In 2004, the Office International des Epizooties (OIE) Expert Surveillance Panel on equine influenza recommended that the American lineage component (H3N8) of equine influenza vaccines (A/eq/Newmarket/1/93-like) be updated to an A/eq/South Africa/4/03-like virus. As a consequence the common European Pharmacopoeia (Ph. Eur.) - OIE reference for equine influenza subtype 2 American-like antiserum had to be complemented by an antiserum raised in horses against an A/eq/South Africa/4/03 strain....
Article & Jan 2008
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The biological nature of vaccines imposes a permanent risk for contamination with extraneous agents. Therefore, testing of vaccines for freedom from extraneous agents is essential in the manufacturing process and quality control. Relevant methods for testing for extraneous agents of avian viral vaccines are specified in the monographs of the European Pharmacopoeia (Ph. Eur.). Currently, most of these methods involve the use of embryonated eggs or chickens. Polymerase chain reaction (PCR) is...
Article & Jan 2008
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The European Directorate for the Quality of Medicines (EDQM) supplies Chemical Reference Substances (CRS) for Interferon (IFN) alfa-2a (CRS I0320300) and for IFN alfa-2b (CRS I0320301) for specified physicochemical tests. However, no information is provided as to their biological activity. In contrast, the World Health Organization (WHO) provides the 2nd International Standards (IS) for IFN alfa-2a (code 95/650) and for IFN alfa-2b (code 95/566), with activity defined in International Units...
Article & Jan 2008
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: European Pharmacopoeia (Ph. Eur.) general chapter 2.6.7. Mycoplasma requires for the culture test reference strains of mycoplasma field isolates with fewer than 15 passages for validation and run control and in the test for inhibitory substances. Low passage field isolates of 5 mycoplasma strains (Mycoplasma hyorhinis, Mycoplasma synoviae, Mycoplasma fermentans, Mycoplasma orale and Acholeplasma laidlawii) have been prepared for this purpose and a small scale collaborative study involving...
Article & Dec 2006
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: An international collaborative study was organised to establish a European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) and United States (US) Food and Drug Administration (FDA) reference preparation for the test for anti-D (anti-Rho) antibodies in human normal immunoglobulin for intravenous administration (IGIV). A candidate positive control (IGIV+anti-D) and negative control IGIV were compared to corresponding World Health Organization (WHO) International Reference...
Article & Dec 2006
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: For the potency assay of human coagulation factor VII concentrate preparations according to the European Pharmacopoeia (Ph. Eur.) a reference preparation calibrated in International Units (IU) is needed. Currently, the 1st International Standard (97/592, potency: 6.3 IU/ampoule) but no Ph. Eur. reference preparation is available. A collaborative study was run to calibrate a candidate Ph. Eur. Biological Reference Preparation (BRP) for human coagulation factor VII concentrate against the 1st...
Article & Dec 2006
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The European Pharmacopoeia (Ph. Eur.) monograph Human tetanus immunoglobulin (0398) gives a clear outline of the in vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the potency estimation. Since no further guidance is given on the in vitro assay, every control laboratory concerned is free to design and validate an in-house method. At the moment there is no...
Article & Dec 2006
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The discontinuation of the Auszyme kit used by vaccine manufacturers and national control laboratories to determine the Hepatitis B surface antigen (HBsAg) content of hepatitis B vaccines has led GlaxoSmithKline (GSK) to develop an alternative inhibition ELISA method. Validation of this ELISA was performed according to The International Conference of Harmonization and reproducibility was assessed in a feasibility study with four Official Medicines Control Laboratories (OMCLs). The dose...
Article & Nov 2006
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A feasibility study was organised to determine the possibilities for development of a common in vitro assay for determination of D-antigen content in inactivated poliomyelitis vaccines (IPV). 3 different methods were tested on a selection of non-combined IPV vaccines from the European market. The results of this preliminary study suggest that for vaccines with a similar strain composition similar results would be achieved regardless of which of the three methods was used. Nevertheless, for...
Article & Oct 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: An International Collaborative Study was organized to replace the current World Health Organization (WHO) International Standard (IS) for Prekallikrein Activator (PKA) and to establish a European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP). The project was jointly organized by the European Directorate for the Quality of Medicines (EDQM) and the National Institute for Biological Standards and Control (NIBSC) to identify and calibrate suitable materials that could act as an...
Article & Oct 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: This paper describes a double antigen ELISA (DAE) for rapid, specific and reliable assessment of the antitetanus immune status of horses and sheep. Compared with the indirect ELISA, the double antigen ELISA has the advantage of species-independent testing of sera. Thanks to its test design, it is more specific since the detected antibodies are forced to bind tetanus toxoid twice. In addition, it is very sensitive to tetanus antibodies, enabling the detection of low antibody titres, in range...
