurement, descriptive or intervention and their trends examined by country and drug type. Intervention studies were classified by type and their evaluation designs classified using the Cochrane Effective Practice and Organisation of Care (EPOC) data collection checklist. There was a statistically significant increase from 1993 to 2014 in the percentage of total publications that were data-based (P Indigenous drug and alcohol field are required. The dominance of descriptive research in the Indigenous drug and alcohol field is less than optimal for generating evidence to inform Indigenous drug and alcohol policy and programs. [Clifford A, Shakeshaft A. A bibliometric review of drug and alcohol research focused on Indigenous peoples of Australia, New Zealand, Canada and the United States. Drug Alcohol Rev 2017;36:509-522]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  17. Research Article. Kinetics and Mechanism of Drug Release from Loratadine Orodispersible Tablets Developed without Lactose

    Directory of Open Access Journals (Sweden)

    Ciurba Adriana

    2017-03-01

    Full Text Available Objective: The aim of this study is to develop lactose-free orodispersible tablets with loratadine for patients with lactose intolerance. Materials and methods: Seven compositions (F1-F7 of 10 mg loratadine were prepared in form of orally disintegrating tablets, by direct compression, using croscarmellose sodium and pre-gelatinized starch in various concentrations as superdisintegrants, diluted with microcrystalline cellulose and combined with mannitol and maltodextrin as binder agents. The tablets had been studied in terms of their pharmacotechnical characteristics, by determining: the weight uniformity of the tablets, their friability, breaking strength and disintegration time, drug content and the dissolution profile of loratadine. The statistical analyses were performed with GraphPad Prism Software Inc. As dependent variables, both the hardness of the tablets and their disintegration ability differ between batches due to their compositional differences (as independent variables. DDSolver were used for modeling the kinetic of the dissolution processes by fitting the dissolution profiles with time-dependent equations (Zero-order, First-order, Higuchi, Korsmeyer-Peppas, Peppas-Sahlin. Results: All proposed formulas shows rapid disintegration, in less than 15 seconds, and the dissolution loratadine spans a period of about 10 minutes. Akaike index as well as R2 adjusted parameter have demonstrated that the studied dissolution profiles are the best fitted by Zero-order kinetic. Conclusion: In conclusion, association of croscarmellose sodium (7.5% with pre-gelatinized starch (6% as superdisintegrants and mannitol as the binder agent (35%, positively influences the dissolution properties of loratadine from orally fast dispersible tablets.

  18. [Incentives and disincentives for research and development of new drugs by the pharmaceutical industry].

    Science.gov (United States)

    Curcio, Pasqualina Curcio

    2008-10-01

    The authors present a model with factors that influence research and development decisions by the pharmaceutical industry: risk of disease transmission and possibility of control; case-fatality and the presence of cure or treatments; income; number of persons who demand the medicine; and opportunity costs for the company. Companies tend to invest in markets with inelastic demand (highly contagious diseases with no possibility of controlling transmission and/or very lethal diseases without treatment) and/or where there is a large population or high per capita income. Companies tend not to invest in markets where marginal costs exceed marginal income, particularly when costs increase permanently as a consequence of rising opportunity costs generated by foregoing profit in other markets. In such cases, policies to subsidize R&D are not effective, and policies must be orientated towards strengthening basic and applied research by public institutions.

  19. Ethical issues in funding research and development of drugs for neglected tropical diseases.

    Science.gov (United States)

    Oprea, L; Braunack-Mayer, A; Gericke, C A

    2009-05-01

    Neglected and tropical diseases, pervasive in developing countries, are important contributors to global health inequalities. They remain largely untreated due to lack of effective and affordable treatments. Resource-poor countries cannot afford to develop the public health interventions needed to control neglected diseases. In addition, neglected diseases do not represent an attractive market for pharmaceutical industry. Although a number of international commitments, stated in the Millennium Development Goals, have been made to avert the risk of communicable diseases, tropical diseases still remain neglected due to delays in international assistance. This delay can be explained by the form international cooperation has generally taken, which is limited to promoting countries' national interests, rather than social justice at a global level. This restricts the international responsibility for global inequalities in health to a humanitarian assistance. We propose an alternative view, arguing that expanding the scope of international cooperation by promoting shared health and economic value at a global level will create new opportunities for innovative, effective and affordable interventions worldwide. It will also promote neglected diseases as a global research priority. We build our argument on a proposal to replace the patenting system that currently regulates pharmaceutical research with a global fund to reward this research based on actual decreases in morbidity and mortality at a global level. We argue that this approach is beneficent because it will decrease global health inequalities and promote social justice worldwide.

  20. Ion beam techniques for the analysis of light elements in thin films, including depth profiling. Final report of a co-ordinated research project 2000-2003

    International Nuclear Information System (INIS)

    2004-10-01

    This publication highlights the achievements of a Coordinated Research Project (CRP) to promote the potential of accelerator-based nuclear techniques of analysis for light elements in thin films. The objectives of this CRP were to develop a coordinated research effort between accelerator laboratories and materials science research groups in order to assist and promote the development of quality assurance methods, to evaluate databases of parameters needed for quantitative analysis, and to develop and apply techniques to selected problems concerning the surface modification of materials and production of thin films. Through various case studies, this publication assesses and demonstrates the effectiveness of accelerator-based nuclear techniques for analysis to provide valuable data and knowledge not readily accessible using other methods

  1. Research in Biological and Medical Sciences Including Biochemistry, Communicable Disease and Immunology, Internal Medicine, Physiology, Psychiatry, Surgery, and Veterinary Medicine. Volume 2

    Science.gov (United States)

    1979-09-01

    further investiga - tion to ascertain whether it is a stable deviation and whether it occurs sufficiently often to be of value in vaccine production...in Sa’de na Amazonia (ANEPS - Sio Paulo, Brazil) 1538 ( CISCv ACCISSION* I, r~v, OF lsu ASPOIT CO-TwOL ?NOOL RESEARCH AND TECHNOLOGY WORK UNIT SUMMARY

  2. Current knowledge from experimental works with radioprotective drugs from the viewpoint of latest scientific research

    International Nuclear Information System (INIS)

    Skalka, J.

    2008-01-01

    The protection of both human and animal population against a radiation impairment proves to be an impulse for continuous intensive searching for plants with radioprotective properties, identification of their radioprotective components and examination of their effects both in vivo an in vitro. I am presenting the results as well as knowledge of a latest scientific research in this field with testing the following plants: Vigna radiata, Mentha piperita, Citrus aurantium var. amara, Syzygium cumini, Tinospora cordifolia, Aegle marmelos, Phyllanthus amarus, Aloe vera, Angelica sinensis, Rosemarinus officinalis, Panax ginseng, Hippophae rhamnoides, Ocimum sanctum, Crataegus microphylla. (authors)

  3. Higher Magnitude Cash Payments Improve Research Follow-up Rates Without Increasing Drug Use or Perceived Coercion

    Science.gov (United States)

    Festinger, David S.; Marlowe, Douglas B.; Dugosh, Karen L.; Croft, Jason R.; Arabia, Patricia L.

    2008-01-01

    In a prior study (Festinger et al., 2005) we found that neither the mode (cash vs. gift card) nor magnitude ($10, $40, or $70) of research follow-up payments increased rates of new drug use or perceptions of coercion. However, higher payments and payments in cash were associated with better follow-up attendance, reduced tracking efforts, and improved participant satisfaction with the study. The present study extended those findings to higher payment magnitudes. Participants from an urban outpatient substance abuse treatment program were randomly assigned to receive $70, $100, $130, or $160 in either cash or a gift card for completing a follow-up assessment at 6 months post-admission (n ≅ 50 per cell). Apart from the payment incentives, all participants received a standardized, minimal platform of follow-up efforts. Findings revealed that neither the magnitude nor mode of payment had a significant effect on new drug use or perceived coercion. Consistent with our previous findings, higher payments and cash payments resulted in significantly higher follow-up rates and fewer tracking calls. In addition participants receiving cash vs. gift cards were more likely to use their payments for essential, non-luxury purchases. Follow-up rates for participants receiving cash payments of $100, $130, and $160 approached or exceeded the FDA required minimum of 70% for studies to be considered in evaluations of new medications. This suggests that the use of higher magnitude payments and cash payments may be effective strategies for obtaining more representative follow-up samples without increasing new drug use or perceptions of coercion. PMID:18395365

  4. Cell line with endogenous EGFRvIII expression is a suitable model for research and drug development purposes.

    Science.gov (United States)

    Stec, Wojciech J; Rosiak, Kamila; Siejka, Paulina; Peciak, Joanna; Popeda, Marta; Banaszczyk, Mateusz; Pawlowska, Roza; Treda, Cezary; Hulas-Bigoszewska, Krystyna; Piaskowski, Sylwester; Stoczynska-Fidelus, Ewelina; Rieske, Piotr

    2016-05-31

    Glioblastoma is the most common and malignant brain tumor, characterized by high cellular heterogeneity. About 50% of glioblastomas are positive for EGFR amplification, half of which express accompanying EGFR mutation, encoding truncated and constitutively active receptor termed EGFRvIII. Currently, no cell models suitable for development of EGFRvIII-targeting drugs exist, while the available ones lack the intratumoral heterogeneity or extrachromosomal nature of EGFRvIII.The reports regarding the biology of EGFRvIII expressed in the stable cell lines are often contradictory in observations and conclusions. In the present study, we use DK-MG cell line carrying endogenous non-modified EGFRvIII amplicons and derive a sub-line that is near depleted of amplicons, whilst remaining identical on the chromosomal level. By direct comparison of the two lines, we demonstrate positive effects of EGFRvIII on cell invasiveness and populational growth as a result of elevated cell survival but not proliferation rate. Investigation of the PI3K/Akt indicated no differences between the lines, whilst NFκB pathway was over-active in the line strongly expressing EGFRvIII, finding further supported by the effects of NFκB pathway specific inhibitors. Taken together, these results confirm the important role of EGFRvIII in intrinsic and extrinsic regulation of tumor behavior. Moreover, the proposed models are stable, making them suitable for research purposes as well as drug development process utilizing high throughput approach.

  5. Life into Space: Space Life Sciences Experiments, Ames Research Center, Kennedy Space Center, 1991-1998, Including Profiles of 1996-1998 Experiments

    Science.gov (United States)

    Souza, Kenneth (Editor); Etheridge, Guy (Editor); Callahan, Paul X. (Editor)

    2000-01-01

    We have now conducted space life sciences research for more than four decades. The continuing interest in studying the way living systems function in space derives from two main benefits of that research. First, in order for humans to engage in long-term space travel, we must understand and develop measures to counteract the most detrimental effects of space flight on biological systems. Problems in returning to the conditions of Earth must be kept to a manageable level. Second, increasing our understanding of how organisms function in the absence of gravity gives us new understanding of fundamental biological processes. This information can be used to improve human health and the quality of life on Earth.

  6. A portfolio of academic, therapeutic practice and research work : including an investigation of counselling psychologists' experience of the role of body in the therapeutic encounter

    OpenAIRE

    Kouloumbri, Maria

    2013-01-01

    This portfolio was submitted to the University of Surrey for the completion of the Doctorate (PsychO) in Psychotherapeutic and Counselling Psychology. It is comprised of three dossiers which reflect the academic, clinical and research work undertaken as part of this degree. The academic dossier consists of three essays. The first essay presents Freud's dream interpretation theory and Jung's dream theory and elaborates on the features of each theory respectively. The second e...

