WorldWideScience

Sample records for prior drug benefits

  1. Hazards and Benefits of Drug Interaction

    Science.gov (United States)

    Labianca, Dominick A.

    1978-01-01

    Most cases of drug toxicity are direct consequences of drug misuse--either intentional or inadvertent. Discusses two types of drug interaction--synergistic and antagonistic. The former produces a combined effect greater than the sum of the effects of the individual drugs concerned; the latter is produced when the desired action of one drug is…

  2. New use of prescription drugs prior to a cancer diagnosis

    DEFF Research Database (Denmark)

    Pottegård, Anton; Hallas, Jesper

    2017-01-01

    PURPOSE: Cancers often have considerable induction periods. This confers a risk of reverse causation bias in studies of cancer risk associated with drug use, as early symptoms of a yet undiagnosed cancer might lead to drug treatment in the period leading up to the diagnosis. This bias can be alle...

  3. Benefits of different drug formulations in psychopharmacology

    NARCIS (Netherlands)

    Frijlink, Henderik W

    Adequate dosage forms are essential for achieving successful pharmacotherapy. Innovative dosage forms or delivery systems may direct a drug to its specific site of action, optimize the timing of the drug release, or increase comfort or convenience for the patient. Thus, such innovations may improve

  4. Which Benefits Are Mentioned Most Often in Drug Development Publications?

    Directory of Open Access Journals (Sweden)

    Vanessa Strüver, MSc

    2017-01-01

    Conclusions: Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.

  5. Benefit and harms of new anti-cancer drugs.

    Science.gov (United States)

    Vera-Badillo, Francisco E; Al-Mubarak, Mustafa; Templeton, Arnoud J; Amir, Eitan

    2013-06-01

    Phase III randomized controlled trials (RCTs) assess clinically important differences in endpoints that reflect benefit to and harm of patients. Defining benefit of cancer drugs can be difficult. Overall survival and quality of life are the most relevant primary endpoints, but difficulty in measuring these mean that other endpoints are often used, although their surrogacy or clinical relevance has not always been established. In general, advances in drug development have led to numerous new drugs to enter the market. Pivotal RCT of several new drugs have shown that benefit appeared greater for targeted anticancer agents than for chemotherapeutic agents. This effect seems particularly evident with targeted agents evaluated in biomarker-driven studies. Unfortunately, new therapies have also shown an increase in toxicity. Such toxicity is not always evident in the initial reports of RCTs. This may be a result of a statistical inability to detect differences between arms of RCTs, or occasionally due to biased reporting. There are several examples where reports of new toxicities could only be found in drug labels. In some cases, the small improvement in survival has come at a cost of substantial excess toxicity, leading some to consider such therapy as having equipoise.

  6. Dependent Prior: An Application in Spinal Anaesthesia Drug Therapy on SBP in Cesarean patients.

    Directory of Open Access Journals (Sweden)

    Atanu Bhattacharjee

    2013-12-01

    Full Text Available Cesarean section is widely used operation procedure in the world. The regional anesthesia is preferred than general anesthesia. The risk of fetus is higher in general than in regional anesthesia. The drug treatment effect on regional anesthesia plays an important role to control the systolic blood pressure (SBP during the surgery. The goal of this work is to know the effective drug to control the SBP among cesarean anesthetic patients. The dependent prior with Bayesian approach is applied in the binary response data set. The secondary data in anesthesia has been applied to compare the two drug treatments, viz. (1 Phenylephrine and (2 Ephedrine, in cesarean patients with spinal anesthesia. In both drug groups the mean of SBP has been found controlled over the duration of the surgery. No rapid changes of SBP level among the patients are observed. At the end of study it is found that the means of SBP cesarean anesthetic patients are found higher in Phenylephrine group. The Bayesian dependent prior is found to offer effective tool for drug treatment effect comparison. The drug treatment effect Ephedrine is found to be more effective to control the SBP over the duration of surgery than Phenylephrine.

  7. A comprehensive approach to benefit-risk assessment in drug development

    DEFF Research Database (Denmark)

    Sarac, Sinan B; Rasmussen, Christian H; Rasmussen, Morten A.

    2012-01-01

    Major regulatory agencies, for example, FDA and EMA, have started to request comprehensive benefit-risk analyses of pharmaceutical products prior to approval or labelling expansion. The purpose of this study is to develop a generally applicable and reliable data-driven benefit-risk assessment......) discussion and formulation of an overall conclusion. To reduce the impact of subjective judgements, scores are assigned to each criterion on the basis of objective information (data) wherever possible. The proposed benefit-risk evaluation approach offers comprehensive, data-driven assessments that can...... method, where two or more drugs/doses can be compared. Our aim is to formulate an approach that is simple to apply, allows direct comparison of different types of risks and benefits, and is tailored for application in different disease areas both during clinical development and in the marketing approval...

  8. 77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

    Science.gov (United States)

    2012-10-25

    ..., U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the... money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

  9. A prior authorization program of a radiology benefits management company and how it has affected utilization of advanced diagnostic imaging.

    Science.gov (United States)

    Levin, David C; Bree, Robert L; Rao, Vijay M; Johnson, Jean

    2010-01-01

    Radiology benefits management companies have evolved in recent years to meet the need to control the rapid growth in advanced diagnostic imaging. The Obama administration and other key policymakers have proposed using them as a cost-control mechanism, but little is known about how they operate or what results they have produced. The main tool they use is prior authorization. The authors describe the inner workings of the call center of one radiology benefits management company and how its prior authorization program seems to have slowed the growth in the utilization of MRI, CT, and PET in the large markets of one commercial payer. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  10. A linear programming computational framework integrates phosphor-proteomics and prior knowledge to predict drug efficacy.

    Science.gov (United States)

    Ji, Zhiwei; Wang, Bing; Yan, Ke; Dong, Ligang; Meng, Guanmin; Shi, Lei

    2017-12-21

    In recent years, the integration of 'omics' technologies, high performance computation, and mathematical modeling of biological processes marks that the systems biology has started to fundamentally impact the way of approaching drug discovery. The LINCS public data warehouse provides detailed information about cell responses with various genetic and environmental stressors. It can be greatly helpful in developing new drugs and therapeutics, as well as improving the situations of lacking effective drugs, drug resistance and relapse in cancer therapies, etc. In this study, we developed a Ternary status based Integer Linear Programming (TILP) method to infer cell-specific signaling pathway network and predict compounds' treatment efficacy. The novelty of our study is that phosphor-proteomic data and prior knowledge are combined for modeling and optimizing the signaling network. To test the power of our approach, a generic pathway network was constructed for a human breast cancer cell line MCF7; and the TILP model was used to infer MCF7-specific pathways with a set of phosphor-proteomic data collected from ten representative small molecule chemical compounds (most of them were studied in breast cancer treatment). Cross-validation indicated that the MCF7-specific pathway network inferred by TILP were reliable predicting a compound's efficacy. Finally, we applied TILP to re-optimize the inferred cell-specific pathways and predict the outcomes of five small compounds (carmustine, doxorubicin, GW-8510, daunorubicin, and verapamil), which were rarely used in clinic for breast cancer. In the simulation, the proposed approach facilitates us to identify a compound's treatment efficacy qualitatively and quantitatively, and the cross validation analysis indicated good accuracy in predicting effects of five compounds. In summary, the TILP model is useful for discovering new drugs for clinic use, and also elucidating the potential mechanisms of a compound to targets.

  11. Potential benefits of maximal exercise just prior to return from weightlessness

    Science.gov (United States)

    Convertino, Victor A.

    1987-01-01

    The purpose of this study was to determine whether performance of a single maximal bout of exercise during weightlessness within hours of return to earth would enhance recovery of aerobic fitness and physical work capacities under a 1G environment. Ten healthy men were subjected to a 10-d bedrest period in the 6-deg headdown position. A graded maximal supine cycle ergometer test was performed before and at the end of bedrest to simulate exercise during weightlessness. Following 3 h of resumption of the upright posture, a second maximal exercise test was performed on a treadmill to measure work capacity under conditions of 1G. Compared to before bedrest, peak oxygen consumption, V(O2), decreased by 8.7 percent and peak heart rate (HR) increased by 5.6 percent in the supine cycle test at the end of bedrest. However, there were no significant changes in peak V(O2) and peak HR in the upright treadmill test following bedrest. These data suggest that one bout of maximal leg exercise prior to return from 10 d of weightlessness may be adequate to restore preflight aerobic fitness and physical work capacity.

  12. One fourth of acutely admitted patients use over-the-counter-drugs 24 hours prior to hospitalisation

    DEFF Research Database (Denmark)

    Pedersen, Magnus; Brabrand, Mikkel

    2014-01-01

    INTRODUCTION: Use of over-the-counter (OTC) drugs is increasing and is poorly registered, which can lead to complications. The most commonly used OTC drugs are analgesics, and their usage is highest among elderly patients. Our study investigates the use of OTC drugs 24 hours prior to hospitalisat......INTRODUCTION: Use of over-the-counter (OTC) drugs is increasing and is poorly registered, which can lead to complications. The most commonly used OTC drugs are analgesics, and their usage is highest among elderly patients. Our study investigates the use of OTC drugs 24 hours prior...... to hospitalisation and the effects of this intake. MATERIAL AND METHODS: Junior physicians on call interviewed patients admitted to the medical admission unit at South-West Jutland Hospital in Esbjerg using a modified chart template. Adult patients aged 15 and older admitted during a two-week period in August 2012...

  13. 20 CFR 404.480 - Paying benefits in installments: Drug addiction or alcoholism.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Paying benefits in installments: Drug addiction or alcoholism. 404.480 Section 404.480 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Deductions; Reductions; and Nonpayments of Benefits § 404.480 Paying benefits in installments:...

  14. 20 CFR 416.544 - Paying benefits in installments: Drug addiction or alcoholism.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Paying benefits in installments: Drug addiction or alcoholism. 416.544 Section 416.544 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Payment of Benefits, Overpayments, and Underpayments § 416.544 Paying benefits in installment...

  15. Role of antithyroid drug treatment prior to radioiodine therapy in hyperthyroidism

    International Nuclear Information System (INIS)

    Das, B.K.; Pradhan, P.K.; Senthilnathan, M.S.; Malhotra, G.

    2005-01-01

    Full text: Radio Iodine (RI) therapy is preceded by anti thyroid drug treatment in most centres. There is a general notion that this is a pre-requisite for RI therapy. There have been some sporadic reports in the past emphasizing that euthyroid state is not necessary in all cases before RI. However, no prospective randomized study has been reported in recent literature. The aim of this prospective study was to find out whether prior treatment with anti thyroid drugs showed any advantage in comparison to direct application of radio iodine in hyperthyroid patients. Seventy-two clinically and bio chemically proven cases of hyperthyroidism were randomized into two groups , each with 36 patients. They were matched by age, sex and size of goiter. After establishment of the diagnosis the patients were either subjected to anti thyroid drug treatment (Group A) or given calculated dose of radio iodine (Group B). After being euthyroid for at least 4 weeks the Group A patients were asked to stop the drugs (Neomercazole) for 3-5 days and radio iodine was administered. Patients in both groups were prescribed beta blockers for 4-6 weeks. Average radio iodine dose in both groups was 5 ± 0.92 mCi. All patients were evaluated both clinically and bio chemically 3, 6, 12 months after the radio iodine application. The duration to achieve euthyroid state, patient tolerance and side effects if any were meticulously recorded. In the pre treated group 72.1, 83.4 and 97.2% of the patients attained euthyroid state at 3, 6, 12 months respectively. Five patients needed a second dose after 3 months. No side effect or complications were observed. In group B 77.7, 88.8 and 94.4% of patients achieved euthyroid status at 3, 6 and 12 months respectively. There was no side effects or complications noted. However, 16.7 and 22.2% of the patients in group A and 27.7 and 36.1% of the group B became hypothyroid at 6 and 12 months respectively. They were treated with Thyroxine supplementation. Overall

  16. Establishing a Baseline: Community Benefit Spending by Not-for-Profit Hospitals Prior to Implementation of the Affordable Care Act.

    Science.gov (United States)

    Leider, Jonathon P; Tung, Greg J; Lindrooth, Richard C; Johnson, Emily K; Hardy, Rose; Castrucci, Brian C

    Community Benefit spending by not-for-profit hospitals has served as a critical, formalized part of the nation's safety net for almost 50 years. This has occurred mostly through charity care. This article examines how not-for-profit hospitals spent Community Benefit dollars prior to full implementation of the Affordable Care Act (ACA). Using data from 2009 to 2012 hospital tax and other governmental filings, we constructed national, hospital-referral-region, and facility-level estimates of Community Benefit spending. Data were collected in 2015 and analyzed in 2015 and 2016. Data were matched at the facility level for a non-profit hospital's IRS tax filings (Form 990, Schedule H) and CMS Hospital Cost Report Information System and Provider of Service data sets. During 2009, hospitals spent about 8% of total operating expenses on Community Benefit. This increased to between 8.3% and 8.5% in 2012. The majority of spending (>80%) went toward charity care, unreimbursed Medicaid, and subsidized health services, with approximately 6% going toward both community health improvement and health professionals' education. By 2012, national spending on Community Benefit likely exceeded $60 billion. The largest hospital systems spent the vast majority of the nation's Community Benefit; the top 25% of systems spent more than 80 cents of every Community Benefit dollar. Community Benefit spending has remained relatively steady as a proportion of total operating expenses and so has increased over time-although charity care remains the major focus of Community Benefit spending overall. More than $60 billion was spent on Community Benefit prior to implementation of the ACA. New reporting and spending requirements from the IRS, alongside changes by the ACA, are changing incentives for hospitals in how they spend Community Benefit dollars. In the short term, and especially the long term, hospital systems would do well to partner with public health, other social services, and even

  17. Trusted Allies with New Benefits: Repositioning Existing Drugs

    KAUST Repository

    Gao, Xin

    2016-01-25

    The classical assumption that one drug cures a single disease by binding to a single drug-target has been shown to be inaccurate. Recent studies estimate that each drug on average binds to at least six known and several unknown targets. Identifying the “off-targets” can help understand the side effects and toxicity of the drug. Moreover, off-targets for a given drug may inspire “drug repositioning”, where a drug already approved for one condition is redirected to treat another condition, thereby overcoming delays and costs associated with clinical trials and drug approval. In this talk, I will introduce our work along this direction. We have developed a structural alignment method that can precisely identify structural similarities between arbitrary types of interaction interfaces, such as the drug-target interaction. We have further developed a novel computational framework, iDTP that constructs the structural signatures of approved and experimental drugs, based on which we predict new targets for these drugs. Our method combines information from several sources including sequence independent structural alignment, sequence similarity, drug-target tissue expression data, and text mining. In a cross-validation study, we used iDTP to predict the known targets of 11 drugs, with 63% sensitivity and 81% specificity. We then predicted novel targets for these drugs—two that are of high pharmacological interest, the peroxisome proliferator-activated receptor gamma and the oncogene B-cell lymphoma 2, were successfully validated through in vitro binding experiments.

  18. Trusted Allies with New Benefits: Repositioning Existing Drugs

    KAUST Repository

    Gao, Xin

    2016-01-01

    types of interaction interfaces, such as the drug-target interaction. We have further developed a novel computational framework, iDTP that constructs the structural signatures of approved and experimental drugs, based on which we predict new targets

  19. [Assessment of actual benefits of new drugs by the Transparency Committee].

    Science.gov (United States)

    Le Jeunne, C

    2008-01-01

    When a drug has been granted a marketing authorization, if the pharmaceutical company wants it to be covered by the National Health Insurance, the company has to submit a file with all the studies concerning the drug, especially drug-drug comparative studies, to be assessed by the Transparency Committee. Drugs are assessed on two criteria: actual or expected benefit (AB) and improvement in actual benefit (IAB). Actual benefit mainly takes into account the severity of the disease concerned, the level of efficacy relative to known side effects (risk-benefit ratio), and the place the drug is intended to take in the therapeutic strategy. At the end of the assessment, AB is considered as important, moderate, poor or insufficient (to justify inclusion of the drug on the list of products to be reimbursed). After actual benefit is determined, improvement of actual benefit is assessed, comparing the estimated benefit of this drug with one of drugs with the same indication that is already reimbursed, to assess whether this drug will improve the patient's disease. This can be assessed by direct comparison (two drugs compared in the same clinical trial) or by indirect comparison (separate studies with the same design). There are four levels of added value, from I (major improvement) to IV (minor improvement). Level V represents no improvement. This second assessment is always relative to another drug. It never provides an absolute score. However, IAB is very important for pharmaceutical companies, because it is a fundamental criterion to determine the price of the drug, which is discussed with the Economic Committee of Health Products in a final phase. Actual benefit and improvement in actual benefit are allocated for each indication of a drug.

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

    National Research Council Canada - National Science Library

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

  1. Impacts of generic competition and benefit management practices on spending for prescription drugs: evidence from Medicare's Part D benefit.

    Science.gov (United States)

    Sheingold, Steven; Nguyen, Nguyen Xuan

    2014-01-01

    This study estimates the effects of generic competition, increased cost-sharing, and benefit practices on utilization and spending for prescription drugs. We examined changes in Medicare price and utilization from 2007 to 2009 of all drugs in 28 therapeutic classes. The classes accounted for 80% of Medicare Part D spending in 2009 and included the 6 protected classes and 6 classes with practically no generic competition. All variables were constructed to measure each drug relative to its class at a specific plan sponsor. We estimated that the shift toward generic utilization had cut in half the rate of increase in the price of a prescription during 2007-2009. Specifically, the results showed that (1) rapid generic penetration had significantly held down costs per prescription, (2) copayment and other benefit practices shifted utilization to generics and favored brands, and (3) price increases were generally greater in less competitive classes of drugs. In many ways, Part D was implemented at a fortuitous time; since 2006, there have been relatively few new blockbuster drugs introduced, and many existing high-volume drugs used by beneficiaries were in therapeutic classes with multiple brands and generic alternatives. Under these conditions, our paper showed that plan sponsors have been able to contain costs by encouraging use of generics or drugs offering greater value within therapeutic classes. It is less clear what will happen to future Part D costs if a number of new and effective drugs for beneficiaries enter the market with no real competitors.

  2. Drug packaging in 2013: small changes would reap big benefits.

    Science.gov (United States)

    2014-05-01

    Drug packaging is important both in protecting and informing patients. Some improvements were made in 2013, but many of the products examined by Prescrire still had poor-quality or even dangerous packaging. Problem packaging is a major concern for patients who are more vulnerable to adverse effects, particularly children and pregnant women. Several problems were noted with products intended for self-medication (umbrella brands), oral solutions sold with dosing devices, and injectable drugs. Looking back at 20 years of Red Cards that Prescrire has issued to products with dangerous packaging reveals several improvements, but too many dangers persist. Urgent action needs to be taken by regulatory agencies and drug companies: patient leaflets must be more explicit with regard to adverse effects, especially those of nonsteroidal anti-inflammatory drugs during pregnancy; accidental ingestion by children must be prevented; and companies must design safer dosing devices. Healthcare professionals and patients must remain vigilant and report all packaging issues to the relevant authorities.

  3. Bayesian joint modelling of benefit and risk in drug development.

    Science.gov (United States)

    Costa, Maria J; Drury, Thomas

    2018-05-01

    To gain regulatory approval, a new medicine must demonstrate that its benefits outweigh any potential risks, ie, that the benefit-risk balance is favourable towards the new medicine. For transparency and clarity of the decision, a structured and consistent approach to benefit-risk assessment that quantifies uncertainties and accounts for underlying dependencies is desirable. This paper proposes two approaches to benefit-risk evaluation, both based on the idea of joint modelling of mixed outcomes that are potentially dependent at the subject level. Using Bayesian inference, the two approaches offer interpretability and efficiency to enhance qualitative frameworks. Simulation studies show that accounting for correlation leads to a more accurate assessment of the strength of evidence to support benefit-risk profiles of interest. Several graphical approaches are proposed that can be used to communicate the benefit-risk balance to project teams. Finally, the two approaches are illustrated in a case study using real clinical trial data. Copyright © 2018 John Wiley & Sons, Ltd.

  4. Reforming private drug coverage in Canada: inefficient drug benefit design and the barriers to change in unionized settings.

    Science.gov (United States)

    O'Brady, Sean; Gagnon, Marc-André; Cassels, Alan

    2015-02-01

    Prescription drugs are the highest single cost component for employees' benefits packages in Canada. While industry literature considers cost-containment for prescription drug costs to be a priority for insurers and employers, the implementation of cost-containment measures for private drug plans in Canada remains more of a myth than a reality. Through 18 semi-structured phone interviews conducted with experts from private sector companies, unions, insurers and plan advisors, this study explores the reasons behind this incapacity to implement cost-containment measures by examining how private sector employers negotiate drug benefit design in unionized settings. Respondents were asked questions on how employee benefits are negotiated; the relationships between the players who influence drug benefit design; the role of these players' strategies in influencing plan design; the broad system that underpins drug benefit design; and the potential for a universal pharmacare program in Canada. The study shows that there is consensus about the need to educate employees and employers, more collaboration and data-sharing between these two sets of players, and for external intervention from government to help transform established norms in terms of private drug plan design. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  5. Drug eruptions presenting at sites of prior radiation damage (sunlight and electron beam)

    International Nuclear Information System (INIS)

    Shelley, W.B.; Shelley, E.D.; Campbell, A.C.; Weigensberg, I.J.

    1984-01-01

    Two patients are described in whom sunburn and electron beam radiodermatitis, respectively, were critical determinants in localizing the initial presentation of drug eruptions. In the first instance, a severe sunburn of the back and thighs was followed 7 months later by the appearance of a toxic epidermal necrolysis drug reaction to trimethoprim-sulfamethoxazole in the exact sites of the previous bullous sunburn reaction. In the second patient, a radiodermatitis of the left upper arm due to electron beam therapy for metastatic breast cancer was followed 7 weeks later by a codeine drug reaction confined to the area of the radiodermatitis. In both instances, oral rechallenge with the offending drug reproduced the eruption

  6. [Development of new drugs: opportunities and benefits for Peru].

    Science.gov (United States)

    Bayona, Andrés; Fajardo, Natalia

    2012-01-01

    The development of innovative drugs allows coming up with new medicines to prevent and better treat illnesses. This improves people's quality of life and makes it more productive. Therefore, the mission of pharmaceutical research is to develop safe and effective drugs. Clinical trials allow the evaluation of the safety and efficacy profiles of new medicines, medical devices and diagnostic tests. Research and development (R&D) of new drugs is a long and costly process, where out of every 5000 to 10000 new components that enter preclinical testing, only one is approved. Compared to 2011, drug development has increased by 7.6%. According to ClinicalTrials.gov, 5% of the trials take place in Latin America, and Peru is in the fifth position. On the other hand, according to the Global Competitiveness Report issued by the World Economic Forum, Peru ranks 61st, its biggest challenges being the functioning of its public institutions, investment in R&D and technological capacity. The complexity of drug R&D results in a search for competitive places to develop clinical trials. Clinical Research is a humanized industry due to its ethical platform, stated in the guidelines of good clinical practices. This industry demands our country to develop a differentiating value that contributes to the development of knowledge and its competitiveness.

  7. How excluding some benefits from value assessment of new drugs impacts innovation.

    Science.gov (United States)

    Cook, Joseph P; Golec, Joseph

    2017-12-01

    Payers often assess the benefits of new drugs relative to costs for reimbursement purposes, but they frequently exclude some drugs' option-related benefits, reducing their reimbursement chances, and making them less attractive R&D investments. We develop and test a real options model of R&D investment that shows that excluding option-related benefits heightens drug developers' incentives to avoid high-risk (volatile) R&D investments and instead encourages them to focus on "safer" (positively skewed) investments. Our model and empirical results could partly explain the decline in the number of risky new molecular entities. Copyright © 2017 John Wiley & Sons, Ltd.

  8. Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

    Science.gov (United States)

    Tungol, Alexandra; Starner, Catherine I; Gunderson, Brent W; Schafer, Jeremy A; Qiu, Yang; Gleason, Patrick P

    2012-01-01

      In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing

  9. Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

    Science.gov (United States)

    Kopp, S W; Bang, H K

    2000-01-01

    As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

  10. Usage, Risk, and Benefit of Weight-Loss Drugs in Primary Care

    Directory of Open Access Journals (Sweden)

    Tomas Forslund

    2011-01-01

    Conclusions. These results suggest that weight-loss drug treatment was often initiated upon patient request but was of limited clinical benefit as it was managed in a large portion of Swedish primary carecenters.

  11. One fourth of acutely admitted patients use over-the-counter-drugs 24 hours prior to hospitalisation

    DEFF Research Database (Denmark)

    Pedersen, Magnus; Brabrand, Mikkel

    2014-01-01

    to hospitalisation and the effects of this intake. MATERIAL AND METHODS: Junior physicians on call interviewed patients admitted to the medical admission unit at South-West Jutland Hospital in Esbjerg using a modified chart template. Adult patients aged 15 and older admitted during a two-week period in August 2012...... were included. Patients were asked about consumed OTC drugs, dosage, indication and effect. RESULTS: From a total of 349 admissions, 188 usable chart templates were registered (54%), and information on OTC usage was registered on 165 of these (88%). The patients where elderly (median: 70 years) and 43......, 60% felt an effect of the intake and the majority felt an effect on pain symptoms. CONCLUSION: One in four patients used OTC drugs 24 hours prior to hospitalisation and primarily analgesics were used. Most patients used OTC drugs relevantly and half with a positive effect. The intake is poorly...

  12. A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis

    NARCIS (Netherlands)

    Tervonen, Tommi; van Valkenhoef, Gert; Buskens, Erik; Hillege, Hans L.; Postmus, Douwe

    2011-01-01

    Drug benefit-risk (BR) analysis is based on firm clinical evidence regarding various safety and efficacy outcomes. In this paper, we propose a new and more formal approach for constructing a supporting multicriteria model that fully takes into account the evidence on efficacy and adverse drug

  13. 76 FR 54599 - Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs

    Science.gov (United States)

    2011-09-01

    ...), prescription drug benefit program (Part D) and section 1876 cost plans including conforming changes to the MA... accounts (MSA) plans, cost-sharing for dual-eligible enrollees in the MA program and prescription drug pricing, coverage, and payment processes in the Part D program, and requirements governing the marketing...

  14. Alcohol, drug and other prior crimes and risk of arrest in handgun purchasers: protocol for a controlled observational study

    Science.gov (United States)

    Wintemute, Garen J; Kass, Philip H; Stewart, Susan L; Cerdá, Magdalena; Gruenewald, Paul J

    2016-01-01

    Background and objective Alcohol abuse is common in the USA and is a well-established risk factor for violence. Other drug use and criminal activity are risk factors as well and frequently occur together with alcohol abuse. Firearm ownership is also common; there are >50 million firearm owners in the USA. This study assesses the relationships between alcohol and drug abuse and future violence among firearm owners, which no prior research has done. Design and study population This records-based retrospective cohort study will involve all persons who legally purchased handguns in California in 2001—approximately 116 000 individuals—with follow-up through the end of 2013. Methods The principal exposures include prior convictions for alcohol-related and drug-related offenses. The primary outcome measure is an arrest following handgun purchase for a violent Crime Index offense: homicide, rape, robbery or aggravated assault. Subjects will be considered at risk for outcome events for only as long as their residence in California can be established independently of outcome events. Covariates include individual characteristics (eg, age, sex, criminal history, firearm purchase history) and community characteristics (eg, demographics, socioeconomic measures, firearm ownership and alcohol outlet density). We will employ survival analytic methods, expressing effects as HRs. Discussion The results of this large-scale study are likely to be generalisable and to have important implications for violence prevention policies and programmes. PMID:26498316

  15. What Are The Benefits In The Association Of SGLT2 Inhibitors And Other Drugs?

    Directory of Open Access Journals (Sweden)

    Deici Aparecida Gomes Rodrigues

    2017-11-01

    Full Text Available The SGLT2 inhibitors are a class of drugs that blocks the sodium-glucose co-transport, which is responsible for 90% of the nephron glucose. Objective: To show the benefits of the SGLT2 inhibitors in monotherapy and in association with other drugs. Results: The association of SGLT2 inhibitors and other drugs has shown several additional benefits after their interaction, including weight loss, reduction of body fat, reduction of triglycerides level, decrease of glycated hemoglobin, decrease in postprandial glucose level, reduction of arterial pressure, decrease of hypoglycemia risk and improvement of glucose metabolism. Therefore, this is a promising interaction for type 2 diabetes.

  16. Use of nonsteroidal anti-inflammatory drugs prior to chronic renal replacement therapy initiation

    DEFF Research Database (Denmark)

    Kristensen, Søren Lund; Fosbøl, Emil L; Kamper, Anne-Lise

    2012-01-01

    PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with severe renal complications, including acute renal failure, reduced glomerular filtration rate and interstitial nephritis. Caution against NSAIDs is therefore recommended in advanced chronic kidney disease. In this study......, we examined NSAID use, aetiology and comorbidity among a national cohort of patients before the initiation of chronic renal replacement therapy (RRT). METHODS: Patients initiated on chronic RRT in the period 1997-2006 were identified in the Danish National Registry on Regular Dialysis...

  17. 78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

    Science.gov (United States)

    2013-03-08

    ... benefit and risk considerations that make up a regulatory decision will help to facilitate balanced and... and the role of those factors in the regulatory decision-making process for human drug and biological... communication of its decisions by making clear the important considerations in the Agency's decision-making...

  18. Optimum Drug Combinations for the Sedation of Growing Boars Prior to Castration

    Science.gov (United States)

    Lehmann, Heidi S.; Blache, Dominique; Drynan, Eleanor; Tshewang, Pema; Blignaut, David J. C.; Musk, Gabrielle C.

    2017-01-01

    Simple Summary Pigs are notoriously challenging patients. They are difficult to handle so the use of predictable and safe sedation techniques is required for husbandry and surgical procedures. Various combinations of sedative and analgesic drugs have been previously investigated in this species, though the combination of midazolam and detomidine with either butorphanol or morphine has not been reported for sedation in pigs. The use of these combinations was investigated in the context of adequate sedation to allow castration of boars with the aid of local anaesthetic infiltration. The combination of midazolam, detomidine with butorphanol provided a more reliable sedation combination than that including morphine. It is proposed that this combination of drugs would be useful for sedation during painful husbandry procedures in pigs. Abstract Juvenile male pigs were sedated for castration. Eight five-month old boars were sedated twice (two weeks apart) with a combination of detomidine (0.1 mg/kg), midazolam (0.2 mg/kg) and either butorphanol (0.2 mg/kg) (Group MDB, n = 8) or morphine (0.2 mg/kg) (Group MDM, n = 8) intramuscularly. The boars were positioned in lateral recumbency and lidocaine (200 mg total) was injected into the testicle and scrotal skin. Castration of a single testicle was performed on two occasions. Sedation and reaction (to positioning and surgery) scores, pulse rate, respiratory rate, haemoglobin oxygen saturation, body temperature, arterial blood gas parameters and the times to immobility and then recovery were recorded. Atipamezole was administered if spontaneous recovery was not evident within 60 min of sedative administration. Data were compared with either a paired-sample t-test or a Wilcoxon-Signed Rank Test. There was no difference in sedation score, body temperature, respiratory rate and haemoglobin oxygen saturation between MDB and MDM. Mild hypoxaemia was noted in both groups. There was less reaction to castration after MDB. The pulse rate

  19. Demand for a Medicare prescription drug benefit: exploring consumer preferences under a managed competition framework.

    Science.gov (United States)

    Cline, Richard R; Mott, David A

    2003-01-01

    Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit.

  20. Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

    Science.gov (United States)

    Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani

    2018-01-01

    The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.

  1. Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising.

    Science.gov (United States)

    West, Suzanne L; Squiers, Linda B; McCormack, Lauren; Southwell, Brian G; Brouwer, Emily S; Ashok, Mahima; Lux, Linda; Boudewyns, Vanessa; O'Donoghue, Amie; Sullivan, Helen W

    2013-05-01

    Under the Food, Drug, and Cosmetic Act, all promotional materials for prescription drugs must strike a fair balance in presentation of risks and benefits. How to best present this information is not clear. We sought to determine if the presentation of quantitative risk and benefit information in drug advertising and labeling influences consumers', patients', and clinicians' information processing, knowledge, and behavior by assessing available empirical evidence. We used PubMed for a literature search, limiting to articles published in English from 1990 forward. Two reviewers independently reviewed the titles and abstracts for inclusion, after which we reviewed the full texts to determine if they communicated risk/benefit information either: (i) numerically (e.g., percent) versus non-numerically (e.g., using text such as "increased risk") or (ii) numerically using different formats (e.g., "25% of patients", "one in four patients", or use of pictographs). We abstracted information from included articles into standardized evidence tables. The research team identified a total of 674 relevant publications, of which 52 met our inclusion criteria. Of these, 37 focused on drugs. Presenting numeric information appears to improve understanding of risks and benefits relative to non-numeric presentation; presenting both numeric and non-numeric information when possible may be best practice. No single specific format or graphical approach emerged as consistently superior. Numeracy and health literacy also deserve more empirical attention as moderators. Copyright © 2013 John Wiley & Sons, Ltd.

  2. 42 CFR 423.464 - Coordination of benefits with other providers of prescription drug coverage.

    Science.gov (United States)

    2010-10-01

    ... fees. CMS may impose user fees on Part D plans for the transmittal of information necessary for benefit...) Provides supplemental drug coverage to individuals based on financial need, age, or medical condition, and... effective exchange of information and coordination between such plan and SPAPs and entities providing other...

  3. A state-of-the-art multi-criteria model for drug benefit-risk analysis

    NARCIS (Netherlands)

    Tervonen, T.; Hillege, H.L.; Buskens, E.; Postmus, D.

    2010-01-01

    Drug benefit-risk analysis is based on firm clinical evidence related to various safety and efficacy outcomes, such as tolerability, treatment response, and adverse events. In this paper, we propose a new approach for constructing a supporting multi-criteria model that fully takes into account this

  4. Randomised controlled single-blind study of conventional versus depot mydriatic drug delivery prior to cataract surgery

    Directory of Open Access Journals (Sweden)

    Madge Simon

    2006-11-01

    Full Text Available Abstract Background A prerequisite for safe cataract surgery is an adequately dilated pupil. The authors conducted a trial to assess the efficacy (in terms of pupil diameter of a depot method of pre-operative pupil dilatation, as compared with repeated instillations of drops (which is time-consuming for the nursing staff and uncomfortable for the patient. Methods A prospective randomised masked trial was conducted comprising 130 patients with no significant ocular history undergoing elective clear corneal phacoemulsification. 65 patients had mydriatic drops (Tropicamide 1%, Phenylephrine 2.5%, Diclofenac sodium 0.1% instilled prior to surgery, 65 had a wick soaked in the same drop mixture placed in the inferior fornix. Horizontal pupil diameters were recorded on a millimetre scale immediately prior to surgery. Results There was no significant difference in pupil size between the two groups (p = 0.255, Student's t-test. Conclusion There was no significant difference between the mydriasis obtained with the depot system compared with conventional drop application. Use of a depot mydriatic delivery system appears to be a safe and efficient method of drug delivery. Trial Registration International Standard Randomised Controlled Trial Number Register ISRCTN78047760

  5. Prior antiplatelet drug use and short-term mortality in older patients with acute ischemic stroke (AIS).

    Science.gov (United States)

    Zuliani, Giovanni; Galvani, Matteo; Bonetti, Francesco; Prandini, Stefano; Magon, Stefania; Gasperini, Beatrice; Ruggiero, Carmelinda; Cherubini, Antonio

    2012-01-01

    Some studies suggest that previous treatment with antiplatelet agents (AA) might reduce ischemic stroke severity and improve outcomes in terms of clinical deficits or mortality. We evaluated the effect of the prior chronic use of AA on short-term (30 days) mortality in a sample of consecutive patients with AIS. Four hundred thirty-nine older patients (>65 years) with "major" AIS (modified Rankin scale ≥ 3) consecutively admitted to the University ward of Internal Medicine or Geriatrics were enrolled. Stroke was classified according to Oxfordshire Community Stroke Project (OCSP). Data recorded included: (1) clinical features; (2) medical history including home therapies, and vascular risk factors; (3) routine clinical chemistry analyzes (verb)/analyses (noun). Short-term (30 days) mortality was 27.6%. One hundred fifteen subjects (26.2%) were taking AA before admission. Compared with subjects not treated, subjects taking AA were characterized by higher prevalence of recurrent stroke (35% vs. 22%). In this group, a trend toward a higher prevalence of congestive heart failure (CHF), smoking, and altered levels of consciousness (ALC) was noted. Stroke type and short-term mortality (33% vs. 26.2%; odds ratio=OR=1.25; 95% confidence interval=CI=0.75-2.10, age and gender adjusted) were not different between the two groups. Adjustment for glucose, CHF, previous stroke, smoking, and ALC did not change mortality risk (OR=0.83; 95%CI=0.40-1.72). We conclude that in older patients hospitalized for "major" AIS, prior use of AA was not associated with any benefit in terms of short-term mortality both in patients with first, as well as in those with recurrent ischemic stroke. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  6. Oncogenic targets, magnitude of benefit, and market pricing of antineoplastic drugs.

    Science.gov (United States)

    Amir, Eitan; Seruga, Bostjan; Martinez-Lopez, Joaquin; Kwong, Ryan; Pandiella, Atanasio; Tannock, Ian F; Ocaña, Alberto

    2011-06-20

    The relationship between market pricing of new anticancer drugs and the magnitude of clinical benefit caused by them has not been reported. Randomized clinical trials (RCTs) that evaluated approved new agents for solid tumors by the U.S. Food and Drug administration since the year 2000 were assessed. Hazard ratios (HRs) and 95% CIs were extracted for time-to-event end points described for each RCT. HRs were pooled for three groups: agents directed against a specific molecular target, for which the target population is selected by a biomarker (group A); less specific biologic targeted agents (group B); and chemotherapeutic agents (group C). Monthly market prices of these different drugs were compared. For overall survival (OS), the pooled HR was 0.69 (95% CI, 0.59 to 0.81) for group A (six drugs, six trials); it was 0.78 (95% CI, 0.74 to 0.83) for group B (seven drugs, 14 trials); and it was 0.84 (95% CI, 0.79 to 0.90) for group C (eight drugs, 12 trials). For progression-free survival (PFS), the pooled HR was 0.42 (95% CI, 0.36 to 0.49) for group A (six drugs, seven trials); it was 0.57 (95% CI, 0.51 to 0.64) for group B (seven drugs, 14 trials); and it was 0.75 (95% CI, 0.66 to 0.85) for group C (six drugs, 10 trials). Tests for heterogeneity between subgroups were highly significant for PFS (P targets are clinically the most beneficial, but their monthly market prices are not significantly different from those of other anticancer agents.

  7. Benefits of Exercise for the Quality of Life of Drug-Dependent Patients.

    Science.gov (United States)

    Giménez-Meseguer, Jorge; Tortosa-Martínez, Juan; de los Remedios Fernández-Valenciano, María

    2015-01-01

    This study combined quantitative and qualitative research methods to evaluate quality-of-life changes in drug-dependent patients after participation in a group-based exercise program. Quality of life (SF-36) and physical fitness (six-minute Walk Test, Timed Get Up and Go Test, and Chair Stand Test) were quantitatively determined in a group (n=37) of drug-dependent patients before and after a 12-week group exercise program (n=18) or routine care (n=19). Additionally, in-depth interviews were conducted at the end of the program with a subsample of 11 participants from the exercise group. Quantitative results showed improvements in fitness and different aspects of quality of life, such as physical function, mental health, vitality, social function, and general health perception. Qualitative results showed specific physical benefits (decreased injuries and muscle pain, decreased weight, and increased vitality with improvement in activities of daily living), psychological benefits (forgetting about everyday problems, improved mood, decreased stress and anxiety), social benefits, and a reduction in craving. The results of this study provide insight into the importance of exercise for the quality of life and recovery process of drug-dependent patients.

  8. A stochastic multicriteria model for evidence-based decision making in drug benefit-risk analysis.

    Science.gov (United States)

    Tervonen, Tommi; van Valkenhoef, Gert; Buskens, Erik; Hillege, Hans L; Postmus, Douwe

    2011-05-30

    Drug benefit-risk (BR) analysis is based on firm clinical evidence regarding various safety and efficacy outcomes. In this paper, we propose a new and more formal approach for constructing a supporting multi-criteria model that fully takes into account the evidence on efficacy and adverse drug reactions. Our approach is based on the stochastic multi-criteria acceptability analysis methodology, which allows us to compute the typical value judgments that support a decision, to quantify decision uncertainty, and to compute a comprehensive BR profile. We construct a multi-criteria model for the therapeutic group of second-generation antidepressants. We assess fluoxetine and venlafaxine together with placebo according to incidence of treatment response and three common adverse drug reactions by using data from a published study. Our model shows that there are clear trade-offs among the treatment alternatives. Copyright © 2011 John Wiley & Sons, Ltd.

  9. Ask the experts: the challenges and benefits of flow chemistry to optimize drug development.

    Science.gov (United States)

    Anderson, Neal; Gernaey, Krist V; Jamison, Timothy F; Kircher, Manfred; Wiles, Charlotte; Leadbeater, Nicholas E; Sandford, Graham; Richardson, Paul

    2012-09-01

    Against a backdrop of a struggling economic and regulatory climate, pharmaceutical companies have recently been forced to develop new ways to provide more efficient technology to meet the demands of a competitive drug industry. This issue, coupled with an increase in patent legislation and a rising generics market, makes these themes common issues in the growth of drug development. As a consequence, the importance of process chemistry and scale-up has never been more under the spotlight. Future Medicinal Chemistry wishes to share the thoughts and opinions of a variety of experts from this field, discussing issues concerning the use of flow chemistry to optimize drug development, the potential regulatory and environmental challenges faced with this, and whether the academic and industrial sectors could benefit from a more harmonized system relevant to process chemistry.

  10. Colchicine in Pericardial Disease: from the Underlying Biology and Clinical Benefits to the Drug-Drug Interactions in Cardiovascular Medicine.

    Science.gov (United States)

    Schenone, Aldo L; Menon, Venu

    2018-06-14

    This is an in-depth review on the mechanism of action, clinical utility, and drug-drug interactions of colchicine in the management of pericardial disease. Recent evidence about therapeutic targets on pericarditis has demonstrated that NALP3 inflammasome blockade is the cornerstone in the clinical benefits of colchicine. Such benefits extend from acute and recurrent pericarditis to transient constriction and post-pericardiotomy syndrome. Despite the increased utilization of colchicine in cardiovascular medicine, safety concerns remains unsolved regarding the long-term use of colchicine in the cardiac patient. Moreover, recent evidence has demonstrated that numerous cardiovascular medications, ranging from antihypertensive medication to antiarrhythmics, are known to interact with the CYP3A4 and/or P-gp system increasing the toxicity potential of colchicine. The use of adjunctive colchicine in the management of inflammatory pericardial diseases is standard of care in current practice. It is advised that a careful medication reconciliation with emphasis on pharmacokinetic is completed before prescribing colchicine in order to avoid harmful interaction by finding an alternative regimen or adjusting colchicine dosing.

  11. Registration for public drug benefits across areas of differing ethnic composition in British Columbia, Canada

    Directory of Open Access Journals (Sweden)

    Wong Sabrina T

    2010-06-01

    Full Text Available Abstract Background In 2003, the government of British Columbia, Canada introduced a universal drug benefit plan to cover drug costs that are high relative to household income. Residents were required to register in order to be eligible for the income-based benefits. Given past research suggesting that registration processes may pose an access barrier to certain subpopulations, we aimed to determine whether registration rates varied across small geographic areas that differed in ethnic composition. Methods Using linked population-based administrative databases and census data, we conducted multivariate logistic regression analyses to determine whether the probability of registration for the public drug plan varied across areas of differing ethnic composition, controlling for household-level predisposing, enabling and needs factors. Results The adjusted odds of registration did not differ across regions characterized by high concentrations (greater than 30% of residents identifying as North American, British, French or other European. Households located in areas with concentrations of residents identifying as an Asian ethnicity had the highest odds of program registration: Chinese (OR = 1.21, CI: 1.19-1.23 and South Asian (OR = 1.19, CI: 1.16-1.22. Despite this positive finding, households residing in areas with relatively high concentrations of recent immigrants had slightly lower adjusted odds of registering for the program (OR = 0.97, CI: 0.95-0.98. Conclusions This study identified ethnic variation in registration for a new public drug benefit program in British Columbia. However, unlike previous studies, the variation observed did not indicate that areas with high concentrations of certain ethnicities experienced disadvantages. Potential explanations are discussed.

  12. Registration for public drug benefits across areas of differing ethnic composition in British Columbia, Canada.

    Science.gov (United States)

    Leong, Vivian W; Morgan, Steve; Wong, Sabrina T; Hanley, Gillian E; Black, Charlyn

    2010-06-17

    In 2003, the government of British Columbia, Canada introduced a universal drug benefit plan to cover drug costs that are high relative to household income. Residents were required to register in order to be eligible for the income-based benefits. Given past research suggesting that registration processes may pose an access barrier to certain subpopulations, we aimed to determine whether registration rates varied across small geographic areas that differed in ethnic composition. Using linked population-based administrative databases and census data, we conducted multivariate logistic regression analyses to determine whether the probability of registration for the public drug plan varied across areas of differing ethnic composition, controlling for household-level predisposing, enabling and needs factors. The adjusted odds of registration did not differ across regions characterized by high concentrations (greater than 30%) of residents identifying as North American, British, French or other European. Households located in areas with concentrations of residents identifying as an Asian ethnicity had the highest odds of program registration: Chinese (OR = 1.21, CI: 1.19-1.23) and South Asian (OR = 1.19, CI: 1.16-1.22). Despite this positive finding, households residing in areas with relatively high concentrations of recent immigrants had slightly lower adjusted odds of registering for the program (OR = 0.97, CI: 0.95-0.98). This study identified ethnic variation in registration for a new public drug benefit program in British Columbia. However, unlike previous studies, the variation observed did not indicate that areas with high concentrations of certain ethnicities experienced disadvantages. Potential explanations are discussed.