Article & Oct 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: Treatment of respiratory allergies can be performed with allergen-specific immunotherapy using allergen extracts. These products are biologicals with an extremely complex and variable composition. Only a few components are of major importance for the disease, the so-called major allergens. At present, standardisation of allergen extracts is dominated by techniques that aim at establishing their overall IgE-binding potencies using pooled sera of allergic patients. Each company in the market...
Article & Oct 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: Upon suggestion of the French Official Medicines Control Laboratory, a collaborative study was initiated by the European Directorate for the Quality of Medicines with the goal of calibrating the candidate European Pharmacopoeia biological reference preparation (Ph. Eur. BRP) for anti-vaccinia immunoglobulin batch 1 in International Units (IU) against the 1(st) British standard (anti-smallpox serum). The candidate BRP batch 1 was obtained by lyophilising a pool of four plasma samples obtained...
Article & Oct 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: In the European Pharmacopoeia, the monographs on somatropin, somatropin bulk solution and somatropin for injection prescribe a number of tests including &related substances&, &dimer and related substances of higher molecular weight& and &isoform distribution& which are intended to control the levels of impurities in the substance. The aim of this study was to verify the robustness of a new method by capillary electrophoresis and to compare its performance with that of the existing test for...
Article & Jan 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A quantification assay for the Haemagglutinin-Neuraminidase (HN) protein of Newcastle Disease Virus (NDV) has been developed at CIDC-Lelystad as a candidate in vitro potency test for inactivated Newcastle disease (ND) vaccines. In studies performed at CIDC-Lelystad, a high correlation was demonstrated between the results of this candidate in vitro potency assay and the results of the serological potency assay (European Pharmacopoeia monograph 0870; test A). Furthermore, a high correlation...
Article & Jan 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The preparation and establishment of the 2nd European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for erythropoietin was the goal of a project run within the framework of the European Biological Standardisation Programme. The project, coded BSP062, was carried out between October 2002 and July 2003. The candidate preparation (cBRP2) was prepared in a similar manner to the first BRP batch (BRP1), as follows: -50:50 (weight/weight) blending of the two erythropoietin...
Article & Jan 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: 9 laboratories from 7 countries including both laboratories from the public and private sector participated in a collaborative study organised under the aegis of the European Directorate for the Quality of Medicines Biological Standardisation Programme in order to establish batch 4 of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for rabies vaccine (inactivated) for veterinary use. Establishment of Ph. Eur. BRP batch 4 was necessary in order to replace Ph. Eur....
Article & Jan 2005
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM), to assign a potency value for candidate batch 2 of European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Hepatitis B (rDNA) antigen in vitro assays, for both method A and method B by calibrating them against the Ph. Eur. BRPs, batch 1 for methods A and B respectively. The study was prompted by the observation that the first batch of BRP for method B appeared to have...
Article & Feb 2004
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: The goal of the collaborative study was to calibrate the B19 DNA content of a candidate Biological Reference Preparation (BRP) that is intended to be used for the validation of the analytical procedure, as threshold control and/or as quantitative reference material in the Nucleic Acid Amplification Technique (NAT) test of plasma pools for detection of B19 contamination. The candidate BRP was calibrated against the 1st International Standard for B19 DNA NAT assays. According to the European...
Article & Feb 2004
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: Collaborative studies were initiated by the European Directorate for the Quality of Medicines (EDQM) to assign potency values for candidate European Pharmacopoeia Chemical Reference Substances (Ph. Eur. CRSs) used for the microbiological assay of antibiotics. The candidates were assayed against their respective International Standard (IS), using the methods by diffusion or turbidimetry. Potencies were assigned to all the antibiotics concerned, which were adopted by the European Pharmacopoeia...
Article & Feb 2004
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: Investigations on the replacement of the mouse neutralisation test for proving vaccine batches of Clostridium (C.) perfringens toxoid vaccines were performed since several years. The European Pharmacopoeia (Ph. Eur.) monograph Clostridium perfringens vaccines for veterinary use (0363) is prescribing a potency test by immunisation of rabbits and checking the induction of specific antibodies against the toxins in a mouse neutralisation test. Since the monograph was revised, immunochemical...
Article & Feb 2004
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Article & Jan 2004
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A Newcastle disease virus antigen quantification assay has been developed at CIDC-Lelystad as a candidate in vitro potency test for inactivated Newcastle disease vaccines. In studies performed at CIDC-Lelystad, a high correlation was demonstrated between the results of this candidate in vitro potency assay and the results of the serological potency assay (European Pharmacopoeia monograph 0870; test A). Furthermore, a high correlation between the serological data (Haemagglutination...
