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Microbial quality analysis of falsified medicines seized by controling agencies
good manufacturing practices (GMP). The potential health risks associated with consuming such compromised medications range from toxic impurities to contamination with pathogenic microorganisms. In this ...
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 ...
Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening.
Keywords: Confidence Intervals DNA, Viral Early Detection of Cancer Female Genotyping Techniques Human Papillomavirus DNA Tests Humans Mass Screening Papillomaviridae Papillomavirus Infections Practice ...
Chemometrical analysis of fingerprints for the detection of counterfeit and falsified medicines
Keywords: aims an analysi analysis AS at Chemometrics Control Counterfeit Counterfeit medicines data detection health Literature Medicine Multivariate ON Practice PRACTICES public public health Public-health ...
Commentary on the MID3 Good Practices Paper.
(MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA ...
Pre-registration efficacy study of a novel marker vaccine against classical swine fever on maternally derived antibody positive (MDA+) target animals.
intramuscularly (n = 15) with a single dose of vaccine candidate produced under Good Laboratory Practice (GLP) conditions. The ten remaining piglets were allocated into the untreated control group. All 40 piglets ...
First Belgian national EQA for special stains in histopathology
score.Eighty-eight laboratories participated in the 2015 survey of which 80% achieved an excellent overall score. In2014, the percentage of participants that achieved a satisfactory mark (optimal or good) for slide ...
Bio-incident notification as a tool to enhance biosafety
compliance conference Context conventional data developing duration European EVALUATION evidence evidence based evidence-based Gain good laboratory practice health incident INFECTION infections Infectious ...
Pre-registration efficacy study of a novel marker vaccine against classical swine fever on Maternally Derived Antibody negative (MDA-) target animals.
candidate CP7_E2alf produced under Good Laboratory Practice (GLP) conditions by Pfizer was tested on 40 six-week-old MDA-piglets according to the European Pharmacopoeia (Ph.Eur.) requirements. Single doses of ...
Towards licensing of CP7_E2alf as marker vaccine against classical swine fever-Duration of immunity.
either orally or intramuscularly vaccinated with a single dose of CP7_E2alf vaccine produced under Good Laboratory Practice (GLP) conditions. Ten additional pigs were included as controls. Six months ...