ich中英文对照

ICH 三方协调指导原则 E6 ICH GCP指导原则

INTRODUCTION 前 言

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

临床试验管理规范（GCP）是设计、实

ICH 三方协调指导原则 E6 ICH GCP指导原则

INTRODUCTION 前 言

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

临床试验管理规范（GCP）是设计、实施

Q7a（中英文对照）

FDA原料药GMP指南

Table of Contents

1. INTRODUCTION 1.1 Objective

1.2 Regulatory Applicability 1.3 Scope

2. QUALITY MANAGEMENT 2.1 Principles

2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self Inspection) 2.5 Product Quality Review

3. PERSONNEL

3.1 Personnel Qualifications 3.2 Personnel Hygiene 3.3 Consultants

4. BUILDINGS AND FACILITIES 4.1 Design and Construction 4.2 Utilities 4.3 Water

4.4 Containment 4.5 Lighting

4.6 Sewage and Refuse

4.7 Sanitation

ICH临床部分术语表

active comparator treatment 阳性对照治疗 active dose 有效剂量

active placebo treatment 阳性安慰剂治疗 active treatment concurrent control 阳性药物并行对照 adaptive allocation 适应性分组法 addendum 附件

add-on study 在标准治疗基础上的对照试验 adjust dosage 调整剂量 adjustments for covariates 协变量调整 administration instruction 用药指南 administrative criteria 用药标准 adoption 采用 adverse consequence 不良后果 adverse drug events (ADE) 药物不良事件 ad

ICH临床部分术语表

active comparator treatment 阳性对照治疗 active dose 有效剂量

active placebo treatment 阳性安慰剂治疗 active treatment concurrent control 阳性药物并行对照 adaptive allocation 适应性分组法 addendum 附件

add-on study 在标准治疗基础上的对照试验 adjust dosage 调整剂量 adjustments for covariates 协变量调整 administration instruction 用药指南 administrative criteria 用药标准 adoption 采用 adverse consequence 不良后果 adverse drug events (ADE) 药物不良事件 ad

cGMP文件,新版

Q7a（中英文对照）

FDA原料药GMP指南

Table of Contents

1. INTRODUCTION 1.1 Objective

1.2 Regulatory Applicability 1.3 Scope

2. QUALITY MANAGEMENT 2.1 Principles

2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self Inspection) 2.5 Product Quality Review

3. PERSONNEL

3.1 Personnel Qualifications 3.2 Personnel Hygiene 3.3 Consultants

4. BUILDINGS AND FACILITIES 4.1 Design and Construction 4.2 Utilities 4.3 Water

4.4 Containment 4.5 Lighting

4.6 Sewage and Refuse

4.7 Sanitation and M

景观中英文对照表（一）

Landscape Design Development Package Drawing Schedule Sheet No Description Sheet Size

Revision Reference Additional Drawing Deleted Drawing Remarks

Drawing File Name

Internal Drawing Date Internal Revision Date Cover Sheet Materials Schedule General Legend

Standard Symbols & Abbreviations

Landscape Plans (LP-) (Bound Separately) Reference Plan Part 01 Client Project Scale Designed By Drawn By Checked By Approved By Setting-Out Plan

Levels/Drainage/Irrigation Plan Materials Plan Lighting Plan

Landscape Sections

工厂及设备

炼钢炼铁 Iron and Steel Making Iron Works Iron Making Steel Works / Steel Mill Blast Furnace Coking Plant Foundry Tapping Slag Tap Tap hole Ladle Converter Baiting Skip 150 T Electric Arc Furnace (EAF) Oxygen Oil Burner The fifth hole continuous automatic charging Water-cooled Furnace Wall Water-cooled Furnace Cover Eccentric Bottom Tapping Ladle Furnace (LF) Continuous Caster Four-strand bow-type continuous caster for round billets Billets Cutting Vacuum Degassing Molten Steel Vacuum Degassing Argon Blowing And Stirri

一、File〈文件〉

New〈新建〉

Reset〈重置〉

Open〈打开〉

Save〈保存〉

Save As〈保存为〉

Save selected〈保存选择〉

XRef Objects〈外部引用物体〉

XRef Scenes〈外部引用场景〉

Merge〈合并〉

Merge Animation〈合并动画动作〉

Replace〈替换〉

Import〈输入〉

Export〈输出〉

Export Selected〈选择输出〉

Archive〈存档〉

Summary Info〈摘要信息〉

File Properties〈文件属性〉

View Image File〈显示图像文件〉

History〈历史〉

Exit〈退出〉

二、Edit〈菜单〉

Undo or Redo〈取消/重做〉

Hold and fetch〈保留/引用〉

Delete〈删除〉

Clone〈克隆〉

Select All〈全部选择〉

Select None〈空出选择〉

Select Invert〈反向选择〉

Select By〈参考选择〉

Color〈颜色选择〉

Name〈名字选择〉

Rectangular Region〈矩形选择〉

Circular Region〈圆形选择〉

Fabce Region〈连点选择〉

Lasso Region〈套索选择〉

Reg

餐具:

coffee pot 咖啡壶 coffee cup 咖啡杯 paper towel 纸巾 napkin 餐巾 table cloth 桌布 tea -pot 茶壶 tea set 茶具 tea tray 茶盘 caddy 茶罐 dish 碟 plate 盘

saucer 小碟子 rice bowl 饭碗 chopsticks 筷子 soup spoon 汤匙 knife 餐刀 cup 杯子 glass 玻璃杯 mug 马克杯

picnic lunch 便当 fruit plate 水果盘 toothpick 牙签 中餐:

bear’s paw 熊掌 dried venison 鹿脯

beche-de-mer; sea cucumber 海参 sea sturgeon 海鳝

salted jelly fish 海蜇皮 kelp, seaweed 海带 abalone 鲍鱼 shark fin 鱼翅 scallops 干贝 lobster 龙虾 bird’s nest 燕窝

roast suckling pig 考乳猪 pig’s knuckle 猪脚

boiled salted duck 盐水鸭 preserved meat 腊肉 b