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按照新的欧盟快速评价程序,欧洲药品局(EMEA)修改了申请批准评价指南。快速审评程序由新的欧盟药物立法提出,适用于具有重大治疗和公众健康利益的药物,这类药物通常采用了新的治疗方法或改进了现有的治疗方式。 相似文献
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全球药物开发,特别是“全球同步开发”这个理念,无论对制药业还是药品审评机构都构成了巨大的挑战。日前,《中国处方药》杂志专访了国家食品药品监督管理局药品审评中心(CDE)主任李国庆,就药品开发全球一体化趋势下我国新药审评程序和机制谈一谈来自CDE的思考。 相似文献
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持续报告制度
荷兰涉及药品安全的法律规章多达数十项,对药物的研发、生产、储运和使用各个环节都有明确规定,并同其他欧盟成员国基本一致。上市销售之前必须获得卫生部下属的药品评估委员会颁发的销售许可。委员会同时确定该药品的药性、包装说明以及该药是处方药还是非处方药。新药初次获得的销售许可只有5年有效期,到期后需重新审核。第二次获得的销售许可才长期有效。 相似文献
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Elan公司和Biogen Idec公司的多发性硬化症(MS)治疗药Tysabri(natalizumab)(Ⅰ)已经通过了安全性审评的第一道门槛。公司对该药品的安全性评估业已完成,没有发现新的进行性多灶性白质性脑病(PML)的病例出现,由于可能引起罕见的神经脱髓鞘失调症,在2005年2月时(Ⅰ)的销售曾一度受到迟滞。 相似文献
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近些年来,随着医药经济的蓬勃发展以及人民群众对健康的日益重视,我国的新药包括仿制药的研发动力空前提高,新药研发呈快速增长趋势。但是,由于我国新药审评力量薄弱、审评专家稀缺,再加上体制机制的问题,使新药研发与新药审评之间的矛盾日益突出。在近几年的全国两会上,来自医药界的代表、委员对此反应强烈。如何解决新药审评领域存在的突出矛盾?药品审评机制需要哪些改革?在今年的全国两会期间,全国人大代表杜振新就此发表了自己的意见。 相似文献
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药品作为一种特殊商品,直接影响人们的身体健康及生命安全,所以各个国家对其都有专门的管理制度和管理体系,以确保其安全、有效。本文详细介绍欧盟的药物审评机构及立法体系,着重说明审评的程序和要求。 相似文献
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2009年5月27日,世界卫生组织确定甲型H1N1流感疫苗(下称甲流疫苗)生产用毒株,国家食品药品监督管理局(SFDA)要求相关甲流疫苗生产企业应及时与世界卫生组织进行联系,获取毒株以备需要。 相似文献
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以“良好审评注册管理规范”(GRP)为基础的药品审评注册管理机制,方能缩短临床试验审批时限,并为这种“缩短”的可持续性奠定真正的基础。 相似文献
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李连达院士现任中国中医研究院首席研究员、国家科技奖励评审委员会委员、国家新药及保健食品审评委员会委员、国家药典委员会委员。自1993年参加保健食品审评工作。十年来先后审评六、七千种保健食品,至2001年末,已批准生产3418种,其中在市场常见的产品1823种。 相似文献
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《Substance use & misuse》2013,48(9-10):1031-1050
Drug involvement is such an intensely social behavior that it lends itself to the notion of a subcultural existence. The social aspects of drug involvement generate a value system that is different from the dominant order. Using a longitudinal sample of college students, the findings indicate two distinctively different types of drug use, marijuana-only versus illicit drug involvement, that correspond to a subcultural or contracul-tural phenomenon. The elements of a subculture or contraculture are amenable to empirical measurement and can be differentiated from the dominant value system. Marijuana use reflects a type of subculture activity that maintains ties to the conventional order. Illicit drug use, on the other hand, is a contracultural activity, representing a pronounced break with the dominant culture. 相似文献
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Significant progress has been made in structure-based drug design by pharmaceutical companies at different stages of drug discovery such as identifying new hits, enhancing molecule binding affinity in hit-to-lead, and reducing toxicities in lead optimization. Drug metabolism is a major consideration for modifying drug clearance and also a primary source for drug metabolite-induced toxicity. With major cytochrome P450 structures identified and characterized recently, structure-based drug metabolism prediction becomes increasingly attractive. In silico methods based on molecular and quantum mechanics such as docking, molecular dynamics and ab initio chemical reactivity calculations bring us closer to understand drug metabolism and predict drug–drug interactions. In this study, we review important progress in drug metabolism and common in silico techniques adopted to predict drug regioselectivity, stereoselectivity, reactive metabolites, induction, inhibition and mechanism-based inactivation, as well as their implementation in hit-to-lead drug discovery. 相似文献
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《Journal of ethnicity in substance abuse》2013,12(1):1-28
The abundance of research on drug use has yielded an expanded and sophisticated data base, a multiplicity of predictors and a proliferation of theories. It is evident that simple models cannot adequatley incorporate the range of influences, and that we must develop multivariate frameworks which include relatively stable characteristics of the person and of the environment. Sixteen such projects are reviewed most of which incorporate longitudinal designs over various period in the life span. Interaction of person and environment can mean a linear addiction (multiple regression) structural modeling, alternate configurations such as person-environment "fit" and mediating influences, and composites of risk factors. Issues involving the direction of causal inference, the role of psychopharmacology and the criteria variable are reviewed. Psychosocial interactionism has not yet become formal, testable theory, and that is good. 相似文献
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儿科临床研究与儿童用药安全 总被引:5,自引:1,他引:4
通过分析我国儿童用药现状,介绍国外儿科药品研究进展,指出我国应积极学习和借鉴国外先进经验,尽早制订出符合我国国情的儿童药品研究政策,进而指导儿科医师合理、安全用药。 相似文献
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药物羟化代谢表型测定与药物血液浓度常规测定结合,可使经羟化作用代谢而浓度-效应曲线陡峭,对仅根据临床表现难以确定治疗效应和毒性效应以及毒性大、疗效确实的药物的合理安全很有用处。 相似文献
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Pardridge WM 《Pharmaceutical research》2007,24(9):1729-1732