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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Ensuring supplies of quality diethylcarbamazine citrate (DEC).
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Ensuring supplies of quality diethylcarbamazine citrate (DEC).

机译：确保供应优质的柠檬酸二乙酯。

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In 1997, the World Health Organization (WHO) made a commitment to eliminate lymphatic filariasis. The WHO Global Program to Eliminate Lymphatic Filariasis (WHO-FIL) needed a reliable supply of diethylcarbamazine citrate (DEC) of known acceptable quality at an affordable price, so in August 1999, it started the DEC Project. Today's standards required development of a modern stability-indicating assay method for DEC and for DEC tablet dissolution. ADD Advanced Drug Delivery Technologies (Switzerland) developed a high-pressure liquid chromatography assay, which was independently validated and is in the United States Pharmacopoeia 25 (2002). After a global search, the project found that almost all existing and potential DEC active pharmaceutical ingredient (API) and tablet manufacturers are in low-income countries. The project constructed an audit team to conduct on-site audits to assess good manufacturing practices according to European Union standards. National/state inspectors accompany the audit team. The team prequalified one DEC API manufacturer and three DEC tablet manufacturers. The project plans to increase the number of prequalified DEC manufacturers. Now, WHO-FIL only purchases from prequalified manufacturers. Consolidation of several national program DEC requirements into a limited international competitive bid reduced the price for DEC tablets between 30% and 45%, compared to previous small-scale WHO purchases.
机译：1997年，世界卫生组织（WHO）承诺消除淋巴丝虫病。世卫组织消除淋巴丝虫病全球规划（WHO-FIL）需要可靠，质量可靠，价格公道的可接受价格的柠檬酸二乙基卡巴嗪（DEC），因此在1999年8月启动了DEC项目。当今的标准要求开发一种用于DEC和DEC片剂溶解的现代稳定性指示测定方法。 ADD Advanced Drug Delivery Technologies（瑞士）开发了一种高压液相色谱分析方法，该方法已独立验证，并在美国药典25（2002）中进行了验证。在全球搜索之后，该项目发现几乎所有现有和潜在的DEC活性药物成分（API）和片剂制造商都在低收入国家。该项目组建了一个审核小组，以进行现场审核，以根据欧盟标准评估良好的生产规范。国家/州检查员陪同审核小组。该团队对一名DEC API制造商和三名DEC平板电脑制造商进行了资格预审。该项目计划增加合格的DEC制造商的数量。现在，WHO-FIL仅从合格的制造商那里购买。与世界卫生组织以前的小规模采购相比，将几个国家计划的DEC要求合并为一个有限的国际竞争性招标，使DEC片剂的价格降低了30％至45％。

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