Q1A(R2)中英文对照

人用药品注册技术要求国际协调会

ICH三方指导文件

新原料药和制剂的稳定性试验Q1A(R2)

现第四版

2003年2月6日制定

Q1A(R2) 文件历程

现第四版

新原料药和制剂的稳定性试验Q1A(R)修订说明

本修订的目的为了明确由于采用了ICH Q1F“在气候带Ⅲ和Ⅳ注册申请的稳定性数据包”而使Q1A(R)而产生的变更。这些变更如下：

1. 在下面章节中将中间储存条件从温度30℃±2℃/相对湿度60%±5%修改为温度

30℃±2℃/相对湿度65%±5%：

2.1.7.1 原料药-储存条件-一般情况

2.2.7.1 制剂-储存条件-一般情况

2.2.7.3 在半渗透性容器中包装的制剂

3 术语-“中间试验”

2. 在下面章节中可以使用温度30℃±2℃/相对湿度65%±5%替代温度25℃±2℃/相对湿度

60%±5%作为长期稳定性试验的条件：

2.1.7.1 原料药-储存条件-一般情况

2.2.7.1 制剂-储存条件-一般情况

3. 在温度25℃±2℃/相对湿度40%±5%的基础上增加了温度30℃±2℃/相对湿度35%±5%

作为长期稳定性试验条件，并且在后面的章节中包括了失水比率相关举例的相关情况：

2.2.7.3 在半透性容器中包装的制剂

在试验阶段中间将中间将储存条件从温度30℃±2℃/相对湿度60%±5%调整为温度

30℃±2℃/相对湿度65%±5%是可以的，但相应的储存条件和调整的日期要在注册申报资料中清楚地说明和列出。

如果适用的话建议ICH三方在公布和执行此修订指南三年后，注册申请资料中完整的试验能够包含在中间储存条件，即温度30℃±2℃/相对湿度65%±5%下的实验资料。

S TABILITY T ESTING OF N EW

D RUG S UBSTANCES AND

P RODUCTS

1. INTRODUCTION

1.1. Objectives of the Guideline The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to other areas of the world.

The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.

1.2. Scope of the Guideline

The guideline addresses the information to be submitted in registration applications for new molecular entities and associated drug products. This guideline does not currently seek to cover the information to be submitted for abbreviated or abridged applications, variations, clinical trial applications, etc.

新原料药和制剂稳定性试验

1. 导言

1.1. 目的

下述的指导原则是ICH Q1A的修订版本，并且它为新原料药和制剂在欧洲、日本、美国三个地区注册所需要的稳定性资料做出规定要求。它并不涵盖世界其它地区或出口到这些地区的注册要求。

本指导原则试图去例证新原料药和制剂的核心稳定性数据，但是留有足够的弹性空间去适应由于特殊的科学考虑和被评估物质特殊性质而导致的各种不同的具体情况。在有科学依据和理由的情况下也可以采用替代的方案。

1.2. 范围

本指导文件所针对的是新分子实体及其相关制剂注册时需提交的信息。此指导文件并不寻求为简略或简化申请，变更申请和临床试验申请提供指导。

在特定的密闭系统中的特殊剂型的抽样和检验的详细指导不包括在此指导文件的范

Specific details of the sampling and testing for particular dosage forms in their proposed container closures are not covered in this guideline.

Further guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidelines Q1C and Q5C, respectively.

1.3. General Principles

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the EC, Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. This guideline addresses climatic zones I and II. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and the United States would be mutually acceptable to the other two regions, provided the information is consistent with this guideline and the labeling is in accord with national/regional requirements. 围中。

有关新剂型和生物技术/生物制品进一步指导请分别参考ICH Q1C和Q5C。

1.3 通则

稳定性试验的目的是为原料药或制剂的各种环境因素，如温度、湿度和光照等，影响下质量在如何随时间变化提供证据，从而为原料药制定复检期或为制剂制定有效期，和推荐的贮存条件。

本指导文件中的试验选择是基于对欧洲、日本、美国这三个地区的气候条件影响分析制定的。世界任何一个地带的平均动力学温度都可以从气象数据中获得，世界被分为四个气候带Ⅰ～Ⅳ，本指导文件描述的是Ⅰ和Ⅱ气候带的情况。一个通用原则已经被确立，即欧洲、日本、美国这三个地区中的任一地区的稳定性资料都应被其他两个地区所互相接受，提供的资料应与本指导文件相一致，标签规格应与各自国家/地区的要求相一致。

2. GUIDELINES

2.1. Drug Substance

2.1.1. General

Information on the stability of the drug substance is an integral part of the systematic approach to stability evaluation.

2.1.2. Stress Testing

Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.

Stress testing is likely to be carried out on a single batch of the drug substance. It should include the effect of temperatures (in 10°C increments (e.g., 50°C, 60°C, etc.) above that for accelerated testing), humidity (e.g., 75% RH or greater) where appropriate, oxidation, and photolysis on the drug substance. The testing should also evaluate the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. Photostability testing should be an integral part of stress testing. The standard conditions for photostability testing are described in ICH Q1B.

Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures. However, it may 2.指导文件

2.1 原料药

2.1.1 概述

原料药的稳定性资料是系统评估稳定性的一个主要组成部分。

2.1.2 影响因素试验

原料药的影响因素试验能帮助确定可能的降解物，这些降解物能依次帮忙确立降解路径，确立分子的内在稳定性和确定验证方法的稳定性指示能力，影响因素试验的本质取决于具体的原料药及所涉及的制剂类别。

影响因素试验可以在一个批次的原料药中展开研究，它包括温度的影响（以10℃为增量单位，如50℃，60℃等，高于加速试验的温度），湿度的影响（例如75%相对湿度或更高），适当情况下氧化和光照的影响。当在溶液中或悬浮液中时，试验也可以通过一定范围的pH值评估原料药水解作用的敏感性。光稳定性试验是影响因素试验的一个主要组成部分。光稳定性试验的标准条件在ICH Q1B中描述。

在影响因素试验条件下检查降解产物能有帮助确立降解路径和开发验证合适的分析方法。但是，对于已知的并且经证明在加速和长期试验条件下没有形成的降解产物没有必要再做特别的检查。

这些试验的结果是向监管部门提交资料的组成部分。

not be necessary to examine specifically for certain degradation products if it has been demonstrated that they are not formed under accelerated or long term storage conditions.

Results from these studies will form an integral part of the information provided to regulatory authorities.

2.1.

3. Selection of Batches

Data from formal stability studies should be provided on at least three primary batches of the drug substance. The batches should be manufactured to a minimum of pilot scale by the same synthetic route as, and using a method of manufacture and procedure that simulates the final process to be used for, production batches. The overall quality of the batches of drug substance placed on formal stability studies should be representative of the quality of the material to be made on a production scale.

Other supporting data can be provided.

2.1.4. Container Closure System The stability studies should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution.

2.1.5. Specification Specification, which is a list of tests, reference to analytical procedures, and proposed acceptance criteria, is addressed in ICH Q6A and Q6B. In addition, specification for degradation products in a drug substance is 2.1.3 批的选择

在正式稳定性研究试验中需要至少提供3个申报批次原料药的研究资料。这些批次应该至少在中式规模下生产，并且与生产批次采用一样的合成路线，一样的生产方法和与最终过程相似的步骤。正式稳定性研究中原料药批次的整体质量应该能够代表生产批次的整体质量。

其他支持性材料也可以提供。

2.1.4容器密闭系统

原料药在稳定性试验中的包装容器应该与拟上市储存和运输的包装相同或相似

2.1.5 质量标准

质量标准是由一系列的测试项目，参考的分析方法和拟研究标准组成，在ICHQ6A 和Q6B中有详细描述。另外，原料药降解产物的质量标准在Q3A中做讨论。

discussed in Q3A.

Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes. Validated stability-indicating analytical procedures should be applied. Whether and to what extent replication should be performed will depend on the results from validation studies.

2.1.6. Testing Frequency

For long term studies, frequency of testing should be sufficient to establish the stability profile of the drug substance. For drug substances with a proposed re-test period of at least 12 months, the frequency of testing at the long term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed re-test period.

At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended. Where an expectation (based on development experience) exists that results from accelerated studies are likely to approach significant change criteria, increased testing should be conducted either by adding samples at the final time point or by including a fourth time point in the study design.

When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage

稳定性研究应该包含对原料药一些储存时容易变化并且影响自身质量、安全性和有效性的一些特性进行测试。在适当的情况下，这些测试应当涵盖物理的，化学的，生物的和微生物的特性。应当使用经过验证的稳定性指示分析方法。是否需要重复试验以及重复的程度取决于验证性研究的结果。

2.1.6 试验频率

长期稳定性试验的测试频率应该足以能够反映原料药的稳定性概况，对于拟复检期至少12个月的原料药，在长期储存条件下的检测频率应该第一年每3个月一次，第二年每6个月一次，拟复检期后每年一次。

在加速试验条件下，要至少3个时间点，包括起始和结束的时间点（例如，0,3,6个月），推荐6个月的试验周期。对于预期（根据开发经验）可能出现加速试验条件下有明显改变的，应当增加试验，可以在最终时间点增加样品或者在试验设计中增加第四个时间点。

当在加速条件下试验下出现明显改变时可以采用中间储存条件试验，至少建立4个时间点，包括起始和最终点（例如：0,6,9,12月），推荐12个月的试验周期。

condition, a minimum of four time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12-month study is recommended.

2.1.7. Storage Conditions

In general, a drug substance should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use. The long term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed re-test period. Additional data accumulated during the assessment period of the registration application should be submitted to the authorities if requested. Data from the accelerated storage condition and, if appropriate, from the intermediate storage condition can be used to evaluate the effect of short term excursions outside the label storage conditions (such as might occur during shipping).

Long term, accelerated, and, where appropriate, intermediate storage conditions for drug substances are detailed in the sections below. The general case applies if the drug substance is not specifically covered by a subsequent section. Alternative storage conditions can be used if justified. 2.1.7 储存条件

通常情况下，应该在原料药的储存条件下（有适当的容差）评估其热稳定性，如果适用的话，还要评估其对水分的敏感性。储存条件和试验周期的周期应当能够涵盖日常储存，运输和后来使用的使用。

在提交申报资料时需要包含至少12个月3个申报批次的长期稳定性数据，并且应当继续进行试验以满足能够覆盖整个拟复验期。另外，如果要求的话，注册评审期间积累的稳定性数据也需要提供给当局。加速条件下试验的数据，如果适用的话，包括中间储存条件下的数据可以用来评估短期偏离标示储存条件的情况（比如可能在运输途中发生）

long term stability studies are performed at 25 ±2°C/60% RH ±5% RH or 30°C ±2°C/65% RH ± 5% RH.

