Search results - 13 results
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 ...
Guideline for Pandemic COVID-19 Vaccine (mRNA)
https://www.edqm.eu/en/ocabr-activities-related-covid-19-vaccines#guidelines File: Version: Published Full text access: Public Access Full text language: English Category: E42 FOS Classification: 3.04 Medical biotechnology ...
Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored vaccine)
Kwaliteit van vaccins en bloedproducten Quality of vaccines and blood products Manuscript versions: DOI: https://www.edqm.eu/en/ocabr-activities-related-covid-19-vaccines#guidelines File: Version: ...
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 ...
Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein)
https://www.edqm.eu/en/ocabr-activities-related-covid-19-vaccines#guidelines File: Version: Published Full text access: Public Access Full text language: English Category: E42 FOS Classification: 3.04 Medical biotechnology ...