  7. Progress report on first year of WP5.2. Including detailed description of planned research for WP 5.2

    Energy Technology Data Exchange (ETDEWEB)

    Ellemers, N.; Van Dijk, E.; Terwel, B.; De Vries, G. [Leiden University, Leiden (Netherlands)

    2010-10-15

    This document contains the progress report on the first half year of the CATO-2 WP5.2 PhD project 'Framing effects in communication about CCS'. In the first few months a literature study has been conducted, both on (factors that influence) public perceptions and acceptance of CCS, and on framing. In the last two month, a first study was designed. This study consists of an experiment designed to examine how framing a company's involvement in CCS in terms of economic benefits and/or CSR of the organization affects the corporate image, trust, and perceived 'greenwashing' (deceit). Furthermore, this experiment serves to test the quality of newly developed questionnaires to measure these variables. In addition, this document contains a detailed description of the research planned for WP5.2 written by senior (CATO-2) researchers from January 2010 on. The objective of the research planned for WP5.2 is to examine whether framing of communications by an organization can improve the perceived credibility and trustworthiness of the organization and the information provided. This issue will be examined by a combination of experimental studies and a survey-type study.

  8. A statistical model for estimation of fish density including correlation in size, space, time and between species from research survey data

    DEFF Research Database (Denmark)

    Nielsen, J. Rasmus; Kristensen, Kasper; Lewy, Peter

    2014-01-01

    Trawl survey data with high spatial and seasonal coverage were analysed using a variant of the Log Gaussian Cox Process (LGCP) statistical model to estimate unbiased relative fish densities. The model estimates correlations between observations according to time, space, and fish size and includes...

  9. Nominal ISOMERs (Incorrect Spellings Of Medicines Eluding Researchers)-variants in the spellings of drug names in PubMed: a database review.

    Science.gov (United States)

    Ferner, Robin E; Aronson, Jeffrey K

    2016-12-14

     To examine how misspellings of drug names could impede searches for published literature.  Database review.  PubMed.  The study included 30 drug names that are commonly misspelt on prescription charts in hospitals in Birmingham, UK (test set), and 30 control names randomly chosen from a hospital formulary (control set). The following definitions were used: standard names-the international non-proprietary names, variant names-deviations in spelling from standard names that are not themselves standard names in English language nomenclature, and hidden reference variants-variant spellings that identified publications in textword (tw) searches of PubMed or other databases, and which were not identified by textword searches for the standard names. Variant names were generated from standard names by applying letter substitutions, omissions, additions, transpositions, duplications, deduplications, and combinations of these. Searches were carried out in PubMed (30 June 2016) for "standard name[tw]" and "variant name[tw] NOT standard name[tw]."  The 30 standard names of drugs in the test set gave 325 979 hits in total, and 160 hidden reference variants gave 3872 hits (1.17%). The standard names of the control set gave 470 064 hits, and 79 hidden reference variants gave 766 hits (0.16%). Letter substitutions (particularly i to y and vice versa) and omissions together accounted for 2924 (74%) of the variants. Amitriptyline (8530 hits) yielded 18 hidden reference variants (179 (2.1%) hits). Names ending in "in," "ine," or "micin" were commonly misspelt. Failing to search for hidden reference variants of "gentamicin," "amitriptyline," "mirtazapine," and "trazodone" would miss at least 19 systematic reviews. A hidden reference variant related to Christmas, "No-el", was rare; variants of "X-miss" were rarer.  When performing searches, researchers should include misspellings of drug names among their search terms. Published by the BMJ Publishing Group Limited. For

  10. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

    Science.gov (United States)

    Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

    2012-12-01

    1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. Applications of Dynamic Clamp to Cardiac Arrhythmia Research: Role in Drug Target Discovery and Safety Pharmacology Testing

    Directory of Open Access Journals (Sweden)

    Francis A. Ortega

    2018-01-01

    Full Text Available Dynamic clamp, a hybrid-computational-experimental technique that has been used to elucidate ionic mechanisms underlying cardiac electrophysiology, is emerging as a promising tool in the discovery of potential anti-arrhythmic targets and in pharmacological safety testing. Through the injection of computationally simulated conductances into isolated cardiomyocytes in a real-time continuous loop, dynamic clamp has greatly expanded the capabilities of patch clamp outside traditional static voltage and current protocols. Recent applications include fine manipulation of injected artificial conductances to identify promising drug targets in the prevention of arrhythmia and the direct testing of model-based hypotheses. Furthermore, dynamic clamp has been used to enhance existing experimental models by addressing their intrinsic limitations, which increased predictive power in identifying pro-arrhythmic pharmacological compounds. Here, we review the recent advances of the dynamic clamp technique in cardiac electrophysiology with a focus on its future role in the development of safety testing and discovery of anti-arrhythmic drugs.

  12. malERA: An updated research agenda for diagnostics, drugs, vaccines, and vector control in malaria elimination and eradication.

    Science.gov (United States)

    2017-11-01

    Since the turn of the century, a remarkable expansion has been achieved in the range and effectiveness of products and strategies available to prevent, treat, and control malaria, including advances in diagnostics, drugs, vaccines, and vector control. These advances have once again put malaria elimination on the agenda. However, it is clear that even with the means available today, malaria control and elimination pose a formidable challenge in many settings. Thus, currently available resources must be used more effectively, and new products and approaches likely to achieve these goals must be developed. This paper considers tools (both those available and others that may be required) to achieve and maintain malaria elimination. New diagnostics are needed to direct treatment and detect transmission potential; new drugs and vaccines to overcome existing resistance and protect against clinical and severe disease, as well as block transmission and prevent relapses; and new vector control measures to overcome insecticide resistance and more powerfully interrupt transmission. It is also essential that strategies for combining new and existing approaches are developed for different settings to maximise their longevity and effectiveness in areas with continuing transmission and receptivity. For areas where local elimination has been recently achieved, understanding which measures are needed to maintain elimination is necessary to prevent rebound and the reestablishment of transmission. This becomes increasingly important as more countries move towards elimination.

  13. Research in Biological and Medical Sciences, Including Biochemistry, Communicable Disease and Immunology, Internal Medicine, Nuclear Medicine, Physiology, Psychiatry, Surgery and Veterinary Medicine. Volume 2

    Science.gov (United States)

    1975-07-01

    during the past fiscal year include 45 ovario- hysterectomles, one caesarean section, one fracture repair, one patent ductus arteriosus repair, one...Following closure of the thoracotomy, SOD was down by 60% and VQJ was> 80% of control levels. SOD and VQO did not relate to each other in a parallel...tions. Two patents were applied for, one for the Electronic Debubbler Circuit and one for the Improved Flow Cell. A paper on this latest

  14. Effects of disciplinary cultures of researchers and research trainees on the acceptability of nanocarriers for drug delivery in different contexts of use: a mixed-methods study

    International Nuclear Information System (INIS)

    Chenel, Vanessa; Boissy, Patrick; Cloarec, Jean-Pierre; Patenaude, Johane

    2015-01-01

    The acceptability of nanomedical applications, which have the potential to generate ethical and societal impacts, is a significant factor in the deployment of nanomedicine. A lack of fit between nanomedical applications and society’s values may result from a partial consideration of such impacts. New approaches for technological evaluation focused on impact perception, acceptance, and acceptability are needed to go beyond traditional technology assessment approaches used with nanotechnology, which focus mainly on toxicological and safety criteria. Using a new evaluative approach based on perceived impacts of nanotechnology, the objective of this study was to assess perceptions among researchers and research trainees familiar with emergent technologies and from different disciplinary background the scope of acceptability judgments made towards the use of nanocarriers. This mixed-methods study was based on scenarios presenting two types of drug-delivery nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer treatment, seasonal flu treatment). Researchers and research trainees in the natural sciences and engineering, and the social sciences and the humanities were invited by email to take part in this project. An online questionnaire followed by semi-directed interviews allowed characterization of disciplinary divergences regarding to impact perception, acceptance, and acceptability of the scenarios. The results suggest that impact perception is influenced by disciplinary culture. Also, trends can be seen between respondents’ profiles and variables of acceptance and acceptability, and certain components of the acceptability judgement are specific to each disciplinary culture. The acknowledgment and consideration of these disciplinary divergences could allow, among others, for opening up interdisciplinary dialogue on matters related to the acceptability of nanomedical applications and their developments

  15. Effects of disciplinary cultures of researchers and research trainees on the acceptability of nanocarriers for drug delivery in different contexts of use: a mixed-methods study

    Energy Technology Data Exchange (ETDEWEB)

    Chenel, Vanessa; Boissy, Patrick, E-mail: patrick.boissy@usherbrooke.ca [Université de Sherbrooke, Interdisciplinary Institute for Technological Innovation (3IT) (Canada); Cloarec, Jean-Pierre [Université de Sherbrooke, Laboratoire Nanotechnologies et Nanosystèmes (LN2), Centre National de la Recherche Scientifique (CNRS) (Canada); Patenaude, Johane [Université de Sherbrooke, Interdisciplinary Institute for Technological Innovation (3IT) (Canada)

    2015-04-15

    The acceptability of nanomedical applications, which have the potential to generate ethical and societal impacts, is a significant factor in the deployment of nanomedicine. A lack of fit between nanomedical applications and society’s values may result from a partial consideration of such impacts. New approaches for technological evaluation focused on impact perception, acceptance, and acceptability are needed to go beyond traditional technology assessment approaches used with nanotechnology, which focus mainly on toxicological and safety criteria. Using a new evaluative approach based on perceived impacts of nanotechnology, the objective of this study was to assess perceptions among researchers and research trainees familiar with emergent technologies and from different disciplinary background the scope of acceptability judgments made towards the use of nanocarriers. This mixed-methods study was based on scenarios presenting two types of drug-delivery nanocarriers (carbon, synthetic DNA) in two contexts of use (lung cancer treatment, seasonal flu treatment). Researchers and research trainees in the natural sciences and engineering, and the social sciences and the humanities were invited by email to take part in this project. An online questionnaire followed by semi-directed interviews allowed characterization of disciplinary divergences regarding to impact perception, acceptance, and acceptability of the scenarios. The results suggest that impact perception is influenced by disciplinary culture. Also, trends can be seen between respondents’ profiles and variables of acceptance and acceptability, and certain components of the acceptability judgement are specific to each disciplinary culture. The acknowledgment and consideration of these disciplinary divergences could allow, among others, for opening up interdisciplinary dialogue on matters related to the acceptability of nanomedical applications and their developments.

  16. The Impact of the 5E Teaching Model on Changes in Neuroscience, Drug Addiction, and Research Methods Knowledge of Science Teachers Attending California's ARISE Professional Development Workshops

    Science.gov (United States)

    Manzo, Rosa D.; Whent, Linda; Liets, Lauren; de la Torre, Adela; Gomez-Camacho, Rosa

    2016-01-01

    This study examined how science teachers' knowledge of research methods, neuroscience and drug addiction changed through their participation in a 5-day summer science institute. The data for this study evolved from a four-year NIH funded science education project called Addiction Research and Investigation for Science Educators (ARISE). Findings…

  17. Drug Facts

    Medline Plus

    Full Text Available ... Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? ... of Health (NIH) , the principal biomedical and behavioral research agency of the United States Government. NIH is ...

  18. Numerate Intends to Join ATOM Consortium to Rapidly Accelerate Preclinical Drug Development | Frederick National Laboratory for Cancer Research

    Science.gov (United States)

    SAN FRANCISCO – Computational drug design company Numerate has signed a letter of intent to join an open consortium of scientists staffed from two U.S. national laboratories, industry, and academia working to transform drug discovery and developmen

  19. Research

    African Journals Online (AJOL)

    ebutamanya

    2015-10-01

    Oct 1, 2015 ... allopathic drugs, especially for chronic conditions also makes TMPs popular ..... sodium benzoate as a preservative in food is established [33]. Tamarindus ... drug-drug interactions since the herbalists did not object to the.

  20. Empirical research on drugs - La recherche empirique dans le domaine des drogues - La ricerca empirica in materia di droga

    Directory of Open Access Journals (Sweden)

    Piselli A.

