Zoekresultaten - 9 results

Ethical approval for controlled human infectious model clinical trial protocols- A workshop report.

requirements are met, assurance that participants are well-informed, and that preparation of study documents must be both ethically and scientifically sound from an early stage. Study applications must clearly ...

Development of a monoclonal antibody sandwich ELISA for the determination of antigen content and quality in diphtheria vaccines.

different human vaccine products. We demonstrate the ability of the assay to discriminate between batches of different content and quality using vaccine batches that were prepared to contain differing amounts ...

Identification and characterization of inorganic food additives and pearlescent pigments in sprays for food decoration by STEM-EDX

the properties of the particles consumers are exposed to. Samples were prepared by spraying 5mL in a glass vial and coated on EM-grids using the grid-on-drop method. Scanning transmission electron ...

Development, validation, and application of a multimatrix UHPLC-MS/MS method for quantification of Datura-type alkaloids in food

spectrometry (UHPLC- MS / MS) method was developed and validated for the determination of tropane alkaloids (TA s), atropine and scopolamine, in a variety of food products. The sample preparation of cereal-based ...

Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology

a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and additionally to prepare the laboratories for the EU  —  IVD revised regulations (IVDR). This paper ...

The Development and Validation of a Targeted LC-HRAM-MS/MS Methodology to Separate and Quantify p-Synephrine and m-Synephrine in Dietary Supplements and Herbal Preparations

Publication Type: Peer reviewed scientific article Authors: Vanhee, Celine; Barhdadi, Sophia; Kamugisha, Angélique; Van Mulders, Tanika; Vanbrusselen, Kevin; Willocx, Marie; Eric Deconinck Source: Separations, Volume 10, Issue 8 (2023) Health Topics:  Hea ...

Regulatory expectations on the use of vaccine reference standards for maintaining product quality.

should meet all requirements regarding safety and efficacy before its release to the market. The use of (international) reference standards or reference preparations plays a key role in assay validation ...

COVID-19 pandemic response in the Meuse-Rhine Euroregion: methods, participation and recommendations of a longitudinal cross-border study

a centralized online environment, mapping out potential challenges related to national regulations in the preparation phase and organizing regional coordination centres to create more familiarity and trust ...

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