Search results - 10 results

Pyrogen testing of phage therapeutic products

is pivotal to limit the risk of non-endotoxin contamination. These pyrogens can be detected by the monocyte activation test (MAT), which employs human blood cells to quantify pyrogenicity in vitro. In ...

A roadmap for regulatory implementation of in vitro models for evaluation of vaccine efficacy

Publication Type: Scientific poster, presentation or proceeding Authors: R. J. Vandebriel; L. Tesolin; K. Veenstra; K. Huber Source: EVI, Niagara falls, Canada (2023) Keywords: in vitro model ...

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 ...

Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme.

divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS /17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this ...

Identification of flavouring substances of genotoxic concern present in e-cigarette refills

transhexanal, there was a clear concern for in vivo genotoxicity. A selection of 4 out of the remaining 22 flavourings was tested in two in vitro genotoxicity assays. Three out of the four tested flavourings ...

Chemical and toxciological characterization of e-liquid cigarettes

information on their genotoxicity was present. For four of these flavourings, a commercial standard was available and thus could be tested in vitro using an Ames- and micronucleus test. One of the four ...

Optimalisatie van in vitro assays voor het bepalen van de pyrogeniciteit en het hemolytisch potentieel van illegale peptidepreparaten

Publication Type: Dissertation Authors: De Pauw, Elisa Source: UGent, Gent, België, p.59 (2017) Accession Number: NA Keywords: hemolytisch potentieel illegale peptidepreparaten in vitro assays ...

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 ...

In vitro screening of South African and Tunisian medicinal plant extracts for genotoxicity and anti-genotoxicity against Aflatoxin B1

Publication Type: Dissertation Authors: Djalat, A. Source: UA, Antwerp, Belgium, p.53 (2016) Accession Number: NA Keywords: aflatoxin B1 antigenotoxicity genotoxicity plant Plant Extracts SCREENING Health Topics:  Effectiveness and safety of vaccines, med ...

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