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Zoekresultaten - 26 results
Pyrogen testing of phage therapeutic products
is pivotal to limit the risk of non-endotoxin contamination. These pyrogens can be detected by the monocyte activation test (MAT), which employs human blood cells to quantify pyrogenicity in vitro. In ...
The analysis of cannabinoids in e-cigarette liquids using LC-HRAM-MS and LC-UV.
using the ‘total error’ approach, applying accuracy profiles and conforming to ISO17025. None of the analysed samples exceeded the legal limit for the total amount of ∆9- THC present. However, of the 20 ...
The analysis of cannabinoids in e-cigarette liquids using LC-HRAM-MS and LC-UV
applying accuracy profiles and conforming to ISO17025. None of the analysed samples exceeded the legal limit for the total amount of ∆9- THC present. However, of the 20 CBD-liquids investigated in this ...
The GEONs API-fingerprint program: Tackling falsifications of APIs
API testing within the network is limited, compared to the surveillance of finished products. To tackle the issue of falsified API detection the API-working group (API- WG) of the GEON organizes ...
CBD oils on the Belgian market: A validated MRM GC-MS/MS method for routine quality control using QuEChERS sample clean up
(0.05–0.1–0.2% (w/v)) for CBN. The detection limits for CBT, CBD, CBC, Δ8- THC, CBN and for the other cannabinoids of interest, were 10 and 14 ng/mL respectively. The accuracy profile values for CBD and CBN showed ...
Use of Whole Genome Sequencing Data for a First in Silico Specificity Evaluation of the RT-qPCR Assays Used for SARS-CoV-2 Detection.
started in December 2019. COVID-19 cases are confirmed by the detection of SARS-CoV-2 RNA in biological samples by RT-qPCR. However, limited numbers of SARS-CoV-2 genomes were available when the first ...
Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium
about 35% of the samples contained known and/or unknown impurities beyond the Ph. Eur. limits [3]. Concerning the dissolution tests, 47% of samples were not compliant as the amount of drug released is ...
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).
and adaptive studies). Pairwise comparisons were also discussed during the workshop; however, mostly for historical reasons. This paper discusses the added value and limitations of these methods as well ...
Development and validation of a HS/GC-MS method for the simultaneous analysis of diacetyl and acetylpropionyl in electronic cigarette refills
5ppm for diacetyl and acetylpropionyl. The obtained accuracy profiles show that the beta-expectation tolerance intervals did not exceed the acceptance limits of+/-10%, meaning that 95% of future ...