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Résultats de la recherche - 9 results

Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium

quantification of active pharmaceutical ingredients (API s) potentially present in these suspicious SF antimicrobials, are paramount. Here, a validated ultra-high performance liquid chromatography-tandem mass ...

Listeria surveillance in Belgium

strains are voluntarily sent to the National Reference Center (NRC). Identity confirmation is performed using biochemical assays and serotyping by slide agglutination. Since 2018, according to recent ...

Comparative dissolution study on substandard and falsified antibiotics encountered in Belgium

parameters of drug quality control [2]. In this context, SF antimicrobials containing the correct dosage of claimed API s can exhibit poor dissolution performance. Thus, it is necessary and crucial to execute ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.

transfer of the analytical methods for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed by the OMCL, this is finally decided by EDQM and depends whether or not ...

The occurrence and formation of benzene in foodstuffs

dietary exposure for the adult Belgium population was performed. In addition, since several reactions in foods may give rise to the generation of hydroxyl radicals, their potential to decarboxylate benzoate ...

Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).

tests already performed by the manufacturer need to be repeated by an OMCL (Official Medicines Control Laboratory) before a release certificate for this specific batch can be granted. In general, testing ...

A new statistical method for evaluating long term analytical performance of laboratories, applied to an external quality assessmetn scheme for flow cytometry

D/2010/2505/52 Keywords: an Evaluating external Flow Cytometry Laboratories method performance Quality report Statistical Term Service:  Quality of laboratories Kwaliteit van laboratoria Qualité des laboratoires ...

An Alternative Method Validation Strategy for the European Decision 2002/657/EC

ISO 11843 standards are used to set up an experimental validation plan that minimizes the number of samples without increasing the uncertainty of the performance characteristics. At each level (0.5, ...

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.

for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed by the OMCL, this is finally decided by EDQM and depends whether or not an OCABR guideline for the type ...

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