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USP〈1225〉药典规程的验证(中英文对照)

<1225>V ALIDATION OF COMPENDIAL PROCEDURES

药典规程的验证

Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.

用于评价药物质量水平的测试规程受到多种要求的影响。根据联邦食品、药物、化妆品法案501款，在美国药典和国家处方集的各论中的含量测定和质量标准构成了法定标准。现行药品优良生产规范【21 CFR 211.194(a)】要求，用于评价药物与既有质量标准之间的符合性的分析规程必须在准确度和可靠性方面达到适当的标准。并且根据这些法规【21 CFR 211.194(a)(2)】，在USP-NF中描述的分析规程的使用者无需验证这些规程的准确度和可靠性，而仅需确认其在实际使用条件下的适用性。认识到USP和NF标准的法律地位，因此，提议采纳新的或更改过的药典分析规程时，以充分的实验室数据作为支持，以记录其有效性，成为基本要求。

The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of Analytical Procedures and the Methodology extension text, which are concerned with analytical procedures included as part of registration applications submitted within the EC, Japan, and the USA.

本信息章节的内容尽可能地与三方国际协调会议（ICH）文件分析规程的验证和方法学的延伸内容保持一致，ICH的内容关注的是作为在欧盟、日本、美国提交注册申请的一部分的分析规程。

SUBMISSIONS TO THE COMPENDIA向药典提交的文件Submissions to the compendia for new or revised analytical procedures should contain sufficient information to enable members of the USP Council of Experts and its Expert Committees to evaluate the relative merit of proposed procedures. In most cases, evaluations involve assessment of the clarity and completeness of the description of the analytical procedures, determination of the need for the procedures, and documentation that they have been appropriately validated. Information may vary depending upon the type of method involved. However, in most cases a submission will consist of the following sections.

向药典提交关于新的或更改过的分析规程的文件应该包括充足的信息，以使USP专家大会和其专家委员会能够评估拟议规程的相对优势。在大多数情况下，这些评估涉及对分析规程描述的清楚和完整程度的评价，对规程的需求的确定，以及它们已经进行了适当验证的记录文件。这些信息可以根据所涉及规程的种类而变化。但是，在大多数情况下，提交的文件将有下面的章节组成。

Rationale---- This section should identify the need for the procedure and describe the capability of the specific procedure proposed and why it is preferred over other types of determinations. For revised procedures, a comparison should be provided of limitations of the current compendial procedure and advantages offered by the proposed procedure.

基本原理----此部分应该辨明对于该规程的需求，并描述具体拟议中规程的能力，以及其为什么优于其他种类检测。对于更改的规程，应该提供对当前药典规程之缺陷与拟议中规程之优势的比较。

Proposed Analytical Procedure---This section should contain a complete description of the analytical procedure sufficiently detailed to enable persons “skilled in the art”to replicate it. The write-up should include all important operational parameters and specific instructions such as preparation of reagents, performance of system suitability tests, description of blanks used, precautions, and explicit formulas for calculation of test results.

拟议的分析规程----此部分包含对该分析规程的完整描述，应足够具体以便能让业内技术熟练

的人重复它。文章应该包括所有重要的操作参数和具体的指令，例如试剂制备、系统适用性测试表现、所使用空白对照的描述、预防措施、用于计算测试结果明确公式。

Data Element----This section should provide thorough and complete documentation of the validation of the analytical procedure. It should include summaries of experimental data and calculations substantiating each of the applicable analytical performance characteristics. These characteristics are described in the following section.

数据要素----此部分应该提供完全彻底的分析规程验证记录文件。其应该包括对于证明每一个实用工作特性的实验数据和计算的总结。这些特性在下面的部分描述。

V ALIDATION验证

Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications. Typical analytical performance characteristics that should be considered in the validation of the types of procedures described in this document are listed in Table 1. Because opinions may differ with respect to terminology and use, each of the performance characteristics is defined in the next section of this chapter, along with a delineation of a typical method or methods by which it may be measured.

分析规程的验证是，通过实验室研究，确定该规程的工作特性达到了预定分析用途要求的过程。在此文件中所描述的规程种类的验证中，应当考虑的常见分析工作特性在表1中列出。因为对于术语和使用的意见可能不同，在此通则的下个部分定义了每个工作性能，以及可以对其进行测量的常用的一个或几个方法的描绘。

Table 1. Typical Analytical Characteristics Used in Method Validation

表1. 在方法验证中使用的常用分析特性

Accuracy准确度

Precision精密度

Specificity专属性

Detection Limit检测限度

Quantitation Limit定量限度

Linearity线性

Range范围

Robustness耐用性

In the case of compendial procedures, revalidation may be necessary in the following cases: a submission to the USP of a revised analytical procedure; or the use of an established general procedure with a new product or raw material (see below in Data Elements Required for Validation). 对于药典规程，在下面的情况下可能必需在验证：向USP提交修改的分析规程；或将已确立的通用规程用于新产品或原料（见下面验证必需的数据要素）

The ICH documents give guidance on the necessity for revalidation in the following circumstances: changes in the synthesis of the drug substance; changes in the composition of the drug product; and changes in the analytical procedure.

ICH文件对于下列情况下再验证的必要性做出了指导：原料药合成中的变更；成药组成中的变更；以及分析规程中的变更。

Analytical Performance Characteristics分析工作特性

ACCURACY准确度

Definition---- The accuracy of an analytical procedure is the closeness of test results obtained by that procedure to the true value. The accuracy of an analytical procedure should be established across its range.

定义----分析规程的准确度是由该规程得到的测试结果与真实值的接近程度。分析规程的准确度应该在其整个范围内得到确立。

Determination----In the case of the assay of a drug substance, accuracy may be determined by application of the analytical procedure to an analyte to known purity (e.g., a Reference Standard) or by comparison of the results of the procedure with those of a second, well-characterized procedure,

the accuracy of which has been stated or defined.

测定---- 对于原料药的含量测定，可以用该分析规程来分析已知纯度的被分析物（例如，某个标准物质），或将以此规程所得的结果与第二种、成熟的、已知准确度的规程所得的结果进行比较，以测定其精确性。

In the case of the assay of a drug in a formulated product, accuracy may be determined by application of the analytical procedure to synthetic mixtures of the drug product components to which known amounts of analyte have been added within the range of the procedure. If it is not possible to obtain samples of all drug product components, it may be acceptable either to add known quantities of the analyte to the drug product (i.e., “to spike”) or to compare results with those of a second, well-characterized procedure, the accuracy of which has been stated or defined.

对于处方产品中某个药物的含量测定，以该分析规程来分析成药各组分的合成混合物，其中已经在这些组分的范围之内加入已知数量的待分析物。如果不可能得到成药的所有组分，也可以将已知数量的待分析物加入到该成药中（例如，“增敏”），或者将结果与用第二种、成熟的、已知准确度的规程得到的结果进行比较，

In the case of quantitative analysis of impurities, accuracy should be assessed on samples (of drug substance or drug product) spiked with known amount of impurities. Where it is not possible to obtain samples of certain impurities or degradation products, results should be compared with those obtained by an independent procedure. In the absence of other information, it may necessary to calculate the amount of an impurity based on comparison of its response to that of the drug substance; the ratio of the response of equal amounts of the impurity and the drug substance (relative response factor) should be used if known.

对于杂质的定量分析，应使用以已知数量杂质增敏的样品来评估准确度。当不可能获得特定杂质或降解产物的样品时，应将结果与得自独立规程的的结果进行比较。在没有其他信息的情况下，可能必需通过将某种杂质的响应值与药物的响应值进行比较来计算杂质的数量；同等数量的杂质与药物的响应值的比值（相对响应因子），如果已知，则应使用。

Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together

with confidence interval.

