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Résultats de la recherche - 12 results
Release of Nano-objects, their aggregates and agglomerates from Masks (RENAAME): validation of a screening method to identify Ti and Ag elements in masks
elements masks nanomaterials Abstract: The objective of the RENAAME project (Release of Nano-objects, their Aggregates and Agglomerates (NOAA) from Masks), supported for 3 years by ANSES and coordinated by ...
Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines
“Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of endotoxin in bacterial vaccines. The limulus amebocyte lysate (LAL) and the recombinant factor C (rFC) ...
Determination of vaccine bacterial endotoxins content by the rFC method
factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...
Panel discussion official forum Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release procedures
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Taiwan FDA to share/discuss about COVID-19 vaccine testing, medicines quality issues, and batch release ...
Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines
Virtual (2021) Keywords: 3R Vaccine Potency Abstract: Routine batch quality testing before vaccine release, notably for potency evaluation, still relies on animal use for several animal and human vaccines. ...
Testing of expired Synflorix bulks: actions taken by three OMCLs and concerns raised by another OMCL.
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Annual OMCL meeting, EDQM, Issue EDQM, Brussels, Belgium (2015) Keywords: batch release meeting TESTING ...
Technical guide on metals and alloys: discussion of draft technical document 3
on metals and alloys: discussion of draft technical document 3 on release testing and comments received. Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of ...
Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume
study case-study compliance meeting Release testing study TESTING Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Efficacité et sécurité des vaccins, ...
Technical guide on metals and alloys: draft technical document 4 on release testing
discussion of draft technical document 4 on release testing and comments received Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité ...
Technical guide on metals and alloys
discussion of draft technical document 4 on release testing and comments received : Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories ...