Zoekresultaten - 58 results
Release of silver and titanium from face masks traded for the general population.
consumers. Direct measurement of release of Ag and TiO particles during normal wearing is problematic by the lack of methodology to test release and to quantify inhaled particles. Therefore in this study, we ...
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 ...
Regulatory expectations on the use of vaccine reference standards for maintaining product quality.
clinical batches that were shown to be safe and efficacious. In any case, when standards are being qualified, the set of release tests should be accompanied by a set of additional characterization assays. ...
Development of a multiplex-based immunoassay for the characterization of diphtheria, tetanus and acellular pertussis antigens in human combined DTaP vaccines.
Vaccines Diphtheria-Tetanus-Pertussis Vaccine Humans Hydrogen Peroxide Immunization, Secondary Immunoassay Reproducibility of Results Tetanus Whooping Cough Abstract: Routine batch quality testing before ...
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 ...
Meer alternatieven voor dierenproeven
Dierenwelzijn, Press release (2022) URL: https://www.benweyts.be/nieuws/meer-alternatieven-voor-dierenproeven?pq=nieuws&page=0#views-row-2 Keywords: 3Rs alternative methods to animal testing new approach ...
Flanders and Brussels join forces to tackle animal testing
://www.brusselstimes.com/belgium-all-news/201812/flanders-and-brussels-combine-forces-to-tackle-animal-testing (2022) URL: https://www.brusselstimes.com/belgium-all-news/201812/flanders-and-brussels-combine-forces-to-tackle-animal-testing ...
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. ...