通过测定被加入到样品中的已知数量的被分析物来计算准确度，得到回收百分比，或得到平均值与接受的真实值之间的差异，并给出置信区间。

The ICH documents recommended that accuracy should be assessed using a minimum of nine determinations over a minimum of three concentration levels, covering the specified range (i.e., three concentrations and three replicates of each concentration).

ICH文件建议精密度的评估应当使用覆盖规定范围的至少三个浓度水平进行至少九次测试（例如，三个浓度并且每个浓度三次重复进样）。

Assessment of accuracy can be accomplished in a variety of ways, including evaluating the recovery of the analyte (percent recovery) across the range of the assay, or evaluating the linearity of the relationship between estimated and actual concentrations. The statistically preferred criterion is that the confidence interval for the slope be contained in an interval around 1.0, or alternatively, that the slope be close to 1.0. In either case, the interval or the definition of closeness should be specified in the validation protocol. The acceptance criterion will depend on the assay and its variability and on the product. Setting an acceptance criterion based on the lack of statistical significance of the test of the null hypothesis that the slop is 1.0 is not an acceptable approach.

准确度的评估可以通过多种不同的方式完成，包括评价在含量测定的整个范围内被分析物的回收率，或评价估计与实际浓度之间关系的线性。具统计学意义的标准有二，一是斜率的置信区间被限定在约1.0的区间，二是此斜率接近1.0。在任意一种情况下，此区间或接近程度的定义应该在验证方案中明确规定。接受标准将取决于含量和其差异性，以及取决于该产品。通过测试证明该斜率为1.0的零假设没有统计学意义，这样的方法不能用于设定接受标准。

PRECISION精密度

Definition---- The precision of an analytical procedure is the degree of agreement among individual test results when the procedure is applied separately to multiple samplings of a homogeneous sample. The precision of an analytical procedure is usually expressed as the standard deviation or relative standard deviation (coefficient of variation) of a series of measurements. Precision may be a measure

of either the degree of reproducibility or of repeatability of the analytical procedure under normal operating conditions. In this context, reproducibility refers to the use of the analytical procedure in different laboratories, as in a collaborative study. Intermediate precision (as known as ruggedness) express within-laboratory variation, as on different days, or with different analysts or equipment within the same laboratory. Repeatability refers to the use of the analytical procedure within a laboratory over a short period of time using the same analyst with the same equipment.

定义----分析规程的精密度是当该分析规程单独分析均质样品的多个样本时，若干检验结果的一致程度。分析规程的精密度通常以一系列测量数值的标准差或相对标准差（变异系数）来表示。精密度可以是分析规程在普通操作条件下可重现性或可重复性程度的度量单位。在此内容里，可重现性涉及在协作研究中，分析规程在不同实验室的使用。中间精密度（也称为“耐久性”）体现了在实验室内的差异，如在相同的实验室，但在不同的日期，或使用不同的分析员或设备。可重复性涉及在同一个实验室内，一段较短的时间内，使用相同的分析员和相同的设备的情况下，对分析规程的应用。

Determination---- The precision of an analytical procedure is determined by assaying a sufficient number of aliquots of a homogeneous sample to be able to calculate statistically valid estimates of standard deviation or relative standard deviation (coefficient of variation). Assays in this context are independent analyses of samples that have been carried through the complete analytical procedure from sample preparation to final test result.

测定----分析规程的精密度的测定，通过对充足数量的均质样品的等分试样做含量测定来进行，以便能够计算标准差或相对标准差（变异系数）的具有统计学意义的估计值。在此内容中的含量测定是样品的多次独立分析，其样品已经用完整分析规程（从样品制备到最终检验结果）进行过分析。

The ICH documents recommended that repeatability should be assessed using a minimum of nine determinations covering the specified range for the procedure (i.e., three concentration and three replicates of each concentration or using a minimum of six determinations at 100% of the test concentration).

ICH文件建议可重复性的评估应该使用最少九次检测，覆盖该分析规程所规定的范围（例如，

三个浓度和每个浓度三次重复进样，或在100%测试浓度上进行最少六次测定）。

SPECIFITY专属性

Definition---- The ICH documents define specificity as the ability to assess unequivocally the analyt in the presence of components that may be expected to be present, such as impurities, degradation products, and matrix components. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedures. [NOTE--- Other reputable international authorities (IUPAC, AOAC-I) have preferred the term “selectivity”, reserving “specificity” for those procedures that are completely selective.] For the tests discussed below, the above definition has the following implications.

定义---- ICH文件将专属性定义是当待分析物含有预期会有的其他组分（例如，杂质、降解产物、矩阵组分）时，准确可靠地评估待分析物的能力。某个分析规程缺乏专属性可以通过其他辅助性分析规程进行补偿。【注意：其他声誉卓著的国际权威机构（IUPAC、AOAC-I）已经提出术语“选择性”，而将“专属性”留给已经具有完全选择性的规程。】对于下面讨论的测试，上述定义具有以下的含义。

Identification Tests: ensure the identity of the analyte.

鉴别检测：确保待分析物的鉴别。

Purity Tests: ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte (e.g., related substances test, heavy metals limit, organic volatile impurities).

纯度检测：确保执行的所有分析规程能够令对于待分析物各杂质含量的准确陈述得以做出。

Assays: provide an exact result, which allow an accurate statement on the content or potency of the analyte in a sample.

含量检测：提供准确的结果，令对样品中待分析物的含量或效力的准确陈述得以做出。

Determination----In the case of qualitative analyses (identification tests), the ability to select

between compounds of closely related structure that are likely to be present should be demonstrated. This should be confirmed by obtaining positive results (perhaps by comparison to a known reference material) from samples containing the analyte, coupled with negative results from samples that do not contain the analyte and by confirming that a positive response is not obtained from materials structurally similar to or closely related to the analyte.

测定----对于定性分析（鉴别检验），应当论证其在可能存在的、结构密切相关的物质中进行选择的能力。从含有待分析物的样品中得到阳性结果（可能通过与已知标准物质的比较），而从不含待分析物的样品得到阴性结果，以对其选择能力加以确认，并还要确认阳性响应不是来自与待分析物结构相似或密切相关的物质。

In the case of analytical procedures for impurities, specificity may be established by spiking the drug substance or product with appropriate levels of impurities and demonstrating that these impurities are determined with appropriate accuracy and precision.

对于检测杂质的分析规程，专属性可以通过以适当水平的杂质将原料药或成药增敏，并论证这些杂质的测定达到了适当的准确度和精密度。

In the case of the assay, demonstration of specificity requires that it can be shown that the procedure is unaffected by the presence of impurities or excipients. In practice, this can be done by spiking the drug substance or product with appropriate levels of impurities or excipients and demonstrating that the assay result is unaffected by the presence of these extraneous materials.

对于含量检测，对专属性的论证要求能够显示出该分析规程不受各杂质或辅料的影响。在实际操作中，通过以适当水平的杂质或辅料将原料药或成药增敏，并证明含量检验结果不受这些外来物质的影响，来完成论证。

If impurity or degradation product standards are unavailable, specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second well-characterized procedure (e.g., Pharmacopeial or other validated procedure). These comparisons should include samples stored under relevant stress conditions (e.g., light, heat, humidity, acid/base hydrolysis, oxidation). In the case of assay, the results should be compared; in the case of chromatographic impurity test, the impurity profiles should be compared.

