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Susanne Pihl, Barry Wa van der Strate, Michaela Golob, Laurent Vermet, Birgit Jaitner, Joanne Goodman, Marianne Scheel Fjording, Philip Timmerman
Critical reagents play a crucial role in ligand binding assays; the robustness and reliability of an assay is defined by the quality and long-term availability of these reagents. However, neither regulatory guidelines nor relevant scientific papers provide clear directions for set-up, life cycle management and, more importantly, the acceptance criteria required for the testing of the critical reagents for pharmacokinetic, biomarker and immunogenicity assays. The ambiguity from current guidelines can be a challenge for the bioanalytical community...
September 18, 2018: Bioanalysis
Santosh Kumar Sreevatsav Adiraju, Kiran Shekar, John F Fraser, Maree T Smith, Sussan Ghassabian
AIM: To develop an LC-MS/MS assay to quantitate well-tolerated substrates; midazolam (CYP3A), omeprazole (CYP2C19), dextromethorphan (CYP2D6), losartan (CYP2C9) and their respective metabolites' concentrations in plasma samples. PATIENTS & METHODS: A solid-phase extraction method was optimized to extract analytes of interest simultaneously from human plasma samples. The assay analyzed plasma samples collected from patients who received equal or lower than therapeutic doses of CYP substrates...
September 18, 2018: Bioanalysis
Rituraj Dubey, Ravi Bhushan
No abstract text is available yet for this article.
September 18, 2018: Bioanalysis
Tiago Rosado, Joana Gonçalves, Ângelo Luís, Sara Malaca, Sofia Soares, Duarte Nuno Vieira, Mário Barroso, Eugenia Gallardo
Synthetic cannabinoids are a new class of chemical drugs capable of modifying human behavior. These products do not contain cannabis, but produce similar effects after consumption. The fact that they are easily accessed, and are many times considered to be harmless, justifies their widespread use among young people. This fact, together with the difficulty in their detection by routine drug tests, makes it extremely important to develop new procedures able to detect and monitor their consumption. The aim of this work is to perform a critical review regarding the human biological samples that can be used for the determination of synthetic cannabinoids, paying special attention to analytical methods and sample preparation techniques...
September 18, 2018: Bioanalysis
Vellalore N Kakkanaiah, Kevin R Lang, Patrick K Bennett
No abstract text is available yet for this article.
September 14, 2018: Bioanalysis
Rasa Santockyte, Hamza Kandoussi, Weiqi Chen, Naiyu Zheng, Lata Venkatarangan, Jinping Gan, Hong Shen, Samuel J Bonacorsi, John Easter, Richard Burrell, Yan J Zhang, Jianing Zeng
AIM: A robust LC-MS/MS assay was developed to quantify endogenous 1, 14-tetradecanedioic acid (TDA) and 1, 16-hexadecanedioic acid (HDA) in human plasma as potential biomarkers for evaluating drug-drug interactions mediated by the hepatic drug transporters, organic anion-transporting polypeptides. RESULTS: This assay was validated using fit-for-purpose approach over standard curve range of 2.5-1000 nM for TDA and HDA using analyte-free charcoal-stripped human plasma as the surrogate matrix...
September 14, 2018: Bioanalysis
Anne Incamps, Celia Saez-Boiteau, Svenja Lena Tiede, Pauline Rebillard, Janin Schulte, Jérôme Vialaret, Andre Beinrucker, Sylvain Lehmann, Christophe Hirtz
BACKGROUND: Serum and plasma are widely used matrices in biological and clinical studies. To improve reliability and consistency of markers quantification, the influence of these matrices on proteins was evaluated by targeted mass spectrometry. RESULTS: 65 proteins were quantified in matched blood samples collected in serum, ethylenediaminetetraacetic acid and heparin plasma tubes from 40 healthy and 10 pathological individuals. Only 52% of the proteins were not impacted by any of the biological matrices tested, and the effects on quantification of proteins affected was matrix and protein dependent...