  13. Treatment of fevers prior to introducing rapid diagnostic tests for malaria in registered drug shops in Uganda

    DEFF Research Database (Denmark)

    Mbonye, Anthony K.; Lal, Sham; Cundill, Bonnie

    2013-01-01

    questionnaire to capture data on drug shops (n=65) including provider characteristics, knowledge on treatment of malaria, previous training received, type of drugs stocked, reported drug sales, and record keeping practices; and a patient questionnaire to capture data from febrile patients (n=540) exiting drug...

  14. Factors that help injecting drug users to access and benefit from services: A qualitative study

    Directory of Open Access Journals (Sweden)

    sheard Laura

    2007-10-01

    Full Text Available Abstract Background International research shows that injecting drug users (IDUs can encounter many barriers when they try to access drug treatment and other services. However, the existing literature is mostly quantitative and does not consider the kinds of factors that injectors themselves identify as enabling them to access and benefit from services. Responding to this gap in knowledge, our paper explores IDUs' own suggestions for improving service engagement and their reports of other factors enabling them to seek help. Methods Semi-structured qualitative interviews were conducted with 75 current illicit drug injectors in three geographically diverse areas of West Yorkshire, England. Recruitment was through needle exchange programmes, with additional snowball sampling to ensure inclusivity of gender, ethnicity and primary drug injected. Transcribed data were analysed thematically using Framework. Results Although participants were often satisfied with current access to services, they made three broad suggestions for improving engagement. These were: providing more services (more providers and more forms of support; better operation of existing services (including better communication systems and more flexibility around individual needs; and staffing-related improvements (particularly, less judgemental and more understanding staff attitudes. Other factors identified as important enablers of help seeking were: having supporting relationships (particularly with family members; personal circumstances/life events (especially becoming a parent; and an injector's state of mind (such as feeling motivated and positive. Conclusion A range of practical suggestions for improving IDUs' access to drug treatment and other services are identified.

  15. Medicinal benefits of marine invertebrates: sources for discovering natural drug candidates.

    Science.gov (United States)

    De Zoysa, Mahanama

    2012-01-01

    Marine invertebrates are one of the major groups of organisms, which could be diversified under the major taxonomic groups of Porifera, Cnidaria, Mollusca, Arthropoda, Echinodermata, and many other minor phyla. To date, range of medicinal benefits and a significant number of marine natural products (MNPs) have been discovered from marine invertebrates. Seafood diet from edible marine invertebrates such as mollusks and crustaceans has been linked with various medicinal benefits to improve human health. Among marine invertebrates, spongers from phylum Porifera is the most dominant group responsible for discovering large number of MNPs, which have been used as template to develop therapeutic drugs. MNPs isolated from invertebrates have shown wide range of therapeutic properties including antimicrobial, antioxidant, antihypertensive, anticoagulant, anticancer, anti-inflammatory, wound healing and immune modulator, and other medicinal effects. Therefore, marine invertebrates are rich sources of chemical diversity and health benefits for developing drug candidates, cosmetics, nutritional supplements, and molecular probes that can be supported to increase the healthy life span of human. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. 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.

  17. Radioprotective efficacy of dipyridamole and AMP combination in fractionated radiation regimen, and its dependence on the time of administration of the drugs prior to irradiation

    International Nuclear Information System (INIS)

    Hofer, M.; Pospisil, M.; Netikova, J.; Hola, J.; Znojil, V.; Vacha, J.

    1995-01-01

    The authors have recently demonstrated that a combined administration of dipyridamole and adenosine monophosphate to mice induces radioprotective effects in terms of postirradiation hematopoietic recovery in animals irradiated with a single dose. The aim of the present experiments was to investigate the radioprotective ability of the drug combination under conditions of fractionated radiation. It was shown that administration of the drugs either 15 or 60 min before each of the five daily 3-Gy doses of gamma radiation enhances hematopoietic recovery and survival of mice exposed to an additional 'top-up' dose of 3.5 Gy. Furthermore, it was ascertained that administration of the drugs 60 min prior to irradiation is more effective than administration of the drugs 15 min prior to irradiation. Due to the evidence that administration of the drugs 15 min prior to irradiation protects the organism mainly via mechanisms of systemic hypoxia while the pretreatment 60 min before irradiation avoids the role of hypoxia and mainly induces cell proliferation effects, the present results suggest a more protective role of mechanisms stimulating hematopoiesis under conditions of fractionated radiation. The data may provide a basis for more rational use of radioprotection in fractionated radiation techniques. (author) 1 tab., 1 fig., 25 refs

  18. Methods for estimating and comparing VA outpatient drug benefits with the private sector.

    Science.gov (United States)

    Render, Marta L; Nowak, John; Hammond, Emmett K; Roselle, Gary

    2003-06-01

    To estimate and compare Veterans Health Administration (VA) expenditures for outpatient pharmaceuticals for veterans at six VA facilities with hypothetical private sector costs. Using the VA Pharmacy Benefits Management Strategic Health Care Group (PBM) database, we extracted data for all dispensed outpatient prescriptions from the six study sites over federal fiscal year 1999. After extensive data validation, we converted prescriptions to the same units and merged relevant VA pricing information by National Drug Code to Redbook listed average wholesale price and the Medicaid maximal allowable charge, where available. We added total VA drug expenditures to personnel cost from the pharmacy portion of that medical center's cost distribution report. Hypothetical private sector payments were $200.8 million compared with an aggregate VA budget of $118.8 million. Using National Drug Code numbers, 97% of all items dispensed from the six facilities were matched to private sector price data. Nonmatched pharmaceuticals were largely generic over-the-counter pain relievers and commodities like alcohol swabs. The most commonly prescribed medications reflect the diseases and complaints of an older male population: pain, cardiovascular problems, diabetes, and depression or other psychiatric disorders. Use of the VA PBM database permits researchers to merge expenditure and prescription data to patient diagnoses and sentinel events. A critical element in its use is creating similar units among the systems. Such data sets permit a deeper view of the variability in drug expenditures, an important sector of health care whose inflation has been disproportionate to that of the economy and even health care.

  19. Balancing the benefits and costs of antibiotic drugs: the TREAT model.

    Science.gov (United States)

    Leibovici, L; Paul, M; Andreassen, S

    2010-12-01

    TREAT is a computerized decision support system aimed at improving empirical antibiotic treatment of inpatients with suspected bacterial infections. It contains a model that balances, for each antibiotic choice (including 'no antibiotics'), expected benefit and expected costs. The main benefit afforded by appropriate, empirical, early antibiotic treatment in moderate to severe infections is a better chance of survival. Each antibiotic drug was consigned three cost components: cost of the drug and administration; cost of side effects; and costs of future resistance. 'No treatment' incurs no costs. The model worked well for decision support. Its analysis showed, yet again, that for moderate to severe infections, a model that does not include costs of resistance to future patients will always return maximum antibiotic treatment. Two major moral decisions are hidden in the model: how to take into account the limited life-expectancy and limited quality of life of old or very sick patients; and how to assign a value for a life-year of a future, unnamed patient vs. the present, individual patient. © 2010 The Authors. Clinical Microbiology and Infection © 2010 European Society of Clinical Microbiology and Infectious Diseases.

  20. Consumption of antihypertensive drugs dispensed under the pharmacy benefit management program

    Directory of Open Access Journals (Sweden)

    Aline Pereira Rocha

    2011-12-01

    Full Text Available Pharmacy benefit management (PBM programs provide attractive discounts for drug purchase, a relevant measure to address costs, mainly of drugs for the treatment of chronic diseases. This study investigated whether PBM may be used as a tool to provide information about the use of antihypertensive medications when they are purchased. The profile of medicines taken to treat high blood pressure by large IT company employees and their dependents was evaluated from January to December 2009. The mean rate of drug boxes purchased to control hypertension was 9.4 ± 10.0 in 2009. Men purchased more drugs than women. The number of drugs purchased for the treatment of hypertension was lower than expected in all age groups except for individuals aged 54-58 and >59 years. Among men, the purchase of drugs to treat hypertension was higher than expected in the 24-28, 34-38 and 54-58 age groups. Among women, results matched expectations, except for the age group 34-38 years, in which purchase was lower than expected. Individuals in the age group 0-18 years were found to consume antihypertensive drugs. Although the PBM system may be used to identify drugs purchased by users, it does not ensure patient adherence to recommended drug treatment to control hypertension.O objetivo do Programa de Benefícios em Medicamentos (PBM é proporcionar descontos atraentes para aquisição de medicamentos, um fator relevante para o custo, principalmente no tratamento de doenças crônicas. O objetivo deste estudo é comprovar se o PBM pode ser utilizado como ferramenta para o fornecimento de informações sobre o consumo de medicamentos antihipertensivos através da aquisição dos mesmos. Foi realizada análise do perfil de medicamentos adquiridos para o tratamento de hipertensão arterial sistêmica por funcionários e seus dependentes de uma empresa de grande porte na área de tecnologia de informação (TI no período compreendido entre janeiro a dezembro de 2009. A taxa de

  1. Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.

    Science.gov (United States)

    Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E

    2018-03-01

    Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.

  2. Antiarrhythmic drugs for the maintenance of sinus rhythm: risks and benefits.

    Science.gov (United States)

    Camm, John

    2012-03-22

    Atrial fibrillation (AF) is the most common arrhythmia seen in clinical practice, and its complications impose a significant economic burden. The development of more effective agents to manage patients with AF is essential. While clinical trials show no major differences in outcomes between rate and rhythm control strategies, some patients with AF require treatment with antiarrhythmic drugs (AADs) to maintain sinus rhythm, reduce symptoms, improve exercise tolerance, and improve quality of life. Currently available AADs, while effective, have limitations including limited efficacy, adverse events, toxicity, and proarrhythmic potential. The 6 most commonly used AADs (amiodarone, disopyramide, dofetilide [USA but not Europe], flecainide, propafenone, sotalol) have proarrhythmic effects (fewer with amiodarone). Amiodarone is the most effective AAD, but its safety profile limits its usefulness. Recent advances in AAD therapy include dronedarone and vernakalant. Dronedarone, approved by the United States Food and Drug Administration and the European Medicines Authority and others, has been proven efficacious in maintaining sinus rhythm and reducing the incidence of hospitalization due to cardiovascular events or death in patients with AF. The intravenous formulation of vernakalant is approved in the European Union, Iceland, and Norway. Oral vernakalant is currently undergoing evaluation for preventing AF recurrence and appears to be effective with an acceptable safety profile. Treatment should be individualized to the patient with consideration of pharmacologic risks and benefits according to AF management guidelines. Accumulating efficacy and safety data for new and emerging AADs holds promise for improved AF management and outcomes. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. Excavating treasure from the amber of the prior art: why the public benefit doctrine is ill-suited to the pharmaceutical sciences.

    Science.gov (United States)

    Hess, Robert Alan

    2011-01-01

    This paper explores incongruities between patents and regulation as applied to the pharmaceutical industry in the United States. Research, development and marketing of a new pharmaceutical agent generally requires large, high-risk investments. The time and expense of conducting clinical trials to obtain pre-market approval from the Food and Drug Administration provides an additional barrier to entry. The patent system stimulates such investment by providing a legal barrier to appropriation of these investments by free-riders and increasing the likelihood of capital return on these investments. These two barriers are intertwined. For the most part, firms only attempt to clear the regulatory barrier when patent protection is certain. As a result of the uniquely challenging economic situation presented by the regulatory barrier, a common line of reasoning in patent policy and jurisprudence, that inventions which are barred from patenting benefit the public, is flawed. To the contrary, the patent/regulatory system forever traps pharmaceutical inventions, once placed in the public domain. Pharmaceutical companies cannot afford to invest the resources needed to clear the regulatory barrier if the investment is quickly appropriated by a free-riding manufacturer. Various implications of, and solutions to, this policy artifact are explored.

  4. Sensation seeking moderates the effects of alcohol and drug use prior to sex on sexual risk in young men who have sex with men.

    Science.gov (United States)

    Newcomb, Michael E; Clerkin, Elise M; Mustanski, Brian

    2011-04-01

    Men who have sex with men (MSM) account for more than half of all new HIV/AIDS diagnoses in the United States each year, and young MSM (ages 13-24) have the highest increases in new infections. Identifying which young MSM engage in sexual risk-taking in which contexts is critical in developing effective behavioral intervention strategies for this population. While studies have consistently found positive associations between the use of certain drugs and sexual risk, research on alcohol use as a predictor of risk has been less consistent. Participants included 114 young MSM from a longitudinal study of LGBT youth (ages 16-20 at baseline). Participants reported number of unprotected sex acts with up to nine partners across three waves of data collection spanning a reporting window of 18 months, for a total of 406 sexual partners. Sensation seeking was evaluated as a moderator of the effects of both alcohol and drug use prior to sex on sexual risk. Higher levels of sensation seeking were found to significantly increase the positive associations between frequency of unprotected sex and frequency of both alcohol use and drug use with partners. Follow-up analysis found that average rates of alcohol use moderated the association between alcohol use prior to sex and sexual risk, such that decreases in average alcohol use increased the positive association between these variables. Results suggest that while drug use with partners increased sexual risk for all young MSM, the effects of alcohol use prior to sex were limited in low sensation-seeking young MSM as well as those who are high alcohol consumers on average. Implications for future research and behavioral interventions are discussed.

  5. Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy.

    Science.gov (United States)

    Palmer, Adam C; Sorger, Peter K

    2017-12-14

    Combination cancer therapies aim to improve the probability and magnitude of therapeutic responses and reduce the likelihood of acquired resistance in an individual patient. However, drugs are tested in clinical trials on genetically diverse patient populations. We show here that patient-to-patient variability and independent drug action are sufficient to explain the superiority of many FDA-approved drug combinations in the absence of drug synergy or additivity. This is also true for combinations tested in patient-derived tumor xenografts. In a combination exhibiting independent drug action, each patient benefits solely from the drug to which his or her tumor is most sensitive, with no added benefit from other drugs. Even when drug combinations exhibit additivity or synergy in pre-clinical models, patient-to-patient variability and low cross-resistance make independent action the dominant mechanism in clinical populations. This insight represents a different way to interpret trial data and a different way to design combination therapies. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Lessons learnt from 20 years surveillance of malaria drug resistance prior to the policy change in Burkina Faso.

    Science.gov (United States)

    Tinto, Halidou; Valea, Innocent; Ouédraogo, Jean-Bosco; Guiguemdé, Tinga Robert

    2016-01-01

    The history of drug resistance to the previous antimalarial drugs, and the potential for resistance to evolve to Artemisinin-based combination therapies, demonstrates the necessity to set-up a good surveillance system in order to provide early warning of the development of resistance. Here we report a review summarizing the history of the surveillance of drug resistance that led to the policy change in Burkina Faso. The first Plasmodium falciparum Chloroquine-Resistance strain identified in Burkina Faso was detected by an in vitro test carried out in Koudougou in 1983. Nevertheless, no further cases were reported until 1987, suggesting that resistant strains had been circulating at a low prevalence before the beginning of the systematic surveillance system from 1984. We observed a marked increase of Chloroquine-Resistance in 2002-2003 probably due to the length of follow-up as the follow-up duration was 7 or 14 days before 2002 and 28 days from 2002 onwards. Therefore, pre-2002 studies have probably under-estimated the real prevalence of Chloroquine-Resistance by not detecting the late recrudescence. With a rate of 8.2% treatment failure reported in 2003, Sulfadoxine-Pyrimethamine was still efficacious for the treatment of uncomplicated malaria in Burkina Faso but this rate might rapidly increase as the result of its spreading from neighboring countries and due to its current use for both the Intermittent Preventive Treatment in pregnant women and Seasonal Malaria Chemoprophylaxis. The current strategy for the surveillance of the Artemisinin-based combination treatments resistance should build on lessons learnt under the previous period of 20 years surveillance of Chloroquine and Sulfadoxine-Pyrimethamine resistance (1994-2004). The most important aspect being to extend the number of sentinel sites so that data would be less patchy and could help understanding the dynamic of the resistance.

  7. Epidemiology of overdose episodes from the period prior to hospitalization for drug poisoning until discharge in Japan: An exploratory descriptive study using a nationwide claims database.

    Science.gov (United States)

    Okumura, Yasuyuki; Sakata, Nobuo; Takahashi, Kunihiko; Nishi, Daisuke; Tachimori, Hisateru

    2017-08-01

    Little is known about the nationwide epidemiology of the annual rate, causative substance, and clinical course of overdose-related admission. We aimed to describe the epidemiology of overdose episodes from the period prior to hospitalization for drug poisoning until discharge to home. We assessed all cases of admission due to overdose (21,663 episodes) in Japan from October 2012 through September 2013 using the National Database of Health Insurance Claims and Specific Health Checkups of Japan. The annual rate of overdose admission was 17.0 per 100,000 population. Women exhibited two peaks in admission rates at 19-34 years (40.9 per 100,000) and ≥75 years (27.8 per 100,000). Men exhibited one peak in the admission rate at ≥75 years (23.7 per 100,000). Within 90 days prior to overdose, ≥60% and ≥9% of patients aged 19-49 years received a prescription for benzodiazepines and barbiturates, respectively. In addition, 59% of patients aged ≥75 years received a prescription for benzodiazepines prior to overdose, 47% had a history of congestive heart failure, and 24% had a diagnosis of poisoning by cardiovascular drugs. The proportion of patients with recent psychiatric treatments decreased with age (65.1% in those aged 35-49 years and 13.9% in those aged ≥75 years). The findings emphasize the need for overdose prevention programs that focus on psychiatric patients aged 19-49 years who are prescribed benzodiazepines or barbiturates and on non-psychiatric patients aged ≥75 years who are prescribed benzodiazepines or digitalis. Copyright © 2017 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

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

    International Nuclear Information System (INIS)

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

    1984-01-01

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

  9. Use and perceived benefits of mobile devices by physicians in preventing adverse drug events in the nursing home.

    Science.gov (United States)

    Handler, Steven M; Boyce, Richard D; Ligons, Frank M; Perera, Subashan; Nace, David A; Hochheiser, Harry

    2013-12-01

    Although mobile devices equipped with drug reference software may help prevent adverse drug events (ADEs) in the nursing home (NH) by providing medication information at the point of care, little is known about their use and perceived benefits. The goal of this study was to conduct a survey of a nationally representative sample of NH physicians to quantify the use and perceived benefits of mobile devices in preventing ADEs in the NH setting. We surveyed physicians who attended the 2010 American Medical Directors Association Annual Symposium about their use of mobile devices, and beliefs about the effectiveness of drug reference software in preventing ADEs. The overall net valid response rate was 70% (558/800) with 42% (236/558) using mobile devices to assist with prescribing in the NH. Physicians with 15 or fewer years of clinical experience were 67% more likely to be mobile device users, compared with those with more than 15 years of clinical experience (odds ratio = 1.68; 95% confidence interval = 1.17-2.41; P = .005). For those who used a mobile device to assist with prescribing, almost all (98%) reported performing an average of 1 or more drug look-ups per day, performed an average of 1 to 2 lookups per day for potential drug-drug interactions (DDIs), and most (88%) believed that drug reference software had helped to prevent at least 1 potential ADE in the preceding 4-week period. The proportion of NH physicians who use mobile devices with drug reference software, although significant, is lower than in other clinical environments. Our results suggest that NH physicians who use mobile devices equipped with drug reference software believe they are helpful for reducing ADEs. Further research is needed to better characterize the facilitators and barriers to adoption of the technology in the NH and its precise impact on NH ADEs. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

  10. Use and Perceived Benefits of Mobile Devices by Physicians in Preventing Adverse Drug Events in the Nursing Home

    Science.gov (United States)

    Handler, Steven M.; Boyce, Richard D.; Ligons, Frank; Perera, Subashan; Nace, David A.; Hochheiser, Harry

    2015-01-01

    Objective Although mobile devices equipped with drug reference software may help prevent adverse drug events (ADEs) in the nursing home (NH) by providing medication information at the point-of-care, little is known about their use and perceived benefits. The goal of this study was to conduct a survey of a nationally representative sample of NH physicians to quantify the use and perceived benefits of mobile devices in preventing ADEs in the NH setting. Design/Setting/Participants We surveyed physicians who attended the 2010 the AMDA Annual Symposium about their use of mobile devices and beliefs about the effectiveness of drug reference software in preventing ADEs. Results The overall net valid response rate was 70% (558/800) with 42% (236/558) using mobile devices to assist with prescribing in the NH. Physicians with ≤15 years clinical experience were 67% more likely to be mobile device users, compared to those with >15 years of clinical experience (odds ratio=1.68; 95% confidence interval=1.17-2.41; p=0.005). For those who used a mobile device to assist with prescribing, almost all (98%) reported performing an average of one or more drug look-ups per day, performed an average of 1-2 lookups per day for potential drug-drug interactions (DDIs), and most (88%) believed that drug reference software had helped to prevent at least one potential ADE in the preceding four-week period. Conclusions The proportion of NH physicians who use mobile devices with drug reference software, while significant, is lower than in other clinical environments. Our results suggest that NH physicians who use mobile devices equipped with drug reference software believe they are helpful for reducing ADEs. Further research is needed to better characterize the facilitators and barriers to adoption of the technology in the NH and its precise impact on NH ADEs. PMID:24094901

  11. Perceived Risks Contra Benefits of Using Biosimilar Drugs in Ulcerative Colitis: Discrete Choice Experiment among Gastroenterologists.

    Science.gov (United States)

    Baji, Petra; Gulácsi, László; Golovics, Petra A; Lovász, Barbara D; Péntek, Márta; Brodszky, Valentin; Rencz, Fanni; Lakatos, Péter L

    2016-09-01

    In middle-income countries, access to biological therapy is limited in ulcerative colitis in terms of the number of patients and the length of therapy. Because of their cost advantages, biosimilars have the potential to improve access to therapy, but physicians have concerns toward their use because of the lack of evidence from randomized clinical trials. To explore the preferences of gastroenterologists for biosimilar drugs in ulcerative colitis as well as to compare our results with results of previous studies on gastroenterologists' preferences toward biosimilars. A discrete choice experiment was carried out involving 51 Hungarian gastroenterologists treating patients with inflammatory bowel disease in May 2014 with the following attributes: type of treatment (biosimilar/originator), severity of disease, availability of continuous medicine supply, and the stopping rule (whether the treatment is covered after 12 months). A conditional logit model was used to estimate the probabilities of choosing a given profile. According to the results, the stopping rule was the most important attribute. The type of treatment mattered only for patients already on biologicals. The probabilities of choosing the biosimilar option with all the benefits offered in the discrete choice experiment over the originator option under the present reimbursement conditions are 85% for new patients and 63% for patients already treated. Most gastroenterologists have concerns about using biosimilars. They, however, are willing to consider the use of biosimilars if they could reallocate the potential savings to provide their patients better access to biological treatment. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  12. Effect of educational intervention on knowledge, perceived benefits, barriers and self-efficacy regarding AIDS preventive behaviors among drug addicts

    Science.gov (United States)

    Bastami, Fatemeh; Mostafavi, Firoozeh; Hassanzadeh, Akbar

    2015-01-01

    Background and Objectives: Addicts account for approximately 68.15% of AIDS cases in Iran and injection drug users are considered as a major factor in the spread of AIDS in Iran. The purpose of this study was to determine the effect of an educational intervention on the perceived self-efficacy, benefits, and barriers concerning AIDS preventive behaviors among drug addicts in Khorramabad, Iran. Methods: This is a quasi-experimental study carried out in 2013 on 88 addicts kept in rehabilitations center in Khorramabad. The data collection instruments included a questionnaire on self-efficacy, perceived benefits, perceived barriers, knowledge and preventive behaviors regarding HIV. Data were analyzed by paired t-test, independent t-test, Chi-square and analysis of covariance. Results: Paired t-test showed that the mean scores for perceived benefits and barriers, knowledge and preventive behaviors significantly increased in the intervention group after the intervention than before the intervention. But the increase in self-efficacy score was not statistically significant. Conclusions: The results of this study showed that training and education based on the health belief model led to an increase in knowledge, self-efficacy, perceived benefits, performance and reduction in perceived barriers in addicts. It is recommended that future studies should include strategies for enhancing self-efficacy and perceived benefits as well as strategies for reducing barriers to the adoption of preventive behaviors. PMID:27462632

  13. Fair Balance? An Analysis of the Functional Equivalence of Risk and Benefit Information in Prescription Drug Direct-to-Consumer Television Advertising

    Science.gov (United States)

    Baird-Harris, Kay

    2009-01-01

    Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…

  14. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

    Science.gov (United States)

    Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

    2011-04-01

    The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

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

    Science.gov (United States)

    Shepherd, Marvin D

    2013-09-01

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

  16. Consumer attitudes and factors related to prescription switching decisions in multitier copayment drug benefit plans.

    Science.gov (United States)

    Ganther-Urmie, Julie M; Nair, Kavita V; Valuck, Robert; McCollum, Marianne; Lewis, Sonya J; Turpin, Robin S

    2004-03-01

    To examine patient attitudes related to formulary medications and medication-related decision making in multitier copayment prescription drug plans. A cross-sectional retrospective analysis. Data were collected via mail survey from a random sample of 25,008 members of a managed care organization. The selected members were enrolled in a variety of 2- and 3-tier copayment plans and were taking prescription medication to treat 1 or more of 5 chronic disease states. Most respondents did not believe that formulary drugs were safer or more effective than nonformulary drugs, but 39.7% thought that formulary drugs were relatively less expensive. Most respondents appeared willing to consider switching from a nonformulary drug to a formulary drug with a lower copayment. The percent of respondents who reported they would be very unlikely or unlikely to switch was only 15.3% for a new prescription and 24.2% for a refill prescription. Medication efficacy and physician opinion were important factors in plan members' switching decisions. Cost was an important factor for some members, but older plan members were less likely to report that cost was important. Multitier plan members generally believed that drugs are placed on the formulary for reasons of cost rather than safety or efficacy. Most plan members were receptive to switching from a nonformulary to a formulary medication, but financial incentives alone may not convince some plan members to make the switch.

  17. [Benefits of spironolactone as the optimal treatment for drug resistant hypertension. Pathway-2 trial review].

    Science.gov (United States)

    Prado, J C; Ruilope, L M; Segura, J

    Pathway-2 is the first randomised, double-blind and crossover trial that compares spironolactone as a fourth drug with alfa-blocker, beta-blocker and placebo. This study shows that spironolactone is the drug with more possibilities of success for the management of patients with difficult-to-treat hypertension in patients with a combination of three drugs and poor control. The results validate the widespread treatment with mineralocorticoid receptor antagonists in resistant hypertension. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. ANTITUBERCULOSIS DRUG DOSAGE FORMS: RANGE, KEY BENEFITS AND PROSPECTS OF TECHNOLOGICAL IMPROVEMENT

    Directory of Open Access Journals (Sweden)

    M. E. Kim

    2016-01-01

    Full Text Available Interest to research in the development of new formulations of antituberculosis drugs due to the high incidence of tuberculosis in the Republic of Kazakhstan and the Russian Federation nowadays, including with acquired drug resistance. The reason for the development of acquired drug resistance is to interrupt the treatment of patients is the high toxicity of antituberculosis drugs. The improving the efficiency of antituberculosis therapy remains one of the most pressing.The aim this study was to review the dosage forms of antituberculosis drugs currently used and the ways to improve them.Methods. The study was conducted on the basis of scientific analysis (eLibrary database, PubMed, Cyberleninca, patent (kzpatents, reference (Klifar, Drugs register and technical literature.Results. It was revealed that the antituberculosis drugs are available in the form of tablets, capsules, granules for oral use and injection solutions. The advantages and disadvantages of oral dosage forms of antituberculosis drugs: tablets, capsules, granules, syrups, suspensions are described. The importance of the development and implementation in practice of pediatric formulations of antituberculosis drugs is mentioned. The state of current research inhaled formulations for the treatment of tuberculosis is described. The prospects of directional inhalation exposure by immobilization of antituberculosis drugs in liposomes, niosomes, nanocapsules, micelles, micro- and nanoparticles are mentioned. The prospect of the rectal formulations use is described. The increase in interest in the molecular encapsulation of medicinal substances with cyclodextrins in connection with the possibility of increasing the bioavailability of active ingredients, reduce the harmful effects on the gastrointestinal tract, extension, elimination of interaction of incompatible components in combination preparations, the protection of unstable substances is

  19. 76 FR 77543 - Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review

    Science.gov (United States)

    2011-12-13

    ... psychology'' (section 3507(b), Pub. L. 111-148, 124 Stat. 530), and to consult manufacturers and consumers... communication of quantitative benefit and risk information. FDA is making available the literature review report...

  20. Adjuvant Anti-Angiogenesis Drugs Are No Benefit in Kidney Cancer

    Science.gov (United States)

    Results from a recent clinical trial show that post-surgical therapy with two anti-angiogenesis drugs does not improve progression-free survival for patients with kidney cancer and may cause serious side effects.

  1. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daniel F. Kripke

    2017-03-01

    Full Text Available This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to the Commissioner of the Food and Drug Administration (United States FDA. Almost every month, new information appears about the risks of hypnotics (sleeping pills. The most important risks of hypnotics include excess mortality, especially overdose deaths, quiet deaths at night, infections, cancer, depression and suicide, automobile crashes, falls, and other accidents, and hypnotic-withdrawal insomnia. Short-term use of one-two prescriptions is associated with greater risk per dose than long-term use. Hypnotics have usually been prescribed without approved indication, most often with specific contraindications, but even when indicated, there is little or no benefit. The recommended doses objectively increase sleep little if at all, daytime performance is often made worse, not better, and the lack of general health benefits is commonly misrepresented in advertising. Treatments such as the cognitive behavioral treatment of insomnia and bright light treatment of circadian rhythm disorders offer safer and more effective alternative approaches to insomnia.

  2. Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Daniel F. Kripke

    2016-05-01

    Full Text Available This is a review of hypnotic drug risks and benefits, reassessing and updating advice presented to the Commissioner of the Food and Drug Administration (United States FDA. Almost every month, new information appears about the risks of hypnotics (sleeping pills. This review includes new information on the growing USA overdose epidemic, eight new epidemiologic studies of hypnotics’ mortality not available for previous compilations, and new emphasis on risks of short-term hypnotic prescription. The most important risks of hypnotics include excess mortality, especially overdose deaths, quiet deaths at night, infections, cancer, depression and suicide, automobile crashes, falls, and other accidents, and hypnotic-withdrawal insomnia. The short-term use of one-two prescriptions is associated with greater risk per dose than long-term use. Hypnotics are usually prescribed without approved indication, most often with specific contraindications, but even when indicated, there is little or no benefit. The recommended doses objectively increase sleep little if at all, daytime performance is often made worse, not better, and the lack of general health benefits is commonly misrepresented in advertising. Treatments such as the cognitive behavioral treatment of insomnia and bright light treatment of circadian rhythm disorders might offer safer and more effective alternative approaches to insomnia.

  3. Lack of benefit for prophylactic drugs of tension-type headache in adults : a systematic review

    NARCIS (Netherlands)

    Verhagen, Arianne P.; Damen, Leonie; Berger, Marjolein Y.; Passchier, Jan; Koes, Bart W.

    Methods. We searched several databases from inception to August 2009. We selected randomized trials that reported the effects of prophylactic drugs in patients with TTH, with a pain measure (intensity, frequency, duration, improvement or index) as outcome measure. Two authors independently assessed

  4. The impact of generic-only drug benefits on patients' use of inhaled corticosteroids in a Medicare population with asthma

    Directory of Open Access Journals (Sweden)

    Newhouse Joseph P

    2008-07-01

    Full Text Available Abstract Background Patients face increasing insurance restrictions on prescription drugs, including generic-only coverage. There are no generic inhaled corticosteroids (ICS, which are a mainstay of asthma therapy, and patients pay the full price for these drugs under generic-only policies. We examined changes in ICS use following the introduction of generic-only coverage in a Medicare Advantage population from 2003–2004. Methods Subjects were age 65+, with asthma, prior ICS use, and no chronic obstructive pulmonary disorder (n = 1,802. In 2004, 74.0% switched from having a $30 brand-copayment plan to a generic-only coverage plan (restricted coverage; 26% had $15–25 brand copayments in 2003–2004 (unrestricted coverage. Using linear difference-in-difference models, we examined annual changes in ICS use (measured by days-of-supply dispensed. There was a lower-cost ICS available within the study setting and we also examined changes in drug choice (higher- vs. lower-cost ICS. In multivariable models we adjusted for socio-demographic, clinical, and asthma characteristics. Results In 2003 subjects had an average of 188 days of ICS supply. Restricted compared with unrestricted coverage was associated with reductions in ICS use from 2003–2004 (-15.5 days-of-supply, 95% confidence interval (CI: -25.0 to -6.0. Among patients using higher-cost ICS drugs in 2003 (n = 662, more restricted versus unrestricted coverage subjects switched to the lower-cost ICS in 2004 (39.8% vs. 10.3%. Restricted coverage was not associated with decreased ICS use (2003–2004 among patients who switched to the lower-cost ICS (18.7 days-of-supply, CI: -27.5 to 65.0, but was among patients who did not switch (-38.6 days-of-supply, CI: -57.0 to -20.3. In addition, restricted coverage was associated with decreases in ICS use among patients with both higher- and lower-risk asthma (-15.0 days-of-supply, CI: -41.4 to 11.44; and -15.6 days-of-supply, CI: -25.8 to -5

  5. Clinical benefits of drug-eluting stent implantation in septuagenarians with coronary artery disease

    International Nuclear Information System (INIS)

    Fang Yuehua; Shen Weifeng; Zhang Ruiyan; Zhang Jiansheng; Hu Jian; Zhang Xian; Zheng Aifang

    2005-01-01

    Objective: This study evaluated the safety and long-term outcomes of drug-eluting stents in septuagenarians with coronary artery disease. Methods: Two hundred and thirty-nine consecutive patients with coronary artery disease underwent drug-eluting stenting, including 88 patients aged ≥70 years (group A) and 151 aged <70 years (group B). Baseline clinical characteristics, procedural success rate, occurrence of cardiac events during follow-up were recorded and compared between the two groups. Results: Procedural success rate and complications were similar for the two groups. During follow-up, group A had higher recurrence rate of chest pain than group B (23.9% vs. 7.3%, P<0.001), and occurrence of cardiac events was higher in group A than in group B (5.7% vs. 2.7%, P<0.296). There was no significant difference in the frequency of restenosis between the two groups. Conclusions: Drug-eluting stent implantation for septuagenarians with coronary artery disease is safe but may have more recurrence of angina than younger ones during long-term follow-up. (authors)

  6. Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis.

    Science.gov (United States)

    Holland, Thomas L; Mikita, Stephen; Bloom, Diane; Roberts, Jamie; McCall, Jonathan; Collyar, Deborah; Santiago, Jonas; Tiernan, Rosemary; Toerner, Joseph

    2016-11-10

    To explore patient, caregiver and physician perceptions and attitudes regarding the balance of benefit and risk in using antibacterial drugs developed through streamlined development processes. Semistructured focus groups and in-depth interviews were conducted to elicit perceptions and attitudes about the use of antibacterial drugs to treat multidrug-resistant infections. Participants were given background information about antibiotic resistance, streamlined drug development programmes and FDA drug approval processes. Audio recordings of focus groups/interviews were reviewed and quotes excerpted and categorised to identify key themes. Two primary stakeholder groups were engaged: one comprising caregivers, healthy persons and patients who had recovered from or were at risk of resistant infection (N=67; 11 focus groups); and one comprising physicians who treat resistant infections (N=23). Responses from focus groups/interviews indicated widespread awareness among patients/caregivers and physicians of the seriousness of the problem of antibacterial resistance. Both groups were willing to accept a degree of uncertainty regarding the balance of risk and benefit in a new therapy where a serious unmet need exists, but also expressed a desire for rigorous monitoring and rapid, transparent reporting of safety/effectiveness data. Both groups wanted to ensure that >1 physician had input on whether to treat patients with antibiotics developed through a streamlined process. Some patients/caregivers unfamiliar with exigencies of critical care suggested a relatively large multidisciplinary team, while physicians believed individual expert consultations would be preferable. Both groups agreed that careful oversight and stewardship of antibacterial drugs are needed to ensure patient safety, preserve efficacy and prevent abuse. Groups comprising patients/caregivers and physicians were aware of serious issues posed by resistant infections and the lack of effective antibacterial drug

  7. Coprescribing proton-pump inhibitors with nonsteroidal anti-inflammatory drugs: risks versus benefits.

    Science.gov (United States)

    Gwee, Kok Ann; Goh, Vernadine; Lima, Graca; Setia, Sajita

    2018-01-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are often coadministered with proton-pump inhibitors (PPIs) to reduce NSAID-induced gastrointestinal (GI) adverse events. This coadministration is generally regarded as safe, and is included in many of the guidelines on NSAID prescription. However, recent evidence indicates that the GI risks associated with NSAIDs can be potentiated when they are combined with PPIs. This review discusses the GI effects and complications of NSAIDs and how PPIs may potentiate these effects, options for prevention of GI side effects, and appropriate use of PPIs in combination with NSAIDs.

  8. Fenspiride: an anti-inflammatory drug with potential benefits in the treatment of endotoxemia.

    Science.gov (United States)

    De Castro, C M; Nahori, M A; Dumarey, C H; Vargaftig, B B; Bachelet, M

    1995-12-29

    Using a model of endotoxemia triggered by the intravenous injection of bacterial lipopolysaccharide (0.1 and 1 mg/kg) to guinea-pigs, we investigated the interference of fenspiride, an anti-inflammatory drug recommended for the treatment of inflammatory diseases of the upper respiratory tract. Administered orally at 60 mg/kg, fenspiride reduced the lipopolysaccharide-induced early rise of tumor necrosis factor concentrations in serum (4.2 +/- 0.9 vs. 2.3 +/- 0.5 ng/ml, P fenspiride (1551.5 +/- 183.7 vs. 771.5 +/- 237.5 pg/mu g protein, P fenspiride reduced the increased serum concentrations of extracellular type II phospholipase A2 (3.9 +/- 1.2 vs. 1.2 +/- 0.1 nmol/ml per min, P fenspiride may result from the inhibition of the formation of tumor necrosis factor, a major mediator of the effects of lipopolysaccharide.

  9. Coprescribing proton-pump inhibitors with nonsteroidal anti-inflammatory drugs: risks versus benefits

    Directory of Open Access Journals (Sweden)

    Gwee KA

    2018-02-01

    Full Text Available Kok Ann Gwee,1 Vernadine Goh,2 Graca Lima,3 Sajita Setia4 1Stomach, Liver, and Bowel Centre, Gleneagles Hospital, 2Department of Pharmacy, National University of Singapore, Singapore; 3Global Medical Affairs, Asia-Pacific Region, Pfizer, Hong Kong; 4Medical Affairs, Pfizer, Singapore Abstract: Nonsteroidal anti-inflammatory drugs (NSAIDs are often coadministered with proton-pump inhibitors (PPIs to reduce NSAID-induced gastrointestinal (GI adverse events. This coadministration is generally regarded as safe, and is included in many of the guidelines on NSAID prescription. However, recent evidence indicates that the GI risks associated with NSAIDs can be potentiated when they are combined with PPIs. This review discusses the GI effects and complications of NSAIDs and how PPIs may potentiate these effects, options for prevention of GI side effects, and appropriate use of PPIs in combination with NSAIDs. Keywords: PPIs, COX2 inhibitors, NSAIDs, enteropathy, gastrointestinal

  10. ANALYSIS OF MUTATIONS OF TUBERCULOUS MYCOBACTERIA DEFINING DRUG RESISTANCE IN HIV POSITIVE AND HIV NEGATIVE TUBERCULOSIS PATIENTS WITHOUT PRIOR HISTORY OF TREATMENT IN SVERDLOVSK REGION

    Directory of Open Access Journals (Sweden)

    G. V. Panov

    2017-01-01

    Full Text Available Goal of the study: to identify profile of mutations of tuberculous mycobacteria responsible for resistance to anti-tuberculosis drugs in HIV positive and HIV negative tuberculosis patients without prior history of treatment.Materials and methods. 165 strains of tuberculous mycobacteria from HIV positive patients and 166 strains of tuberculous mycobacteria from HIV negative patients were studied in Sverdlovsk Region (TB Dispensary, Yekaterinburg. Mutations in genes were identified using microchips of TB-BIOCHIP® and TB-BIOCHIP®-2 in compliance with the manufacturer's guidelines (OOO Biochip-IMB, Moscow.Results. It was observed that 85/165 (51.52% strains isolated from HIV positive tuberculosis patients and 58/166 (34.94% strains isolated from tuberculosis patients not associated with HIV possessed MDR genotype (p < 0.01. The majority of MDR strains had mutations in the 531th codon of rpoB (Ser→Leu and 315th codon of katG (Ser→Thr (64/85, 75.29% and 38/58, 65.52% respective the groups, resulting in the high level of resistance to rifampicin and isoniazid. Each group also had approximately equal ratio (11/165, 6.67% and 12/166, 7.23% respective the groups of strains with genomic mutations defining the resistance to isoniazid, rifampicin and fluoruquinolones. No confident difference was found in mutation patterns of genome of tuberculous mycobacteria isolated from HIV positive and HIV negative tuberculosis patients. 

  11. Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Krentz Hartmut B

    2010-06-01

    Full Text Available Abstract Background Anti-epileptic drugs (AEDs are frequently prescribed to persons with HIV/AIDS receiving combination antiretroviral therapy (cART although the extent of AED use and their interactions with cART are uncertain. Herein, AED usage, associated toxicities and immune consequences were investigated. Methods HIV replication was analysed in proliferating human T cells during AED exposure. Patients receiving AEDs in a geographically-based HIV care program were assessed using clinical and laboratory variables in addition to assessing AED indication, type, and cumulative exposures. Results Valproate suppressed proliferation in vitro of both HIV-infected and uninfected T cells (p 0.05 but AED exposures did not affect HIV production in vitro. Among 1345 HIV/AIDS persons in active care between 2001 and 2007, 169 individuals were exposed to AEDs for the following indications: peripheral neuropathy/neuropathic pain (60%, seizure/epilepsy (24%, mood disorder (13% and movement disorder (2%. The most frequently prescribed AEDs were calcium channel blockers (gabapentin/pregabalin, followed by sodium channel blockers (phenytoin, carbamazepine, lamotrigine and valproate. In a nested cohort of 55 AED-treated patients receiving cART and aviremic, chronic exposure to sodium and calcium channel blocking AEDs was associated with increased CD4+ T cell levels (p 0.05 with no change in CD8+ T cell levels over 12 months from the beginning of AED therapy. Conclusions AEDs were prescribed for multiple indications without major adverse effects in this population but immune status in patients receiving sodium or calcium channel blocking drugs was improved.

  12. Analysis of the Risks and Benefits of New Chemical Entities Approved by the US Food and Drug Administration (FDA) and Subsequently Withdrawn From the US Market.

    Science.gov (United States)

    Patriarca, Peter A; Van Auken, R Michael; Kebschull, Scott A

    2018-01-01

    Benefit-risk evaluations of drugs have been conducted since the introduction of modern regulatory systems more than 50 years ago. Such judgments are typically made on the basis of qualitative or semiquantitative approaches, often without the aid of quantitative assessment methods, the latter having often been applied asymmetrically to place emphasis on benefit more so than harm. In an effort to preliminarily evaluate the utility of lives lost or saved, or quality-adjusted life-years (QALY) lost and gained as a means of quantitatively assessing the potential benefits and risks of a new chemical entity, we focused our attention on the unique scenario in which a drug was initially approved based on one set of data, but later withdrawn from the market based on a second set of data. In this analysis, a dimensionless risk to benefit ratio was calculated in each instance, based on the risk and benefit quantified in similar units. The results indicated that FDA decisions to approve the drug corresponded to risk to benefit ratios less than or equal to 0.136, and that decisions to withdraw the drug from the US market corresponded to risk to benefit ratios greater than or equal to 0.092. The probability of FDA approval was then estimated using logistic regression analysis. The results of this analysis indicated that there was a 50% probability of FDA approval if the risk to benefit ratio was 0.121, and that the probability approaches 100% for values much less than 0.121, and the probability approaches 0% for values much greater than 0.121. The large uncertainty in these estimates due to the small sample size and overlapping data may be addressed in the future by applying the methodology to other drugs.

  13. [Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].

    Science.gov (United States)

    Martelli, Luisa; Venegoni, Mauro

    2013-06-01

    Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.

  14. Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs.

