Résultats de la recherche - 70 results
Physicochemical characterization and genotoxicity assessment of nanomaterials using new approach methodologies
studies, thereby avoiding the need for conducting additional in vivo studies. Although many NAM s are available, experience in using them to support risk assessment is scarce and the majority of the NAM ...
Animal use reporting: 2019-2023
https://connect.edqm.eu/accounts/login/?next=/home/ Keywords: in-vivo TESTING vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des vaccins et produits sanguins Kwaliteit van ...
Assessment of receptor-mediated activity (AhR and ERα), mutagenicity, and teratogenicity of metal shredder wastes in Wallonia, Belgium.
the bacterial reverse gene mutation test using the Salmonella typhimurium TA98 and TA100 strains. Except for the sludge sample (site 3), all samples induced a mutagenic response in the TA98 strain (± ...
Impact of environmental nitrogen enrichment on birch pollen allergy
representing the nitrogen gradient, was used to determine their allergenicity in pollen-allergic adult patients (n = 60 in total) using ex vivo basophil activation testing (BAT) and specific IgE (sIgE) ...
Animal use reporting: 2019-2022
Extranet, Issue EDQM, Ohrid, North Macedonia (2024) URL: https://connect.edqm.eu/accounts/login/?next=/home/ Keywords: in-vivo TESTING vaccine Health Topics: Vaccine batch conformity Vaccin lot conformiteit ...
Annual use reporting: overview 2019-2022
France (2024) URL: https://connect.edqm.eu/accounts/login/?next=/home/ Keywords: in-vivo TESTING vaccine Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of ...
Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.
to play a key role in a control strategy no longer including an in vivo potency test. The mAb ELISA is highly specific, has good dilutional linearity, and is suitable for detecting DT xd in a range of ...
Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.
Issue 1, Number 377 (2023) Abstract: INTRODUCTION: There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal ...
In vitro and in vivo local tolerability of a synergistic anti-tuberculosis drug combination intended for pulmonary delivery.
Vancomycin Abstract: A drug combination, vancomycin (VAN) plus tetrahydrolipstatin (THL), has demonstrated an effective synergistic action in vitro against Mycobacterium tuberculosis (Mtb). The poor oral ...
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision
Publication Type: Peer reviewed scientific article Authors: L. Tesolin; J.-F. Dierick; Wim Van Molle Source: Open Research Europe (2022) Keywords: human vaccines in vitro testing in vivo testing ...