Showing results 977 - 992 of 91813 for .
Showing results 977 - 992 of 91813 for .
Mining PubMed for Biomarker-Disease Associations to Guide Discovery,5466940-POS-615826-02b.indd
Molecular Med Tri-Con (MMTC) 2012
Development and Validation of a Novel Method to Stabilize Peripheral Blood Plasmablasts Suitable for Use in a Multi-Center Clinical Trial
ICCS 2016 -- Plasmablasts and plasma cells are antibody-producing cells that are implicated in the pathogenesis of autoantibody-driven immune diseases. Plasmablasts are terminally differentiating B cells that are rapidly produced with the majority becoming short-lived effector cells and the minority becoming long-lived plasma cells. Here we describe a fit-for-purpose approach to develop and validate a flow cytometric plasmablast assay using a combination of cell surface markers against...
Using Big Data to Facilitate Clinical Trial Enrolment Planning
PSI Conference 2017 -- According to a paper published in Clinical Trials in 2015, 19% of studies, closed or terminated in 2011, either failed to meet accrual goals (85% of expected enrolment) or were terminated due to insufficient accrual. This poster presents an application of statistical methodology in the field of Big Data to help identify new sources of patients and investigators and to help evaluate the impact of inclusion/exclusion criteria on enrolment rates (screen failure rate)...
Evidence-Based Guidance for Contraceptive Use in Phase I and Clinical Pharmacology Trials Including Women of Child-Bearing Potential
Tag Protein Interference in Confirmation Assay
AAPS-NBC 2015 -- Overcoming challenges in non-specific inhibition using a Tag protein attached to a drug in an immunogenicity assay
Overcoming Challenges for Improved Assay Sensitivity: A Case Study in ELISA Method Development
Overcoming the Challenge of Rheumatoid Factor Interference in Immunogenicity Assays for Human Monoclonal Antibody Therapeutics
WRIB 2017 -- Bridging anti-therapeutic antibody (ATA) assays are vulnerable to matrix factors that can bridge the conjugated therapeutic and generate false positive signals. Rheumatoid factor (RF) and autoimmune antibodies associated with rheumatoid arthritis (RA) pose this problem. The object of this study was to develop a sensitive, drug tolerant and robust assay to detect ATA against therapeutic protein X (TPX) in RA patients. The TPX is a humanized monoclonal antibody for the treatment...
Resolution and Characterisation of Co-Eluting Isomeric Metabolites Using an Ion Mobility Enabled QToF Mass Spectrometer
ISSX 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...
Implementation of Three in-vitro Test Methods for Skin Sensitisation Safety Assessement
BTS 2017 -- Until 2016, assessment of skin sensitising potential of chemicals required classical in-vivo tests. Skin sensitisation testing is expected to make up the largest proportion of tests required for the 2018 REACH deadline and the Annex VII update in 2016 now means non-animal tests are the default data requirement for skin sensitisation testing. Development of adverse outcome pathways (AOPs) for assay development and Integrated Testing Strategies (ITS) as part of Integrated...
Application of Induced Pluripotent Stem Cell-Derived Keratinocytes for Toxicology Endpoints: Assay Development
ESTIV 2016 -- The Seventh Amendment to the Cosmetics Directive (76/768/EEC) has driven in vitro toxicology investment and development to a point where there are now many in vitro assays that can be used for toxicology endpoints. Regulatory necessity further pushes demand and through international funding agencies as well as private industry, new technologies and assays are continually being developed. The Adverse Outcome Pathway (AOP) paradigm created a framework that highlighted the...
Application of Induced Pluripotent Stem Cell-Derived Neurons for Toxicology Endpoints: Proof of Concept
ESTIV 2016 -- The adverse outcome pathway (AOP) paradigm allows identification of key biological events in a "cellular to tissue to organ to organism" manner such that those key events can be identified and assayed to predict the organism response. The application of this paradigm in recent years has given rise to a multitude of new in vitro assays spanning a large number of endpoints with neurons (primary/cell line/stem cell derived) being a major focus. lt-NES cells are long-term...
Normal and Disease-State Serum Cut Point Evaluation for a Clinical Anti-Drug Antibody Method
Amount of Radioactivity and Estimated Effective Dose Equivalents for Research Subjects Given 14C/3H Drugs in Absorption, Metabolism and Excretion Studies