    2009-08-01

    Full Text Available The article deals with some methodological topics related to researches on drug phenomena. The main consideration pertains to that kind of “crime without victim” that is largely hidden (dark figure. The solutions adopted to approach these and other problems include the rigorous logical and semantic definition of the objects and the use of specific analysis criteria taken from other disciplines, like demography and urban topography. Official statistics figures must be corrected by specific criteria; on the one hand by the statistical projection of the outcome data, and on the other hand by the case studies. Cet article aborde le sujet des méthodes de recherche qui doivent être utilisées par les études empiriques des phénomènes liés à la drogue. À ce propos il faut avant tout étudier ce phénomène en tant que « crime sans victime » qui alimente le chiffre noir. Les solutions adoptées pour essayer de résoudre ce problème particulier et d’autres problèmes typiques incluent la rigureuse définition logique et sémantique des termes objet d’étude et l’utilisation de critères d’analyse empruntés à d’autres disciplines, notamment à la démographie et à la topographie urbaine. Les données provenantes des statistiques officielles doivent être corrigées de la façon suivante : d’un côté par la projection statistique des résultats et, de l’autre côté, par l’étude de cas.L’articolo discute alcuni elementi di metodo da tenere presenti nell’ambito dello studio dei fenomeni connessi alla droga. Prioritaria al riguardo è la considerazione di tale fenomeno criminale come “reato senza vittima” e la preponderante presenza della cifra oscura. Le soluzioni adottate per bilanciare questi e altri problemi tipici includono la rigorosa definizione logico/semantica dei termini oggetto di studio e il ricorso a criteri di analisi mutuati da altre discipline, su tutti la demografia e la topografia urbana. Di

  1. Disposal project for LLW and VLLW generated from research facilities in Japan: A feasibility study for the near surface disposal of VLLW that includes uranium

    International Nuclear Information System (INIS)

    Sakai, Akihiro; Hasegawa, M.; Sakamoto, Y.; Nakatani, T.

    2016-01-01

    Conclusion and future work: • JAEA plans trench disposal of U-bearing waste with less than 100 Bq/g. • Two safety measures of trench disposal of U-bearing waste have been discussed taking into account increasing radioactivity over a long period of time. 1. First is to carry out dose assessment of site use scenario by using a conservatively stylized condition. 2. Second is to control the average concentration of U in the trench facilities based on the concept of the existing exposure situation. • We are continuously developing the method for safety measures of near surface disposal of VLLW including U-bearing waste.

  2. NASA/DOD Aerospace Knowledge Diffusion Research Project. Report 10: Summary report to phase 3 academic library respondents including frequency distributions

    Science.gov (United States)

    Pinelli, Thomas E.; Kennedy, John M.; White, Terry F.

    1991-01-01

    Phase 3 of a 4 part study was undertaken to study the use of scientific and technical information (STI) in the academic aerospace community. Phase 3 of this project used three questionnaires that were sent to three groups (i.e., faculty, librarians, and students) in the academic aerospace community. Specific attention was paid to the types of STI used and the methods in which academic users acquire STI. The responses of the academic libraries are focussed on herein. Demographic information on academic aerospace libraries is provided. Data regarding NASA interaction with academic aerospace libraries is also included, as is the survey instrument.

  3. A statistical model for estimation of fish density including correlation in size, space, time and between species from research survey data.

    Directory of Open Access Journals (Sweden)

    J Rasmus Nielsen

    Full Text Available Trawl survey data with high spatial and seasonal coverage were analysed using a variant of the Log Gaussian Cox Process (LGCP statistical model to estimate unbiased relative fish densities. The model estimates correlations between observations according to time, space, and fish size and includes zero observations and over-dispersion. The model utilises the fact the correlation between numbers of fish caught increases when the distance in space and time between the fish decreases, and the correlation between size groups in a haul increases when the difference in size decreases. Here the model is extended in two ways. Instead of assuming a natural scale size correlation, the model is further developed to allow for a transformed length scale. Furthermore, in the present application, the spatial- and size-dependent correlation between species was included. For cod (Gadus morhua and whiting (Merlangius merlangus, a common structured size correlation was fitted, and a separable structure between the time and space-size correlation was found for each species, whereas more complex structures were required to describe the correlation between species (and space-size. The within-species time correlation is strong, whereas the correlations between the species are weaker over time but strong within the year.

  4. Child Maltreatment and Its Relationship to Drug Use in Latin America and the Caribbean: An Overview and Multinational Research Partnership

    Science.gov (United States)

    Longman-Mills, Samantha; Gonzalez, Yolanda W.; Melendez, Marlon O.; Garcia, Monica R.; Gomez, Juan D.; Juarez, Cristina G.; Martinez, Eduardo A.; Penalba, Sobeyda J.; Pizzanelli, Miguel E.; Solorzano, Lucia I.; Wright, Gloria; Cumsille, Francisco; Sapag, Jaime; Wekerle, Christine; Hamilton, Hayley; Erickson, Patricia; Mann, Robert

    2011-01-01

    Child maltreatment and substance abuse are both international public health priorities. Research shows that child maltreatment increases the risk for substance use and problems. Thus, recognition of this relationship may have important implications for substance demand reduction strategies, including efforts to prevent and treat substance use and…

  5. [Orphan drugs].

    Science.gov (United States)

    Golocorbin Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojsa; Mikov, Momir

    2013-01-01

    Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in "adopting" them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. THE BEGINNING OF ORPHAN DRUGS DEVELOPMENT: This problem was first recognized by Congress of the United States of America in January 1983, and when the "Orphan Drug Act" was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs.

  6. Analysis of technological innovation in Danish wind turbine industry - including the Test Station for Windturbines dual roll as research institution and certification authority

    International Nuclear Information System (INIS)

    Dannemand Andersen, P.

    1993-01-01

    The overall aim of this thesis is to examine the interactions between the Danish wind turbine industry and the Test Station for Wind Turbines. Because these interactions are concerning technological innovation, it follows that the innovation processes within the enterprises must be analyzed and modelled. The study is carried out as an iterative model-developing process using case study methods. The findings from some less structured interviews are discussed with literature and forms a basis for models and new interviews. The thesis is based on interviews with 20 R and D engineers in the Danish wind turbine industry, 7 engineers at The Test Station and 7 people involved in wind power abroad (American and British). The theoretical frame for this thesis is sociology/organizational theory and industrial engineering. The thesis consists of five main sections, dealing with technology and knowledge, innovation processes, organizational culture, innovation and interaction between the Test Station's research activities and the companies' innovation processes, and finally interaction through the Test Stations certification activity. First a taxonomy for technology and knowledge is established in order to clarify what kind of technology the interactions are all about, and what kind of knowledge is transferred during the interactions. This part of the thesis also contains an analysis of the patents drawn by the Danish wind turbine industry. The analysis shows that the Danish wind turbine industry do not use patents. Instead the nature of the technology and the speed of innovation are used to protect the industry's knowledge. (EG) (192 refs.)

  7. The British research evidence for recovery, papers published between 2006 and 2009 (inclusive). Part two: a review of the grey literature including book chapters and policy documents.

    Science.gov (United States)

    Stickley, T; Wright, N

    2011-05-01

    This paper is the second in a series of two which reviews the current UK evidence base for recovery in mental health. As outlined in the previous paper, over the last 4 years a vast amount has written about recovery in mental health (approximately 60% of all articles). Whereas the first review focused on the peer-reviewed evidence; this paper specifically focuses on the grey/non-peer-reviewed literature. In total, our search strategy yielded the following: 3 books, a further 11 book chapters, 12 papers, 6 policy documents and 3 publications from voluntary sector organizations. Each group of publications was analysed for content, and they are discursively presented by publication group. The findings are then presented as themes in the discussion section. The themes are: social, historical and political critique; philosophy of hope for the individual; individual identity and narrative; models and guidance for mental health practice. We conclude that there is a need for both empirical research into recovery and a clearer theoretical exposition of the concept. © 2010 Blackwell Publishing.

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

    International Nuclear Information System (INIS)

    2016-08-01

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

  9. The method of quality marker research and quality evaluation of traditional Chinese medicine based on drug properties and effect characteristics.

    Science.gov (United States)

    Zhang, Tiejun; Bai, Gang; Han, Yanqi; Xu, Jun; Gong, Suxiao; Li, Yazhuo; Zhang, Hongbing; Liu, Changxiao

    2018-05-15

    Quality of traditional Chinese medicine (TCM) plays a critical role in industry of TCM. Rapid development of TCM pharmaceutical areas is, however, greatly limited, since there are many issues not been resolved, concerning the quality study of TCM. Core concept of TCM quality as well as the characteristics of TCM was discussed, in order to guide the quality research and evaluation of TCM, further improve the level of TCM quality control. In this review, on the basis of systematic analysis of fundamental property and features of TCM in clinical application, the approaches and methods of quality marker (Q-marker) study were proposed through combination of transitivity and traceability of essentials of quality, correlation between chemical ingredients and drug property/efficacy, as well as analysis of endemicity of ingredients sharing similar pharmacophylogenetic and biosynthetic approaches. The approaches and methods of Q-marker study were proposed and the novel integrated pattern for quality assessment and control of TCM was established. The core concept of Q-marker has helped to break through the bottleneck of the current fragmented quality research of TCM and improved the scientificity, integrity and systematicness of quality control. Copyright © 2018 Elsevier GmbH. All rights reserved.

  10. The creativity of Crumb: research on the effects of psychedelic drugs on the comic art of Robert Crumb.

    Science.gov (United States)

    Jones, Matthew T

    2007-09-01

    This article investigates the influence of perception that is altered by psychedelic drugs on processes of creativity through a case study of the work of well-known comic artist Robert Crumb. Samples of Crumb's work before, during, and after the period of his use of psychedelic drugs are content analyzed and compared according to the categorization offered by Janiger and Dobkin de Rios (1989). The results of the comparison indicate that Robert Crumb's drug use significantly altered the stylistic approach of his artwork not only during the period of his drug use, but long after he had stopped using drugs.

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

    International Nuclear Information System (INIS)

    2005-01-01

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

  12. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Women and Drugs Publications Search Publications Orderable DrugFacts Research Reports Mind Over Matter Science of Addiction Funding Funding Opportunities Clinical Research Post- ...

  13. Short and long-term safety and efficacy of polymer-free vs. durable polymer drug-eluting stents. A comprehensive meta-analysis of randomized trials including 6178 patients

    NARCIS (Netherlands)

    Navarese, E.P.; Kowalewski, M.; Cortese, B.; Kandzari, D.; Dias, S.; Wojakowski, W.; Buffon, A.; Lansky, A.; Angelini, P.; Torguson, R.; Kubica, J.; Kelm, M.; Boer, M.J. de; Waksman, R.; Suryapranata, H.

    2014-01-01

    BACKGROUND: The efficacy and safety of polymer-free drug-eluting stents (DESs) in clinical practice is currently subject of debate; randomized trials (RCTs) conducted so far provided conflicting results or were underpowered to definitively address this question; we aimed to investigate the efficacy

  14. [How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine].

