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所属行业:医药制造业

  • 33161.新版维生素用量标准制订在即

    [医药制造业] [2013-12-06]

    关键词:新版维生素;用量标准
  • 33162.泊沙康唑注射剂新药申请获FDA优先审评资格

    [医药制造业] [2013-12-04]

    关键词:泊沙康唑;注射剂;FDA;优先审评
  • 33163.2013年11月(下半月)医药行业要闻综述

    [医药制造业] [2013-12-04]

    《中国证券报》11月20日报道,国家食品药品监督管理总局发布《关于修订含毒性中药饮片中成药说明书的通知》,要求凡处方中含《医疗用毒性药品管理办法》所收载28种毒性药材的中药饮片中成药品种,或其他已被证明具有毒性、易导致严重不良反应的中药饮片中成药品种,生产企业应注明警示。涉及国家秘密技术的中成药品种若含有毒性中药饮片,则以同样标准修订说明书,相关生产企业应于2013年12月31日前提出修订说明书的补充申请。此外,本次说明书修订不涉及保护期内的国家中药一级保护品种。
    关键词:医药行业;要闻综述
  • 33164.创伤性脑损伤退伍军人的个体化用药

    [医药制造业] [2013-12-03]

    The study was designed to identify clinically accessible molecular biomarkers of traumatic brain injury (TBI) prior to definitive clinical diagnosis using high throughput microRNA technology. Specifically, these studies were meant to identify, characterize, and validate microRNA biomarker species whose content in peripheral blood mononuclear cells (PBMC) could help to distinguish TBI cases from the Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veteran population. During the past years, we conducted a Biomarker Discovery study using a high-throughput Array chip platform and identified 18 candidate TBI small RNA biomarkers. Using independent Q-PCR assays, we confirmed that 13 of these candidate small RNA biomarker species are, indeed, significantly down-regulated in PBMC of TBI compared to non-TBI control veteran cases. Additionally, we used unsupervised clustering analysis and demonstrated that the differential regulation of these small RNA biomarkers in clinically accessible blood cells is capable of distinguishing between TBI and non-TBI OEF/OIF veteran cases. Lastly, we identified a 3-biomarker panel capable of distinguishing TBI from non-TBI control veteran cases with 89accuracy 82selectivity and
    78specificity. The majority of TBI cases in our biomarker study were co-morbid with PTSD, and our non-TBI control cases were selected to match for PTSD diagnosis. Thus, our identified panel of 13 small RNA biomarkers likely represents biological indices selective for TBI. During the past year, we recruited 13 new cases (6 TBI and 7 non-TBI cases). Together with the cases recruited in previous years, we currently have a total of 83 cases, comprised of 17 TBI and 66 non-TBI control cases, which are available for Biomarker Validation studies.
    关键词:医药;血细胞;创伤性脑损伤;临床医学;创伤性休克;退伍军人
  • 33165.国家癌症研究所2010年的补充和替代医学的年度报告

    [医药制造业] [2013-12-03]

    The research the National Cancer Institute (NCI) supports, both in our own laboratories and at institutions worldwide, is focused on the ultimate goal of helping cancer patients. That mission achieved through rigorous science extends to NCIs program on complementary and alternative medicine, also known as CAM. Among the highlights of NCIs CAM-related activities in fiscal year (FY) 2010, was the collaboration between NCI, the National Institutes of Healths Office of Dietary Supplements (ODS), and the National Center for Complementary and Alternative Medicine (NCCAM) to co-fund two Botanical Research Centers. The Botanical Research Centers Program aims to promote collaborative, integrated, interdisciplinary study of botanicals, particularly those found as ingredients in dietary supplements, and to conduct research with high potential for being translated into practical benefits for human health.
    关键词:医药;医学研究;癌症;治疗;疾病防治
  • 33166.新兴产业周刊——2013年44期

    [计算机、通信和其他电子设备制造业,专用设备制造业,医药制造业,电力、热力、燃气及水生产和供应业,通用设备制造业,信息传输、软件和信息技术服务业,汽车制造业,水利、环境和公共设施管理业] [2013-12-03]

    本刊以七大战略性新兴产业——节能环保、新一代信息技术、生物、高端装备制造、新能源、新材料、新能源汽车为研究重点,关注国家高层和各部委的动态,剖析国家和地方的新兴产业政策。本刊设有政策导读、领导讲话、七大战略性新兴产业本周国内外行业动态和重点企业新闻、投资专题四大板块,能够实时监测新兴产业和重点企业动态,把握新兴产业发展方向,研究发展重点,寻求发展机遇。
    关键词:节能环保;新一代信息技术;生物;高端装备制造;新能源;新材料;新能源汽车
  • 33167.纽约生物医学院:CDM灾难医学和新兴感染的培训中心

    [医药制造业] [2013-12-03]

    The project was aimed at creating a pilot emergency management training program. This program would then be delivered to target test audiences with pre and post course cognitive, pyschomotor and affective evaluations. During the first year of this grant baseline data and evaluation has occurred on existing programs with identification of potential course topics and refinement of target audience.
    关键词:医药;灾害医学;传染病预防
  • 33168.美国陆军军医部门的中西医结合疗法

    [医药制造业] [2013-12-03]

    While it is praiseworthy that the Army has acknowledged the value of Integrative Medicine (IM) in its Pain Management Task Force Final Report (2010), its vision for this enabler remains limited. IM is seen as having a place only in specialty care; IM research, while ongoing, is not centrally directed; and the Office of the Surgeon General lacks a voice that can speak for IM. Since IM offers the ability to reduce health care costs and improve Soldier resiliency, Army Medicine needs a vision for IM that will enable its full potential. The Patient-Centered Medical Home concept offers an opportunity to integrate IM into primary care; and a Consultant to The Surgeon General could insure both that IM research moves in the directions that the enterprise needs, and that IM has a champion at the highest levels of the organization. Once a strategic vision is in place, the Army can fully utilize IM’s ability to improve the care of its patients. The Army should also strongly consider a demonstration project of an IM-based clinic to prove this concept, and provide real-world cost and outcome data to guide further progress.
    关键词:医药;医疗保健;医疗;中西结合疗法;军事医学
  • 33169.浙江:基药招标欲参考山东山东模式或被全国借鉴

    [医药制造业] [2013-12-03]

    关键词:浙江;基药招标;山东模式;全国借鉴
  • 33170.行业指南:共晶药品监管分类

    [医药制造业] [2013-12-03]

    This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's current thinking on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that you, the applicant, should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification. The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co-crystalline forms.
    关键词:医药;共晶药品;制药业;药物评价
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