Findings on the heavy metal content in herbal drugs and essential oils - an update [0.03%]
药用植物和精油中重金属含量的研究进展
H Albert,B Klier,M Knödler et al.
H Albert et al.
In this contribution, data for 7 elemental impurities originating from quality control analysis of manufacturers of herbal products is evaluated in light of the current requirements of the European Pharmacopoeia (Ph. Eur.) and the European ...
Collaborative study for the establishment of human immunoglobulin BRP replacement batches [0.03%]
人免疫球蛋白BRP替代批协作研究
D Karra,E Regourd,A Costanzo
D Karra
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...
Replacement, Reduction, Refinement - Animal welfare progress in European Pharmacopoeia monographs: activities of the European Pharmacopoeia Commission from 2007 to 2017 [0.03%]
活体替代、减少和优化——2007至2017年欧洲药典委员会在欧洲药典通则中的动物福利进展
C Lang,O Kolaj-Robin,G Cirefice et al.
C Lang et al.
Since the opening for signature of the European Convention for the Protection of Animals Used for Experimental and Other Scientific Purposes in 1986, the European Pharmacopoeia Commission and its experts have carried out a programme of work...
Establishment of detection antibodies BRRs batch 4 for in vitro potency assay of hepatitis A vaccines by ELISA [0.03%]
用于体外检测甲肝疫苗效力的第4批BRRs检测抗体的确立实验
S Morgeaux,A Koy,I Manniam et al.
S Morgeaux et al.
The European Pharmacopoeia (Ph. Eur.) standard ELISA method for determination of antigen content of hepatitis A vaccines (HAV) requires specific coating and detection Biological Reference Reagents (BRRs). The 3rd batch of detection antibodi...
Assessment of UV spectrophotometry for determination of plasmid DNA concentration in vector preparations for human gene therapy products [0.03%]
紫外分光光度法测定人基因治疗产品质粒DNA浓度的评估研究
X Chenivesse,B Anliker,A Daas et al.
X Chenivesse et al.
The European Pharmacopoeia (Ph. Eur.) general chapter 5.14. Gene transfer medicinal products for human use suggests the use of absorbance measurements at 260 nm to determine the DNA concentration of plasmid vectors used for the preparation ...
Multicenter Study
Pharmeuropa bio & scientific notes. 2017:2017:88-112. DOI: 2017
Validation of ELISA methods for quantification of the major birch allergen Bet v 1 (BSP090) [0.03%]
用于量化主要杨树过敏原Bet v 1（BSP090）的酶联免疫吸附试验方法的验证
S Kaul,J Zimmer,O Dehus et al.
S Kaul et al.
To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers w...
Multicenter Study
Pharmeuropa bio & scientific notes. 2017:2017:69-87. DOI: 2017
Establishment of the Ph. Eur. Hepatitis A virus RNA for NAT testing BRP batch 1 [0.03%]
建立欧洲药典乙肝病毒RNA（HBV DNA）主序批BRP Batch 1 标准品
M Chudy,C M Nübling,J Blümel et al.
M Chudy et al.
Detection of viral contamination in plasma donations is critical to prevent transmission of infectious diseases. The European Pharmacopoeia (Ph. Eur.) monograph 1646 'Human plasma (pooled and treated for virus inactivation)', requires that ...
Multicenter Study
Pharmeuropa bio & scientific notes. 2017:2017:29-43. DOI: 2017
Collaborative study on saccharide quantification of the Haemophilus influenzae type b component in liquid vaccine presentations [0.03%]
b型流感嗜血杆菌结合疫苗糖含量测定联合研究
U Rosskopf,A Daas,E Terao et al.
U Rosskopf et al.
Before release onto the market, it must be demonstrated that the total and free polysaccharide (poly ribosyl-ribitol-phosphate, PRP) content of Haemophilus influenzae type b (Hib) vaccine complies with requirements. However, manufacturers u...
Multicenter Study
Pharmeuropa bio & scientific notes. 2017:2017:44-68. DOI: 2017
In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical? [0.03%]
寻找小鼠组胺敏感性试验(HIST)可接受的替代方法：哪些是可行和实际的？
L Wagner,R Isbrucker,C Locht et al.
L Wagner et al.
The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test (HIST): What is Possible and Practical?...
European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated): collaborative study for the establishment of batch No. 3 [0.03%]
用于灭活脊髓灰质炎疫苗的欧洲药典生物参考品：第3批的确立协作试验
J Martin,A Daas,C Milne
J Martin
Inactivated poliomyelitis vaccines are an important part of the World Health Organization (WHO) control strategy to eradicate poliomyelitis. Requirements for the quality control of poliomyelitis vaccines (inactivated) include the use of an ...