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Bioanalysis

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https://www.readbyqxmd.com/read/28705025/improving-the-sensitivity-and-specificity-of-a-bioanalytical-assay-for-the-measurement-of-certolizumab-pegol
#1
John Smeraglia, John-Paul Silva, Kieran Jones
AIM: In order to evaluate placental transfer of certolizumab pegol (CZP), a more sensitive and selective bioanalytical assay was required to accurately measure low CZP concentrations in infant and umbilical cord blood. Results & methodology: A new electrochemiluminescence immunoassay was developed to measure CZP levels in human plasma. Validation experiments demonstrated improved selectivity (no matrix interference observed) and a detection range of 0.032-5.0 μg/ml. Accuracy and precision met acceptance criteria (mean total error ≤20...
July 14, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28692346/the-validation-of-an-lc-ms-ms-assay-for-perhexiline-and-major-hydroxy-metabolites-and-its-application-to-therapeutic-monitoring-in-patient-plasma
#2
Patrick Camilleri, Duxi Zhang, Mark Midei, William Daly, James Copp, Cindy Flinn, Carl Luongo, Pirouz Shamszad
AIM: Perhexiline (PEX), being developed to treat hypertrophic cardiomyopathy, is toxic at levels above the therapeutic range. Plasma level monitoring is therefore essential. The absence of a UV-absorbing chromophore has in the past required quantitative analysis of PEX in plasma using lengthy derivatization methods, followed by HPLC and fluorescence detection. The routine and urgent analysis of a large number of patient plasma samples necessitates faster and reliable analytical methodology...
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28692312/new-investigator-award-announcing-our-finalists
#3
Swarnapali De Silva Indrasekara, Matthew Ryen Lockett, Michael Witting, Yu Shrike Zhang
No abstract text is available yet for this article.
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28692309/development-and-validation-of-a-lc-ms-ms-method-for-the-quantification-of-the-checkpoint-kinase-1-inhibitor-sra737-in-human-plasma
#4
Monique Zangarini, Philip Berry, Julieann Sludden, Florence I Raynaud, Udai Banerji, Paul Jones, David Edwards, Gareth J Veal
AIM: SRA737 is an orally active small-molecule inhibitor of checkpoint kinase 1 being investigated in an oncology setting. A HPLC-MS/MS method for quantifying plasma concentrations of SRA737 was validated. METHODS & RESULTS: Sample preparation involved protein precipitation with acetonitrile following addition of (13)C(15)N-deuterated SRA737 as internal standard. A rapid and selective method was fully validated across a range of 5-20,000 ng/ml, exhibiting good sensitivity, overall precision (expressed as coefficient of variation) ≤8...
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28692308/lc-ms-determination-of-triazolam-and-its-hydroxy-metabolites-in-mouse-dried-blood-spots-application-to-transgenic-mouse-pharmacokinetic-studies
#5
Prashant Kole, Abhijith Rao, Vishwanath Kurawattimath, Sandhya Mandlekar
AIM: The objective of this study was to develop a LC-MS/MS method for the simultaneous determination of triazolam (TRZ) and its two hydroxy metabolites in transgenic mouse dried blood spots (DBS) using BALB/c mouse blood as a surrogate biomatrix. METHODOLOGY/RESULTS: The DBS method involved spotting volume of 10 μl using Ahlstrom 226 sample collection cards. A 'whole spot' analysis (6-mm punch) involved extraction of analytes using water and acetonitrile containing an internal standard...
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28692306/development-and-validation-of-an-electrochemiluminescent-elisa-for-quantitation-of-oral-insulin-tregopil-in-diabetes-mellitus-serum
#6
Shilpa G Ramaswamy, Vivek G Nayak, Sumit Kumar Jha, Vishika Hegde, Vinit S Waichale, Ramakrishnan Melarkode, Narendra Chirmule, Anita U Rao, Nilanjan Sengupta
AIM: Tregopil, a novel PEGylated human insulin is in clinical development for oral delivery in diabetes treatment. The aim of the study was to develop and validate a sensitive and specific ELISA method for quantitating Tregopil in diabetes subjects on basal Glargine, since most commercially available insulin kits either do not detect Tregopil or show significant reactivity to Glargine. METHODS: An electrochemiluminescent ELISA was developed and validated for Tregopil quantitation in diabetes serum...