    Science.gov (United States)

    Niehaus, Ines; Dintsios, Charalabos-Markos

    2018-03-26

    The early benefit assessment of pharmaceuticals in Germany and their preceding market authorization pursue different objectives. This is reflected by the inclusion of varying confirmatory endpoints within the evaluation of oncology drugs in early benefit assessment versus market authorization, with both relying on the same evidence. Data from assessments up to July 2015 are used to estimate the impact of explorative in comparison to confirmatory endpoints on market authorization and early benefit assessment by contrasting the benefit-risk ratio of EMA and the benefit-harm balance of the HTA jurisdiction. Agreement between market authorization and early benefit assessment is examined by Cohen's kappa (k). 21 of 41 assessments were considered in the analysis. Market authorization is more confirmatory than early benefit assessment because it includes a higher proportion of primary endpoints. The latter implies a primary endpoint to be relevant for the benefit-harm balance in only 67% of cases (0.078). Explorative mortality endpoints reached the highest agreement regarding the mutual consideration for the risk-benefit ratio and the benefit-harm balance (0.000). For explorative morbidity endpoints (-0.600), quality of life (-0.600) and side effects (-0.949) no agreement is ascertainable. To warrant a broader confirmatory basis for decisions supported by HTA, closer inter-institutional cooperation of approval authorities and HTA jurisdictions by means of reliable joint advice for manufacturers regarding endpoint definition would be favorable. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. Cardiovascular mechanisms of SSRI drugs and their benefits and risks in ischemic heart disease and heart failure.

    Science.gov (United States)

    Andrade, Chittaranjan; Kumar, Chethan B; Surya, Sandarsh

    2013-05-01

    Depression and heart disease are commonly comorbid. Selective serotonin reuptake inhibitors (SSRIs) are commonly used to treat depression. In March 2011, we carried out a 15-year search of PubMed for preclinical and clinical publications related to SSRIs and ischemic heart disease (IHD) or congestive heart failure (CHF). We identify and discuss a number of mechanisms by which SSRIs may influence cardiovascular functioning and health outcomes in patients with heart disease; many of the mechanisms that we present have received little attention in previous reviews. We examine studies with positive, neutral, and negative outcomes in IHD and CHF patients treated with SSRIs. SSRIs influence cardiovascular functioning and health through several different mechanisms; for example, they inhibit serotonin-mediated and collagen-mediated platelet aggregation, reduce inflammatory mediator levels, and improve endothelial function. SSRIs improve indices of ventricular functioning in IHD and heart failure without adversely affecting electrocardiographic parameters. SSRIs may also be involved in favorable or unfavorable drug interactions with medications that influence cardiovascular functions. The clinical evidence suggests that, in general, SSRIs are safe in patients with IHD and may, in fact, exert a cardioprotective effect. The clinical data are less clear in patients with heart failure, and the evidence for benefits with SSRIs is weak.

  16. 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

  17. 21 CFR 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and...

    Science.gov (United States)

    2010-04-01

    ... making the final decision on approvability. As part of this evaluation, consistent with the statement of.... (b) In making decisions on whether to grant marketing approval for products that have been the... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Risk-benefit analysis in review of marketing...

  18. Use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs in high doses increases mortality and risk of reinfarction in patients with prior myocardial infarction

    DEFF Research Database (Denmark)

    Sørensen, Rikke; Abildstrøm, Steen Zabell; Torp-Pedersen, C.

    2008-01-01

    The selective cyclooxygenase-2 (COX-2) inhibitors and other nonselective nonsteroidal antiinflammatory drugs (NSAIDs) have been associated with increased cardiovascular risk, but the risk in patients with established cardiovascular disease is unknown. In the present study, we analyzed the risk of...

  19. Is law enforcement of drug-impaired driving cost-efficient? An explorative study of a methodology for cost-benefit analysis.

    Science.gov (United States)

    Veisten, Knut; Houwing, Sjoerd; Mathijssen, M P M René; Akhtar, Juned

    2013-03-01

    Road users driving under the influence of psychoactive substances may be at much higher relative risk (RR) in road traffic than the average driver. Legislation banning blood alcohol concentrations above certain threshold levels combined with roadside breath-testing of alcohol have been in lieu for decades in many countries, but new legislation and testing of drivers for drug use have recently been implemented in some countries. In this article we present a methodology for cost-benefit analysis (CBA) of increased law enforcement of roadside drug screening. This is an analysis of the profitability for society, where costs of control are weighed against the reduction in injuries expected from fewer drugged drivers on the roads. We specify assumptions regarding costs and the effect of the specificity of the drug screening device, and quantify a deterrence effect related to sensitivity of the device yielding the benefit estimates. Three European countries with different current enforcement levels were studied, yielding benefit-cost ratios in the approximate range of 0.5-5 for a tripling of current levels of enforcement, with costs of about 4000 EUR per convicted and in the range of 1.5 and 13 million EUR per prevented fatality. The applied methodology for CBA has involved a simplistic behavioural response to enforcement increase and control efficiency. Although this methodology should be developed further, it is clearly indicated that the cost-efficiency of increased law enforcement of drug driving offences is dependent on the baseline situation of drug-use in traffic and on the current level of enforcement, as well as the RR and prevalence of drugs in road traffic. Copyright © 2012 Elsevier B.V. All rights reserved.

  20. Macromolecular bipill of gemcitabine and methotrexate facilitates tumor-specific dual drug therapy with higher benefit-to-risk ratio

    DEFF Research Database (Denmark)

    Das, Manasmita; Jain, Roopal; Agrawal, Ashish Kumar

    2014-01-01

    -PEG-MTX conjugate over all other pharmaceutical preparations including free drugs, physical mixture of GEM and MTX, and PEGylated GEM/MTX. Toxicity studies in tumor bearing rats as well as healthy mice corroborated that dual drug conjugation is an effective means to synergize the therapeutic indices of potential...

  1. Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Campo, Gianluca; Pavasini, Rita; Morciano, Giampaolo

    2017-01-01

    AIMS: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. METHODS...

  2. Fialuridine induces acute liver failure in chimeric TK-NOG mice: a model for detecting hepatic drug toxicity prior to human testing.

    Directory of Open Access Journals (Sweden)

    Dan Xu

    2014-04-01

    Full Text Available Seven of 15 clinical trial participants treated with a nucleoside analogue (fialuridine [FIAU] developed acute liver failure. Five treated participants died, and two required a liver transplant. Preclinical toxicology studies in mice, rats, dogs, and primates did not provide any indication that FIAU would be hepatotoxic in humans. Therefore, we investigated whether FIAU-induced liver toxicity could be detected in chimeric TK-NOG mice with humanized livers.Control and chimeric TK-NOG mice with humanized livers were treated orally with FIAU 400, 100, 25, or 2.5 mg/kg/d. The response to drug treatment was evaluated by measuring plasma lactate and liver enzymes, by assessing liver histology, and by electron microscopy. After treatment with FIAU 400 mg/kg/d for 4 d, chimeric mice developed clinical and serologic evidence of liver failure and lactic acidosis. Analysis of liver tissue revealed steatosis in regions with human, but not mouse, hepatocytes. Electron micrographs revealed lipid and mitochondrial abnormalities in the human hepatocytes in FIAU-treated chimeric mice. Dose-dependent liver toxicity was detected in chimeric mice treated with FIAU 100, 25, or 2.5 mg/kg/d for 14 d. Liver toxicity did not develop in control mice that were treated with the same FIAU doses for 14 d. In contrast, treatment with another nucleotide analogue (sofosbuvir 440 or 44 mg/kg/d po for 14 d, which did not cause liver toxicity in human trial participants, did not cause liver toxicity in mice with humanized livers.FIAU-induced liver toxicity could be readily detected using chimeric TK-NOG mice with humanized livers, even when the mice were treated with a FIAU dose that was only 10-fold above the dose used in human participants. The clinical features, laboratory abnormalities, liver histology, and ultra-structural changes observed in FIAU-treated chimeric mice mirrored those of FIAU-treated human participants. The use of chimeric mice in preclinical toxicology

  3. Fialuridine induces acute liver failure in chimeric TK-NOG mice: a model for detecting hepatic drug toxicity prior to human testing.

    Science.gov (United States)

    Xu, Dan; Nishimura, Toshi; Nishimura, Sachiko; Zhang, Haili; Zheng, Ming; Guo, Ying-Ying; Masek, Marylin; Michie, Sara A; Glenn, Jeffrey; Peltz, Gary

    2014-04-01

    Seven of 15 clinical trial participants treated with a nucleoside analogue (fialuridine [FIAU]) developed acute liver failure. Five treated participants died, and two required a liver transplant. Preclinical toxicology studies in mice, rats, dogs, and primates did not provide any indication that FIAU would be hepatotoxic in humans. Therefore, we investigated whether FIAU-induced liver toxicity could be detected in chimeric TK-NOG mice with humanized livers. Control and chimeric TK-NOG mice with humanized livers were treated orally with FIAU 400, 100, 25, or 2.5 mg/kg/d. The response to drug treatment was evaluated by measuring plasma lactate and liver enzymes, by assessing liver histology, and by electron microscopy. After treatment with FIAU 400 mg/kg/d for 4 d, chimeric mice developed clinical and serologic evidence of liver failure and lactic acidosis. Analysis of liver tissue revealed steatosis in regions with human, but not mouse, hepatocytes. Electron micrographs revealed lipid and mitochondrial abnormalities in the human hepatocytes in FIAU-treated chimeric mice. Dose-dependent liver toxicity was detected in chimeric mice treated with FIAU 100, 25, or 2.5 mg/kg/d for 14 d. Liver toxicity did not develop in control mice that were treated with the same FIAU doses for 14 d. In contrast, treatment with another nucleotide analogue (sofosbuvir 440 or 44 mg/kg/d po) for 14 d, which did not cause liver toxicity in human trial participants, did not cause liver toxicity in mice with humanized livers. FIAU-induced liver toxicity could be readily detected using chimeric TK-NOG mice with humanized livers, even when the mice were treated with a FIAU dose that was only 10-fold above the dose used in human participants. The clinical features, laboratory abnormalities, liver histology, and ultra-structural changes observed in FIAU-treated chimeric mice mirrored those of FIAU-treated human participants. The use of chimeric mice in preclinical toxicology studies could improve

  4. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method: An Example with Alendronate

    NARCIS (Netherlands)

    van de Glind, Esther M. M.; Willems, Hanna C.; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F.; Hooft, Lotty; de Rooij, Sophia E.; Black, Dennis M.; van Munster, Barbara C.

    2016-01-01

    For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in

  5. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method :  An Example with Alendronate

    NARCIS (Netherlands)

    van de Glind, Esther M M; Willems, Hanna C.; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F.; Hooft, Lotty; de Rooij, Sophia E.; Black, Dennis M.; van Munster, Barbara C.

    2016-01-01

    Background For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. Objective The aim of this study was to investigate the usefulness of statistical process control (SPC) for

  6. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method : An Example with Alendronate

    NARCIS (Netherlands)

    van de Glind, Esther M. M.; Willems, Hanna C.; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F.; Hooft, Lotty; de Rooij, Sophia E.; Black, Dennis M.; van Munster, Barbara C.

    For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in

  7. Impact of Risk-Benefit Perception and Trust on Medical Technology Acceptance in Relation to Drug and Device Lag: A Tripartite Cross-Sectional Survey.

    Science.gov (United States)

    Todaka, Koji; Kishimoto, Junji; Ikeda, Masayuki; Ikeda, Koji; Yamamoto, Haruko

    2017-01-01

    New drug and medical device introduction in Japan usually lags behind that in the West. Many reports indicate that in Japan, the associated risks are considered greater than the benefits recognized in other countries. This study aimed to compare the relationship between risk-benefit perception and acceptance of medical technologies in 3 leading markets. A tripartite cross-sectional survey of the general public was used. In total, 3345 adults in the United Kingdom, the United States, and Japan participated, and sexes and age groups were equally represented. Questions about the perception of risk, benefit, and acceptance of medical and other scientific technologies, and trust of medical product providers or regulatory authorities were included. Five-step Likert coding for risk/benefit/acceptance of 4 medical items (x-rays, antibiotics, vaccines, and cardiac pacemakers) and 6 general items (such as automobiles and airplanes) were collected. Relationships between benefit perception and acceptance were linear for 4 medical technologies. The relationship had a similar slope but was shifted downward in Japan compared with the UK and US ( P medical technologies, benefits of medical technologies, trust in doctors, and trust in the Department of Health. The UK and US attributes were clustered with positive responses such as "useful," "acceptable," and "trustworthy," whereas Japan was clustered with intermediate to negative responses such as "neither" and "untrustworthy." Acceptance of medical technologies was low in Japan because of significant differences in trust for doctors and authorities compared with that in the UK and US. This is a possible basis for delays of 24 to 60 months for medical product approval in Japan.

  8. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

    Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  9. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method: An Example with Alendronate

    OpenAIRE

    van de Glind, Esther M. M.; Willems, Hanna C.; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F.; Hooft, Lotty; de Rooij, Sophia E.; Black, Dennis M.; van Munster, Barbara C.

    2016-01-01

    Background For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. Objective The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in relation to fracture risk with alendronate versus placebo in postmenopausal women. Methods We performed a post?hoc analysis of the Fracture Intervention Trial (FIT), a randomized, con...

  10. 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.

  11. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method: An Example with Alendronate.

    Science.gov (United States)

    van de Glind, Esther M M; Willems, Hanna C; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F; Hooft, Lotty; de Rooij, Sophia E; Black, Dennis M; van Munster, Barbara C

    2016-05-01

    For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in relation to fracture risk with alendronate versus placebo in postmenopausal women. We performed a post hoc analysis of the Fracture Intervention Trial (FIT), a randomized, controlled trial that investigated the effect of alendronate versus placebo on fracture risk in postmenopausal women. We used SPC, a statistical method used for monitoring processes for quality control, to determine if and when the intervention group benefited significantly more than the control group. SPC discriminated between the normal variations over time in the numbers of fractures in both groups and the variations that were attributable to alendronate. The TTB was defined as the time point from which the cumulative difference in the number of clinical fractures remained greater than the upper control limit on the SPC chart. For the total group, the TTB was defined as 11 months. For patients aged ≥70 years, the TTB was 8 months [absolute risk reduction (ARR) = 1.4%]; for patients aged <70 years, it was 19 months (ARR = 0.7%). SPC is a clear and understandable graphical method to determine the TTB. Its main advantage is that there is no need to define a prespecified time point, as is the case in traditional survival analyses. Prescribing alendronate to patients who are aged ≥70 years is useful because the TTB shows that they will benefit after 8 months. Investigators should report the TTB to simplify clinical decision making.

  12. Benefits of smart pumps for automated changeovers of vasoactive drug infusion pumps: a quasi-experimental study.

    Science.gov (United States)

    Cour, M; Hernu, R; Bénet, T; Robert, J M; Regad, D; Chabert, B; Malatray, A; Conrozier, S; Serra, P; Lassaigne, M; Vanhems, P; Argaud, L

    2013-11-01

    Manual changeover of vasoactive drug infusion pumps (CVIP) frequently lead to haemodynamic instability. Some of the newest smart pumps allow automated CVIP. The aim of this study was to compare automated CVIP with manual 'Quick Change' relays. We performed a prospective, quasi-experimental study, in a university-affiliated intensive care unit (ICU). All adult patients receiving continuous i.v. infusion of vasoactive drugs were included. CVIP were successively performed manually (Phase 1) and automatically (Phase 2) during two 6-month periods. The primary endpoint was the frequency of haemodynamic incidents related to the relays, which were defined as variations of mean arterial pressure >15 mm Hg or heart rate >15 bpm. The secondary endpoints were the nursing time dedicated to relays and the number of interruptions in care because of CVIP. A multivariate mixed effects logistic regression was fitted for analytic analysis. We studied 1329 relays (Phase 1: 681, Phase 2: 648) from 133 patients (Phase 1: 63, Phase 2: 70). Incidents related to CVIP decreased from 137 (20%) in Phase 1 to 73 (11%) in Phase 2 (Ppumps in limiting the frequency of haemodynamic incidents related to relays and in reducing the nursing workload.

  13. The risk/benefit profile of biologic drugs in real-world rheumatology practice. From ANTARES to MonitorNet

    Directory of Open Access Journals (Sweden)

    C.M. Montecucco

    2011-09-01

    Full Text Available Le principali artriti croniche ad eziopatogenesi immunoflogistica, nelle quali trovano applicazione i farmaci “biologici” (v. oltre sono la reumatoide e le sieronegative: artrite psoriasica, spondilite anchilosante, artriti reattive ed artriti “enteropatiche” (1-7. L’artrite reumatoide (AR è una malattia cronica progressiva delle articolazioni associata a significativa morbilità, deformità e riduzione della qualità di vita. La prevalenza nella popolazione, a livello mondiale, è compresa tra 0,3 ed 1%. Pur interessando in modo elettivo le articolazioni, l’AR è una malattia sistemica che può condurre a severa disabilità ed a complicanze talora fatali. La terapia farmacologica tradizionale si basa su varie combinazioni di farmaci definiti sintomatici, come gli anti-infiammatori non-steroidei (FANS, gli analgesici ed i corticosteroidi e quelli “di fondo” chiamati correntemente DMARDs (disease modifying anti-rheumatic drugs...

  14. Constrained noninformative priors

    International Nuclear Information System (INIS)

    Atwood, C.L.

    1994-10-01

    The Jeffreys noninformative prior distribution for a single unknown parameter is the distribution corresponding to a uniform distribution in the transformed model where the unknown parameter is approximately a location parameter. To obtain a prior distribution with a specified mean but with diffusion reflecting great uncertainty, a natural generalization of the noninformative prior is the distribution corresponding to the constrained maximum entropy distribution in the transformed model. Examples are given

  15. Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.

    Science.gov (United States)

    Kazandjian, Dickran; Khozin, Sean; Blumenthal, Gideon; Zhang, Lijun; Tang, Shenghui; Libeg, Meredith; Kluetz, Paul; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard

    2016-01-01

    Metastatic squamous non-small-cell lung cancer (SQ NSCLC) is a serious and life-threatening malignant condition with unmet medical need. In late December 2014, the US Food and Drug Administration (FDA) obtained the data monitoring committee report of a planned interim analysis of a trial in second-line SQ NSCLC (CM017) that demonstrated an overall survival benefit for patients treated with nivolumab compared with docetaxel. In that trial, 272 patients with metastatic SQ NSCLC patients had been randomized to receive nivolumab (n = 135) or docetaxel (n = 137). Median overall survival was 9.2 months for patients randomized to nivolumab and 6.0 months for those randomized to docetaxel (hazard ratio, 0.59; 95% CI, 0.44-0.79; P chemotherapy. The approval provides an important treatment option for these patients, affecting routine care and clinical trials.

  16. A population model evaluating the consequences of the evolution of double-resistance and tradeoffs on the benefits of two-drug antibiotic treatments.

    Science.gov (United States)

    Campbell, Ellsworth M; Chao, Lin

    2014-01-01

    The evolution of antibiotic resistance in microbes poses one of the greatest challenges to the management of human health. Because addressing the problem experimentally has been difficult, research on strategies to slow the evolution of resistance through the rational use of antibiotics has resorted to mathematical and computational models. However, despite many advances, several questions remain unsettled. Here we present a population model for rational antibiotic usage by adding three key features that have been overlooked: 1) the maximization of the frequency of uninfected patients in the human population rather than the minimization of antibiotic resistance in the bacterial population, 2) the use of cocktails containing antibiotic pairs, and 3) the imposition of tradeoff constraints on bacterial resistance to multiple drugs. Because of tradeoffs, bacterial resistance does not evolve directionally and the system reaches an equilibrium state. When considering the equilibrium frequency of uninfected patients, both cycling and mixing improve upon single-drug treatment strategies. Mixing outperforms optimal cycling regimens. Cocktails further improve upon aforementioned strategies. Moreover, conditions that increase the population frequency of uninfected patients also increase the recovery rate of infected individual patients. Thus, a rational strategy does not necessarily result in a tragedy of the commons because benefits to the individual patient and general public are not in conflict. Our identification of cocktails as the best strategy when tradeoffs between multiple-resistance are operating could also be extended to other host-pathogen systems. Cocktails or other multiple-drug treatments are additionally attractive because they allow re-using antibiotics whose utility has been negated by the evolution of single resistance.

  17. Unemployment Benefit Exhaustion

    DEFF Research Database (Denmark)

    Filges, Trine; Pico Geerdsen, Lars; Knudsen, Anne-Sofie Due

    2015-01-01

    This systematic review studied the impact of exhaustion of unemployment benefits on the exit rate out of unemployment and into employment prior to benefit exhaustion or shortly thereafter. Method: We followed Campbell Collaboration guidelines to prepare this review, and ultimately located 12...

  18. Effects of antiretroviral drug recall on perception of therapy benefits and on adherence to antiretroviral treatment in HIV-infected children.

    Science.gov (United States)

    Giannattasio, Antonietta; Barbarino, Alessandro; Lo Vecchio, Andrea; Bruzzese, Eugenia; Mango, Carmela; Guarino, Alfredo

    2009-09-01

    In June 2007, the European Medicines Agency announced the recall by Roche of nelfinavir from European Union markets because of contamination of tablets with ethyl mesylate. Based on this event, we investigated the effect of switching therapy because of nelfinavir recall or for other reasons on the perception of therapy benefits and adherence to treatment in HIV-infected children and their caregivers. Thirty-eight children (mean age 12.1+/-6.7 years) were enrolled. A 35-item questionnaire was administered to the caregivers of enrolled children. Adherence was evaluated through a 4-day recall adherence instrument. Enrolled children were divided into 3 groups: patients who were shifted because of nelfinavir recall (group A, 8 patients); patients who were shifted for other reasons (group B, 12 patients); patients who were not shifted in the last 6 months (group C, 18 patients). All caregivers considered antiretroviral therapy necessary and effective for their children. However, drug shifting generated anxiety in most of them, irrespective of the reason for shifting. At baseline, 74% patients adhered to therapy. Adherence rate was related to the type of caregivers being higher in children cared for by foster parents than in children cared for by biological parents or second-degree relatives. Adherence rates did not change significantly in groups A and B after switching. Drug-switching raises concern in caregivers of HIV-infected children and induces a negative feeling irrespective of the reason for switching. However, switching, including the shift due to nelfinavir recall, did not affect adherence rates.

  19. Senior Benefits

    Science.gov (United States)

    Information Medicaid Public Health Centers Temporary "Cash" Assistance Senior Benefits Program GovDelivery Skip Navigation Links Health and Social Services > Public Assistance > Senior Benefits Page Content Senior Benefits Senior Benefits Logo Senior Benefits Fact Sheet - June, 2016 Reduction Information

  20. The Prior-project

    DEFF Research Database (Denmark)

    Engerer, Volkmar Paul; Roued-Cunliffe, Henriette; Albretsen, Jørgen

    digitisation of Arthur Prior’s Nachlass kept in the Bodleian Library, Oxford. The DH infrastructure in question is the Prior Virtual Lab (PVL). PVL was established in 2011 in order to provide researchers in the field of temporal logic easy access to the papers of Arthur Norman Prior (1914-1969), and officially......In this paper, we present a DH research infrastructure which relies heavily on a combination of domain knowledge with information technology. The general goal is to develop tools to aid scholars in their interpretations and understanding of temporal logic. This in turn is based on an extensive...

  1. Percutaneous coronary intervention with second-generation drug-eluting stent versus bare-metal stent: Systematic review and cost-benefit analysis.

    Science.gov (United States)

    Poder, Thomas G; Erraji, Jihane; Coulibaly, Lucien P; Koffi, Kouamé

    2017-01-01

    Drug-eluting stents (DESs) were considered as ground-breaking technology promising to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention. Soon after DESs were released on the market, however, there were reports of a potential increase in mortality and of early or late thrombosis. In addition, DESs are far more expensive than bare-metal stents (BMSs), which has led to their limited use in many countries. The technology has improved over the last few years with the second generation of DESs (DES-2). Moreover, costs have come down and an improved safety profile with decreased thrombosis has been reported. Perform a cost-benefit analysis of DES-2s versus BMSs in the context of a publicly funded university hospital in Quebec, Canada. A systematic review of meta-analyses was conducted between 2012 and 2016 to extract data on clinical effectiveness. The clinical outcome of interest for the cost-benefit analysis was target-vessel revascularization (TVR). Cost units are those used in the Quebec health-care system. The cost-benefit analysis was based on a 2-year perspective. Deterministic and stochastic models (discrete-event simulation) were used, and various risk factors of reintervention were considered. DES-2s are much more effective than BMSs with respect to TVR rate ratio (i.e., 0.29 to 0.62 in more recent meta-analyses). DES-2s seem to cause fewer deaths and in-stent thrombosis than BMSs, but results are rarely significant, with the exception of the cobalt-chromium everolimus DES. The rate ratio of myocardial infraction is systematically in favor of DES-2s and very often significant. Despite the higher cost of DES-2s, fewer reinterventions can lead to huge savings (i.e., -$479 to -$769 per patient). Moreover, the higher a patient's risk of reintervention, the higher the savings associated with the use of DES-2s. Despite the higher purchase cost of DES-2s compared to BMSs

  2. Arthur Prior and 'Now'

    DEFF Research Database (Denmark)

    Blackburn, Patrick Rowan; Jørgensen, Klaus Frovin

    2016-01-01

    ’s search led him through the work of Castañeda, and back to his own work on hybrid logic: the first made temporal reference philosophically respectable, the second made it technically feasible in a modal framework. With the aid of hybrid logic, Prior built a bridge from a two-dimensional UT calculus...

  3. Prior Knowledge Assessment Guide

    Science.gov (United States)

    2014-12-01

    assessment in a reasonable amount of time. Hands-on assessments can be extremely diverse in makeup and administration depending on the subject matter...DEVELOPING AND USING PRIOR KNOWLEDGE ASSESSMENTS TO TAILOR TRAINING D-3 ___ Brush and scrub ___ Orchards ___ Rice

  4. Drug plan design incentives among Medicare prescription drug plans.

    Science.gov (United States)

    Huskamp, Haiden A; Keating, Nancy L; Dalton, Jesse B; Chernew, Michael E; Newhouse, Joseph P

    2014-07-01

    Medicare Advantage prescription drug plans (MA-PDs) and standalone prescription drug plans (PDPs) face different incentives for plan design resulting from the scope of covered benefits (only outpatient drugs for PDPs versus all drug and nondrug services for Medicare Advantage [MA]/MA-PDs). The objective is to begin to explore how MA-PDs and PDPs may be responding to their different incentives related to benefit design. We compared 2012 PDP and MA-PD average formulary coverage, prior authorization (PA) or step therapy use, and copayment requirements for drugs in 6 classes used commonly among Medicare beneficiaries. We primarily used 2012 Prescription Drug Plan Formulary and Pharmacy Network Files and MA enrollment data. 2011 Truven Health MarketScan claims were used to estimate drug prices and to compute drug market share. Average coverage and PA/step rates, and average copayment requirements, were weighted by plan enrollment and drug market share. MA-PDs are generally more likely to cover and less likely to require PA/step for brand name drugs with generic alternatives than PDPs, and MA-PDs often have lower copayment requirements for these drugs. For brands without generics, we generally found no differences in average rates of coverage or PA/step, but MA-PDs were more likely to cover all brands without generics in a class. We found modest, confirmatory evidence suggesting that PDPs and MA-PDs respond to different incentives for plan design. Future research is needed to understand the factors that influence Medicare drug plan design decisions.

  5. Sets of priors reflecting prior-data conflict and agreement

    NARCIS (Netherlands)

    Walter, G.M.; Coolen, F.P.A.; Carvalho, J.P.; Lesot, M.-J.; Kaymak, U.; Vieira, S.; Bouchon-Meunier, B.; Yager, R.R.

    2016-01-01

    Bayesian inference enables combination of observations with prior knowledge in the reasoning process. The choice of a particular prior distribution to represent the available prior knowledge is, however, often debatable, especially when prior knowledge is limited or data are scarce, as then

  6. Prior indigenous technological species

    Science.gov (United States)

    Wright, Jason T.

    2018-01-01

    One of the primary open questions of astrobiology is whether there is extant or extinct life elsewhere the solar system. Implicit in much of this work is that we are looking for microbial or, at best, unintelligent life, even though technological artefacts might be much easier to find. Search for Extraterrestrial Intelligence (SETI) work on searches for alien artefacts in the solar system typically presumes that such artefacts would be of extrasolar origin, even though life is known to have existed in the solar system, on Earth, for eons. But if a prior technological, perhaps spacefaring, species ever arose in the solar system, it might have produced artefacts or other technosignatures that have survived to present day, meaning solar system artefact SETI provides a potential path to resolving astrobiology's question. Here, I discuss the origins and possible locations for technosignatures of such a prior indigenous technological species, which might have arisen on ancient Earth or another body, such as a pre-greenhouse Venus or a wet Mars. In the case of Venus, the arrival of its global greenhouse and potential resurfacing might have erased all evidence of its existence on the Venusian surface. In the case of Earth, erosion and, ultimately, plate tectonics may have erased most such evidence if the species lived Gyr ago. Remaining indigenous technosignatures might be expected to be extremely old, limiting the places they might still be found to beneath the surfaces of Mars and the Moon, or in the outer solar system.

  7. Duration of Treatment With Nonsteroidal Anti-Inflammatory Drugs and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior Myocardial Infarction: A Nationwide Cohort Study

    DEFF Research Database (Denmark)

    Schjerning Olsen, Anne-Marie; Fosbøl, Emil L; Lindhardsen, Jesper

    2011-01-01

    Background- Despite the fact that nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated among patients with established cardiovascular disease, many receive NSAID treatment for a short period of time. However, little is known about the association between NSAID treatment duration and ...

  8. Prior Elicitation, Assessment and Inference with a Dirichlet Prior

    Directory of Open Access Journals (Sweden)

    Michael Evans

    2017-10-01

    Full Text Available Methods are developed for eliciting a Dirichlet prior based upon stating bounds on the individual probabilities that hold with high prior probability. This approach to selecting a prior is applied to a contingency table problem where it is demonstrated how to assess the prior with respect to the bias it induces as well as how to check for prior-data conflict. It is shown that the assessment of a hypothesis via relative belief can easily take into account what it means for the falsity of the hypothesis to correspond to a difference of practical importance and provide evidence in favor of a hypothesis.

  9. Health Benefits of Particle Filtration

    OpenAIRE

    Fisk, William J.

    2013-01-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and as...

  10. Modeling antibiotic treatment in hospitals: A systematic approach shows benefits of combination therapy over cycling, mixing, and mono-drug therapies.

    Science.gov (United States)

    Tepekule, Burcu; Uecker, Hildegard; Derungs, Isabel; Frenoy, Antoine; Bonhoeffer, Sebastian

    2017-09-01

    Multiple treatment strategies are available for empiric antibiotic therapy in hospitals, but neither clinical studies nor theoretical investigations have yielded a clear picture when which strategy is optimal and why. Extending earlier work of others and us, we present a mathematical model capturing treatment strategies using two drugs, i.e the multi-drug therapies referred to as cycling, mixing, and combination therapy, as well as monotherapy with either drug. We randomly sample a large parameter space to determine the conditions determining success or failure of these strategies. We find that combination therapy tends to outperform the other treatment strategies. By using linear discriminant analysis and particle swarm optimization, we find that the most important parameters determining success or failure of combination therapy relative to the other treatment strategies are the de novo rate of emergence of double resistance in patients infected with sensitive bacteria and the fitness costs associated with double resistance. The rate at which double resistance is imported into the hospital via patients admitted from the outside community has little influence, as all treatment strategies are affected equally. The parameter sets for which combination therapy fails tend to fall into areas with low biological plausibility as they are characterised by very high rates of de novo emergence of resistance to both drugs compared to a single drug, and the cost of double resistance is considerably smaller than the sum of the costs of single resistance.

  11. 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.

  12. A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multicriteria decision analysis model in the development of combination therapy for overactive bladder.

    Science.gov (United States)

    de Greef-van der Sandt, I; Newgreen, D; Schaddelee, M; Dorrepaal, C; Martina, R; Ridder, A; van Maanen, R

    2016-04-01

    A multicriteria decision analysis (MCDA) approach was developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of overactive bladder (OAB). The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. The MCDA model was developed using efficacy, safety, and tolerability attributes and the results of a phase II factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5+25 and 5+50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for phase III clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. © 2015 The American Society for Clinical Pharmacology and Therapeutics.

  13. Accommodating Uncertainty in Prior Distributions

    Energy Technology Data Exchange (ETDEWEB)

    Picard, Richard Roy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Vander Wiel, Scott Alan [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-01-19

    A fundamental premise of Bayesian methodology is that a priori information is accurately summarized by a single, precisely de ned prior distribution. In many cases, especially involving informative priors, this premise is false, and the (mis)application of Bayes methods produces posterior quantities whose apparent precisions are highly misleading. We examine the implications of uncertainty in prior distributions, and present graphical methods for dealing with them.

  14. Effects of prior testing lasting a full year in NCANDA adolescents: Contributions from age, sex, socioeconomic status, ethnicity, site, family history of alcohol or drug abuse, and baseline performance

    Directory of Open Access Journals (Sweden)

    Edith V. Sullivan

    2017-04-01

    Full Text Available Longitudinal study provides a robust method for tracking developmental trajectories. Yet inherent problems of retesting pose challenges in distinguishing biological developmental change from prior testing experience. We examined factors potentially influencing change scores on 16 neuropsychological test composites over 1 year in 568 adolescents in the National Consortium on Alcohol and NeuroDevelopment in Adolescence (NCANDA project. The twice-minus-once-tested method revealed that performance gain was mainly attributable to testing experience (practice with little contribution from predicted developmental effects. Group mean practice slopes for 13 composites indicated that 60% to ∼100% variance was attributable to test experience; General Ability accuracy showed the least practice effect (29%. Lower baseline performance, especially in younger participants, was a strong predictor of greater gain. Contributions from age, sex, ethnicity, examination site, socioeconomic status, or family history of alcohol/substance abuse were nil to small, even where statistically significant. Recognizing that a substantial proportion of change in longitudinal testing, even over 1-year, is attributable to testing experience indicates caution against assuming that performance gain observed during periods of maturation necessarily reflects development. Estimates of testing experience, a form of learning, may be a relevant metric for detecting interim influences, such as alcohol use or traumatic episodes, on behavior.

  15. The Prior Internet Resources 2017

    DEFF Research Database (Denmark)

    Engerer, Volkmar Paul; Albretsen, Jørgen

    2017-01-01

    The Prior Internet Resources (PIR) are presented. Prior’s unpublished scientific manuscripts and his wast letter correspondence with fellow researchers at the time, his Nachlass, is now subject to transcription by Prior-researchers worldwide, and form an integral part of PIR. It is demonstrated...

  16. The Importance of Prior Knowledge.

    Science.gov (United States)

    Cleary, Linda Miller

    1989-01-01

    Recounts a college English teacher's experience of reading and rereading Noam Chomsky, building up a greater store of prior knowledge. Argues that Frank Smith provides a theory for the importance of prior knowledge and Chomsky's work provided a personal example with which to interpret and integrate that theory. (RS)

  17. [Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk].

    Science.gov (United States)

    Decamps-Mini, D; Pelofi, J; Treisser, A

    2015-06-01

    The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an "over-cautious" practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession. Copyright © 2015. Published by Elsevier SAS.

  18. Antineoplastic Drugs

    Science.gov (United States)

    Sadée, Wolfgang; El Sayed, Yousry Mahmoud

    The limited scope of therapeutic drug-level monitoring in cancer chemotherapy results from the often complex biochemical mechanisms that contribute to antineoplastic activity and obscure the relationships among drug serum levels and therapeutic benefits. Moreover, new agents for cancer chemotherapy are being introduced at a more rapid rate than for the treatment of other diseases, although the successful application of therapeutic drug-level monitoring may require several years of intensive study of the significance of serum drug levels. However, drug level monitoring can be of considerable value during phase I clinical trials of new antineoplastic agents in order to assess drug metabolism, bioavailability, and intersubject variability; these are important parameters in the interpretation of clinical studies, but have no immediate benefit to the patient. High performance liquid chromatography (HPLC) probably represents the most versatile and easily adaptable analytical technique for drug metabolite screening (1). HPLC may therefore now be the method of choice during phase I clinical trials of antineoplastic drugs. For example, within a single week we developed an HPLC assay—using a C18 reverse-phase column, UV detection, and direct serum injection after protein precipitation—for the new radiosensitizer, misonidazole (2).

  19. The potential benefits and inherent risks of vibration as a non-drug therapy for the prevention and treatment of osteoporosis.

    Science.gov (United States)

    Chan, M Ete; Uzer, Gunes; Rubin, Clinton T

    2013-03-01

    The delivery of mechanical signals to the skeleton using vibration is being considered as a non-drug treatment of osteoporosis. Delivered over a range of magnitudes and frequencies, vibration has been shown to be both anabolic and anti-catabolic to the musculoskeletal tissues, yet caution must be emphasized as these mechanical signals, particularly chronic exposure to higher intensities, is a known pathogen to many physiological systems. In contrast, accumulating preclinical and clinical evidence indicates that low intensity vibration (LIV) improves bone quality through regulating the activity of cells responsible for bone remodeling, as well as biasing the differentiation fate of their mesenchymal and hematopoietic stem cell progenitors. In vitro studies provide insights into the biologic mechanisms of LIV, and indicate that cells respond to these low magnitude signals through a distinct mechanism driven not by matrix strain but acceleration. These cell, animal, and human studies may represent the foundation of a safe, non-drug means to protect and improve the musculoskeletal system of the elderly, injured, and infirmed.

  20. Desarrollo de nuevos medicamentos: oportunidades y beneficios para el Perú Development of new drugs: opportunities and benefits for Peru

    Directory of Open Access Journals (Sweden)

    Andrés Bayona

    2012-12-01

    Full Text Available El desarrollo de drogas innovadoras permite la obtención de nuevos medicamentos para así prevenir y tratar mejor las enfermedades, ello mejora la calidad de vida y la hace más productiva; por tanto, la misión de la investigación farmacéutica es desarrollar drogas seguras y eficaces. Los ensayos clínicos permiten evaluar los perfiles de seguridad y eficacia de nuevos medicamentos, dispositivos médicos y pruebas diagnósticas. La investigación y el desarrollo de nuevas drogas es un proceso largo y costoso en donde por cada 5000 a 10 000 nuevos compuestos que ingresan a las pruebas preclínicas, solo uno es aprobado. En la actualidad, el desarrollo de drogas muestra un crecimiento de 7,6% con respecto al 2011. Según ClinicalTrials.gov, el 5% de los ensayos se implementan en Latinoamérica, en donde, Perú ocupa el quinto lugar, con un descenso de estudios aprobados desde el año 2009. De otro lado, según el Reporte Global de Competitividad del Foro Económico Mundial, Perú ocupa el puesto 61 con retos principalmente en el funcionamiento de sus instituciones públicas, inversión en I&D y capacidad tecnológica. La complejidad de la I&D de medicamentos explica la búsqueda de locaciones competitivas para el desarrollo de estudios clínicos. La Investigación Clínica es una industria humanizada por su plataforma ética enunciada en las guías de buenas prácticas clínicas, y que exige de nuestro país desarrollar un valor diferenciador que contribuya con el desarrollo de conocimiento y su competitividad.The development of innovative drugs allows coming up with new medicines to prevent and better treat illnesses. This improves people´s quality of life and makes it more productive. Therefore, the mission of pharmaceutical research is to develop safe and effective drugs. Clinical trials allow the evaluation of the safety and efficacy profiles of new medicines, medical devices and diagnostic tests. Research and development (R&D of new

  1. Immunological effects of iron oxide nanoparticles and iron-based complex drug formulations: Therapeutic benefits, toxicity, mechanistic insights, and translational considerations.

    Science.gov (United States)

    Shah, Ankit; Dobrovolskaia, Marina A

    2018-04-01

    Nanotechnology offers several advantages for drug delivery. However, there is the need for addressing potential safety concerns regarding the adverse health effects of these unique materials. Some such effects may occur due to undesirable interactions between nanoparticles and the immune system, and they may include hypersensitivity reactions, immunosuppression, and immunostimulation. While strategies, models, and approaches for studying the immunological safety of various engineered nanoparticles, including metal oxides, have been covered in the current literature, little attention has been given to the interactions between iron oxide-based nanomaterials and various components of the immune system. Here we provide a comprehensive review of studies investigating the effects of iron oxides and iron-based nanoparticles on various types of immune cells, highlight current gaps in the understanding of the structure-activity relationships of these materials, and propose a framework for capturing their immunotoxicity to streamline comparative studies between various types of iron-based formulations. Copyright © 2018 Elsevier Inc. All rights reserved.

  2. Recruiting for Prior Service Market

    Science.gov (United States)

    2008-06-01

    perceptions, expectations and issues for re-enlistment • Develop potential marketing and advertising tactics and strategies targeted to the defined...01 JUN 2008 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Recruiting for Prior Service Market 5a. CONTRACT NUMBER 5b. GRANT...Command First Handshake to First Unit of Assignment An Army of One Proud to Be e e to Serve Recruiting for Prior Service Market MAJ Eric Givens / MAJ Brian

  3. Reference drug programs: Effectiveness and policy implications☆

    Science.gov (United States)

    Schneeweiss, Sebastian

    2010-01-01

    In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP. In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering

  4. Multiple Benefits.

    Science.gov (United States)

    Kreider, Beth

    1997-01-01

    Discusses the benefits of dome architecture for a community's middle- and high-school multi-purpose facility. The dome construction is revealed as being cost effective in construction and in maintenance and energy costs. (GR)

  5. Benefits | NREL

    Science.gov (United States)

    flexible work environment that enables and encourages a good work/life balance A growing, changing exceptional work. A woman riding her bike past the NREL entrance sign. Hundreds of NREL employees opt out of their cars, cycling to work, to take part in Bike To Work Day each year. Benefits Package NREL's

  6. Fringe Benefits.

    Science.gov (United States)

    Podgursky, Michael

    2003-01-01

    Uses statistics from the National Center for Education Statistics and the Bureau of Labor Statistics to examine teacher salaries and benefits. Discusses compensation of teachers compared with nonteachers. Asserts that statistics from the American Federation of Teachers and the National Education Association underestimate teacher compensation…

  7. 20 CFR 404.1247 - When to report wages-for wages paid prior to 1987.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false When to report wages-for wages paid prior to... Report Wages and Contributions-for Wages Paid Prior to 1987 § 404.1247 When to report wages—for wages paid prior to 1987. A State shall report wages for the calendar year in which they were actually paid...

  8. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

    Science.gov (United States)

    Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-09-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  9. Drug interactions with oral sulphonylurea hypoglycaemic drugs.

    Science.gov (United States)

    Hansen, J M; Christensen, L K

    1977-01-01

    The effect of the oral sulphonylurea hypoglycaemic drugs may be influenced by a large number of other drugs. Some of these combinations (e.g. phenylbutazone, sulphaphenazole) may result in cases of severe hypoglycaemic collapse. Tolbutamide and chlorpropamide should never be given to a patient without a prior careful check of which medicaments are already being given. Similarly, no drug should be given to a diabetic treated with tolbutamide and chlorpropamide without consideration of the possibility of interaction phenomena.

  10. Who benefits?

    DEFF Research Database (Denmark)

    Hjorth, Frederik Georg

    2016-01-01

    Cross-border welfare rights for citizens of European Union member states are intensely contested, yet there is limited research into voter opposition to such rights, sometimes denoted ‘welfare chauvinism’. We highlight an overlooked aspect in scholarly work: the role of stereotypes about benefici...... recipient identity. These effects are strongest among respondents high in ethnic prejudice and economic conservatism. The findings imply that stereotypes about who benefits from cross-border welfare rights condition public support for those rights....

  11. Quantum steganography using prior entanglement

    International Nuclear Information System (INIS)

    Mihara, Takashi

    2015-01-01

    Steganography is the hiding of secret information within innocent-looking information (e.g., text, audio, image, video, etc.). A quantum version of steganography is a method based on quantum physics. In this paper, we propose quantum steganography by combining quantum error-correcting codes with prior entanglement. In many steganographic techniques, embedding secret messages in error-correcting codes may cause damage to them if the embedded part is corrupted. However, our proposed steganography can separately create secret messages and the content of cover messages. The intrinsic form of the cover message does not have to be modified for embedding secret messages. - Highlights: • Our steganography combines quantum error-correcting codes with prior entanglement. • Our steganography can separately create secret messages and the content of cover messages. • Errors in cover messages do not have affect the recovery of secret messages. • We embed a secret message in the Steane code as an example of our steganography

  12. Quantum steganography using prior entanglement

    Energy Technology Data Exchange (ETDEWEB)

    Mihara, Takashi, E-mail: mihara@toyo.jp

    2015-06-05

    Steganography is the hiding of secret information within innocent-looking information (e.g., text, audio, image, video, etc.). A quantum version of steganography is a method based on quantum physics. In this paper, we propose quantum steganography by combining quantum error-correcting codes with prior entanglement. In many steganographic techniques, embedding secret messages in error-correcting codes may cause damage to them if the embedded part is corrupted. However, our proposed steganography can separately create secret messages and the content of cover messages. The intrinsic form of the cover message does not have to be modified for embedding secret messages. - Highlights: • Our steganography combines quantum error-correcting codes with prior entanglement. • Our steganography can separately create secret messages and the content of cover messages. • Errors in cover messages do not have affect the recovery of secret messages. • We embed a secret message in the Steane code as an example of our steganography.

