Collaborative study for the calibration of Ph. Eur. Heparin Sodium Biological Reference Preparation batch 4 [0.03%]
欧洲药典硫酸肝素生物参考准备品第四批的协作标定研究
V Lièvre,N Goujon,D Le Tallec et al.
V Lièvre et al.
An international collaborative study was organised under the aegis of the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union to calibrate a replacement batch for the European Pharmacopoeia (Ph. Eur.) ...
Proposal for a standardised method for the identification of essential oils by HPTLC [0.03%]
通过HPTLC识别精油的标准化方法的提案
T K T Do,I Trettin,R De Vaumas et al.
T K T Do et al.
The European Pharmacopoeia (Ph. Eur.), includes both individual monographs on essential oils and a general monograph that covers all essential oils for pharmaceutical use, whether covered by an individual monograph or not. The individual mo...
Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens - Part 2: Optimisation of cell line assays [0.03%]
破伤风疫苗抗原生产过程中的毒力及抗原性检定细胞实验验证国际合作计划（第二部分）：细胞实验之优化
M-E Behr-Gross,B Siklodi,D Le Tallec et al.
M-E Behr-Gross et al.
During the production of clostridial vaccines large numbers of mice are used for various in-process control tests. Replacement in vitro assays had been developed for the testing of the toxins and toxoids of several clostridial species, but ...
Calibration of the Ph. Eur. human coagulation Factor VIII Concentrate BRP batch 6 [0.03%]
人凝血因子VIII标示液BRP批次6 calibration
S Raut,D Le Tallec,A Costanzo
S Raut
The European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human coagulation Factor VIII (FVIII) Concentrate is used as working standard for potency determination of human coagulation FVIII preparations by chromogenic ...
Establishment of Pertussis toxin BRP batch 2 for CHO clustering assay [0.03%]
用于CHO聚群实验的百日咳毒素BRP第二批次建立
M Wall,A Costanzo,D Le Tallec et al.
M Wall et al.
Recently, the Chinese hamster ovary (CHO) cell-based clustering assay replaced the in vivo Histamine Sensitisation Test (HIST) in mice in European Pharmacopoeia (Ph. Eur.) general chapter 2.6.33. ‘Residual pertussis toxin’ as the recommen...
Calibration of the WHO 5th IS for Blood Coagulation Factor IX, Concentrate and Ph. Eur. Human Coagulation Factor IX Concentrate Biological Reference Preparation Batch 3 and investigation of the suitability of an IS as potency standard for purified full-length recombinant FIX [0.03%]
世界卫生组织第5号IX因子标准品和欧洲药典人凝血酶原复合物中FIX生物参考制品批3的定值及其作为全长重组FIX制品含量标准适用性的研究
E Gray,J Hogwood,T Dougall et al.
E Gray et al.
A joint World Health Organization (WHO) - European Directorate for the Quality of Medicines & HealthCare (EDQM) study was run to calibrate the WHO 5th International Standard (IS) for Blood Coagulation Factor IX (FIX), Concentrate, and Europ...
An alternative and simplified approach to identification and test for minimum content of TCM herbal drugs [0.03%]
中药饮片最小均剂识别与检定的替代简易方法研究
D A Frommenwiler,C Sabatini-Samori,R Scherübl et al.
D A Frommenwiler et al.
Following a decision of the European Pharmacopoeia (Ph. Eur.) Commission, the Traditional Chinese Medicines (TCM) Working Party started a pilot phase to examine the suitability of a high-performance thin-layer chromatography (HPTLC) minimum...
Collaborative study for the establishment of Etanercept Biological Reference Preparation Batch 1 [0.03%]
依那西普生物参比制剂第一批次的合作研究
M Wadhwa,P Rigsby,M-E Behr-Gross
M Wadhwa
Three preparations of the human tumour necrosis factor (TNF) receptor II Fc fusion protein (TNFR II-Fc) Etanercept were formulated and lyophilised at the National Institute for Biological Standards & Control (NIBSC) prior to evaluation in a...
Establishment of Ph. Eur. Bordetella pertussis mouse antiserum Biological Reference Preparation batches 2, 3 and 4 [0.03%]
欧洲药典百日咳博德特氏菌小鼠抗血清生物参考物质2、3和4批标准品的建立
S Morgeaux,P Chagnaud,P Variot et al.
S Morgeaux et al.
A project aimed at establishing replacement batches for the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) Bordetella (B.) pertussis mouse antiserum was started in 2013 under the aegis of the Biological Standardisa...
Production and characterisation of a candidate hyper-immune serum for the replacement of the Bordetella pertussis mouse antiserum Biological Reference Preparation [0.03%]
用于替代鲍氏奥密克鼠抗血清生物参考物质的超免疫血清候选物的生产和特征分析
S Morgeaux,N Bornstein,C Mourton-Gilles et al.
S Morgeaux et al.
For acellular pertussis (aP) vaccines, the current European Pharmacopoeia (Ph. Eur.) monograph Pertussis vaccine (acellular, component, adsorbed) (1356) requires an immunogenicity assay in mice or guinea pigs to assess the potency of each l...