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  • jinyachao
    jinyachao  回复了帖子 关于呕吐用维生素B6! 70天前
    您没有权限阅读该帖子
  • jinyachao
    jinyachao  发布了新帖 维生素b6过量对胎儿的影响 70天前

    孕11周剧吐,在医院输了4天维生素b6,输液及停药三天了,晚上睡醒后,双手无名指、小指及尺侧胳膊发麻。会不会使胎儿患vb6依赖症,该怎么办?

  • jinyachao
    jinyachao  回复了帖子 已经发表的外文杂志文章怎样修改通讯作者邮箱呢? 134天前
    要报销钱款,邮箱不在本单位,报不了
  • jinyachao
  • jinyachao
    jinyachao  回复了帖子 什么是21 CFR? 139天前
    更多法规介绍,参见微信公众号:药学英语
  • jinyachao
    jinyachao  发布了新帖 什么是21 CFR? 139天前

    一、21 CFR架构图二、CFR的介绍《美国联邦法规》(Code of Federal Regulations,简称CFR)是美国联邦政府执行机构和部门在“联邦公报“(Federal Register,简称FR)中发表与公布的一般性和永久性规则的集成。具有普遍适用性和法律效应。CFR是由联邦公报管理委员会(Administrative Committee of the Federal Register)负责将其从每一家具有普遍适用性和法律效应的政府机构获取的,由该机构在FR(Federal Register)上公布或发表的,或者向FR管理委员会递交的成文法律文件的草案和特别出版物及其修改版装订的法规集成。三、CFR的结构1.CFR共有50篇(title),部分有分篇(subtitle),分别

  • jinyachao
    jinyachao  回复了帖子 药品注册管理办法(征求意见稿)通读笔记——更新完毕(10.16继续更新) 143天前
    请教各位老师,为什么“附件 化学药品新注册分类申报资料要求(试行)”中与“ 化学药品注册分类及申报资料要求“相比,去掉了原” 化学药品注册分类及申报资料要求“第五部分临床试验要求的部分,现在哪类药看需要做哪些临床试验都不知道了?
  • jinyachao
    jinyachao  回复了帖子 Sec.312.30 方案修正案 144天前
    微信公众号:药学英语
  • jinyachao
    jinyachao  发布了新帖 Sec.312.30 方案修正案 144天前

    Sec. 312.30 Protocol amendments.Sec.312.30 方案修正案Once an IND is in effect, a sponsor shall amend it as needed to ensure that the clinical investigations are conducted according to protocols included in the application. This section sets forth the provisions under which new protocols may be submitted and changes in previously submitted protocols may

  • jinyachao
    jinyachao  发布了新帖 CFR21临床研究分期 147天前

    CFR21临床研究分期Sec. 312.21 Phases of an investigation.Sec. 312.21 研究分期An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are

  • jinyachao
    jinyachao  发布了新帖 FDA药品labeling介绍 149天前

    Overview of Website网站概览FDA’s Prescription Drug Labeling Resources website [formerly known as the PLR Requirements for Prescribing Information website] provides resources for the development of human prescription drug, including biological product, labeling regulated under New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbr

  • jinyachao
    jinyachao  发布了新帖 DMF 药物主文件 150天前

    Drug Master Files (DMFs)药物主文件Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They:药物主文件是提交给FDA用于提供详细的关于人用药生产、制造、包装和存储过程中使用的生产设备、生产工艺和使用原料的信息的保密文件。他们:l  Allow parties to ref

  • jinyachao
    jinyachao  发布了新帖 加速审批、快速审批通道、突破疗法资格和优先审评资格认定的简单介绍 153天前

    Accelerated Approval加速审批In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint”

  • jinyachao
    jinyachao  发布了新帖 Medication Guides 用药指南 154天前

    Medication Guides用药指南Providing information on proper drug use, safety, and storage提供正确用药、药品安全和药品贮藏信息 Search the Medication Guides Database 在用药指南数据库内搜索What are Medication Guides?什么是用药指南?Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, an

  • jinyachao
    jinyachao  发布了新帖 FDA批准了Eliquis的首个仿制药 155天前

    FDA approves first generics of EliquisFDA批准了Eliquis的首个仿制药 December 23, 20192019年12月23日The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism ['ɛmbə,lɪzəm] 血管栓塞 in patients with nonvalvular atrial fibrillation非瓣膜性房颤. Apixaban is also

  • jinyachao
    jinyachao  发布了新帖 FDA批准治疗晚期尿路上皮癌的新方法 160天前

    FDA approves new type of therapy to treat advanced urothelial cancerFDA批准治疗晚期尿路上皮癌的新方法December 18, 20192019年12月18日Today, the U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate [kɑndʒəɡet]偶联物, meaning the drug specifically targets cancer

  • jinyachao
    jinyachao  发布了新帖 美国食品药品管理局批准降低某些成年患者心脑血管发病风险用药 163天前

    FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups美国食品药品管理局批准降低某些成年患者心脑血管发病风险用药 December 13, 20192019年12月13日The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy 辅助治疗to reduce the risk of cardiovascular events among adults with ele

  • jinyachao
    jinyachao  发布了新帖 FDA批准Gilenya的首仿申请 173天前

    FDA approves first generics of GilenyaFDA批准Gilenya的首仿申请December 05, 20192019年12月05日The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.美国食品药品管理局批准Gilenya(芬戈莫德)胶囊的三项首访申请,用于治疗复发型多发性硬化症成人患者。“Approving

  • jinyachao
    jinyachao  回复了帖子 FDA网站上对Brand-Name Drugs的定义是什么?是否等同于原研药 173天前
    丁香园真是藏龙卧虎,受教了
  • jinyachao
    jinyachao  回复了帖子 【丁香调查报告】41.6%医护人员表示:身边医护发表论文存在造假 180天前
    一直为自己没发论文耿耿于怀,现在释然了

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