Secondly, these methods were fully validated for a concentration range of 70 130% of the target active content using the accuracy profile approach based on β-expectation tolerance intervals.
It is easily collectable and fully validated for a wide variety of substances and reference materials.
Once fully validated for a wider range of agents and shown to have predictive value for therapeutic efficacy, we believe such assays will become a mainstay of the preclinical functional tumor assay portfolio and reduce the need for extensive testing in animal tumor models.
Although no scoring system can be fully validated for an influenza pandemic given that the pattern of the disease is currently unknown, we have demonstrated, using community-acquired pneumonia as a proxy, that a non-disease-specific physiological-social score performs as effectively to triage patients to appropriate levels of care as a disease-specific score.
The developed quantitation method was fully validated for its recovery, matrix effect, linearity, repeatability, precision and accuracy, and storage stability.
Using the selected conditions, a GC MS method was fully validated for the quantitative determination of the 21 free primary aroma compounds.
To demonstrate its ability to quantify the targeted molecules, the developed and transferred method was fully validated for two active ingredients commonly used in association, sulbactam and ceftriaxone, using the accuracy profile as decision tool.
To investigate deeply into the preclinical pharmacokinetics and prescription design of esomeprazole, a sensitive, high throughput and robust UHPLC MS/MS method had been developed and fully validated for the analysis of esomeprazole in dog plasma.
This is the first time that direct PCR – DNA amplification without prior DNA extraction – was successfully developed and fully validated for rapid and economical simultaneous identification of six commonly consumed meat species.
To study the pharmacokinetic profiles of berberine, epiberberine, coptisine, palmatine, jatrorrhizine, magnoflorine, berberrubine, corynoline and acetylcorynoline in human after administration of SBT, a sensitive liquid chromatography tandem mass spectrometry method was developed and fully validated for the simultaneous quantification of these nine alkaloids in human plasma.
