Search results - 15 results
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.
should meet all requirements regarding safety and efficacy before its release to the market. The use of (international) reference standards or reference preparations plays a key role in assay validation ...
Development of strain-level shotgun metagenomics approaches to detect and characterize microbiological contaminants in the context of food safety
microbiological foodborne contaminants to the strain level and with achievement of a relatedness study (phylogeny), with a focus on the applicability of the method in order to be easily implemented in reference ...
Report on the collaborative study for the standardization of D-Ag potency assays for inactivated polio vaccines made with Sabin live-attenuated poliovirus strains
Keywords: biological reference preparation collaborative study D antigen European Pharmacopoeia in vitro assay poliomyelitis vaccine (inactivated) Health Topics: Infantile paralysis Kinderverlamming ...
European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated)
Bio&SN, Issue December, Number 149, Strasbourg, France, p.16 (2016) Accession Number: NA Keywords: poliomyelitis vaccine (inactivated); D antigen; biological reference preparation; European Pharmacopoeia; ...
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
(2nd) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability ofthe candidate preparations to act as the reference standard in assays for endotoxin performed according to ...
Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6
Eur.) prekallikrein activator (PKA) in albumin biological reference preparation (BRP), whose stocks were dwindling. The study was run in the frameworkof the Biological Standardisation Programme (BSP) of ...
Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3
Eur.) Biological Reference Preparation (BRP) is used for the in vitro potency assay of HAV as prescribed by the Ph. Eur. general chapter 2.7.14 Assay of hepatitis A vaccine. This reference preparation was ...
Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV)
for the quality control (QC) of polio vaccines. Stocks of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 for the assay of OPV are dwindling and therefore ...
Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3
to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human immunoglobulin for electrophoresis, in 2013, the European Directorate ...
Collaborative study for the establishment of the 2 Ph. Eur. Human Immunoglobulin for Electrophoresis BRP batch 3 3
programme Project Quality routine study TESTING use Users Abstract: The current European Pharmacopoeia (Ph. Eur.) Human immunoglobulin for electrophoresis Biological Reference Preparation (BRP) batch 2 was ...