1.1 本规程提供了一个通用程序，用于评估符合剂量单位均匀性（UDU）测试的能力。此测试在一般章节中给出 <905>USP剂量单位的均匀性，欧洲药典2.9.40剂量单位的一致性，以及JP 6.02剂量单位的统一性，这些版本实际上是可互换的。对于这种多阶段测试，该程序根据剂量单位样本在规定置信水平下的统计估计，计算通过UDU测试的概率下限。 1.2 该方法可用于生成验收限值表，该表定义了一组样本均值和标准偏差，以确保在规定的概率下限、置信水平和样本量下通过UDU测试。 1.3 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 4.1 该方法最初是开发的 ( 1- 4. ) 6. 用于药物含量均匀性和溶出度，但一般应用于具有多个验收标准的任何多级测试。实践 E2709 总结了该方法的统计方面。本规程采用《规程》的一般方法 E2709 特别是UDU测试。 4.1.1 虽然可以使用其他方法来估计通过UDU测试的概率，但它们不在本实践的范围内。 4.2 UDU测试程序描述了一种两阶段抽样测试，在每个阶段，一个人可以通过或继续测试，失败的决定推迟到第二阶段。 在每个阶段，测试结果都有验收标准，如中所述 表1 。 4.3 UDU测试是市场标准。USP一般注意事项包括以下关于药典标准的声明。“与统计程序的相似性似乎表明了对某个更大的单元组进行推断的意图，但在所有情况下，关于是否符合药典标准的声明仅适用于测试的单元。”因此，UDU程序并非用于检验批次/批次放行的成品的一致性，也不是作为批次检验程序。 4.3.1 UDU测试定义了在产品发布和整个保质期内需要满足的产品要求。 4.3.2 通过一次UDU测试并不能提供一批药品符合特定统计质量控制标准的统计保证。 4.4 该实践提供了当需要剂量单位的均匀性时可以应用的实用规范。 定义了一组测试结果的平均值和标准偏差的接受区域，以便在规定的置信水平下，该批次的未来样本通过UDU测试的概率大于或等于预先指定的概率下限。测试结果落在可接受范围内可以保证样本至少以指定的下限概率通过UDU测试。该程序不考虑保质期内效力的任何下降，这可能会影响满足UDU测试要求的能力。 4.5 该实践可作为工艺演示或验证、连续工艺验证、过程中测试或批量放行（验收）的一个要素。由于这些不同应用领域的情况和可用信息各不相同，本实践并未规定具体的目标、样本量、概率下限或置信水平。 这些必须由用户前瞻性地选择，并且可能与本实践中提供的验收限值表中使用的不同。

1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter <905> Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units. 1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 The methodology was originally developed ( 1- 4 ) 6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test. 4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice. 4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1 . 4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure. 4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product. 4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria. 4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance region provides assurance that a sample would pass the UDU test with at least the specified lower bound probability. This procedure does not account for any decrease in potency during the shelf life, which could affect the ability to meet the UDU test requirements. 4.5 This practice can be used as an element for process demonstration or validation, continuous process verification, in-process testing, or lot release (acceptance). As the circumstances and available information vary in these different application areas, this practice does not prescribe a specific target, sample size, lower probability bound, or confidence level. These must be prospectively selected by the user and may be different from those used in the acceptance limit tables provided in this practice.