Article & Aug 2003
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A collaborative study was initiated by the European Directorate for the Quality of Medicines (EDQM) to assign a potency value for the candidate Ph Eur BRP batch 2 against the 2nd International Standard (IS) in order to replace the dwindling stocks of Ph Eur BRP batch 1. The candidate material is a concentrated trivalent bulk (Type 1 (Mahoney), Type 2 (MEF1) and Type 3 (SAUKETT)) from a commercially available IPV vaccine. Nine laboratories participated in the collaborative study. Eight...
Article & Aug 2003
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
Abstract: A stable liquid candidate Biological Reference Preparation (BRP) for diphtheria toxin was prepared in peptone buffer (nominal content of diphtheria toxin: 1 Lf/ml, 0.4 micro g/ml), filled in ampoules (filling volume: 1 ml) and characterised in a collaborative study. The toxin is to be used in the test &Absence of toxin and irreversibility of toxoid& as described in the current European Pharmacopoeia (Ph. Eur.) monograph Diphtheria Vaccine (Adsorbed) (). Eleven laboratories assessed...
Article & Jul 2003
& Pharmeuropa bio / the Biological Standardisation Programme, EDQM
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【原创】如何解读EDQM中原料药质量标准的最新动态
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这个帖子发布于4年零319天前，其中的信息可能已发生改变或有所发展。
前提：这是本人的一些理解，由于英语水平的限制以及个人能力的问题，难免会有一些错误，欢迎各路高手指出。定位为扫盲篇吧！EDQM（European Directorate for the Quality of Medicines），欧洲药典质量理事会的简写，它是由欧洲药典委员会技术秘书处演化而来，它有很多职能，具体职能如下：1、欧洲药典委员会的技术秘书处提供技术支持2、负责欧洲药典及相关产品的出版与发行3、负责化学药物标准品和生物制品标准品的制备与销售4、负责对欧洲药典各论的适用性认证5、负责构建欧洲官方药品检验实验室网络，承担生物制品批签发与上市药品的监督任务。我们这里主要讨论与职能2相关的原料药标准的最新动态如何查询一级如何解读这些信息。EDQM的官方网址是：http://www.edqm.eu/en/edqm-homepage-628.html，点击Databases进入。Databases里面有很多信息，其中Knowledge主要讲解的是原料药或通论的一些信息。在这里原料药标准的最新信息在此每天更新着。从Knowledge Databases进入后，有一个对该数据库的简介，该数据库包含的信息有各论号、英文、法文和拉丁文名，工作状态，最新各论草案在药典论坛公布在多少卷，最新公开版在欧洲药典的位置、当前各论是否有过修订记录、是否有PDF格式色谱图、以及一些试剂、色谱柱或生物包的商品名。这些信息可以帮助我们了解标准的一些信息以及方便方法的重现。Knowledge Databases提供了四种搜索方式，其中3种为该化合物的英文名检索、法文名检索和拉丁文名检索，最后一个为EDQM为该化合物的个论编号。
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111 编辑于
举例讲解，以阿立哌咗为例，英文名字Aripiprazole。搜索后陆续看到以下信息：如何解读上面表中的信息呢？
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晴天1210 编辑于
在解读上图的意思前，先解释一下其中几个跟我们了解该原料药标准现状的几个信息：l State of Work 工作状态State of Work 包括以下6种状态：0：EDQM已经给予该化合物个论编号，但是没有进行任何工作的开展，会计划在几年内将该化合物纳入药典。或者药典已经收载了该方法，但是由于某些原因，已列入计划会重新修订该方法，该项工作的工作状态即为0；1：工作已经启动。此时EDQM会面向大众，主要是一些生产该原料药的大公司，搜集标准（此处肯定不对）。2：各论已经授权在药典论坛上公布（参见其药典论坛编号，例如Pharmeurope23.2），处于可讨论状态，此时主要是面向大众征集该标准中的一些问题。3：各论已经递交给欧洲药典委员会，以确定该各论是否会被采纳收载入欧洲药典，此时还在只能在药典论坛中查看，但是已经终止讨论了。4：各论已经被欧洲药典采纳。5：各论将要上欧洲药典，或者已经上欧洲药典（参见增补号以及对应的日程表）。注意公布在药典论坛（阶段2—咨询期）和药典（阶段5—最终版本）中内容的差别。
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下表是原料药标准建立或修订的流程表
有点儿错位了 改天继续更新 吃饭先
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晴天1210 编辑于
丁香园荣誉版主
这就开课了呀，支持一下
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欧洲药典论坛:此处显示的数字是各论草案公布的最新版本。此处简单介绍一下欧洲药典论坛.1987年开始出版,出了1卷,1988年~1989年共出了5卷,其中第5卷分为ab两版 ,1990年出了3卷,从1991年开始,每年出4卷,分别在1月\4月\7月\10月出.在2011年10月以前,欧洲药典论坛是收费查询的,在10月以后,只要注册就可以免费使用,更方便大众对标准草案等的讨论与反馈.欧洲药典论坛入口:左边的Texts for comment,是处于工作状态2的一些各论等,放在此处让公众讨论;右边的Pharmeuropa archives,已经经过讨论后的,这里有从1987年开始的所有信息.