**If 30°C ± 2°C/65% RH ± 5% RH is the long-term condition, there is no intermediate condition.

If long-term studies are conducted at 25°C ±2°C/60% RH ±5% RH and “significant change” occurs at any time during 6 months’ testing at t he accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. Testing at the intermediate storage condition should include all tests, unless otherwise justified. The initial application should include a

minimum of 6 months’ data from a 12-month study at the intermediate storage condition. 2.1.7.1 一般情况

由申请者决定稳定性研究采用25 ±2°C/60% RH ± 5% RH还是30°C ± 2°C/65% RH ± 5% RH。

如果选用30°C ±2°C/65% RH ±5% RH作为长期储存条件，就不需要中间储存条件。

如果在25°C ± 2°C/60% RH ± 5% RH 条件下进行长期稳定性试验，并且在6个月的加速试验条件中任一时间点出现了“明显改变”，应当在中间储存条件试验中增加试验来对比评估这些明显改变的项目。在中间储存条件下应当包含全部的测试，除非经过另外的论证。最初的申请文件应当至少包含12个月周期的中间储存条件试验中6个月的试验数据。

“明显改变”是指一个原料药不符合

“Significant change” for a drug substance is defined as failure to meet its specification.

2.1.7.2. Drug substances intended for storage

be assessed according to the evaluation section of this guideline, except where explicitly noted below.

If significant change occurs between 3 and 6 months’ testing at the accelerated storage condition, the proposed re-test period should be based on the real time data available at the long term storage condition.

If significant change occurs within the first 3 months’ testing at the accelerated storage condition, a discussion should be provided to address the effect of short term excursions outside the label storage condition, e.g., during shipping or handling. This discussion can be supported, if appropriate, by further testing on a single batch of the drug substance for a period shorter than 3 months but with more frequent testing than usual. It is considered unnecessary to continue to

test a drug 其质量标准。

2.1.7.2 拟冷藏储存的原料药

冷藏储存条件下的数据应该根据本指南评估部分的要求进行评估，除了下面明确提到的情况：

如果在加速试验条件下第3到6个月间发生变化，那拟复检期应该根据长期储存条件下的真实时间数据。

如果在加速试验条件试验下的前3个月发生变化，那么需要讨论短期偏离标示储运条件的影响，例如运输和搬运过程中。如果适用的话，这个讨论可以通过对单批原料药进行短于3个月但是比平常更多检测频率的进一步试验来完成。当原料药试验在前3个月发生明显改变时，通常认为不需要继续进行6个月的试验。

substance through 6 months when a significant change has occurred within the first 3 months.

2.1.7.

3. Drug substances intended for storage

storage in a freezer, the re-test period should be based on the real time data obtained at the long term storage condition. In the absence of an accelerated storage condition for drug substances intended to be stored in a freezer, testing on a single batch at an elevated temperature (e.g., 5°C ± 3°C or 25°C ±2°C) for an appropriate time period should be conducted to address the effect of short term excursions outside the proposed label storage condition, e.g., during shipping or handling.

2.1.7.4. Drug substances intended for storage below -20°C

Drug substances intended for storage below -20°C should be treated on a case-by-case basis.

2.1.8. Stability Commitment

When available long term stability data on primary batches do not cover the proposed re-test period granted at the time of approval, a commitment should be made to continue the stability studies post approval in order to firmly

2.1.7.3 拟冷冻储存的原料药

对已拟冷冻的原料药，其复检期应当基于长期试验条件下的真实时间数据。拟冷冻的原料药不存在加速试验，但是应当对单批原料药在适当时间周期内适当提高温度（例如，5°C ± 3°C或25°C ± 2°C)以针对短期偏离标示储运条件下的影响。

2.1.7.4 拟在-20°C以下储存的原料药

拟在-20°C以下储存的原料药要具体情况具体分析。

2.1.8 稳定性承诺

当一个原料药在获得批准后其申报批次的长期稳定性数据还不能涵盖其拟复检期时，应当做出一个在批准后继续进行稳定性研究以确立复检期的承诺。

establish the re-test period.

Where the submission includes long term stability data on three production batches covering the proposed re-test period, a post approval commitment is considered unnecessary. Otherwise, one of the following commitments should be made:

1. If the submission includes data from

stability studies on at least three

production batches, a commitment

should be made to continue these

studies through the proposed

re-test period.

2. If the submission includes data from

stability studies on fewer than

three production batches, a

commitment should be made to

continue these studies through the

proposed re-test period and to place

additional production batches, to a

total of at least three, on long term

stability studies through the

proposed re-test period.

3. If the submission does not include

stability data on production

batches, a commitment should be

made to place the first three

production batches on long term

stability studies through the

proposed re-test period.

The stability protocol used for long term studies for the stability commitment should be the same as that for the primary batches, unless otherwise scientifically justified.

2.1.9. Evaluation

The purpose of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability

当申请资料包含3个生产批次并且涵盖拟复检期的长期稳定性数据，就没有必要进行上述承诺。否则，应当做出以下任何一种承诺：

1. 如果申请资料中包含至少3个生产批次稳定性研究数据，应当做出一个在复检期间继续进行稳定性研究的承诺。

2. 如果申请资料中包含了少于3个生产批次的稳定性研究数据，应承诺在拟复检期间继续进行研究，并加入额外的批次使总批次达到至少3批，并且拟复检期间进行长期稳定性研究。

3. 如果在申请资料中没有包含生产批次的稳定性研究数据，应当做出一个对前三批生产批次在拟复检期能进行长期稳定性研究的承诺。

承诺的长期稳定性研究的方案应该与申报批次的方案一致，除非经过科学的论证。

2.1.9 评估

稳定性研究的目的是基于至少3个批次的稳定性试验和稳定性评估信息（包括，如

information (including, as appropriate, results of the physical, chemical, biological, and microbiological tests), a re-test period applicable to all future batches of the drug substance manufactured under similar circumstances. The degree of variability of individual batches affects the confidence that a future production batch will remain within specification throughout the assigned re-test period. The data may show so little degradation and so little variability that it is apparent from looking at the data that the requested re-test period will be granted. Under these circumstances, it is normally unnecessary to go through the formal statistical analysis; providing a justification for the omission should be sufficient.

