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Résultats de la recherche - 12 results
Collaborative study for the establishment of the WHO 3rd international standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354
and the European Directorate for the Quality of Medicines & HealthCare (EDQM /Council of Europe) for the establishment of harmonised replacement endotoxinstandards for these 3 organisations. ...
The vaccines consistency approach project: an EPAA initiative
highly sensitive non-animal methods, the consistency approach has the potential to improve the quality of testing and to foster the 3Rs (replacement,refinement and reduction of animal use) for quality ...
Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6
collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for thecurrent European Pharmacopoeia (Ph. ...
Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3
content. Consequently, the European Directorate for the Qualityof Medicines and HealthCare (EDQM) established replacement batches for this BRP, calibrated against the 1st WHO International Standard (IS) for ...
Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV)
a collaborative study was initiated by the European Directorate for the Quality of Medicines and HealthCare (EDQM) with the goal to establish a replacement batch as a working standard. Ten laboratories took part in ...
Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines
use vaccine vaccines Validate VALIDATION VIRUS Abstract: The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of ...
Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3
for the Quality of Medicines and HealthCare (EDQM) initiated an international collaborative study for the establishment of a replacement batch. The study was run under the aegis of the Biological ...
Collaborative study for the establishment of the 2 Ph. Eur. Human Immunoglobulin for Electrophoresis BRP batch 3 3
of this BRP, the Biological Standardisation Programme Steering Committee decided to endorse a project, BSP123, in order to establish a replacement batch. The project leader forthe study was Dr. Stefan ...
Calibration of the human immunoglobulin BRPs for ACA and molecular size (batch 1) and for Fc function and molecular size (batches 1 & 2)
Abstract: The current European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation batch 3 (BRP3) for Human Immunoglobulin was established in 2005. Stocks of this BRP are dwindling and a replacement ...
Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).
(126.3-173.1) IU /ampoule. The inter-laboratory GCV was 64.3 % for guinea pig assays and 45.2 % for mouse assays.From the collaborative study, Preparation A appeared more suitable to be the replacement Ph. Eur. ...