  13. Prior information in structure estimation

    Czech Academy of Sciences Publication Activity Database

    Kárný, Miroslav; Nedoma, Petr; Khailova, Natalia; Pavelková, Lenka

    2003-01-01

    Roč. 150, č. 6 (2003), s. 643-653 ISSN 1350-2379 R&D Projects: GA AV ČR IBS1075102; GA AV ČR IBS1075351; GA ČR GA102/03/0049 Institutional research plan: CEZ:AV0Z1075907 Keywords : prior knowledge * structure estimation * autoregressive models Subject RIV: BC - Control Systems Theory Impact factor: 0.745, year: 2003 http://library.utia.cas.cz/separaty/historie/karny-0411258.pdf

  14. Long-term health benefits of appetite suppressants remain unproven

    Directory of Open Access Journals (Sweden)

    Francisco José Roma Paumgartten

    2011-12-01

    Full Text Available Because of the increasing prevalence of obesity, prevention and treatment of overweight has become a major public health concern. In addition to diet and exercise, drugs are needed for patients who failed to lose weight with behavioral treatment. The current article aimed to summarize recent concerns on the safety and efficacy of appetite suppressants. Several appetite suppressants have been banned for safety reasons. In 2010, sibutramine was withdrawn from the market because a long-term study showed it increased the risks of cardiovascular events. So far no study with a sufficiently large sample size has demonstrated that appetite suppressants can reduce morbidity and mortality associated with overweight. The withdrawal of sibutramine highlights that guidelines for the evaluation of weight control drugs must be more stringent, and studies on their long-term health benefits are needed prior to their marketing.

  15. Health Conditions Prior to Imprisonment and the Impact of Prison on Health: Views of Detained Women.

    Science.gov (United States)

    Alves, Joana; Maia, Ângela; Teixeira, Filipa

    2016-05-01

    Detained women have certain health conditions prior to incarceration and these conditions can improve, worsen, or remain the same in prison, depending on the prisoner's background, the characteristics of the prison, and the arrest experience. This study investigated the health of detained women and the influence of incarceration from their perspective. Three focus groups were conducted among 15 inmates, and data were analyzed according to thematic analysis procedures. Detainer's health backgrounds varied with regard to their level of health concerns, contact with health services, and health behaviors. A positive influence of incarceration was described by patients with chronic illness, patients with drug addiction, and victims of interpersonal violence. Among women with mental illnesses or those without previous health problems, reports do not reveal benefits of imprisonment for mental health. These data emphasize the importance of specialized health care and the need to invest in mental health care in corrective institutions. © The Author(s) 2015.

  16. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    Science.gov (United States)

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  17. The Complex Nature of Parental Substance Use: Examining Past Year and Prior Use Behaviors as Correlates of Child Maltreatment Frequency.

    Science.gov (United States)

    Kepple, Nancy Jo

    2017-05-12

    Child maltreatment studies predominantly have operationalized parental substance use as dichotomous variables for any use, any harmful/risky use, or any substance use disorder (SUD). This limits our understanding about how a range of use behaviors may contribute to child maltreatment. Build upon prior studies by incorporating a multi-faceted approach to operationalizing parental substance use. Cross-sectional, secondary data analyses were conducted using the National Survey of Child and Adolescent Well-being (NSCAW I). The study used weighted negative binomial regression to examine relationships between annual child maltreatment frequency and different ways of operationalizing substance use among 2,100 parents. Several, inter-related behaviors (i.e., heavy drinking, illicit drug use, polysubstance use, SUD, and prior SUD child maltreatment frequencies. A gradient effect was detected across five substance use behavior patterns: (1) lowest estimated counts were observed for nonusers, light-to-moderate drinkers, and parents with a prior (but not past year) SUD (ӯ child harm. Parents reporting risky substance use behaviors may benefit from prevention or brief intervention services related to both their substance use and parenting behaviors. Administrative systems also could benefit from detailed tracking of substance use behaviors for future program evaluation and development.

  18. Confusing the drug facts on one nonprescription drug label with those on another: The Drug Facts Label as a text schema

    Directory of Open Access Journals (Sweden)

    Michael P Ryan

    2016-04-01

    Full Text Available The Drug Facts Label is designed to guide consumers in comparing nonprescription drugs. Undergraduates studied and recalled drug facts for three analgesic or non-analgesic labels using Drug Facts Label headings as retrieval cues. They then studied and recalled drug facts from an aspirin label. Aspirin recall was greater when the prior labels were analgesics, but prior-label intrusion errors were also greater. These two effects were associated with the number of prior drug labels on which facilitating and interfering drug facts appeared. Using the Drug Facts Label schema to read drug labels can both enhance and degrade the recall of nonprescription drug facts.

  19. Benefit-Risk Assessment in Drug Development

    DEFF Research Database (Denmark)

    Sarac, Sinan

    developed, tested and used. Standardised diagrams for the visualisation of results from the assessment have been established, and different diagrams have been developed for different scenarios. For the visualisation of results from single and/or multiple similar trial assessments, tornado-like diagrams were...

  20. Projecting future drug expenditures--2009.

    Science.gov (United States)

    Hoffman, James M; Shah, Nilay D; Vermeulen, Lee C; Doloresco, Fred; Martin, Patrick K; Blake, Sharon; Matusiak, Linda; Hunkler, Robert J; Schumock, Glen T

    2009-02-01

    Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures.

  1. Academic Drug Discovery Centres

    DEFF Research Database (Denmark)

    Kirkegaard, Henriette Schultz; Valentin, Finn

    2014-01-01

    Academic drug discovery centres (ADDCs) are seen as one of the solutions to fill the innovation gap in early drug discovery, which has proven challenging for previous organisational models. Prior studies of ADDCs have identified the need to analyse them from the angle of their economic...

  2. Food-Drug Interactions

    Directory of Open Access Journals (Sweden)

    Arshad Yar Khan

    2011-03-01

    Full Text Available The effect of drug on a person may be different than expected because that drug interacts with another drug the person is taking (drug-drug interaction, food, beverages, dietary supplements the person is consuming (drug-nutrient/food interaction or another disease the person has (drug-disease interaction. A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substances. Regarding food-drug interactions physicians and pharmacists recognize that some foods and drugs, when taken simultaneously, can alter the body's ability to utilize a particular food or drug, or cause serious side effects. Clinically significant drug interactions, which pose potential harm to the patient, may result from changes in pharmaceutical, pharmacokinetic, or pharmacodynamic properties. Some may be taken advantage of, to the benefit of patients, but more commonly drug interactions result in adverse drug events. Therefore it is advisable for patients to follow the physician and doctors instructions to obtain maximum benefits with least fooddrug interactions. The literature survey was conducted by extracting data from different review and original articles on general or specific drug interactions with food. This review gives information about various interactions between different foods and drugs and will help physicians and pharmacists prescribe drugs cautiously with only suitable food supplement to get maximum benefit for the patient.

  3. Drug Facts

    Medline Plus

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

  4. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... HIV Learn the Link - Drugs and HIV ... Drugs can change the way the brain works, disrupting the parts of the brain that people use to weigh risks and benefits when making decisions. ...

  5. Generalized multiple kernel learning with data-dependent priors.

    Science.gov (United States)

    Mao, Qi; Tsang, Ivor W; Gao, Shenghua; Wang, Li

    2015-06-01

    Multiple kernel learning (MKL) and classifier ensemble are two mainstream methods for solving learning problems in which some sets of features/views are more informative than others, or the features/views within a given set are inconsistent. In this paper, we first present a novel probabilistic interpretation of MKL such that maximum entropy discrimination with a noninformative prior over multiple views is equivalent to the formulation of MKL. Instead of using the noninformative prior, we introduce a novel data-dependent prior based on an ensemble of kernel predictors, which enhances the prediction performance of MKL by leveraging the merits of the classifier ensemble. With the proposed probabilistic framework of MKL, we propose a hierarchical Bayesian model to learn the proposed data-dependent prior and classification model simultaneously. The resultant problem is convex and other information (e.g., instances with either missing views or missing labels) can be seamlessly incorporated into the data-dependent priors. Furthermore, a variety of existing MKL models can be recovered under the proposed MKL framework and can be readily extended to incorporate these priors. Extensive experiments demonstrate the benefits of our proposed framework in supervised and semisupervised settings, as well as in tasks with partial correspondence among multiple views.

  6. Anticipatory parental care: acquiring resources for offspring prior to conception.

    OpenAIRE

    Boutin, S; Larsen, K W; Berteaux, D

    2000-01-01

    Many organisms acquire and defend resources outside the breeding season and this is thought to be for immediate survival and reproductive benefits. Female red squirrels (Tamiasciurus hudsonicus) acquire traditional food cache sites up to four months prior to the presence of any physiological or behavioural cues associated with mating or offspring dependency. They subsequently relinquish these resources to one of their offspring at independence (ten months later). We experimentally show that a...

  7. 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 ...

  8. 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 ...

  9. 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 ...

  10. Divergent Priors and well Behaved Bayes Factors

    NARCIS (Netherlands)

    R.W. Strachan (Rodney); H.K. van Dijk (Herman)

    2011-01-01

    textabstractDivergent priors are improper when defined on unbounded supports. Bartlett's paradox has been taken to imply that using improper priors results in ill-defined Bayes factors, preventing model comparison by posterior probabilities. However many improper priors have attractive properties

  11. Impacts of Generic Competition and Benefit Management...

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to findings reported in Impacts of Generic Competition and Benefit Management Practices on Spending for Prescription Drugs - Evidence from Medicares Part D...

  12. [The costs of new drugs compared to current standard treatment].

    Science.gov (United States)

    Ujeyl, Mariam; Schlegel, Claudia; Gundert-Remy, Ursula

    2013-01-01

    Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions. Copyright © 2013. Published by Elsevier GmbH.

  13. Rings in drugs.

    Science.gov (United States)

    Taylor, Richard D; MacCoss, Malcolm; Lawson, Alastair D G

    2014-07-24

    We have analyzed the rings, ring systems, and frameworks in drugs listed in the FDA Orange Book to understand the frequency, timelines, molecular property space, and the application of these rings in different therapeutic areas and target classes. This analysis shows that there are only 351 ring systems and 1197 frameworks in drugs that came onto the market before 2013. Furthermore, on average six new ring systems enter drug space each year and approximately 28% of new drugs contain a new ring system. Moreover, it is very unusual for a drug to contain more than one new ring system and the majority of the most frequently used ring systems (83%) were first used in drugs developed prior to 1983. These observations give insight into the chemical novelty of drugs and potentially efficient ways to assess compound libraries and develop compounds from hit identification to lead optimization and beyond.

  14. Iterated random walks with shape prior

    DEFF Research Database (Denmark)

    Pujadas, Esmeralda Ruiz; Kjer, Hans Martin; Piella, Gemma

    2016-01-01

    the parametric probability density function. Then, random walks is performed iteratively aligning the prior with the current segmentation in every iteration. We tested the proposed approach with natural and medical images and compared it with the latest techniques with random walks and shape priors......We propose a new framework for image segmentation using random walks where a distance shape prior is combined with a region term. The shape prior is weighted by a confidence map to reduce the influence of the prior in high gradient areas and the region term is computed with k-means to estimate....... The experiments suggest that this method gives promising results for medical and natural images....

  15. Drug development: from concept to marketing!

    Science.gov (United States)

    Tamimi, Nihad A M; Ellis, Peter

    2009-01-01

    Drug development is an expensive, long and high-risk business taking 10-15 years and is associated with a high attrition rate. It is driven by medical need, disease prevalence and the likelihood of success. Drug candidate selection is an iterative process between chemistry and biology, refining the molecular properties until a compound suitable for advancing to man is found. Typically, about one in a thousand synthesised compounds is ever selected for progression to the clinic. Prior to administration to humans, the pharmacology and biochemistry of the drug is established using an extensive range of in vitro and in vivo test procedures. It is also a regulatory requirement that the drug is administered to animals to assess its safety. Later-stage animal testing is also required to assess carcinogenicity and effects on the reproductive system. Clinical phases of drug development include phase I in healthy volunteers to assess primarily pharmacokinetics, safety and toleration, phase II in a cohort of patients with the target disease to establish efficacy and dose-response relationship and large-scale phase III studies to confirm safety and efficacy. Experience tells us that approximately only 1 in 10 drugs that start the clinical phase will make it to the market. Each drug must demonstrate safety and efficacy in the intended patient population and its benefits must outweigh its risks before it will be approved by the regulatory agencies. Strict regulatory standards govern the conduct of pre-clinical and clinical trials as well as the manufacturing of pharmaceutical products. The assessment of the new medicinal product's safety continues beyond the initial drug approval through post-marketing monitoring of adverse events. Copyright 2009 S. Karger AG, Basel.

  16. Think It Through: Managing the Benefits and Risks of Medicines

    Science.gov (United States)

    ... Drugs) Think It Through: Managing the Benefits and Risks of Medicines Share Tweet Linkedin Pin it More ... make decisions about the medicines you use. Managing Risk When a medicine's benefits outweigh its known risks, ...

  17. 20 CFR 404.1243 - Use of reporting forms-for wages paid prior to 1987.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Use of reporting forms-for wages paid prior to 1987. 404.1243 Section 404.1243 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE...) Reporting on magnetic tape or other media. After approval by SSA, a State may substitute magnetic tape or...

  18. 21 CFR 610.1 - Tests prior to release required for each lot.

    Science.gov (United States)

    2010-04-01

    ....1 Section 610.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... release required for each lot. No lot of any licensed product shall be released by the manufacturer prior... considered in determining whether or not the test results meet the test objective, except that a test result...

  19. 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 ...

  20. 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, ...

  1. Immunosuppressive drugs and fertility

    OpenAIRE

    Leroy, Clara; Rigot, Jean-Marc; Leroy, Maryse; Decanter, Christine; Le Mapihan, Kristell; Parent, Anne-Sophie; Le Guillou, Anne-Claire; Yakoub-Agha, Ibrahim; Dharancy, Sébastien; Noel, Christian; Vantyghem, Marie-Christine

    2015-01-01

    Immunosuppressive drugs are used in the treatment of inflammatory and autoimmune diseases, as well as in transplantation. Frequently prescribed in young people, these treatments may have deleterious effects on fertility, pregnancy outcomes and the unborn child. This review aims to summarize the main gonadal side effects of immunosuppressants, to detail the effects on fertility and pregnancy of each class of drug, and to provide recommendations on the management of patients who are seen prior ...

  2. Drug Interactions in Clinical Practice | Ohaju-Obodo | Nigerian ...

    African Journals Online (AJOL)

    The existence of numerous drugs available today for clinical management of patients require consideration of their potential interactions - alteration of the effects of one drug by the concurrent or prior administration of one or more drugs (drug-drug interactions). There could also be alteration of the effects of a drug by food ...

  3. Aspirin and the risk of cardiovascular events in atherosclerosis patients with and without prior ischemic events.

    Science.gov (United States)

    Bavry, Anthony A; Elgendy, Islam Y; Elbez, Yedid; Mahmoud, Ahmed N; Sorbets, Emmanuel; Steg, Philippe Gabriel; Bhatt, Deepak L

    2017-09-01

    The benefit of aspirin among patients with stable atherosclerosis without a prior ischemic event is not well defined. Aspirin would be of benefit in outpatients with atherosclerosis with prior ischemic events, but not in those without ischemic events. Subjects from the Reduction of Atherothrombosis for Continued Health registry were divided according to prior ischemic event (n =21 724) vs stable atherosclerosis, but no prior ischemic event (n = 11 872). Analyses were propensity score matched. Aspirin use was updated at each clinic visit and considered as a time-varying covariate. The primary outcome was the first occurrence of cardiovascular death, myocardial infarction, or stroke. In the group with a prior ischemic event, aspirin use was associated with a marginally lower risk of the primary outcome at a median of 41 months (hazard ratio [HR]: 0.81, 95% confidence interval [CI]: 0.65-1.01, P = 0.06). In the group without a prior ischemic event, aspirin use was not associated with a lower risk of the primary outcome at a median of 36 months (HR: 1.03, 95% CI: 0.73-1.45, P = 0.86). In this observational analysis of outpatients with stable atherosclerosis, aspirin was marginally beneficial among patients with a prior ischemic event; however, there was no apparent benefit among those with no prior ischemic event. © 2017 Wiley Periodicals, Inc.

  4. QUANTIFYING BENEFITS FOR COST-BENEFIT ANALYSIS

    OpenAIRE

    Attila GYORGY; Nicoleta VINTILA; Florian GAMAN

    2014-01-01

    Cost Benefit Analysis is one of the most widely used financial tools to select future investment projects in public and private sector. This method is based on comparing costs and benefits in terms of constant prices. While costs are easier to predict and monetize, the benefits should be identified not only in direct relation with the investment, but also widening the sphere of analysis to indirect benefits experienced by the community from the neighbourhood or the whole society. During finan...

  5. Penalised Complexity Priors for Stationary Autoregressive Processes

    KAUST Repository

    Sø rbye, Sigrunn Holbek; Rue, Haavard

    2017-01-01

    The autoregressive (AR) process of order p(AR(p)) is a central model in time series analysis. A Bayesian approach requires the user to define a prior distribution for the coefficients of the AR(p) model. Although it is easy to write down some prior, it is not at all obvious how to understand and interpret the prior distribution, to ensure that it behaves according to the users' prior knowledge. In this article, we approach this problem using the recently developed ideas of penalised complexity (PC) priors. These prior have important properties like robustness and invariance to reparameterisations, as well as a clear interpretation. A PC prior is computed based on specific principles, where model component complexity is penalised in terms of deviation from simple base model formulations. In the AR(1) case, we discuss two natural base model choices, corresponding to either independence in time or no change in time. The latter case is illustrated in a survival model with possible time-dependent frailty. For higher-order processes, we propose a sequential approach, where the base model for AR(p) is the corresponding AR(p-1) model expressed using the partial autocorrelations. The properties of the new prior distribution are compared with the reference prior in a simulation study.

  6. Penalised Complexity Priors for Stationary Autoregressive Processes

    KAUST Repository

    Sørbye, Sigrunn Holbek

    2017-05-25

    The autoregressive (AR) process of order p(AR(p)) is a central model in time series analysis. A Bayesian approach requires the user to define a prior distribution for the coefficients of the AR(p) model. Although it is easy to write down some prior, it is not at all obvious how to understand and interpret the prior distribution, to ensure that it behaves according to the users\\' prior knowledge. In this article, we approach this problem using the recently developed ideas of penalised complexity (PC) priors. These prior have important properties like robustness and invariance to reparameterisations, as well as a clear interpretation. A PC prior is computed based on specific principles, where model component complexity is penalised in terms of deviation from simple base model formulations. In the AR(1) case, we discuss two natural base model choices, corresponding to either independence in time or no change in time. The latter case is illustrated in a survival model with possible time-dependent frailty. For higher-order processes, we propose a sequential approach, where the base model for AR(p) is the corresponding AR(p-1) model expressed using the partial autocorrelations. The properties of the new prior distribution are compared with the reference prior in a simulation study.

  7. 21 CFR 316.23 - Timing of requests for orphan-drug designation; designation of already approved drugs.

    Science.gov (United States)

    2010-04-01

    ...) A sponsor may request orphan-drug designation at any time in the drug development process prior to... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Timing of requests for orphan-drug designation..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ORPHAN DRUGS Designation of an Orphan...

  8. Employee benefits managers' opinions about addiction treatment.

    Science.gov (United States)

    McFarland, Bentson H; Lierman, Walter K; Penner, Norman R; McCamant, Lynn E; Zani, Brigid G

    2003-01-01

    Employee benefits managers arrange addictive disease treatment insurance coverage for the majority of people in the United States but little is known about these decision-makers. Managers were surveyed to learn their opinions about addiction treatment. Subjects were 131 people (61 percent female, 94 percent white, average age 46, average of 14 years in the human resources field). Managers were asked to rank health benefits (physical health, dental, alcohol-drug, vision, mental health, employee assistance program, and pharmaceuticals) on 15 dimensions. Managers ranked alcohol-drug abuse treatment worst on fiveitems and second to the worst on another four of the 15 dimensions. On the item considered most important by the managers, respondents noted that employees often (2.8) ask for improved physical health benefits but rarely do so for alcohol and drug (4.1) benefits (p < .001). Education of workers and payers will be needed to change opinions about treatment of addictive disorders.

  9. Health benefits of particle filtration.

    Science.gov (United States)

    Fisk, W J

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also, reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percentage improvement in health outcomes is typically modest, for example, 7% to 25%. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air. Published 2013. This article is a US Government work and is in the public domain in the USA.

  10. Health Benefits of Particle Filtration

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also, reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percent age improvement in health outcomes is typically modest, for example, 7percent to 25percent. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air.

  11. Health Benefits of Particle Filtration

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percentage improvement in health outcomes is typically modest, e.g., 7percent to 25percent. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air.

  12. Reproducing kernel Hilbert spaces of Gaussian priors

    NARCIS (Netherlands)

    Vaart, van der A.W.; Zanten, van J.H.; Clarke, B.; Ghosal, S.

    2008-01-01

    We review definitions and properties of reproducing kernel Hilbert spaces attached to Gaussian variables and processes, with a view to applications in nonparametric Bayesian statistics using Gaussian priors. The rate of contraction of posterior distributions based on Gaussian priors can be described

  13. Improving Open Access through Prior Learning Assessment

    Science.gov (United States)

    Yin, Shuangxu; Kawachi, Paul

    2013-01-01

    This paper explores and presents new data on how to improve open access in distance education through using prior learning assessments. Broadly there are three types of prior learning assessment (PLAR): Type-1 for prospective students to be allowed to register for a course; Type-2 for current students to avoid duplicating work-load to gain…

  14. Quantitative Evidence Synthesis with Power Priors

    NARCIS (Netherlands)

    Rietbergen, C.|info:eu-repo/dai/nl/322847796

    2016-01-01

    The aim of this thesis is to provide the applied researcher with a practical approach for quantitative evidence synthesis using the conditional power prior that allows for subjective input and thereby provides an alternative tgbgo deal with the difficulties as- sociated with the joint power prior

  15. Health benefits of Moringa oleifera.

    Science.gov (United States)

    Abdull Razis, Ahmad Faizal; Ibrahim, Muhammad Din; Kntayya, Saie Brindha

    2014-01-01

    Phytomedicines are believed to have benefits over conventional drugs and are regaining interest in current research. Moringa oleifera is a multi-purpose herbal plant used as human food and an alternative for medicinal purposes worldwide. It has been identified by researchers as a plant with numerous health benefits including nutritional and medicinal advantages. Moringa oleifera contains essential amino acids, carotenoids in leaves, and components with nutraceutical properties, supporting the idea of using this plant as a nutritional supplement or constituent in food preparation. Some nutritional evaluation has been carried out in leaves and stem. An important factor that accounts for the medicinal uses of Moringa oleifera is its very wide range of vital antioxidants, antibiotics and nutrients including vitamins and minerals. Almost all parts from Moringa can be used as a source for nutrition with other useful values. This mini-review elaborate on details its health benefits.

  16. 21 CFR 1.283 - What happens to food that is imported or offered for import without adequate prior notice?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What happens to food that is imported or offered for import without adequate prior notice? 1.283 Section 1.283 Food and Drugs FOOD AND DRUG... Imported Food Consequences § 1.283 What happens to food that is imported or offered for import without...

  17. Drug-Target Kinetics in Drug Discovery.

    Science.gov (United States)

    Tonge, Peter J

    2018-01-17

    The development of therapies for the treatment of neurological cancer faces a number of major challenges including the synthesis of small molecule agents that can penetrate the blood-brain barrier (BBB). Given the likelihood that in many cases drug exposure will be lower in the CNS than in systemic circulation, it follows that strategies should be employed that can sustain target engagement at low drug concentration. Time dependent target occupancy is a function of both the drug and target concentration as well as the thermodynamic and kinetic parameters that describe the binding reaction coordinate, and sustained target occupancy can be achieved through structural modifications that increase target (re)binding and/or that decrease the rate of drug dissociation. The discovery and deployment of compounds with optimized kinetic effects requires information on the structure-kinetic relationships that modulate the kinetics of binding, and the molecular factors that control the translation of drug-target kinetics to time-dependent drug activity in the disease state. This Review first introduces the potential benefits of drug-target kinetics, such as the ability to delineate both thermodynamic and kinetic selectivity, and then describes factors, such as target vulnerability, that impact the utility of kinetic selectivity. The Review concludes with a description of a mechanistic PK/PD model that integrates drug-target kinetics into predictions of drug activity.

  18. Benefits of Java

    Science.gov (United States)

    ... Wellness Preventing Illness Benefits of Coffee Print Email Benefits of Coffee Reviewed by Taylor Wolfram, MS, RDN, ... your daily cup (or three) provides some health benefits as well. Drinking moderate amounts of coffee (including ...

  19. Benefits of quitting tobacco

    Science.gov (United States)

    ... your risk of many serious health problems . THE BENEFITS OF QUITTING You may enjoy the following when ... about $2,000 a year on cigarettes. HEALTH BENEFITS Some health benefits begin almost immediately. Every week, ...

  20. Electronics Environmental Benefits Calculator

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Electronics Environmental Benefits Calculator (EEBC) was developed to assist organizations in estimating the environmental benefits of greening their purchase,...

  1. Terminology for pregnancy loss prior to viability

    DEFF Research Database (Denmark)

    Kolte, A M; Bernardi, L A; Christiansen, O B

    2015-01-01

    Pregnancy loss prior to viability is common and research in the field is extensive. Unfortunately, terminology in the literature is inconsistent. The lack of consensus regarding nomenclature and classification of pregnancy loss prior to viability makes it difficult to compare study results from...... different centres. In our opinion, terminology and definitions should be based on clinical findings, and when possible, transvaginal ultrasound. With this Early Pregnancy Consensus Statement, it is our goal to provide clear and consistent terminology for pregnancy loss prior to viability....

  2. 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 ...

  3. 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 ...

  4. 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 ...

  5. Drug Facts

    Medline Plus

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

  6. Club Drugs

    Science.gov (United States)

    ... uses. Other uses of these drugs are abuse. Club drugs are also sometimes used as "date rape" drugs, to make someone unable to say no to or fight back against sexual assault. Abusing these drugs can ...

  7. A Simulation of Pell Grant Awards and Costs Using Prior-Prior Year Financial Data

    Science.gov (United States)

    Kelchen, Robert; Jones, Gigi

    2015-01-01

    We examine the likely implications of switching from a prior year (PY) financial aid system, the current practice in which students file the Free Application for Federal Student Aid (FAFSA) using income data from the previous tax year, to prior-prior year (PPY), in which data from two years before enrollment is used. While PPY allows students to…

  8. Prior Authorization of PMDs Demonstration - Status Update

    Data.gov (United States)

    U.S. Department of Health & Human Services — CMS implemented a Prior Authorization process for scooters and power wheelchairs for people with Fee-For-Service Medicare who reside in seven states with high...

  9. Short Report Biochemical derangements prior to emergency ...

    African Journals Online (AJOL)

    MMJ VOL 29 (1): March 2017. Biochemical derangements prior to emergency laparotomy at QECH 55. Malawi Medical Journal 29 (1): March 2017 ... Venepuncture was performed preoperatively for urgent cases, defined as those requiring.

  10. PET image reconstruction using multi-parametric anato-functional priors

    Science.gov (United States)

    Mehranian, Abolfazl; Belzunce, Martin A.; Niccolini, Flavia; Politis, Marios; Prieto, Claudia; Turkheimer, Federico; Hammers, Alexander; Reader, Andrew J.

    2017-08-01

    In this study, we investigate the application of multi-parametric anato-functional (MR-PET) priors for the maximum a posteriori (MAP) reconstruction of brain PET data in order to address the limitations of the conventional anatomical priors in the presence of PET-MR mismatches. In addition to partial volume correction benefits, the suitability of these priors for reconstruction of low-count PET data is also introduced and demonstrated, comparing to standard maximum-likelihood (ML) reconstruction of high-count data. The conventional local Tikhonov and total variation (TV) priors and current state-of-the-art anatomical priors including the Kaipio, non-local Tikhonov prior with Bowsher and Gaussian similarity kernels are investigated and presented in a unified framework. The Gaussian kernels are calculated using both voxel- and patch-based feature vectors. To cope with PET and MR mismatches, the Bowsher and Gaussian priors are extended to multi-parametric priors. In addition, we propose a modified joint Burg entropy prior that by definition exploits all parametric information in the MAP reconstruction of PET data. The performance of the priors was extensively evaluated using 3D simulations and two clinical brain datasets of [18F]florbetaben and [18F]FDG radiotracers. For simulations, several anato-functional mismatches were intentionally introduced between the PET and MR images, and furthermore, for the FDG clinical dataset, two PET-unique active tumours were embedded in the PET data. Our simulation results showed that the joint Burg entropy prior far outperformed the conventional anatomical priors in terms of preserving PET unique lesions, while still reconstructing functional boundaries with corresponding MR boundaries. In addition, the multi-parametric extension of the Gaussian and Bowsher priors led to enhanced preservation of edge and PET unique features and also an improved bias-variance performance. In agreement with the simulation results, the clinical results

  11. Attentional and Contextual Priors in Sound Perception.

    Science.gov (United States)

    Wolmetz, Michael; Elhilali, Mounya

    2016-01-01

    Behavioral and neural studies of selective attention have consistently demonstrated that explicit attentional cues to particular perceptual features profoundly alter perception and performance. The statistics of the sensory environment can also provide cues about what perceptual features to expect, but the extent to which these more implicit contextual cues impact perception and performance, as well as their relationship to explicit attentional cues, is not well understood. In this study, the explicit cues, or attentional prior probabilities, and the implicit cues, or contextual prior probabilities, associated with different acoustic frequencies in a detection task were simultaneously manipulated. Both attentional and contextual priors had similarly large but independent impacts on sound detectability, with evidence that listeners tracked and used contextual priors for a variety of sound classes (pure tones, harmonic complexes, and vowels). Further analyses showed that listeners updated their contextual priors rapidly and optimally, given the changing acoustic frequency statistics inherent in the paradigm. A Bayesian Observer model accounted for both attentional and contextual adaptations found with listeners. These results bolster the interpretation of perception as Bayesian inference, and suggest that some effects attributed to selective attention may be a special case of contextual prior integration along a feature axis.

  12. Varying prior information in Bayesian inversion

    International Nuclear Information System (INIS)

    Walker, Matthew; Curtis, Andrew

    2014-01-01

    Bayes' rule is used to combine likelihood and prior probability distributions. The former represents knowledge derived from new data, the latter represents pre-existing knowledge; the Bayesian combination is the so-called posterior distribution, representing the resultant new state of knowledge. While varying the likelihood due to differing data observations is common, there are also situations where the prior distribution must be changed or replaced repeatedly. For example, in mixture density neural network (MDN) inversion, using current methods the neural network employed for inversion needs to be retrained every time prior information changes. We develop a method of prior replacement to vary the prior without re-training the network. Thus the efficiency of MDN inversions can be increased, typically by orders of magnitude when applied to geophysical problems. We demonstrate this for the inversion of seismic attributes in a synthetic subsurface geological reservoir model. We also present results which suggest that prior replacement can be used to control the statistical properties (such as variance) of the final estimate of the posterior in more general (e.g., Monte Carlo based) inverse problem solutions. (paper)

  13. 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.

  14. Ranking Adverse Drug Reactions With Crowdsourcing

    KAUST Repository

    Gottlieb, Assaf; Hoehndorf, Robert; Dumontier, Michel; Altman, Russ B

    2015-01-01

    Background: There is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs

  15. Matching Judicial Supervision to Clients' Risk Status in Drug Court

    Science.gov (United States)

    Marlowe, Douglas B.; Festinger, David S.; Lee, Patricia A.; Dugosh, Karen L.; Benasutti, Kathleen M.

    2006-01-01

    This article reports outcomes from a program of experimental research evaluating the risk principle in drug courts. Prior studies revealed that participants who were high risk and had (a) antisocial personality disorder or (b) a prior history of drug abuse treatment performed better in drug court when scheduled to attend biweekly judicial status…

  16. Metabolic Benefits of Prior Weight Loss with and without Exercise on Subsequent 6-Month Weight Regain.

    Science.gov (United States)

    Ryan, Alice S; Serra, Monica C; Goldberg, Andrew P

    2018-01-01

    To determine the 6-month follow-up effects after intentional 6-month weight loss alone (WL) and after weight loss with aerobic exercise (AEX + WL) on body composition, glucose metabolism, and cardiovascular disease risk factors in older postmenopausal women and to identify the mechanisms for weight regain. Women (n = 65, BMI > 25 kg/m 2 ) underwent maximal oxygen consumption testing, dual-energy x-ray absorptiometry, computed tomography scans, and oral glucose tolerance tests before and after 6 months of AEX + WL or WL and at 12 months ad libitum follow-up. Insulin sensitivity (M) (hyperinsulinemic-euglycemic clamp) was measured at baseline and 6 months. Thirty WL and thirty-five AEX + WL women completed a follow-up at 12 months. Similar weight loss was observed (-8%) in both groups from 0 to 6 months. Total fat mass, fat-free mass, visceral fat area, subcutaneous abdominal and midthigh fat areas, fasting glucose, insulin levels, homeostatic model assessment of insulin resistance (HOMA-IR), insulin areas under the curve, and triglyceride levels decreased similarly after WL and AEX + WL and remained lower at 12 months than at baseline, despite weight regain at 12 months. Initial M was associated with weight regain (r = -0.40, P < 0.01). Weight regain was related to independent changes in leptin and HOMA-IR from 6 to 12 months in a multiple regression model (r = 0.77, P < 0.0001). Reductions in body fat and improvements in insulin sensitivity after AEX + WL and WL were maintained at 12 months despite modest weight regain. Baseline insulin resistance partially predicted the magnitude of weight regain in postmenopausal women. © 2017 The Obesity Society.

  17. Benefits and challenges of a QSP approach through case study: Evaluation of a hypothetical GLP-1/GIP dual agonist therapy.

    Science.gov (United States)

    Rieger, Theodore R; Musante, Cynthia J

    2016-10-30

    Quantitative Systems Pharmacology (QSP) is an emerging science with increasing application to pharmaceutical research and development paradigms. Through case study we provide an overview of the benefits and challenges of applying QSP approaches to inform program decisions in the early stages of drug discovery and development. Specifically, we describe the use of a type 2 diabetes systems model to inform a No-Go decision prior to lead development for a potential GLP-1/GIP dual agonist program, enabling prioritization of exploratory programs with higher probability of clinical success. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Heuristics as Bayesian inference under extreme priors.

    Science.gov (United States)

    Parpart, Paula; Jones, Matt; Love, Bradley C

    2018-05-01

    Simple heuristics are often regarded as tractable decision strategies because they ignore a great deal of information in the input data. One puzzle is why heuristics can outperform full-information models, such as linear regression, which make full use of the available information. These "less-is-more" effects, in which a relatively simpler model outperforms a more complex model, are prevalent throughout cognitive science, and are frequently argued to demonstrate an inherent advantage of simplifying computation or ignoring information. In contrast, we show at the computational level (where algorithmic restrictions are set aside) that it is never optimal to discard information. Through a formal Bayesian analysis, we prove that popular heuristics, such as tallying and take-the-best, are formally equivalent to Bayesian inference under the limit of infinitely strong priors. Varying the strength of the prior yields a continuum of Bayesian models with the heuristics at one end and ordinary regression at the other. Critically, intermediate models perform better across all our simulations, suggesting that down-weighting information with the appropriate prior is preferable to entirely ignoring it. Rather than because of their simplicity, our analyses suggest heuristics perform well because they implement strong priors that approximate the actual structure of the environment. We end by considering how new heuristics could be derived by infinitely strengthening the priors of other Bayesian models. These formal results have implications for work in psychology, machine learning and economics. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  19. External Prior Guided Internal Prior Learning for Real-World Noisy Image Denoising

    Science.gov (United States)

    Xu, Jun; Zhang, Lei; Zhang, David

    2018-06-01

    Most of existing image denoising methods learn image priors from either external data or the noisy image itself to remove noise. However, priors learned from external data may not be adaptive to the image to be denoised, while priors learned from the given noisy image may not be accurate due to the interference of corrupted noise. Meanwhile, the noise in real-world noisy images is very complex, which is hard to be described by simple distributions such as Gaussian distribution, making real noisy image denoising a very challenging problem. We propose to exploit the information in both external data and the given noisy image, and develop an external prior guided internal prior learning method for real noisy image denoising. We first learn external priors from an independent set of clean natural images. With the aid of learned external priors, we then learn internal priors from the given noisy image to refine the prior model. The external and internal priors are formulated as a set of orthogonal dictionaries to efficiently reconstruct the desired image. Extensive experiments are performed on several real noisy image datasets. The proposed method demonstrates highly competitive denoising performance, outperforming state-of-the-art denoising methods including those designed for real noisy images.

  20. Targeted Memory Reactivation during Sleep Depends on Prior Learning.

    Science.gov (United States)

    Creery, Jessica D; Oudiette, Delphine; Antony, James W; Paller, Ken A

    2015-05-01

    When sounds associated with learning are presented again during slow-wave sleep, targeted memory reactivation (TMR) can produce improvements in subsequent location recall. Here we used TMR to investigate memory consolidation during an afternoon nap as a function of prior learning. Twenty healthy individuals (8 male, 19-23 y old). Participants learned to associate each of 50 common objects with a unique screen location. When each object appeared, its characteristic sound was played. After electroencephalography (EEG) electrodes were applied, location recall was assessed for each object, followed by a 90-min interval for sleep. During EEG-verified slow-wave sleep, half of the sounds were quietly presented over white noise. Recall was assessed 3 h after initial learning. A beneficial effect of TMR was found in the form of higher recall accuracy for cued objects compared to uncued objects when pre-sleep accuracy was used as an explanatory variable. An analysis of individual differences revealed that this benefit was greater for participants with higher pre-sleep recall accuracy. In an analysis for individual objects, cueing benefits were apparent as long as initial recall was not highly accurate. Sleep physiology analyses revealed that the cueing benefit correlated with delta power and fast spindle density. These findings substantiate the use of targeted memory reactivation (TMR) methods for manipulating consolidation during sleep. TMR can selectively strengthen memory storage for object-location associations learned prior to sleep, except for those near-perfectly memorized. Neural measures found in conjunction with TMR-induced strengthening provide additional evidence about mechanisms of sleep consolidation. © 2015 Associated Professional Sleep Societies, LLC.

  1. 20 CFR 439.635 - Drug-free workplace.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Drug-free workplace. 439.635 Section 439.635 Employees' Benefits SOCIAL SECURITY ADMINISTRATION GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 439.635 Drug-free workplace. Drug-free workplace means a site for the...

  2. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Science.gov (United States)

    2013-08-02

    ... made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money... number. Please include the user fee ID number on your check, bank draft, or postal money order and make... Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be sent by a courier that requests a...

  3. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... of the brain that people use to weigh risks and benefits when making decisions. This page connects ... not just injection) can put a person at risk for getting HIV. Drug and alcohol intoxication affect ...

  4. Offending prior to first psychiatric contact

    DEFF Research Database (Denmark)

    Stevens, H; Agerbo, E; Dean, K

    2012-01-01

    There is a well-established association between psychotic disorders and subsequent offending but the extent to which those who develop psychosis might have a prior history of offending is less clear. Little is known about whether the association between illness and offending exists in non-psychot......-psychotic disorders. The aim of this study was to determine whether the association between mental disorder and offending is present prior to illness onset in psychotic and non-psychotic disorders.......There is a well-established association between psychotic disorders and subsequent offending but the extent to which those who develop psychosis might have a prior history of offending is less clear. Little is known about whether the association between illness and offending exists in non...

  5. GENERAL ASPECTS REGARDING THE PRIOR DISCIPLINARY RESEARCH

    Directory of Open Access Journals (Sweden)

    ANDRA PURAN (DASCĂLU

    2012-05-01

    Full Text Available Disciplinary research is the first phase of the disciplinary action. According to art. 251 paragraph 1 of the Labour Code no disciplinary sanction may be ordered before performing the prior disciplinary research.These regulations provide an exception: the sanction of written warning. The current regulations in question, kept from the old regulation, provides a protection for employees against abuses made by employers, since sanctions are affecting the salary or the position held, or even the development of individual employment contract. Thus, prior research of the fact that is a misconduct, before a disciplinary sanction is applied, is an essential condition for the validity of the measure ordered. Through this study we try to highlight some general issues concerning the characteristics, processes and effects of prior disciplinary research.

  6. Bayesian Prior Probability Distributions for Internal Dosimetry

    Energy Technology Data Exchange (ETDEWEB)

    Miller, G.; Inkret, W.C.; Little, T.T.; Martz, H.F.; Schillaci, M.E

    2001-07-01

    The problem of choosing a prior distribution for the Bayesian interpretation of measurements (specifically internal dosimetry measurements) is considered using a theoretical analysis and by examining historical tritium and plutonium urine bioassay data from Los Alamos. Two models for the prior probability distribution are proposed: (1) the log-normal distribution, when there is some additional information to determine the scale of the true result, and (2) the 'alpha' distribution (a simplified variant of the gamma distribution) when there is not. These models have been incorporated into version 3 of the Bayesian internal dosimetric code in use at Los Alamos (downloadable from our web site). Plutonium internal dosimetry at Los Alamos is now being done using prior probability distribution parameters determined self-consistently from population averages of Los Alamos data. (author)

  7. Priming in implicit memory tasks: prior study causes enhanced discriminability, not only bias.

    Science.gov (United States)

    Zeelenberg, René; Wagenmakers, Eric-Jan M; Raaijmakers, Jeroen G W

    2002-03-01

    R. Ratcliff and G. McKoon (1995, 1996, 1997; R. Ratcliff, D. Allbritton, & G. McKoon, 1997) have argued that repetition priming effects are solely due to bias. They showed that prior study of the target resulted in a benefit in a later implicit memory task. However, prior study of a stimulus similar to the target resulted in a cost. The present study, using a 2-alternative forced-choice procedure, investigated the effect of prior study in an unbiased condition: Both alternatives were studied prior to their presentation in an implicit memory task. Contrary to a pure bias interpretation of priming, consistent evidence was obtained in 3 implicit memory tasks (word fragment completion, auditory word identification, and picture identification) that performance was better when both alternatives were studied than when neither alternative was studied. These results show that prior study results in enhanced discriminability, not only bias.

  8. Prior alcohol use enhances vulnerability to compulsive cocaine self-administration by promoting degradation of HDAC4 and HDAC5

    OpenAIRE

    Griffin, Edmund A.; Melas, Philippe A.; Zhou, Royce; Li, Yang; Mercado, Peter; Kempadoo, Kimberly A.; Stephenson, Stacy; Colnaghi, Luca; Taylor, Kathleen; Hu, Mei-Chen; Kandel, Eric R.; Kandel, Denise B.

    2017-01-01

    Addiction to cocaine is commonly preceded by experiences with legal or decriminalized drugs, such as alcohol, nicotine, and marijuana. The biological mechanisms by which these gateway drugs contribute to cocaine addiction are only beginning to be understood. We report that in the rat, prior alcohol consumption results in enhanced addiction-like behavior to cocaine, including continued cocaine use despite aversive consequences. Conversely, prior cocaine use has no effect on alcohol preference....

  9. Can natural selection encode Bayesian priors?

    Science.gov (United States)

    Ramírez, Juan Camilo; Marshall, James A R

    2017-08-07

    The evolutionary success of many organisms depends on their ability to make decisions based on estimates of the state of their environment (e.g., predation risk) from uncertain information. These decision problems have optimal solutions and individuals in nature are expected to evolve the behavioural mechanisms to make decisions as if using the optimal solutions. Bayesian inference is the optimal method to produce estimates from uncertain data, thus natural selection is expected to favour individuals with the behavioural mechanisms to make decisions as if they were computing Bayesian estimates in typically-experienced environments, although this does not necessarily imply that favoured decision-makers do perform Bayesian computations exactly. Each individual should evolve to behave as if updating a prior estimate of the unknown environment variable to a posterior estimate as it collects evidence. The prior estimate represents the decision-maker's default belief regarding the environment variable, i.e., the individual's default 'worldview' of the environment. This default belief has been hypothesised to be shaped by natural selection and represent the environment experienced by the individual's ancestors. We present an evolutionary model to explore how accurately Bayesian prior estimates can be encoded genetically and shaped by natural selection when decision-makers learn from uncertain information. The model simulates the evolution of a population of individuals that are required to estimate the probability of an event. Every individual has a prior estimate of this probability and collects noisy cues from the environment in order to update its prior belief to a Bayesian posterior estimate with the evidence gained. The prior is inherited and passed on to offspring. Fitness increases with the accuracy of the posterior estimates produced. Simulations show that prior estimates become accurate over evolutionary time. In addition to these 'Bayesian' individuals, we also

  10. Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

    Science.gov (United States)

    Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y

    2018-02-01

    The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

  11. 20 CFR 404.1267 - Failure to make timely payments-for wages paid prior to 1987.

    Science.gov (United States)

    2010-04-01

    ... Governments If A State Fails to Make Timely Payments-for Wages Paid Prior to 1987 § 404.1267 Failure to make... to the State under the other provision of the Social Security Act. [53 FR 32976, Aug. 29, 1988, as... paid prior to 1987. 404.1267 Section 404.1267 Employees' Benefits SOCIAL SECURITY ADMINISTRATION...

  12. 19 CFR 351.518 - Exemption, remission, or deferral upon export of prior-stage cumulative indirect taxes.

    Science.gov (United States)

    2010-04-01

    ... prior-stage cumulative indirect taxes. 351.518 Section 351.518 Customs Duties INTERNATIONAL TRADE... indirect taxes. (a) Benefit—(1) Exemption of prior-stage cumulative indirect taxes. In the case of a... production of an exported product, a benefit exists to the extent that the exemption extends to inputs that...

  13. Benefits of Exercise

    Science.gov (United States)

    ... activity into your life. To get the most benefit, you should try to get the recommended amount ... likely even live longer. What are the health benefits of exercise? Regular exercise and physical activity may ...

