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QC as a basis for human application of phage therapy in Belgium
phage treatment thanks to a novel, dedicated regulatory framework established in 2018, known as “The Magistral Phage”. This pragmatic personalized therapy approach allows the use of phage products as ...
Characterization of a Bacteriophage GEC_vB_Bfr_UZM3 Active against.
drug-resistant human pathogens, but cases of the refractory infections, caused by strains that are not susceptible to the common antibiotic regimes established for have been more frequently reported. ...
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
Pieter Source: Biologicals, Volume 74 (2021) Abstract: There is an increasing need to establish quality principles for designing, developing and manufacturing challenge agents as currently these agents are ...
Identification of flavouring substances of genotoxic concern present in e-cigarette refills
establish a screening strategy to prioritize the flavouring substances of highest concern for human health. In the present study, a prioritization strategy combining analytical screening, in silico tools and ...
Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills
toxicity of e-cigarette vapours remains unclear. Considering the large number of e-liquid flavours available on the market (> 7000), there is an urgent need to establish an efficient screening strategy to ...
Analysis of illegal peptide drugs via HILIC-DAD-MS.
p.562-571 (2017) Abstract: Biopharmaceuticals have established themselves as highly efficient medicines, and are still one of the fastest growing parts of the health-product industry. Unfortunately, the ...
A new approach to define acceptance limits for hematology in external quality assessment schemes.
Laboratory Medicine (EQALM) decided to perform a statistical study with the aim of establishing appropriate acceptance limits (AL) allowing harmonization between the evaluation procedures of European EQAS ...
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).
current paradigm in dose and regimen selection and highlight the availability and usefulness of well-established and regulatory-acceptable methods, the European Medicines Agency (EMA) in collaboration with ...
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 ...
Development and validation of a HS/GC-MS method for the simultaneous analysis of diacetyl and acetylpropionyl in electronic cigarette refills
The use of e-cigarettes as alternative for tobacco cigarettes has become increasingly popular, even though their safety has not yet been scientifically established. One of the frequently raised concerns ...