An approach for analyzing the data on a quantitative attribute that is expected to change with time is to determine the time at which the 95% one-sided confidence limit for the mean curve intersects the acceptance criterion. If analysis shows that the batch-to-batch variability is small, it is advantageous to combine the data into one overall estimate. This can be done by first applying appropriate statistical tests (e.g., p values for level of significance of rejection of more than 0.25) to the slopes of the regression lines and zero time intercepts for the individual batches. If it is inappropriate to combine data from several batches, the overall re-test period should be based on the minimum time a batch can be expected to remain within acceptance criteria.

The nature of any degradation 果适用的话，物理，化学，生物，微生物测试的结果）来建立一个对以后在相似环境下生产的更多批次的原料药适用的复检期。各个批次间差异的程度会影响到后续生产批次是否在复检期内符合质量标准要求的置信水平。（confidence翻译成置信水平参考其他版本）

对于一些在试验期间降解很少和变化很小的数据，直观上就能通过这些数据看出其要求的复检期是可以接受的。在这样的情况下，通常没有必要进行正式的统计学分析，只需要为这种省略做出一个论证就可以了。

对于预期会随时间发生变化的某种能够定量的特性来说，其分析方法是确定在95%的单侧置信度的平均曲线与验收标准相交的时间点（此句参考其他版翻译）。如果分析显示批间差异很小，将全部数据进行组合成一个整体进行评估是更好的方法。可以首先对各个批次的回归直线的斜率和0点截距进行合适的统计检验（例如将p值大于0.25作为非显著性差异的标准）。如果不适合将各个批次的信息总结，则整体的复检期应当基于能够保持在验收标准中的最短时间的一个批次。

降解关系的特性决定了是否对数据进行线性回归分析。通常情况下，这个关系可以通过一个一次，二次或三次的算术或对数函数表现。应当对全部批次和单个批次的降解直线或曲线的拟合程度进行统计，如果适用

relationship will determine whether the data should be transformed for linear regression analysis. Usually the relationship can be represented by a linear, quadratic, or cubic function on an arithmetic or logarithmic scale. Statistical methods should be employed to test the goodness of fit of the data on all batches and combined batches (where appropriate) to the assumed degradation line or curve.

Limited extrapolation of the real time data from the long term storage condition beyond the observed range to extend the re-test period can be undertaken at approval time, if justified. This justification should be based on what is known about the mechanism of degradation, the results of testing under accelerated conditions, the goodness of fit of any mathematical model, batch size, existence of supporting stability data, etc. However, this extrapolation assumes that the same degradation relationship will continue to apply beyond the observed data.

Any evaluation should cover not only the assay, but also the levels of degradation products and other appropriate attributes.

2.1.10. Statements/Labeling

A storage statement should be established for the labeling in accordance with relevant national/regional requirements. The statement should be based on the stability evaluation of the drug substance. Where applicable, specific instructions should be provided, particularly for drug substances that cannot tolerate freezing. Terms such as 的话。

在适当的情况下，如果经过论证，基于长期稳定性试验的真实时间数据可以在观察时间范围之外被有限的外推来延长复检期。这个论证需要基于对降解机制了解的程度，在加速试验条件下的结果，数学模型的拟合程度，批量大小，现有的稳定性支持数据等。但是，这个外推法是假设降解关系在观察期之外继续保持之前的情况。

任何评价都不能仅仅包含含量测定，还需要包含降解产物的水平和其他相关的特性。

2.1.1.10 说明书（或译为标识）/标签

根据所在国家与地区的相关要求制定标签上的储存说明。这个说明应当基于原料药的稳定性评估。在适当的情况下，应当提供明确的说明指导，尤其对于一些不能冷冻的药品。诸如像“环境条件”和“室温”这样的词应当避免使用。

“ambient conditions” or “room temperature” should be avoided.

A re-test period should be derived from the stability information, and a retest date should be displayed on the container label if appropriate.

2.2. Drug Product

2.2.1. General

The design of the formal stability studies for the drug product should be based on knowledge of the behavior and properties of the drug substance and from stability studies on the drug substance and on experience gained from clinical formulation studies. The likely changes on storage and the rationale for the selection of attributes to be tested in the formal stability studies should be stated.

2.2.2. Photostability Testing Photostability testing should be conducted on at least one primary batch of the drug product if appropriate. The standard conditions for photostability testing are described in ICH Q1B.

2.2.

3. Selection of Batches

Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing. The manufacturing process used for primary batches should simulate that to be applied to production batches and should provide

复检期应当来源于稳定性信息，如果合适的话，复检日期应当在包装容器的标签中标识出。

2.2 制剂

2.2.1 通则

制剂的正式稳定性研究设计应当基于对原料药性能和特性的了解和原料药的稳定性研究数据，和临床处方研究经验。正式稳定性研究中存储的改变和检测项目的选择依据应当被说明。

2.2.2 光稳定性试验

如果适用的话，光稳定性试验应当至少在一个申报批次中进行。光稳定性试验的标准条件在ICH Q1B中被详细描述。

2.2.3 批次选择

稳定性研究应当提供至少3个申报批次的数据。申报批次应当与拟上市批次采用一样的配方和一样的包装容器系统。申报批次的生产过程应当与生产批次相似，并且产品质量和达到的质量标准应该与拟上市的产品一样。三批中至少要有两批是在中式规模下

product of the same quality and meeting the same specification as that intended for marketing. Two of the three batches should be at least pilot scale batches and the third one can be smaller, if justified. Where possible, batches of the drug product should be manufactured by using different batches of the drug substance. Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied.

