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Résultats de la recherche - 11 results
Guideline VBRN: Best Practice Guide for Electronic Platforms
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: S. Levi; VBRN Advisory group Source: EDQM, Council of Europe, Strasbourg, France, p.10 (2024) Keywords: batch release electronic platform Immunological Veterinary Me ...
Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology
equipment are common practice for today’s anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent ...
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 ...
"WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines"
Publication Type: Scientific poster, presentation or proceeding Authors: D. Lei; H. Meyer; T. Jivapaisarnpong; L. Tesolin Source: "WHO Workshop on Implementation of Guidelines for procedures ...
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.
the study (‘sliding scale Good Manufacturing Practice’), and, hence, is much more open to speedy drug development than anticipated. Recommendations included: the development of guidelines for human ...
Analysis of illegal peptide drugs via HILIC-DAD-MS.
(MS) and quantification via UV. Validation was performed via accuracy profiles based on the ISO 17025 guideline. The obtained validated HILIC-method allows for the detection and quantification of the ...
Brief update on Malaria vaccine art 58 OCABR guideline
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: Annual OMCL meeting, NA, Issue EDQM, NA (2015) Keywords: Malaria meeting ON vaccine Health Topics: Effectiveness and safety of vaccines, medicines and health prod ...
Concept paper: rationale for deletion of the O-acetyl test on meningoccocal vaccines guidelines
Publication Type: Sci. report, recommendat°, guidance doc., directive, monograph Authors: L. Tesolin; Christina von Hunolstein Source: (2020) Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laborator ...
Development and validation of a targeted LC-MS/MS quantitation method to monitor cell culture expression of tetanus neurotoxin during vaccine production
further upstream purification and detoxification. The quantitation method, validated according to ICH guidelines and by the application of the total error approach, was utilized to assess the amount of TeNT ...