如果没有杂质或降解产物的标准品，可以通过将含有杂质或降解产物的样品的测试结果与第二种、成熟规程（例如，药典或其他验证过的规程）的结果进行比较，来论证专属性。这些比较应该包括在相关破坏性条件下（例如，光、热、湿度、酸/碱水解、氧化作用）存储的样品。对于含量测定，应比较其结果；对于色谱法杂质检测，应比较杂质概况。

The ICH documents state that when chromatographic procedures are used, representative chromatograms should be presented to demonstrate the degree of selectivity, and peaks should be appropriately labeled. Peak purity tests (e.g., using diode array or mass spectrometry) may be useful to show that the analyte chromatographic peak is not attributable to more than one component.

ICH文件声明，当使用色谱分析规程时，应提交具代表性的色谱图，以论证选择性的程度，而且应对色谱峰作适当的标识。也可以使用色谱峰纯度测试（例如，使用二极管阵列或质谱仪），来显示待分析物的色谱峰仅产生于一个组分。

DETECTION LIMIT检测限度

Definition---- The detection limit is a characteristic of limit tests. It is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions. Thus, limit tests merely substantiate that the amount of analyte is above or below a certain level. The detection limit is usually expressed as the concentration of analyte (e.g., percentage, parts per billion) in the sample.

定义----检测限度是限度检测的特性。它是指在规定的试验条件下，样品中可被检测到的待分析物的最小数量，但是无需定量。因此，限度检测仅仅说明了待分析物的数量高于或低于某个特定水平。检测限度通常以在样品中的待分析物浓度（例如，百分比、十亿分率）表示。

Determination---- For non-instrumental procedures, the detection limit is generally determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be reliably detected.

测定----对于非仪器分析规程，检测限度的测定方法通常为，对含有已知浓度待分析物的样品进行分析，并确立能够可靠地被检测出来的待分析物的最低水平。

For instrumental procedures, the same approach may be used as for non-instrumental procedures. In the case of procedures submitted for consideration as official compendial procedures, it is almost never necessary to determine the actual detection limit. Rather, the detection limit is shown to be sufficiently low by the analysis of samples with known concentrations of analyte above and below the required detection level. For example, if it is required to detect an impurity at the level of 0.1%, it should be demonstrated that the procedure will reliably detect the impurity at that level.

对于仪器分析规程，可以使用与非仪器分析规程相同的方法。对于提交用于官方药典规程的备选方法，其几乎从来不需要确定实际的检测限度。而是，通过分析含有高于和低于必需的检测水平的、已知待分析物浓度的样品，以显示检测限度足够低。例如，如果必需检测浓度在0.1%的杂质，则应当证明该分析规程将可靠地检测在这个水平的杂质。

In the case of instrumental analytical procedures that exhibit background noise, the ICH documents describe a common approach, which is to compare measured signals from samples with known low concentrations of analyte with those of blank samples. The minimum concentration at which the analyte can reliably be detected is established. Typically acceptable signal-to-noise ratios are 2:1 or 3:1. Other approaches depend on the determination of the slope of the calibration curve and the standard deviation of responses. Whatever method is used, the detection limit should be subsequently validated by the analysis of a suitable number of samples known to be near, or prepared at, the detection limit.

对于展示出背景噪音的仪器分析规程，ICH文件描述了一个通用方法，用来比较从以下样品测得的信号，这些样品分别为含已知低浓度被分析物的样品和空白样品。这样就确立了能够可靠检测的待分析物的最低浓度。可接受的典型信噪比是2:1或3:1。其他方法取决于校正曲线斜率的测定和响应值的标准差。无论用什么方法，均应该在随后通过分析适当数量的、已知接近或制备于检测限度的样品，来验证检测限度。

QUANTITATION LIMIT定量限度

Definition----The quantitation limit is a characteristic of quantitative assay for low levels of compounds in sample matrices, such as impurities in bulk drug substances and degradation products in finished pharmaceuticals. It is the lowest amount of analyte in a sample that can be determined

with acceptable precision and accuracy under the stated experimental conditions. The quantitation limit is expressed as the concentration of analyte (e.g., percentage, parts per billion) in the sample.

定义----定量限度是样品矩阵中低含量物质的定量分析的特性，例如在原料药中的杂质和成品药物中的降解产物。它是在规定试验条件下，能够以可接受的精密度和精确度进行测定的样品中待分析物的最小量。定量限度以样品中待分析物的浓度（例如，百分比、十亿分率）来表示。

Determination----For non-instrumental procedures, the quantitation limit is generally determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be determined with acceptable accuracy and precision.

测定----对于非仪器分析规程，定量限度的测定方法通常为对含有已知浓度待分析物的样品进行分析，并确立能够以可接受的准确度和精密度被检测出来的待分析物的最低水平。

For instrumental procedures, the same approach may be used as for non-instrumental procedures. In the case of procedures submitted for consideration as official compendial procedures, it is almost never necessary to determine the actual quantitaion limit. Rather, the quantitation limit is shown to be sufficiently low by the analysis of samples with know concentrations of analyte above and below the quantitation level. For example, if it is required that an analyte be assayed at the level of 0.1 mg per tablet, it should be demonstrated that the procedure will reliably quantitate the analyte at that level.

对于仪器分析规程，可以使用与非仪器分析规程相同的方法。对于提交用于官方药典规程的备选方法，其几乎从来不需要确定实际的检测限度。而是，通过分析含有高于和低于必需的定量水平的、已知待分析物浓度的样品，以显示定量限度足够低。例如，如果必需在0.1mg每片的水平评估待分析物，则应当证明该分析规程将可靠地这个水平定量待分析物。

In the case of instrumental analytical procedures that exhibit background noise, the ICH documents describe a common approach, which is to compare measured signals from samples with known low concentrations of analyte with those of blank samples. The minimum concentration at which the analyte can reliably be quantified is established. A typically acceptable signal-to-noise ratio is 10:1. Other approaches depend on the determination of the slope of the calibration curve and the standard deviation of responses. Whatever method is used, the quantitation limit should be subsequently

validated by the analysis of a suitable number of samples known to be near, or prepared at, the quantitation limit.

对于展示出背景噪音的仪器分析规程，ICH文件描述了一个通用方法，用来比较从以下样品测得的信号，这些样品分别为含已知低浓度被分析物的样品和空白样品。这样就确立了能够可靠地定量待分析物的最低浓度。可接受的典型信噪比是10:1。其他方法取决于校正曲线斜率的测定和响应值的标准差。无论用什么方法，均应该在随后通过分析适当数量的、已知接近或制备于定量限度的样品，来验证定量限度。

LINEARITY AND RANGE线性和范围

Definition of Linearity---- The linearity of an analytical procedure is its ability to elicit test results that are directly, or by a well-defined mathematical transformation, proportional to the concentration of analyte in samples within a given range. Thus, in this section, “linearity” refers to the linearity of the relationship of concentration and assay measurement. In some cases, to attain linearity, the concentration and/or the measurement may be transformed. (Note that the weighing factors used in the regression analysis may change when a transformation is applied.) Possible transformations may include log, square root, or reciprocal, although other transformations are acceptable. If linearity is not attainable, a non-linear model may be used. The goal is to have a model, whether linear or non-linear, that describes closely the concentration-response relationship.

线性的定义----分析规程的线性是该规程直接地、或通过明确给出的数学转换而间接地，得出与特定范围内的样品中待分析物浓度呈比例关系的测试结果的能力。因此，在此部分，“线性”是指浓度与检验结果之间的线性关系。在某些情况下，为了实现线性，浓度和/或测量数据可以进行转换。（注意：当进行转换时，在回归分析中用到的权重因子可以变化。）虽然其他转换方式也是可以接受的，但是可能的转换包括对数、平方根、倒数。如果无法实现线性，可以使用非线性模型。其目的是得到一个精确描述浓度-响应值关系的模型，不论是线性还是非线性。

Definition of Range---- The range of an analytical procedure is the interval between the upper and lower levels of analyte (including these levels) that have been demonstrated to be determined with a suitable level of precision, accuracy, and linearity using the procedure as written. The range is normally expressed in the same units as test results (e.g., percent, parts per million) obtained by the

analytical procedure.

