Search results - 49 results

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 analysis of cannabinoids in e-cigarette liquids using LC-HRAM-MS and LC-UV.

of several minor alkaloids in comparison to the “classic” CBD e-liquids where the acidic forms of the cannabinoids were not present. Currently, no legislation is available for the regulation of CBD ...

The analysis of cannabinoids in e-cigarette liquids using LC-HRAM-MS and LC-UV

in comparison to the “classic” CBD e-liquids where the acidic forms of the cannabinoids were not present. Currently, no legislation is available for the regulation of CBD e-liquids, however these ...

Regulation of Clostridium tetani Neurotoxin Expression by Culture Conditions

Publication Type: Peer reviewed scientific article Authors: Jeroen L A Pennings; Eric Abachin; Raphael Esson; Hennie Hodemaekers; Antoine Francotte; Jean-Baptiste Claude; Celine Vanhee; Sylvie Uhlrich; Rob J. Vandebriel Source: Toxins, Volume 14, Issue 1 ...

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.

for early exchange with regulators to ensure acceptability of strain selection and manufacturing for later drug development; sharing of models and challenge agents. Health Topics:  Effectiveness and ...

Chemometrics and chromatographic fingerprints to classify plant food supplements according to the content of regulated plants.

regulated or toxic plants is an important issue, especially when the products are purchased from irregular sources. This paper focusses on this problem by using specific chromatographic fingerprints for five ...

Detection of regulated herbs and plants in plant food supplements and traditional medicines using infrared spectroscopy.

identification of a specific toxic or regulated plant in herbal preparations or plant food supplements is a real challenge, since they are often powdered, mixed with other herbal or synthetic powders and ...

The use of Stationary Phase Optimized Selectivity Liquid Chromatography for the development of herbal fingerprints to detect targeted plants in plant food supplements.

control is performed and that they could contain herbs or plants that are regulated. Stationary Phase Optimized Selectivity Liquid Chromatography (SOS- LC) was evaluated for the development of specific ...

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).

for drug developers and regulators were presented. These methods are described in the present report: they include five advanced methods for data analysis (empirical regression models, pharmacometrics ...

Commentary on the MID3 Good Practices Paper.

regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group ...

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