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目的 进行临床前研究的主要原因在于,保证研究中新药探索实验中尤其是研发早期试验人群的安全,因为只是减少健康志愿者身上的风险无益于保证(所有)受试者的安全.内容 本文从新药研发的两个阶段分别对病理学在临床前风险控制研究中的作用进行了讨论.结论 在非临床前新药研发阶段的风险控制中,让病理学家参与到新药研发的风险管理队伍中来,帮助研发、监控研发,是成功研发与优良的风险管理策略相衔接的关键. 相似文献
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杜冠华 《中国实验动物学杂志》2011,(10):24-26
本文讨论了药物临床前研究与实验动物和动物模型之间的关系,探讨了实验动物和动物模型在新药研发过程中实现转化研究的要求和条件.讨论了实验动物质量对新药研发的影响,分析了实验动物质量的影响因素;讨论了实验动物模型的主要类型和特点,分析了进行实验动物模型研究的要点和要求;分析了动物模型与新药研发过程中实现转化研究的条件,提出加强转化研究需要实验动物和动物模型研究的支撑. 相似文献
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创新药研发对企业研发能力要求高,目前我国大部分药企仍然处于仿创阶段,但随着政策环境的改善,国家不断释放鼓励创新信号, 创新型药企不断涌现,传统药企积极布局,创新药物迎来发展机遇。借鉴国外创新药研发经验,探讨我国创新药的 3 种研发模式及估值方法, 解析创新药研发的机遇与风险。 相似文献
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新药研发是制药行业的核心活动之一,成功发现和开发对疾病具有疗效的新药物需要跨学科的合作、大量的投资和对创新的不断追求。近年来全球新药研发竞争格局不断加速演变,我国众多创新药企寻求深层次变革与转型发展,并加快拓展海外市场。2023年,全球获批上市的创新药数量持续增长,同比增长17%,临床研究管线数量亦不断扩大;生物技术和基因疗法的发展日新月异,罕见病药物研发逐渐增多,免疫疗法领域研发取得显著成果。本研究从创新药物的类别和研发新格局等角度出发,对2023年新药研发发展态势进行梳理与总结,并展望未来发展趋势。 相似文献
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军事医学科学院药物毒理学研究30年回顾 总被引:1,自引:0,他引:1
军事医学科学院的药物毒理学研究源远流长、与时俱进,经过近30年的积累与发展,已建立一整套服务于新药发现、临床前开发、临床实验及上市后监督再评价等完整研发链条的药物毒理学研究体系和学科群,涵盖新药早期发现毒理学、非临床安全性评价以及药物毒性作用机制研究等内容,通过与新药研发体系中其他学科互动与协作,为军事医学科学院乃至全国的新药研发提供了良好的非临床安全性评价的技术平台和保障. 相似文献
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对2012 年全球上市新药的基本信息,包括通用名、商品名、结构式、CAS 号、研发公司、上市国家和主要适应证进行汇总,为新药研发工作者提供参考。 相似文献
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创新药物研发是国家医药产业发展的原动力,美国作为全球新药研发能力最强的国家,这与其食品药品管理局在新药审批过程中给
予的技术支持和政策鼓励密不可分。通过分析比较我国与美国的新药评审相关政策的异同,学习和借鉴美国的成功经验,为我国创新药物
注册审评制度的调整与完善提供参考。 相似文献
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Lundstrom K 《Journal of cellular and molecular medicine》2007,11(2):224-238
Structure determination has already proven useful for lead optimization and direct drug design. The number of high-resolution structures available in public databases today exceeds 30,000 and will definitely aid in structure-based drug design. Structural genomics approaches covering whole genomes, topologically similar proteins or gene families are great assets for further progress in the development of new drugs. However, membrane proteins representing 70% of current drug targets are poorly characterized structurally. The problems have been related to difficulties in obtaining large amount of recombinant membrane proteins as well as their purification and structure determination. Structural genomics has proven successful in developing new methods in areas from expression to structure determination by studying a large number of target proteins in parallel. 相似文献
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随着后基因组时代的到来,药物发现研究领域不断涌现出一系列新思路、新技术、新方法,从而迅速推进药物发现的多元化发展。一方面,基因组学、蛋白质组学、转录组学、代谢组学、生物信息学、系统生物学等新兴学科的崛起与发展,为药物发现提供更为广泛而深刻的理论基础;另一方面,计算机辅助药物设计、高通量筛选、高内涵筛选、生物芯片、转基因和RNA干扰等高新技术的发展和完善,为药物发现提供了新的技术手段和有力工具,极大地拓宽了药物发现的途径。本文结合近年来现代生物学的研究进展,综述现代生物学对药物发现过程的影响。 相似文献
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The use of existing drugs for new therapeutic applications, commonly referred to as drug repositioning, is a way for fast and cost-efficient drug discovery. Drug repositioning in oncology is commonly initiated by in vitro experimental evidence that a drug exhibits anticancer cytotoxicity. Any independent verification that the observed effects in vitro may be valid in a clinical setting, and that the drug could potentially affect patient survival in vivo is of paramount importance. Despite considerable recent efforts in computational drug repositioning, none of the studies have considered patient survival information in modelling the potential