范围的定义----分析规程的范围是分析物的较高浓度和较低浓度（含）之间的区间，已经证实在此区间内，使用该规程进行测定具有适当水平的精密度、准确度、和线性。该范围通常以与该分析规程得到的测试结果相同的单位表示，例如百分比，百万分率等。

Determination of Linearity and Range---- Linearity should be established across the range of the analytical procedure. It should be established initially by visual examination of a plot of signals as a function of analyte concentration of content. If there appears to be a linear relationship, test results should be established by appropriate statistical methods (e.g., by calculation of a regression line by the method of least squares). Data from the regression line itself may be helpful to provide mathematical estimates of the degree of linearity. The correlation coefficient, y-intercept, slope of the regression line, and residual sum of squares should be submitted.

线性和范围的确定----应在分析规程整个范围内确立线性。线性的确立最开始应该通过目测代表内容物中待分析物浓度的多个信号构成的图表来进行。如果其呈现线性关系，测试结果应该通过适当的统计学方法（例如，以最小二乘方来计算回归线）来确立。来自回归线自身的数据可以用于提供线性程度的数学评估。应该提交其相关系数、Y轴截距、回归线斜率、残差平方和。

The range of the procedure is validated by verifying that the analytical procedure provides acceptable precision, accuracy, and linearity when applied to sample containing analyte at the extremes of the range as well as within the range.

通过用规程分析含有待分析物的、浓度在范围的极限值上和在范围中的样品，确认该分析规程提供了可接受的精密度、准确度、线性，以进行该规程范围的验证。

ICH recommends that, for the establishment of linearity, a minimum of five concentrations normally be used. It is also recommended that the following minimum specified ranges should be considered: ICH建议，为了确立线性，通常使用最少五个浓度。其还建议，应考虑下列的最小范围的规定。

Assay of a Drug Substance (or a finished product): from 80% to 120% of the test concentration.

原料药（或成药）的含量测定：供试浓度的80%到120%。

Determination of an Impurity: from 50% to 120% of the acceptable criterion.

杂质的测定：接受标准的50%到120%。

For Content Uniformity:a minimum of 70% to 130% of the test concentration, unless a wider or more appropriate range based on the nature of the dosage form (e.g., metered-dose inhalers) is justified.

对于内容物的均一性：最少供试浓度的70%到130%，除非由于剂型的特性（例如，定量吸入气雾剂）而支持应用更宽或更适合的范围。

For Dissolution Testing:±20% over the specified range (e.g., if the acceptance criteria for a controlled-release product cover a region from 20%, after 1 hour, and up to 90%, after 24 hours, the validated range would be 0% to 110% of the label claim)

对于溶出度检测：在规定范围上±20%（例如，如果一个控释产品的接受标准覆盖了从1小时后20%到24小时后最多90%的区域，则验证区域应该为标签声称值的0%到110%）。

ROBUSTNESS耐用性

Definition----The robustness of an analytical procedure is a measure of its capability to remain unaffected by small but deliberate variations in procedural parameters listed in the procedure documentation and provides an indication of its suitability during normal usage. Robustness may be determined during development of the analytical procedure.

定义----分析规程的耐用性是规程文件中列出的操作参数在微小、故意的变更中不受影响的能力的衡量单位，并在日常使用中提供了其适用性的指标。耐用性可以在分析规程的研发中确定。

SYSTEM SUITABILITY系统适用性

If measurements are susceptible to variations in analytical conditions, these should be suitably controlled, or a precautionary statement should be included in the procedure. One consequence of the

evaluation of robustness and ruggedness should be that a series of system suitability parameters is established to ensure that the validity of the analytical procedure is maintained whenever used. Typical variations are the stability of analytical solutions, different equipment, and different analysts. In the case of liquid chromatography, typical variations are the pH of the mobile phase, the mobile phase composition, different lots or suppliers of columns, the temperature, and the flow rate. In the case of gas chromatography, typical variations are different lots or suppliers of columns, the temperature, and the flow rate.

如果检测结果易受分析条件中的差异影响，则这些差异应当被适当地控制，或应当在规程中加入预防性的陈述。评估耐用性的一个结果就是确立一系列系统适用性参数，以确保不论何时使用，均可维持分析规程的有效性。典型的差异是分析溶液、不同设备、不同分析员的稳定性。对于液相色谱法而言，典型的差异是流动相pH值、流动相构成、不同批号或供应商的色谱柱、温度、流速。对于气相色谱法而言，典型差异是不同批号或供应商的色谱柱、温度、流速。

System suitability tests are based on the concept that the equipment, electronics, analytical operations, and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being evaluated. They are especially important in the case of chromatographic procedures. Submissions to the USP should make note of the requirements under the System Suitability section in the general test chapter Chromatography <621>.

系统适用性测试基于这个概念，即这些设备、电子仪器、分析操作、供试样品构成了一个完整系统，此系统可以作为整体进行评估。为某个特定规程设定的系统适用性测试参数取决于被评估的规程的种类。对于色谱规程，它们尤其重要。向USP提交的文件应该应该注明在通则色谱法<621>中系统适用性章节下的要求。

Data Elements Required for Validation验证所需的数据要素Compendial test requirements vary form highly exacting analytical determinations to subjective evaluation of attributes. Considering this broad variety, it is only logical that different test procedures require different validation schemes. This chapter covers only the most common categories of tests for which validation data should be required. These categories are as follows:

药典测试的要求差别较大，从高度精确的分析测定到特性的主观评估。考虑到此宽幅差异，则可以理解不同测试规程需要不同的验证计划。此章节仅覆盖了这些需要验证数据的测试中最常见的种类。这些种类如下：

Category I---- Analytical procedures for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products.

第一类：对成药中原料药或活性成分（包括防腐剂）的主要组分进行定量测定的分析规程。

Category II----Analytical procedures for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These procedures include quantitative assays and limit tests.

第二类：对成药中原料药或降解物质中杂质进行测定的分析规程。这些规程包括定量测定和限度测定。

Category III----Analytical procedures for determination of performance characteristics (e.g., dissolution, drug release).

第三类：对工作特性（例如，溶出度、药物释放）进行测定的分析规程。

Category IV---- Identification tests.

第四类：鉴别测试。

For each category, different analytical information is needed. Listed in Table 2 are data elements that are normally required for each of these categories.

每一个类别均需要不同的分析信息。每个种类通常所需要的数据要素在表2中列出。

Table 2. Data Elements Required for Validation

Analytical Performance Characteristics

Category II

Category I Quantitative Limit

Tests

Category III Category IV

Accuracy Yes Yes * * No

Precision Yes Yes No Yes No

Specificity Yes Yes Yes * Yes

Detection Limit No No Yes * No

Quantitation Limit No Yes No * No

Linearity Yes Yes No * No

Range Yes Yes * * No

*May be required, depending on the nature of the specific test.

表2. 验证必需的数据要素

第二类

分析工作特性

第一类定量测试限度测试第三类第四类准确度是是* * 否

精密度是是否是否

专属性是是是* 是

检测限度否否是* 否

定量限度否是否* 否

线性是是否* 否

范围是是* * 否

可能需要，取决于具体测试的特性

Already established general procedure (e.g., titrimetric determination of water, bacterial endotoxins) should be ▲verified to establish their suitability for use, such as▲USP31 their accuracy (and absence of possible interference) when used for a new product or raw material.

