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May 23, 2017: Bioanalysis
David Coleman, Graeme Smith, Rachel Lawrence, Deborah McManus, Sunetha Diaram, Joanna Edwards
Microsampling has the 3R benefits of refining blood collection techniques while reducing the number of animals required for rodent safety assessment studies. There are significant scientific benefits of correlating study findings with systemic exposure and consequently, there is an industry drive to utilize microsampling in regulatory toxicology studies. This article will focus on capillary microsampling and will discuss the initial considerations before using capillary microsampling, study design and some practicalities of sample collection...
May 19, 2017: Bioanalysis
Yiqiao Gao, Quan Liu, Fengguo Xu
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
Marco Michi, Massimo Breda, Justin Keane Belardi, Steven Dworetzky, Lara Solazzo
AIM: Development of a high-sensitivity chiral LC-MS/MS method was required to evaluate a combination of pramipexole (S-PPX) and its enantiomer dexpramipexole (R-PPX) in a proposed clinical trial. The previously available methods suffered from low sensitivity for the (S)-enantiomer in the presence of the more abundant (R)-enantiomer. Based on the projected dosing regimen in the clinical trial, a 5000-fold improvement in sensitivity was required for the (S)-enantiomer. METHODOLOGY: Spiked human plasma samples were extracted by liquid-liquid extraction using ethyl acetate and injected onto a CHIRALPAK ID column under pH gradient conditions...
May 18, 2017: Bioanalysis
Rituraj Dubey, Ravi Bhushan
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
Philip Timmerman, Marianne Scheel Fjording, John Allinson, Cecilia Arfvidsson, Begoña Barroso, Ulf Diczfalusy, Adrian Freeman, Elizabeth Hickford, Hamza Kandousi, Sidath Katugampola, Ulrich Kunz, Robert Nelson, John Smeraglia
European Bioanalysis Forum, Lisbon, Portugal, 9-10 June 2016 At the recent European Bioanalysis Forum's Focus Workshop 'Bringing Assay Validation and Analysis of Biomarkers into Practice', the discussion on best practice for biomarker assay validation continued. Both the presentations and the adjacent panel discussions yielded valuable food for thought for the broader bioanalytical community. The present conference report summarizes the essence from these discussions and from the proposals or conclusions made by all delegates on how to increase the necessary connectivity of the stakeholders involved in the bioanalysis of biomarkers...
May 18, 2017: Bioanalysis
Florin Marcel Musteata
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
Josep Esteve Romero, Jaume Albiol Chiva, Juan Peris-Vicente, Enrique Ochoa-Aranda
AIM: A micellar liquid chromatographic method to determine several anticancer drugs (pazopanib, dabrafenib and regorafenib) in plasma was developed and validated by the guidelines of the EMA. EXPERIMENTAL: Plasma samples were directly injected, after a 1/5-dilution in a micellar solution. The drugs were resolved in <18 min using a C18 column. The mobile phase was an aqueous solution of 0.12 M SDS - 2% 1-pentanol, buffered at pH 7. The detection was performed by absorbance at 260 nm...
May 18, 2017: Bioanalysis
Min Meng, Jianbo Zhang, Aihua Liu, Scott Reuschel, Pete Sazani, Michael Wong
AIM: AVI-7100 (Radavirsen) is a 20-mer phosphorodiamidate morpholino oligomer (PMOplus®) for the treatment of influenza. Results/methodology: An automated solid-phase extraction method was used to extract plasma samples (200 μl). The extracts were analyzed using liquid chromatography coupled with tandem mass spectrometry under the positive ionization mode. This method was fully validated over the calibration curve range of 5.00-1000 ng/ml. The between-run precision and accuracy ranged from 0...
May 18, 2017: Bioanalysis
Uwe Wessels, Eginhard Schick, Mirko Ritter, Frank Kowalewsky, Julia Heinrich, Kay Stubenrauch
AIM: Bridging immunoassays for detection of antidrug antibodies (ADAs) are typically susceptible to high concentrations of residual drug. Sensitive drug-tolerant assays are, therefore, needed. MATERIALS & METHODS: An immune complex assay to detect ADAs against therapeutic antibodies bearing Pro329Gly mutation was established. The assay uses antibodies specific for the Pro329Gly mutation for capture and human soluble Fcγ receptor for detection. RESULTS: When compared with a bridging assay, the new assay showed similar precision, high sensitivity to IgG1 ADA and dramatically improved drug tolerance...
May 18, 2017: Bioanalysis
Meiyu Shen, Lixin Leo Xu
No abstract text is available yet for this article.
May 17, 2017: Bioanalysis
Heather Walker, Michael Burrell, Janet Flatley, Hilary Powers
AIM: With the advent of rapid metabolic profiling techniques and of portable mass spectrometers we examined whether cells distinguished by their cytology and persistence of human papillomavirus infection, could be easily differentiated by their metabolite profile. MATERIALS & METHODS: Direct injection electrospray mass spectrometry was used in a nontargeted double-blind experiment. Samples were collected from women diagnosed with one of two grades of cervical cytology and exhibiting either human papilloma virus persistence or clearance...