  14. Medicare Hospice Benefits

    Science.gov (United States)

    CENTERS for MEDICARE & MEDICAID SERVICES Medicare Hospice Benefits This official government booklet includes information about Medicare hospice benefits: Who’s eligible for hospice care What services are included in hospice care How ...

  15. Employee motivation and benefits

    OpenAIRE

    Březíková, Tereza

    2009-01-01

    The topic of my bachelor's thesis is the employee motivation and benefits. The thesis is divided in two parts, a theoretical one and a practical one. The theoretical part deals with the theory of motivation and individual employee benefits. The practical part describes employee benefits in ČSOB, where I did my research by questionnaires that were filled in by employees from different departments of ČSOB. These employees answered questions about their work motivation and benefits. The resultts...

  16. Analysis of benefits

    OpenAIRE

    Kováříková, Kamila

    2012-01-01

    This master thesis deals with employee benefits in the current labour market, especially from the perspective of young employees. The first part is focused on the theory of motivation and employee benefits also with their tax impact on employee's income. Employee benefits in the current labour market, employee's satisfaction and employer's attitude to this issue are analyzed in the second part of this thesis.

  17. Drug allergies

    Science.gov (United States)

    Allergic reaction - drug (medication); Drug hypersensitivity; Medication hypersensitivity ... A drug allergy involves an immune response in the body that produces an allergic reaction to a medicine. The first time ...

  18. Study Drugs

    Science.gov (United States)

    ... to quit, they may have withdrawal symptoms like depression, thoughts of suicide, intense drug cravings, sleep problems, and fatigue. The health risks aren't the only downside to study drugs. Students caught with illegal prescription drugs may get suspended ...

  19. Drug Facts

    Medline Plus

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

  20. Drug Facts

    Medline Plus

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

  1. Drug Reactions

    Science.gov (United States)

    ... problem is interactions, which may occur between Two drugs, such as aspirin and blood thinners Drugs and food, such as statins and grapefruit Drugs and supplements, such as ginkgo and blood thinners ...

  2. Drug Facts

    Science.gov (United States)

    ... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

  3. Recognition of Prior Learning: The Participants' Perspective

    Science.gov (United States)

    Miguel, Marta C.; Ornelas, José H.; Maroco, João P.

    2016-01-01

    The current narrative on lifelong learning goes beyond formal education and training, including learning at work, in the family and in the community. Recognition of prior learning is a process of evaluation of those skills and knowledge acquired through life experience, allowing them to be formally recognized by the qualification systems. It is a…

  4. Validity in assessment of prior learning

    DEFF Research Database (Denmark)

    Wahlgren, Bjarne; Aarkrog, Vibe

    2015-01-01

    , the article discusses the need for specific criteria for assessment. The reliability and validity of the assessment procedures depend on whether the competences are well-defined, and whether the teachers are adequately trained for the assessment procedures. Keywords: assessment, prior learning, adult...... education, vocational training, lifelong learning, validity...

  5. PET reconstruction via nonlocal means induced prior.

    Science.gov (United States)

    Hou, Qingfeng; Huang, Jing; Bian, Zhaoying; Chen, Wufan; Ma, Jianhua

    2015-01-01

    The traditional Bayesian priors for maximum a posteriori (MAP) reconstruction methods usually incorporate local neighborhood interactions that penalize large deviations in parameter estimates for adjacent pixels; therefore, only local pixel differences are utilized. This limits their abilities of penalizing the image roughness. To achieve high-quality PET image reconstruction, this study investigates a MAP reconstruction strategy by incorporating a nonlocal means induced (NLMi) prior (NLMi-MAP) which enables utilizing global similarity information of image. The present NLMi prior approximates the derivative of Gibbs energy function by an NLM filtering process. Specially, the NLMi prior is obtained by subtracting the current image estimation from its NLM filtered version and feeding the residual error back to the reconstruction filter to yield the new image estimation. We tested the present NLMi-MAP method with simulated and real PET datasets. Comparison studies with conventional filtered backprojection (FBP) and a few iterative reconstruction methods clearly demonstrate that the present NLMi-MAP method performs better in lowering noise, preserving image edge and in higher signal to noise ratio (SNR). Extensive experimental results show that the NLMi-MAP method outperforms the existing methods in terms of cross profile, noise reduction, SNR, root mean square error (RMSE) and correlation coefficient (CORR).

  6. Prior learning assessment and quality assurance practice ...

    African Journals Online (AJOL)

    The use of RPL (Recognition of Prior Learning) in higher education to assess RPL candidates for admission into programmes of study met with a lot of criticism from faculty academics. Lecturers viewed the possibility of admitting large numbers of under-qualified adult learners, as a threat to the institution's reputation, or an ...

  7. Action priors for learning domain invariances

    CSIR Research Space (South Africa)

    Rosman, Benjamin S

    2015-04-01

    Full Text Available behavioural invariances in the domain, by identifying actions to be prioritised in local contexts, invariant to task details. This information has the effect of greatly increasing the speed of solving new problems. We formalise this notion as action priors...

  8. Unemployment Benefit Exhaustion: Incentive Effects on Job-Finding Rates

    Science.gov (United States)

    Filges, Trine; Geerdsen, Lars Pico; Knudsen, Anne-Sofie Due; Jørgensen, Anne-Marie Klint

    2015-01-01

    Purpose: This systematic review studied the impact of exhaustion of unemployment benefits on the exit rate out of unemployment and into employment prior to benefit exhaustion or shortly thereafter. Method: We followed Campbell Collaboration guidelines to prepare this review, and ultimately located 12 studies for final analysis and interpretation.…

  9. The Production Effect: Costs and Benefits in Free Recall

    Science.gov (United States)

    Jones, Angela C.; Pyc, Mary A.

    2014-01-01

    The production effect, the memorial benefit for information read aloud versus silently, has been touted as a simple memory improvement tool. The current experiments were designed to evaluate the relative costs and benefits of production using a free recall paradigm. Results extend beyond prior work showing a production effect only when production…

  10. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... brain that people use to weigh risks and benefits when making decisions. This page connects you to information about the ... brain that people use to weigh risks and benefits when making decisions. Watch the "Send the Message About Drugs and ...

  11. Diabetes Drugs and Cardiovascular Safety

    Directory of Open Access Journals (Sweden)

    Ji Cheol Bae

    2016-06-01

    Full Text Available Diabetes is a well-known risk factor of cardiovascular morbidity and mortality, and the beneficial effect of improved glycemic control on cardiovascular complications has been well established. However, the rosiglitazone experience aroused awareness of potential cardiovascular risk associated with diabetes drugs and prompted the U.S. Food and Drug Administration to issue new guidelines about cardiovascular risk. Through postmarketing cardiovascular safety trials, some drugs demonstrated cardiovascular benefits, while some antidiabetic drugs raised concern about a possible increased cardiovascular risk associated with drug use. With the development of new classes of drugs, treatment options became wider and the complexity of glycemic management in type 2 diabetes has increased. When choosing the appropriate treatment strategy for patients with type 2 diabetes at high cardiovascular risk, not only the glucose-lowering effects, but also overall benefits and risks for cardiovascular disease should be taken into consideration.

  12. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... in the spread of HIV infection in the United States. Drugs can change the way the brain works, disrupting the parts of the brain that people use to weigh risks and benefits when making decisions. This page connects you to information about the link between drug misuse and HIV ...

  13. 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

  14. Benefícios de técnicas cognitivocomportamentais em terapia de grupo para o uso indevido de álcool e drogas Benefits of cognitive behavior techniques in group therapy for alcohol and drug abuse

    Directory of Open Access Journals (Sweden)

    Ana Carolina Robbe Mathias

    2007-01-01

    Full Text Available A entrevista motivacional e a prevenção de recaída são abordagens de tratamento para pessoas com problemas relativos ao uso indevido de álcool e drogas. Neste trabalho, apresentamos o caso de um paciente demonstrando a utilização das duas abordagens associadas em tratamento em grupo e descrevemos o uso das técnicas, as várias etapas do tratamento e os resultados alcançados. São discutidos os resultados encontrados e as vantagens das técnicas.Motivational Interviewing and relapse prevention are treatment approaches for individuals with alcohol or drug abuse problems. This article describes a group therapy treatment case, showing the association of both techniques. Each step of the treatment techniques is demonstrated and exemplified as long as their results. Results and advantages of the techniques are discussed.

  15. 20 CFR 404.1284 - Offsetting underpayments against overpayments-for wages paid prior to 1987.

    Science.gov (United States)

    2010-04-01

    ... fails to make adjustment for allowance of credit. If SSA notifies a State that a credit is due the State... opportunity to make the adjustment. (b) State fails to make adjustment for underpayment of contributions or...-for wages paid prior to 1987. 404.1284 Section 404.1284 Employees' Benefits SOCIAL SECURITY...

  16. 20 CFR 404.1292 - How to request review-for wages paid prior to 1987.

    Science.gov (United States)

    2010-04-01

    ... 1987. 404.1292 Section 404.1292 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE... Review of Decisions on Credits, Refunds, Or Assessments-for Wages Paid Prior to 1987 § 404.1292 How to... disallowance being questioned; (2) Describe the specific issue on which the review is requested; (3) Contain...

  17. 21 CFR 1.281 - What information must be in a prior notice?

    Science.gov (United States)

    2010-04-01

    ... by truck, bus, or rail, the trip number; (v) For food arriving as containerized cargo by water, air... arrived by truck, bus, or rail, the trip number; (v) For food that arrived as containerized cargo by water... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What information must be in a prior notice? 1.281...

  18. A Qualitative Study of Vape Shop Operators' Perceptions of Risks and Benefits of E-Cigarette Use and Attitude Toward Their Potential Regulation by the US Food and Drug Administration, Florida, Georgia, South Carolina, or North Carolina, 2015.

    Science.gov (United States)

    Nayak, Pratibha; Kemp, Catherine B; Redmon, Pamela

    2016-05-19

    Approximately 8,500 vape shops in the United States sell a variety of electronic nicotine delivery systems (ENDS). This study examined vape shop operators' perceptions of benefits and risk of ENDS use, what they perceive to be the reasons for ENDS use, their source of product information, what information they shared with customers, and the impact of existing and future regulation of ENDS on its use and on their business. We conducted qualitative interviews with 20 vape shop operators located in Florida, Georgia, South Carolina, and North Carolina in spring 2015. A semi-structured interview guide was used, and interviews were audio-recorded and transcribed verbatim. The transcripts were analyzed using NVIVO software. Vape shop owners perceived ENDS to be less harmful and more economical than conventional cigarettes and indicated that most of their customers used ENDS as a smoking cessation tool. Most owners were former smokers and used ENDS to quit. Shop owners relied on their personal experiences and the Internet for information, and shared information with customers at point of sale by using the shop's website and social media. Most expressed concern that complying with potential regulations, including banning flavors or tax increases, would jeopardize their business. Some felt that ENDS should not be regulated as tobacco products and felt that big tobacco was behind these proposed regulations. Most owners supported age restrictions and quality controls for e-liquid. Vape shop owners are in a unique position to serve as frontline consumer educators. Interventions should focus on providing them with current information on benefits and risks of ENDS and information on national, state, and local regulations and compliance requirements.

  19. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... 4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from drugs. But she's afraid ...

  1. Random template placement and prior information

    International Nuclear Information System (INIS)

    Roever, Christian

    2010-01-01

    In signal detection problems, one is usually faced with the task of searching a parameter space for peaks in the likelihood function which indicate the presence of a signal. Random searches have proven to be very efficient as well as easy to implement, compared e.g. to searches along regular grids in parameter space. Knowledge of the parameterised shape of the signal searched for adds structure to the parameter space, i.e., there are usually regions requiring to be densely searched while in other regions a coarser search is sufficient. On the other hand, prior information identifies the regions in which a search will actually be promising or may likely be in vain. Defining specific figures of merit allows one to combine both template metric and prior distribution and devise optimal sampling schemes over the parameter space. We show an example related to the gravitational wave signal from a binary inspiral event. Here the template metric and prior information are particularly contradictory, since signals from low-mass systems tolerate the least mismatch in parameter space while high-mass systems are far more likely, as they imply a greater signal-to-noise ratio (SNR) and hence are detectable to greater distances. The derived sampling strategy is implemented in a Markov chain Monte Carlo (MCMC) algorithm where it improves convergence.

  2. Social and clinical predictors of drug-resistant tuberculosis in a public hospital, Monterrey, Mexico.

    Science.gov (United States)

    Young, Bonnie N; Burgos, Marcos; Handal, Alexis J; Baker, Jack; Rendón, Adrian; Rosas-Taraco, Adrian; Long, Jeffrey; Hunley, Keith

    2014-10-01

    Drug-resistant tuberculosis (DRTB) is steadily increasing in Mexico, but little is known of patient risk factors in the Mexico-United States border region. This preliminary case-control study included 95 patients with active pulmonary TB with drug susceptibility results attending the José E. González University Hospital in the urban hub of Nuevo León-the Monterrey Metropolitan Area. We report potential social and clinical risk factors of DRTB among this hospital-based sample. We collected data through face-to-face interviews and medical record reviews from 25 cases with DRTB and 70 drug-sensitive controls. DNA was collected to assess an effect of genetic ancestry on DRTB by using a panel of 291,917 genomic markers. We calculated crude and multivariate logistic regression. After adjusting for potential confounding factors, we found that prior TB treatment (odds ratio, 4.5; 95% confidence interval, 0.9-21.1) and use of crack cocaine (odds ratio, 4.6; 95% confidence interval, 1.1-18.7) were associated with DRTB. No other variables, including genetic ancestry and comorbidities, were predictive. Health care providers may benefit from recognizing predictors of DRTB in regions where routine drug susceptibility testing is limited. Prior TB treatment and illicit drug use, specifically crack cocaine, may be important risk factors for DRTB in this region. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Analysis of Employee Benefits

    OpenAIRE

    Burešová, Lenka

    2013-01-01

    The target of this bachelor thesis is to analyze employee benefits from the perspective of employees and to employers suggest possible ideas to improve their provision. The work is divided into two parts: theoretical and practical. The theoretical part describes the overal remuneration of employees, payroll system and employee benefits. Benefits are included in the remuneration system, broken and some of them are defined. The practical part presents a survey among employees in the Czech Repub...

  4. 8 CFR 1244.5 - Temporary treatment benefits for eligible aliens.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Temporary treatment benefits for eligible aliens. 1244.5 Section 1244.5 Aliens and Nationality EXECUTIVE OFFICE FOR IMMIGRATION REVIEW, DEPARTMENT... § 1244.5 Temporary treatment benefits for eligible aliens. (a) Prior to the registration period. Prior to...

  5. Childhood emotional abuse, dissociation, and suicidality among patients with drug dependency in Turkey.

    Science.gov (United States)

    Tamar-Gurol, Defne; Sar, Vedat; Karadag, Figen; Evren, Cuneyt; Karagoz, Mustafa

    2008-10-01

    The aim of the present study was to determine the prevalence and correlates of dissociative disorders among patients with drug dependency. The Dissociative Experiences Scale (DES) was used to screen 104 consecutive patients at an addiction treatment center. Thirty-seven patients who had scores >or=30 were compared with 21 patients who scored suicide attempt and/or childhood emotional abuse was significant predictors of a dissociative disorder. The majority (59.3%) of dissociative drug users reported that dissociative experiences had existed prior to substance use. More patients in the dissociative disorder than in the non-dissociative group stopped their treatment prematurely. A considerable proportion of drug users have a dissociative disorder, which may also interfere with treatment process. The relatively young age of this subgroup of patients and frequent reports of childhood emotional abuse underline potential preventive benefits of early intervention among adolescents with developmental trauma history and dissociative psychopathology.

  6. Transit Benefit Program Data -

    Data.gov (United States)

    Department of Transportation — This data set contains information about any US government agency participating in the transit benefits program, funding agreements, individual participating Federal...

  7. Mucoadhesive drug delivery systems

    Directory of Open Access Journals (Sweden)

    Rahamatullah Shaikh

    2011-01-01

    Full Text Available Mucoadhesion is commonly defined as the adhesion between two materials, at least one of which is a mucosal surface. Over the past few decades, mucosal drug delivery has received a great deal of attention. Mucoadhesive dosage forms may be designed to enable prolonged retention at the site of application, providing a controlled rate of drug release for improved therapeutic outcome. Application of dosage forms to mucosal surfaces may be of benefit to drug molecules not amenable to the oral route, such as those that undergo acid degradation or extensive first-pass metabolism. The mucoadhesive ability of a dosage form is dependent upon a variety of factors, including the nature of the mucosal tissue and the physicochemical properties of the polymeric formulation. This review article aims to provide an overview of the various aspects of mucoadhesion, mucoadhesive materials, factors affecting mucoadhesion, evaluating methods, and finally various mucoadhesive drug delivery systems (buccal, nasal, ocular, gastro, vaginal, and rectal.

  8. A drug's life: the pathway to drug approval.

    Science.gov (United States)

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  9. Putting Paid to Benefits

    NARCIS (Netherlands)

    Stella Hoff; Gerda Jehoel-Gijsbers; J.M. Wildeboer Schut

    2003-01-01

    Original title: De uitkering van de baan. A good deal of time, money and effort is invested in the reintegration of benefit claimants. What is the result? How many recipients of disability, unemployment or social assistance benefit are in principle capable of working but are currently not

  10. Nanocosmetics: benefits and risks

    OpenAIRE

    Shokri, Javad

    2017-01-01

    Summary Various nanomaterials/nanoparticles (NPs) have been used for the development of cosmetic products - a field so-called nanocosmetic formulations. These advanced materials offer some benefits, while their utilization in the cosmetic formulations may be associated with some risks. The main aim of this editorial is to highlight the benefits and risks of the nanomaterials used in the cosmetic products.

  11. Who Benefits from Religion?

    Science.gov (United States)

    Mochon, Daniel; Norton, Michael I.; Ariely, Dan

    2011-01-01

    Many studies have documented the benefits of religious involvement. Indeed, highly religious people tend to be healthier, live longer, and have higher levels of subjective well-being. While religious involvement offers clear benefits to many, in this paper we explore whether it may also be detrimental to some. Specifically, we examine in detail…

  12. Wellbeing or welfare benefits

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Kristiansen, Maria; Nørredam, Marie Louise

    2016-01-01

    This debate article debunks the myth that migrants are driven primarily by the size of the welfare benefits in the host country, when they decide where to migrate to. We show that instead of welfare benefits, migrants are driven by a desire for safety, wellbeing, social networks and opportunities...

  13. Quantitative decisions in drug development

    CERN Document Server

    Chuang-Stein, Christy

    2017-01-01

    This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support dru...

  14. Sparse Multivariate Modeling: Priors and Applications

    DEFF Research Database (Denmark)

    Henao, Ricardo

    This thesis presents a collection of statistical models that attempt to take advantage of every piece of prior knowledge available to provide the models with as much structure as possible. The main motivation for introducing these models is interpretability since in practice we want to be able...... a general yet self-contained description of every model in terms of generative assumptions, interpretability goals, probabilistic formulation and target applications. Case studies, benchmark results and practical details are also provided as appendices published elsewhere, containing reprints of peer...

  15. Genome position specific priors for genomic prediction

    DEFF Research Database (Denmark)

    Brøndum, Rasmus Froberg; Su, Guosheng; Lund, Mogens Sandø

    2012-01-01

    casual mutation is different between the populations but affects the same gene. Proportions of a four-distribution mixture for SNP effects in segments of fixed size along the genome are derived from one population and set as location specific prior proportions of distributions of SNP effects...... for the target population. The model was tested using dairy cattle populations of different breeds: 540 Australian Jersey bulls, 2297 Australian Holstein bulls and 5214 Nordic Holstein bulls. The traits studied were protein-, fat- and milk yield. Genotypic data was Illumina 777K SNPs, real or imputed Results...

  16. Models for Validation of Prior Learning (VPL)

    DEFF Research Database (Denmark)

    Ehlers, Søren

    The national policies for the education/training of adults are in the 21st century highly influenced by proposals which are formulated and promoted by The European Union (EU) as well as other transnational players and this shift in policy making has consequences. One is that ideas which in the past...... would have been categorized as utopian can become realpolitik. Validation of Prior Learning (VPL) was in Europe mainly regarded as utopian while universities in the United States of America (USA) were developing ways to obtain credits to those students which was coming with experiences from working life....

  17. Clinical benefits of aspirin desensitization in patients with nonsteroidal anti-inflammatory drug exacerbated respiratory disease are not related to urinary eicosanoid release and are accompanied with decreased urine creatinine.

    Science.gov (United States)

    Makowska, Joanna S; Olszewska-Ziąber, Agnieszka; Bieńkiewicz, Barbara; Lewandowska-Polak, Anna; Kurowski, Marcin; Woźniakowski, Bartłomiej; Rotkiewicz, Arkadiusz; Kowalski, Marek L

    2016-05-01

    Treatment with acetylsalicylic acid (ASA) after desensitization may be a therapeutic option in patients with nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The mechanisms that lead to improvement in rhinosinusitis and asthma symptoms remain unknown. To attribute the documented clinical effects of ASA treatment of chronic rhinosinusitis and/or asthma to the release of eicosanoid metabolites in urine. Fourteen patients with NERD were successfully desensitized, and, eventually, eight patients were treated with 650 mg of ASA daily for 3 months. In addition to clinical assessments, nuclear magnetic resonance imaging and smell test were performed before and after treatment with ASA. Venous blood and urine were collected before desensitization and after 1 and 3 months of treatment. The levels of urinary leukotrienes (LT) (cysteinyl LT and LTE4) and tetranor PGDM (metabolite of prostaglandin D2) were measured by enzyme-linked immunosorbent assay. Treatment with ASA after desensitization alleviated symptoms of rhinosinusitis, improved nasal patency (mean, 50% decrease in peak nasal inspiratory flow) and sense of smell (fourfold increase in smell test score) in as early as 4 weeks. Clinical improvements were not accompanied by any change in sinonasal mucosa thickness as assessed with nuclear magnetic resonance. Urinary cysteinyl LTs, LTE4, and prostaglandin D2 metabolite remained relatively stable during ASA treatment and did not correlate with clinical improvements. Desensitization was associated with a progressive decrease of urinary creatinine. Clinical improvement in rhinosinusitis and/or asthma after ASA desensitization was not related to concentrations of urinary eicosanoid metabolites. A decrease of urinary creatinine requires further study to determine the renal safety of long-term treatment with ASA after desensitization.

  18. Substance use - prescription drugs

    Science.gov (United States)

    Substance use disorder - prescription drugs; Substance abuse - prescription drugs; Drug abuse - prescription drugs; Drug use - prescription drugs; Narcotics - substance use; Opioid - substance use; Sedative - substance ...

  19. The role of radio pharmacological imaging in streamlining the drug development process

    International Nuclear Information System (INIS)

    Campbell, D. B.

    1997-01-01

    Radio imaging techniques have found a place in clinical diagnosis, but there has been a hesitancy to use this approach in drug development. This reluctance may have been due to the availability of ligands, the time and cost of synthesis and the number of centres and for many the benefits are not evident. The use in drug development is potentially large since tomography can measure drug levels, specific binding, blood flow and activity within the human body. In drug discovery, the synthesis of candidate drugs with specific binding properties are dependent on understanding the disease and using appropriate in vitro or animal models. Using small animal tomographs, these can be validated using radio imaging. Pharmacokinetics and metabolic problems, such as the distribution of inhaled gases, drug targeting into tumours of the brain or specific gastrointestinal absorption sites can be investigated within the human rather than relying on animals. The high specific activity allows low doses to be administered to man with limited safety studies permitting kinetic and metabolic studies to be undertaken early in development. Safety studies and ensuing toxicological endpoints in animals rely on histopathology for gross degenerative in physiological function. Where concern exists, radio imaging could detect early in situ changes in humans, for example hepatic toxicity, before they become hazardous. In clinical studies, the action of drugs can be measured directly at the effector site prior to undertaking longer studies, which is important for many diseases, but particularly for those such as Alzheimer's disease, where improvements may be slow or subtle

  20. Psychiatry & the psychedelic drugs. Past, present & future.

    Science.gov (United States)

    Rucker, James J H; Iliff, Jonathan; Nutt, David J

    2017-12-25

    The classical psychedelic drugs, including psilocybin, lysergic acid diethylamide and mescaline, were used extensively in psychiatry before they were placed in Schedule I of the UN Convention on Drugs in 1967. Experimentation and clinical trials undertaken prior to legal sanction suggest that they are not helpful for those with established psychotic disorders and should be avoided in those liable to develop them. However, those with so-called 'psychoneurotic' disorders sometimes benefited considerably from their tendency to 'loosen' otherwise fixed, maladaptive patterns of cognition and behaviour, particularly when given in a supportive, therapeutic setting. Pre-prohibition studies in this area were sub-optimal, although a recent systematic review in unipolar mood disorder and a meta-analysis in alcoholism have both suggested efficacy. The incidence of serious adverse events appears to be low. Since 2006, there have been several pilot trials and randomised controlled trials using psychedelics (mostly psilocybin) in various non-psychotic psychiatric disorders. These have provided encouraging results that provide initial evidence of safety and efficacy, however the regulatory and legal hurdles to licensing psychedelics as medicines are formidable. This paper summarises clinical trials using psychedelics pre and post prohibition, discusses the methodological challenges of performing good quality trials in this area and considers a strategic approach to the legal and regulatory barriers to licensing psychedelics as a treatment in mainstream psychiatry. Copyright © 2017. Published by Elsevier Ltd.

  1. Depth image enhancement using perceptual texture priors

    Science.gov (United States)

    Bang, Duhyeon; Shim, Hyunjung

    2015-03-01

    A depth camera is widely used in various applications because it provides a depth image of the scene in real time. However, due to the limited power consumption, the depth camera presents severe noises, incapable of providing the high quality 3D data. Although the smoothness prior is often employed to subside the depth noise, it discards the geometric details so to degrade the distance resolution and hinder achieving the realism in 3D contents. In this paper, we propose a perceptual-based depth image enhancement technique that automatically recovers the depth details of various textures, using a statistical framework inspired by human mechanism of perceiving surface details by texture priors. We construct the database composed of the high quality normals. Based on the recent studies in human visual perception (HVP), we select the pattern density as a primary feature to classify textures. Upon the classification results, we match and substitute the noisy input normals with high quality normals in the database. As a result, our method provides the high quality depth image preserving the surface details. We expect that our work is effective to enhance the details of depth image from 3D sensors and to provide a high-fidelity virtual reality experience.

  2. Drug Facts

    Medline Plus

    Full Text Available ... abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can ...

  3. Prescription Drugs

    Science.gov (United States)

    ... different competition is going on: the National Football League (NFL) vs. drug use. Read More » 92 Comments ... Future survey highlights drug use trends among the Nation’s youth for marijuana, alcohol, cigarettes, e-cigarettes (e- ...

  4. Drug Facts

    Medline Plus

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

  5. Drug Facts

    Medline Plus

    Full Text Available ... form Search Menu Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts ... addiction, and treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain ...

  6. Drug Facts

    Medline Plus

    Full Text Available ... Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of ... Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1- ...

  7. Drug Control

    Science.gov (United States)

    Leviton, Harvey S.

    1975-01-01

    This article attempts to assemble pertinent information about the drug problem, particularily marihuana. It also focuses on the need for an educational program for drug control with the public schools as the main arena. (Author/HMV)

  8. Drug Facts

    Medline Plus

    Full Text Available ... Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs ... Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call ...

  9. Drug Facts

    Medline Plus

    Full Text Available ... Nicotine Facts Other Drugs of Abuse What is Addiction? What are some signs and symptoms of someone ... use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted ...

  10. Drug Facts

    Medline Plus

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

  11. Drug Facts

    Medline Plus

    Full Text Available ... Home Drugs That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) ... treatment. Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice ( ...

  12. Drug Facts

    Medline Plus

    Full Text Available ... call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I ... The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , the ...

  13. 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 ...

  14. Drug Testing

    Science.gov (United States)

    ... testing, substance abuse testing, toxicology screen, tox screen, sports doping tests What is it used for? Drug screening is used to find out whether or not a person has taken a certain drug or drugs. It ... Sports organizations. Professional and collegiate athletes usually need to ...

  15. Drug Facts

    Medline Plus

    Full Text Available ... to main content Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts ... Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page ...

  16. Drug Facts

    Medline Plus

    Full Text Available ... can call 1-800-662-HELP (4357) at any time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  17. Drug Facts

    Medline Plus

    Full Text Available ... the computer will read the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos ... I want my daughter to avoid drugs. "Debbie" has been drug-free for years. She wants her daughter to stay away from ...

  18. Drug Facts

    Medline Plus

    Full Text Available ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs ... adicción. English Español About the National Institute on Drug Abuse (NIDA) | About This Website Tools and Resources | Contact ...

  19. Drug Facts

    Medline Plus

    Full Text Available ... Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

  1. Cost-effectiveness of bone densitometry among Caucasian women and men without a prior fracture according to age and body weight.

    Science.gov (United States)

    Schousboe, J T; Gourlay, M; Fink, H A; Taylor, B C; Orwoll, E S; Barrett-Connor, E; Melton, L J; Cummings, S R; Ensrud, K E

    2013-01-01

    We used a microsimulation model to estimate the threshold body weights at which screening bone densitometry is cost-effective. Among women aged 55-65 years and men aged 55-75 years without a prior fracture, body weight can be used to identify those for whom bone densitometry is cost-effective. Bone densitometry may be more cost-effective for those with lower body weight since the prevalence of osteoporosis is higher for those with low body weight. Our purpose was to estimate weight thresholds below which bone densitometry is cost-effective for women and men without a prior clinical fracture at ages 55, 60, 65, 75, and 80 years. We used a microsimulation model to estimate the costs and health benefits of bone densitometry and 5 years of fracture prevention therapy for those without prior fracture but with femoral neck osteoporosis (T-score ≤ -2.5) and a 10-year hip fracture risk of ≥3%. Threshold pre-test probabilities of low BMD warranting drug therapy at which bone densitometry is cost-effective were calculated. Corresponding body weight thresholds were estimated using data from the Study of Osteoporotic Fractures (SOF), the Osteoporotic Fractures in Men (MrOS) study, and the National Health and Nutrition Examination Survey (NHANES) for 2005-2006. Assuming a willingness to pay of $75,000 per quality adjusted life year (QALY) and drug cost of $500/year, body weight thresholds below which bone densitometry is cost-effective for those without a prior fracture were 74, 90, and 100 kg, respectively, for women aged 55, 65, and 80 years; and were 67, 101, and 108 kg, respectively, for men aged 55, 75, and 80 years. For women aged 55-65 years and men aged 55-75 years without a prior fracture, body weight can be used to select those for whom bone densitometry is cost-effective.

  2. Extended Linear Models with Gaussian Priors

    DEFF Research Database (Denmark)

    Quinonero, Joaquin

    2002-01-01

    In extended linear models the input space is projected onto a feature space by means of an arbitrary non-linear transformation. A linear model is then applied to the feature space to construct the model output. The dimension of the feature space can be very large, or even infinite, giving the model...... a very big flexibility. Support Vector Machines (SVM's) and Gaussian processes are two examples of such models. In this technical report I present a model in which the dimension of the feature space remains finite, and where a Bayesian approach is used to train the model with Gaussian priors...... on the parameters. The Relevance Vector Machine, introduced by Tipping, is a particular case of such a model. I give the detailed derivations of the expectation-maximisation (EM) algorithm used in the training. These derivations are not found in the literature, and might be helpful for newcomers....

  3. Contraceptives with novel benefits.

    Science.gov (United States)

    Su, Ying; Lian, Qing-Quan; Ge, Ren-Shan

    2012-01-01

    Progesterone receptor (PR) agonists (progestins) and antagonists are developed for female contraceptives. However, non-contraceptive applications of newer progestins and PR modulators are being given more attention. The newer PR agonists including drospirenone, nomegestrol, trimegestone, dienogest and nestorone are being evaluated as contraceptives with health benefits because of their unique pharmacological properties. The selective PR modulators (SPRM; PR antagonists with PR agonistic properties) are under development not only for emergency contraception but also for other health benefits such as the treatment of endometritis and leiomyoma. After searching the literature from PubMed, clinicaltrials.gov and patent database, this review focuses on the effects and mechanisms of these progestins, and SPRMs as contraceptives with other health benefits. PR agonists and antagonists that have novel properties may generate better contraceptive effects with other health benefits.

  4. Benefits of being biased!

    Indian Academy of Sciences (India)

    Administrator

    Journal of Genetics, Vol. 83, No. 2, August 2004. Keywords. codon bias; alcohol dehydrogenase; Darwinian ... RESEARCH COMMENTARY. Benefits of being biased! SUTIRTH DEY*. Evolutionary Biology Laboratory, Evolutionary & Organismal Biology Unit,. Jawaharlal Nehru Centre for Advanced Scientific Research,.

  5. Benefits of CHP Partnership

    Science.gov (United States)

    Learn about the benefits of being a EPA CHP Partner, which include expert advice and answers to questions, CHP news, marketing resources, publicity and recognition, and being associated with EPA through a demonstrated commitment to CHP.

  6. Low Cost Benefit Suggestions.

    Science.gov (United States)

    Doyel, Hoyt W.; McMillan, John D.

    1980-01-01

    Outlines eight low-cost employee benefits and summarizes their relative advantages. The eight include a stock ownership program, a sick leave pool, flexible working hours, production incentives, and group purchase plans. (IRT)

  7. Benefits at risk

    DEFF Research Database (Denmark)

    Lassen, Jesper; Sandøe, Peter

    2007-01-01

    Herbicide resistant GM plants have been promoted as a tool in the development of more environment-friendly agriculture. The environmental benefits here, however, depend not only on farmer's acceptance of GM crops as such, but also on their willingness to use herbicides in accordance with altered ...... spraying plans. In this paper, we will argue that factors driving the spraying practices of Danish farmers may hamper efforts to secure the environmental benefits of the new crops....

  8. Benefits for handicapped children

    CERN Multimedia

    2003-01-01

    The introduction of long-term care benefits within the CERN Health Insurance Scheme requires the coordination of the benefits foreseen for handicapped children. Measures were adopted by the Management following the recommendation made by the Standing Concertation Committee on 26 March 2003. A document clarifying these measures is available on the Web at the following address: http://humanresources.web.cern.ch/humanresources/external/soc/Social_affairs/social_affairs.asp Social Affairs Service 74201

  9. Risks and Benefits of Bisphosphonate Therapies

    DEFF Research Database (Denmark)

    Reyes, Carlen; Hitz, Mette; Prieto-Alhambra, Daniel

    2016-01-01

    -term adverse effects. Some of the adverse effects identified include an increased risk of atypical femur fractures, osteonecrosis of the jaw, gastrointestinal side effects, or atrial fibrillation. The harm/benefit thinking and the constant update regarding these medications are vital in the day-to-day decision-making...... in clinical practices. The aims of this review are to compile the basic characteristics of these drugs and outline the most important benefits and side effects and provide a clinical context as well as a research agenda to fill the gaps in our knowledge....

  10. WAr on DrugS

    African Journals Online (AJOL)

    2009-04-12

    Apr 12, 2009 ... ABStrAct. Since drugs became both a public and social issue in Nigeria, fear about both the real and .... drugs as being morally reprehensible, and ..... tice system (see for instance, Shaw, 1995; ..... A cut throat business:.

  11. Savings for visuomotor adaptation require prior history of error, not prior repetition of successful actions.

    Science.gov (United States)

    Leow, Li-Ann; de Rugy, Aymar; Marinovic, Welber; Riek, Stephan; Carroll, Timothy J

    2016-10-01

    When we move, perturbations to our body or the environment can elicit discrepancies between predicted and actual outcomes. We readily adapt movements to compensate for such discrepancies, and the retention of this learning is evident as savings, or faster readaptation to a previously encountered perturbation. The mechanistic processes contributing to savings, or even the necessary conditions for savings, are not fully understood. One theory suggests that savings requires increased sensitivity to previously experienced errors: when perturbations evoke a sequence of correlated errors, we increase our sensitivity to the errors experienced, which subsequently improves error correction (Herzfeld et al. 2014). An alternative theory suggests that a memory of actions is necessary for savings: when an action becomes associated with successful target acquisition through repetition, that action is more rapidly retrieved at subsequent learning (Huang et al. 2011). In the present study, to better understand the necessary conditions for savings, we tested how savings is affected by prior experience of similar errors and prior repetition of the action required to eliminate errors using a factorial design. Prior experience of errors induced by a visuomotor rotation in the savings block was either prevented at initial learning by gradually removing an oppositely signed perturbation or enforced by abruptly removing the perturbation. Prior repetition of the action required to eliminate errors in the savings block was either deprived or enforced by manipulating target location in preceding trials. The data suggest that prior experience of errors is both necessary and sufficient for savings, whereas prior repetition of a successful action is neither necessary nor sufficient for savings. Copyright © 2016 the American Physiological Society.

  12. Preferred drug lists: Potential impact on healthcare economics

    Directory of Open Access Journals (Sweden)

    Kimberly Ovsag

    2008-04-01

    Full Text Available Kimberly Ovsag, Sabrina Hydery, Shaker A MousaPharmaceutical Research Institute at Albany College of Pharmacy, Albany, New York, USAObjectives: To analyze the implementation of Medicaid preferred drug lists (PDLs in a number of states and determine its impact on quality of care and cost relative to other segments of healthcare.Methods: We reviewed research and case studies found by searching library databases, primarily MEDLINE and EBSCOHost, and searching pertinent journals. Keywords initially included “drug lists,” “prior authorization,” “prior approval,” and “Medicaid.” We added terms such as “influence use of other healthcare services,” “quality of care,” and “overall economic impact.” We mainly used primary sources.Results: Based on our literature review, we determined that there are a number of issues regarding Medicaid PDLs that need to be addressed. Some issues include: (a the potential for PDLs to influence the utilization of other healthcare services, (b criteria used by Medicaid for determining acceptance of drugs onto a PDL, (c the effect of PDL implementation on compliance to new regimens, (d the potential effects of restricting medication availability on quality of care, (e administrative costs associated with PDLs, and (f satisfaction rates among patients and medical providers. This review highlighted expected short-term cost savings with limited degree of compromised quality of PDL implementation, but raised the concern about the potential long-term decline in quality of care and overall economic impact.Conclusions: The number of concerns raised indicates that further studies are warranted regarding both short-term cost benefits as well as potential long-term effects of Medicaid PDL implementation. Objective analysis of these effects is necessary to ensure cost-effectiveness and quality of care.Keywords: preferred drug lists, medicaid, healthcare costs, managed care

  13. Drugs and taste aversion

    International Nuclear Information System (INIS)

    Rondeau, D.B.; Jolicoeur, F.B.; Merkel, A.D.; Wayner, M.J.

    1981-01-01

    The literature on the effects of drugs on the acquisition and the magnitude of taste aversion is reviewed and discussed. Then, the results of a series of experiments on the effects of phenobarbital and related drugs on taste aversion are reported. A standard taste aversion model was used in all experiments; test drugs were injected prior to drinking in a one bottle situation on the first test day following the taste aversion treatment. Phenobarbital in doses ranging from 20 to 80 mg/kg significantly attenuated taste aversion induced by lithium chloride (LiCl) and x-radiation, the maximal effect occurred with the 60 mg/kg dose. The attenuating effect was found to be dependent upon the magnitude of the aversion to the sapid solution. Phenobarbital completely abolished aversion produced by 0.375 mEq LiCl while the attenuation effect decreased linearly with higher doses of LiCl. Results also indicate that phenobarbital's attenuating effect cannot be solely attributed to its dipsogenic characteristic or to its state dependent learning effect. Attenuation of LiCl aversion to a saccharin solution was also observed following single doses of amobarbital, 30 mg/kg, pentobarbital, 15 mg/kg, and chloropromazine, 0.75 mg/kg. Taste aversion was not affected by other doses of those drugs or by hexobarbital, barbital, and chlordiazepoxide. Phenobarbital's attenuating effect on taste aversion is discussed in relation to other known behavioral and neurophysiological effects of the drug

  14. Defined contribution health benefits.

    Science.gov (United States)

    Fronstin, P

    2001-03-01

    This Issue Brief discusses the emerging issue of "defined contribution" (DC) health benefits. The term "defined contribution" is used to describe a wide variety of approaches to the provision of health benefits, all of which have in common a shift in the responsibility for payment and selection of health care services from employers to employees. DC health benefits often are mentioned in the context of enabling employers to control their outlay for health benefits by avoiding increases in health care costs. DC health benefits may also shift responsibility for choosing a health plan and the associated risks of choosing a plan from employers to employees. There are three primary reasons why some employers currently are considering some sort of DC approach. First, they are once again looking for ways to keep their health care cost increases in line with overall inflation. Second, some employers are concerned that the public "backlash" against managed care will result in new legislation, regulations, and litigation that will further increase their health care costs if they do not distance themselves from health care decisions. Third, employers have modified not only most employee benefit plans, but labor market practices in general, by giving workers more choice, control, and flexibility. DC-type health benefits have existed as cafeteria plans since the 1980s. A cafeteria plan gives each employee the opportunity to determine the allocation of his or her total compensation (within employer-defined limits) among various employee benefits (primarily retirement or health). Most types of DC health benefits currently being discussed could be provided within the existing employment-based health insurance system, with or without the use of cafeteria plans. They could also allow employees to purchase health insurance directly from insurers, or they could drive new technologies and new forms of risk pooling through which health care services are provided and financed. DC health

  15. Emerging Frontiers in Drug Delivery.

    Science.gov (United States)

    Tibbitt, Mark W; Dahlman, James E; Langer, Robert

    2016-01-27

    Medicine relies on the use of pharmacologically active agents (drugs) to manage and treat disease. However, drugs are not inherently effective; the benefit of a drug is directly related to the manner by which it is administered or delivered. Drug delivery can affect drug pharmacokinetics, absorption, distribution, metabolism, duration of therapeutic effect, excretion, and toxicity. As new therapeutics (e.g., biologics) are being developed, there is an accompanying need for improved chemistries and materials to deliver them to the target site in the body, at a therapeutic concentration, and for the required period of time. In this Perspective, we provide an historical overview of drug delivery and controlled release followed by highlights of four emerging areas in the field of drug delivery: systemic RNA delivery, drug delivery for localized therapy, oral drug delivery systems, and biologic drug delivery systems. In each case, we present the barriers to effective drug delivery as well as chemical and materials advances that are enabling the field to overcome these hurdles for clinical impact.

  16. Balancing the risks and the benefits.

    Science.gov (United States)

    Klopack

    2000-04-01

    Pharmaceutical research organizations can benefit from outsourcing discovery activities that are not core competencies of the organization. The core competencies for a discovery operation are the expertise and systems that give the organization an advantage over its competition. Successful outsourcing ventures result in cost reduction, increased operation efficiency and optimization of resource allocation. While there are pitfalls to outsourcing, including poor partner selection and inadequate implementation, outsourcing can be a powerful tool for enhancing drug discovery operations.

  17. Putting Priors in Mixture Density Mercer Kernels

    Science.gov (United States)

    Srivastava, Ashok N.; Schumann, Johann; Fischer, Bernd

    2004-01-01

    This paper presents a new methodology for automatic knowledge driven data mining based on the theory of Mercer Kernels, which are highly nonlinear symmetric positive definite mappings from the original image space to a very high, possibly infinite dimensional feature space. We describe a new method called Mixture Density Mercer Kernels to learn kernel function directly from data, rather than using predefined kernels. These data adaptive kernels can en- code prior knowledge in the kernel using a Bayesian formulation, thus allowing for physical information to be encoded in the model. We compare the results with existing algorithms on data from the Sloan Digital Sky Survey (SDSS). The code for these experiments has been generated with the AUTOBAYES tool, which automatically generates efficient and documented C/C++ code from abstract statistical model specifications. The core of the system is a schema library which contains template for learning and knowledge discovery algorithms like different versions of EM, or numeric optimization methods like conjugate gradient methods. The template instantiation is supported by symbolic- algebraic computations, which allows AUTOBAYES to find closed-form solutions and, where possible, to integrate them into the code. The results show that the Mixture Density Mercer-Kernel described here outperforms tree-based classification in distinguishing high-redshift galaxies from low- redshift galaxies by approximately 16% on test data, bagged trees by approximately 7%, and bagged trees built on a much larger sample of data by approximately 2%.

  18. Prior expectations facilitate metacognition for perceptual decision.

    Science.gov (United States)

    Sherman, M T; Seth, A K; Barrett, A B; Kanai, R

    2015-09-01

    The influential framework of 'predictive processing' suggests that prior probabilistic expectations influence, or even constitute, perceptual contents. This notion is evidenced by the facilitation of low-level perceptual processing by expectations. However, whether expectations can facilitate high-level components of perception remains unclear. We addressed this question by considering the influence of expectations on perceptual metacognition. To isolate the effects of expectation from those of attention we used a novel factorial design: expectation was manipulated by changing the probability that a Gabor target would be presented; attention was manipulated by instructing participants to perform or ignore a concurrent visual search task. We found that, independently of attention, metacognition improved when yes/no responses were congruent with expectations of target presence/absence. Results were modeled under a novel Bayesian signal detection theoretic framework which integrates bottom-up signal propagation with top-down influences, to provide a unified description of the mechanisms underlying perceptual decision and metacognition. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Washing of waste prior to landfilling.