已经确立的通用规程（例如，水分滴定测定、细菌内毒素）应当▲进行确认，以确立在用于新

其准确度（和无可能的干扰因素）。

的产品或原料时的适用性，例如

▲USP31

The validity of an analytical procedure can be verified only by laboratory studies. Therefore, documentation of the successful completion of such studies is a basic requirement for determining

whether a procedure is suitable for its intended application(s). Current compendial procedures are also subject to regulations that require demonstration of suitability under actual conditions of use ▲(see Verification of Compendial Procedures<1226> for principles relative to the verification of compendial procedures).▲USP31 Appropriate documentation should accompany any proposal for new or revised compendial analytical procedures.

分析规程的有效性可以通过实验室研究来确认。因此，此类研究成功完成的记录文件是确定某个规程是否适用于其预定用途的基本要求。当前的药典规程也要符合相关管理规定，要证实在实际使用条件下的适用性。▲（见药典规程的确认<1226>，以了解与药典规程确认相关的基本适当的记录文件应伴随着任何有关新的或修改过的药典分析规程的方案。

原则）

▲USP31

NBA 篮球专业术语(英汉对照)

篮球术语 Jump ball 跳球 Travering 走步 Technical foul 技术犯规 3-second violation 3秒违例 Point scored 罚球 Personal foul 个人犯规 3-point shot 3分球 3-point line 3分线 Sideline 边线 Endline 端线 Midcourtline 中线 Center court 中场 Backboard 篮板 Free throw lane 罚球区 Offense 进攻 Defense 防守 Passing the ball 传球 Receiving the ball 接球 Shoot 投篮 Dunk 扣篮 Lay-up 檫板入蓝 Jump shot 跳投 Hook 勾手投篮 Dribbling 运球 Block off 防堵 Steal the ball 抢断球 Rebound 抢篮板球 Half-court offense 前场进攻 Fast-break offense 快攻 Playing big 高大中锋战术 Playing small 小个子战术 Spreading the court 拉开进攻 Setting up plays 组织进攻 Screen 掩护 Pick and roll 掩护转身切入 Give and go 传切上篮 Posting up 策应 Three-point shooting 三分球战术Isolations 孤立打法 Drawing a foul 导致对方犯规Blocking out 抢篮板时将对方挡在外面Man to man 人盯人

NBA术语中英版

N B A术语中英版文档编制序号：[KKIDT-LLE0828-LLETD298-POI08]

场上用语： a flat shot:一个弧线低平的投篮 alley-oop:空接扣篮 Arena:比赛场；竞技场。比如Seattle的主场名叫Key Arena arc:三分线 Arm in the rim dunk :手肘插进篮筐的灌篮 Air ball：“三不沾”，投出的球什么都没碰到 Alley-oop:空中接力。一个运动员把球抛向空中，另一个队员在空中接住球把球扣入篮筐 ankle－breaker：脚踝终结者。指的是一些球员在告诉交叉运球过程中将防守队员弄到并导致其受伤。 and one：打进加罚,即加罚 a strong finish：有力的结束。球员强力灌篮后，解说员的解说词 away game：客场比赛 baby hook:小勾手 backcourt：后场 back to the basket:背筐 bank shot:擦板球 Baseline：底线。球场两端的边界线 behind-the-back:背后运球 between－the－leg:胯下运球 bounc:反弹传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作backdoor cut：从两边底线往篮下的战术 Back pass:背后传球 backcourt violation：回场违例 baseball pass：快攻时的长传 baseline driver：底线切入的球员 be sidelined：不能上场，退出比赛 beat the shot clock：在出手时限结束之前（完成出手投篮的动作）。在出手时限结束之前（完成出手投篮的动作）.NBA规定进攻一方必须在内24秒出手投篮，但在球过中线以后在前场的发球后，必须在 14 内秒出手投篮，否则违例。 behind-the-back dribble：背后运球 Bench:替补队员 bench warmer：上场时间很少的球员，通常在场下把板凳都坐暖了 blocking foul：阻挡犯规 block out：卡位 Bounce pass:击地传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作brick：球打在篮筐或篮板上被崩出来，许多公牛队的球迷在客队罚球时都手执一块上写“Brick”的牌子在罚球队员的眼前不停的晃动，扰乱他的视线，以达到干扰罚球的目的。 bury a shot：投篮命中 Buzzer beater：零秒出手，即投压哨球

NBA必备英文词汇

N B A必备英文词汇Last revision on 21 December 2020

看NBA必备的篮球词汇大全球队一览： Eastern Conference 东部联盟 Boston Celtics 波士顿凯尔特人 New Jersey Nets 新泽西网 New York Knicks 纽约尼克斯 Philadelphia 76ers 费城76人 Toronto Raptors 多伦多猛龙 Chicago Bulls 芝加哥公牛 Cleveland Cavaliers 克里夫兰骑士 Detroit Pistons 底特律活塞 Indiana Pacers 印第安纳步行者 Milwaukee Bucks 密尔沃基雄鹿 Atlanta Hawks 亚特兰大老鹰 Charlotte Bobcats 夏洛特山猫 Miami Heat 迈阿密热火 Orlando Magic 奥兰多魔术 Washington Wizards 华盛顿奇才 Western Conference 西部联盟 Denver Nuggets 丹佛掘金 Minnesota Timberwolves 明尼苏达森林狼Oklahoma City Thunder 俄克拉何马城雷霆

Portland Trail Blazers 波特兰开拓者 Utah Jazz 犹他爵士 Golden State Warriors 金州勇士 Los Angeles Clippers 洛杉矶快船 Los Angeles Lakers 洛杉矶湖人 Phoenix Suns 菲尼克斯太阳 Sacramento Kings 萨克拉门托国王 Dallas Mavericks 达拉斯小牛 Houston Rockets 休斯敦火箭 Memphis Grizzlies 孟菲斯灰熊 New Orleans Hornets 新奥尔良黄蜂 San Antonio Spurs 圣安东尼奥马刺球队组成： assistant coach：助理教练 backcourt：后卫组(包括控球后卫及得分后卫) backup：后备(替换，支持)球员 bench：(指全体)后备(替换，支持)球员 bench player：(指个人)后备(替换，支持)球员center：中锋(又称5号位置球员) coach：教练 frontline：锋线(包括大前锋，小前锋，中锋) GM(general manager)：球队经理

NBA篮球术语英文缩写

NBA 各种投篮方式 (slam) dunk：(强力)灌篮 bank shot：擦板球 double pump：拉杆式投篮(verb) fade-away shot：后仰式跳投 hook shot：钩射投篮 jump shot：跳投 layup：带球上篮 perimeter shot：中距离投篮 set shot：立定投篮 three-point shot：三分球 NBA 各种统计术语 assist：助攻 block shot：阻攻，盖火锅儿 defensive rebound：防守篮板球 field goal percentage：投球命中率 field goal：投球命中 free throw percentage：罚球命中率 free throw：罚球offensive rebound：进攻篮板球rebound：篮板球 scoring：得分 steal：抢断

three-point shot percentage：三分球命中率 turnover：失误 NBA场地装备 backboard：篮板 back court：后场 freethrow lane：罚球圈，禁区 freethrow line：罚球线 front court：前场 game clock：比赛用时钟 halftime：中场休息时间 hoop：篮框，篮圈 mid-court：中场 net：篮网 painted area：罚球圈，禁区 restricted area near the basket：禁区内篮框下的小圆圈区域 rim：篮框，篮圈 scoring table：记录台，记分台 shot clock：时限钟（进攻方在24秒内必须投篮，并且球必须触及篮框，否则即违例) three-point line：三分（球）线 top of the circle：靠近禁区顶端之三分（球）线附近 wing：（左、右两边）底线区域 NBA规则

