行业研究报告题录
制造业--医药制造业(2014年第29期)
(报告加工时间:2014-10-24 -- 2014-10-31)

行业资讯

境内分析报告

  • 20141029市场要闻——医药
    据国家卫计委网站消息,卫计委日前就《全国医疗卫生服务体系规划纲要(2015-2020 年)》文件进行解读,解读称《规划纲要》提出了公立医院、基层医疗卫生机构、专业公共卫生机构的设置原则。
  • 市场要闻——医药
    记者从江西省发改委获悉,江西目前已率先在全国放开了省管的全部601 种非处方药品价格。江西省发改委副主任、省物价局局长叶柏青说,根据江西日前出台的《关于进一步深化价格管理改革的意见》,放开省管的全部非处方药品价格后,省价格主管部门不再对原省管价格的非处方药品制定最高零售价,药品生产经营企业依据市场自主定价;另外取消低价药品最高零售价,建立低价药品清单制度。此外,江西省还将逐步放开服务价格,鼓励社会办医办教。放开非公立医疗机构医疗服务价格等收费后,这些机构可根据市场供求及竞争情况,按照公平、合法和诚实信用的原则自主制定价格,并保持一定时期内价格水平相对稳定,政府不进行不当干预。
  • 中国胰岛素市场报告(2014-2018年)
    This report covers the present scenario and the growth prospects of the Insulin market in China for the period 2014-2018. To calculate the market size, the report considers the revenue generated through the sales of various second- and third-generation insulin products. The report presents the vendor landscape and a corresponding detailed analysis of the top four vendors in the Insulin market in China. In addition, it discusses the major drivers that influence the growth of the market. It also outlines the challenges faced by the vendors and the market at large, as well  as the key trends that are emerging in the market.
  • 20141027市场要闻——医药
    25 日,广东省网络医院经过1 个多月试运行,在广东省第二人民医院正式上线启用。这是全国首家获得卫生计生部门许可的网络医院。
  • 中药新药申请生产药学审评中的常见问题及建议
    依据我国现行《药品注册管理办法》(局令第28号),中药新药的注册申请分为申请临床试验和申请生产(包括新药证书)。从申请临床到获准上市,大约经历10年之久,且申请生产的成功率较低,目前存在问题较多。从药学审评看,主要存在合规性和技术性2个方面的问题。主要表现为不经国家主管部门批准的擅自变更,如:临床试验用样品的制备工艺与批准的工艺有较大改变。技术性问题主要有申报资料不全或申报资料不符合技术审评要求,如:不提供生产工艺验证资料、临床试验用样品的制备工艺及现场检查用生产工艺资料,或提供的资料不符合技术要求等。该文对常见问题进行了总结并提出建议,提醒申请人关注,以便及时发现问题,规避风险,提高注册申请的质量和效率。
  • 医药汇编-第596期
    报告从政策环境、市场行情、厂商动态、科技研发、国际资讯、行业数据、分析评论等几个方面对医药行业进行了分析评论。

境外分析报告

  • 谈欧美各国对原料药的GMP现场检查
    浅析欧美各国对原料药的GMP现场检查的方法。方法:针对欧美各国关于原料药GMP现场检查的重点进行详细论述和分析。结果与结论:企业如果建立了有效的GMP制度,那么企业完全能够通过欧美各国的GMP的认证。
  • 2014年第四季度越南疗器械报告
    The Vietnamese medical device market is expected to remain one of the strongest in Asia, despite a moderation in import growth over the past couple of years.

外文技术报告

  • 医疗检查:临床特权和气道管理,马里昂医学中心,伊利诺斯州
    The VA Office of Inspector General Office of Healthcare Inspections conducted an inspection to determine the validity of allegations regarding quality of care at the Marion VA Medical Center, Marion, IL. Four complaints were received between October 2011 and January 2012 regarding the clinical practice of two physicians. In February 2012, Senator Richard J. Durbin forwarded additional allegations concerning one of the physicians. This report addresses allegations regarding quality of care provided for the three patients named by complainants, and describes findings from our site visit. Not addressed in this report are allegations regarding quality of care for additional patients not specifically identified, and allegations regarding a second physician. In the care of one patient, the risk of complications requiring urgent intervention should have been discussed with the patient as part of the informed consent process prior to a procedure, at which time the patients therapeutic preferences could have been clarified. We identified no deficiencies in quality of care for the other two patients. We also found that a physician who was hired after not being in clinical practice for many years was granted clinical privileges with the understanding that his competence would be confirmed by direct observation. However, competence was never documented for invasive procedures that he subsequently performed.
  • 通过去除雄激素、放射治疗和MR指导脉冲高强度聚焦超声增强的基因治疗来进行前列腺癌的治疗
    This work aimed to test the hypothesis that MR guided pulsed HIFU exposures enhance gene delivery and increase the efficacy of gene therapy in inhibiting prostate cancer growth in vivo, particularly when combined with AD or RT. We developed techniques for the treatment of prostate tumor-bearing mice using a clinical MRgHIFU device. We performed animal studies for quantitative measurement of the doxorubicin concentration in HIFU treated prostate tumors to evaluate the optimal ultrasonic parameters derived from experiments using an acoustic phantom. We also performed experiments on the efficacy of MRgHIFU enhancement of docetaxel delivery combined with RT in inhibiting prostate tumor growth in vivo. We investigated the MRgHIFU effect on the enhancement of gene therapy using AS-MDM2 and bcl-2 in implanted prostate tumors in mice in vivo by measuring the protein expression level of MDM2, p53 and p21 using immunohistochemical staining and west blotting techniques. We also performed experiments on the efficacy of MRgHIFU enhancement of AS-MDM2 delivery in inhibiting prostate tumor growth in vivo. Our results show that MRgHIFU is safe and effective for the enhancement of drug delivery in prostate tumor.

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