Other supporting data can be provided .

2.2.4. Container Closure System Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label). Any available studies carried out on the drug product outside its immediate container or in other packaging materials can form a useful part of the stress testing of the dosage form or can be considered as supporting information, respectively.

2.2.5. Specification Specification, which is a list of tests, reference to analytical procedures, and proposed acceptance criteria, including the concept of different acceptance criteria for release and shelf life specifications, is addressed in ICH Q6A and Q6B. In addition, specification for degradation products in a drug product is addressed in Q3B.

Stability studies should include testing of those attributes of the drug product 生产，第三批经过论证可以适当小一点。如果可能的话，不同批次的制剂应该采用不同批次的原料药。

除非采用括号法或矩阵方案设计，每一种单规格和容器尺寸的制剂都应该进行稳定性研究。

其他支持性数据也可以提交。

2.2.4 容器密闭系统

制剂的稳定性试验应当在拟上市的包装容器中进行（包括，如果适用的话，任何二级包装和容器标签）。对于除去直接接触的包装或者采用其他包装材料的制剂所做的研究资料可以分别作为制剂影响因素试验的一部分或作为支持性数据。

2.2.5 质量标准

质量标准，包含一系列的测试项目，参考的试验方法，和拟验收标准，包含放行标准和货架期标准两个概念，这两个概念在ICH Q6A和Q6B中专门介绍。另外，制剂降解产物的质量标准在Q3B中专门介绍。

稳定性研究应该包含对原料药一些储存时容易变化并且影响自身质量、安全性和有

that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system). Analytical procedures should be fully validated and stability indicating. Whether and to what extent replication should be performed will depend on the results of validation studies.

Shelf life acceptance criteria should be derived from consideration of all available stability information. It may be appropriate to have justifiable differences between the shelf life and release acceptance criteria based on the stability evaluation and the changes observed on storage. Any differences between the release and shelf life acceptance criteria for antimicrobial preservative content should be supported by a validated correlation of chemical content and preservative effectiveness demonstrated during drug development on the product in its final formulation (except for preservative concentration) intended for marketing.

A single primary stability batch of the drug product should be tested for antimicrobial preservative effectiveness (in addition to preservative content) at the proposed shelf life for verification purposes, regardless of whether there is a difference between the release and shelf life acceptance criteria for preservative content.

2.2.6. Testing Frequency

For long term studies, frequency of 效性的一些特性进行测试。在适当的情况下，这些测试应当涵盖物理的，化学的，生物的和微生物的特性，保护剂含量（例如，抗氧剂，抗菌防腐及），和功能性测试（如，药物递送系统）。应当使用经过验证的稳定性指示分析方法。是否需要重复试验以及重复的程度取决于验证研究的结果。

货架期标准应当源于所有稳定性研究数据的考虑。可以根据稳定性评估和储存过程中观察到的变化对货架期标准和放行标准之间的差别做出论证。放行标准和货架期标准之间的抗菌防腐剂含量的任何差别都需要进行到化学含量与抗菌防腐功效的相关性的验证支持，这种相关性是在最终拟上市配方（除了防腐剂浓度）的研发过程中得到论证的。不论在放行标准和货架期标准之间是否存在保护剂含量的差异，一个单独的申报批次的制剂应当用来研究验证在有效期内的抗菌防腐功效。

2.2.6 试验频率

长期稳定性试验的试验频率应该足以能

testing should be sufficient to establish the stability profile of the drug product. For products with a proposed shelf life of at least 12 months, the frequency of testing at the long term storage condition should normally be every 3 months over the first year, every 6 months over the second year, and annually thereafter through the proposed shelf life.

At the accelerated storage condition, a minimum of three time points, including the initial and final time points (e.g., 0, 3, and 6 months), from a 6-month study is recommended. Where an expectation (based on development experience) exists that results from accelerated testing are likely to approach significant change criteria, increased testing should be conducted either by adding samples at the final time point or by including a fourth time point in the study design.

When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum of four time points, including the initial and final time points (e.g., 0, 6, 9, 12 months), from a 12-month study is recommended.

Reduced designs, i.e., matrixing or bracketing, where the testing frequency is reduced or certain factor combinations are not tested at all, can be applied, if justified.

2.2.7. Storage Conditions

In general, a drug product should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture or potential 够反映制剂的稳定性概况，对于拟有效期至少12个月的制剂，在长期储存条件下的检测频率应该第一年每3个月一次，第二年每6个月一次，拟有效期后每年一次。

在加速试验条件下，要至少3个时间点，包括起始和结束的时间点（例如，0,3,6个月），推荐6个月的试验周期。对于预期（根据开发经验）可能出现加速试验条件下有明显改变的，应当增加试验，可以在最终时间点增加样品或者在试验设计中增加第四个时间点。

当在加速条件下试验下出现明显改变时可以采用中间储存条件试验，至少建立4个时间点，包括起始和最终点（例如：0,6,9,12月），推荐12个月的试验周期。

简化后的设计，例如，在经过论证后，可以采用矩阵法或括号法减少检测频率或不进行某些综合因素的测试。

2.2.7 储存条件

在通常情况下，制剂应当在储存条件下（包含适当的容差）评估其热稳定性，如果适用的话，和对水分的敏感性以及潜在的溶

for solvent loss. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment, and subsequent use. Stability testing of the drug product after constitution or dilution, if applicable, should be conducted to provide information for the labeling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period on primary batches as part of the formal stability studies at initial and final time points and, if full shelf life long term data will not be available before submission, at 12 months or the last time point for which data will be available. In general, this testing need not be repeated on commitment batches.