NBA术语中英版

场上用语： a flat shot:一个弧线低平的投篮 alley-oop:空接扣篮 Arena:比赛场；竞技场。比如Seattle的主场名叫Key Arena arc:三分线 Arm in the rim dunk :手肘插进篮筐的灌篮 Air ball：“三不沾”，投出的球什么都没碰到 Alley-oop:空中接力。一个运动员把球抛向空中，另一个队员在空中接住球把球扣入篮筐ankle－breaker：脚踝终结者。指的是一些球员在告诉交叉运球过程中将防守队员弄到并导致其受伤。 and one：打进加罚,即加罚 a strong finish：有力的结束。球员强力灌篮后，解说员的解说词 away game：客场比赛? baby hook:小勾手 backcourt：后场 back to the basket:背筐 bank shot:擦板球? Baseline：底线。球场两端的边界线 behind-the-back:背后运球 between－the－leg:胯下运球 bounc:反弹传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作backdoor cut：从两边底线往篮下的战术 Back pass:背后传球 backcourt violation：回场违例? baseball pass：快攻时的长传 baseline driver：底线切入的球员? be sidelined：不能上场，退出比赛? beat the shot clock：在出手时限结束之前（完成出手投篮的动作）。在出手时限结束之前（完成出手投篮的动作）.NBA规定进攻一方必须在内24秒出手投篮，但在球过中线以后在前场的发球后，必须在14 内秒出手投篮，否则违例。 behind-the-back dribble：背后运球? Bench:替补队员 bench warmer：上场时间很少的球员，通常在场下把板凳都坐暖了 blocking foul：阻挡犯规 block out：卡位? Bounce pass:击地传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作brick：球打在篮筐或篮板上被崩出来，许多公牛队的球迷在客队罚球时都手执一块上写“Brick”的牌子在罚球队员的眼前不停的晃动，扰乱他的视线，以达到干扰罚球的目的。bury a shot：投篮命中 Buzzer beater：零秒出手，即投压哨球 catch-and-shoot:接球就投 cross-over:交叉过人?

NBA常用英语词汇

NBA解说里的英文表达（slam）dunk 灌篮（强力） bank shot 擦板球美 double pump 拉杆式投篮 fade-away shot 后仰式跳投 hook shot 钩射投篮美 layup 带球上篮 perimeter shot 中距离投篮各种统计术语 block shot 阻攻，盖火锅defensive rebound 防守篮板球 offensive rebound 进攻篮板球 field goal percentage 投球命中率 field goal 投球命中 free throw percentage 罚球命中率 free throw 罚球 rebound 篮板球 turnover 失误 freethrow lane 罚球圈，禁区freethrow line 罚球线 game clock 比赛用时钟 halftime 中场休息时间 hoop/rim 篮框，篮圈 painted area 罚球圈，禁区restricted area near the basket禁区：篮框，篮圈 top of the circle 禁区顶三分线附近wing （左右）底线区域规则篇 blocking foul 阻挡犯规 buzzer 蜂鸣器（T终换人等）charging foul （带球）撞人 dead ball 死球（停止比赛）defensive basket interference干扰篮 delay of game 阻碍比赛进行disqualification 犯满离场 double dribble 两次运球 ejection 驱逐出场美[I’d??k??n] expiration（of game, first half）（比赛，上半场）结束first period 比赛的第 five ticks left on the（game clock, shot clock…）：（全场比赛，时限钟上…的）时间只剩下5秒钟 flagrant foul 恶犯[’fleɡr?nt]、美[fa?l] foul out 犯满离场 foul trouble 快要犯满离场 full timeout：全时（100秒的）暂停goaltending 干扰球 hand-checking 推人 held ball 持球（双方均持球不放）illegal defense 防守违例 illegal offense 进攻违例（见isolation）isolation 拉开单打 jump ball 争球，跳球loose ball foul 争夺篮板球犯规offensive basket interference 进攻方干扰投篮得分overtime 加时赛，延长赛referee 裁判 shot clock violation 24秒 substitute 换人 suspension 停止出赛（之处罚）technical foul 技术犯规 ten-second violation 10秒钟内未带球过中场three-second violation 3秒违例 throw a punch 出拳打架 traveling 走步战术篇 backdoor cut 从两边底线往篮下的战术block out 卡位 cut 切入 double team 两位球员包夹 dribble out the time 运球方式消耗掉比赛时间eat up the clock 运球或传球耗掉比赛时间fast break 快攻 foul strategy 犯规战术 give and go 传切战术 jockey for position （篮下）卡位 milk the time away 运球或传球耗掉比赛时间one-one-one defense：人盯人防守 pick and roll 挡切战术 post-up play 背身单打 triple team 三位球员包夹 zone defense 区域联防动作篇（throw a）baseball pass （快攻时）长传（shoot）an air ball 没占板 behind-the-back dribble 背后（换手）运球carrying the ball “翻球” cross-leg dribble 胯下运球 dribble 运球 driving to the hoop 带球上篮 hacking 打手犯规 holding 拉手犯规 make the basket 投篮得分 make the hoop 投篮得分 monster dunk 狂猛灌篮 nothing but the net 空心球（入篮）palming “翻球” reverse dunk 倒灌篮 reverse lay-up 反手走篮 shoot behind the arc 投三分球 score a basket 投篮得分 swish 空心球（入篮） tap in 托球入篮 three-point play 2+1

NBA 篮球术语中英文对照

NBA 篮球专业术语中英文对照投篮方式篇：扣篮：dunk 擦板球：bank shot 拉杆式投篮：double pump 后仰式投篮：fade-away shot 钩射投篮：hook shot 跳投：jump shot 带球上篮：layup 中距离投篮：perimeter shot 立定投篮：set shot 三分投篮：three-point shot 统计术语篇：助攻：assist 盖帽：block shot 篮板球：rebound 防守篮板：defensive rebound 投篮命中：field goal 投篮命中率：field goal percentage 罚球：free trrow 进攻篮板：offensive rebound 得分：scoring 抢断：steal 三分球命中率：three-point shot percentage 失误：turn over 场地装备篇：篮板、篮架：backboard 篮筐：hoop 篮网：net 篮圈、篮框：rim 记录台、记分台：scoring table 前场：front court 中场：mid-court 后场：back court 罚球圈：freethrow lane 罚球线：freethrow line 罚球区：painted area 合理冲撞区：restricted area near the basket 比赛用时钟：game clock 中场休息时间：halftime

时限钟（24秒计时器）：shot clock 三分线：three-point line 靠近进去顶端的三分球线附近：top of the circle 左右底线区域：wing 动作篇 (throw a) baseball pass：（快攻时)长传 (shoot) an air ball：(投)篮外空心球，“面包“ behind-the-back dribble：背后（换手）运球carrying the ball：“翻球” cross-leg dribble：胯下运球 dribble：运球 driving to the hoop：带球上篮 four-point play：投进3分球后因被犯规再罚进一分hacking：打手犯规 holding：拉手犯规 make the basket：投篮得分 make the hoop：投篮得分 monster dunk：狂猛灌篮 nothing but the net：空心球（入篮） palming：“翻球” reverse dunk：倒灌篮 reverse lay-up：反手走篮 shoot behind the arc：投三分球 score a basket：投篮得分 swish：空心球（入篮） tap in：托球入篮 three-point play：投进2分球后因被犯规再罚进一分球队球员篇 assistant coach：助理教练 backcourt：后卫组（包括控球后卫及得分后卫）backup：后备（替换，支持）球员 bench：（指全体）后备（替换，支持）球员bench player：（指个人）后备（替换，支持）球员center中锋（又称5号位置球员） coach：教练 frontline：锋线（包括大前锋，小前锋，中锋） GM（general manager）：球队经理 Mascot：球队吉祥物

