Résultats de la recherche - 101 results
Reorientation of scope of OMCL API Working Group- Change of focus of future MSS and MSSFP studies
Publication Type: Scientific poster, presentation or proceeding Authors: Eric Deconinck; Jelena Acevska Source: AdGEON meeting December 2023, EDQM, Issue EDQM, Online (2023) Keywords: API-testing Chemometrics fingerprint studies Abstract: NA Health Topics ...
OCABR: Respiratory Syncytial Virus (rDNA) Vaccine
p.15 (2023) Accession Number: PA/PH/OMCL (23) 3 DEF Keywords: EDQM guideline OCABR RSV Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Service: Qualité des ...
Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines
3R (2023) Keywords: Endotoxin " vaccine " quality control " recombinant factor c " LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following ...
Determination of vaccine bacterial endotoxins content by the rFC method
Publication Type: Scientific poster, presentation or proceeding Authors: Flore Laurent Source: NA, OMCL annual meeting Madrid 2023 (2023) Keywords: Endotoxin; vaccine; quality control; recombinant ...
Phase 2 testing: where are we now?
Publication Type: Scientific poster, presentation or proceeding Authors: M. Bruysters; L. Tesolin; J. Lange Source: OMCL Annual Meeting EDQM 2023, EDQM, Madrid, SPain (2023) Keywords: bulk phase ...
aP serology change from RP to GMU for Hexaxim and Tetravac
Publication Type: Scientific poster, presentation or proceeding Authors: J. Auquier Source: Annual OMCL meeting 2023, EDQM, Madrid (2023) Keywords: Pertussis Vaccine serology Health Topics: Vaccin ...
Replacement of Diphtheria and Tetanus potency challenge method by serology in mice
Publication Type: Scientific poster, presentation or proceeding Authors: J. Auquier Source: Annual OMCL Meeting 2023, EDQM, Madrid (2023) Keywords: 3R Diphtheria serology Tetanus vaccine Health ...
The Role of EDQM and OMCLs
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Responsable des affaires réglementaires, Issue Culture in vivo ASBL (2023) Health Topics: Effectiveness and safety of vaccines, medicines and health products- ...
Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection
fingerprint GEON/OMCL network illegal medicinal products Tadalafil Abstract: This paper reports the results of the active pharmaceutical ingredient (API) fingerprint study, organised by the General European ...
The batch release procedure in Europe
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Seminaire etudiants en pharmacie ULB, ULB, Brussels, Belgium (2022) Keywords: batch release Europe OMCL ...