Zoekresultaten - 8 results

Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines

3R (2023) Keywords: Endotoxin " vaccine " quality control " recombinant factor c " LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following ...

Determination of vaccine bacterial endotoxins content by the rFC method

factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...

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

responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the ...

Development of a Stationary Phase Optimised Selectivity Liquid Chromatography based screening method for adulterations of food supplements for the treatment of pain.

the screening to be performed with diode array detection and is fully compatible with mass spectrometry. The method was validated for its selectivity following the guidelines as described for the ...

Evaluation of the residual solvent content of counterfeit tablets and capsules.

Keywords: Capsules Carbolines Counterfeit Drugs Gas Chromatography-Mass Spectrometry Guidelines as Topic Phosphodiesterase 5 Inhibitors Piperazines Purines Sildenafil Citrate Solvents Sulfones Tablets ...

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