    Science.gov (United States)

    Cossu, Raffaello; Lai, Tiziana

    2012-05-01

    The main impact produced by landfills is represented by the release of leachate emissions. Waste washing treatment has been investigated to evaluate its efficiency in reducing the waste leaching fraction prior to landfilling. The results of laboratory-scale washing tests applied to several significant residues from integrated management of solid waste are presented in this study, specifically: non-recyclable plastics from source separation, mechanical-biological treated municipal solid waste and a special waste, automotive shredded residues. Results obtained demonstrate that washing treatment contributes towards combating the environmental impacts of raw wastes. Accordingly, a leachate production model was applied, leading to the consideration that the concentrations of chemical oxygen demand (COD) and total Kjeldahl nitrogen (TKN), parameters of fundamental importance in the characterization of landfill leachate, from a landfill containing washed wastes, are comparable to those that would only be reached between 90 and 220years later in the presence of raw wastes. The findings obtained demonstrated that washing of waste may represent an effective means of reducing the leachable fraction resulting in a consequent decrease in landfill emissions. Further studies on pilot scale are needed to assess the potential for full-scale application of this treatment. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Pitch perception prior to cortical maturation

    Science.gov (United States)

    Lau, Bonnie K.

    Pitch perception plays an important role in many complex auditory tasks including speech perception, music perception, and sound source segregation. Because of the protracted and extensive development of the human auditory cortex, pitch perception might be expected to mature, at least over the first few months of life. This dissertation investigates complex pitch perception in 3-month-olds, 7-month-olds and adults -- time points when the organization of the auditory pathway is distinctly different. Using an observer-based psychophysical procedure, a series of four studies were conducted to determine whether infants (1) discriminate the pitch of harmonic complex tones, (2) discriminate the pitch of unresolved harmonics, (3) discriminate the pitch of missing fundamental melodies, and (4) have comparable sensitivity to pitch and spectral changes as adult listeners. The stimuli used in these studies were harmonic complex tones, with energy missing at the fundamental frequency. Infants at both three and seven months of age discriminated the pitch of missing fundamental complexes composed of resolved and unresolved harmonics as well as missing fundamental melodies, demonstrating perception of complex pitch by three months of age. More surprisingly, infants in both age groups had lower pitch and spectral discrimination thresholds than adult listeners. Furthermore, no differences in performance on any of the tasks presented were observed between infants at three and seven months of age. These results suggest that subcortical processing is not only sufficient to support pitch perception prior to cortical maturation, but provides adult-like sensitivity to pitch by three months.

  1. Febrile seizures prior to sudden cardiac death

    DEFF Research Database (Denmark)

    Stampe, Niels Kjær; Glinge, Charlotte; Jabbari, Reza

    2018-01-01

    Aims: Febrile seizure (FS) is a common disorder affecting 2-5% of children up to 5 years of age. The aim of this study was to determine whether FS in early childhood are over-represented in young adults dying from sudden cardiac death (SCD). Methods and results: We included all deaths (n = 4595...... with FS was sudden arrhythmic death syndrome (5/8; 62.5%). Conclusion: In conclusion, this study demonstrates a significantly two-fold increase in the frequency of FS prior to death in young SCD cases compared with the two control groups, suggesting that FS could potentially contribute in a risk......) nationwide and through review of all death certificates, we identified 245 SCD in Danes aged 1-30 years in 2000-09. Through the usage of nationwide registries, we identified all persons admitted with first FS among SCD cases (14/245; 5.7%) and in the corresponding living Danish population (71 027/2 369 785...

  2. COPD - control drugs

    Science.gov (United States)

    Chronic obstructive pulmonary disease - control drugs; Bronchodilators - COPD - control drugs; Beta agonist inhaler - COPD - control drugs; Anticholinergic inhaler - COPD - control drugs; Long-acting inhaler - COPD - control drugs; ...

  3. Deserving social benefits?

    DEFF Research Database (Denmark)

    Esmark, Anders; Richardt Schoop, Sarah

    2017-01-01

    welfare reforms involving reductions of social benefits in Denmark in 2005 and 2013, the article analyses the frames used by politicians supporting and opposing reform, as well as the frames used by the media. The article shows, first, that political reforms reducing social benefits are followed...... by increased framing of recipients as undeserving. The article finds a strong correlation between the political objective of reducing benefits and the reliance on frames that position recipients as undeserving. Second, the article shows that media framing remains significantly different from political framing......The article contributes to the growing literature on framing of deservingness as an alternative to ‘blame avoidance’ strategies in the politics of welfare retrenchment. In particular, the article focuses on the interplay between political framing and media framing. Based on an analysis of two major...

  4. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty

    DEFF Research Database (Denmark)

    Villadsen, Allan; Overgaard, Søren; Holsgaard-Larsen, Anders

    2014-01-01

    neuromuscular exercise prior to total joint arthroplasty (TJA) of the hip or knee did not confer additional benefits 3 months postoperatively compared with TJA alone. However, the intervention group experienced a statistically significant short-term benefit in ADL and pain, suggesting an earlier onset......OBJECTIVE: To investigate the postoperative efficacy of a supervised programme of neuromuscular exercise prior to hip or knee arthroplasty. METHODS: In this assessor-blinded randomised controlled trial, we included 165 patients scheduled for hip or knee arthroplasty due to severe osteoarthritis (OA......). An 8-week preoperative neuromuscular supervised exercise programme was delivered twice a week for 1 h as adjunct treatment to the standard arthroplasty procedure and compared with the standard arthroplasty procedure alone. The primary outcome was self-reported physical function measured...

  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. Accelerating time to benefit

    DEFF Research Database (Denmark)

    Svejvig, Per; Geraldi, Joana; Grex, Sara

    Despite the ubiquitous pressure for speed, our approaches to accelerate projects remain constrained to the old-fashioned understanding of the project as a vehicle to deliver products and services, not value. This article explores an attempt to accelerate time to benefit. We describe and deconstruct...... of the time. Although all cases valued speed and speed to benefit, and implemented most practices proposed by the methodology, only three of the five projects were more successful in decreasing time to speed. Based on a multi-case study comparison between these five different projects and their respective...

  7. BenefitClaimWebServiceBean/BenefitClaimWebService

    Data.gov (United States)

    Department of Veterans Affairs — A formal or informal request for a type of monetary or non-monetary benefit. This service provides benefit claims and benefit claim special issues data, allows the...

  8. The Economic Side Effects of Dangerous Drug Announcements.

    OpenAIRE

    Dranove, David; Olsen, Chris

    1994-01-01

    Immediately prior to the passage of the 1962 Food and Drug Administration Amendments, there were a number of drugs recalled from markets worldwide. Announcements about the dangerous side effects of these drugs were associated with lower-share prices for their manufacturers and the industry as a whole. We perform several analyses to sort out alternative explanations for the observed declines. We find that dangerous drug announcements had no effect on the sales of other drugs and didn't affect ...

  9. AIDSinfo Drug Database

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content Drugs Home Drugs Find information on FDA-approved HIV/ ... infection drugs and investigational HIV/AIDS drugs. Search Drugs Search drug Search Icon What's this? Close Popup ...

  10. Mature women and the New Zealand qualifications framework. realising the potential of recognising prior learning

    OpenAIRE

    Kamp, Annelies

    2003-01-01

    Against a backtground of 'second-wave' lifelong learning in Aotearoa New Zealand a new framework for post-compulsory national qualfications was introduced. The restulting competency-based system was argued to present a number of benefits for mature women including flexibility in curriculum and delivery and portability across educational sectors. Competency-based education was to include provision for recognition of prior skills and knowledge gained in formal learning environments and the work...

  11. California Drug and Alcohol Treatment Assessment (CALDATA-1991-1993)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The California Drug and Alcohol Treatment Assessment (CALDATA) was designed to study the costs, benefits, and effectiveness of the state's alcohol and drug treatment...

  12. Criminal charges prior to and after initiation of office-based buprenorphine treatment

    Directory of Open Access Journals (Sweden)

    Harris Elizabeth E

    2012-03-01

    Full Text Available Abstract Background There is little data on the impact of office-based buprenorphine therapy on criminal activity. The goal of this study was to determine the impact of primary care clinic-based buprenorphine maintenance therapy on rates of criminal charges and the factors associated with criminal charges in the 2 years after initiation of treatment. Methods We collected demographic and outcome data on 252 patients who were given at least one prescription for buprenorphine. We searched a public database of criminal charges and recorded criminal charges prior to and after enrollment. We compared the total number of criminal cases and drug cases 2 years before versus 2 years after initiation of treatment. Results There was at least one criminal charge made against 38% of the subjects in the 2 years after initiation of treatment; these subjects were more likely to have used heroin, to have injected drugs, to have had any prior criminal charges, and recent criminal charges. There was no significant difference in the number of subjects with any criminal charge or a drug charge before and after initiation of treatment. Likewise, the mean number of all cases and drug cases was not significantly different between the two periods. However, among those who were opioid-negative for 6 or more months in the first year of treatment, there was a significant decline in criminal cases. On multivariable analysis, having recent criminal charges was significantly associated with criminal charges after initiation of treatment (adjusted odds ratio 3.92; subjects who were on opioid maintenance treatment prior to enrollment were significantly less likely to have subsequent criminal charges (adjusted odds ratio 0.52. Conclusions Among subjects with prior criminal charges, initiation of office-based buprenorphine treatment did not appear to have a significant impact on subsequent criminal charges.

  13. PENSION FUND BENEFITS SERVICE

    CERN Multimedia

    Benefits Service

    2002-01-01

    Please note that from now on, our offices (5-1-030) will be opened to members and beneficiaries on Tuesday, Wednesday and Thursday from 10 to 12 a.m. and from 3 to 5 p.m. We are otherwise available but by appointment only. Benefits Service (tel. 79194 / 72738)

  14. PENSION FUND BENEFITS SERVICE

    CERN Multimedia

    Benefits Service

    2002-01-01

    Please note that from now on, our offices will be opened to members and beneficiaries on Tuesday, Wednesday and Thursday from 10 to 12 a.m. and from 3 to 5 p.m. We are otherwise available but by appointment only. Benefits Service 5-1-030 tel. 79194 / 72738

  15. Bayesian benefits with JASP

    NARCIS (Netherlands)

    Marsman, M.; Wagenmakers, E.-J.

    2017-01-01

    We illustrate the Bayesian approach to data analysis using the newly developed statistical software program JASP. With JASP, researchers are able to take advantage of the benefits that the Bayesian framework has to offer in terms of parameter estimation and hypothesis testing. The Bayesian

  16. Studies Highlight Biodiesel's Benefits

    Science.gov (United States)

    , Colo., July 6, 1998 — Two new studies highlight the benefits of biodiesel in reducing overall air Energy's National Renewable Energy Laboratory (NREL) conducted both studies: An Overview of Biodiesel and Petroleum Diesel Life Cycles and Biodiesel Research Progress, 1992-1997. Biodiesel is a renewable diesel

  17. Your Medicare Benefits

    Science.gov (United States)

    ... schedule a lung cancer screening counseling and shared decision making visit with your doctor to discuss the benefits ... when they’re available in your MyMedicare.gov account. 58 Section 3: For more information Visit Medicare. gov for general information about Medicare ...

  18. Neuropharmacological Consequences of Variant Drugs

    Directory of Open Access Journals (Sweden)

    Mahnoor Amjad Butt

    2017-11-01

    Full Text Available Neuropharmacological effects deals with the influence of drugs on nervous system which harvest the changes in mood, behavioral action of an individual. The drugs are characterized by the chemical substances that communicate with the neurons which have different impacts on nervous system. It may either conducts the abusive or pleasure response which depends on the neural chemicals activity and concerns with the licit and illicit drugs. The elucidation of drugs via LC/MS shows its exertion on the brain components. The computational model helps in the identification of signaling pathways that trigger or inhibit the neurotransmitters. The licit drugs have indisputable responses on CNS. It imparts neuroprotection by either stimulating or inhibiting the receptor, by down regulation yield antinociceptors. However, the illicit drugs have negative acknowledgment on the body as in nicotine the fewer amounts provides benefits but in higher amount mimics the activity of brain receptors and replaces it. Many other drugs induce neurodegenerative disorders. Due to advances in field of neuropharmacology innumerable drugs are available for feasible treatment. The main objective of this review is neuropharmacological consequences in correlation to licit and illicit drugs that what type of responses generated by using these drugs, the neurodegenerative disorders, and their restoration via current treatment.

  19. Projected benefits of actinide partitioning

    International Nuclear Information System (INIS)

    Braun, C.; Goldstein, M.

    1976-05-01

    Possible benefits that could accrue from actinide separation and transmutations are presented. The time frame for implementing these processes is discussed and the expected benefits are qualitatively described. These benefits are provisionally quantified in a sample computation

  20. Social Security and Medicare Benefits

    Data.gov (United States)

    Social Security Administration — Cash benefits and rehabilitation benefits paid in each year from the Old-Age and Survivors Insurance, and Disability Insurance Trust Funds, and benefits paid from...

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

    National Research Council Canada - National Science Library

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

  2. Drug Facts

    Medline Plus

    Full Text Available ... Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of Abuse What ... Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1-800- ...

  3. Drug Facts

    Medline Plus

    Full Text Available ... Oxy, Vike) Facts Spice (K2) Facts Tobacco and Nicotine Facts Other Drugs of Abuse What is Addiction? ... Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can call 1-800-662- ...

  4. Drugged Driving

    Science.gov (United States)

    ... Survey Results Synthetic Cannabinoids (K2/Spice) Unpredictable Danger Drug and Alcohol Use in College-Age Adults in 2016 Monitoring the Future 2016 Survey Results Drug and Alcohol Use in College-Age Adults in 2015 View All NIDA Home ...

  5. Prior Mental Fatigue Impairs Marksmanship Decision Performance

    Directory of Open Access Journals (Sweden)

    James Head

    2017-09-01

    Full Text Available Purpose: Mental fatigue has been shown to impair subsequent physical performance in continuous and discontinuous exercise. However, its influence on subsequent fine-motor performance in an applied setting (e.g., marksmanship for trained soldiers is relatively unknown. The purpose of this study was to investigate whether prior mental fatigue influences subsequent marksmanship performance as measured by shooting accuracy and judgment of soldiers in a live-fire scenario.Methods: Twenty trained infantry soldiers engaged targets after completing either a mental fatigue or control intervention in a repeated measure design. Heart rate variability and the NASA-TLX were used to gauge physiological and subjective effects of the interventions. Target hit proportion, projectile group accuracy, and precision were used to measure marksmanship accuracy. Marksmanship accuracy was assessed by measuring bullet group accuracy (i.e., how close a group of shots are relative to center of mass and bullet group precision (i.e., how close are each individual shot to each other. Additionally, marksmanship decision accuracy (correctly shooting vs. correctly withholding shot when engaging targets was used to examine marksmanship performance.Results: Soldiers rated the mentally fatiguing task (59.88 ± 23.7 as having greater mental workload relative to the control intervention [31.29 ± 12.3, t(19 = 1.72, p < 0.001]. Additionally, soldiers completing the mental fatigue intervention (96.04 ± = 37.1 also had lower time-domain (standard deviation of normal to normal R-R intervals heart rate variability relative to the control [134.39 ± 47.4, t(18 = 3.59, p < 0.001]. Projectile group accuracy and group precision failed to show differences between interventions [t(19 = 0.98, p = 0.34, t(19 = 0.18, p = 0.87, respectively]. Marksmanship decision errors significantly increased after soldiers completed the mental fatigue intervention (48% ± 22.4 relative to the control

  6. Digital communication constraints in prior space missions

    Science.gov (United States)

    Yassine, Nathan K.

    2004-01-01

    Digital communication is crucial for space endeavors. Jt transmits scientific and command data between earth stations and the spacecraft crew. It facilitates communications between astronauts, and provides live coverage during all phases of the mission. Digital communications provide ground stations and spacecraft crew precise data on the spacecraft position throughout the entire mission. Lessons learned from prior space missions are valuable for our new lunar and Mars missions set by our president s speech. These data will save our agency time and money, and set course our current developing technologies. Limitations on digital communications equipment pertaining mass, volume, data rate, frequency, antenna type and size, modulation, format, and power in the passed space missions are of particular interest. This activity is in support of ongoing communication architectural studies pertaining to robotic and human lunar exploration. The design capabilities and functionalities will depend on the space and power allocated for digital communication equipment. My contribution will be gathering these data, write a report, and present it to Communications Technology Division Staff. Antenna design is very carefully studied for each mission scenario. Currently, Phased array antennas are being developed for the lunar mission. Phased array antennas use little power, and electronically steer a beam instead of DC motors. There are 615 patches in the phased array antenna. These patches have to be modified to have high yield. 50 patches were created for testing. My part is to assist in the characterization of these patch antennas, and determine whether or not certain modifications to quartz micro-strip patch radiators result in a significant yield to warrant proceeding with repairs to the prototype 19 GHz ferroelectric reflect-array antenna. This work requires learning how to calibrate an automatic network, and mounting and testing antennas in coaxial fixtures. The purpose of this

  7. Erectile dysfunction in patients taking psychotropic drugs and treated with phosphodiesterase-5 inhibitors

    Directory of Open Access Journals (Sweden)

    Rossella Mazzilli

    2018-03-01

    Full Text Available Objectives: The aim of this study was to assess the prevalence of patients with Erectile Dysfunction (ED receiving psychotropic drugs, the impact of these drugs on hormonal profile, and the efficacy of PDE5-i in these patients. Materials and methods: We recruited 1872 patients referring for ED to our Andrology Unit. Assessment included serum testosterone, gonadotropins, TSH, prolactin, and PSA, and the IIEF-5 questionnaire for ED diagnosis. Inclusion criteria were age 21-75 years and IIEF-5 total score ≤ 21; exclusion criteria included hypogonadism, diabetes mellitus, previous prostatectomy, other medication intake, and ED diagnosis prior to psychotropic drug treatment. Efficacy was rated with the IIEF-5 (remission: total score ≥ 22. Results: The prevalence of ED patients treated with psychotropic drugs since ≥ 3 months was 9.5% (178/1872, subdivided according to the drugs used into: Group A, 16 patients treated with atypical antipsychotics (9.0%; Group B, 55 patients with benzodiazepines (30.9%; Group C, 33 patients with antidepressant drugs (18.5%; and Group D, 74 patients with multiple psychotropic drugs (41.6%. Patients in Group A were significantly younger than other groups (p < 0.05. The hormonal profile presented only higher prolactin level in patients treated with antipsychotics, alone or in combination (p < 0.05. Overall, 146 patients received PDE5-i. Remission rate, after three months of treatment, was significantly higher in Group B compared to C and D groups (p < 0.05. Conclusions: A substantial portion of patients receiving psychotropic drugs show ED. Sexual performance in these patients benefits from PDE5-i. Age, effects of psychiatric disorders, psychotropic drugs, and PDE5-i treatment modality accounted for variability of response in this sample.

  8. Estimating security betas using prior information based on firm fundamentals

    NARCIS (Netherlands)

    Cosemans, M.; Frehen, R.; Schotman, P.C.; Bauer, R.

    2010-01-01

    This paper proposes a novel approach for estimating time-varying betas of individual stocks that incorporates prior information based on fundamentals. We shrink the rolling window estimate of beta towards a firm-specific prior that is motivated by asset pricing theory. The prior captures structural

  9. Potential drug-drug and drug-disease interactions in well-functioning community-dwelling older adults.

    Science.gov (United States)

    Hanlon, J T; Perera, S; Newman, A B; Thorpe, J M; Donohue, J M; Simonsick, E M; Shorr, R I; Bauer, D C; Marcum, Z A

    2017-04-01

    There are few studies examining both drug-drug and drug-disease interactions in older adults. Therefore, the objective of this study was to describe the prevalence of potential drug-drug and drug-disease interactions and associated factors in community-dwelling older adults. This cross-sectional study included 3055 adults aged 70-79 without mobility limitations at their baseline visit in the Health Aging and Body Composition Study conducted in the communities of Pittsburgh PA and Memphis TN, USA. The outcome factors were potential drug-drug and drug-disease interactions as per the application of explicit criteria drawn from a number of sources to self-reported prescription and non-prescription medication use. Over one-third of participants had at least one type of interaction. Approximately one quarter (25·1%) had evidence of had one or more drug-drug interactions. Nearly 10·7% of the participants had a drug-drug interaction that involved a non-prescription medication. % The most common drug-drug interaction was non-steroidal anti-inflammatory drugs (NSAIDs) affecting antihypertensives. Additionally, 16·0% had a potential drug-disease interaction with 3·7% participants having one involving non-prescription medications. The most common drug-disease interaction was aspirin/NSAID use in those with history of peptic ulcer disease without gastroprotection. Over one-third (34·0%) had at least one type of drug interaction. Each prescription medication increased the odds of having at least one type of drug interaction by 35-40% [drug-drug interaction adjusted odds ratio (AOR) = 1·35, 95% confidence interval (CI) = 1·27-1·42; drug-disease interaction AOR = 1·30; CI = 1·21-1·40; and both AOR = 1·45; CI = 1·34-1·57]. A prior hospitalization increased the odds of having at least one type of drug interaction by 49-84% compared with those not hospitalized (drug-drug interaction AOR = 1·49, 95% CI = 1·11-2·01; drug-disease interaction AOR = 1·69, CI = 1·15-2

  10. How Many Drugs Are Catecholics

    Directory of Open Access Journals (Sweden)

    Da-Peng Yang

    2007-04-01

    Full Text Available By examination of the 8659 drugs recorded in the Comprehensive Medicinal Chemistry (CMC database, 78 catecholics (including five pyrogallolics were identified, of which 17 are currently prescribed by FDA. Through analyzing the substitutent patterns, ClogPs and O-H bond dissociation enthalpies(BDEs of the catecholic drugs, some molecular features that may benefit circumventing the toxicity of catecholics were revealed: i strong electron-donating substituents are excluded; ii ClogP 3; iii an energy penalty exists for quinone formation. Besides, the present analyses also suggest that the clinical usage and dosage of currently prescribed catecholic drugs are of importance in designing or screening catecholic antioxidants.

  11. Nasal Inserts for Drug Delivery: An Overview

    African Journals Online (AJOL)

    In this review, the benefits, limitations and absorption mechanisms of the nasal route, as well ... molecules including peptide and proteins for ... (Mw) drugs, rapid and fast onset of action due to ... while the former act by disrupting the nasal.

  12. Medicare Prescription Drug Coverage - General Information

    Data.gov (United States)

    U.S. Department of Health & Human Services — The MMA legislation provides seniors and people with disabilities with the first comprehensive prescription drug benefit ever offered under the Medicare program, the...

  13. Natural gas benefits

    International Nuclear Information System (INIS)

    1999-01-01

    The General Auditor in the Netherlands studied the natural gas policy in the Netherlands, as has been executed in the past decades, in the period 1997-1999. The purpose of the study is to inform the Dutch parliament on the planning and the backgrounds of the natural gas policy and on the policy risks with respect to the benefits for the Dutch State, taking into account the developments in the policy environment. The final conclusion is that the proposed liberalization of the national natural gas market will result in a considerable deprivation of income for the State in case the benefit policy is not adjusted. This report includes a reaction of the Dutch Minister of Economic Affairs and an afterword of the General Auditor. In the appendix an outline is given of the natural gas policy

  14. Drug repurposing based on drug-drug interaction.

    Science.gov (United States)

    Zhou, Bin; Wang, Rong; Wu, Ping; Kong, De-Xin

    2015-02-01

    Given the high risk and lengthy procedure of traditional drug development, drug repurposing is gaining more and more attention. Although many types of drug information have been used to repurpose drugs, drug-drug interaction data, which imply possible physiological effects or targets of drugs, remain unexploited. In this work, similarity of drug interaction was employed to infer similarity of the physiological effects or targets for the drugs. We collected 10,835 drug-drug interactions concerning 1074 drugs, and for 700 of them, drug similarity scores based on drug interaction profiles were computed and rendered using a drug association network with 589 nodes (drugs) and 2375 edges (drug similarity scores). The 589 drugs were clustered into 98 groups with Markov Clustering Algorithm, most of which were significantly correlated with certain drug functions. This indicates that the network can be used to infer the physiological effects of drugs. Furthermore, we evaluated the ability of this drug association network to predict drug targets. The results show that the method is effective for 317 of 561 drugs that have known targets. Comparison of this method with the structure-based approach shows that they are complementary. In summary, this study demonstrates the feasibility of drug repurposing based on drug-drug interaction data. © 2014 John Wiley & Sons A/S.

  15. [Club drugs].

    Science.gov (United States)

    Guerreiro, Diogo Frasquilho; Carmo, Ana Lisa; da Silva, Joaquim Alves; Navarro, Rita; Góis, Carlos

    2011-01-01

    Club drugs are the following substances: Methylenedioxymethamphetamine (MDMA); Methamphetamine; Lysergic Acid Diethylamide (LSD); Ketamine; Gamma-hydroxybutyrate (GHB) and Flunitrazepam. These substances are mainly used by adolescents and young adults, mostly in recreational settings like dance clubs and rave parties. These drugs have diverse psychotropic effects, are associated with several degrees of toxicity, dependence and long term adverse effects. Some have been used for several decades, while others are relatively recent substances of abuse. They have distinct pharmacodynamic and pharmacokinetic properties, are not easy to detect and, many times, the use of club drugs is under diagnosed. Although the use of these drugs is increasingly common, few health professionals feel comfortable with the diagnosis and treatment. The authors performed a systematic literature review, with the goal of synthesising the existing knowledge about club drugs, namely epidemiology, mechanism of action, detection, adverse reactions and treatment. The purpose of this article is creating in Portuguese language a knowledge data base on club drugs, that health professionals of various specialties can use as a reference when dealing with individual with this kind of drug abuse.

  16. Harnessing natural ventilation benefits.

    Science.gov (United States)

    O'Leary, John

    2013-04-01

    Making sure that a healthcare establishment has a good supply of clean fresh air is an important factor in keeping patients, staff, and visitors, free from the negative effects of CO2 and other contaminants. John O'Leary of Trend Controls, a major international supplier of building energy management solutions (BEMS), examines the growing use of natural ventilation, and the health, energy-saving, and financial benefits, that it offers.

  17. Prior methylphenidate self-administration alters the subsequent reinforcing effects of methamphetamine in rats.

    Science.gov (United States)

    Baladi, Michelle G; Nielsen, Shannon M; Umpierre, Anthony; Hanson, Glen R; Fleckenstein, Annette E

    2014-12-01

    Methylphenidate (MPD) is clinically effective in treating the symptoms of attention-deficit hyperactivity disorder; however, its relatively widespread availability has raised public health concerns on nonmedical use of MPD among certain adult populations. Most preclinical studies investigate whether presumed therapeutically relevant doses of MPD alter sensitivity to the reinforcing effects of other drugs, but it remains unclear whether doses of MPD likely exceeding therapeutic relevance impact the subsequent reinforcing effects of drugs. To begin to address this question, the effect of prior MPD self-administration (0.56 mg/kg/infusion) on the subsequent reinforcing effects of methamphetamine (METH, 0.032 or 0.1 mg/kg/infusion) was investigated in male Sprague-Dawley rats. For comparison, it was also determined whether prior experimenter-administered MPD, injected daily at a presumed therapeutically relevant dose (2 mg/kg), altered the subsequent reinforcing effects of METH. Results indicated that, under the current conditions, only a history of MPD self-administration increased sensitivity to the subsequent reinforcing effects of METH. Furthermore, MPD did not impact food-maintained responding, suggesting that the effect of MPD might be specific to drug reinforcers. These data suggest that short-term, nonmedical use of MPD might alter the positive reinforcing effects of METH in a manner relevant to vulnerability to drug use in humans.

  18. The Psychological Benefits of Superstitious Rituals in Top Sport

    NARCIS (Netherlands)

    M.C. Schippers (Michaéla); P.A.M. van Lange (Paul)

    2005-01-01

    textabstractThe current research addresses the psychological benefits of superstitious rituals in top sport, examining the circumstances under which top-class sportsmen are especially committed to enacting rituals prior to a game (ritual commitment). Consistent with hypotheses, findings revealed

  19. Benefits of transmission interconnections

    International Nuclear Information System (INIS)

    Lyons, D.

    2006-01-01

    The benefits of new power transmission interconnections from Alberta were discussed with reference to the challenges and measures needed to move forward. Alberta's electricity system has had a long period of sustained growth in generation and demand and this trend is expected to continue. However, no new interconnections have been built since 1985 because the transmission network has not expanded in consequence with the growth in demand. As such, Alberta remains weakly interconnected with the rest of the western region. The benefits of stronger transmission interconnections include improved reliability, long-term generation capability, hydrothermal synergies, a more competitive market, system efficiencies and fuel diversity. It was noted that the more difficult challenges are not technical. Rather, the difficult challenges lie in finding an appropriate business model that recognizes different market structures. It was emphasized that additional interconnections are worthwhile and will require significant collaboration among market participants and governments. It was concluded that interties enable resource optimization between systems and their benefits far exceed their costs. tabs., figs

  20. Generalized Bayesian inference with sets of conjugate priors for dealing with prior-data conflict : course at Lund University

    NARCIS (Netherlands)

    Walter, G.

    2015-01-01

    In the Bayesian approach to statistical inference, possibly subjective knowledge on model parameters can be expressed by so-called prior distributions. A prior distribution is updated, via Bayes’ Rule, to the so-called posterior distribution, which combines prior information and information from

  1. The Influence of Prior Knowledge on the Retrieval-Directed Function of Note Taking in Prior Knowledge Activation

    Science.gov (United States)

    Wetzels, Sandra A. J.; Kester, Liesbeth; van Merrienboer, Jeroen J. G.; Broers, Nick J.

    2011-01-01

    Background: Prior knowledge activation facilitates learning. Note taking during prior knowledge activation (i.e., note taking directed at retrieving information from memory) might facilitate the activation process by enabling learners to build an external representation of their prior knowledge. However, taking notes might be less effective in…

  2. Prior Sensitivity Analysis in Default Bayesian Structural Equation Modeling.

    Science.gov (United States)

    van Erp, Sara; Mulder, Joris; Oberski, Daniel L

    2017-11-27

    Bayesian structural equation modeling (BSEM) has recently gained popularity because it enables researchers to fit complex models and solve some of the issues often encountered in classical maximum likelihood estimation, such as nonconvergence and inadmissible solutions. An important component of any Bayesian analysis is the prior distribution of the unknown model parameters. Often, researchers rely on default priors, which are constructed in an automatic fashion without requiring substantive prior information. However, the prior can have a serious influence on the estimation of the model parameters, which affects the mean squared error, bias, coverage rates, and quantiles of the estimates. In this article, we investigate the performance of three different default priors: noninformative improper priors, vague proper priors, and empirical Bayes priors-with the latter being novel in the BSEM literature. Based on a simulation study, we find that these three default BSEM methods may perform very differently, especially with small samples. A careful prior sensitivity analysis is therefore needed when performing a default BSEM analysis. For this purpose, we provide a practical step-by-step guide for practitioners to conducting a prior sensitivity analysis in default BSEM. Our recommendations are illustrated using a well-known case study from the structural equation modeling literature, and all code for conducting the prior sensitivity analysis is available in the online supplemental materials. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Toxicological evaluation of a dietary supplement formulated for male sexual health prior to market release.

    Science.gov (United States)

    Clewell, A; Qureshi, I; Endres, J; Horváth, J; Financsek, I; Neal-Kababick, J; Jade, K; Schauss, A G

    2010-06-01

    The dietary supplement, 112 Degrees, was formulated with the goal of supporting sexual functioning in men. Due to rampant problems with drug adulteration for this category of products, a comprehensive screening for active pharmaceutical agents, with an emphasis on drugs prescribed for erectile dysfunction such as type 5 phosphodiesterase (PDE-5) inhibitors, and known unapproved PDE-5 drug analogues, was performed along with preclinical toxicology studies prior to the introduction of this product into the marketplace. 112 Degrees was found to be free of all pharmaceutical adulterants tested, and was not mutagenic, clastogenic, or genotoxic as demonstrated by the Ames test, chromosomal aberration assay, and mouse micronucleus assay, respectively. The LD(50) in the 14-day acute oral toxicity study was greater than 5000 mg/kg, the highest dose tested. (c) 2009 Elsevier Inc. All rights reserved.

  4. Understanding Medicare Prescription Drug Coverage

    Science.gov (United States)

    ... to know what your insurance company is paying…Health Insurance: Understanding What It CoversRead Article >>Insurance & BillsHealth Insurance: Understanding What It CoversYour insurance policy lists a package of medical benefits such as tests, drugs, and treatment services. These ...

  5. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Plan Search Share ... HIV infection in the United States. Drugs can change the way the brain works, disrupting the parts of the brain that people use to weigh risks and benefits when making decisions. This page connects you to ...

  6. Food irradiation: benefits and concerns

    International Nuclear Information System (INIS)

    Thayer, D.W.

    1990-01-01

    The benefits and concerns about treating foods with ionizing radiation are reviewed. Radioactivity cannot be induced in foods by treatment with gamma rays from 137 Cs or 60 Co, X-ray sources of 5 MeV or lower energy, or electrons of 10 MeV or lower energy. The evidence supports the safety and efficacy of using ionizing radiation for insect disinfestation of grains; dried spices, vegetables and fruits; and fresh fruit. Species and dose dependent phytotoxic and vitamin changes may occur in some fruits at greater doses than currently approved by the U.S. Food and Drug Administration. Irradiation can inactivate protozoan or helminth parasites and significantly decrease the probability of viable food-borne bacterial pathogens in fish, poultry, and red meats. The titers of amino acids, fatty acids, and vitamins of chicken meat sterilized by thermal, electron-beam, or gamma radiation are presented. On the whole, the data support the safely and efficacy of the process

  7. Drug Facts

    Medline Plus

    Full Text Available ... MDMA (Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco ... Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You ...

  8. Drug Facts

    Medline Plus

    Full Text Available ... Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA ( ... Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/ ...

  9. Drug Facts

    Medline Plus

    Full Text Available ... Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth ( ... Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine ...

  10. Drug Facts

    Medline Plus

    Full Text Available ... Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain ... About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other ...

  11. Drug Metabolism

    Indian Academy of Sciences (India)

    Home; Journals; Resonance – Journal of Science Education; Volume 19; Issue 3. Drug Metabolism: A Fascinating Link Between Chemistry and Biology. Nikhil Taxak Prasad V Bharatam. General Article Volume 19 Issue 3 March 2014 pp 259-282 ...

  12. Drugged Driving

    Science.gov (United States)

    ... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...

  13. Club Drugs

    Science.gov (United States)

    ... Alcohol Club Drugs Cocaine Fentanyl Hallucinogens Inhalants Heroin Marijuana MDMA (Ecstasy/Molly) Methamphetamine Opioids Over-the-Counter Medicines Prescription Medicines Steroids (Anabolic) Synthetic Cannabinoids (K2/Spice) Synthetic Cathinones (Bath Salts) Tobacco/ ...

  14. Drug Metabolism

    Indian Academy of Sciences (India)

    IAS Admin

    behind metabolic reactions, importance, and consequences with several ... required for drug action. ... lism, which is catalyzed by enzymes present in the above-men- ... catalyze the transfer of one atom of oxygen to a substrate produc-.

  15. Drug Facts

    Medline Plus

    Full Text Available ... Ecstasy, Molly) Facts Meth (Crank, Ice) Facts Pain Medicine (Oxy, Vike) Facts Spice (K2) Facts Tobacco and ... Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine Other Drugs You can ...

  16. Drug Facts

    Medline Plus

    Full Text Available ... 800-662-HELP (4357) at any time to find drug treatment centers near you. I want my ... is making positive changes in her life. She finds support from family and friends who don't ...

  17. Drug Facts

    Medline Plus

    Full Text Available ... That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, ... Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) ...

  18. 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 ...

  19. Drug Reactions

    Science.gov (United States)

    ... Kids and Teens Pregnancy and Childbirth Women Men Seniors Your Health Resources Healthcare Management End-of-Life Issues Insurance & Bills Self Care Working With Your Doctor Drugs, Procedures & Devices Over-the- ...

  20. Drug Facts

    Medline Plus

    Full Text Available ... prescription drugs. The addiction slowly took over his life. I need different people around me. To stop ... marijuana, "Cristina" is making positive changes in her life. She finds support from family and friends who ...

  1. Drug Resistance

    Science.gov (United States)

    ... Drug-resistance testing is also recommended for all pregnant women with HIV before starting HIV medicines and also in some pregnant women already taking HIV medicines. Pregnant women will work with their health ...

  2. Drug Facts

    Medline Plus

    Full Text Available ... Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana (Weed, Pot) Facts MDMA (Ecstasy, Molly) Facts Meth (Crank, ... Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) Tobacco/Nicotine ...

  3. Drug Addiction

    Science.gov (United States)

    ... as hearing colors Impulsive behavior Rapid shifts in emotions Permanent mental changes in perception Rapid heart rate ... Drug use can negatively affect academic performance and motivation to excel in school. Legal issues. Legal problems ...

  4. Drug Facts

    Medline Plus

    Full Text Available ... That People Abuse Alcohol Facts Bath Salts Facts Cocaine (Coke, Crack) Facts Heroin (Smack, Junk) Facts Marijuana ( ... Watch Videos Information About Drugs Alcohol Bath Salts Cocaine Heroin Marijuana MDMA Meth Pain Medicines Spice (K2) ...

  5. Conjunctival sac bacterial flora isolated prior to cataract surgery

    Directory of Open Access Journals (Sweden)

    Suto C

    2012-01-01

    Full Text Available Chikako Suto1,2, Masahiro Morinaga1,2, Tomoko Yagi1,2, Chieko Tsuji3, Hiroshi Toshida41Department of Ophthalmology, Saiseikai Kurihashi Hospital, Saitama; 2Department of Ophthalmology, Tokyo Women's Medical University, Tokyo; 3Department of Clinical Laboratory, Saiseikai Kurihashi Hospital, Saitama; 4Department of Ophthalmology, Juntendo University Shizuoka Hospital, Izunokuni, Shizuoka, JapanObjective: To determine the trends of conjunctival sac bacterial flora isolated from patients prior to cataract surgery.Subjects and methods: The study comprised 579 patients (579 eyes who underwent cataract surgery. Specimens were collected by lightly rubbing the inferior palpebral conjunctival sac with a sterile cotton swab 2 weeks before surgery, and then cultured for isolation of bacteria and antimicrobial sensitivity testing. The bacterial isolates and percentage of drug-resistant isolates were compared among age groups and according to whether or not patients had diabetes mellitus, hyperlipidemia, dialysis therapy, oral steroid use, dry eye syndrome, or allergic conjunctivitis.Results: The bacterial isolation rate was 39.2%. There were 191 strains of Gram-positive cocci, accounting for the majority of all isolates (67.0%, among which methicillin-sensitive coagulase-negative staphylococci was the most frequent (127 strains, 44.5%, followed by methicillin-resistant coagulase-negative staphylococci (37 strains, 12.7%. All 76 Gram-positive bacillary isolates (26.7% were from the genus Corynebacterium. Among the 16 Gram-negative bacillary isolates (5.9%, the most frequent was Escherichia coli (1.0%. The bacterial isolation rate was higher in patients >60 years old, and was lower in patients with dry eye syndrome, patients under topical treatment for other ocular disorders, and patients with hyperlipidemia. There was no significant difference in bacterial isolation rate with respect to the presence/absence of diabetes mellitus, steroid therapy, dialysis, or

  6. Suicide attempts prior to fatal drug overdose in Luxembourg from 1994 to 2011

    OpenAIRE

    Origer, Alain; Baumann, Michèle

    2013-01-01

    Educational Objectives: This study may help participants to recognize factors influencing suicidal behavior that should be assessed or monitored in the context of substance use. Purpose: To assess the prevalence of lifetime suicide attempts in opiate and cocaine related (FOD) cases. To analyze associations between suicide attempts and socio-demographic, life and substance use profiles of FOD victims . Methods: A triangulation approach allowed to cross-examining data from national law enfor...

  7. Pharmacokinetics of Repeated Melatonin Drug Administrations Prior to and After Surgery

    DEFF Research Database (Denmark)

    Harpsøe, Nathja Groth; Andersen, Lars Peter Kloster; Mielke, Louise Vennegaard

    2016-01-01

    BACKGROUND: Recent clinical studies have documented the analgesic, anti-inflammatory, antioxidative and anxiolytic effects of exogenous melatonin. The pharmacokinetic properties of melatonin have primarily been investigated in experimental studies. OBJECTIVE: The aim of this study was to estimate...... the pharmacokinetics of melatonin in patients undergoing surgery and general anesthesia. METHODS: The study was designed as a prospective, two-phase cohort study. Patients were candidates for subpectoral breast augmentation surgery, and surgical procedures were performed by a single surgeon. The perioperative...... treatment protocol was standardized between patients. During the study, each patient received two separate oral administrations of melatonin 10 mg. Melatonin was administered 60 min before surgery, and at 9:00 p.m. the evening after surgery. The pharmacokinetic variables absorption half-life (t ½ absorption...

  8. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

    Science.gov (United States)

    Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet

    2018-01-01

    Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  9. Immunosuppressive drugs and fertility.

    Science.gov (United States)

    Leroy, Clara; Rigot, Jean-Marc; Leroy, Maryse; Decanter, Christine; Le Mapihan, Kristell; Parent, Anne-Sophie; Le Guillou, Anne-Claire; Yakoub-Agha, Ibrahim; Dharancy, Sébastien; Noel, Christian; Vantyghem, Marie-Christine

    2015-10-21

    Immunosuppressive drugs are used in the treatment of inflammatory and autoimmune diseases, as well as in transplantation. Frequently prescribed in young people, these treatments may have deleterious effects on fertility, pregnancy outcomes and the unborn child. This review aims to summarize the main gonadal side effects of immunosuppressants, to detail the effects on fertility and pregnancy of each class of drug, and to provide recommendations on the management of patients who are seen prior to starting or who are already receiving immunosuppressive treatment, allowing them in due course to bear children. The recommendations for use are established with a rather low level of proof, which needs to be taken into account in the patient management. Methotrexate, mycophenolate, and le- and teri-flunomide, cyclophosphamide, mitoxanthrone are contraindicated if pregnancy is desired due to their teratogenic effects, as well as gonadotoxic effects in the case of cyclophosphamide. Anti-TNF-alpha and mTOR-inhibitors are to be used cautiously if pregnancy is desired, since experience using these drugs is still relatively scarce. Azathioprine, glucocorticoids, mesalazine, anticalcineurins such as cyclosporine and tacrolimus, ß-interferon, glatiramer-acetate and chloroquine can be used during pregnancy, bearing in mind however that side effects may still occur. Experience is limited concerning natalizumab, fingolimod, dimethyl-fumarate and induction treatments. Conclusion: At the time of prescription, patients must be informed of the possible consequences of immunosuppressants on fertility and of the need for contraception. Pregnancy must be planned and the treatment modified if necessary in a pre-conception time period adapted to the half-life of the drug, imperatively in relation with the prescriber of the immunosuppressive drugs.

  10. 20 CFR 10.609 - How does OWCP decide whether new evidence requires modification of the prior decision?

    Science.gov (United States)

    2010-04-01

    ... requires modification of the prior decision? 10.609 Section 10.609 Employees' Benefits OFFICE OF WORKERS.... (b) A claims examiner who did not participate in making the contested decision will conduct the merit... all the evidence in the record. A copy of the decision will be provided to the agency. (c) An employee...

  11. Psychedelic Drugs in Biomedicine.

    Science.gov (United States)

    Kyzar, Evan J; Nichols, Charles D; Gainetdinov, Raul R; Nichols, David E; Kalueff, Allan V

    2017-11-01

    Psychedelic drugs, such as lysergic acid diethylamide (LSD), mescaline, and psilocybin, exert profound effects on brain and behavior. After decades of difficulties in studying these compounds, psychedelics are again being tested as potential treatments for intractable biomedical disorders. Preclinical research of psychedelics complements human neuroimaging studies and pilot clinical trials, suggesting these compounds as promising treatments for addiction, depression, anxiety, and other conditions. However, many questions regarding the mechanisms of action, safety, and efficacy of psychedelics remain. Here, we summarize recent preclinical and clinical data in this field, discuss their pharmacological mechanisms of action, and outline critical areas for future studies of psychedelic drugs, with the goal of maximizing the potential benefits of translational psychedelic biomedicine to patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. 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

  13. Benefiting through partnering

    International Nuclear Information System (INIS)

    Carr, T.J.

    2000-01-01

    As a consequence of dramatic changes in the world market in nuclear services over the last decade, BNFL has embarked on a comprehensive strategic review of its business. Central to this review has been the need for the company to achieve cost reduction and improved efficiency in all aspects of its business. An area where substantial benefits can be gained is in improved efficiency in the discharge of the capital expenditure programme. This paper focuses on the opportunity of profiting through partnering in capital project delivery. (author)

  14. Cost-benefit

    International Nuclear Information System (INIS)

    1975-01-01

    A critical review of the cost benefit analysis is given for the LMFBR-type reactor development program given in an environmental impact statement of AEC. Several methodological shortcomings are signalled. As compared with a HTGR-type/LWR-type mix of reactors the LMFBR-type reactor will not be competitive until the U 3 O 8 prices reach a level of $ 50/lb which is not likely to happen before the year 2020. It is recommended to review the draft of the ZEC document and include timing as one of the issues. Deferal of the LMFBR-type reactor development program if necessary will not be intolerably costly

  15. Impact of imatinib interruption and duration of prior hydroxyurea on the treatment outcome in patients with chronic myeloid leukemia: Single institution experience

    Directory of Open Access Journals (Sweden)

    Wael Abdelgawad Edesa

    2015-06-01

    Conclusion: Duration of prior hydroxyurea had no impact on response or progression free survival, while patients regular on imatinib had statistically significant difference with respect to major molecular response, complete molecular response and progression free survival compared to those who had periods of drug interruption, thus we need more governmental support to supply the drug without interruption to improve the outcome of therapy.