    Science.gov (United States)

    Jin, Fang

    2017-05-01

    On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation

  15. How might schools influence young people's drug use? Development of theory from qualitative case-study research.

    Science.gov (United States)

    Fletcher, Adam; Bonell, Chris; Sorhaindo, Annik; Strange, Vicki

    2009-08-01

    To explore young people's experiences of school and drug use, generate hypotheses regarding the pathways through which schools may influence students' drug use, and examine how these may vary according to students' sociodemographic characteristics. Qualitative data were collected through semistructured interviews with 30 students (aged 14-15) and 10 teachers in two case-study schools. Students were purposively sampled to encompass variations in socioeconomic status, gender, ethnicity, and school engagement. Techniques associated with thematic content analysis and grounded theory were used to analyze the data and generate hypotheses. Three potential pathways via which school effects on drug use may occur were identified: (1) peer-group sorting and drug use as a source of identity and bonding among students who are disconnected from the main institutional markers of status; (2) students' desire to "fit in" at schools perceived to be unsafe and drug use facilitating this; and/or (3) drug use as a strategy to manage anxieties about school work and escape unhappiness at schools lacking effective social support systems. Various pathways may plausibly underlie school effects on drug use. These support the idea of "whole-school" interventions to reduce drug use through: recognizing students' varied achievements and promoting a sense of belonging, reducing bullying and aggression, and providing additional social support for students. Such interventions should be piloted and evaluated in a range of settings to examine effects on students' drug use. Broader policies relating to secondary school targets, curricula, assessment, and streaming may also influence rates of adolescent drug use.

  16. Drugs Approved for Breast Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Raloxifene Hydrochloride Tamoxifen Citrate Drugs ...

  17. Translational medicine and drug discovery

    National Research Council Canada - National Science Library

    Littman, Bruce H; Krishna, Rajesh

    2011-01-01

    ..., and examples of their application to real-life drug discovery and development. The latest thinking is presented by researchers from many of the world's leading pharmaceutical companies, including Pfizer, Merck, Eli Lilly, Abbott, and Novartis, as well as from academic institutions and public- private partnerships that support translational research...

  18. Alcohol & drug abuse: Revisiting employee assistance programs and substance use problems in the workplace: key issues and a research agenda.

    Science.gov (United States)

    Merrick, Elizabeth S Levy; Volpe-Vartanian, Joanna; Horgan, Constance M; McCann, Bernard

    2007-10-01

    This column describes employee assistance program (EAPs) and identifies key issues for contemporary EAPs. These programs began as occupational alcohol programs and have evolved into more comprehensive resources. To better understand contemporary EAPs, the authors suggest a research agenda that includes descriptive studies to provide an up-to-date picture of services; investigations of how contemporary EAPs address substance use problems, including management consultation for early identification; further study of EAPs' effects on outcomes, such as productivity and work group outcomes; examination of the relationship between EAPs and other workplace resources; further examination of influences on EAP utilization; and development and testing of EAP performance measures.

  19. Review Statement and Evaluation of the Swedish Nuclear Fuel and Waste Management Co's RDandD Programme 2004. Programme for Research, Development and Demonstration of Methods for the Management and Disposal of Nuclear Waste, including Social Science Research

    International Nuclear Information System (INIS)

    2005-12-01

    verify the models in time prior to a licence application. Furthermore, the authorities assume that more long-term biosphere issues are being taken into account in SKB's new plan of action. - In its biosphere research, SKB should take into account the possibility of using radionuclide concentrations and flows as complementary safety indicators. - SKB should more clearly explain how it will ensure that studied climate scenarios will shed light on the most important climate-related stresses on the barrier function. - It is justifiable for the research conducted by SKB and Sweden in the area of PandT to maintain its current level so that international developments can be followed and to maintain and develop scientific and technical expertise in areas of importance for nuclear safety. - A clarification of the account of deep boreholes prior to the ultimate choice of a method and prior to licensing under the Environmental Code is needed. A comparison should be made with the KBS-3 method which utilizes safety assessment methodology including simple calculations. - SKB needs to intensify the work on decommissioning issues and in order to present detailed plans and considerations in RDandD Programme 2007. - SKB should investigate the shortest time required for the start of a licensing process for the disposal of decommissioning waste. - In the next RDandD programme, SKB should provide a more detailed description of the programme for long-lived low and intermediate-level waste. - SKB should take into account the viewpoint that long-term interim storage of waste while waiting for the construction of a repository should, as far as possible, be avoided and take this into consideration in its planning. - It is positive that SKB has incorporated social science research into its programme, since the findings from the research should be useful for the stakeholders to apply the research findings in ongoing and future consultation processes for an encapsulation plant and repository

  20. Review Statement and Evaluation of the Swedish Nuclear Fuel and Waste Management Co's RDandD Programme 2004. Programme for Research, Development and Demonstration of Methods for the Management and Disposal of Nuclear Waste, including Social Science Research

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-12-15

    verify the models in time prior to a licence application. Furthermore, the authorities assume that more long-term biosphere issues are being taken into account in SKB's new plan of action. - In its biosphere research, SKB should take into account the possibility of using radionuclide concentrations and flows as complementary safety indicators. - SKB should more clearly explain how it will ensure that studied climate scenarios will shed light on the most important climate-related stresses on the barrier function. - It is justifiable for the research conducted by SKB and Sweden in the area of PandT to maintain its current level so that international developments can be followed and to maintain and develop scientific and technical expertise in areas of importance for nuclear safety. - A clarification of the account of deep boreholes prior to the ultimate choice of a method and prior to licensing under the Environmental Code is needed. A comparison should be made with the KBS-3 method which utilizes safety assessment methodology including simple calculations. - SKB needs to intensify the work on decommissioning issues and in order to present detailed plans and considerations in RDandD Programme 2007. - SKB should investigate the shortest time required for the start of a licensing process for the disposal of decommissioning waste. - In the next RDandD programme, SKB should provide a more detailed description of the programme for long-lived low and intermediate-level waste. - SKB should take into account the viewpoint that long-term interim storage of waste while waiting for the construction of a repository should, as far as possible, be avoided and take this into consideration in its planning. - It is positive that SKB has incorporated social science research into its programme, since the findings from the research should be useful for the stakeholders to apply the research findings in ongoing and future consultation processes for an encapsulation plant and repository.

  1. Drug abuse in athletes

    Directory of Open Access Journals (Sweden)

    Reardon CL

    2014-08-01

    Full Text Available Claudia L Reardon, Shane Creado Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA Abstract: Drug abuse occurs in all sports and at most levels of competition. Athletic life may lead to drug abuse for a number of reasons, including for performance enhancement, to self-treat otherwise untreated mental illness, and to deal with stressors, such as pressure to perform, injuries, physical pain, and retirement from sport. This review examines the history of doping in athletes, the effects of different classes of substances used for doping, side effects of doping, the role of anti-doping organizations, and treatment of affected athletes. Doping goes back to ancient times, prior to the development of organized sports. Performance-enhancing drugs have continued to evolve, with “advances” in doping strategies driven by improved drug testing detection methods and advances in scientific research that can lead to the discovery and use of substances that may later be banned. Many sports organizations have come to ban the use of performance-enhancing drugs and have very strict consequences for people caught using them. There is variable evidence for the performance-enhancing effects and side effects of the various substances that are used for doping. Drug abuse in athletes should be addressed with preventive measures, education, motivational interviewing, and, when indicated, pharmacologic interventions. Keywords: doping, athletes, steroids, drug abuse, mental illness

  2. Drugs Approved for Rhabdomyosarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for rhabdomyosarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries. There may be drugs used in rhabdomyosarcoma that are not listed here.

  3. Information for Consumers (Drugs)

    Science.gov (United States)

    ... approved drugs Drugs@FDA Information on FDA-approved brand name and generic drugs including labeling and regulatory history Drugs with Approved Risk Evaluation and Mitigation Strategies (REMS) REMS is a risk management plan required by FDA for certain prescription drugs, ...

  4. Why Antidiabetic Vanadium Complexes are Not in the Pipeline of "Big Pharma" Drug Research? A Critical Review.

    Science.gov (United States)

    Scior, Thomas; Guevara-Garcia, Jose Antonio; Do, Quoc-Tuan; Bernard, Philippe; Laufer, Stefan

    2016-01-01

    Public academic research sites, private institutions as well as small companies have made substantial contributions to the ongoing development of antidiabetic vanadium compounds. But why is this endeavor not echoed by the globally operating pharmaceutical companies, also known as "Big Pharma"? Intriguingly, today's clinical practice is in great need to improve or replace insulin treatment against Diabetes Mellitus (DM). Insulin is the mainstay therapeutically and economically. So, why do those companies develop potential antidiabetic drug candidates without vanadium (vanadium- free)? We gathered information about physicochemical and pharmacological properties of known vanadium-containing antidiabetic compounds from the specialized literature, and converted the data into explanations (arguments, the "pros and cons") about the underpinnings of antidiabetic vanadium. Some discoveries were embedded in chronological order while seminal reviews of the last decade about the Medicinal chemistry of vanadium and its history were also listed for further understanding. In particular, the concepts of so-called "noncomplexed or free" vanadium species (i.e. inorganic oxido-coordinated species) and "biogenic speciation" of antidiabetic vanadium complexes were found critical and subsequently documented in more details to answer the question.

  5. Fiscal 2000 pioneering research report on the basic technology for novel DNA drug creation using anti-gene engineering; 2000 nendo anti gene kogaku ni yoru shinki DNA drug soshutsu kiban gijutsu chosa kenkyu hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-03-01

    Research is conducted concerning the possibility of anti-gene engineering basic to the application of DNA (deoxyribonucleic acid) drugs capable of serving as functional DNAs to the control of the expression of industrially useful substance producing genes or of anomalous genes and concerning the possibility of novel industry creation on the strength of the said engineering. The specific research items are described below. Technical seeds are investigated relating to the tissue- and cell-specific drug delivery system for the expression of the molecular device function of the DNA drug. Concerning molecular target technologies such as the anti-sense method, possibilities are studied of utilizing the currently available technical seeds for the eventual creation of novel industries. Concerning novel designing methods utilizing genome information such as SNPs (single nucleotide polymorphisms), investigations are conducted to determine if they would help novel technology development and novel material development. The domestic state is surveyed in relation to DNA drugs, and possibilities are investigated of novel substance production and novel medicine creation with the aid of anti-gene engineering. (NEDO)

  6. Antibody-linked drug destroys tumor cells and tumor blood vessels in many types of cancer | Center for Cancer Research

    Science.gov (United States)

    A team led by Brad St. Croix, Ph.D., Senior Associate Scientist, Mouse Cancer Genetics Program, has developed an antibody-drug conjugate (ADC) that destroys both tumor cells and the blood vessels that nourish them. The drug significantly shrank breast tumors, colon tumors and several other types of cancer and prolonged survival. Learn more...  

  7. Data Collection and Harmonization in HIV Research: The Seek, Test, Treat, and Retain Initiative at the National Institute on Drug Abuse.

    Science.gov (United States)

    Chandler, Redonna K; Kahana, Shoshana Y; Fletcher, Bennett; Jones, Dionne; Finger, Matthew S; Aklin, Will M; Hamill, Kathleen; Webb, Candace

    2015-12-01

    Large-scale, multisite data sets offer the potential for exploring the public health benefits of biomedical interventions. Data harmonization is an emerging strategy to increase the comparability of research data collected across independent studies, enabling research questions to be addressed beyond the capacity of any individual study. The National Institute on Drug Abuse recently implemented this novel strategy to prospectively collect and harmonize data across 22 independent research studies developing and empirically testing interventions to effectively deliver an HIV continuum of care to diverse drug-abusing populations. We describe this data collection and harmonization effort, collectively known as the Seek, Test, Treat, and Retain Data Collection and Harmonization Initiative, which can serve as a model applicable to other research endeavors.

  8. Drug Facts

    Medline Plus

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

  9. Addiction research centres and the nurturing of creativity: The Swiss Institute for the Prevention of Alcohol and Drug Problems. Past, present and future

    NARCIS (Netherlands)

    Kuntsche, E.N.; Maffli, E.; Kuntsche, S.; Delgrande Jordan, M.