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@llb1978,欢迎常来的，我这就是抛砖引玉呢，砖头已经扔出去了，坐等玉的到来
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注意：欧洲药典英文版本所提及的版本号，通常也和法文版的相同，当只有一个语种的版本出现校正时，可能会出现差别。欧洲药典的法语版本的用户建议参考最新增补版的索引。注意：从第7版起，如果一个标准在新的版本或增补版没有技术上的修订，版本将会保留上一版的版本号，以提高可追溯性。因此，上药典的品种，只需要关注此处就可以了，不需要费劲力气想知道最新药典版本是否有更改。修订进展：指一个各论是否正在进行修订。如果一个原料药标准从未上过药典，正在药典论坛中，那只能叫建立标准，而不是修订；如果一个原料药标准已经上药典了，出于某些原因，又有新的标准草案开始在药典论坛出现，那Revision in progress就应该是Yes；但是如果工作状态已经是5，那么说明修订已经完成，此时Revision in progress就变为No；l View History : contains information concerning certain technical modifications to some revised/corrected texts published since Ph.Eur. 5.0. This information complements the modifications indicated by lines in the margin in the supplements and is not necessarily exhaustive.
从欧洲药典5.0开始，会刊登技术更改上的信息，比如一些修订/校正
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晴天1210 编辑于
那么现在回头来看上面的图片信息，我们基本上可以得出如下信息：阿立派唑，以前未上过欧洲药典，现在可以在欧洲药典论坛24.3中查找到它的质量标准草案，该草案处于comment（说明：实际上已经过了，感觉未能及时更新该消息） 其实我们有时候需要进入药典论坛才能更放心我们所了解到的信息是否准确,尤其是在刚接触时,比如前几天这位战友的疑问:如果对这个界面比较熟悉,看到上面的信息后,会奇怪,为什么上面有关物质没有版本号,而下面的却有?如果我们点进View History就会发现:7.0只是校正,而实际上有关物质在6.3基本上就是最新的了.基本上可以猜测应该用下面的柱子更合适.EDITION 7.0: correctedSUPPLEMENT 6.3Related substances: an improved LC method with a gradient has been introduced which allows better separation and control of the impurities. However, as the monohydrated substance is purer, limits and specified impurities are not the same as for anhydrous beclometasone dipropionate (0654).PUBLICATION 6.0: correctedSUPPLEMENT 5.5: following the establishment of beclometasone dipropionate for system suitability CRS and beclometasone dipropionate for peak identification CRS, the identification of impurities D and M has been modified. In addition, relative retentions of the other detectable impurities have been deleted according to usual practice.
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晴天1210 编辑于
大家有时间可以自己查询一下:Caprylic acid
Pertussis vaccine
Cisapride tartrate
Hydrochlorothiade
Dorzolamide
calcifediol
Levofloxacin
欢迎大家把自己的理解拿出来和大家一起讨论.