The long term testing should cover a minimum of 12 months’ duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life. Additional data accumulated during the assessment period of the registration application should be submitted to the authorities if requested. Data from the accelerated storage condition and, if appropriate, from the intermediate storage condition can be used to evaluate the effect of short term excursions outside the label storage conditions (such as might occur during shipping).

Long term, accelerated, and, where appropriate, intermediate storage conditions for drug products are detailed in the sections below. The general case applies if the drug product is not specifically covered by a 剂损失。储存条件和研究周期的选择应当能够涵盖整个储存，运输和后续的使用。

对于需要溶解配制或稀释后才能使用的制剂，如果适用的话，应当在标签中提供包括准备条件，储存条件，配制或稀释后使用期限。这项试验应该采用一个申报批次在拟使用期内对配制或稀释后制剂进行稳定性检测，作为正式稳定性试验起始和最终时间点研究的一部分，并且，如果整个有效期长期稳定性试验数据在提交申请时还不能获得，则至少提交12个月或最后时间点的稳定性数据。通常情况下，这些试验不需要在商业批中再次重复。

长期稳定性试验在提交申请时应当至少包含3个申报批次最少12个月的数据，并且应当继续进行试验以包括整个拟有效期。如果有要求，注册申报期间积累的稳定性数据也需要向当局提供。加速试验条件下的数据，如果适用的话，包裹中间储存条件下的数据能够用来评价短期偏离标示储存条件的影响（例如可能在运输途中发生）。

制剂的长期试验，加速试验，适当时候，包括中间储存条件试验在下面部分会被详细的介绍。不属于后续章节提到的特殊药品制剂都适用于一般情况。替代的储存条件须经过论证方可采用。

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钟表中英文对照术语表，希望对各位表迷有所帮助 10J - 10天动力储备 Abbreviation for 10 days power reserve in the Patek Philippe typology.在百达翡丽而言是“10 days power reserve - 10天动力储备”的缩写。 24H - 24小时表盘 Abbreviation for "24-hour dial", in the Patek Philippe typology.在百达翡丽而言是“24-hour dial - 24 小时表盘”的缩写。 Amplitude - 摆幅

Measurement in degrees of the movement of a balance and spring assembly: amplitude is the angle between the position of equilibrium and its maximum elongation.测量摆轮游丝装置的摆动角度：摆幅即是游丝装置的平衡位置与最大距角之间的角度。 Analogue - 指针式时间显示 Refers to time display using hands.指采用指针来显示时间。 Aperture - 视窗、孔径

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插座——socket 表盖——meter cover 表壳——meter case 可触及导电部件——accessible conductive part 保护接地端——protective earth terminal 端子座——terminal block 端子盖——terminal cover 间隙——clearance 爬电距离——creepage distance 基本绝缘——basic insulation 附加绝缘——supplementary insulation 双重绝缘——double insulation 加强绝缘——reinforced insulation I类防护绝缘包封仪表——insulating encased meter of protective class I II类防护绝缘包封仪表——insulating encased meter of protective class II 参比电流——reference current 基本电流*（Ib)——basic current （Ib) 额定电流*（In)——rated current （In) 最大电流*（Imax)——maximum current （Imax)

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具体名词 concret noun 物质名词 material noun 集体名词 collective noun 个体名词 individual noun 介词 preposition 连词 conjunction 动词 verb 主动词 main verb 及物动词 transitive verb 不及物动词 intransitive verb 系动词 link verb 助动词 auxiliary verb 情态动词 modal verb 规则动词 regular verb 不规则动词 irregular verb 短语动词 phrasal verb 限定动词 finite verb 非限定动词 infinite verb 使役动词 causative verb 感官动词 verb of senses 动态动词 event verb 静态动词 state verb 感叹词 exclamation 形容词 adjective

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财务专业术语中英文对照表修订版

财务专业术语中英文对 照表 集团标准化小组：[VVOPPT-JOPP28-JPPTL98-LOPPNN]

财务专业术语中英文对照表 英文中文说明 Account 帐户 Accounting system 会计系统 American Accounting Association 美国会计协会 American Institute of CPAs 美国注册会计师协会 Audit 审计 Balance sheet 资产负债表 Bookkeepking 簿记 Cash flow prospects 现金流量预测 Certificate in Internal Auditing 内部审计证书 Certificate in Management Accounting 管理会计证书 Certificate Public Accountant 注册会计师 Cost accounting 成本会计 External users 外部使用者 Financial accounting 财务会计 Financial Accounting Standards Board 财务会计准则委员会 Financial forecast 财务预测 Generally accepted accounting principles 公认会计原则 General-purpose information 通用目的信息 Government Accounting Office 政府会计办公室 Income statement 损益表 Institute of Internal Auditors 内部审计师协会 Institute of Management Accountants 管理会计师协会 Integrity 整合性 Internal auditing 内部审计 Internal control structure 内部控制结构

PCB术语中英文对照表

Adhesion 附着力 Annular Ring 孔环 AOI（automatic optical inspection）自动光学检测 AQL（acceptable quality level）可接受的质量等级 B²it(buried bump interconnection technology) 埋入凸块焊点互连技术 BBH(buried blind hole) 埋盲孔 BGA(ball grid array) 球栅阵列 Blister 起泡 Board Edges 板边 Burr 毛头/毛刺 BUM(Build-up multilayer) 积层式多层板 BVH（buried/blind via hole）埋/盲导通孔 CAD(computer aided design) 计算机辅助设计

