临床试验专用术语实用小词典

2014-05-08

                               
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简化新药申请（ABBREVIATED NEW DRUG APPLICATION,ANDA）
$ P  e* m' l+ v- U  e0 s参考其他新药申请数据的新药申请简略版。
Shortened version of a New Drug Application referencing data from other NDAs.

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审查异议信件(ACTION LETTER)
  h* K% w' S$ ~) R& L* [美国食品药品管理局发给申请人的信函，表明对已提交申请的审查决定。可批准函表明待一些
小问题解决后，申报的药品即可被批准；未批准信函表明申请中有重大缺陷需要更正。
. a) L: w, w% \1 G( {! J" p5 l; R, xA letter from the Food and Drug Administration to a sponsor indicating a decision on an application submittal. An upprovable letter indicates the product can be approved after minor issues are resolved. A approvable letter describes significant deficiencies in the application that require correction before the application can be considered.

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积极治疗(ACTIVE TREATMENT)
临床试验中使用的一种治疗方法，通常是已知有效，并作为试验药物的阳性对照。
$ V/ b! m- W! `/ ]8 r' C2 XA treatment in a clinical trial where an active medication, known to be effective,
) ^# r% u( X  pis used, usually as a positive control compared to the investigational agent.

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辅助治疗(ADJUVANT)
基本治疗方法以外的附加治疗方法。
* ?  }+ {+ }! T/ nTreatment used in addition to the primary therapy.

ADME
药物的吸收、分布、代谢和排泄。
Refers to the absorption, distribution, metabolism, and excretion of a drug compound.

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行政视察(ADMINISTRATIVE LOOK)
a.检查正在进行的非验证性试验的数据或
b.检查正在进行的验证性试验的数据，用于后期试验设计、分配制造资源等
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6 \" @. I( L! |a. Review of data from an ongoing nonconfirmatory study or
b. Review of data from an ongoing confirmatory trial that is used to make administrative decisions about the design of future trials, allocated manufacturing resources, and so on but NOT to modify the ongoing trial.

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药物不良反应（ADVERSE DRUG REACTION ,ADR）
及不良反应（ADVERSE REACTION）
见不良经历（AE）。
See Adverse Experience (AE).

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不良经历（ADVERSE EXPERIENCE，AE）
临床试验中受试者经历的任何不良症状或事件，不一定与研究药物有因果关系。也可称为不良反应、不良事件、药物不良反应（ADR）和副作用。
Any undesirable symptom or occurrence that a trial subject experiences during the clinical trial; it may or may not be considered related to the study agent. Also referred to us adverse reaction, adverse event, adverse drug reaction (ADR), and side effect.

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咨询委员会（ADVISORY COMMITTEE）
委员会由美国食品药品管理局（FDA）委任的外部专家组成，主要审查递交至FDA的新药申请（NDA）数据。组成委员会的专家可根据需要来自各个领域。FDA的各个咨询委员会因治疗领域不同而异。委员会无权批准新药申请，只能向FDA建议申请的价值。
A committee of outside experts assembled by the Food and Drug Administration (FDA) to review data from a New Drug Application (NDA) submitted to the FDA. The committee consists of experts in the field and meets as needed. Many advisory committees to the FDA exist and differ for different therapeutic areas. The committee does not approve an NDA but only advises the FDA on the merit of the application.

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修正案（AMENDMENT）
对于新药研究（IND）申请：指的是对提交给美国食品药品管理局的IND申请的更改或增加，通常包括新方案，现有方案的修改或新的研究者。
7 [1 x" g9 S7 s7 Q3 |7 J2 m- _& D) k对于新药申请(NDA)：指对未批准的新药申请进行资料补充，如新的安全性信息或补充研究所得数据。
对于方案：指要求修订的试验方案的变更。
! K$ X3 J4 x) _3 \/ z- QTo an Investigational New Drug (IND) Application: A change or addition to an IND filed with the Food and Drug Administration; generally, these include a new protocol, a change to an existing protocol, or a new investigator.
5 n; ?6 y0 F2 d' F6 }: yTo a New Drug Application (NDA): A supplement to a pending NDA, such as a safety update or data obtained from a supplementary study.
( ^* x% O; Z, A4 rTo a protocol: A change in a study protocol requiring an amendment to the protocol.

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