有空继续更
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丁香园荣誉版主
我这人向来吹毛求疵，aripiprazole的中文通用名应为：阿立哌唑因为我们是professional的
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llb1978 编辑于
llb1978 我这人向来吹毛求疵，aripiprazole的中文通用名应为：阿立哌唑因为我们是professional的纯属笔误。。。。
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继续欣赏大作呢！
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学习了，谢谢！！
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支持，开始听课学习。
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太实用了，谢谢斑竹
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仔细读了一下，确实值得收藏，特别对于英语水平差的。
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药典论坛的确是个好东东
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好东西，收藏~
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晴天美女懂得好多啊！学习！
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正在发愁的问题得到了很好的解答！太好了
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药典论坛上查看原料药标准，怎么找不到注册的地方
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我今天上这个网，前后都有，唯独没有24.3？显示97个结果，但电脑屏幕知道24.2，另一部分从24.4开始。
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张大米粒 药典论坛上查看原料药标准，怎么找不到注册的地方#从上面网址进入后，在右上角有login，点击进入以后，可以看到注册即可。
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likeduyanru 我今天上这个网，前后都有，唯独没有24.3？显示97个结果，但电脑屏幕知道24.2，另一部分从24.4开始。再仔细找找，应该都有的。
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给力，学习
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看了24.3里面一个分析方法的计算公式好像不太对，同事们算了几遍都觉得应该加上EDTA的浓度，请问已经完成conmment的项目，是不是没办法提出来询问一下？或者请告知一下，询问的方式是什么
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可以单独开贴，大家一起来讨论这个问题，看是你们理解错了，还是药典论坛错误了~~我感觉我知道你说的是哪个个论~~
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欢迎单独开贴，深入讨论。
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晴天1210 前提：这是本人的一些理解，由于英语水平的限制以及个人能力的问题，难免会有一些错误，欢迎各路高手指出。定位为扫盲篇吧！EDQM（European Directorate for the Quality of Medicines），欧洲药典质量理事会的简写，它是由欧洲药典委员会技术秘书处演化而来，它有很多职能，具体职能如下：1、欧洲药典委员会的技术秘书处提供技术支持2、负责欧洲药典及相关产品的出版与发行3、负责化学药物标准品和生物制品标准品的制备与销售4、负责对欧洲药典各论的适用性认证5、负责构建欧洲官方药品检验实验室网络，承担生物制品批签发与上市药品的监督任务。我们这里主要讨论与职能2相关的原料药标准的最新动态如何查询一级如何解读这些信息。EDQM的官方网址是：http://www.edqm.eu/en/edqm-homepage-628.html，点击Databases进入。Databases里面有很多信息，其中Knowledge主要讲解的是原料药或通论的一些信息。在这里原料药标准的最新信息在此每天更新着。从Knowledge Databases进入后，有一个对该数据库的简介，该数据库包含的信息有各论号、英文、法文和拉丁文名，工作状态，最新各论草案在药典论坛公布在多少卷，最新公开版在欧洲药典的位置、当前各论是否有过修订记录、是否有PDF格式色谱图、以及一些试剂、色谱柱或生物包的商品名。这些信息可以帮助我们了解标准的一些信息以及方便方法的重现。Knowledge Databases提供了四种搜索方式，其中3种为该化合物的英文名检索、法文名检索和拉丁文名检索，最后一个为EDQM为该化合物的个论编号。看了晴天版主这个帖子，学到了很多知识，有一个疑问想请教一下。见下面的图：工作状态是4，各论草案是17.1，药典版本是6.0，修订进展是正在修订。那么，6.0是在17.1的基础上修订完毕，正式公开的呢？还是17.1在6.0的基础上提出的可讨论草案呢？哪个是最新的？有点糊涂，希望得到晴天版主的指导，谢谢！
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EDQM确实有些各论，查database时工作状态是4，修订状态是yes，而实际上早已上药典了。你举的这个例子，由于现在已经到25.1，17.1的应该早已修订完毕，毕竟已经过了8年。而且我们看到这个化合物最终已经上药典，那么肯定是根据药典论坛17.1进行修订的。
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晴天1210 EDQM确实有些各论，查database时工作状态是4，修订状态是yes，而实际上早已上药典了。你举的这个例子，由于现在已经到25.1，17.1的应该早已修订完毕，毕竟已经过了8年。而且我们看到这个化合物最终已经上药典，那么肯定是根据药典论坛17.1进行修订的。也就是说，目前最新标准就是6.0的？会不会存在这样一种情况：最新公开版本是6.0，有计划要再次修订，所以修订状态是yes，但最新草案还未公开，网站上显示的是以前的老草案17.1？
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晴天1210 举例讲解，以阿立哌咗为例，英文名字Aripiprazole。搜索后陆续看到以下信息：如何解读上面表中的信息呢？楼主，我搜索埃索美拉唑二水目前是在论坛24.3，工作进度为2。根据你所说的，应该已经完成了comment了，是不是指24.3里面的内容不会再变了？可以尽早作为CEP注册的标准来参考了？等到进度5，正式收编入EP大约还要多久呢？
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In useMonograph NumberEnglish NameFrench NameLatin NamePinyin Name
Chinese Name
Pharmeuropa
25.1Published in English Supplement
8.3Published in French Supplement
8.3Chromatogram
AvailableAdditional information
Not availableHistory
View historyInterchangeable (ICH_Q4B)
NOInternational Harmonisation chapter 5.8
NO请问红色的表示什么意思呢，按草案看还是药典增补看呢？
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不好意思，发重了
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