May 16, 2017: Bioanalysis
Linda Vårdal, Astrid Gjelstad, Chuixiu Huang, Elisabeth Leere Øiestad, Stig Pedersen-Bjergaard
AIM: For the first time, extracts obtained from human plasma samples by electromembrane extraction (EME) were investigated comprehensively with particular respect to phospholipids using ultra-high-performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS). Thhe purpose was to investigate the potential of EME for phospholipid cleanup in different EME systems. RESULTS & DISCUSSION: No traces of phospholipids were detected in any of the acceptor solutions, whereas the model analytes were extracted with recoveries up to 50%...
May 16, 2017: Bioanalysis
Naveen Dakappagari, Hui Zhang, Laurie Stephen, Lakshmi Amaravadi, Masood U Khan
With the wide use of biomarkers to enable critical drug-development decisions, there is a growing concern from scientific community on the need for a 'standardized process' for ensuring biomarker specimen stability and hence, a strong desire to share best practices on preserving the integrity of biomarker specimens in clinical trials and the design of studies to evaluate analyte stability. By leveraging representative industry experience, we have attempted to provide an overview of critical aspects of biomarker specimen stability commonly encountered during clinical development, including: planning of clinical sample collection procedures, clinical site training, selection of sample preservation buffers, shipping logistics, fit-for-purpose stability assessments in the analytical laboratory and presentation of case studies covering widely utilized biomarker specimen types...
May 15, 2017: Bioanalysis
Michael Gröschl
Saliva is gaining increasing attention as a bioanalytical sample matrix. Mostly because of the easy and noninvasive collection, it is not only beneficial in endocrinological and behavioral science, but also in pediatrics. Saliva also has the advantage of being the only body fluid which can be collected even during physical exercise, for example, during sportive activities, and there are physiological characteristics that make it superior to serum/plasma or urine for specific scientific questions. This review provides an insight into the physiology of saliva formation, explaining how certain compounds enter this bodily fluid, and gives advice for collection, storage and analytical methods...
May 15, 2017: Bioanalysis
Niels Kruse, Omar M El-Agnaf, Brit Mollenhauer
AIM: α-Synuclein (aSyn), a putative cerebrospinal fluid biomarker, may support the diagnosis of neurodegenerative diseases. Previous studies led to conflicting results due to different preanalytical and analytical procedures. Standardized assays are required to allow for comparison of results from different laboratories. MATERIALS & METHODS: We performed a side-by-side validation of a commercially available (Meso Scale Discovery, MD, USA) and a 'homebrew' assay for quantification of aSyn according to published guidelines...
May 15, 2017: Bioanalysis
Yan Li, Mark Hoffmann, Paul Severin
AIM: Naloxegol is an oral peripherally acting μ-opioid receptor antagonist approved for the treatment of opioid-induced constipation. Sensitive, robust, bioanalytical methods were required to quantitate naloxegol in human biological matrices as part of the clinical development program. Results/methodology: Analytical plasma samples were prepared using Solid Phase Extraction (SPE) coupled with concentration. The method's linearity was established at 0.1-50 ng/ml with up to 100-fold dilution...
May 15, 2017: Bioanalysis
Michael A Partridge, Uma Vijayam, Elif Kabuloglu Karayusuf, Enoch Shum, Thanoja Sirimanne, John Garlits, Jihua Chen, Albert Torri, Giane Sumner
AIM: A bridging immunogenicity assay for a human IgG4 mAb therapeutic was transferred to an automation system to increase throughput. However, background signal increased five- to six-fold during the 6- to 8-h run. RESULTS: Noncovalent Fc contacts formed between labeled IgG4 drugs in reagent solutions stored during the automation run. This generated substantial background signal, reducing assay sensitivity by approximately sixfold. Fc interactions also significantly impacted the confirmation assay...
May 10, 2017: Bioanalysis
Harilal Patel, Krunal Soni, Rucha Trivedi, Heather Heading, Jason Geue, Kevinkumar Kansagra, Rahul J Gupta, Vrajesh B Pandya, Nuggehally R Srinivas, Pankaj R Patel, Ranjit C Desai
AIM: A sensitive LC-MS/MS method was developed and validated for estimation of ZYAN1 in human blood/urine. METHODS: An analog internal standard IOX2 along with ZYAN1 was quantified using selective reaction monitoring in positive mode. The chromatographic separation was performed by gradient elution with C18 analytical column (3 µm, 50 mm × 2.0 mm) with 4-min run time using an acidified mobile phase consisting of ammonium formate and acetonitrile. Protein precipitation enabled extraction of analytes from diluted blood/urine...
May 10, 2017: Bioanalysis
James W Howard, Richard G Kay, Ben Jones, Jaimini Cegla, Tricia Tan, Steve Bloom, Colin S Creaser
AIM: The performance of glucagon and GLP-1 immunoassays is often poor, but few sensitive LC-MS/MS methods exist as alternatives. EXPERIMENTAL: A multiplexed LC-MS/MS method using a 2D extraction technique was developed. RESULTS: The method was established for the quantitation of endogenous glucagon (LLOQ: 15 pg/ml) and dosed GLP-1 (LLOQ: 25 pg/ml) in human plasma, and is the first such method avoiding immunoenrichment. Specificity of endogenous glucagon quantitation was assured using a novel approach with a supercharging mobile phase additive to access a sensitive qualifier SRM...
May 10, 2017: Bioanalysis
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