接触性过敏原皮肤试验的贴片试验的质量保证和标准化。

Jürgen Brinkmann
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引用次数: 0

摘要

在过去十年中,在制药工业的生产过程中,贴敷试验制造中使用的原材料贴错商标和这些试验材料的最终产品造假的问题变得越来越重要。为了保证半固体药物检测试剂的性能和安全性,必须了解不同国家和国际法规所要求的质量标准和官方要求。此外,有必要了解影响斑贴试验质量的主要因素,从而最终影响医学过敏诊断的质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality assurance and standardisation of patch tests for contact allergens skin testing.

The misbranding of raw materials used in the manufacturing of patch tests and the counterfeiting of the final product of these test materials have gained increasing importance in the last decade with respect to the production process in the pharmaceutical industry. To guarantee the performance and safety of a semi-solid pharmaceutical testing form, it is important to make oneself acquainted with the different quality standards and official requirements demanded by the national and international regulations. Moreover it will be necessary to get an idea about the major factors which influence the quality of patch tests and therefore finally the quality of the medical allergic diagnosis.

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