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"WHO Workshop on Implementation of Guidelines for procedures and data requirements for changes to approved vaccines"
and data requirements for changes to approved vaccines", WHO, Mascate, Oman sultanate (2022) Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...
Praktijkrichtlijn voor het opzetten van een kwaliteitssysteem in de erkende laboratoria voor pathologische anatomie werkzaam binnen het kader van het Erkenningsbesluit
te lichten. De huidige revisie van de Praktijkrichtlijn werd geïnspireerd door: De norm NBN EN ISO 15189:2012 ‘Medical laboratories – Requirements for quality and competence’ De Praktijkrichtlijn voor het ...
Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.
exposure studies need to be safe and results should be meaningful, e.g. contribute to a better cure. Both in the US and in Europe, the level of Good Manufacturing Practice required is related to the phase of ...
Scientific & organizing committee and Chair
Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Focus on Quality Requirements for Challenge Agents, Issue IABS (2019) Health Topics: Effectiveness and ...
Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market.
”total error” approach in accordance with the validation requirements of ISO-17025 was employed for the validation. 57 real-life illegal samples, seized by inspectors from the Belgium Federal Agency for ...
Development and validation of chromatographic methods for screening and subsequent quantification of suspected illegal antimicrobial drugs encountered on the Belgian market
resulted in a validation set of 11 antimicrobials and 1 beta-lactamase inhibitor. The ”total error” approach in accordance with the validation requirements of ISO-17025 was employed for the validation. 57 ...
Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills
genotoxic potential. Data for the remaining components was missing or ambiguous and hence additional toxicological data is required in order to be able to exclude genotoxic potential. The above findings ...
Analysis of illegal peptide drugs via HILIC-DAD-MS.
been developed to detect and quantify these peptides. The emerging of more polar peptides however requires the introduction of other separation techniques. Therefore, we set out to develop and validate ...
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).
issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by regulatory institutions. In an effort to shift the ...
Characterization of suspected dermal fillers containing hyaluronic acid
identity confirmation and quantification with the carbazole micro-assay. The method was successfully validated using the “total error” approach in accordance with the validation requirements of ISO-17025. ...