Joint WHO/EDQM Collaborative study for the establishment of WHO 3rd International Standard and Ph. Eur. Biological Reference Preparation for Prekallikrein activator in albumin batch 7 [0.03%]
世卫组织/欧洲药典委员会联合协作研究建立第3国际标准和欧洲药典生物参考试剂（批号7）血浆前激酶促活性物测定人血清白蛋白制品的研究报告
B Fox,E Regourd,P Rigsby et al.
B Fox et al.
An international collaborative study was jointly organised by the World Health Organization (WHO) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the WHO 3rd International Standard (IS) for Prekall...
Collaborative study for the establishment of Human immunoglobulin (molecular size) BRP replacement batches 4, 5 and 6 [0.03%]
人免疫球蛋白（分子大小）BRP替代批4、5和6的协作研究项目
S Jouette,E Regourd
S Jouette
Human immunoglobulin products are used for the treatment of a number of diseases, such as primary or secondary immunodeficiencies and autoimmune conditions due to the complete absence of antibodies or the production of defective immunoglobu...
International collaborative study to assess new stocks of candidate reference preparations to control the level of anti-D in IVIG [0.03%]
国际协作研究评估新的候选参考品以控制IVIG中抗D水平的项目研究报告
S J Thorpe,M L Virata,B Fox et al.
S J Thorpe et al.
The level of anti-D antibodies in human immunoglobulin products for intravenous administration (IVIG) is controlled by the direct haemagglutination method prescribed by the European Pharmacopoeia (Ph. Eur.) that requires 2 control reference...
Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2 [0.03%]
人破伤风免疫球蛋白第二批欧洲药典适应性生物参考品协作标定研究
P Stickings,R Tierney,J Hockley et al.
P Stickings et al.
This publication describes the outcome of a project to develop a replacement European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin (TIg) as well as for the World Health Organization (WHO) ...
Ph. Eur. testing for histamine and depressor substances using guinea-pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur [0.03%]
欧洲药典中用于组胺和降压物质检测的豚鼠和猫实验：一个时代的终结。去除欧洲药典中的组胺和降压物质动物测试及其残留物的战略
M Bratos,O Kolaj-Robin,M Antoni et al.
M Bratos et al.
For more than 50 years, in vivo assays have been used for testing pharmaceutical product safety due to their assumed ability to broadly detect potential unidentified contaminants. As part of these in vivo tests, the animal tests for depress...
Determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay: Evaluation of test kit sensitivity, reference standard performance and product formulation effects on the FXIa assay [0.03%]
FXIa色谱法测定人免疫球蛋白中促凝活性：试验试剂盒敏感度、参考标准和产品配方对FXIa法影响的评估
M-E Behr-Gross,D Le Tallec,N Sinitskaya et al.
M-E Behr-Gross et al.
In 2010, the reporting of thrombotic adverse events for one subcutaneous and certain intravenous immunoglobulins (IGs) raised some concerns. In Europe, regulatory bodies rapidly revised compendial specifications for therapeutic IGs to ensur...
Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2 [0.03%]
人破伤风免疫球蛋白第二批欧洲药典生物参考品的建立合作研究
P Stickings,R Tierney,J Hockley et al.
P Stickings et al.
This publication describes the outcome of a project to develop a replacement European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human tetanus immunoglobulin (TIg) as well as for the World Health Organization (WHO) ...
Collaborative study for the establishment of replacement batches of Ph. Eur. Heparin Low-Molecular-Mass for Calibration CRS [0.03%]
欧洲药典低分子量肝素校准协作研究批次的建立及其协作研究
S Caruncho Garcia-Moreno,B Mulloy,I Rodrigo-Castro et al.
S Caruncho Garcia-Moreno et al.
An international collaborative study was run within the framework of the Biological Standardisation Programme (BSP) of the Council of Europe and the Commission of the European Union to establish replacement batches for European Pharmacopoei...
Validation and application of a SEC-HPLC method for the determination of total protein in therapeutic immunoglobulins as an alternative to the European Pharmacopoeia methods [0.03%]
一种用于测定治疗用免疫球蛋白总蛋白的SEC-HPLC方法的确证及应用并作为欧洲药典方法的替代方法
V Esposito,A Carocci,F Luciani et al.
V Esposito et al.
Several analytical procedures are described in the European Pharmacopoeia (Ph. Eur.) to determine total protein content. However, the method for the determination of protein content in therapeutic immunoglobulins prescribed in the Ph. Eur. ...
Informal investigation on the added value of a potential certification system for the qualification of raw materials for the production of ATMPs [0.03%]
关于潜在认证系统对先进治疗产品原料资格增益的非正式调查研究
S Le Maux,V Closson-Carella,O Kolaj-Robin et al.
S Le Maux et al.
The manufacture of advanced therapy medicinal products (ATMPs) is critically impacted by the quality of the raw materials (RMs) used. Following the need expressed by stakeholders to establish a certification scheme for biological RMs used i...