名词解释题药物临床试验（drug clinical trial）
题目
名词解释题
药物临床试验（drug clinical trial）
相似考题
参考答案和解析
正确答案：
任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示药物的作用、药物不良反应及/或其吸收、分布、代谢和排泄，目的是确定药物的疗效及安全性。
解析：
暂无解析
更多“药物临床试验（drug clinical trial）”相关问题
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第1题：
共用题干
Clinical Trials
1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.
2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.
3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.
4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.Paragraph 2______
A: Are clinical trials safe?
B: What are clinical trials?
C: What should people know before participating in a clinical trial?
D: Who should consider clinical trials and why?
E: Where are clinical trials conducted?
F: Why are clinical trials done?答案：D解析：第一段主要讲为什么要进行临床试验，其中谈到要研究如何安全有效地使用新药物或新仪器，如何使用方便并减少副作用，或用于不同人群等。
第二段主要讲什么人为什么参加临床试验，比方说，要观察不同人群的不同疗效，有的人已没有别的方法治疗，也有的人要为医疗事业作贡献等。
第三段主要讲参加临床试验的安全性问题。尽管FDA等会做出努力，但是新治疗方法的不确定性是不可避免的。
第四段主要讲人们参加临床试验前可以与有关医务人员充分讨论问题，了解试验的详情以及试验的利弊等。
短文第一句就说到，新药物或新仪器用于人体是否安全有效需要进行临床试验。
第二段第三句说到，有些人对于常规的治疗方法已无可选择，所以参加临床试验，当然就是他们的唯一希望了。
第三段第一句说到，FDA要保证，在人们决定是否参加临床试验的时候要获得可靠信，息。
整个第四段说到，准备参加临床试验的人们要尽可能多地了解有关临床试验的情况。 -
第2题：
共用题干
Clinical Trials
1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.
2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.
3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.
4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.Learn as much as you can about a clinical trial______.
A: candidates for clinical trials
B: during the trial
C: medical knowledge
D: in humans
E: before participation
F: for some patients答案：E解析：第一段主要讲为什么要进行临床试验，其中谈到要研究如何安全有效地使用新药物或新仪器，如何使用方便并减少副作用，或用于不同人群等。
第二段主要讲什么人为什么参加临床试验，比方说，要观察不同人群的不同疗效，有的人已没有别的方法治疗，也有的人要为医疗事业作贡献等。
第三段主要讲参加临床试验的安全性问题。尽管FDA等会做出努力，但是新治疗方法的不确定性是不可避免的。
第四段主要讲人们参加临床试验前可以与有关医务人员充分讨论问题，了解试验的详情以及试验的利弊等。
短文第一句就说到，新药物或新仪器用于人体是否安全有效需要进行临床试验。
第二段第三句说到，有些人对于常规的治疗方法已无可选择，所以参加临床试验，当然就是他们的唯一希望了。
第三段第一句说到，FDA要保证，在人们决定是否参加临床试验的时候要获得可靠信，息。
整个第四段说到，准备参加临床试验的人们要尽可能多地了解有关临床试验的情况。 -
第3题：
药物的相互作用（drug interaction）答案：解析：联合应用两种或两种以上的药物时所产生的影响较单独应用时产生的效应，使之增强或减弱。 -
第4题：
下列关于GCP叙述错误的是A.GCP即为药物临床试验管理规范
B.目的在于保证临床试验过程的规范
C.是Good Clinical Practice的简称
D.是指任何在人体(特指患者)进行的药品系统性研究
E.可揭示试验用药品的作用和不良反应等答案：D解析： -
第5题：
中药材种植单位必须执行（）
- A、GAP中药材生产质量管理规范
- B、GLP药物非临床研究质量管理规范
- C、GCP药品临床试验管理规范（Good Clinical Practice,GCP）
- D、GMP药品生产质量管理规范药品经营质量管理规范
正确答案:A -
第6题：
在Pubmed中检索有关“感冒的药物治疗”的循证医学文献，最佳途径为（）
- A、Search （Common Cold and drug therapy）
- B、Search （Common Cold and drug therapy） Limits：Systematic Reviews
- C、Search （Common Cold /drug therapy） Limits：Systematic Reviews
- D、Search （Common Cold and drug therapy and EBM）
正确答案:C -
第7题：
结合型药物（bound drug）
正确答案:大多数药物在血浆中均可与血浆蛋白不同程度的结合而形成结合型药物。 -
第8题：
临床试验（clinical trial）
正确答案:指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。 -
第9题：
“me-too” 药物（“me-too”drug）
正确答案:“Me-too”药物特指具有自己知识产权的药物，其药效和结构与同类的已有的专利药物相似。 -
第10题：
名词解释题药物（drug）正确答案： 药物是人类用来预防、治疗、诊断疾病、或为了调节人体功能，提高生活质量，保持身体健康的特殊化学品。解析： 暂无解析 -
第11题：
名词解释题游离型药物（free drug）正确答案： 血中没有与血浆蛋白结合的药物。解析： 暂无解析 -
第12题：
单选题关于《药物临床试验质量管理规范》和《药物临床试验管理质量规范》，下列哪项不正确（）A《药物临床试验质量管理规范》是有关临床试验的准则
B《药物临床试验管理质量规范》是有关临床试验的技术标准
C《药物临床试验管理质量规范》是关于临床试验方案设计、组织实施、监查、审视、记录、分析、总结和报告标准
D《药物临床试验质量管理规范》是临床试验全过程的标准
正确答案： D解析： 暂无解析 -
第13题：
共用题干
Clinical Trials
1 Many clinical trials are done to see if a new drug or device is safe and effective for people
to use .Sometimes clinical trials are used to study different ways to use the standard
treatments so they will be more effective,easier to use,and/or decrease side effects.
