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Showing results 1073 - 1088 of 91813 for .

Showing results 1073 - 1088 of 91813 for .

Evaluation of an Acoustic Focusing Flow Cytometer for Enumeration of Probiotic Organisms
IPA 2017 -- Probiotic manufacturers and consumers are demanding to know more about the identity and quantity of organisms in probiotic products. Enumeration provides the most basic required information with methodologies evolving to provide improved accuracy, precision and turnaround times. Flow cytometry has shown promise in rapidly providing precise, quantitative and qualitative probiotic information.
Second Generation B Cell Assay to Distinguish Plasmablasts and Plasma Cells
CYTO 2017 -- A flow cytometric method for analysis of B cell panel subsets was developed and validated using samples from apparently healthy volunteers. The intended use of the data was to serve as a biomarker in the clinical evaluation of a new molecular entity (NME) for targeted B cell depletion. Reportable results in this panel were total B cells, naïve B cells, memory B cells, un-switched memory B cells, switched memory B cells, double negative B cells, IgD+ transitional B cells, and...
Assay Validation to Clinical Testing: How Do the Data Compare During the Clinical Trial?
ICCS 2016 -- A flow cytometric method for analysis of B cell panel subsets was developed and validated using samples from apparently healthy volunteers. The intended use of the data was to serve as a biomarker in the clinical evaluation of a new molecular entity (NME) for targeted B cell depletion. During the testing of patient samples, some unexpected patterns appeared in the bivariate plots for a limited number of patients. More specifically, two unusual populations appeared in the...
Optimization of miRNA Extraction from Serum
Molecular Med Tri-Con (MMTC) 2012
Investigation of the Stability Discrepancy Between Endogenous and Exogenous Fumarate, a Small Molecule Biomarker
APA 2016 -- Fumaric acid is an unsaturated organic acid, extensively used as an excipient in pharmaceutical products. Fumarate is the ionized dicarboxylate form of fumaric acid at physiological pH and a key intermediate in the tricarboxylic acid (TCA) cycle. Fumarate was recently identified as a metabolic biomarker for diabetic kidney disease.
Quantification of Bile Acids and Their Conjugates in Human Plasma by UPLC-HR/AM Mass Spectrometry
ASMS 2017 -- Bile acid profile in plasma is of interest as a biomarker of hepatobiliary disease as well as an indicator of hepatotoxicity when investigating the adverse effects of new drug therapies. Detection of bile acids in human plasma using LC-MS/MS has been a challenge due to the lack of a predominant product ion of the steroid backbone and the presence of several groups of isomers. In this study, a selective and efficient UPLC-HR/AM MS method was developed and qualified for the...
Isotope Dilution LC-MS/MS Analysis of Vitamin B12 in Infant Formula and Nutritional Supplements
AOAC 2015 - Dietary supplements in a variety of forms are widely used to ensure adequate intake of essential nutrients. The determination of vitamin levels in these supplements is important for both regulatory compliance and safety.
Early Genetic Toxicology Screening, Mini Ames and Micro-TK6 with 20mg of Test Article
UKEMS 2017 -- Important endpoints for the assessment of genetic toxicology include gene mutation and structural and numerical chromosome aberrations. These three endpoints form the basis of the standard genetic toxicology testing battery for novel compounds. The use of the Ames test and human TK6 (p53 competent) micronucleus assay covers these endpoints and are routinely used in standard GLP assay design. Early screening using small quantities of compound is vital to avoid unnecessary costs...
LC-MS/MS Strategies for Quantification of Therapeutic Antibodies to Support Clinical and Preclinical Studies
AAPS-NBC 2016 - LC-MS/MS technologies now offer the opportunity to quantify monoclonal antibodies at pharmacokinetic relevant levels. An advantage of LC-MS/MS over ELISA is that there is no for analyte-specific reagents, and assays can be more robust and offer a larger dynamic range. We have seen an increase in demand for this service to complement our existing Biopharm CMC and solutions.