    2009-01-01

    The aim of this paper is to offer an account of the history, the current status and the future of substance use research at the Swiss Institute for the Prevention of Alcohol and Drug Problems (SIPA). Although founded originally by the temperance movement in 1901, its policy has shifted over time

  10. Characterization of Adolescent Prescription Drug Abuse and Misuse Using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R]) System

    Science.gov (United States)

    Zosel, Amy; Bartelson, Becki Bucher; Bailey, Elise; Lowenstein, Steven; Dart, Rick

    2013-01-01

    Objective: To describe the characteristics and health effects of adolescent (age 13-19 years) prescription drug abuse and misuse using the Researched Abuse Diversion and Addiction-Related Surveillance (RADARS[R])) System. Method: Secondary analysis of data collected from RADARS System participating poison centers was performed. Data for all…

  11. Ketamine - A Multifaceted Drug.

    Science.gov (United States)

    Meng, Lingzhong; Li, Jian; Lu, Yi; Sun, Dajin; Tao, Yuan-Xiang; Liu, Renyu; Luo, Jin Jun

    There is a petition for tight control of ketamine from the Chinese government to classify ketamine as a Schedule I drug, which is defined as a drug with no currently accepted medical use but a high potential for abuse. However, ketamine has unique properties that can benefit different patient populations. Scholars from the Translational Perioperative and Pain Medicine and the International Chinese Academy of Anesthesiology WeChat groups had an interactive discussion on ketamine, including its current medical applications, future research priorities, and benefits versus risks. The discussion is summarized in this manuscript with some minor edits.

  12. Comparative studies on drug binding to the purified and pharmaceutical-grade human serum albumins: Bridging between basic research and clinical applications of albumin.

    Science.gov (United States)

    Ashrafi-Kooshk, Mohammad Reza; Ebrahimi, Farangis; Ranjbar, Samira; Ghobadi, Sirous; Moradi, Nastaran; Khodarahmi, Reza

    2015-09-01

    Human serum albumin (HSA), the most abundant protein in blood plasma, is a monomeric multidomain protein that possesses an extraordinary capacity for binding, so that serves as a circulating depot for endogenous and exogenous compounds. During the heat sterilization process, the structure of pharmaceutical-grade HSA may change and some of its activities may be lost. In this study, to provide deeper insight on this issue, we investigated drug-binding and some physicochemical properties of purified albumin (PA) and pharmaceutical-grade albumin (PGA) using two known drugs (indomethacin and ibuprofen). PGA displayed significantly lower drug binding capacity compared to PA. Analysis of the quenching and thermodynamic parameters indicated that intermolecular interactions between the drugs and the proteins are different from each other. Surface hydrophobicity as well as the stability of PGA decreased compared to PA, also surface hydrophobicity of PA and PGA increased upon drugs binding. Also, kinetic analysis of pseudo-esterase activities indicated that Km and Vmax parameters for PGA enzymatic activity are more and less than those of PA, respectively. This in vitro study demonstrates that the specific drug binding of PGA is significantly reduced. Such studies can act as connecting bridge between basic research discoveries and clinical applications. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  13. Mortality rates and causes of death in children with epilepsy prescribed antiepileptic drugs: a retrospective cohort study using the UK General Practice Research Database.

    Science.gov (United States)

    Ackers, Ruth; Besag, Frank M C; Hughes, Elaine; Squier, Waney; Murray, Macey L; Wong, Ian C K

    2011-05-01

    Patients with epilepsy, including children, have an increased risk of mortality compared with the general population. Antiepileptic drugs (AEDs) were the most frequent class of drugs reported in a study looking at fatal suspected adverse drug reactions in children in the UK. The objective of the study was to identify cases and causes of death in a paediatric patient cohort prescribed AEDs with an associated epilepsy diagnosis. This was a retrospective cohort study supplemented with general practitioner-completed questionnaires, post-mortem reports and death certificates. The setting was UK primary care practices contributing to the General Practice Research Database. Participants were children and adolescents aged 0-18 years prescribed AEDs between 1993 and 2005. Causality assessment was undertaken by a consensus panel comprising paediatric specialists in neuropathology, neurology, neuropsychiatry, paediatric epilepsy, pharmacoepidemiology and pharmacy to determine crude mortality rate (CMR) and standardized mortality ratios (SMRs), and the likelihood of an association between AED(s) and the event of death. There were 6190 subjects in the cohort (contributing 26,890 person-years of data), of whom 151 died. Median age at death was 8.0 years. CMR was 56.2 per 10,000 person-years and the SMR was 22.4 (95% CI 18.9, 26.2). The majority of deceased subjects had severe underlying disorders. Death was attributable to epilepsy in 18 subjects; in 9 the cause of death was sudden unexpected death in epilepsy (SUDEP) [3.3 per 10 000 person-years (95% CI 1.5, 6.4)]. AEDs were probably (n = 2) or possibly (n = 3) associated causally with death in five subjects. Two status epilepticus deaths were associated causally with AED withdrawal. Children prescribed AEDs have an increased risk of mortality relative to the general population. Most of the deaths were in children with serious underlying disorders. A small number of SUDEP cases were identified. AEDs are not a major

  14. Research

    African Journals Online (AJOL)

    Research. May 2016, Vol. 8, No. 1 AJHPE 37. Students who enrol in occupational therapy (OT) at the. University of Kwa Zulu-Natal (UKZN), Durban, South Africa ... The latter may include becoming familiar with the disintegrating social systems in primary .... They also lacked the skills needed to adapt sessions and failed to ...

  15. Research

    African Journals Online (AJOL)

    2018-03-20

    Mar 20, 2018 ... student health professionals in various institutions, both in South Africa. (SA) and internationally. ... field include dentists, dental therapists and oral hygienists in training, .... The College of Health Sciences at UKZN has four schools: clinical ..... Journal of Emerging Trends in Educational Research and Policy ...

  16. Research and development in drug innovation: reflections from the 2013 bioeconomy conference in China, lessons learned and future perspectives.

    Science.gov (United States)

    Liu, Changxiao; Constantinides, Panayiotis P; Li, Yazhuo

    2014-04-01

    The enormous progress biotechnology, bioinformatics and nanotechnology made in recent years provides opportunities and scientific framework for development of biomedicine and constitutes a paradigm shift in pharmaceutical R&D and drug innovation. By analyzing the data and related information at R&D level over the past decades, developmental tendency and R&D patterns were summarized. We found that a growing number of biologics in the pipeline of pharma companies with successful products already in the market though, small molecular entities have primarily dominated drug innovation. Additionally, small/medium size companies will continue to play a key role in the development of small molecule drugs and biologics in a multi-channel integrated process. More importantly, modern and effective R&D strategies in biomedicine development to predict and evaluate efficacy and/or safety of 21st century therapeutics are urgently needed. To face new challenges, developmental strategies were proposed, in terms of molecular targeted medicine, generic drugs, new drug delivery system and protein-based drugs. Under the current circumstances, interdisciplinary cooperation mode and policy related to drug innovation in China were deeply discussed as well.

  17. 4-IBP, a σ1 Receptor Agonist, Decreases the Migration of Human Cancer Cells, Including Glioblastoma Cells, In Vitro and Sensitizes Them In Vitro and In Vivo to Cytotoxic Insults of Proapoptotic and Proautophagic Drugs

    Directory of Open Access Journals (Sweden)

    Veronique Mégalizzi

    2007-05-01

    Full Text Available Although the molecular function of cr receptors has not been fully defined and the natural ligand(s is still not known, there is increasing evidence that these receptors and their ligands might play a significant role in cancer biology. 4-(N-tibenzylpiperidin-4-yl-4iodobenzamide (4-IBP, a selective σ1, agonist, has been used to investigate whether this compound is able to modify: 1 in vitro the migration and proliferation of human cancer cells; 2 in vitro the sensitivity of human glioblastoma cells to cytotoxic drugs; and 3 in vivo in orthotopic glioblastoma and non-small cell lung carcinoma (NSCLC models the survival of mice coadministered cytotoxic agents. 4-IBP has revealed weak anti proliferative effects on human U373-MG glioblastoma and C32 melanoma cells but induced marked concentration-dependent decreases in the growth of human A549 NSCLC and PC3 prostate cancer cells. The compound was also significantly antimigratory in all four cancer cell lines. This may result, at least in U373-MG cells, from modifications to the actin cytoskeleton. 4-IBP modified the sensitivity of U373-MG cells in vitro to proapoptotic lomustin and proautophagic temozolomide, and markedly decreased the expression of two proteins involved in drug resistance: glucosylceramide synthase and Rho guanine nucleotide dissociation inhibitor. In vivo, 4-IBP increased the antitumor effects of temozolomide and irinotecan in immunodeficient mice that were orthotopically grafted with invasive cancer cells.

  18. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  19. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  20. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  2. Drugs Approved for Skin Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  3. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  4. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Malignant Mesothelioma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  8. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Collaboration for rare disease drug discovery research [v1; ref status: indexed, http://f1000r.es/4l6

    Directory of Open Access Journals (Sweden)

    Nadia K. Litterman

    2014-10-01

    Full Text Available Rare disease research has reached a tipping point, with the confluence of scientific and technologic developments that if appropriately harnessed, could lead to key breakthroughs and treatments for this set of devastating disorders. Industry-wide trends have revealed that the traditional drug discovery research and development (R&D model is no longer viable, and drug companies are evolving their approach. Rather than only pursue blockbuster therapeutics for heterogeneous, common diseases, drug companies have increasingly begun to shift their focus to rare diseases. In academia, advances in genetics analyses and disease mechanisms have allowed scientific understanding to mature, but the lack of funding and translational capability severely limits the rare disease research that leads to clinical trials. Simultaneously, there is a movement towards increased research collaboration, more data sharing, and heightened engagement and active involvement by patients, advocates, and foundations. The growth in networks and social networking tools presents an opportunity to help reach other patients but also find researchers and build collaborations. The growth of collaborative software that can enable researchers to share their data could also enable rare disease patients and foundations to manage their portfolio of funded projects for developing new therapeutics and suggest drug repurposing opportunities. Still there are many thousands of diseases without treatments and with only fragmented research efforts. We will describe some recent progress in several rare diseases used as examples and propose how collaborations could be facilitated. We propose that the development of a center of excellence that integrates and shares informatics resources for rare diseases sponsored by all of the stakeholders would help foster these initiatives.

  10. Collaboration with Pharma Will Introduce Nanotechnologies in Early Stage Drug Development | Frederick National Laboratory for Cancer Research

    Science.gov (United States)

    The Frederick National Lab has begun to assist several major pharmaceutical companies in adopting nanotechnologies in early stage drug development, when the approach is most efficient and cost-effective. For some time, the national lab’s Nanotechno

  11. The development of a healing model of care for an Indigenous drug and alcohol residential rehabilitation service: a community-based participatory research approach.