July 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28644046/paper-based-point-of-care-testing-in-disease-diagnostics
#7
Leila Syedmoradi, Frank A Gomez
No abstract text is available yet for this article.
June 23, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28627228/affinity-extraction-lc-ms-for-small-molecule-drug-quantification-considerations-challenges-and-potential-applications
#8
John T Mehl
No abstract text is available yet for this article.
June 19, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28617037/quantitative-determination-of-a-sirna-ad00370-in-rat-plasma-using-peptide-nucleic-acid-probe-and-hplc-with-fluorescence-detection
#9
Qingguo Tian, Juan Rogness, Min Meng, Zheng Li
AIM: Toxicokinetic and pharmacokinetic studies of therapeutic oligonucleotides require validated bioanalytical methods for sensitive and specific quantification of oligonucleotide drug candidates in biological samples. RESULTS: A peptide nucleic acid (PNA) hybridization-based HPLC-fluorescence assay was developed and validated for quantification of Arrowhead Pharmaceuticals' proprietary siRNA in rat plasma samples via hybridization and anion-exchange-HPLC (AEX-HPLC) with fluorescence detection...
June 15, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28617033/a-uplc-ms-ms-method-for-quantification-of-5%C3%AE-androst-3%C3%AE-5-6%C3%AE-triol-in-human-plasma-development-validation-and-its-application-in-clinical-pharmacokinetic-study
#10
Zhenlei Wang, Huanhuan Wang, Pei Hu, Ji Jiang, Qian Zhao
AIM: 5α-androst-3β,5,6β-triol is a novel ischemic stroke drug under clinical development. The objective of this study was to develop and validate a simple ultraperformance liquid chromatography tandem mass spectrometry method for 5α-androst-3β,5,6β-triol in human plasma and its application in clinical pharmacokinetic study. Methodology & results: After being pretreated using an automatized solid-phase extraction procedure, plasma sample was separated on a Waters(®) Acquity™ BEH C18 column (2...
June 15, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28534642/corrigendum
#11
(no author information available yet)
No abstract text is available yet for this article.
May 23, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28524734/capillary-microsampling-in-nonclinical-safety-assessment-practical-sampling-and-bioanalysis-from-a-cro-perspective
#12
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
https://www.readbyqxmd.com/read/28520467/challenges-in-metabolomics-based-disease-molecular-classification-an-analytical-perspective
#13
Yiqiao Gao, Quan Liu, Fengguo Xu
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28520466/development-and-validation-of-a-highly-sensitive-gradient-chiral-separation-of-pramipexole-in-human-plasma-by-lc-ms-ms
#14
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
https://www.readbyqxmd.com/read/28520462/activity-based-proteomics-in-bioanalysis-past-present-and-future
#15
Rituraj Dubey, Ravi Bhushan
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28520457/measuring-and-using-free-drug-concentrations-has-there-been-real-progress
#16
Florin Marcel Musteata
No abstract text is available yet for this article.
May 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28520456/development-and-validation-of-a-micellar-liquid-chromatographic-method-to-determine-three-antitumorals-in-plasma
#17
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
https://www.readbyqxmd.com/read/28520455/quantitative-determination-of-avi-7100-radavirsen-a-phosphorodiamidate-morpholino-oligomer-pmoplus-%C3%A2-in-human-plasma-using-lc-ms-ms
#18
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
https://www.readbyqxmd.com/read/28517957/novel-drug-and-soluble-target-tolerant-antidrug-antibody-assay-for-therapeutic-antibodies-bearing-the-p329g-mutation
#19
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
https://www.readbyqxmd.com/read/28513183/design-and-statistical-analysis-of-method-transfer-studies-for-biotechnology-products
#20
Meiyu Shen, Lixin Leo Xu
No abstract text is available yet for this article.
May 17, 2017: Bioanalysis
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