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1、 unit 41.unwanted effects 非预期的反应2.normal therapeutic doses 常规治疗剂量3.mimics 相似4.diverse clinical signs and symptoms 各种临床症状和体征5.type a and type b a 型和 b 型6.pharmacological effect 药理作用7.low therapeutic index 低治疗指数8.predictable 预测9.dose-related 剂量相关10.erious or even fatal 严重的甚至致命11.intracranial bleeding
2、颅内出血12. incorrect dosage 不适量给药13.disordered pharmacokinetics 代谢紊乱14.impaired drug elimination 消除不正常15.side-effects 副作用16.pharmacodynamics:药效学17.pharmacokinetics:药动学18.idiosyncratic 特异性反应19. pathophysiology 病理生理学20.genetic or immunological 遗传学和免疫学21.occur infrequently 发生率较低22.continuous reactions 持续反
3、应23.long-term drug use 长期用药24. delayed reactions 延迟反应25.alkylating agents leading to carcinogenesis 烷化剂致癌26.teratogenesis 致畸27.end-of-use reactions:停药反应28. withdrawal syndromes: wdr:lsndrmz 戒断-综合征29.discontinuation:dskntnjen 停止30.antidepressants :抗抑郁31. depressants:dpresnt 镇静剂32.fatalities 死亡时间33.fa
4、tality-fatalities:ftlti死亡34.hepatic or renal disease 肝肾疾病35.surveillance pharmacovigilance36.high degree of sensitivity and specificity 高度的敏感性和针对性37.detect rare but severe 罕见但严重38.the incidence of 发生率39.predisposing factors 易感因素40.quantify 量化41.continued surveillance is mandatory 持续性监测 42.many ill e
5、ffects 副作用43.uncommon adverse effects 罕见不良反应44.assessing the tolerability and dose-response relationship of new therapeutic agents. 新药的耐受性和量效关系45.serious toxicity 严重的毒性46.the incidence of common adverse reactions 一般不良反应的发生率47.dropping out 撤出48.resembles spontaneous disease 原患疾病的表现相似49.magnitude 数量级u
6、nit 61.a natural product is a chemical compound or substance produced by a living organism - foundin nature that usually has a pharmacological or biological activity for use in pharmaceuticaldrug discovery and drug design. a natural product can be considered as such even if it can beprepared by tota
7、l synthesis. 天然产物是指活的有机体产生的化合物或物质,在天然条件下通常有一定药理或生物活性,它用于药物研发和药物设计。尽管天然产物可以通过全合成来制备,人们仍可认定其天然属性。2.natural product:天然产物;3.5.drug discovery:药物研发;4.6.total synthesis:全合成;5.high throughput screening(hts)6.lc-ms 液质联用7.7.lc-nmr 液相色谱-核磁共振联用8.high throughput screening(hts) 高通量筛选9.high throughput screening(ht
8、s) 高通量筛选10. lc-ms 液相色谱-质谱联用11.lc-nmr 液相色谱-核磁共振联用unit 71.drug delivery 药物给药系统2.peak-and-trough 波峰-波谷3.constant concentrations of drugs 稳定的药物浓度4.sustained-release technology 缓释技术5.controlled-release delivery system 控制释放给药系统6.nonoral 非口服7.at a constant rate 稳定的速度8.the plethora of preparations 控释技术9.wat
9、er-soluble drug 水溶性的药物10.large molecules 逃离迷宫11.drug-containing complex 含有药物的复合体12.positive electric charge 用电离子渗透法 13.pill pump 渗透泵片14.semipermeable membrane 半透膜15.osmotic pressure 渗透压16.the rate of drug delivery 给药速度17.liver cancer drugs 肝癌药物18.delivery rate 运输速率19.at a constant rate 固定速度20.partic
10、le size. 颗粒的大小21.liver and lungs 肝脏和肺部22.systemic toxicity 全身性毒性23.monoclonal antibodies 单克隆抗体24.in the concept stage. 处于概念阶段25.computer-guided drug dosing 计算机指导制定药物剂量26.computer-aided diagnosis 计算机辅助诊断27.transmucosal delivery28.osmotic devices29.respiratory delivery30.liposomesunit 81. by utilizing
11、 the methodologies and techniques in physics, chemistry, biology andmicrobiology, pharmaceutical analysis focuses on qualitative and quantitative analysis of drugs,quality control and development of new drugs.它运用物理学、化学、物理化学、生物学和微生物学等的方法和技术研究药物的定性和定量分析、药物的质量控制和新药开发。2. a selective reaction or test is
12、one that can occur with other substances but exhibits a degreeof preference for the substance of interest.选择性反应或鉴别是指可以和其他物质发生反应但对敏感物质显示一定程度偏好。3. a specific reaction or test is one that occurs only with the substance of interest.专属性反应或鉴别是指仅与敏感物质发生反应。unit 101.drug standard usually includes official na