    Science.gov (United States)

    Munro, Alice; Shakeshaft, Anthony; Clifford, Anton

    2017-12-04

    Given the well-established evidence of disproportionately high rates of substance-related morbidity and mortality after release from incarceration for Indigenous Australians, access to comprehensive, effective and culturally safe residential rehabilitation treatment will likely assist in reducing recidivism to both prison and substance dependence for this population. In the absence of methodologically rigorous evidence, the delivery of Indigenous drug and alcohol residential rehabilitation services vary widely, and divergent views exist regarding the appropriateness and efficacy of different potential treatment components. One way to increase the methodological quality of evaluations of Indigenous residential rehabilitation services is to develop partnerships with researchers to better align models of care with the client's, and the community's, needs. An emerging research paradigm to guide the development of high quality evidence through a number of sequential steps that equitably involves services, stakeholders and researchers is community-based participatory research (CBPR). The purpose of this study is to articulate an Indigenous drug and alcohol residential rehabilitation service model of care, developed in collaboration between clients, service providers and researchers using a CBPR approach. This research adopted a mixed methods CBPR approach to triangulate collected data to inform the development of a model of care for a remote Indigenous drug and alcohol residential rehabilitation service. Four iterative CBPR steps of research activity were recorded during the 3-year research partnership. As a direct outcome of the CBPR framework, the service and researchers co-designed a Healing Model of Care that comprises six core treatment components, three core organisational components and is articulated in two program logics. The program logics were designed to specifically align each component and outcome with the mechanism of change for the client or organisation

  12. Drug repositioning: playing dirty to kill pain.

    Science.gov (United States)

    Bastos, Leandro Francisco Silva; Coelho, Márcio Matos

    2014-01-01

    The number of approved new molecular entity drugs has been decreasing as the pharmaceutical company investment in research and development is increasing. As we face this painful crisis, called an innovation gap, there is increasing awareness that development of new uses of existing drugs may be a powerful tool to help overcome this obstacle because it takes too long, costs too much and can be risky to release drugs developed de novo. Consequently, drug repositioning is emerging in different therapeutic areas, including the pain research area. Worldwide, pain is the main reason for seeking healthcare, and pain relief represents an unmet global clinical need. Therefore, development of analgesics with better efficacy, safety and cost effectiveness is of paramount importance. Despite the remarkable advancement in research on cellular and molecular mechanisms underlying pain pathophysiology over the past three decades, target-based therapeutic opportunities have not been pursued to the same extent. Phenotypic screening remains a more powerful tool for drug development than target-based screening so far. It sounds somewhat heretical, but some multi-action drugs, rather than very selective ones, have been developed intentionally. In the present review, we first critically discuss the utility of drug repositioning for analgesic drug development and then show examples of 'old' drugs that have been successfully repositioned or that are under investigation for their analgesic actions. We conclude that drug repositioning should be more strongly encouraged to help build a bridge between basic research and pain relief worldwide.

  13. Drug Facts

    Medline Plus

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

  14. Drug Facts

    Medline Plus

    Full Text Available ... Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, ... Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug Use and Kids ...

  15. Drug Facts

    Medline Plus

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

  16. Hidden wholesale: The drug diffusing capacity of online drug cryptomarkets.

    Science.gov (United States)

    Aldridge, Judith; Décary-Hétu, David

    2016-09-01

    customers themselves. Cryptomarkets provide researchers and policy makers with a rich source of drug monitoring information. Further research should ascertain whether their virtual location may reduce the violence associated with middle market drug activity. We caution that conflict may instead manifest in other ways, including threats, fraud, and blackmail. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

  17. Drug use among adolescents within vocational schools: health promotion, social relations and institutional organization. Abstract. 13th Biennial Conference of the European Association for Research on Adolescence, Island of Spetses, Greece. 29 August – 1 September 2012 (p. 60)

    DEFF Research Database (Denmark)

    Ingholt, Liselotte; Sørensen, Betina Bang; Axel, Erik

    Druguse among Adolescents within Vocational Schools: Health Promotion, Social Relations and Institutional Organization. L. Ingholt1, B.B. Sørensen1, E. Axel2, V.A. Frank3 1 National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark. 2 The Department of Psychology...... and Educational Studies, Roskilde University, Roskilde, Denmark. 3 Department of Psychology and Behavioural Sciences – Centre for Alcohol and Drug Research, Aarhus University, Aarhus, Denmark. Objectives: The paper explores the significance of drug use and peer relations for students’ participation in vocational...... education. Design: From 22 qualitative interviews two girls' case stories are analyzed, one still being in, the other having left vocational education. The paper is rooted in theory of social practice and critical psychology. Key concepts include institutional and personal trajectories of participation...

  18. Drug-induced psychosis: how to avoid star gazing in schizophrenia research by looking at more obvious sources of light

    Directory of Open Access Journals (Sweden)

    Alessandra Paparelli

    2011-01-01

    Full Text Available The prevalent view today is that schizophrenia is a syndrome rather than a specific disease. Liability to schizophrenia is highly heritable. It appears that multiple genetic and environmental factors operate together to push individuals over a threshold into expressing the characteristic clinical picture. One environmental factor which has been curiously neglected is the evidence that certain drugs can induce schizophrenia-like psychosis. In the last 60 years, improved understanding of the relationship between drug abuse and psychosis has contributed substantially to our modern view of the disorder suggesting that liability to psychosis in general, and to schizophrenia in particular, is distributed trough the general population in a similar continuous way to liability to medical disorders such as hypertension and diabetes. In this review we examine the main hypotheses resulting from the link observed between the most common psychomimetic drugs (LSD, amphetamines, cannabis, PCP and schizophrenia.

  19. Research on Optimization of Pooling System and Its Application in Drug Supply Chain Based on Big Data Analysis.

    Science.gov (United States)

    Wu, DengFeng; Mao, Hongyi

    2017-01-01

    Reform of drug procurement is being extensively implemented and expanded in China, especially in today's big data environment. However, the pattern of supply mode innovation lags behind procurement improvement. Problems in financial strain and supply break frequently occur, which affect the stability of drug supply. Drug Pooling System is proposed and applied in a few pilot cities to resolve these problems. From the perspective of supply chain, this study analyzes the process of setting important parameters and sets out the tasks of involved parties in a pooling system according to the issues identified in the pilot run. The approach is based on big data analysis and simulation using system dynamic theory and modeling of Vensim software to optimize system performance. This study proposes a theoretical framework to resolve problems and attempts to provide a valuable reference for future application of pooling systems.

  20. Research

    African Journals Online (AJOL)

    abp

    2017-12-06

    Dec 6, 2017 ... Abstract. Introduction: Vaginal candidiasis is considered as an important public health problem worldwide and its incidence has increased nowadays. In recent years, inappropriate and disproportionate use of antifungal drugs, automedication as well as non compliance have caused drug resistance.

  1. Research

    African Journals Online (AJOL)

    abp

    2017-11-03

    Nov 3, 2017 ... Furosemide, lisinopril and amlodipine were the most frequently prescribed drugs and had the greatest likelihood for nephrotoxicity. The number of medications and hypertension (as co-morbidity) were significant and independent predictors of DDIs among the patients. About 70% of the drug combinations ...

  2. A gap in science's and the media images of people who use drugs and sex workers: research on organizations of the oppressed.

    Science.gov (United States)

    Dziuban, Agata; Friedman, Samuel R

    2015-03-01

    This paper discusses organizations of the oppressed, such as drug user and sex worker groups, and the images of themselves that they construct. We suggest that analysis of these organizationally-produced collective self-images -frequently overlooked in scholarly research -is crucial to understanding the complex internal dynamics of users' and sex workers' organizations and struggles they engage in when defining their collective (organizational) identities and course of action.

  3. Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | Frederick National Laboratory for Cancer Research

    Science.gov (United States)

    A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the dru

  4. Antimicrobial (Drug) Resistance

    Science.gov (United States)

    ... with facebook share with twitter share with linkedin Antimicrobial (Drug) Resistance Go to Information for Researchers ► Credit: ... and infectious diseases. Why Is the Study of Antimicrobial (Drug) Resistance a Priority for NIAID? Over time, ...

  5. 77 FR 63842 - National Institute on Drug Abuse; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-17

    ... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

  6. 76 FR 65517 - National Institute on Drug Abuse Notice of Closed Meeting

    Science.gov (United States)

    2011-10-21

    ... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

  7. 78 FR 55265 - National Institute on Drug Abuse; Notice of Closed Meeting

    Science.gov (United States)

    2013-09-10

    ... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

  8. Adolescent Brain Development and Drugs

    Science.gov (United States)

    Winters, Ken C.; Arria, Amelia

    2011-01-01

    Research now suggests that the human brain is still maturing during adolescence. The developing brain may help explain why adolescents sometimes make decisions that are risky and can lead to safety or health concerns, including unique vulnerabilities to drug abuse. This article explores how this new science may be put to use in our prevention and…

  9. Felt Stigma in Injection Drug Users and Sex Workers: Focus Group Research with HIV-Risk Populations in Puerto Rico.

    Science.gov (United States)

    Jiménez, Julio; Puig, Marieva; Sala, Ana Cecilia; Ramos, Juan Carlos; Castro, Eida; Morales, Marangelie; Santiago, Lydia; Zorrilla, Carmen

    Though many studies have conclusively linked felt stigma and HIV, few have focused on the experiences of rejection felt by members of such socially marginalized groups as intravenous drug users (IDU) and sex workers (SW). Using focus groups, our study explored these experiences in 34 individuals (17 male UDUs and 17 female SWs) at risk of becoming infected with HIV, the objective being to discover why they engaged in maladaptive behaviors as a way of coping with felt stigma. We used deductive and inductive analysis to codify the resulting data. Concepts associated with the word stigma, emotional reactions to felt stigma, and the impact of felt stigma on self-schema helped elucidate how the internalization of felt stigma can lead to negative affective states and self-destructive behaviors (e.g., drug use and syringe exchange). Results underline the importance of developing intervention models that reduce stigma as a means of HIV prevention in vulnerable populations.

  10. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Twitter YouTube Flickr RSS Menu Home Drugs of Abuse Commonly Abused Drugs Charts Emerging Trends and Alerts ... to HIV and progression of AIDS. Drugs of abuse and HIV both affect the brain. Research has ...

  11. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available Skip to main content En español Researchers Medical & Health Professionals Patients & Families Parents & Educators Children & Teens Search ... Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse Hepatitis (Viral) HIV/ ...

  12. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  13. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Science Adolescent Brain Comorbidity College-Age & Young Adults Criminal Justice Drugged Driving Drug Testing Drugs and the ... AIDS, as well as HIV/AIDS research and policies. AIDS.gov New Media Tools : These new media ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used Drugs in the Past Drug Use ... Videos Information About Drugs Alcohol ...

  15. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  16. Molecular Signature Reveals Which Liver Cancer Patients May Benefit from a New Drug | Center for Cancer Research

    Science.gov (United States)

    Only one drug currently on the market has the potential to extend survival for patients with advanced-stage liver cancer and only 30 percent of patients are eligible to receive it. As the fastest-growing type of cancer by incidence in the United States, liver cancer represents a major public health problem and there is an urgent need to develop new treatment strategies.

  17. Drug-Induced Psychosis: How to Avoid Star Gazing in Schizophrenia Research by Looking at More Obvious Sources of Light

    OpenAIRE

    Paparelli, Alessandra; Di Forti, Marta; Morrison, Paul D.; Murray, Robin M.

    2011-01-01

    The prevalent view today is that schizophrenia is a syndrome rather than a specific disease. Liability to schizophrenia is highly heritable. It appears that multiple genetic and environmental factors operate together to push individuals over a threshold into expressing the characteristic clinical picture. One environmental factor which has been curiously neglected is the evidence that certain drugs can induce schizophrenia-like psychosis. In the last 60 years, improved understanding of the re...

  18. Research

    African Journals Online (AJOL)

    abp

    2012-07-27

    Jul 27, 2012 ... Even though a national strategic plan of increasing this coverage ... Chi square test was used in contingency tables and a two tailed p value with a .... drugs adverse events, case definition, grading, laboratory diagnosis and.

  19. International Drug Control Policy

    Science.gov (United States)

    2009-08-24

    Common illegal drugs include cannabis, cocaine, opiates, and synthetic drugs. International trade in these drugs represents a lucrative and what...into effect, decriminalizing “personal use” amounts of marijuana , heroin, cocaine, methamphetamine, and other internationally sanctioned drugs.15 While...President Calls for Legalizing Marijuana ,”CNN.com, May 13, 2009. 15 “Mexico Legalizes Drug Possession,” Associated Press, August 21, 2009. 16 In support

  20. Need of the regulation for profit percentage investment by pharmaceutical companies in new drug discovery research from the various local traditional medicinal and plant systems.

