Zoekresultaten - 21 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 ...
Evaluation of a point-of-care test for the diagnosis of Taenia solium neurocysticercosis in rural southern Tanzania: a diagnostic accuracy study.
positive for cysticercosis on the TS POC test and every tenth patient who was negative for cysticercosis received a brain CT examination and underwent reference testing for T solium cysticercosis (ie, rT24H- ...
Biological reference standards for multivalent vaccines: qualification strategies and challenges from a national control lab perspective
reference qualification reference vaccine Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments ...
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, ...
Use of Whole Genome Sequencing Data for a First in Silico Specificity Evaluation of the RT-qPCR Assays Used for SARS-CoV-2 Detection.
human reference genome and 2624 closely related other respiratory viral genomes. The specificity of the assays was generally good and stable over time. An exception is the first method developed by the ...
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.
challenge agents; a focus on strain selection, in particular with regard to strain infectivity, stability and purity; the use of whole genome sequencing; a reference repository of challenge agents, the need ...
Chromatographic fingerprinting as a strategy to identify regulated plants in illegal herbal supplements.
Tribulus terrestris. The full factorial design demonstrated that for all three plant references a C8 column (250mm×4.6mm; 5µm particle size) is best suited; methanol and an ammonium formate buffer (pH 3) ...
European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated)
Bio&SN, Issue December, Number 149, Strasbourg, France, p.16 (2016) Accession Number: NA Keywords: poliomyelitis vaccine (inactivated); D antigen; biological reference preparation; European Pharmacopoeia; ...
Ensuring batch continuity of non-compendial reference & standard materials from biological origin
Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin; C. Domicent; M. Lejeune Source: OMCL Annual Meeting 2016, NA, Issue European Directorate for the Quality of Medicines & HealthCare (EDQM),Council of Europe, NA (2016) ...
Detection and risk evaluation of counterfeit medicines based on physico-chemical properties: the fingerprint and chemometrics approach
commonly referred to as ‘life style drugs’ and comprise PDE-5 Inhibitors for the treatment of erectile dysfunction and weight loss products. High amounts of counterfeit pharmaceuticals enter the European ...