CAM(computer aided manufacturing) 计算机辅助制造 Carbon oil 碳油 CEM(composite epoxy material) 环氧树脂复合板材 chamfer 倒角 Characteristic impedance 特性阻抗 CNC（computerized numerical control）计算机化数字控制Conductor Crack 导体破裂 Conductor Spacing 导线间距 connector 连接器 Copper foil 铜箔（皮） Crazing 微裂纹(白斑) Delamination 分层 Dewetting 半润湿(缩锡) DFM（design for manufacturing）可制造性设计

2.常见的大数据术语表(中英文对照版)

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行为分析法（Behavioural Analytics） - 这种分析法是根据用户的行为如"怎么做"，"为什么这么做"，以及"做了什么"来得出结论，而不是仅仅针对人物和时间的一门分析学科，它着眼于数据中的人性化模式 大数据科学家（Big Data Scientist） - 能够设计大数据算法使得大数据变得有用的人 大数据创业公司（Big data startup） - 指研发最新大数据技术的新兴公司 生物测定术（Biometrics） - 根据个人的特征进行身份识别 B字节（BB: Brontobytes） - 约等于1000 YB（Yottabytes），相当于未来数字化宇宙的大小。1 B字节包含了27个0！ 商业智能（Business Intelligence） - 是一系列理论、方法学和过程，使得数据更容易被理解 C 分类分析（Classification analysis） - 从数据中获得重要的相关性信息的系统化过程；这类数据也被称为元数据（meta data），是描述数据的数据 云计算（Cloud computing） - 构建在网络上的分布式计算系统，数据是存储于机房外的（即云端） 聚类分析（Clustering analysis） - 它是将相似的对象聚合在一起，每类相似的对象组合成一个聚类（也叫作簇）的过程。这种分析方法的目的在于分析数据间的差异和相似性 冷数据存储（Cold data storage） - 在低功耗服务器上存储那些几乎不被使用的旧数据。但这些数据检索起来将会很耗时 对比分析（Comparative analysis） - 在非常大的数据集中进行模式匹配时，进行一步步的对比和计算过程得到分析结果 复杂结构的数据（Complex structured data） - 由两个或多个复杂而相互关联部分组成的数据，这类数据不能简单地由结构化查询语言或工具（SQL）解析 计算机产生的数据（Computer generated data） - 如日志文件这类由计算机生成的数据

世界手表专业词汇中英文对照

钢Steel 显示Display 手工组装Hand-fitting 手工Hand 调节Fit, adjust 振动Vibration 避震装置Shock-absorber 擒纵叉Pallets 防震Shock-resistant 防磁Antimagnetic 防尘Dustproof 立体时标，刻度Applique 条轴Barrel-arbor 银质，镀银Silver, silver-plate 轮（和齿轮）Wheel (and pinion) 自动上链Self-winding, automatic 蜗形花纹Snailed 摆轮Balance 发条盒Barrel 杆Bar, lug 倒角Bevel 表扣Buckle

表壳Watch-case 表带Wristlet 手镯，手镯型Bangle 指针Arm 夹具Clamp 环状凸缘Flange, collar 圆头饰钉Cabochon 表盘，面盘Dial 万年历Perpetual calendar 机芯Calibre, caliber 凹槽，（表冠周围或表壳侧边的）凹凸纹路Flute 时轮Hour-wheel 克拉Carat 铆压（将表钻压入位置）Driving 镶嵌（宝石）Setting 分轮Cannon-pinion 计时表Chronograph 精密时计，天文台时计Chronometer 集成电路Integrated circuit 同轴Coaxial 混合Combo 复杂功能Complication

读数器，计数器，计时器Register, Coanter, timer 摆轮夹板Balance-cock 表耳表壳与表带连接处Horn 弯曲Curved 表冠Crown 陶瓷Ceramics 跳日期型Jumping date 烫金Gild 分离器Disconnecting-gear 传送Transfer 展示盒Presentation-case 机电式Electromechanically 珐琅工艺Enamel 离合，连接Clutch 宝石，镶宝石Jewel 棘轮结构Click 齿轮结构Gear 定位销，销钉Catch 防水Water-resistant 密封性，防水性Sealing 超薄型Extra-flat 表扣，搭扣Clasp

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语文课程与教学论名词术语中英文对照表 A Term List of the Chinese Course and Teaching and Learning Theory in Chinese and English 1. 教材（JC）Teaching materials 教材编写editing teaching materials /语文教材/Chinese Teaching Materials /编写教材/edit teaching materials /统编教材/Uniformed Chinese Teaching Materials /实验教材/Experimental Teaching Materials /母语教材/Mother Tongue Teaching Materials /新课程教材/Teaching Materials of the New Course *课本*textbook *读本*reading book *教学参考书（教参）*teaching reference book *练习册*exercises book *学案*studying plan 2. 技术（JS）Technology /教育技术/Educational Technology /现代教育技术/Modern Educational Technology /语文教育技术/Educational Technology in Chinese Teaching /多媒体技术/multi-media technology /网络技术/net technology /云服务技术/cloud serving technology *白板*white board *网络会议*net meeting *聊天室*chat room *博克*blog 3. 教学(JX) Teaching 教学基本理论Basic Theory of the Teaching 教学目的teaching aim 教学任务teaching task 教学目标teaching objective 教学模式teaching model 教学策略teaching tactics 教学原则teaching principle 教学大纲teaching program 教学改革teaching reform 教学案例teaching case 教学课件Courseware 教学资源teaching resources 教学实验teaching experiment /母语教学/mother tongue teaching