  16. Specialist Drug Knowledge In Patient Treatment

    African Journals Online (AJOL)

    1974-09-14

    Sep 14, 1974 ... relieve the physician, at his discretion, in the medication management of patients. S. Afr. Med. J., 48, 1920 (1974). The practice of medicine has both benefited and suffered from the vast upsurge of drug discovery in the past 30 to 40 years. Thus, in accepting the benefits, there has come the realisation of ...

  17. Laboratory markers in personalized drug therapy

    NARCIS (Netherlands)

    Geerts, A.F.J.

    2012-01-01

    During the last decade two major trends have influenced the thinking about the benefit-risk balance in drug therapy.The first trend showed that this balance is not only determined by the interaction of the pharmacological properties of the drug with the patient’s (patho)physiological profile, but is

  18. Discrepancies between multicriteria decision analysis-based ranking and intuitive ranking for pharmaceutical benefit-risk profiles in a hypothetical setting.

    Science.gov (United States)

    Hoshikawa, K; Ono, S

    2017-02-01

    Multicriteria decision analysis (MCDA) has been generally considered a promising decision-making methodology for the assessment of drug benefit-risk profiles. There have been many discussions in both public and private sectors on its feasibility and applicability, but it has not been employed in official decision-makings. For the purpose of examining to what extent MCDA would reflect the first-hand, intuitive preference of evaluators in practical pharmaceutical assessments, we conducted a questionnaire survey involving the participation of employees of pharmaceutical companies. Showing profiles of the efficacy and safety of four hypothetical drugs, each respondent was asked to rank them following the standard MCDA process and then to rank them intuitively (i.e. without applying any analytical framework). These two approaches resulted in substantially different ranking patterns from the same individuals, and the concordance rate was surprisingly low (17%). Although many respondents intuitively showed a preference for mild, balanced risk-benefit profiles over profiles with a conspicuous advantage in either risk or benefit, the ranking orders based on MCDA scores did not reflect the intuitive preference. Observed discrepancies between the rankings seemed to be primarily attributed to the structural characteristics of MCDA, which assumes that evaluation on each benefit and risk component should have monotonic impact on final scores. It would be difficult for MCDA to reflect commonly observed non-monotonic preferences for risk and benefit profiles. Possible drawbacks of MCDA should be further investigated prior to the real-world application of its benefit-risk assessment. © 2016 John Wiley & Sons Ltd.

  19. Liquid fuel concept benefits

    International Nuclear Information System (INIS)

    Hron, M.

    1996-01-01

    There are principle drawbacks of any kind of solid nuclear fuel listed and analyzed in the first part of the paper. One of the primary results of the analyses performed shows that the solid fuel concept, which was to certain degree advantageous in the first periods of a nuclear reactor development and operation, has guided this branch of a utilization of atomic nucleus energy to a death end. On the background of this, the liquid fuel concept and its benefits are introduced and briefly described in the first part of the paper, too. As one of the first realistic attempts to utilize the advantages of liquid fuels, the reactor/blanket system with molten fluoride salts in the role of fuel and coolant simultaneously, as incorporated in the accelerator-driven transmutation technology (ADTT) being proposed and currently having been under development in the Los Alamos National Laboratory, will be studied both theoretically and experimentally. There is a preliminary design concept of an experimental assembly LA-O briefly introduced in the paper which is under preparation in the Czech Republic for such a project. Finally, there will be another very promising concept of a small low power ADTT system introduced which is characterized by a high level of safety and economical efficiency. In the conclusion, the overall survey of principal benefits which may be expected by introducing liquid nuclear fuel in nuclear power and research reactor systems is given and critically analyzed. 7 refs, 4 figs

  20. Radiation: cost or benefit?

    International Nuclear Information System (INIS)

    Crouch, D.

    1988-01-01

    In a previous issue of SCRAM it was argued that the apparent increased incidence of child leukaemia around nuclear power stations could have been caused by radioactive discharges into the environment. The National Radiological Protection Board (NRPB) claim that the known levels of contamination could not be responsible for the observed cancer rates. NRPB estimates of radiation risk are, however, considered to be underestimates. The NRPB is criticised for its study of the Sellafield workforce which excluded ex-employees and which revealed, when a statistical mistake was put right, a significant excess of myeloma amongst the Windscale workforce. The radiation protection philosophy of the NRPB is based on a cost benefit analysis which balances the cost of protection against the benefits of power generation. Criticism is made of NRPB, not only for ignoring long-term risks and costs but also for suggesting that some levels of radiation exposure are acceptable. The Board is also accused of not being independent of the nuclear industry. (UK)

  1. Essential drugs for cancer chemotherapy. WHO consultation.

    OpenAIRE

    1994-01-01

    The WHO recommendation on essential drugs for cancer chemotherapy has been updated. General principles on the proper role of cancer chemotherapeutic agents in relation to efficacy and on the classification of tumours with respect to their curative potential are discussed. Curable cancers and those cancers where the cost-benefit ratio clearly favours drug treatment can be managed appropriately based on only 24 drugs. Fourteen of them should ideally be available for the treatment of the ten mos...

  2. 77 FR 43601 - Risks and Benefits of Hydroxyethyl Starch Solutions; Public Workshop

    Science.gov (United States)

    2012-07-25

    ...] Risks and Benefits of Hydroxyethyl Starch Solutions; Public Workshop AGENCY: Food and Drug... public workshop entitled: ``Risks and Benefits of Hydroxyethyl Starch Solutions.'' The purpose of this public workshop is to discuss new information on the risks and benefits of FDA-approved hydroxyethyl...

  3. 8 CFR 244.5 - Temporary treatment benefits for eligible aliens.

    Science.gov (United States)

    2010-01-01

    ... 8 Aliens and Nationality 1 2010-01-01 2010-01-01 false Temporary treatment benefits for eligible aliens. 244.5 Section 244.5 Aliens and Nationality DEPARTMENT OF HOMELAND SECURITY IMMIGRATION... for eligible aliens. (a) Prior to the registration period. Prior to the registration period...

  4. Ethnobotany/ethnopharmacology and mass bioprospecting: issues on intellectual property and benefit-sharing.

    Science.gov (United States)

    Soejarto, D D; Fong, H H S; Tan, G T; Zhang, H J; Ma, C Y; Franzblau, S G; Gyllenhaal, C; Riley, M C; Kadushin, M R; Pezzuto, J M; Xuan, L T; Hiep, N T; Hung, N V; Vu, B M; Loc, P K; Dac, L X; Binh, L T; Chien, N Q; Hai, N V; Bich, T Q; Cuong, N M; Southavong, B; Sydara, K; Bouamanivong, S; Ly, H M; Thuy, Tran Van; Rose, W C; Dietzman, G R

    2005-08-22

    Ethnobotany/ethnopharmacology has contributed to the discovery of many important plant-derived drugs. Field explorations to seek and document indigenous/traditional medical knowledge (IMK/TMK), and/or the biodiversity with which the IMK/TMK is attached, and its conversion into a commercialized product is known as bioprospecting or biodiversity prospecting. When performed in a large-scale operation, the effort is referred to as mass bioprospecting. Experiences from the mass bioprospecting efforts undertaken by the United States National Cancer Institute, the National Cooperative Drug Discovery Groups (NCDDG) and the International Cooperative Biodiversity Groups (ICBG) programs demonstrate that mass bioprospecting is a complex process, involving expertise from diverse areas of human endeavors, but central to it is the Memorandum of Agreement (MOA) that recognizes issues on genetic access, prior informed consent, intellectual property and the sharing of benefits that may arise as a result of the effort. Future mass bioprospecting endeavors must take heed of the lessons learned from past and present experiences in the planning for a successful mass bioprospecting venture.

  5. The Role of Prior Knowledge in International Franchise Partner Recruitment

    OpenAIRE

    Wang, Catherine; Altinay, Levent

    2006-01-01

    Purpose To investigate the role of prior knowledge in the international franchise partner recruitment process and to evaluate how cultural distance influences the role of prior knowledge in this process. Design/Methodology/Approach A single embedded case study of an international hotel firm was the focus of the enquiry. Interviews, observations and document analysis were used as the data collection techniques. Findings Findings reveal that prior knowledge of the franchisor enab...

  6. Spectrally Consistent Satellite Image Fusion with Improved Image Priors

    DEFF Research Database (Denmark)

    Nielsen, Allan Aasbjerg; Aanæs, Henrik; Jensen, Thomas B.S.

    2006-01-01

    Here an improvement to our previous framework for satellite image fusion is presented. A framework purely based on the sensor physics and on prior assumptions on the fused image. The contributions of this paper are two fold. Firstly, a method for ensuring 100% spectrally consistency is proposed......, even when more sophisticated image priors are applied. Secondly, a better image prior is introduced, via data-dependent image smoothing....

  7. Acquisition of multiple prior distributions in tactile temporal order judgment

    Directory of Open Access Journals (Sweden)

    Yasuhito eNagai

    2012-08-01

    Full Text Available The Bayesian estimation theory proposes that the brain acquires the prior distribution of a task and integrates it with sensory signals to minimize the effect of sensory noise. Psychophysical studies have demonstrated that our brain actually implements Bayesian estimation in a variety of sensory-motor tasks. However, these studies only imposed one prior distribution on participants within a task period. In this study, we investigated the conditions that enable the acquisition of multiple prior distributions in temporal order judgment (TOJ of two tactile stimuli across the hands. In Experiment 1, stimulation intervals were randomly selected from one of two prior distributions (biased to right hand earlier and biased to left hand earlier in association with color cues (green and red, respectively. Although the acquisition of the two priors was not enabled by the color cues alone, it was significant when participants shifted their gaze (above or below in response to the color cues. However, the acquisition of multiple priors was not significant when participants moved their mouths (opened or closed. In Experiment 2, the spatial cues (above and below were used to identify which eye position or retinal cue position was crucial for the eye-movement-dependent acquisition of multiple priors in Experiment 1. The acquisition of the two priors was significant when participants moved their gaze to the cues (i.e., the cue positions on the retina were constant across the priors, as well as when participants did not shift their gazes (i.e., the cue positions on the retina changed according to the priors. Thus, both eye and retinal cue positions were effective in acquiring multiple priors. Based on previous neurophysiological reports, we discuss possible neural correlates that contribute to the acquisition of multiple priors.

  8. Training shortest-path tractography: Automatic learning of spatial priors

    DEFF Research Database (Denmark)

    Kasenburg, Niklas; Liptrot, Matthew George; Reislev, Nina Linde

    2016-01-01

    Tractography is the standard tool for automatic delineation of white matter tracts from diffusion weighted images. However, the output of tractography often requires post-processing to remove false positives and ensure a robust delineation of the studied tract, and this demands expert prior...... knowledge. Here we demonstrate how such prior knowledge, or indeed any prior spatial information, can be automatically incorporated into a shortest-path tractography approach to produce more robust results. We describe how such a prior can be automatically generated (learned) from a population, and we...

  9. Crowdsourcing prior information to improve study design and data analysis.

    Directory of Open Access Journals (Sweden)

    Jeffrey S Chrabaszcz

    Full Text Available Though Bayesian methods are being used more frequently, many still struggle with the best method for setting priors with novel measures or task environments. We propose a method for setting priors by eliciting continuous probability distributions from naive participants. This allows us to include any relevant information participants have for a given effect. Even when prior means are near-zero, this method provides a principle way to estimate dispersion and produce shrinkage, reducing the occurrence of overestimated effect sizes. We demonstrate this method with a number of published studies and compare the effect of different prior estimation and aggregation methods.

  10. Prior knowledge in recalling arguments in bioethical dilemmas

    Directory of Open Access Journals (Sweden)

    Hiemke Katharina Schmidt

    2015-09-01

    Full Text Available Prior knowledge is known to facilitate learning new information. Normally in studies confirming this outcome the relationship between prior knowledge and the topic to be learned is obvious: the information to be acquired is part of the domain or topic to which the prior knowledge belongs. This raises the question as to whether prior knowledge of various domains facilitates recalling information. In this study 79 eleventh-grade students completed a questionnaire on their prior knowledge of seven different domains related to the bioethical dilemma of prenatal diagnostics. The students read a text containing arguments for and arguments against prenatal diagnostics. After one week and again 12 weeks later they were asked to write down all the arguments they remembered. Prior knowledge helped them recall the arguments one week (r = .350 and 12 weeks (r = .316 later. Prior knowledge of three of the seven domains significantly helped them recall the arguments one week later (correlations between r = .194 to r = .394. Partial correlations with interest as a control item revealed that interest did not explain the relationship between prior knowledge and recall. Prior knowledge of different domains jointly supports the recall of arguments related to bioethical topics.

  11. Drug-resistant spinal tuberculosis

    Directory of Open Access Journals (Sweden)

    Anil K Jain

    2018-01-01

    Full Text Available Drug-resistant spinal tuberculosis (TB is an emerging health problem in both developing and developed countries. In this review article, we aim to define management protocols for suspicion, diagnosis, and treatment of such patients. Spinal TB is a deep-seated paucibacillary lesion, and the demonstration of acid-fast bacilli on Ziehl-Neelsen staining is possible only in 10%–30% of cases. Drug resistance is suspected in patients showing the failure of clinicoradiological improvement or appearance of a fresh lesion of osteoarticular TB while on anti tubercular therapy (ATT for a minimum period of 5 months. The conventional culture of Mycobacterium tuberculosis remains the gold standard for both bacteriological diagnosis and drug sensitivity testing (DST; however, the high turn around time of 2–6 weeks for detection with added 3 weeks for DST is a major limitation. To overcome this problem, rapid culture methods and molecular methods have been introduced. From a public health perspective, reducing the period between diagnosis and treatment initiation has direct benefits for both the patient and the community. For all patients of drug-resistant spinal TB, a complete Drug-O-Gram should be prepared which includes details of all drugs, their doses, and duration. Patients with confirmed multidrug-resistant TB strains should receive a regimen with at least five effective drugs, including pyrazinamide and one injectable. Patients with resistance to additional antitubercular drugs should receive individualized ATT as per their DST results.

  12. Biomaterials for drug delivery patches.

    Science.gov (United States)

    Santos, Lúcia F; Correia, Ilídio J; Silva, A Sofia; Mano, João F

    2018-06-15

    The limited efficiency of conventional drugs has been instigated the development of new and more effective drug delivery systems (DDS). Transdermal DDS, are associated with numerous advantages such its painless application and less frequent replacement and greater flexibility of dosing, features that triggered the research and development of such devices. Such systems have been produced using either biopolymer; or synthetic polymers. Although the first ones are safer, biocompatible and present a controlled degradation by human enzymes or water, the second ones are the most currently available in the market due to their greater mechanical resistance and flexibility, and non-degradation over time. This review highlights the most recent advances (mainly in the last five years) of patches aimed for transdermal drug delivery, focusing on the different materials (natural, synthetic and blends) and latest designs for the development of such devices, emphasizing also their combination with drug carriers that enable enhanced drug solubility and a more controlled release of the drug over the time. The benefits and limitations of different patches formulations are considered with reference to their appliance to transdermal drug delivery. Furthermore, a record of the currently available patches on the market is given, featuring their most relevant characteristics. Finally, a list of most recent/ongoing clinical trials regarding the use of patches for skin disorders is detailed and critical insights on the current state of patches for transdermal drug delivery are also provided. Copyright © 2018. Published by Elsevier B.V.

  13. Chromosomal differences between acute nonlymphocytic leukemia in patients with prior solid tumors and prior hematologic malignancies. A study of 14 cases with prior breast cancer

    International Nuclear Information System (INIS)

    Mamuris, Z.; Dumont, J.; Dutrillaux, B.; Aurias, A.

    1989-01-01

    A cytogenetic study of 14 patients with secondary acute nonlymphocytic leukemia (S-ANLL) with prior treatment for breast cancer is reported. The chromosomes recurrently involved in numerical or structural anomalies are chromosomes 7, 5, 17, and 11, in decreasing order of frequency. The distribution of the anomalies detected in this sample of patients is similar to that observed in published cases with prior breast or other solid tumors, though anomalies of chromosome 11 were not pointed out, but it significantly differs from that of the S-ANLL with prior hematologic malignancies. This difference is principally due to a higher involvement of chromosome 7 in patients with prior hematologic malignancies and of chromosomes 11 and 17 in patients with prior solid tumors. A genetic determinism involving abnormal recessive alleles located on chromosomes 5, 7, 11, and 17 uncovered by deletions of the normal homologs may be a cause of S-ANLL. The difference between patients with prior hematologic malignancies or solid tumors may be explained by different constitutional mutations of recessive genes in the two groups of patients

  14. 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.

  15. Legal Drugs Are Good Drugs and Illegal Drugs Are Bad Drugs

    OpenAIRE

    Indrati, Dina; Prasetyo, Herry

    2011-01-01

    ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing s...

  16. Making benefit transfers work

    DEFF Research Database (Denmark)

    Bateman, I.J.; Brouwer, R.; Ferrini, S.

    We develop and test guidance principles for benefits transfers. These argue that when transferring across relatively similar sites, simple mean value transfers are to be preferred but that when sites are relatively dissimilar then value function transfers will yield lower errors. The paper also...... provides guidance on the appropriate specification of transferable value functions arguing that these should be developed from theoretical rather than ad-hoc statistical principles. These principles are tested via a common format valuation study of water quality improvements across five countries. Results...... support our various hypotheses providing a set of principles for future transfer studies. The application also considers new ways of incorporating distance decay, substitution and framing effects within transfers and presents a novel water quality ladder....

  17. PESTICIDES: BENEFITS AND HAZARDS

    Directory of Open Access Journals (Sweden)

    Ivan Maksymiv

    2015-05-01

    Full Text Available Pesticides are an integral part of modern life used to prevent growth of unwanted living  organisms. Despite the fact that scientific statements coming from many toxicological works provide indication on the low risk of the pesticides and their residues, the community especially last years is deeply concerned about massive application of pesticides in diverse fields. Therefore evaluation of hazard risks particularly in long term perspective is very important. In the fact there are at least two clearly different approaches for evaluation of pesticide using: the first one is defined as an objective or probabilistic risk assessment, while the second one is the potential economic and agriculture benefits. Therefore, in this review the author has considered scientifically based assessment of positive and negative effects of pesticide application and discusses possible approaches to find balance between them.

  18. Drugs@FDA: FDA Approved Drug Products

    Science.gov (United States)

    ... Cosmetics Tobacco Products Home Drug Databases Drugs@FDA Drugs@FDA: FDA Approved Drug Products Share Tweet Linkedin Pin it More sharing ... Download Drugs@FDA Express for free Search by Drug Name, Active Ingredient, or Application Number Enter at ...

  19. University Benefits Survey. Part 1 (All Benefits Excluding Pensions).

    Science.gov (United States)

    University of Western Ontario, London.

    Results of a 1983 survey of benefits, excluding pensions, for 17 Ontario, Canada, universities are presented. Information is provided on the following areas: whether the university self-administers insurance plans, communication of benefits, proposed changes in benefits, provision of life and dismemberment insurance, maternity leave policy,…

  20. Study Drugs

    OpenAIRE

    Lam, Stephanie Phuong; Roosta, Natalie; Nielsen, Mikkel Fuhr; Meyer, Maria Holmgaard; Friis, Katrine Birk

    2016-01-01

    In recent years, students around the world, started to use preparations as Ritalin and Modafinil,also known as study drugs, to improve their cognitive abilities1. It is a common use among thestudents in United States of America, but it is a new tendency in Denmark. Our main focus is tolocate whether study drugs needs to be legalized in Denmark or not. To investigate this ourstarting point is to understand central ethical arguments in the debate. We have chosen twoarguments from Nick Bostrom a...

  1. Financial risk management of pharmacy benefits.

    Science.gov (United States)

    Saikami, D

    1997-10-01

    Financial risk management of pharmacy benefits in integrated health systems is explained. A managed care organization should assume financial risk for pharmacy benefits only if it can manage the risk. Horizontally integrated organizations often do not have much control over the management of drug utilization and costs. Vertically integrated organizations have the greatest ability to manage pharmacy financial risk; virtual integration may also be compatible. Contracts can be established in which the provider is incentivized or placed at partial or full risk. The main concerns that health plans have with respect to pharmacy capitation are formulary management and the question of who should receive rebates from manufacturers. The components needed to managed pharmacy financial risk depend on the type of contract negotiated. Health-system pharmacists are uniquely positioned to take advantage of opportunities opening up through pharmacy risk contracting. Functions most organizations must provide when assuming pharmacy financial risk can be divided into internal and external categories. Internally performed functions include formulary management, clinical pharmacy services and utilization management, and utilization reports for physicians. Functions that can be outsourced include claims processing and administration, provider- and customer support services, and rebates. Organizations that integrate the pharmacy benefit across the health care continuum will be more effective in controlling costs and improving outcomes than organizations that handle this benefit as separate from others. Patient care should not focus on payment mechanisms and unit costs but on developing superior processes and systems that improve health care.

  2. Testability evaluation using prior information of multiple sources

    Directory of Open Access Journals (Sweden)

    Wang Chao

    2014-08-01

    Full Text Available Testability plays an important role in improving the readiness and decreasing the life-cycle cost of equipment. Testability demonstration and evaluation is of significance in measuring such testability indexes as fault detection rate (FDR and fault isolation rate (FIR, which is useful to the producer in mastering the testability level and improving the testability design, and helpful to the consumer in making purchase decisions. Aiming at the problems with a small sample of testability demonstration test data (TDTD such as low evaluation confidence and inaccurate result, a testability evaluation method is proposed based on the prior information of multiple sources and Bayes theory. Firstly, the types of prior information are analyzed. The maximum entropy method is applied to the prior information with the mean and interval estimate forms on the testability index to obtain the parameters of prior probability density function (PDF, and the empirical Bayesian method is used to get the parameters for the prior information with a success-fail form. Then, a parametrical data consistency check method is used to check the compatibility between all the sources of prior information and TDTD. For the prior information to pass the check, the prior credibility is calculated. A mixed prior distribution is formed based on the prior PDFs and the corresponding credibility. The Bayesian posterior distribution model is acquired with the mixed prior distribution and TDTD, based on which the point and interval estimates are calculated. Finally, examples of a flying control system are used to verify the proposed method. The results show that the proposed method is feasible and effective.

  3. Testability evaluation using prior information of multiple sources

    Institute of Scientific and Technical Information of China (English)

    Wang Chao; Qiu Jing; Liu Guanjun; Zhang Yong

    2014-01-01

    Testability plays an important role in improving the readiness and decreasing the life-cycle cost of equipment. Testability demonstration and evaluation is of significance in measuring such testability indexes as fault detection rate (FDR) and fault isolation rate (FIR), which is useful to the producer in mastering the testability level and improving the testability design, and helpful to the consumer in making purchase decisions. Aiming at the problems with a small sample of testabil-ity demonstration test data (TDTD) such as low evaluation confidence and inaccurate result, a test-ability evaluation method is proposed based on the prior information of multiple sources and Bayes theory. Firstly, the types of prior information are analyzed. The maximum entropy method is applied to the prior information with the mean and interval estimate forms on the testability index to obtain the parameters of prior probability density function (PDF), and the empirical Bayesian method is used to get the parameters for the prior information with a success-fail form. Then, a parametrical data consistency check method is used to check the compatibility between all the sources of prior information and TDTD. For the prior information to pass the check, the prior credibility is calculated. A mixed prior distribution is formed based on the prior PDFs and the corresponding credibility. The Bayesian posterior distribution model is acquired with the mixed prior distribution and TDTD, based on which the point and interval estimates are calculated. Finally, examples of a flying control system are used to verify the proposed method. The results show that the proposed method is feasible and effective.

  4. Lessons learned: the effect of prior technology use on Web-based interventions.

    Science.gov (United States)

    Carey, Joanne C; Wade, Shari L; Wolfe, Christopher R

    2008-04-01

    This study examined the role of regular prior technology use in treatment response to an online family problem-solving (OFPS) intervention and an Internet resource intervention (IRI) for pediatric traumatic brain injury (TBI). Participants were 150 individuals in 40 families of children with TBI randomly assigned to OFPS intervention or an IRI. All families received free computers and Internet access to TBI resources. OFPS families received Web-based sessions and therapist-guided synchronous videoconferences focusing on problem solving, communication skills, and behavior management. All participants completed measures of depression, anxiety, and computer usage. OFPS participants rated treatment satisfaction, therapeutic alliance, and Web site and technology comfort. With the OFPS intervention, depression and anxiety improved significantly more among technology using parents (n = 14) than nontechnology users (n = 6). Technology users reported increasing comfort with technology over time, and this change was predictive of depression at followup. Satisfaction and ease-of-use ratings did not differ by technology usage. Lack of regular prior home computer usage and nonadherence were predictive of anxiety at followup. The IRI was not globally effective. However, controlling for prior depression, age, and technology at work, there was a significant effect of technology at home for depression. Families with technology experience at home (n = 11) reported significantly greater improvements in depression than families without prior technology experience at home (n = 8). Although Web-based OFPS was effective in improving caregiver functioning, individuals with limited computer experience may benefit less from an online intervention due to increased nonadherence.

  5. A new prize system for drug innovation.

    Science.gov (United States)

    Gandjour, Afschin; Chernyak, Nadja

    2011-10-01

    We propose a new prize (reward) system for drug innovation which pays a price based on the value of health benefits accrued over time. Willingness to pay for a unit of health benefit is determined based on the cost-effectiveness ratio of palliative/nursing care. We solve the problem of limited information on the value of health benefits by mathematically relating reward size to the uncertainty of information including information on potential drug overuse. The proposed prize system offers optimal incentives to invest in research and development because it rewards the innovator for the social value of drug innovation. The proposal is envisaged as a non-voluntary alternative to the current patent system and reduces excessive marketing of innovators and generic drug producers. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  6. Landfill Gas Energy Benefits Calculator

    Science.gov (United States)

    This page contains the LFG Energy Benefits Calculator to estimate direct, avoided, and total greenhouse gas reductions, as well as environmental and energy benefits, for a landfill gas energy project.

  7. Construction and test of the PRIOR proton microscope; Aufbau und Test des Protonenmikroskops PRIOR

    Energy Technology Data Exchange (ETDEWEB)

    Lang, Philipp-Michael

    2015-01-15

    The study of High Energy Density Matter (HEDM) in the laboratory makes great demands on the diagnostics because these states can usually only be created for a short time and usual diagnostic techniques with visible light or X-rays come to their limit because of the high density. The high energy proton radiography technique that was developed in the 1990s at the Los Alamos National Laboratory is a very promising possibility to overcome those limits so that one can measure the density of HEDM with high spatial and time resolution. For this purpose the proton microscope PRIOR (Proton Radiography for FAIR) was set up at GSI, which not only reproduces the image, but also magnifies it by a factor of 4.2 and thereby penetrates matter with a density up to 20 g/cm{sup 2}. Straightaway a spatial resolution of less than 30 μm and a time resolution on the nanosecond scale was achieved. This work describes details to the principle, design and construction of the proton microscope as well as first measurements and simulations of essential components like magnetic lenses, a collimator and a scintillator screen. For the latter one it was possible to show that plastic scintillators can be used as converter as an alternative to the slower but more radiation resistant crystals, so that it is possible to reach a time resolution of 10 ns. Moreover the characteristics were investigated for the system at the commissioning in April 2014. Also the changes in the magnetic field due to radiation damage were studied. Besides that an overview about future applications is given. First experiments with Warm Dense Matter created by using a Pulsed Power Setup have already been performed. Furthermore the promising concept of combining proton radiography with particle therapy has been investigated in context of the PaNTERA project. An outlook on the possibilities with future experiments at the FAIR accelerator facility is given as well. Because of higher beam intensity an energy one can expect even

  8. A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study.

    Science.gov (United States)

    Newman, William G; Payne, Katherine; Tricker, Karen; Roberts, Stephen A; Fargher, Emily; Pushpakom, Sudeep; Alder, Jane E; Sidgwick, Gary P; Payne, Debbie; Elliott, Rachel A; Heise, Marco; Elles, Robert; Ramsden, Simon C; Andrews, Julie; Houston, J Brian; Qasim, Faeiza; Shaffer, Jon; Griffiths, Christopher E M; Ray, David W; Bruce, Ian; Ollier, William E R

    2011-06-01

    To conduct a pragmatic, randomized controlled trial to assess whether thiopurine methyltransferase (TPMT) genotyping prior to azathioprine reduces adverse drug reactions (ADRs). A total of 333 participants were randomized 1:1 to undergo TPMT genotyping prior to azathioprine or to commence treatment without genotyping. There was no difference in the primary outcome of stopping azathioprine due to an adverse reaction (ADR, p = 0.59) between the two study arms. ADRs were more common in older patients (p = 0.01). There was no increase in stopping azathioprine due to ADRs in TPMT heterozygotes compared with wild-type individuals. The single individual with TPMT variant homozygosity experienced severe neutropenia. Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine.

  9. The employee motivation and benefits

    OpenAIRE

    Fuhrmannová, Petra

    2013-01-01

    The aim of this bachelor's study is to describe and analyze the employee motivation and benefits in the payroll system and human recources field. Theoretical part attends to general terms as the employee motivation, the theory of the motivation,the types of the employee benefits, the influence of benefits to the employee's working performance. The practial part focuses on Elanor company, includes introduction of the company, it's history and the present, the offer of the employee benefits. Ne...

  10. Drug Facts

    Medline Plus

    Full Text Available ... Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the button ... sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse (NIDA) | ...

  11. Drugs reviews

    African Journals Online (AJOL)

    Angel_D

    tests (LFTs) to monitor hepatotoxicity (liver [hepatic] damage) is uncommon in many resource-poor ... cholesterol ester storage disease. ... The problem with many patients is that they are taking several drugs often ... Urine, saliva and other body fluids may be coloured orange-red: this can be very alarming to patients.

  12. Drug resistance

    NARCIS (Netherlands)

    Gorter, J.A.; Potschka, H.; Noebels, J.L.; Avoli, M.; Rogawski, M.A.; Olsen, R.W.; Delgado-Escueta, A.V.

    2012-01-01

    Drug resistance remains to be one of the major challenges in epilepsy therapy. Identification of factors that contribute to therapeutic failure is crucial for future development of novel therapeutic strategies for difficult-to-treat epilepsies. Several clinical studies have shown that high seizure

  13. Capping Drugs

    Indian Academy of Sciences (India)

    preventing disease in human beings or in animals. In the process ... of requirement. In the process, they may cause toxic side effects. .... the liver to release the physiologically active drug. Similarly ... patients addicted to alcohol. However, it is a ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... Prevention Phone Numbers and Websites Search Share Listen English Español Information about this page Click on the ... información sobre el abuso de drogas, y adicción. English Español About the National Institute on Drug Abuse ( ...

  15. Adaptive nonparametric Bayesian inference using location-scale mixture priors

    NARCIS (Netherlands)

    Jonge, de R.; Zanten, van J.H.

    2010-01-01

    We study location-scale mixture priors for nonparametric statistical problems, including multivariate regression, density estimation and classification. We show that a rate-adaptive procedure can be obtained if the prior is properly constructed. In particular, we show that adaptation is achieved if

  16. Nudging toward Inquiry: Awakening and Building upon Prior Knowledge

    Science.gov (United States)

    Fontichiaro, Kristin, Comp.

    2010-01-01

    "Prior knowledge" (sometimes called schema or background knowledge) is information one already knows that helps him/her make sense of new information. New learning builds on existing prior knowledge. In traditional reporting-style research projects, students bypass this crucial step and plow right into answer-finding. It's no wonder that many…

  17. Drunkorexia: Calorie Restriction Prior to Alcohol Consumption among College Freshman

    Science.gov (United States)

    Burke, Sloane C.; Cremeens, Jennifer; Vail-Smith, Karen; Woolsey, Conrad

    2010-01-01

    Using a sample of 692 freshmen at a southeastern university, this study examined caloric restriction among students prior to planned alcohol consumption. Participants were surveyed for self-reported alcohol consumption, binge drinking, and caloric intake habits prior to drinking episodes. Results indicated that 99 of 695 (14%) of first year…

  18. Personality, depressive symptoms and prior trauma exposure of new ...

    African Journals Online (AJOL)

    Background. Police officers are predisposed to trauma exposure. The development of depression and post-traumatic stress disorder (PTSD) may be influenced by personality style, prior exposure to traumatic events and prior depression. Objectives. To describe the personality profiles of new Metropolitan Police Service ...

  19. 34 CFR 303.403 - Prior notice; native language.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Prior notice; native language. 303.403 Section 303.403... TODDLERS WITH DISABILITIES Procedural Safeguards General § 303.403 Prior notice; native language. (a... file a complaint and the timelines under those procedures. (c) Native language. (1) The notice must be...

  20. On the use of a pruning prior for neural networks

    DEFF Research Database (Denmark)

    Goutte, Cyril

    1996-01-01

    We address the problem of using a regularization prior that prunes unnecessary weights in a neural network architecture. This prior provides a convenient alternative to traditional weight-decay. Two examples are studied to support this method and illustrate its use. First we use the sunspots...

  1. Bayesian Inference for Structured Spike and Slab Priors

    DEFF Research Database (Denmark)

    Andersen, Michael Riis; Winther, Ole; Hansen, Lars Kai

    2014-01-01

    Sparse signal recovery addresses the problem of solving underdetermined linear inverse problems subject to a sparsity constraint. We propose a novel prior formulation, the structured spike and slab prior, which allows to incorporate a priori knowledge of the sparsity pattern by imposing a spatial...

  2. 5 CFR 6201.103 - Prior approval for outside employment.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Prior approval for outside employment. 6201.103 Section 6201.103 Administrative Personnel EXPORT-IMPORT BANK OF THE UNITED STATES SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXPORT-IMPORT BANK OF THE UNITED STATES § 6201.103 Prior...

  3. Prior authorisation schemes: trade barriers in need of scientific justification

    NARCIS (Netherlands)

    Meulen, van der B.M.J.

    2010-01-01

    Case C-333/08 Commission v. French Republic ‘processing aids’ [2010] ECR-0000 French prior authorisation scheme for processing aids in food production infringes upon Article 34 TFEU** 1. A prior authorisation scheme not complying with the principle of proportionality, infringes upon Article 34 TFEU.

  4. The interpretation of hair analysis for drugs and drug metabolites.

    Science.gov (United States)

    Cuypers, Eva; Flanagan, Robert J

    2018-02-01

    Head hair analysis for drugs and drug metabolites has been used widely with the aim of detecting exposure in the weeks or months prior to sample collection. However, inappropriate interpretation of results has likely led to serious miscarriages of justice, especially in child custody cases. The aim of this review is to assess critically what can, and perhaps more importantly, what cannot be claimed as regards the interpretation of hair test results in a given set of circumstances in order to inform future testing. We searched the PubMed database for papers published 2010-2016 using the terms "hair" and "drug" and "decontamination", the terms "hair" and "drug" and "contamination", the terms "hair" and "drug-facilitated crime", the terms "hair" and "ethyl glucuronide", and the terms "hair", "drug testing" and "analysis". Study of the reference lists of the 46 relevant papers identified 25 further relevant citations, giving a total of 71 citations. Hair samples: Drugs, drug metabolites and/or decomposition products may arise not only from deliberate drug administration, but also via deposition from a contaminated atmosphere if drug(s) have been smoked or otherwise vaporized in a confined area, transfer from contaminated surfaces via food/fingers, etc., and transfer from sweat and other secretions after a single large exposure, which could include anesthesia. Excretion in sweat of endogenous analytes such as γ-hydroxybutyric acid is a potential confounder if its use is to be investigated. Cosmetic procedures such as bleaching or heat treatment of hair may remove analytes prior to sample collection. Hair color and texture, the area of the head the sample is taken from, the growth rate of individual hairs, and how the sample has been stored, may also affect the interpretation of results. Toxicological analysis: Immunoassay results alone do not provide reliable evidence on which to base judicial decisions. Gas or liquid chromatography with mass spectrometric detection

  5. Perturbations in different forms of cost/benefit decision making induced by repeated amphetamine exposure.

    Science.gov (United States)

    Floresco, Stan B; Whelan, Jennifer M

    2009-08-01

    Psychostimulant abuse has been linked to impairments in cost-benefit decision making. We assessed the effects of repeated amphetamine (AMPH) treatment in rodents on two distinct forms of decision making. Separate groups of rats were trained for 26 days on either a probabilistic (risk) or effort-discounting task, each consisting of four discrete blocks of ten choice trials. One lever always delivered a smaller reward (one or two pellets), whereas another lever delivered a four-pellet reward. For risk-discounting, the probability of receiving the larger reward decreased across trial blocks (100-12.5%), whereas on the effort task, four pellets could be obtained after a ratio of presses that increased across blocks (2-20). After training, rats received 15 saline or AMPH injections (escalating from 1 to 5 mg/kg) and were then retested during acute and long-term withdrawal. Repeated AMPH administration increased risky choice 2-3 weeks after drug exposure, whereas these treatments did not alter effort-based decision making in a separate group of animals. However, prior AMPH exposure sensitized the effects of acute AMPH on both forms of decision making, whereby lower doses were effective at inducing "risky" and "lazy" patterns of choice. Repeated AMPH exposure leads to relatively long-lasting increases in risky choice, as well as sensitization to the effects of acute AMPH on different forms of cost/benefit decision making. These findings suggest that maladaptive decision-making processes exhibited by psychostimulant abusers may be caused in part by repeated drug exposure.

  6. Pharmacogenetic testing prior to carbamazepine treatment of epilepsy: patients' and physicians' preferences for testing and service delivery.

    Science.gov (United States)

    Powell, Graham; Holmes, Emily A F; Plumpton, Catrin O; Ring, Adele; Baker, Gus A; Jacoby, Ann; Pirmohamed, Munir; Marson, Anthony G; Hughes, Dyfrig A

    2015-11-01

    Pharmacogenetic studies have identified the presence of the HLA-A*31:01 allele as a predictor of cutaneous adverse drugs reactions (ADRs) to carbamazepine. This study aimed to ascertain the preferences of patients and clinicians to inform carbamazepine pharmacogenetic testing services. Attributes of importance to people with epilepsy and neurologists were identified through interviews and from published sources. Discrete choice experiments (DCEs) were conducted in 82 people with epilepsy and 83 neurologists. Random-effects logit regression models were used to determine the importance of the attributes and direction of effect. In the patient DCE, all attributes (seizure remission, reduction in seizure frequency, memory problems, skin rash and rare, severe ADRs) were significant. The estimated utility of testing was greater, at 0.52 (95% CI 0.19, 1.00) than not testing at 0.33 (95% CI -0.07, 0.81). In the physician DCE, cost, inclusion in the British National Formulary, coverage, negative predictive value (NPV) and positive predictive value (PPV) were significant. Marginal rates of substitution indicated that neurologists were willing to pay £5.87 for a 1 percentage point increase in NPV and £3.99 for a 1 percentage point increase in PPV. The inclusion of both patients' and clinicians' perspectives represents an important contribution to the understanding of preferences towards pharmacogenetic testing prior to initiating carbamazepine. Both groups identified different attributes but had generally consistent preferences. Patients' acceptance of a decrease in treatment benefit for a reduced chance of severe ADRs adds support for the implementation of HLA-A*31:01 testing in routine practice. © 2015 The British Pharmacological Society.

  7. Corporate benefits of CSR activities

    OpenAIRE

    Maja Żychlewicz

    2014-01-01

    The main aim of the paper is to present the benefits that a company may derive from socially responsible activities. The paper lists various definitions of CSR that indicate the expected benefits stemming from its use. Both in theory and in practice, there is observed the need for strategic connection between the CSR concept and its real-life benefits.

  8. Corporate benefits of CSR activities

    Directory of Open Access Journals (Sweden)

    Maja Żychlewicz

    2014-11-01

    Full Text Available The main aim of the paper is to present the benefits that a company may derive from socially responsible activities. The paper lists various definitions of CSR that indicate the expected benefits stemming from its use. Both in theory and in practice, there is observed the need for strategic connection between the CSR concept and its real-life benefits.

  9. Cost benefit analysis vs. referenda

    OpenAIRE

    Martin J. Osborne; Matthew A. Turner

    2007-01-01

    We consider a planner who chooses between two possible public policies and ask whether a referendum or a cost benefit analysis leads to higher welfare. We find that a referendum leads to higher welfare than a cost benefit analyses in "common value" environments. Cost benefit analysis is better in "private value" environments.

  10. Benefit-based tree valuation

    Science.gov (United States)

    E.G. McPherson

    2007-01-01

    Benefit-based tree valuation provides alternative estimates of the fair and reasonable value of trees while illustrating the relative contribution of different benefit types. This study compared estimates of tree value obtained using cost- and benefit-based approaches. The cost-based approach used the Council of Landscape and Tree Appraisers trunk formula method, and...

  11. 76 FR 41434 - Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for...

    Science.gov (United States)

    2011-07-14

    .... FDA-2011-N-0446] Removal of Certain Requirements Related to the Prescription Drug Marketing Act... Food and Drug Administration (FDA) is proposing to remove a section of the Prescription Drug Marketing... prior sale, purchase, or trade of such drug,'' starting with the manufacturer, and that the identifying...

  12. Variational segmentation problems using prior knowledge in imaging and vision

    DEFF Research Database (Denmark)

    Fundana, Ketut

    This dissertation addresses variational formulation of segmentation problems using prior knowledge. Variational models are among the most successful approaches for solving many Computer Vision and Image Processing problems. The models aim at finding the solution to a given energy functional defined......, prior knowledge is needed to obtain the desired solution. The introduction of shape priors in particular, has proven to be an effective way to segment objects of interests. Firstly, we propose a prior-based variational segmentation model to segment objects of interest in image sequences, that can deal....... Many objects have high variability in shape and orientation. This often leads to unsatisfactory results, when using a segmentation model with single shape template. One way to solve this is by using more sophisticated shape models. We propose to incorporate shape priors from a shape sub...

  13. Logarithmic Laplacian Prior Based Bayesian Inverse Synthetic Aperture Radar Imaging.

    Science.gov (United States)

    Zhang, Shuanghui; Liu, Yongxiang; Li, Xiang; Bi, Guoan

    2016-04-28

    This paper presents a novel Inverse Synthetic Aperture Radar Imaging (ISAR) algorithm based on a new sparse prior, known as the logarithmic Laplacian prior. The newly proposed logarithmic Laplacian prior has a narrower main lobe with higher tail values than the Laplacian prior, which helps to achieve performance improvement on sparse representation. The logarithmic Laplacian prior is used for ISAR imaging within the Bayesian framework to achieve better focused radar image. In the proposed method of ISAR imaging, the phase errors are jointly estimated based on the minimum entropy criterion to accomplish autofocusing. The maximum a posterior (MAP) estimation and the maximum likelihood estimation (MLE) are utilized to estimate the model parameters to avoid manually tuning process. Additionally, the fast Fourier Transform (FFT) and Hadamard product are used to minimize the required computational efficiency. Experimental results based on both simulated and measured data validate that the proposed algorithm outperforms the traditional sparse ISAR imaging algorithms in terms of resolution improvement and noise suppression.

  14. Total Variability Modeling using Source-specific Priors

    DEFF Research Database (Denmark)

    Shepstone, Sven Ewan; Lee, Kong Aik; Li, Haizhou

    2016-01-01

    sequence of an utterance. In both cases the prior for the latent variable is assumed to be non-informative, since for homogeneous datasets there is no gain in generality in using an informative prior. This work shows in the heterogeneous case, that using informative priors for com- puting the posterior......, can lead to favorable results. We focus on modeling the priors using minimum divergence criterion or fac- tor analysis techniques. Tests on the NIST 2008 and 2010 Speaker Recognition Evaluation (SRE) dataset show that our proposed method beats four baselines: For i-vector extraction using an already...... trained matrix, for the short2-short3 task in SRE’08, five out of eight female and four out of eight male common conditions, were improved. For the core-extended task in SRE’10, four out of nine female and six out of nine male common conditions were improved. When incorporating prior information...

  15. Example-driven manifold priors for image deconvolution.

    Science.gov (United States)

    Ni, Jie; Turaga, Pavan; Patel, Vishal M; Chellappa, Rama

    2011-11-01

    Image restoration methods that exploit prior information about images to be estimated have been extensively studied, typically using the Bayesian framework. In this paper, we consider the role of prior knowledge of the object class in the form of a patch manifold to address the deconvolution problem. Specifically, we incorporate unlabeled image data of the object class, say natural images, in the form of a patch-manifold prior for the object class. The manifold prior is implicitly estimated from the given unlabeled data. We show how the patch-manifold prior effectively exploits the available sample class data for regularizing the deblurring problem. Furthermore, we derive a generalized cross-validation (GCV) function to automatically determine the regularization parameter at each iteration without explicitly knowing the noise variance. Extensive experiments show that this method performs better than many competitive image deconvolution methods.

  16. Drug abuse first aid

    Science.gov (United States)

    ... use of these drugs is a form of drug abuse. Medicines that are for treating a health problem ... about local resources. Alternative Names Overdose from drugs; Drug abuse first aid References Myck MB. Hallucinogens and drugs ...