Sometimes,studies are done to learn how to best use the treatment in a different group,
such as children,in whom the treatment was not previously tested.
2 It is important to test drugs and medical products in the people they are meant to help,It
is also important to conduct research in a variety of people because different people may
respond differently to treatments.Some people participate in clinical trials because they
have exhausted standard treatment options.Other people participate in trials because they
want to contribute to the advancement of medical knowledge.
3 The FDA（食品及药物管理局）works to protect participants in clinical trials and to
ensure that people have reliable information as they decide whether to join a clinical trial.
Although efforts are made to control the risks to clinical trial participants,some risks may be
unavoidable because of the uncertainty inherent（内在的）in medical research studies
involving new medical treatments.
4 People should learn as much as possible about the clinical trials that interest them.They
should also feel comfortable discussing their questions and concerns with members of the
health care team. Prospective（预期的）participants should understand what happens
during the trial,the type of health care they will receive,and any costs to them.Anyone
considering a clinical trial should also know that there are benefits and risks associated with
participating.Reliable information should be available to_________.
A: for some patients
B: before participation
C: in humans
D:medical knowledge
E: during the trial
F: candidates for clinical trials答案：F解析： -
第14题：
共用题干
Clinical Trials
1. Many clinical trials are done to see if a new drug or device is safe and effective for people to use.Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective,easier to use,and/or decrease side effects.Sometimes,studies are done to learn how to best use the treatment in a different population,such as children,in whom the treatment was not previously tested.
2. It is important to test drugs and medical products in the people they are meant to help.It is also important to conduct research in a variety of people because different people may respond differently to treatments.Some people participate in clinical trials because they have exhausted standard treatment options .Other people participate in trials because they want to contribute to the ad-vancement of medical knowledge.
3. The FDA（食品及药物管理局）works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.Although efforts are made to control the risks to clinical trial participants,some risks may be unavoidable because of the uncertainty inherent（内在的）in medical research studies involving new medical treatments.
4. People should learn as much as possible about the clinical trials that interest them.They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective（预期的）participants should understand what happens during the trial ,the type of health care they will receive,and any costs to them.Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.Clinical trials provide the only hope______.
A: candidates for clinical trials
B: during the trial
C: medical knowledge
D: in humans
E: before participation
F: for some patients答案：F解析：第一段主要讲为什么要进行临床试验，其中谈到要研究如何安全有效地使用新药物或新仪器，如何使用方便并减少副作用，或用于不同人群等。
第二段主要讲什么人为什么参加临床试验，比方说，要观察不同人群的不同疗效，有的人已没有别的方法治疗，也有的人要为医疗事业作贡献等。
第三段主要讲参加临床试验的安全性问题。尽管FDA等会做出努力，但是新治疗方法的不确定性是不可避免的。
第四段主要讲人们参加临床试验前可以与有关医务人员充分讨论问题，了解试验的详情以及试验的利弊等。
短文第一句就说到，新药物或新仪器用于人体是否安全有效需要进行临床试验。
第二段第三句说到，有些人对于常规的治疗方法已无可选择，所以参加临床试验，当然就是他们的唯一希望了。
第三段第一句说到，FDA要保证，在人们决定是否参加临床试验的时候要获得可靠信，息。
整个第四段说到，准备参加临床试验的人们要尽可能多地了解有关临床试验的情况。 -
第15题：
药物（drug）答案：解析：药物一般是指可以改变或者查明生理功能及病理状态，可以防、治、诊断疾病的化学物质。 -
第16题：
药物临床试验是指任何在人体进行的药物系统性研究，以证实或揭示试验药物的作用，临床试验分为四期药物治疗作用确证阶段属于A、Ⅱ期临床试验
B、Ⅰ期临床试验
C、Ⅲ期临床试验
D、Ⅳ期临床试验答案：C解析： -
第17题：
关于《药物临床试验质量管理规范》和《药物临床试验管理质量规范》，下列哪项不正确（）
- A、《药物临床试验质量管理规范》是有关临床试验的准则
- B、《药物临床试验管理质量规范》是有关临床试验的技术标准
- C、《药物临床试验管理质量规范》是关于临床试验方案设计、组织实施、监查、审视、记录、分析、总结和报告标准
- D、《药物临床试验质量管理规范》是临床试验全过程的标准
正确答案:B -
第18题：
药物作用（drug action）
正确答案: 药物对机体的初始作用，是动因，具有特异性和选择性。 -
第19题：
多中心临床试验（multicenter clinical trial）
正确答案:由多位研究者按同一试验方案在不同地点和单位同时进行的临床试验。各中心同期开始与结束试验。多中心试验由一位主要研究者总负责，并作为临床试验各中心间的协调研究者。 -
第20题：
计算机辅助药物设计（computer-aided drug design, CADD）
正确答案:用于药物的发现、药物设计、活性化合物的结构优化的计算机技术的总和。 -
第21题：
名词解释题临床试验（clinical trial）正确答案： 指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。解析： 暂无解析 -
第22题：
名词解释题合理药物设计（rational drug design）正确答案： 根据药物作用的靶点生物大分子（受体或酶）的三维空间结构来模拟与其相嵌合互补的天然配体或底物的结构片段来设计活性化合物分子的方法。解析： 暂无解析 -
第23题：
名词解释题多中心临床试验（multicenter clinical trial）正确答案： 由多位研究者按同一试验方案在不同地点和单位同时进行的临床试验。各中心同期开始与结束试验。多中心试验由一位主要研究者总负责，并作为临床试验各中心间的协调研究者。解析： 暂无解析