两性霉素B第三个国际标准的制定合作研究。

Q4 Medicine
Pharmeuropa bio & scientific notes Pub Date : 2020-01-01
Sylvie Jorajuria, Manuela Fernandes, Michèle Vees, Valérie Dujardin, Elena Regourd
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引用次数: 0

摘要

组织了一项国际合作研究,以制定世界卫生组织(世卫组织)第三项两性霉素b国际标准。来自不同国家的16个实验室参加了这项研究。候选材料的效价通过敏感微生物的微生物测定来估计。为了保证连续批次之间的连续性,以两性霉素B的第2个IS作为对照。根据研究结果,2019年世卫组织生物标准化专家委员会(ECBS)会议通过了两性霉素B的第三个标准,指定效力为每毫克953国际单位(IU)。两性霉素B的第三个信息系统可从欧洲药品和保健质量理事会(EDQM)获得。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Collaborative study for the establishment of the 3rd international standard for amphotericin B.

An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for amphotericin B. Sixteen laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches, the 2nd IS for amphotericin B was used as a reference. Based on the results of the study, the 3rd IS for amphotericin B was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2019 with an assigned potency of 953 International Units (IU) per mg. The 3rd IS for amphotericin B is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).

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来源期刊
Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
CiteScore
0.70
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