    Science.gov (United States)

    Bhattarai, M D

    2012-01-01

    In the modern medical systems the active pharmacological ingredients, effective against any disease is identified, purified and studied for its various effects and side-effects whereas it is not so in the traditional systems. Therefore, it is not surprising that safety concerns have often been raised about the traditional medical products. The major issue now, is to make appropriate situation with basic supports to bring all the available experts and resources together for the identification, purification, and study of efficacy and safety of the active molecules of the popular traditional medicines. Government and public sectors in the countries with such rich traditional medicinal and plant systems have related experts, but they also have much hurdle regarding recruitment and retention of expert human resources, getting fund, purchase and maintenance of equipment, bureaucratic formalities and others. The pharmaceutical companies have basic laboratories with related infrastructure and human resources as well as interest about bringing the drug molecules. To bridge the gap, there is a need of the regulation which will make the pharmaceutical companies to invest certain percentage of their profit in the field of research to identify new drug molecules and to study their effects. It is just not an issue of discovering the active molecule but also of creating the concept and culture of research, purity and quality of drugs, safety of people, and future direction of the human society.

  1. Effect of drug law enforcement on drug market violence: a systematic review.

    Science.gov (United States)

    Werb, Dan; Rowell, Greg; Guyatt, Gordon; Kerr, Thomas; Montaner, Julio; Wood, Evan

    2011-03-01

    Violence is amongst the primary concerns of communities around the world and research has demonstrated links between violence and the illicit drug trade, particularly in urban settings. Given the growing emphasis on evidence-based policy-making, and the ongoing severe drug market violence in Mexico and other settings, we conducted a systematic review to examine the impacts of drug law enforcement on drug market violence. We conducted a systematic review using Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. Specifically, we undertook a search of English language electronic databases (Academic Search Complete, PubMed, PsycINFO, EMBASE, Web of Science, Sociological Abstracts, Social Service Abstracts, PAIS International and Lexis-Nexis), the Internet (Google, Google Scholar), and article reference lists, from database inception to January 24, 2011. Overall, 15 studies were identified that evaluated the impact of drug law enforcement on drug market violence, including 11 (73%) longitudinal analyses using linear regression, 2 (13%) mathematical drug market models, and 2 (13%) qualitative studies. Fourteen (93%) studies reported an adverse impact of drug law enforcement on levels of violence. Ten of the 11 (91%) studies employing longitudinal qualitative analyses found a significant association between drug law enforcement and drug market violence. Our findings suggest that increasing drug law enforcement is unlikely to reduce drug market violence. Instead, the existing evidence base suggests that gun violence and high homicide rates may be an inevitable consequence of drug prohibition and that disrupting drug markets can paradoxically increase violence. In this context, and since drug prohibition has not meaningfully reduced drug supply, alternative regulatory models will be required if drug supply and drug market violence are to be meaningfully reduced. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Drugs for rare disorders.

    Science.gov (United States)

    Cremers, Serge; Aronson, Jeffrey K

    2017-08-01

    Estimates of the frequencies of rare disorders vary from country to country; the global average defined prevalence is 40 per 100 000 (0.04%). Some occur in only one or a few patients. However, collectively rare disorders are fairly common, affecting 6-8% of the US population, or about 30 million people, and a similar number in the European Union. Most of them affect children and most are genetically determined. Diagnosis can be difficult, partly because of variable presentations and partly because few clinicians have experience of individual rare disorders, although they may be assisted by searching databases. Relatively few rare disorders have specific pharmacological treatments (so-called orphan drugs), partly because of difficulties in designing trials large enough to determine benefits and harms alike. Incentives have been introduced to encourage the development of orphan drugs, including tax credits and research aids, simplification of marketing authorization procedures and exemption from fees, and extended market exclusivity. Consequently, the number of applications for orphan drugs has grown, as have the costs of using them, so much so that treatments may not be cost-effective. It has therefore been suggested that not-for-profit organizations that are socially motivated to reduce those costs should be tasked with producing them. A growing role for patient organizations, improved clinical and translational infrastructures, and developments in genetics have also contributed to successful drug development. The translational discipline of clinical pharmacology is an essential component in drug development, including orphan drugs. Clinical pharmacologists, skilled in basic pharmacology and its links to clinical medicine, can be involved at all stages. They can contribute to the delineation of genetic factors that determine clinical outcomes of pharmacological interventions, develop biomarkers, design and perform clinical trials, assist regulatory decision

  3. FIND Tuberculosis Strain Bank: a Resource for Researchers and Developers Working on Tests To Detect Mycobacterium tuberculosis and Related Drug Resistance.

    Science.gov (United States)

    Tessema, Belay; Nabeta, Pamela; Valli, Eloise; Albertini, Audrey; Collantes, Jimena; Lan, Nguyen Huu; Romancenco, Elena; Tukavdze, Nestani; Denkinger, Claudia M; Dolinger, David L

    2017-04-01

    The spread of multidrug-resistant (MDR) tuberculosis (TB) and extensively drug-resistant (XDR) TB hampers global efforts in the fight against tuberculosis. To enhance the development and evaluation of diagnostic tests quickly and efficiently, well-characterized strains and samples from drug-resistant tuberculosis patients are necessary. In this project, the Foundation for Innovative New Diagnostics (FIND) has focused on the collection, characterization, and storage of such well-characterized reference materials and making them available to researchers and developers. The collection is being conducted at multiple centers in Southeast Asia, South America, Eastern Europe, and soon the sub-Saharan Africa regions. Strains are characterized for their phenotypic resistances and MICs to first-line drugs (FLDs) and second-line drugs (SLDs) using the automated MGIT 960 system following validated procedures and WHO criteria. Analysis of resistance-associated mutations is done by whole-genome sequencing (WGS) using the Illumina NextSeq system. Mycobacterial interspersed repetitive-unit-variable-number tandem-repeat analysis and WGS are used to determine strain lineages. All strains are maintained frozen at -80°C ± 10°C as distinct mother and daughter lots. All strains are extensively quality assured. The data presented here represent an analysis of the initial part of the collection. Currently, the bank contains 118 unique strains with extracted genomic DNA and matched sputum, serum, and plasma samples and will be expanded to a minimum of 1,000 unique strains over the next 3 years. Analysis of the current strains by phenotypic resistance testing shows 102 (86.4%), 10 (8.5%), and 6 (5.1%) MDR, XDR, and mono/poly resistant strains, respectively. Two of the strains are resistant to all 11 drugs that were phenotypically tested. WGS mutation analysis revealed FLD resistance-associated mutations in the rpoB , katG , inhA , embB , embA , and pncA genes; SLD resistance in the gyr

  4. Drugs@FDA Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of...

  5. Prescription Drug Abuse

    Science.gov (United States)

    ... what the doctor prescribed, it is called prescription drug abuse. It could be Taking a medicine that ... purpose, such as getting high Abusing some prescription drugs can lead to addiction. These include opioids, sedatives, ...

  6. Retrovirus XMRV Is Inhibited by Host Proteins and Anti-HIV Drugs AZT, Tenofovir, and Raltegravir | Center for Cancer Research

    Science.gov (United States)

    A newly discovered retrovirus, XMRV, isolated from prostate cancer tissues for the first time in 2006, has recently been reported in patients with this cancer, as well as in patients with chronic fatigue syndrome (CFS). However, five subsequent studies could not validate these reports. Since XMRV was isolated from the T and B cells of CFS patients, Vinay Pathak and his colleagues in the HIV Drug Resistance Program sought to determine how XMRV was countering intracellular defense mechanisms that inhibit retroviral replication in human cells.

  7. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    Science.gov (United States)

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  8. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    Science.gov (United States)

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  9. Laser microbeams for DNA damage induction, optical tweezers for the search on blood pressure relaxing drugs: contributions to ageing research

    Science.gov (United States)

    Grigaravicius, P.; Monajembashi, S.; Hoffmann, M.; Altenberg, B.; Greulich, K. O.

    2009-08-01

    One essential cause of human ageing is the accumulation of DNA damages during lifetime. Experimental studies require quantitative induction of damages and techniques to visualize the subsequent DNA repair. A new technique, the "immuno fluorescent comet assay", is used to directly visualize DNA damages in the microscope. Using DNA repair proteins fluorescently labeled with green fluorescent protein, it could be shown that the repair of the most dangerous DNA double strand breaks starts with the inaccurate "non homologous end joining" pathway and only after 1 - 1 ½ minutes may switch to the more accurate "homologous recombination repair". One might suggest investigating whether centenarians use "homologous recombination repair" differently from those ageing at earlier years and speculate whether it is possible, for example by nutrition, to shift DNA repair to a better use of the error free pathway and thus promote healthy ageing. As a complementary technique optical tweezers, and particularly its variant "erythrocyte mediated force application", is used to simulate the effects of blood pressure on HUVEC cells representing the inner lining of human blood vessels. Stimulating one cell induces in the whole neighbourhood waves of calcium and nitric oxide, known to relax blood vessels. NIFEDIPINE and AMLODIPINE, both used as drugs in the therapy of high blood pressure, primarily a disease of the elderly, prolong the availability of nitric oxide. This partially explains their mode of action. In contrast, VERAPAMILE, also a blood pressure reducing drug, does not show this effect, indicating that obviously an alternative mechanism must be responsible for vessel relaxation.

  10. Notes on Commercialization of Biotechnology Research

    DEFF Research Database (Denmark)

    Høy Jakobsen, Palle

    This book introduces aspects of commercialization of biomedical & biotech research including pharmaceutical drug and medical device development, innovation concepts, patent protection & commercialisation of research by securing investments in new companies and by licensing of the commersialisatio...

  11. New seismograph includes filters

    Energy Technology Data Exchange (ETDEWEB)

    1979-11-02

    The new Nimbus ES-1210 multichannel signal enhancement seismograph from EG and G geometrics has recently been redesigned to include multimode signal fillers on each amplifier. The ES-1210F is a shallow exploration seismograph for near subsurface exploration such as in depth-to-bedrock, geological hazard location, mineral exploration, and landslide investigations.

  12. FY2000 report of the research results of medical/engineering cooperative research project, basic research on systems for minimally invasive diagnostic/treatment of circulatory system diseases, including prognostic diagnosis; 2000 nendo igaku kogaku renkeigata kenkyu jigyo, junkankikei shikkan ni taisuru yogo shindan wo fukumu teishinshu shindan chiryo system ni kansuru kiso kenkyu seika hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    The basic researches on minimally invasive diagnostic/treatment systems are conducted for circulatory system diseases, and the FY 2000 results are reported. The program for developing the heart surgery supporting manipulator includes development of the manipulator of 7 degree of freedom and fail-safe mechanisms to be incorporated in the patient-side system, and research and development of the heart motion compensation type robot system. The program for developing the diagnosis/treatment system aided by intravascular optical analysis includes development of intravascular endoscopy by the aid of LED emitting blue color of high brightness, and automatic analyzer for the in vivo vascular endothelial cell functions. The program for the minimally invasive diagnostic system includes development of superimposing system for integrating the images by the NOGA system and cine-coronary angiography. The other R and D items include artificial vascular systems to be put in the blood vessels, adhesives for a living body, suture instruments for fine blood vessels, heart surgery supporting system, based on the infrared spectroscopy, endoscopic system for the cranical bones, arterialization method, and gene-aided treatment. (NEDO)

  13. Personalized Medicine: Pharmacogenomics and Drug Development

    Directory of Open Access Journals (Sweden)

    Somayeh Mirsadeghi

    2017-03-01

    Full Text Available Personalized medicine aims is to supply the proper drug to the proper patient within the right dose. Pharmacogenomics (PGx is to recognize genetic variants that may influence drug efficacy and toxicity. All things considered, the fields cover a wide area, including basic drug discovery researches, the genetic origin of pharmacokinetics and pharmacodynamics, novel drug improvement, patient genetic assessment and clinical patient administration. At last, the objective of Pharmacogenomics is to anticipate a patient’s genetic response to a particular drug as a way of presenting the best possible medical treatment. By predicting the drug response of an individual, it will be possible to increase the success of therapies and decrease the incidence of adverse side effect.