of existing/new drugs in the management of cancer. Therefore, we have developed DRUGSURV; this is the first computational tool to estimate the potential effects of a drug using patient survival information derived from clinical cancer expression data sets. DRUGSURV provides statistical evidence that a drug can affect survival outcome in particular clinical conditions to justify further investigation of the drug anticancer potential and to guide clinical trial design. DRUGSURV covers both approved drugs (∼1700) as well as experimental drugs (∼5000) and is freely available at http://www.bioprofiling.de/drugsurv. 相似文献
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壳聚糖是一种天然多糖,具有无毒、可生物降解、生物相容性等诸多优点,但水溶性差的自身特点限制了其在药剂学中的应用,而其经合理的结构设计、修饰和优化,可获得性能良好的两亲性壳聚糖衍生物,这些衍生物在水溶液中能自组装成具有良好药物传输性能(如载药量、稳定性、刺激敏感性、靶向性等)的胶束,并被广泛应用于构建药物传递系统,以改善药物的溶解性、靶向性、生物利用度及耐药性,降低药物的毒副作用。综述壳聚糖衍生物结构对其胶束药物传输性能的影响以及壳聚糖衍生物及其胶束的功能化修饰和在药物传递系统中的应用。 相似文献
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2015 年 9 月,美国、欧盟和日本共批准 46 个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。
本文对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。 相似文献
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Those pharmaceutical companies whose goal is to generate novel innovative drugs are faced with the challenge that only a fraction of the compounds tested in clinical trials eventually become a registered drug. This problem of attrition is compounded by the fact that the clinical trial or development stage is by far the most costly phase of bringing a new drug to market, consuming around 80 per cent of the total spend. Transgenic technology represents an attractive approach to reducing the attrition rate of compounds entering clinical trials by increasing the quality of the target and compound combinations making the transition from discovery into development. Transgenic technology can impact at many points in the discovery process, including target identification and target validation, and provides models designed to alert researchers early to potential problems with drug metabolism and toxicity, as well as providing better models for human diseases. In target identification, transgenic animals harbouring large DNA fragments can be used to narrow down genetic regions. Genetic studies often result in the identification of large genomic regions and one way to decrease the region size is to do complementation studies in transgenic animals using, for example, inserts from bacterial artificial chromosome (BAC) clones. In target validation, transgenic animals can be used for in vivo validation of a specific target. Considerable efforts are being made to establish new, rapid and robust tools with general utility for in vivo validation, but, so far, only transgenic animals work reliably on a wide range of targets. Transgenic animals can also be used to generate better disease models. Predictive animal models to test new compounds and targets will significantly speed up the drug discovery process and, more importantly, increase the quality of the compounds taken further in the research and development process. Humanised transgenic animals harbouring the human target molecule can be used to understand the effect of a compound acting on the human target in vivo. Also, models mimicking human drug metabolism will provide a means of assessing the effect of human-specific metabolites and of understanding the pharmacokinetic properties of potential drugs. In toxicology studies, transgenic animals are providing more predictive models. A good example of this are those models routinely used to look for carcinogenicity associated with new compounds. 相似文献