手表行业术语中英对照表

手表行业术语中英对照表(二) 1> 表壳加工处理电镀( Electro-plating ) 电染( Anode-oxidizing ) 蚀字( Acid Etching ) 镶石( Stone setting/mounting ) 丝印( Silk printing ) 烧焊( Solder/Braze ) 烧青( Epoxy ) 线切割( Wire-Cut ) 2> 表面内影(Inner Ring) 太阳纹底纹(Sunray) 油压底纹(Deep press pattern/texture pattern) 搪瓷面 (Enamel) 半消光(Semi-Glossy) 镶钉(植钉/真钉/铆钉) (Applied Index Riveted) 贴钉( UP 钉) (UP labeling) 车 CD 纹(眼钉) (Circular /CD pattern) 啤凸(Emboss) 3> 表针(Hands) 时针(Hour hand) 分针(Minute hand) 长秒针(Second hand) 小秒针(small hand) 浅绿色夜光(Light green luminous) 白夜光(White Luminous) 4> 表带( Watch band ) 不锈钢带(S/S band )(Bracelet) 实芯钢带(Solid S/S band) 包边钢带(Rolled S/S band) 片钢带(Folded S/S band) 弹弓带( Spring buckle ) 保险带 (Safety buckle) 实芯蝴蝶扣(Solid butterfly buckle) 成表配件中英文对照 1> 成表 (Completed Watch) 石英表 (Quartz Watch) 计时码表 (Chronograph watch) 自动表 (Automatic Watch) 跳字行针表 (Analogical Digital Watch) 2> 表壳壳胚(Blank) 玻璃 (Glass 、 lens) 普通玻璃 (Mineral Glass) 蓝宝石玻璃( Sapphire Glass ) 半蓝宝石玻璃 (Semi-sapphire glass) I 令(I ring) 霸的(表冠) (Crown) 霸的 管( Crown Tube ) 按的 (Pusher) 壳圈( Bezel ) 分圈 (Top Ring) 锑片 (Aluminium foil) 内罩 (Movement Holder) 底盖 (Case Back) 铜底盖 (S/S case back) 透视 底盖 (See-through case back) 锁底盖 (Screw back) O 令(O-ring)(Gasket) 生耳 / 钢闩( End-piece/pin ) 3> 表壳打磨拉沙( Hair Brushed ) 12/6H 方向直沙 (912/6H vertical brushed) 3/9H 方向横沙 (3/6H horizontal brushed) 圆沙 (Circle brushed) 喷沙 (Fine Sand Blasted) 光令( Satin/Polish ) 壳 :Case 表胚： watch blank 表圈： watch bezel 表面： dial 晌圈： springed metal ring 内影： metal case decoratiue ring 不锈钢实心表带： stainless steel semi-solid band 包边带： side-wrapped band 包边不锈钢表带： side-wrapped stainless steel band 织网表带： mesh band 芯片： chip 钨钢： tungsten steel 皮表带： leather strap 皮带扣： buckle forstap 霸的： crown 霸管： crown tube 霸芯及驳管： stem and stem extension 胶内影： housing/movement holder 蓝宝

中英文对照术语表

---------------------------------------------------------------最新资料推荐------------------------------------------------------ 中英文对照术语表 A Absorption costing（完全成本法）Accelerated depreciation method（加速折旧法） Account（账户） Account form （账户式） Account payable（应付账款） Account receivable （应收账款） Accounting（会计） Accounting cycle（会计循环）Accounting equation（会计恒等式） Accounting period concept （会计期间概念） Accounting system（会计系统） Accounts payable subsidiary ledger（应付账款明细分类账）（应付账款明细分类账） Accounts receivable subsidiary ledger（应收账款明细分类账）（应收账款明细分类账） Accounts receivable turnover （应收账款周转率） Accrual basis（应计制；权责发生制）Accruals（应计项目） Accrued assets（应计资产） Accrued expenses（应计费用） Accrued liabilities（应计负债） Accrued revenues（应计收入） Accumulated depreciation（累计折旧）Accumulated other comprehensive income（累计其他全面收益）（累计其他全面收益） Activity base (driver)（作业基础/动因）Activity-based costing (ABC)（作业成本计算法） Adjusted trial balance（调整后试算平衡表） Adjusting entries（调整分录）Adjusting process（调整过程）Administrative expenses (general expenses)（管理费用（一般费用））Aging the receivables（应收账款账龄分析） Allowance method（备抵法） 1 / 12

数学中英文词汇对照表

集合set 非负整数集the set of all non-negative integers 自然数集the set of all natural numbers 整数集the set of all positive integers 有理数集the set of all rational numbers 实数集the set of all real numbers 元素element 属于belong to 不属于not belong to 有限集finite set 无限集infinite set 空集empty set 包含inclusion ,include 包含于lie in 子集subset 真子集proper subset 补集（余集）complementary set 全集universe 交集intersection 偶数集the set of all even numbers 奇数集the set of all odd numbers 含绝对值的不等式inequality with absolute value 一元二次不等式one-variable quadratic inequality 逻辑logic 逻辑联结词logical connective 或or 且and 非not 真true 假false 真值表truth table 原命题original proposition 逆命题converse proposition 否命题negative proposition 逆否命题converse-negative proposition 充分条件sufficient condition 必要条件necessary condition ……的充要条件是………if and only if… 函数function 自变量argument 定义域domain 值域range 区间interval 闭区间closed interval