Search results - 373 results
The strategic change of the API fingerprint programme: from verification of authenticity of API sources to identifying potential quality issues
North-Macedonia (2024) Keywords: API GEON Quality Control Abstract: Since its creation the API-surveillance programme, performed under the hospices of the API-working group, focused a lot on the authenticity of API ...
Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities.
quality in the past decades, the types and uses of standards have expanded with technological advances in manufacture and testing of vaccines. The needs of stakeholders are evolving in response to the ...
Quality indicators for infection prevention and control in Belgian acute hospitals- Supplement report 2023
Number: D/2024.14.440/24 URL: https://www.sciensano.be/en/projects/quality-indicators-infection-prevention-and-control-acute-hospitals Keywords: infection prevention and control IPC programme quality of ...
Quality indicators for infection prevention and control in acute care hospitals- Report 2023- Data up to and including 2022
Number: D/2024.14.440/24 Keywords: Antimicrobial resistance Belgian Acute Hospitals healthcare associated infections infection prevention and control IPC IPC programme quality indicators quality of care ...
Clinical performance of the novel full-genotyping OncoPredict HPV Quantitative Typing assay using the VALGENT framework.
multiplex real-time PCR quantitative assay targeting E6 / E7 genes, allowing individual viral load determination of 12 high-risk (HR) HPV types. Quality controls for sample adequacy, efficiency of nucleic ...
Ethical approval for controlled human infectious model clinical trial protocols- A workshop report.
Shobana; Neels, Pieter Source: Biologicals, Volume 85 (2024) Keywords: Drug Development Healthy Volunteers Humans Research Design Abstract: Controlled Human Infectious Model studies (CHIM) involve ...
Regulatory workshop on challenge strain development and GMP manufacture- A stakeholder meeting report.
challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 ...
Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.
able to serve as a reference antigen for local standardization of the method. The assay is ideally suited for incorporation into a consistency approach for routine diphtheria vaccine quality control ...
Assessment of the clinical and analytical performance of three Seegene Allplex SARS-CoV-2 assays within the VALCOR framework.
Cocuzza, Clementina E; Steven Van Gucht; Marc Van Ranst; M. Arbyn Source: Microbiol Spectr (2024) Keywords: Allplex COVID-19 diagnostics test accuracy Quality Control reference materials RT-PCR SARS-CoV-2 ...
Substandard and falsified ivermectin tablets obtained for self-medication during the COVID-19 pandemic as a source of potential harm.
self-administration of substandard or falsified (SF) medicines bearing harmful quality deficiencies have contributed to this phenomenon. In order to have a better view on the nature of these harmful quality ...