NBA-篮球术语-中英文对照

场地装备篇：篮板、篮架：backboard 篮筐：hoop 篮网：net 篮圈、篮框：rim 记录台、记分台：scoringtable 前场：frontcourt 中场：mid-court 后场：backcourt 罚球圈：freethrowlane 罚球线：freethrowline 罚球区：paintedarea 合理冲撞区：restrictedareanearthebasket 比赛用时钟：gameclock 中场休息时间：halftime 时限钟（24秒计时器）：shotclock 三分线：three-pointline 靠近进去顶端的三分球线附近：topofthecircle 左右底线区域：wing 动作篇 (throwa)baseballpass：（快攻时)长传(shoot)anairball：(投)篮外空心球，“面包“behind-the-backdribble：背后（换手）运球carryingtheball：“翻球” cross-legdribble：胯下运球 dribble：运球

NBA篮球术语中英文对照

NBA 篮球术语中英文对照 NBA 篮球专业术语中英文对照投篮方式篇: 扣篮: dunk 擦板球: bank shot 拉杆式投篮: double pump 后仰式投篮:fade-away shot 钩射投篮: hook shot 跳投: jump shot 带球上篮: layup 中距离投篮:perimeter shot 立定投篮:set shot 三分投篮: three-point shot 统计术语篇: 助攻: assist 盖帽: block shot 篮板球: rebound 防守篮板:defensive rebound 投篮命中: field goal 投篮命中率:field goal percentage 罚球: free trrow 进攻篮板:offensive rebound 得分: scoring 抢断:steal 三分球命中率:three-point shot percentage 失误:turn over 场地装备篇:

篮板、篮架:backboard 篮筐: hoop 篮网:net 篮圈、篮框:rim 记录台、记分台:scoring table 前场:front court 中场:mid-court 后场:back court 罚球圈:freethrow lane 罚球线:freethrow line 罚球区:painted area 合理冲撞区:restricted area near the basket 比赛用时钟:game clock 中场休息时间: halftime 时限钟(24秒计时器):shot clock 三分线: three-point line 靠近进去顶端的三分球线附近:top of the circle 左右底线区域: wing 动作篇 (throw a) baseball pass:(快攻时)长传 (shoot) an air ball:(投)篮外空心球，“面包“ behind-the-back dribble:背后(换手)运球 carrying the ball:“翻球” cross-leg dribble:胯下运球 dribble:运球 driving to the hoop:带球上篮 four-point play:投进3分球后因被犯规再罚进一分 hacking:打手犯规 holding:拉手犯规 make the basket:投篮得分

NBA篮球技术统计中英文对照名词解释资料

次全称：field goal percentage three-point shot percentage free throw percentage

如果还有疑问欢迎继续追问哦~满意的请采纳呢，您的支持是我回复的最大动力。Field Goal 投球FGA Field Goal Attempted 投射(次数) FGM Field Goal Made 命中 (次数) 3P ：三分球（3-point field goals），80赛季开始运用到NBA 3PA ：三分出手次数（3-point field goal attempts） 3PG% ：三分球命中率Age ：球员年龄，一般采用每年2月1日这一天球员的年龄 a-of-b shooting：投篮b次命中a次 All-Defensive Team : 最佳防守阵容。 All-NBA Team：NBA最佳阵容 All-Rookie Team：最佳新秀阵容 All -Star: 全明星 APG: 平均每场助攻(assist per game) Assist Ratio：助攻比（缩写为ASR） 1978赛季开始采用. 计算公式是:AsR=100*(AST / (FGA + 0.44*FTA + AST+TO)) 助攻比=100*(助攻次数/(投篮次数+0.44*罚球次数+助攻次数+失误次数)) Assist: 助攻(缩写：Ast.) Attempts：出手次数。BA：被盖帽次数（Blocks Against） Backboard: 篮板。注意不是basketboard。 bench score：板凳球员得分 Block shot: 盖帽(缩写：Blk.)。 Box score: 技术统计。 BPG：平均每场盖帽Career-high：职业生涯最高记录decent numbers：漂亮的，华丽的数据 DEF:防守篮板（后场篮板）。 Defensive efficiency：防守效率（简称Def Eff）. 计算公式: Def Eff = 100*(Opp PTS / Opp Poss); 防守效率=100*(对手得分/对手进攻机会) DNP 未出场,[Did Not Play (Participate)]，数据统计时，若一个球员未上场（通常是由于伤病、教练的决定或者私人事情），则记为DNP double doubles：两双 DPOY:年度防守球员(Defensive Player of the year年度防守球员),常规赛结束后评选该年度最佳防守球员 DRtg：防守效率指数（Defensive rating= OppPts/OppPos * 100）FG% 球

NBA术语中英版完整版

N B A术语中英版集团标准化办公室：[VV986T-J682P28-JP266L8-68PNN]

bank shot:擦板球 Baseline：底线。球场两端的边界线 behind-the-back:背后运球 between－the－leg:胯下运球 bounc:反弹传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作backdoor cut：从两边底线往篮下的战术 Back pass:背后传球 backcourt violation：回场违例 baseball pass：快攻时的长传 baseline driver：底线切入的球员 be sidelined：不能上场，退出比赛

beat the shot clock：在出手时限结束之前（完成出手投篮的动作）。在出手时限结束之前（完成出手投篮的动作）.NBA规定进攻一方必须在内24秒出手投篮，但在球过中线以后在前场的发球后，必须在 14 内秒出手投篮，否则违例。 behind-the-back dribble：背后运球 Bench:替补队员 bench warmer：上场时间很少的球员，通常在场下把板凳都坐暖了 blocking foul：阻挡犯规 block out：卡位 Bounce pass:击地传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作brick：球打在篮筐或篮板上被崩出来，许多公牛队的球迷在客队罚球时都手执一块上写“Brick”的牌子在罚球队员的眼前不停的晃动，扰乱他的视线，以达到干扰罚球的目的。 bury a shot：投篮命中 Buzzer beater：零秒出手，即投压哨球 catch-and-shoot:接球就投

NBA-篮球规则英文术语

．NBA 各种投篮方式 (slam) dunk：(强力) 灌篮 bank shot：擦板球 double pump：拉杆式投篮(verb) fade-away shot：后仰式跳投 hook shot：钩射投篮 jump shot：跳投 layup ：带球上篮 perimeter shot：中距离投篮 set shot：立定投篮 three-point shot：三分球 2．NBA 各种统计术语 assist ：助功 block shot：阻攻，盖火锅儿 defensive rebound：防守篮板球 field goal percentage：投球命中率 field goal：投球命中 free throw percentage：罚球命中率 free throw：罚球offensive rebound：进攻篮板球rebound ：篮板球 scoring ：得分 steal ：抄截 three-point shot percentage：三分球命中率turnover ：失误 3．场地装备篇 backboard ：篮板 back court：后场 freethrow lane：罚球圈，禁区 freethrow line：罚球线 front court：前场 game clock：比赛用时钟 halftime ：中场休息时间 hoop ：篮框，篮圈 mid-court ：中场 net ：篮网 painted area：罚球圈，禁区 restricted area near the basket：禁区内篮框下的小圆圈区域 rim ：篮框，篮圈 scoring table：记录台，记分台 shot clock：时限钟（进攻方在24秒内必须投篮，并且球必须触及篮框，否则即违例) three-point line：三分（球）线 top of the circle：靠近禁区顶端之三分（球）线附近 wing ：（左、右两边）底线区域 4．规则篇 blocking foul：阻挡犯规 buzzer ：（比赛用的）蜂鸣器（表示时间终了，换人…等）

