Buchheit K H
European Directorate for the Quality of Medicines (EDQM), Council of Europe, F-Strasbourg.
ALTEX. 2001;18(1):19-22.
Due to the complexity of their composition and mode of action and because of the absence of adequate alternative methods the quality control of biologicals (e.g. vaccines, sera) continues to be performed to a large extent in animal experiments. In most cases, the properties of the compounds are compared to those of a reference preparation. For Europe, the specifications for the biologicals are listed in the European Pharmacopoeia, which is published by the European Directorate for the Quality of Medicines (EDQM) in Strasbourg, on behalf of the member states. The EDQM is also in charge of the organisation of the Biological Standardisation Programme and the network of the national control laboratories (Official Medicines Control Laboratories, OMCL). The Biological Standardisation Programme pursues the goal to establish common European reference preparations and to standardise the methods used for the quality control of biologicals with the explicit goal to develop alternative methods whenever possible. This survey describes how the EDQM via the European Pharmacopoeia, the Biological Standardisation Programme and the OMCL network, supports the 3R concept and shows examples of its successful application.
由于生物制品（如疫苗、血清）成分和作用方式的复杂性，以及缺乏足够的替代方法，生物制品的质量控制在很大程度上仍需通过动物实验来进行。在大多数情况下，将这些化合物的特性与参考制剂的特性进行比较。对于欧洲而言，生物制品的规范列于《欧洲药典》中，该药典由位于斯特拉斯堡的欧洲药品质量管理局（EDQM）代表成员国出版。EDQM还负责组织生物标准化计划以及国家控制实验室网络（官方药品控制实验室，OMCL）。生物标准化计划的目标是建立通用的欧洲参考制剂，并使生物制品质量控制所使用的方法标准化，明确目标是尽可能开发替代方法。本综述描述了EDQM如何通过《欧洲药典》、生物标准化计划和OMCL网络支持3R概念，并展示其成功应用的实例。