  14. Analytic device including nanostructures

    KAUST Repository

    Di Fabrizio, Enzo M.; Fratalocchi, Andrea; Totero Gongora, Juan Sebastian; Coluccio, Maria Laura; Candeloro, Patrizio; Cuda, Gianni

    2015-01-01

    A device for detecting an analyte in a sample comprising: an array including a plurality of pixels, each pixel including a nanochain comprising: a first nanostructure, a second nanostructure, and a third nanostructure, wherein size of the first nanostructure is larger than that of the second nanostructure, and size of the second nanostructure is larger than that of the third nanostructure, and wherein the first nanostructure, the second nanostructure, and the third nanostructure are positioned on a substrate such that when the nanochain is excited by an energy, an optical field between the second nanostructure and the third nanostructure is stronger than an optical field between the first nanostructure and the second nanostructure, wherein the array is configured to receive a sample; and a detector arranged to collect spectral data from a plurality of pixels of the array.

  15. Saskatchewan resources. [including uranium

    Energy Technology Data Exchange (ETDEWEB)

    1979-09-01

    The production of chemicals and minerals for the chemical industry in Saskatchewan are featured, with some discussion of resource taxation. The commodities mentioned include potash, fatty amines, uranium, heavy oil, sodium sulfate, chlorine, sodium hydroxide, sodium chlorate and bentonite. Following the successful outcome of the Cluff Lake inquiry, the uranium industry is booming. Some developments and production figures for Gulf Minerals, Amok, Cenex and Eldorado are mentioned.

  16. ASM Inaugural Lecture 2010: Single crystal X-ray structural determination: A powerful technique for natural products research and drug discovery

    International Nuclear Information System (INIS)

    Fun Hoong Kun; Chantrapromma, S.; Boonnak, N.; Lee, V.S.

    2010-01-01

    Drug discovery from natural products resources have been extensively studied worldwide because natural products with their great structural diversity have traditionally provided most of the drugs in use. They offer major opportunities for finding novel low molecular weight leading-structures that are active against a wide range of assay targets. The most important step in the discovery process is the identification of compounds with interesting biological activity. Single crystal X-ray structure determination is a powerful technique for natural products research and drug discovery. The detailed three-dimensional structures that emerge can be co-related to the activities to these structures. In this article the following is presented: (i) co-crystal and disorder structures; (ii) determination of absolute configuration and (iii) the ability to distinguish between whether a natural product compound is a natural product or a natural product artifact. All these three properties are unique to the technique of single crystal X-ray structure determination. Case (iii) was demonstrated with a compound containing a chromene ring, namely macluraxanthone (which was isolated from Cratoxylum formosum subsp. pruniflorum, a Thai medicinal plant). (author)

  17. Biomarker-guided repurposing of chemotherapeutic drugs for cancer therapy: a novel strategy in drug development

    Directory of Open Access Journals (Sweden)

    Jan eStenvang

    2013-12-01

    Full Text Available Cancer is a leading cause of mortality worldwide and matters are only set to worsen as its incidence continues to rise. Traditional approaches to combat cancer include improved prevention, early diagnosis, optimized surgery, development of novel drugs and honing regimens of existing anti-cancer drugs. Although discovery and development of novel and effective anti-cancer drugs is a major research area, it is well known that oncology drug development is a lengthy process, extremely costly and with high attrition rates. Furthermore, those drugs that do make it through the drug development mill are often quite expensive, laden with severe side-effects and, unfortunately, to date, have only demonstrated minimal increases in overall survival. Therefore, a strong interest has emerged to identify approved non-cancer drugs that possess anti-cancer activity, thus shortcutting the development process. This research strategy is commonly known as drug repurposing or drug repositioning and provides a faster path to the clinics. We have developed and implemented a modification of the standard drug repurposing strategy that we review here; rather than investigating target-promiscuous non-cancer drugs for possible anti-cancer activity, we focus on the discovery of novel cancer indications for already approved chemotherapeutic anti-cancer drugs. Clinical implementation of this strategy is normally commenced at clinical phase II trials and includes pre-treated patients. As the response rates to any non-standard chemotherapeutic drug will be relatively low in such a patient cohort it is a pre-requisite that such testing is based on predictive biomarkers. This review describes our strategy of biomarker-guided repurposing of chemotherapeutic drugs for cancer therapy, taking the repurposing of topoisomerase I inhibitors and topoisomerase I as a potential predictive biomarker as case in point.

  18. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... or reduce their drug use and related risk behaviors, including drug injection and unsafe sexual practices. Drug use disorder treatment programs also serve an important role in providing ...

  19. Drugs Approved for Pancreatic Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  20. Drugs Approved for Lung Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  1. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  2. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... or reduce their drug use and related risk behaviors, including drug injection and unsafe sexual practices. Drug use disorder treatment programs also serve an important role in ...

  3. A Review of Economic Behaviour of Drug Consumers

    Directory of Open Access Journals (Sweden)

    Shahrzad Borumand

    2003-11-01

    Full Text Available Illicit drug problem is one of the most worrying issues of the presenet century in all countries and anti-drug addiction programs are included in the agenda of all governments and international community. Drug abuse/addiction in Iran has been one of the most important social and economical problems for several years and the number and percentage of drug users/addicts are growing. Campaign against this phenomenon needs in-depth recognition of all aspects (economic, social and political of this problem. So, such programs will be successful in fighting against illicit drugs and drug addiction if they are developed and implemented through a realistic recognition. One can not hope the success of anti-drug programs if they are not planned on the basis of researches. Therefore, reviewing the economical aspect of illicit drugs via usrers’ viewpoints will help to undrestand illicit drug addiction phenomenon. In this article, the behaviour of drug usres is studied on the basis of micro-economic traditional assumptions. The relation between deman and prices of illicit drugs, the relation between tendency to drug consumption and the amount of drug consumption and the relaion between drug consumption and criminal acts are among the discussed issues of this article. Finally, a summary of the situation of illicit drug consumption is presented.

  4. Species differences in drug glucuronidation: Humanized UDP-glucuronosyltransferase 1 mice and their application for predicting drug glucuronidation and drug-induced toxicity in humans.

    Science.gov (United States)

    Fujiwara, Ryoichi; Yoda, Emiko; Tukey, Robert H

    2018-02-01

    More than 20% of clinically used drugs are glucuronidated by a microsomal enzyme UDP-glucuronosyltransferase (UGT). Inhibition or induction of UGT can result in an increase or decrease in blood drug concentration. To avoid drug-drug interactions and adverse drug reactions in individuals, therefore, it is important to understand whether UGTs are involved in metabolism of drugs and drug candidates. While most of glucuronides are inactive metabolites, acyl-glucuronides that are formed from compounds with a carboxylic acid group can be highly toxic. Animals such as mice and rats are widely used to predict drug metabolism and drug-induced toxicity in humans. However, there are marked species differences in the expression and function of drug-metabolizing enzymes including UGTs. To overcome the species differences, mice in which certain drug-metabolizing enzymes are humanized have been recently developed. Humanized UGT1 (hUGT1) mice were created in 2010 by crossing Ugt1-null mice with human UGT1 transgenic mice in a C57BL/6 background. hUGT1 mice can be promising tools to predict human drug glucuronidation and acyl-glucuronide-associated toxicity. In this review article, studies of drug metabolism and toxicity in the hUGT1 mice are summarized. We further discuss research and strategic directions to advance the understanding of drug glucuronidation in humans. Copyright © 2017 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

  5. Tropical Journal of Pharmaceutical Research

    African Journals Online (AJOL)

    We seek to encourage pharmaceutical and allied research of tropical and ... and related disciplines (including biotechnology, cell and molecular biology, drug ... with ibrutinib reduces proliferation, migration and invasion of lung cancer cells ...

  6. Batteries not included

    Energy Technology Data Exchange (ETDEWEB)

    Cooper, M.

    2001-09-08

    This article traces the development of clockwork wind-up battery chargers that can be used to recharge mobile phones, laptop computers, torches or radio batteries from the pioneering research of the British inventor Trevor Baylis to the marketing of the wind-up gadgets by Freeplay Energy who turned the idea into a commercial product. The amount of cranking needed to power wind-up devices is discussed along with a hand-cranked charger for mobile phones, upgrading the phone charger's mechanism, and drawbacks of the charger. Details are given of another invention using a hand-cranked generator with a supercapacitor as a storage device which has a very much higher capacity for storing electrical charge.

  7. Batteries not included

    International Nuclear Information System (INIS)

    Cooper, M.

    2001-01-01

    This article traces the development of clockwork wind-up battery chargers that can be used to recharge mobile phones, laptop computers, torches or radio batteries from the pioneering research of the British inventor Trevor Baylis to the marketing of the wind-up gadgets by Freeplay Energy who turned the idea into a commercial product. The amount of cranking needed to power wind-up devices is discussed along with a hand-cranked charger for mobile phones, upgrading the phone charger's mechanism, and drawbacks of the charger. Details are given of another invention using a hand-cranked generator with a supercapacitor as a storage device which has a very much higher capacity for storing electrical charge

  8. Research

    African Journals Online (AJOL)

    abp

    2017-11-07

    Nov 7, 2017 ... Key words: Rational drug use, prescribing indicators, patient indicators, University of Cape Coast Hospital, Ghana, antibiotic prescription. Received: ... were generally not satisfactory with a low patronage of STG among prescribers. In order .... respiratory infections (29.9%), followed by urinary tract infections.

  9. Research

    African Journals Online (AJOL)

    abp

    2016-05-13

    May 13, 2016 ... Hospital, Port Harcourt, Nigeria. &Corresponding author: Charles Tobin-West, .... retraining and health worker-patient ratio; and infrastructure such as waiting areas, examination rooms, equipment ... Others were Facility maintenance; Supplies; and Anti-TB drugs. It was administered via a walk-through ...

  10. Research

    African Journals Online (AJOL)

    ebutamanya

    2015-12-16

    Dec 16, 2015 ... ... motivation among health workers (62%), overwhelming workload (89%) and abuse of services by clients ... which permits unrestricted use, distribution, and reproduction in any medium, provided the ..... additional drugs and other supplies [12]. .... disruptive effects of user fee exemption policies on health.

  11. Research

    African Journals Online (AJOL)

    abp

    2015-01-27

    Jan 27, 2015 ... 3. Ferrajolo C, Verhamme KM, Trifirò G, 't Jong GW, Giaquinto C,. Picelli G, Oteri A, de Bie S, Valkhoff VE, Schuemie MJ,. Mazzaglia G, Cricelli C, Rossi F, Capuano A, Sturkenboom MC. Idiopathic acute liver injury in paediatric outpatients: incidence and signal detection in two European countries. Drug Saf.

  12. Research

    African Journals Online (AJOL)

    abp

    2013-09-10

    Sep 10, 2013 ... item questionnaire and collection of 2ml venous blood for hepatitis B surface antigens (HBsAg) and anti-HCV antibodies. .... Limitations: HBV DNA and HCV RNA by polymerase chain reaction were not done due ... Data Collection on Adverse Events of Anti-HIV drugs (D:A:D) .... blood donor group, Nigeria.

  13. The inflammatory & neurodegenerative (I&ND) hypothesis of depression: leads for future research and new drug developments in depression

    DEFF Research Database (Denmark)

    Maes, Michael; Yirmyia, Raz; Noraberg, Jens

    2009-01-01

    Despite extensive research, the current theories on serotonergic dysfunctions and cortisol hypersecretion do not provide sufficient explanations for the nature of depression. Rational treatments aimed at causal factors of depression are not available yet. With the currently available antidepressa...

  14. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for cervical cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  15. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  16. Drugs Approved for Testicular Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for testicular cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Hodgkin lymphoma. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  18. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  19. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  20. Drug Facts

    Medline Plus

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