  17. Prior elicitation and Bayesian analysis of the Steroids for Corneal Ulcers Trial.

    Science.gov (United States)

    See, Craig W; Srinivasan, Muthiah; Saravanan, Somu; Oldenburg, Catherine E; Esterberg, Elizabeth J; Ray, Kathryn J; Glaser, Tanya S; Tu, Elmer Y; Zegans, Michael E; McLeod, Stephen D; Acharya, Nisha R; Lietman, Thomas M

    2012-12-01

    To elicit expert opinion on the use of adjunctive corticosteroid therapy in bacterial corneal ulcers. To perform a Bayesian analysis of the Steroids for Corneal Ulcers Trial (SCUT), using expert opinion as a prior probability. The SCUT was a placebo-controlled trial assessing visual outcomes in patients receiving topical corticosteroids or placebo as adjunctive therapy for bacterial keratitis. Questionnaires were conducted at scientific meetings in India and North America to gauge expert consensus on the perceived benefit of corticosteroids as adjunct treatment. Bayesian analysis, using the questionnaire data as a prior probability and the primary outcome of SCUT as a likelihood, was performed. For comparison, an additional Bayesian analysis was performed using the results of the SCUT pilot study as a prior distribution. Indian respondents believed there to be a 1.21 Snellen line improvement, and North American respondents believed there to be a 1.24 line improvement with corticosteroid therapy. The SCUT primary outcome found a non-significant 0.09 Snellen line benefit with corticosteroid treatment. The results of the Bayesian analysis estimated a slightly greater benefit than did the SCUT primary analysis (0.19 lines verses 0.09 lines). Indian and North American experts had similar expectations on the effectiveness of corticosteroids in bacterial corneal ulcers; that corticosteroids would markedly improve visual outcomes. Bayesian analysis produced results very similar to those produced by the SCUT primary analysis. The similarity in result is likely due to the large sample size of SCUT and helps validate the results of SCUT.

  18. Radioiodine therapy in patients with Graves' disease and the effects of prior carbimazole therapy.

    Science.gov (United States)

    Karyampudi, Arun; Hamide, Abdoul; Halanaik, Dhanapathi; Sahoo, Jaya Prakash; Kamalanathan, Sadishkumar

    2014-09-01

    The use of radioiodine as the first line of treatment in Graves' disease is restricted in India because of its limited availability and an unrealistic risk perception associated with it. Additionally, the effectiveness of radioiodine ablation in Graves' disease is influenced by many factors. Prior medical antithyroid therapy is one such important factor. To analyze the efficacy of low dose radioiodine therapy (5 mCi) in treatment of naive patients of Graves' disease in comparison to that in which it was already primed with an antithyroid drug, carbimazole. A non-randomized, interventional study conducted in the Department of Medicine and Endocrinology of a tertiary care institute in South India. The study had two groups; Group A (36 treatment naive, uncomplicated Graves' disease patients) and B (34 Graves' disease patients on carbimazole prior to radioiodine therapy). Both groups had baseline clinical, biochemical evaluation and were reassessed at 3 and 6 months for evaluating the clinical status for possible documentation of cure. The cure rate was 61.1% in drug naive group and 58.8% in pretreated group at 6 months following radioiodine (P = 0.845). Higher baseline 999m technicium (99m Tc) uptake, male gender, BMI and higher baseline free thyroxine (fT4) level predicted treatment failure following radioiodine therapy. Administration of carbimazole prior to low dose radioiodine therapy does not alter the efficacy of radioiodine. Low fixed dose (5 mCi) of radioactive iodine may be a safe and effective primary therapeutic option in Graves' disease patients pretreated with antithyroid drugs.

  19. 76 FR 20823 - Agency Information Collection (Veterans Benefits Administration (VBA) Voice of the Veteran (VOV...

    Science.gov (United States)

    2011-04-13

    ... AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In... to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room... benefit claim within 30 days prior to the fielding period. The sample will be stratified as follows: (1...

  20. How isotopes benefit industry

    International Nuclear Information System (INIS)

    1967-01-01

    The life of bus engines and the time taken to make beer are not at first sight connected with atomic energy. Yet the first has been considerably lengthened and the second even more considerably shortened in different countries as a result of using nuclear techniques and materials. They are only two examples; there are many others which have improved efficiency in factories, oilfields, chemical plants and other industries. They indicate not only the results of ingenuity but the rewards possible from more widespread use of the new methods. At a symposium on radioisotope tracers in industry and geophysics organized by the Agency and held in Prague during November many reports showed not only what is possible but what is actually being accomplished in a number of industries as a matter of daily routine. The economic benefits were also demonstrated, and although the developments have been mainly in countries already highly industrialized, the potential for new industries in developing countries was clear. Research to improve performance of motorcar, aircraft and tractor engines has been directed at establishing the causes of friction, corrosion and wear. In brewing beer it has been possible to accelerate fermentation. Pollution both of water and air can be reduced and methods of waste disposal improved. Many economies have been effected in oil production. Better quality and lower costs have resulted from work in chemical plants and processes such as glass making, metal refining, plastics and many others. Dams and railways were also mentioned among the great variety of subjects suitable for radioisotope techniques

  1. Cardiovascular benefits of exercise

    Directory of Open Access Journals (Sweden)

    Agarwal SK

    2012-06-01

    Full Text Available Shashi K AgarwalMedical Director, Agarwal Health Center, NJ, USAAbstract: Regular physical activity during leisure time has been shown to be associated with better health outcomes. The American Heart Association, the Centers for Disease Control and Prevention and the American College of Sports Medicine all recommend regular physical activity of moderate intensity for the prevention and complementary treatment of several diseases. The therapeutic role of exercise in maintaining good health and treating diseases is not new. The benefits of physical activity date back to Susruta, a 600 BC physician in India, who prescribed exercise to patients. Hippocrates (460–377 BC wrote “in order to remain healthy, the entire day should be devoted exclusively to ways and means of increasing one's strength and staying healthy, and the best way to do so is through physical exercise.” Plato (427–347 BC referred to medicine as a sister art to physical exercise while the noted ancient Greek physician Galen (129–217 AD penned several essays on aerobic fitness and strengthening muscles. This article briefly reviews the beneficial effects of physical activity on cardiovascular diseases.Keywords: exercise, cardiovascular disease, lifestyle changes, physical activity, good health

  2. Environmental benefits of ethanol

    International Nuclear Information System (INIS)

    1998-11-01

    The environmental benefits of ethanol blended fuels in helping to reduce harmful emissions into the atmosphere are discussed. The use of oxygenated fuels such as ethanol is one way of addressing air pollution concerns such as ozone formation. The state of California has legislated stringent automobile emissions standards in an effort to reduce emissions that contribute to the formation of ground-level ozone. Several Canadian cities also record similar hazardous exposures to carbon monoxide, particularly in fall and winter. Using oxygenated fuels such as ethanol, is one way of addressing the issue of air pollution. The net effect of ethanol use is an overall decrease in ozone formation. For example, use of a 10 per cent ethanol blend results in a 25-30 per cent reduction in carbon monoxide emissions by promoting a more complete combustion of the fuel. It also results in a 6-10 per cent reduction of carbon dioxide, and a seven per cent overall decrease in exhaust VOCs (volatile organic compounds). The environmental implications of feedstock production associated with the production of ethanol for fuel was also discussed. One of the Canadian government's initiatives to address the climate change challenge is its FleetWise initiative, in which it has agreed to a phased-in acquisition of alternative fuel vehicles by the year 2005. 9 refs

  3. Emissions - problems and benefits

    International Nuclear Information System (INIS)

    Rossi, C.; Hurd, P.J.

    1992-01-01

    Air pollution due to emissions arising from the use of biomass in electricity generation is discussed. One of the most attractive aspects of the use of biomass is that there is no net increase of carbon dioxide in the atmosphere. During growth biomass absorbs CO 2 ; during combustion, either directly or as biomass derived fuels, it releases CO 2 , making a closed cycle. Another benefit from the use of biomass is its typically very low sulphur content and the consequent low sulphur oxide emissions from biomass-fired generation plants. Biomass is, however, less satisfactory in relation to nitrogen oxides (NO x ). Control of the nitrogen content of the biomass feedstock, advanced high technology combustion techniques and some post-engine treatment may all be necessary to comply with the legal limits for NO x emissions. The low ash content of biomass, particularly biomass derived oils, makes it possible to limit particulate emission to very low levels. It will be important, though, to bear in mind the need to limit the sodium and potassium content to below 1 ppm by mass in bio-oil to be used in a high temperature gas turbine. Levels of micropollutants will be low if the chlorine content of biomass feedstock is low. However, residence times at peak temperature in typical gas turbines combustors are too short to destroy some micropollutants. (UK)

  4. How isotopes benefit industry

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1967-02-15

    The life of bus engines and the time taken to make beer are not at first sight connected with atomic energy. Yet the first has been considerably lengthened and the second even more considerably shortened in different countries as a result of using nuclear techniques and materials. They are only two examples; there are many others which have improved efficiency in factories, oilfields, chemical plants and other industries. They indicate not only the results of ingenuity but the rewards possible from more widespread use of the new methods. At a symposium on radioisotope tracers in industry and geophysics organized by the Agency and held in Prague during November many reports showed not only what is possible but what is actually being accomplished in a number of industries as a matter of daily routine. The economic benefits were also demonstrated, and although the developments have been mainly in countries already highly industrialized, the potential for new industries in developing countries was clear. Research to improve performance of motorcar, aircraft and tractor engines has been directed at establishing the causes of friction, corrosion and wear. In brewing beer it has been possible to accelerate fermentation. Pollution both of water and air can be reduced and methods of waste disposal improved. Many economies have been effected in oil production. Better quality and lower costs have resulted from work in chemical plants and processes such as glass making, metal refining, plastics and many others. Dams and railways were also mentioned among the great variety of subjects suitable for radioisotope techniques

  5. The benefits of visibility

    International Nuclear Information System (INIS)

    Krupnick, A.; DeWitt, D.

    1994-01-01

    The benefits of visibility improvement (or the damages with additional degradation) refer to increases (or decreases) in utility obtained in three different dimensions. The first of these is associated with the nature of the visibility change. Visual range may be improved so that features of an area become more distinct or the sky becomes clearer. Alternatively, normal features of an area may be marred, say by the site of a power plant or its plume (called plume blight). The second dimension is the location of the change: in an urban area, in a rural setting, or in a recreational area or area of particular beauty, such as the Grand Canyon. The third dimension is the type of value: use or non-use. Thus, a person who visits the Grand Canyon (or may visit it in the future) may hold use values for improving his view of the Canyon or its surroundings and may also old non-use values for improved visibility (whether for altruistic or other reasons) irrespective of present or planned visits. In all, therefore, there are 12 possible combinations of the elements in these three dimension, each of which is logically distinct from the others and which demands attention in the literature to derive willingness to pay (WTP)

  6. The benefits of visibility

    Energy Technology Data Exchange (ETDEWEB)

    Krupnick, A; DeWitt, D

    1994-07-01

    The benefits of visibility improvement (or the damages with additional degradation) refer to increases (or decreases) in utility obtained in three different dimensions. The first of these is associated with the nature of the visibility change. Visual range may be improved so that features of an area become more distinct or the sky becomes clearer. Alternatively, normal features of an area may be marred, say by the site of a power plant or its plume (called plume blight). The second dimension is the location of the change: in an urban area, in a rural setting, or in a recreational area or area of particular beauty, such as the Grand Canyon. The third dimension is the type of value: use or non-use. Thus, a person who visits the Grand Canyon (or may visit it in the future) may hold use values for improving his view of the Canyon or its surroundings and may also old non-use values for improved visibility (whether for altruistic or other reasons) irrespective of present or planned visits. In all, therefore, there are 12 possible combinations of the elements in these three dimension, each of which is logically distinct from the others and which demands attention in the literature to derive willingness to pay (WTP)

  7. The benefits of cooling boar semen in long-term extenders prior to cryopreservation on sperm quality characteristics.

    Science.gov (United States)

    Wasilewska, K; Zasiadczyk, Ł; Fraser, L; Mogielnicka-Brzozowska, M; Kordan, W

    2016-10-01

    This study investigated the effects of long-term extenders on post-thaw sperm quality characteristics following different holding times (HT) of boar semen at 17 and 10°C. Sperm-rich fractions, collected from five boars, were diluted in Androhep(®) Plus (AHP), Androstar(®) Plus (ASP), Safecell(®) Plus and TRIXcell(®) Plus (TCP) extenders. The extended semen samples were held for 2 hr at 17°C (HT 1) and additionally for 24 hr at 10°C (HT 2), after they were evaluated and frozen. CASA sperm motility and motion patterns, mitochondrial membrane potential (MMP), plasma membrane integrity (PMI) and normal apical ridge (NAR) acrosome integrity were assessed in the pre-freeze and frozen-thawed semen. The Vybrant Apoptosis Assay Kit was used to analyse the proportions of viable and plasma membrane apoptotic-like changes in spermatozoa. Results indicated that boar variability, extender and HT significantly affected the sperm quality characteristics, particularly after freezing-thawing. Differences in the pre-freeze semen were more marked in the sperm motion patterns between the HTs. Pre-freeze semen in HT 2 showed significantly higher VCL and VAP, whereas no marked effects were observed in the sperm membrane integrity and viability (YO-PRO-1(-) /PI(-) ) among the extenders. Post-thaw sperm TMOT and PMOT were significantly higher in the AHP and ASP extenders of HT 2 group, whereas VSL, VCL and VAP were markedly lower in the TCP extender. Furthermore, spermatozoa from the AHP- and ASP-extended semen of HT 2 group were characterized by higher MMP, PMI and NAR acrosome integrity following freezing-thawing. In most of the extenders, the incidence of frozen-thawed spermatozoa with apoptotic-like changes was greater in HT 1. The findings of this study indicate that holding of boar semen at 10°C for 24 hr in long-term preservation extenders modulates post-thaw sperm quality characteristics in an extender-dependent manner. These results will further contribute to the improvement in the cryopreservation technology of boar semen. © 2016 Blackwell Verlag GmbH.

  8. Injection drug users’ involvement in drug dealing in the downtown eastside of Vancouver: Social organization and systemic violence

    Science.gov (United States)

    Small, Will; Maher, Lisa; Lawlor, Jeff; Wood, Evan; Shannon, Kate; Kerr, Thomas

    2014-01-01

    Background Illicit drug markets are a key component of the risk environment surrounding injection drug use. However, relatively few studies have explored how injection drug users’ (IDUs) involvement in drug dealing shapes their experiences of drug market-related harm. This exploratory qualitative study aims to understand IDUs’ dealing activities and roles, as well as the perceived benefits and risks related to participation in illicit drug markets, including experiences of drug market violence. Methods Ten IDUs with extensive involvement in drug dealing activities were recruited from the Vancouver Injection Drug User Study (VIDUS) and participated in semi-structured qualitative interviews, which elicited discussion of experiences dealing drugs, perceived benefits and hazards related to dealing, and understandings of drug market violence. Results Participant's involvement in drug market activities included corporate sales, freelance or independent sales, and opportunistic sales termed “middling” as well as drug market-related hustles entailing selling bogus drugs and robbing dealers. Participants primarily dealt drugs to support their own illicit drug use, and we found that arrest and criminal justice involvement, hazards stemming from drug debts, and drug market-related violence were key risks related to dealing activities. Conclusion The challenges of managing personal consumption while selling drugs exacerbates the hazards associated with drug dealing. Efforts to address drug dealing among IDUs should consider both drug dependency and the material conditions that propel drug users towards dealing activities. Interventions should explore the potential of combining enhanced drug treatment programs with low threshold employment and alternative income generation opportunities. PMID:23664788

  9. Therapeutic drug monitoring in pregnancy.

    Science.gov (United States)

    Matsui, Doreen M

    2012-10-01

    Therapeutic drug monitoring (TDM) is commonly recommended to optimize drug dosing regimens of various medications. It has been proposed to guide therapy in pregnant women, in whom physiological changes may lead to altered pharmacokinetics resulting in difficulty in predicting the appropriate drug dosage. Ideally, TDM may play a role in enhancing the effectiveness of treatment while minimizing toxicity of both the mother and fetus. Monitoring of drug levels may also be helpful in assessing adherence to prescribed therapy in selected cases. Limitations exist as therapeutic ranges have only been defined for a limited number of drugs and are based on data obtained in nonpregnant patients. TDM has been suggested for anticonvulsants, antidepressants, and antiretroviral drugs, based on pharmacokinetic studies that have shown reduced drug concentrations. However, there is only relatively limited (and sometimes inconsistent) information regarding the clinical impact of these pharmacokinetic changes during pregnancy and the effect of subsequent dose adjustments. Further studies are required to determine whether implementation of TDM during pregnancy improves outcome and is associated with any benefit beyond that achieved by clinical judgment alone. The cost effectiveness of TDM programs during pregnancy also remains to be examined.

  10. The influence of prior knowledge on the retrieval-directed function of note taking in prior knowledge activation

    NARCIS (Netherlands)

    Wetzels, Sandra; Kester, Liesbeth; Van Merriënboer, Jeroen; Broers, Nick

    2010-01-01

    Wetzels, S. A. J., Kester, L., Van Merriënboer, J. J. G., & Broers, N. J. (2011). The influence of prior knowledge on the retrieval-directed function of note taking in prior knowledge activation. British Journal of Educational Psychology, 81(2), 274-291. doi: 10.1348/000709910X517425

  11. 20 CFR 638.511 - Drug use and abuse.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Drug use and abuse. 638.511 Section 638.511... TITLE IV-B OF THE JOB TRAINING PARTNERSHIP ACT Center Operations § 638.511 Drug use and abuse. The Job... and education programs related to drug and alcohol use and abuse. ...

  12. Drug Safety: Managing Multiple Drugs

    Science.gov (United States)

    ... This series is produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project sup- ported by grants from the Engelberg Foundation and the National Library of Medicine of ... Consumer and Prescriber Education Grant Program which is funded ...

  13. A benefit-risk assessment of class III antiarrhythmic agents

    DEFF Research Database (Denmark)

    Brendorp, Bente; Pedersen, Oledyg; Torp-Pedersen, Christian

    2002-01-01

    , which differentiates them from the others. However, all have potential serious adverse events. Proarrhythmia, especially torsade de pointes, is a common problem making the benefit-risk ratio of these drugs a key question. Class III drugs have been evaluated in different settings: primary and secondary...... prevention of ventricular arrhythmias and in treatment of atrial fibrillation or flutter. Based on existing evidence there is no routine indication for antiarrhythmic drug therapy other than beta-blockers in patients at high risk of sudden death. Subgroup analyses of trials with amiodarone and dofetilide......-intervals or - in the future - from genetic testing. Class III drugs are effective in converting atrial fibrillation to sinus rhythm and for the maintenance of sinus rhythm after conversion. This is currently by far the most important indication for this class of drugs. As defined by recent guidelines, amiodarone...

  14. Will growth in cryptomarket drug buying increase the harms of illicit drugs?

    Science.gov (United States)

    Aldridge, Judith; Stevens, Alex; Barratt, Monica J

    2018-05-01

    Cryptomarkets-on-line, anonymous market-places for illicit goods and services that specialize mainly in drugs-account for a small but rapidly growing share of the illicit drug market in many countries. Policy responses so far are based generally on the assumption that their rise will only increase drug harms. In this contribution for debate, we question this assumption. We provide a narrative review of the emerging literature connected to drug cryptomarkets. We use MacCoun & Reuter's formula to understand the effect of population-level increases in use on total harm as depending on the level of harm associated with each unit of use. We then consider the potential for cryptomarkets to increase or decrease the harms and benefits related to each unit of drug use, with specific attention to the quality of drugs sold and the non-drug-related harms and benefits for customers. It is likely that cryptomarkets will increase both the amount and the range of substances that are sold. However, we argue that the effects on harms will depend upon whether cryptomarkets also increase the quality and safety of products that are sold, provide harm-reducing information to consumers and reduce transactional conflict involved in drug purchasing. There is an emerging and rapidly growing evidence base connected to the macro and micro harms and benefits of cryptomarkets for drug users. Future researchers should use appropriately matched comparative designs to establish more firmly the differential harms and benefits of sourcing drugs both on- and off-line. While it is unlikely that the on-line drug trade can be eradicated completely, cryptomarkets will respond to regulation and enforcement in ways that have complex, and sometimes unanticipated, effects on both harms and benefits. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

  15. Bayesian road safety analysis: incorporation of past evidence and effect of hyper-prior choice.

    Science.gov (United States)

    Miranda-Moreno, Luis F; Heydari, Shahram; Lord, Dominique; Fu, Liping

    2013-09-01

    This paper aims to address two related issues when applying hierarchical Bayesian models for road safety analysis, namely: (a) how to incorporate available information from previous studies or past experiences in the (hyper) prior distributions for model parameters and (b) what are the potential benefits of incorporating past evidence on the results of a road safety analysis when working with scarce accident data (i.e., when calibrating models with crash datasets characterized by a very low average number of accidents and a small number of sites). A simulation framework was developed to evaluate the performance of alternative hyper-priors including informative and non-informative Gamma, Pareto, as well as Uniform distributions. Based on this simulation framework, different data scenarios (i.e., number of observations and years of data) were defined and tested using crash data collected at 3-legged rural intersections in California and crash data collected for rural 4-lane highway segments in Texas. This study shows how the accuracy of model parameter estimates (inverse dispersion parameter) is considerably improved when incorporating past evidence, in particular when working with the small number of observations and crash data with low mean. The results also illustrates that when the sample size (more than 100 sites) and the number of years of crash data is relatively large, neither the incorporation of past experience nor the choice of the hyper-prior distribution may affect the final results of a traffic safety analysis. As a potential solution to the problem of low sample mean and small sample size, this paper suggests some practical guidance on how to incorporate past evidence into informative hyper-priors. By combining evidence from past studies and data available, the model parameter estimates can significantly be improved. The effect of prior choice seems to be less important on the hotspot identification. The results show the benefits of incorporating prior

  16. Learning priors for Bayesian computations in the nervous system.

    Directory of Open Access Journals (Sweden)

    Max Berniker

    Full Text Available Our nervous system continuously combines new information from our senses with information it has acquired throughout life. Numerous studies have found that human subjects manage this by integrating their observations with their previous experience (priors in a way that is close to the statistical optimum. However, little is known about the way the nervous system acquires or learns priors. Here we present results from experiments where the underlying distribution of target locations in an estimation task was switched, manipulating the prior subjects should use. Our experimental design allowed us to measure a subject's evolving prior while they learned. We confirm that through extensive practice subjects learn the correct prior for the task. We found that subjects can rapidly learn the mean of a new prior while the variance is learned more slowly and with a variable learning rate. In addition, we found that a Bayesian inference model could predict the time course of the observed learning while offering an intuitive explanation for the findings. The evidence suggests the nervous system continuously updates its priors to enable efficient behavior.

  17. Implicit Priors in Galaxy Cluster Mass and Scaling Relation Determinations

    Science.gov (United States)

    Mantz, A.; Allen, S. W.

    2011-01-01

    Deriving the total masses of galaxy clusters from observations of the intracluster medium (ICM) generally requires some prior information, in addition to the assumptions of hydrostatic equilibrium and spherical symmetry. Often, this information takes the form of particular parametrized functions used to describe the cluster gas density and temperature profiles. In this paper, we investigate the implicit priors on hydrostatic masses that result from this fully parametric approach, and the implications of such priors for scaling relations formed from those masses. We show that the application of such fully parametric models of the ICM naturally imposes a prior on the slopes of the derived scaling relations, favoring the self-similar model, and argue that this prior may be influential in practice. In contrast, this bias does not exist for techniques which adopt an explicit prior on the form of the mass profile but describe the ICM non-parametrically. Constraints on the slope of the cluster mass-temperature relation in the literature show a separation based the approach employed, with the results from fully parametric ICM modeling clustering nearer the self-similar value. Given that a primary goal of scaling relation analyses is to test the self-similar model, the application of methods subject to strong, implicit priors should be avoided. Alternative methods and best practices are discussed.

  18. Legal Drugs Are Good Drugs And Illegal Drugs Are Bad Drugs

    Directory of Open Access Journals (Sweden)

    Dina Indrati

    2011-07-01

    Full Text Available ABSTRACT : Labelling drugs are important issue nowadays in a modern society. Although it is generally believed that legal drugs are good drugs and illegal drugs are bad drugs, it is evident that some people do not aware about the side effects of drugs used. Therefore, a key contention of this philosophical essay is that explores harms minimisation policy, discuss whether legal drugs are good drugs and illegal drugs are bad drugs and explores relation of drugs misuse in a psychiatric nursing setting and dual diagnosis.Key words: Legal, good drugs, illegal, bad drugs.

  19. Sex Under the Influence of Drugs or Alcohol: Common for Men in Substance Abuse Treatment and Associated with High Risk Sexual Behavior

    Science.gov (United States)

    Calsyn, Donald A.; Cousins, Sarah J.; Hatch-Maillette, Mary A.; Forcehimes, Alyssa; Mandler, Raul; Doyle, Suzanne R.; Woody, George

    2010-01-01

    Sex under the influence of drugs or alcohol is associated with high risk sexual behavior. Heterosexual men (n=505) in substance abuse treatment completed a computer administered interview assessing sexual risk behaviors. Most men (73.3%) endorsed sex under the influence in the prior 90 days, and 39.1% endorsed sex under the influence during their most recent sexual event. Sex under the influence at the most recent event was more likely to involve anal intercourse, sex with a casual partner, and less condom use. Patients might benefit from interventions targeting sexual behavior and substance use as mutual triggers. PMID:20163383

  20. Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy.

    Science.gov (United States)

    Navar, Ann Marie; Taylor, Benjamin; Mulder, Hillary; Fievitz, Eugene; Monda, Keri L; Fievitz, Anna; Maya, Juan F; López, J Antonio G; Peterson, Eric D

    2017-11-01

    Although PCSK9 inhibitors (PCSK9i) were approved in 2015, their high cost has led to strict prior authorization practices and high copays, and use of PSCK9i in clinical practice has been low. To evaluate patient access to PCSK9i among those prescribed therapy. Using pharmacy transaction data, we evaluated 45 029 patients who were newly prescribed PCSK9i in the United States between August 1, 2015, and July 31, 2016. The proportion of PCSK9i prescriptions approved and abandoned (approved but unfilled); multivariable analyses examined factors associated with approval/abandonment including payor, prescriber specialty, pharmacy benefit manager, out-of-pocket cost (copay), clinical diagnoses, lipid-lowering medication use, and low-density lipoprotein cholesterol levels. Of patients given an incident PCSK9i prescription, 51.2% were women, 56.6% were 65 years or older, and 52.5% had governmental insurance. Of the patients given a prescription, 20.8% received approval on the first day, and 47.2% ever received approval. Of those approved, 65.3% filled the prescription, resulting in 30.9% of those prescribed PCSK9i ever receiving therapy. After adjustment, patients who were older, male, and had atherosclerotic cardiovascular disease were more likely to be approved, but approval rates did not vary by patient low-density lipoprotein cholesterol level nor statin use. Other factors associated with drug approval included having government vs commercial insurance (odds ratio [OR], 3.3; 95% CI, 2.8-3.8), and those filled at a specialty vs retail pharmacy (OR, 1.96; 95% CI, 1.66-2.33). Approval rates varied nearly 3-fold among the top 10 largest pharmacy benefit managers. Prescription abandonment by patients was most associated with copay costs (C statistic, 0.86); with abandonment rates ranging from 7.5% for those with $0 copay to more than 75% for copays greater than $350. In the first year of availability, only half of patients prescribed a PCSK9i received approval, and one

  1. 20 CFR 10.809 - How are payments for medicinal drugs determined?

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false How are payments for medicinal drugs determined? 10.809 Section 10.809 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF... for medicinal drugs determined? Payment for medicinal drugs prescribed by physicians shall not exceed...

  2. An evaluation of the benefits and value of libraries

    CERN Document Server

    Nyström, Viveca

    2011-01-01

    An Evaluation of the Benefits and Value of Libraries provides guidance on how to evaluate libraries and contains many useful examples of methods that can be used throughout this process. There is substantial focus on the importance of goals and objectives, along with advice on strategies that can be used in the case of libraries that may not be well resourced for conducting surveys. The text will be useful as a handbook, and does not assume prior knowledge of finance or economics. A guide on how to conduct a cost-benefit analysis on library services and a discussion on how to use scenario anal

  3. Complicated lichenoid drug eruption.

    Science.gov (United States)

    Armour, Katherine; Lowe, Patricia

    2005-02-01

    We report a case of severe lichenoid drug eruption with multiple possible causative agents. A hepatitis C-positive male presented with a short history of painful erosions of the vermilion, lichenoid lesions on the buccal mucosa and glans penis, and erosions and lichenification of the scrotum. In addition, he had a pruritic polymorphic eruption over the scalp, trunk and limbs, comprising psoriasiform and eczematous lesions. He had received combination therapy of pegylated interferon-alpha-2a and ribavirin, along with granulocyte colony-stimulating factor for interferon-induced leucopenia, and propranolol for portal hypertension. The former three agents were ceased 3 weeks prior to presentation, but he remained on propranolol at the initial dermatology consultation. The polymorphous clinical picture was consistent with lichenoid drug eruption, which was confirmed on histology. The papulosquamous eruption responded quickly to 2 weeks of oral prednisone 25 mg daily, which was tapered to 1 mg over 3 months and then ceased. The mucosal lesions were slow to improve and required the addition of tacrolimus 0.03% solution t.d.s. for complete resolution.

  4. Drugs for insomnia.

    Science.gov (United States)

    Zisapel, Nava

    2012-09-01

    Sleep is a vital neurochemical process involving sleep-promoting and arousal centers in the brain. Insomnia is a pervasive disorder characterized by difficulties in initiating or maintaining or non-refreshing (poor quality) sleep and clinically significant daytime distress. Insomnia is more prevalent in women and old age and puts sufferers at significant physical and mental health risks. This review summarizes published data on the current and emerging insomnia drug classes, rationale for development and associated risks/benefits. (Summary of Product Characteristics and Medline search on "hypnotic" or specific drug names and "Insomnia"). GABA(A) receptor modulators facilitate sleep onset and some improve maintenance but increase risk of dependence, memory, cognitive and psychomotor impairments, falls, accidents and mortality. Melatonin receptor agonists improve quality of sleep and/or sleep onset but response may develop over several days. They have more benign safety profiles and are indicated for milder insomnia, longer usage and (prolonged release melatonin) older patients. Histamine H-1 receptor antagonists improve sleep maintenance but their effects on cognition, memory and falls remain to be demonstrated. Late-stage pipeline orexin OX1/OX2 and serotonin 5HT2A receptor antagonists may hold the potential to address several unmet needs in insomnia pharmacotherapy but safety issues cast some doubts over their future. Current and new insomnia drugs in the pipeline target different sleep regulating mechanisms and symptoms and have different tolerability profiles. Drug selection would ideally be based on improvement in the quality of patients' sleep, overall quality of life and functional status weighed against risk to the individual and public health.

  5. MANAGEMENT OF HAEMATOLOGICAL PATIENTS TREATED WITHCARDIOTOXIC DRUG

    Directory of Open Access Journals (Sweden)

    Jure Dolenc

    2008-04-01

    Predisposing factors to cardiotoxicity should be taken into consideration when dealingwith such pacients. Careful history, clinical examination, electrocardiography, echocardiography and NT-proBNP measurement should be performed prior and at the end of thetreatment with cardiotoxic drugs. Pacients with slightest clinical, laboratory or echocardiographic parameters of developing heart failure should immediately be reffered to a cardiologist to start with appropriate treatment

  6. Antimalarial drug induced decrease in creatinine clearance

    NARCIS (Netherlands)

    Landewé, R. B.; Vergouwen, M. S.; Goeei The, S. G.; van Rijthoven, A. W.; Breedveld, F. C.; Dijkmans, B. A.

    1995-01-01

    To confirm the antimalarial drug induced increase of creatinine to determine the factors contributing to this effect. Patients with rheumatoid arthritis (RA) (n = 118) who have used or still use antimalarials (chloroquine or hydroxychloroquine). Serum creatinines prior to antimalarials and serum

  7. Scientific perspectives on extending the provision for waivers of in vivo bioavailability and bioequivalence studies for drug products containing high solubility-low permeability drugs (BCS-Class 3).

    Science.gov (United States)

    Stavchansky, Salomon

    2008-06-01

    Recently, there has been increased interest in extending the provision for waivers of in vivo bioavailability and bioequivalence (BA-BE) studies that appeared in the guidance published by the Food and Drug Administration (FDA) (1) to pharmaceutical products containing Class 3 drugs (High solubility-Low Permeability). The extension of the Biopharmaceutics Classification System (BCS) to Class 3 drugs is meritorious because of its impact on public health policy considerations. The rate limiting step in the absorption of Class 3 drugs is the permeability through the intestinal membrane. This commentary will focus its attention on the scientific considerations which need to be examined to assess the risk and the benefit prior to granting a waiver of in vivo bioavailability and/or bioequivalence studies for Class 3 drugs. It will examine the forces affecting the interconnectivity of the neuronal, immunological and hormonal systems in the gastrointestinal tract that may affect its permeability and functionality. It will also challenge the assumption that in vitro dissolution and in vitro permeability studies in tissue cultures in the presence and absence of excipients are good predictors for in vivo dissolution and in vivo permeability which are at the heart of the BCS.

  8. Benefit-Risk Analysis for Decision-Making: An Approach.

    Science.gov (United States)

    Raju, G K; Gurumurthi, K; Domike, R

    2016-12-01

    The analysis of benefit and risk is an important aspect of decision-making throughout the drug lifecycle. In this work, the use of a benefit-risk analysis approach to support decision-making was explored. The proposed approach builds on the qualitative US Food and Drug Administration (FDA) approach to include a more explicit analysis based on international standards and guidance that enables aggregation and comparison of benefit and risk on a common basis and a lifecycle focus. The approach is demonstrated on six decisions over the lifecycle (e.g., accelerated approval, withdrawal, and traditional approval) using two case studies: natalizumab for multiple sclerosis (MS) and bedaquiline for multidrug-resistant tuberculosis (MDR-TB). © 2016 American Society for Clinical Pharmacology and Therapeutics.

  9. Estimating Functions with Prior Knowledge, (EFPK) for diffusions

    DEFF Research Database (Denmark)

    Nolsøe, Kim; Kessler, Mathieu; Madsen, Henrik

    2003-01-01

    In this paper a method is formulated in an estimating function setting for parameter estimation, which allows the use of prior information. The main idea is to use prior knowledge of the parameters, either specified as moments restrictions or as a distribution, and use it in the construction of a...... of an estimating function. It may be useful when the full Bayesian analysis is difficult to carry out for computational reasons. This is almost always the case for diffusions, which is the focus of this paper, though the method applies in other settings.......In this paper a method is formulated in an estimating function setting for parameter estimation, which allows the use of prior information. The main idea is to use prior knowledge of the parameters, either specified as moments restrictions or as a distribution, and use it in the construction...

  10. 29 CFR 452.40 - Prior office holding.

    Science.gov (United States)

    2010-07-01

    ... DISCLOSURE ACT OF 1959 Candidacy for Office; Reasonable Qualifications § 452.40 Prior office holding. A.... 26 26 Wirtz v. Hotel, Motel and Club Employees Union, Local 6, 391 U.S. 492 at 504. The Court stated...

  11. Form of prior for constrained thermodynamic processes with uncertainty

    Science.gov (United States)

    Aneja, Preety; Johal, Ramandeep S.

    2015-05-01

    We consider the quasi-static thermodynamic processes with constraints, but with additional uncertainty about the control parameters. Motivated by inductive reasoning, we assign prior distribution that provides a rational guess about likely values of the uncertain parameters. The priors are derived explicitly for both the entropy-conserving and the energy-conserving processes. The proposed form is useful when the constraint equation cannot be treated analytically. The inference is performed using spin-1/2 systems as models for heat reservoirs. Analytical results are derived in the high-temperatures limit. An agreement beyond linear response is found between the estimates of thermal quantities and their optimal values obtained from extremum principles. We also seek an intuitive interpretation for the prior and the estimated value of temperature obtained therefrom. We find that the prior over temperature becomes uniform over the quantity kept conserved in the process.

  12. On the prior probabilities for two-stage Bayesian estimates

    International Nuclear Information System (INIS)

    Kohut, P.

    1992-01-01

    The method of Bayesian inference is reexamined for its applicability and for the required underlying assumptions in obtaining and using prior probability estimates. Two different approaches are suggested to determine the first-stage priors in the two-stage Bayesian analysis which avoid certain assumptions required for other techniques. In the first scheme, the prior is obtained through a true frequency based distribution generated at selected intervals utilizing actual sampling of the failure rate distributions. The population variability distribution is generated as the weighed average of the frequency distributions. The second method is based on a non-parametric Bayesian approach using the Maximum Entropy Principle. Specific features such as integral properties or selected parameters of prior distributions may be obtained with minimal assumptions. It is indicated how various quantiles may also be generated with a least square technique

  13. Prior Expectations Bias Sensory Representations in Visual Cortex

    NARCIS (Netherlands)

    Kok, P.; Brouwer, G.J.; Gerven, M.A.J. van; Lange, F.P. de

    2013-01-01

    Perception is strongly influenced by expectations. Accordingly, perception has sometimes been cast as a process of inference, whereby sensory inputs are combined with prior knowledge. However, despite a wealth of behavioral literature supporting an account of perception as probabilistic inference,

  14. Bayesian optimal experimental design for priors of compact support

    KAUST Repository

    Long, Quan

    2016-01-01

    to account for the bounded domain of the uniform prior pdf of the parameters. The underlying Gaussian distribution is obtained in the spirit of the Laplace method, more precisely, the mode is chosen as the maximum a posteriori (MAP) estimate

  15. What good are actions? Accelerating learning using learned action priors

    CSIR Research Space (South Africa)

    Rosman, Benjamin S

    2012-11-01

    Full Text Available The computational complexity of learning in sequential decision problems grows exponentially with the number of actions available to the agent at each state. We present a method for accelerating this process by learning action priors that express...

  16. Assessment of prior learning in vocational education and training

    DEFF Research Database (Denmark)

    Wahlgren, Bjarne; Aarkrog, Vibe

    ’ knowledge, skills and competences during the students’ performances and the methods that the teachers apply in order to assess the students’ prior learning in relation to the regulations of the current VET-program. In particular the study focuses on how to assess not only the students’ explicated knowledge......The article deals about the results of a study of the assessment of prior learning among adult workers who want to obtain formal qualifications as skilled workers. The study contributes to developing methods for assessing prior learning including both the teachers’ ways of eliciting the students...... and skills but also their competences, i.e. the way the students use their skills and knowledge to perform in practice. Based on a description of the assessment procedures the article discusses central issues in relation to the assessment of prior learning. The empirical data have been obtained in the VET...

  17. Valid MR imaging predictors of prior knee arthroscopy

    International Nuclear Information System (INIS)

    Discepola, Federico; Le, Huy B.Q.; Park, John S.; Clopton, Paul; Knoll, Andrew N.; Austin, Matthew J.; Resnick, Donald L.

    2012-01-01

    To determine whether fibrosis of the medial patellar reticulum (MPR), lateral patellar reticulum (LPR), deep medial aspect of Hoffa's fat pad (MDH), or deep lateral aspect of Hoffa's fat pad (LDH) is a valid predictor of prior knee arthroscopy. Institutional review board approval and waiver of informed consent were obtained for this HIPPA-compliant study. Initially, fibrosis of the MPR, LPR, MDH, or LDH in MR imaging studies of 50 patients with prior knee arthroscopy and 100 patients without was recorded. Subsequently, two additional radiologists, blinded to clinical data, retrospectively and independently recorded the presence of fibrosis of the MPR in 50 patients with prior knee arthroscopy and 50 without. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for detecting the presence of fibrosis in the MPR were calculated. κ statistics were used to analyze inter-observer agreement. Fibrosis of each of the regions examined during the first portion of the study showed a significant association with prior knee arthroscopy (p < 0.005 for each). A patient with fibrosis of the MPR, LDH, or LPR was 45.5, 9, or 3.7 times more likely, respectively, to have had a prior knee arthroscopy. Logistic regression analysis indicated that fibrosis of the MPR supplanted the diagnostic utility of identifying fibrosis of the LPR, LDH, or MDH, or combinations of these (p ≥ 0.09 for all combinations). In the second portion of the study, fibrosis of the MPR demonstrated a mean sensitivity of 82%, specificity of 72%, PPV of 75%, NPV of 81%, and accuracy of 77% for predicting prior knee arthroscopy. Analysis of MR images can be used to determine if a patient has had prior knee arthroscopy by identifying fibrosis of the MPR, LPR, MDH, or LDH. Fibrosis of the MPR was the strongest predictor of prior knee arthroscopy. (orig.)

  18. Valid MR imaging predictors of prior knee arthroscopy

    Energy Technology Data Exchange (ETDEWEB)

    Discepola, Federico; Le, Huy B.Q. [McGill University Health Center, Jewsih General Hospital, Division of Musculoskeletal Radiology, Montreal, Quebec (Canada); Park, John S. [Annapolis Radiology Associates, Division of Musculoskeletal Radiology, Annapolis, MD (United States); Clopton, Paul; Knoll, Andrew N.; Austin, Matthew J.; Resnick, Donald L. [University of California San Diego (UCSD), Division of Musculoskeletal Radiology, San Diego, CA (United States)

    2012-01-15

    To determine whether fibrosis of the medial patellar reticulum (MPR), lateral patellar reticulum (LPR), deep medial aspect of Hoffa's fat pad (MDH), or deep lateral aspect of Hoffa's fat pad (LDH) is a valid predictor of prior knee arthroscopy. Institutional review board approval and waiver of informed consent were obtained for this HIPPA-compliant study. Initially, fibrosis of the MPR, LPR, MDH, or LDH in MR imaging studies of 50 patients with prior knee arthroscopy and 100 patients without was recorded. Subsequently, two additional radiologists, blinded to clinical data, retrospectively and independently recorded the presence of fibrosis of the MPR in 50 patients with prior knee arthroscopy and 50 without. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy for detecting the presence of fibrosis in the MPR were calculated. {kappa} statistics were used to analyze inter-observer agreement. Fibrosis of each of the regions examined during the first portion of the study showed a significant association with prior knee arthroscopy (p < 0.005 for each). A patient with fibrosis of the MPR, LDH, or LPR was 45.5, 9, or 3.7 times more likely, respectively, to have had a prior knee arthroscopy. Logistic regression analysis indicated that fibrosis of the MPR supplanted the diagnostic utility of identifying fibrosis of the LPR, LDH, or MDH, or combinations of these (p {>=} 0.09 for all combinations). In the second portion of the study, fibrosis of the MPR demonstrated a mean sensitivity of 82%, specificity of 72%, PPV of 75%, NPV of 81%, and accuracy of 77% for predicting prior knee arthroscopy. Analysis of MR images can be used to determine if a patient has had prior knee arthroscopy by identifying fibrosis of the MPR, LPR, MDH, or LDH. Fibrosis of the MPR was the strongest predictor of prior knee arthroscopy. (orig.)

  19. Mathematical modeling of drug dissolution.

    Science.gov (United States)

    Siepmann, J; Siepmann, F

    2013-08-30

    The dissolution of a drug administered in the solid state is a pre-requisite for efficient subsequent transport within the human body. This is because only dissolved drug molecules/ions/atoms are able to diffuse, e.g. through living tissue. Thus, generally major barriers, including the mucosa of the gastro intestinal tract, can only be crossed after dissolution. Consequently, the process of dissolution is of fundamental importance for the bioavailability and, hence, therapeutic efficacy of various pharmaco-treatments. Poor aqueous solubility and/or very low dissolution rates potentially lead to insufficient availability at the site of action and, hence, failure of the treatment in vivo, despite a potentially ideal chemical structure of the drug to interact with its target site. Different physical phenomena are involved in the process of drug dissolution in an aqueous body fluid, namely the wetting of the particle's surface, breakdown of solid state bonds, solvation, diffusion through the liquid unstirred boundary layer surrounding the particle as well as convection in the surrounding bulk fluid. Appropriate mathematical equations can be used to quantify these mass transport steps, and more or less complex theories can be developed to describe the resulting drug dissolution kinetics. This article gives an overview on the current state of the art of modeling drug dissolution and points out the assumptions the different theories are based on. Various practical examples are given in order to illustrate the benefits of such models. This review is not restricted to mathematical theories considering drugs exhibiting poor aqueous solubility and/or low dissolution rates, but also addresses models quantifying drug release from controlled release dosage forms, in which the process of drug dissolution plays a major role. Copyright © 2013 Elsevier B.V. All rights reserved.

  20. Fractional Gaussian noise: Prior specification and model comparison

    KAUST Repository

    Sø rbye, Sigrunn Holbek; Rue, Haavard

    2017-01-01

    Fractional Gaussian noise (fGn) is a stationary stochastic process used to model antipersistent or persistent dependency structures in observed time series. Properties of the autocovariance function of fGn are characterised by the Hurst exponent (H), which, in Bayesian contexts, typically has been assigned a uniform prior on the unit interval. This paper argues why a uniform prior is unreasonable and introduces the use of a penalised complexity (PC) prior for H. The PC prior is computed to penalise divergence from the special case of white noise and is invariant to reparameterisations. An immediate advantage is that the exact same prior can be used for the autocorrelation coefficient ϕ(symbol) of a first-order autoregressive process AR(1), as this model also reflects a flexible version of white noise. Within the general setting of latent Gaussian models, this allows us to compare an fGn model component with AR(1) using Bayes factors, avoiding the confounding effects of prior choices for the two hyperparameters H and ϕ(symbol). Among others, this is useful in climate regression models where inference for underlying linear or smooth trends depends heavily on the assumed noise model.