92 research outputs found

    Effects of antihypertensive drugs on blood velocity in rhesus monkeys

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    Increasing evidence suggests that higher blood velocity, by causing turbulence and high shear rates at the endo-thelial surfaces of arteries, may be important in the pathogenesis of atherosclerosis. In order to measure the effects of antihypertensive agents on blood velocity, an improved method has been developed for analysis of Doppler ultrasound velocity recordings. The audio signal from a Doppler velocity meter is subjected to spectral analysis; the sonagraph thus obtained is digitized with the use of a magnetic table on-line with a calculator. Four monkeys were maintained at a hypertensive baseline for six weeks by infusion of angiotensin and iso-proterenol. The effects on blood velocity of 72-hour infusions of propranolol, clonidine, hydralazine, and methyldopa were studied. In doses that reduced diastolic pressure by 13-28%, propranolol decreased mean blood velocity (mv) by 17%, clonidine decreased mv by 14%, while methyldopa increased mv 12%, and hydralazine increased mv by 52% (p \u3c.00001). Antihypertensive drugs appear to have different effects on blood velocity; these differences may influence choice of antihypertensive drugs for the prevention of arterial disease. © 1977 American Heart Association, Inc

    Analysis of the Workforce and Workplace for Rheumatology, and the Research Activities of Rheumatologists Early in Their Careers

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    [Excerpt] The scope and scale of clinical research is unknown for any medical or surgical specialty beyond snapshots of the broad aims and expenditures of research programs sponsored by federal agencies or the pharmaceutical industry. As a consequence, the workforce and workplace for clinical investigation is enigmatic and unexamined even after explicit warnings that an essential arm for advancing clinical practice has been disabled. The present study was designed to assess the workforce and workplace for rheumatology, and the extent and type of research prevailing among rheumatologists early in their careers. Our findings provide fresh insights about the workforce and the workplace for rheumatology, and justify interventions to address gaps in both the scope and scale of clinical research in arthritis and rheumatism

    The columbia registry of controlled clinical computer trials

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    pre-printNumerous reports on randomized controlled clinical trials of comnputer-based interventions have been published. These trials provide useful evaluations of the impact of information technology on patient care. Unfortunately, several obstacles make access to the trial reports difficult. Barriers include the large variety of publications in which reports may appear, non-standard descriptors, and incomplete indexing. Some analyzers indicate inadequate testing of computer methods. The purpose of establishing a registry of randomized controlled clinical computer trials was to assist the identification of computer services with demonstrated ability to improve the process or outcome of patient care. A report collection, selection, information extraction, and registration method was developed and implemented. One hundred and six reports on computer trials have been collected. A large variety of computer-assisted interventions have been tested in the registered trials (40% reminder, 15% feedback, 14% dose planning, 14% patient education, 12% medical record). 76% of the registered reports were published in the United States and most of the remainder in various European countries. In reporting computer trial results, 77% of the authors did not use both tile "computer" and "trial" keywords in the title or abstract of their papers. We conclude that a major obstacle to adequate computer technology assessment is inadequate access to the published results

    Elaborarea metodei spectrofotometrice UV-VIS de determinare cantitativă a izohidrafuralului, metiluracilului și benzocainei din unguentul combinat.

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    Utilizarea medicamentelor combinate în tratamentul plăgilor infectate facilitează cu mult farmacoterapia. Izohidrafural este un compus organic care are acţiune antibacteriană, metiluracilul este o substanță regenerantă și benzocaina este un anestezic local. Combinația acestor trei substanțe medicamentoase într-un unguent combinat are un efect mai benefi c și mai rapid în tratarea plăgilor purulente. S-a elaborat metoda spectrofotometrică UV-VIS de determinarea cantitativă a izohidrafuralului, metiluracilului și benzocainei din unguentul combinat. Metoda este exactă şi precisă, erorile fiind în limitele admise de exigenţele controlului medicamentelor pentru substanţele active (valorile RSD pentru izohidrafural – 1,464%, metiluracil – 0,554% și benzocaină – 0,392%)

    Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era

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    To assess the impact of the March 2009 decision in Wyeth v. Levine, it is crucial to understand that the Supreme Court ruled on actions that the U.S. Food and Drug Administration (FDA) took under a statutory scheme that already had been amended by the time the case was decided. The Food and Drug Administration Amendments Act of 2007 (FDAAA) transformed drug regulation, adding significant new powers to develop evidence and make new types of decisions in the postmarket period. This article explores how the contours of drug regulation are likely to change after FDAAA, which is the most profound reworking of the U.S. drug regulatory framework in half a century. FDAAA envisions heavy use, during the period after drugs are approved, of evidence from large observational studies that rely on interoperable health data networks. Understanding what was wrong with FDA\u27s old evidentiary paradigm, which dates back to 1962, is essential to understanding its new one. Parts II and III of this article discuss the evidentiary limitations of premarket drug trials;important aspects of modern legal doctrine rest on misconceptions about their evidentiary power. Part IV then explores how scientific advances flowing from the Human Genome Project over the past decade further undermined FDA\u27s old evidentiary paradigm. FDAAA was Congress\u27s response to these problems. Part V identifies seven pillars of the new evidentiary paradigm: seven novel propositions that reject foundational assumptions of twentieth-century drug regulation. Collapse of these assumptions sets off ripple effects in various doctrinal areas. Part VI provides two examples, with the aim of opening a scholarly debate about these and other impacts of FDA\u27s new evidentiary paradigm

    Seven Pillars of a New Evidentiary Paradigm: The Food, Drug, and Cosmetic Act Enters the Genomic Era

    Get PDF
    To assess the impact of the March 2009 decision in Wyeth v. Levine, it is crucial to understand that the Supreme Court ruled on actions that the U.S. Food and Drug Administration (FDA) took under a statutory scheme that already had been amended by the time the case was decided. The Food and Drug Administration Amendments Act of 2007 (FDAAA) transformed drug regulation, adding significant new powers to develop evidence and make new types of decisions in the postmarket period. This article explores how the contours of drug regulation are likely to change after FDAAA, which is the most profound reworking of the U.S. drug regulatory framework in half a century. FDAAA envisions heavy use, during the period after drugs are approved, of evidence from large observational studies that rely on interoperable health data networks. Understanding what was wrong with FDA\u27s old evidentiary paradigm, which dates back to 1962, is essential to understanding its new one. Parts II and III of this article discuss the evidentiary limitations of premarket drug trials;important aspects of modern legal doctrine rest on misconceptions about their evidentiary power. Part IV then explores how scientific advances flowing from the Human Genome Project over the past decade further undermined FDA\u27s old evidentiary paradigm. FDAAA was Congress\u27s response to these problems. Part V identifies seven pillars of the new evidentiary paradigm: seven novel propositions that reject foundational assumptions of twentieth-century drug regulation. Collapse of these assumptions sets off ripple effects in various doctrinal areas. Part VI provides two examples, with the aim of opening a scholarly debate about these and other impacts of FDA\u27s new evidentiary paradigm
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