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Showing results 913 - 928 of 91813 for .

Showing results 913 - 928 of 91813 for .

Overcoming Data Integration Challenges to Produce SEND Datasets
ACT 2016 -- Nonclinical toxicology studies that include phases run at multiple test sites (aka multi-site studies) are commonplace in the industry and can involve one or more organizations. With the FDA requirement for including SEND (Standard for Exchange of Nonclinical Data) datasets in NDA submissions taking effect on 17 Dec 2016, integrating data generated from the test facility and multiple test sites into one submission-ready and compliant SEND dataset is challenging. Covance...
Elimination of Ionization Suppressing Dosing Excipient from LC-MS Method for Bendamustine and M3 in Human Plasma
ASMS 2017 -- Intravenously administered chemotherapy drug Bendamustine is readily hydrolyzed in vivo to mainly inactive metabolites, and partly to cytotoxic M3. Because Bendamustine is also unstable in aqueous solution, different dosing formulations have been tested to reduce this instability. Some of these excipients remain in the extracts following protein precipitation of the plasma samples and caused severe ionization suppression when using HILIC chromatography coupled with positive...
Extended Treatment with Recovery is Required for Detection of Certain Chemicals in the HPBL Micronucleus Assay
UKEMS 2016 -- The in vitro micronucleus (IVMN) test was endorsed for regulatory genotoxicity testing with the adoption of OECD test guideline (TG) 487 in 2010. In this study we measured average generation time (AGT) of human peripheral blood lymphocytes following phytohaemagglutinin (PHA) stimulation at various sample times up to 144 hours.
Resolution and Characterisation of Co-Eluting Isomeric Metabolites by Collisional Cross Section Measurements Using a Novel Geometry Travelling-Wave IMS-QTof Mass Spectrometer
ASMS 2016 -- The separation of isomeric metabolites in metabolite profiling experiments often presents a challenge. The characterisation of co-eluting isomers is made particularly difficult as the resulting MS/MS experiments always contain a mixture of product ions from a precursor ion that represents two chemical entities. Ion Mobility Spectrometry (IMS) and the resulting collisional cross section (CCS) measurements present a novel mode of separation that can be employed on a UPLC time...
Evaluation of a Cyclic Mobility-Enabled Research Platform with Multiple-Pass Ion Geometry for Metabolite Characterisation Studies
ASMS 2017 -- The performance of routine ion mobility in a production mass spectrometer has shown great utility in mapping the chemical space of the metabolite characterisation experiment, capable of discriminating between isomeric metabolites in complex samples. In this proof-of-concept work, the use of a High Resolution cyclic Ion-mobility (HR-cycIMS)-enabled research platform is discussed with the aim of providing greatly increased ion-mobility resolution and analytical flexibility,...
Analytical Method for Determination of Various Arsenic Species in Marine Oils by IC-ICP-MS
AOAC 2016 -- Many IC-ICP-MS methods are now able to separate and determine the inorganic species and various organic species of arsenic but many matrices still present unique problems. Oven extractions in nitric acid result in poor recoveries and hexane separations adapted for edible and fish oils can yield problematic emulsions when applied to krill and mussel oils. In order to combat these difficulties, a modified extraction method was developed using hexane and chloroform to disrupt the...
More of What Works: Detection of Informative Sites During the Conduct of Clinical Trials Using Machine Learning
DIA 2017 -- Across all indications, more than one third of Phase III trials have failed in the last ten years. Imprecise and subjective outcome measures and a trend for increasing placebo response over time have made it increasingly challenging to demonstrate a treatment effect in indications in which these factors dominate. A central assumption of risk-based monitoring, backed by empirical evidence, is that sites differ in the quality of the data that they produce during the conduct of a...