Résultats de la recherche - 23 results
EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects
submitted to a thorough physicochemical characterisation. A battery of in vitro tests was used to provide insight into NC hazard and mode of action according to a tiered approach, which lead to selection of ...
Praktijkrichtlijn voor het opzetten van een kwaliteitssysteem in de erkende laboratoria voor pathologische anatomie werkzaam binnen het kader van het Erkenningsbesluit
2017/746 van 5 april 2017 betreffende de medische hulpmiddelen voor In-Vitro Diagnostiek (IVDR). Volgens de IVDR (van toepassing met ingang op 26 mei 2022) mogen in de laboratoria alleen nog CE gelabelde IVD ...
Directive Pratique pour la mise en place d'un système qualité dans les laboratoires d'anatomie pathologique agréés dans le cadre de l'Arrêté d'agrément
le contexte de la réglementation européenne de 2017/746 du 5 avril 2017 sur les dispositifs médicaux de diagnostic in vitro (IVDR). Selon cette réglementation IVDR qui entrera en vigueur le 26 Mai ...
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)
collaborative study; in vitro assay Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits ...
The vaccines consistency approach project: an EPAA initiative
for release testing of established vaccines promotes the use of in vitro, analytical, non-animal based systems allowing the monitoring of quality parameters duringthe whole production process. By using ...
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 ...
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 ...
In vitro onderzoek naaar het genotoxisch potentieel van enkele Zuid-Afrikaanse traditionele medicinale plantenextracten en commerciële preparaten
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: B Gorissen Source: Universiteit Antwerpen, Antwerpen, p.60 (2012) Keywords: cytoomtest genotoxiciteit Hypoxis medicinale planten neutraal rood opname Category: E1 ...
In vitro studies:ELF and Alzheimer's disease
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: Luc Verschaeve; Annemarie Maes; R. Anthonissen; Moukhliss,H. Source: WIV-ISP, Brussels, p.98 (2012) Keywords: Alzheimer disease Category: E1 ...