13、me, description, identification, purity test, content(potency or activity) assay, dosage, strength, storage and preparation etc.因此,药品标准一般包括以下内容:法定名称、性状、鉴别、纯度检查、含量(效价或活性)测定、剂量、规格、贮藏、制剂等等。2.some important pharmacopeias includes united states pharmacopoeia/national formulary,british pharmacopoeia, euro
14、pean pharmacopoeia, japanese pharmacopoeia.现在世界上主要药典有:美国药典/国家处方集、英国药典、欧洲药典、日本药局方。3.the international conference on harmonisation of technical requirements for registration ofpharmaceuticals for human use (ich) 人用药物注册技术要求国际协调会 4.the united states pharmacopoeia (usp)the national formulary (nf) 美国药典/国家
15、处方集unit 141.health and human services 美国人类健康服务部(hhs)2.federal executive departments 联邦行政机构3.protect and promote:保护和促进4.regulation and supervision:管理和监督5.public health service act 公共健康法案6.sanitation n. 环境卫生7.no drug is absolutely safe.没有任何药品是绝对安全的8.some risk of an adverse reaction 发生药品不良反应的风险9.ts whe
16、n the benefits outweigh the risks that fda considers a drug safe enough to approve.只有当收益大于风险时美国 fda 才会认定该药足够安全,可以批准。10.pre-market safety approval of all new drugs药品上市前的安全性证明11.premarket efficacy and safety 药品上市前安全性和有效性证明12.the idea of risk vs. benefit that is now the key to new drug approval. 这一思想现在
17、成为了新药审批的关键13.providing evidence of safety before marketing was first required by the federal food, drugand cosmetic act in 1938, but not until the drug amendments of 1962 did firms also have toshow a drugs effectiveness before marketing. 1938年的 fdca 法案开始要求药品上市前必须证明其安全性,但是直到 1962 药品修正案才要求药品上市前也要提供证明其
18、有效性。14.a thorough evaluation 全面的评估15.ntended use 预期作用16.broader use 更广泛的使用17.desperately ill and dying patients 垂危病人18.promising is the key word in this broadened use of unapproved drugs. 扩大使用未被批准药物的关键是这些药“有前途”19.a try anythingapproach 任何均可尝试的方法20.fda requires that experimental drugs, too, satisfy a
19、 certain benefit-to-risk ratio.fda要求实验性药物同样要满足一定的风险效益比。21.investigational new drug application ind 试验用新药申请/临床试验申请22.new drug applicationnda 新药申请23. a drug is first reviewed, however, when a sponsor submits an investigational new drugapplication (ind) to fda before tests with people begin.责任人要首先向 fda
20、 提交新药临床试验申请(ind),审评后方可开展人体试验。24.f so, the ind is considered to be “in effect” and the clinical study may proceed; if not, fdamay place the study on hold until the sponsor makes needed changes.如果是,新药临床研究申请被认为有效,临床试验可以开展。如果不是,fda 则会搁置该申请,直到申请者提供必要的改进。25.sponsors are encouraged to meet with fda before
21、the final phase of human tests, which arethe large-scale controlled clinical trials. at this conference, fda gives advice about the design of the sponsors study plan to ensure that the trials will be acceptable. fda鼓励责任人在开展最后一期大规模临床对照试验前与其会晤。在这次会晤上,fda 会对申请者的试验方案给予意见,以保证临床试验可被许可。26.review time 审批时间2
22、7.an average of 10 to 18 months less time 一般少于 10 到 18 个月28.averaged just 131/2 months 平均只用了 13.5 个月的时间29.a reviewers day 审评员的一天30.four ndas 4 份新药申请31.only about 60 percent of a reviewers time is actually spent reviewing 此外,审评员只有60%的时间真正花在审评上。32.the basis of fdas evaluation of safety and effectivene
23、ss. 它是 fda 评估其安全性和有效性的基础。33.they help to clarify the drugs benefit-to-risk relationship.有助于明确该药的风险效益关系34.drugs professional labeling 药专业说明书上的信息35. a classification system. 分类系统36. as fda resources are limited, the idea is to give priority to drugs with the greatestpotential benefit.fda 资源优先,因此其思想是将优
24、先权给予具有最大潜在效益的药物。37. a significant medical advance over existing therapies for any other disease.其次在治疗其他疾病上比现有药物有重大突破的药物。38.when an important new drug is about to be approved, a“summary basis for approval” iswritten, laying out fdas basis for deciding the drug is safe and effective. 当一个重要的新药快被通过审批时,需要起草一份“药物批准概要依据”来陈述 fda 认定该药安全有效的依据39.fda staff may visit the sites of some of the studies to compare results provid
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