NBA必备英文词汇

Minnesota Timberwolves 明尼苏达森林狼Oklahoma City Thunder 俄克拉何马城雷霆Portland Trail Blazers 波特兰开拓者 Utah Jazz 犹他爵士 Golden State Warriors 金州勇士 Los Angeles Clippers 洛杉矶快船 Los Angeles Lakers 洛杉矶湖人 Phoenix Suns 菲尼克斯太阳 Sacramento Kings 萨克拉门托国王 Dallas Mavericks 达拉斯小牛 Houston Rockets 休斯敦火箭 Memphis Grizzlies 孟菲斯灰熊 New Orleans Hornets 新奥尔良黄蜂 San Antonio Spurs 圣安东尼奥马刺球队组成： assistant coach：助理教练 backcourt：后卫组(包括控球后卫及得分后卫) backup：后备(替换，支持)球员 bench：(指全体)后备(替换，支持)球员 bench player：(指个人)后备(替换，支持)球员center：中锋(又称5号位置球员)

篮球英文术语

进攻类数据： PPG-Points Per Game：场均得分=总得分/球员出场场次PTS-Points：总得分 RPG-Rebounds Per Game：场均篮板=总篮板/球员出场场次REB-Rebounds=篮板总数 OFF RBS-Offense Rebounds：进攻篮板次数 DEF RBS-Defensive Rebounds：防守篮板次数 APG-Assists Per Game：场均助攻=总助攻/球员出场场次ATS-Assists：助攻总数防守类数据： SPG-Steals Per Game：场均抢断=总抢断/球员出场场次STLS-Steals：抢断总数 BPG-Blocks Per Game：场均封盖=总封盖次数/球员出场场次BLKS-Blocks：封盖总数 PF-Personal Foul：球员犯规次数 TO-Turnover：失误次数效率类数据： FG%-Field Goal%：投篮命中率 FT%-Free Throw%：罚球命中率 FGM- Field Goal Made：投篮命中数字 FGA- Field Goal Attempted：投篮尝试数字 FTM- Free Throw Made：罚球命中数字 FTA- Free Throw Attempted：罚球线机会次数 G-Games：比赛场次 GS-Games Starter：先发资格次数 Min-Minutes：上场总时间 MPG- Minutes Per Game：场均上长时间统计术语篇 assist 助攻 block shot 阻攻 defensive rebound 防守篮板球 field goal percentage 投球命中率 field goal 投球命中 free throw percentage 罚球命中率 free throw 罚球 offensive rebound 进攻篮板球 rebound 篮板球 scoring 得分 steal 抄截 three-point shot percentage 三分球命中率 turnover 失误

NBA术语中英版

N B A术语中英版 Document serial number【NL89WT-NY98YT-NC8CB-NNUUT-NUT108】

场上用语： a flat shot:一个弧线低平的投篮 alley-oop:空接扣篮 Arena:比赛场；竞技场。比如Seattle的主场名叫Key Arena arc:三分线 Arm in the rim dunk :手肘插进篮筐的灌篮 Air ball：“三不沾”，投出的球什么都没碰到 Alley-oop:空中接力。一个运动员把球抛向空中，另一个队员在空中接住球把球扣入篮筐 ankle－breaker：脚踝终结者。指的是一些球员在告诉交叉运球过程中将防守队员弄到并导致其受伤。 and one：打进加罚,即加罚 a strong finish：有力的结束。球员强力灌篮后，解说员的解说词 away game：客场比赛? baby hook:小勾手 backcourt：后场 back to the basket:背筐 bank shot:擦板球? Baseline：底线。球场两端的边界线 behind-the-back:背后运球 between－the－leg:胯下运球 bounc:反弹传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作 backdoor cut：从两边底线往篮下的战术 Back pass:背后传球 backcourt violation：回场违例? baseball pass：快攻时的长传 baseline driver：底线切入的球员? be sidelined：不能上场，退出比赛? beat the shot clock：在出手时限结束之前（完成出手投篮的动作）。在出手时限结束之前（完成出手投篮的动作）.NBA规定进攻一方必须在内24秒出手投篮，但在球过中线以后在前场的发球后，必须在 14 内秒出手投篮，否则违例。 behind-the-back dribble：背后运球? Bench:替补队员 bench warmer：上场时间很少的球员，通常在场下把板凳都坐暖了 blocking foul：阻挡犯规 block out：卡位? Bounce pass:击地传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作

篮球术语中英文对照

A: Agent 经纪人。Air ball:投出的球什么都没碰到，三不沾。 All-Defensive Team :最佳防守阵容。Alley-oop:空中接力。一个运动员把球抛向空中，另一个队员在空中接住球把球扣入篮筐。All-NBA Team:NBA最佳阵容。All-Rookie Team:最佳新秀阵容。 All -Star:全明星。APG:平均每场助攻。Arena:比赛场；竞技场。比如Seattle的主场名叫Key Arena。arc:三分线。 Assist:助攻(缩写：Ast.)。Attempts:出手次数。 Atlantic Division:大西洋赛区。 B: Babyhook:小勾手。Backboard:篮板。注意不是basketboard。Backcourt:后场。一支球队本方的半场为后场，即这支球队所要防守的那半场。Backdoor paly:篮球基本战术之一。当一个队员在罚球弧周围接到球时，另一个动员立刻从弱侧切入篮下，接队友的传球投篮得分。Back pass:背后传球。Baseline:底线。球场两端的边界线。Basket:篮筐。也作ring，还有一种通俗的说法是hoop。Bench:替补队员。Block shot:盖帽(缩写：Blk.)。Blocking Foul：阻挡犯规。Boo:嘘声(n)；发出嘘声(v)。球迷发泄不满的一种方法。Bounce pass:击地传球。Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作。Box score:技术统计。 Bounce pass:地板反弹传球。BPG:平均每场盖帽。Brick：球打在篮筐或篮板上被崩出来。许多公牛队的球迷在客队罚球时都手执一块上写"Brick"的牌子在罚球队员的眼前不停的晃动，扰乱他的视线，以达到干扰罚球的目的。Bury a shot:投篮命中。Buzzer beater:比赛结束前的最后一投。buzzer是比赛用的蜂鸣器。 C: Captian:队长。队长是场上惟一有资格与裁判讨论规则和判罚的人。 Career-high:职业生涯最高纪录。Carry the ball:翻腕违例。Center:中锋。Cental Division: 中部赛区。Charge:冲撞。Chief Official:主裁判。Close calls:比分接近的比赛。Clutch shot:至胜入球。Clutch time:生死时刻，投入一球可决定胜负的决定性时刻。Coach:教练。比如Head coach是主教练，Assistant coach是助理教练。Coast-to-coast:从球场的一端到另一端(n)。例如：coast-to-coast pass。Collactive Bargaining Agreement:劳资协定。Conference:联盟。NBA分东、西两个联盟(Eastern Conference和Western Conference)，每个联盟都有自己的logo。Commissioner:总裁。NBA的现任总裁是David Stern。Court:球场；赛场。 home court主场。Crossover:交叉运球过人。是Tim Hardaway的商标动作。Crunch time：关键时间（通常指最后两分钟）。 Cut:切入。 D: Debut:首次上场。DEF:防守篮板（后场篮板）。Dead ball:死球。Defense:防守。当客队进攻时，我们经常能听到主场的球迷在体育馆音效师的带领下高喊"Defense! Defense!"。Deny the ball:绕前防守。 Disqualification:被罚下场(缩写：DQ.)。Division:赛区。NBA共有四个赛区，每个联盟下属两个赛区。DNP：没有出场。Double-double:两双，即两项技术统计指标达两位数。

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