September 12, 2018: Bioanalysis
Marina Ollé Hurtado, Isabelle Kohler, Elizabeth Cm de Lange
Alzheimer's disease (AD) is a complex disease driven mainly by neuronal loss due to accumulation of intracellular neurofibrillary tangles and amyloid β aggregates in the brain. The diagnosis of AD currently relies on clinical symptoms while the disease can only be confirmed at autopsy. The few available biomarkers allowing for diagnosis are typically detected many years after the onset of the disease. New diagnostic approaches, particularly in easily-accessible biofluids, are essential. By providing an exhaustive information of the phenotype, metabolomics is an ideal approach for identification of new biomarkers...
September 10, 2018: Bioanalysis
Hiroaki Shida, Takafumi Naito, Kaito Shibata, Yasuhide Yamada, Junichi Kawakami
BACKGROUND: Proteomics-based LC-MS/MS methods using trypsin solution have some problems including ion suppression and long protein digestion times. Few practical methods to quantify denosumab in human serum have been published. METHODOLOGY: Immunoglobulins in serum were extracted using immobilized protein G. Denatured, reduced and alkylated serum samples were digested with immobilized trypsin for 14 min. A denosumab-unique peptide was identified using a Fourier transform mass spectrometer as a signature peptide...
September 10, 2018: Bioanalysis
Junji Komaba, Jun Hosogi, Harue Igarashi, Hiroshi Kamimori, Keiko Nakai, Takahiro Nakamura, Yosuke Kawai, Yoshihisa Sano, Takeru Yamaguchi
The ninth Japan Bioanalysis Forum symposium took place at tower hall Funabori, Tokyo, Japan, between 6 and 8 February, 2018. Bioanalytical scientists from the pharmaceutical industry, CROs, academia and regulatory bodies had many meaningful and relevant discussions on current topics of interest in bioanalysis. The 3-day symposium featured updated perspectives and experiences on regulated bioanalysis of small and large molecules, biomarker measurement and assessment of immunogenicity, as well as new areas of bioanalytical validation such as quantitative polymerase chain reaction(qPCR) and flow cytometry...
September 10, 2018: Bioanalysis
Naidong Weng, Wenying Jian
No abstract text is available yet for this article.
September 10, 2018: Bioanalysis
Mengmeng Wang, Yutian Zhan, Shawn P O'Neil, Stephen Harris, Claire Henson, Andrew McEwen, Rob Webster, Denise M O'Hara
AIM: Tools for mapping and quantifying monoclonal antibody (mAb) and peptide biotherapeutics distribumtion were evaluated by comparing data from three independent methods conducted at the whole body, organ or tissue, and cellular levels. MATERIALS & METHODS: [3 H]-mAb1 and [3 H]-peptide A were administered intravenously to rats followed by quantitative whole-body autoradiography, kidney macro-autoradiography and micro-autoradiography. RESULTS: [3 H]-mAb1 and [3 H]-peptide A concentrations were measured in anatomical regions ranging from whole body to whole organ to sub-organ level, such as the kidney glomerulus, with increasing resolution...
September 10, 2018: Bioanalysis
Stephanie Keane, Geoff Wallace, Coral Munday, Michael Wright
AIM: To develop and validate an LC-MS/MS assay for the quantification of digoxin in human plasma. An LLOQ of 10 pg/ml using a 100 μl sample was required to support drug-drug interactions studies. RESULTS: Digoxin formed multiple precursor ions in positive and negative ESI and methods based on several of these have been reported previously. After screening viable precursor ions, we found the ammonium adduct gave the best combination of sensitivity and selectivity on our LC-MS/MS platform...
September 5, 2018: Bioanalysis
Linzhi Chen, Siyu Liu, Shirin Pagels, Caitlin Quatrano, Dave Roos, Elsy Philip, Henry Zhao, Hongbin Yu
BACKGROUND: Magnetic bead immunocapture-LC-MS has been widely used for bioanalysis of biotherapeutic proteins. However, magnetic beads are difficult to be fully automated and more costly than ELISA plates. AIM: Develop an ELISA-LC-MS hybrid assay as an alternate platform. RESULTS: Among seven ELISA plates tested, Pierce streptavidin plates, which did not require time-consuming capture antibody precoating steps, provided the best sensitivity and assay dynamic range (5-2500 ng/ml or 10-5000 ng/ml), similar to magnetic bead immunocapture-LC-MS assay and better than an ELISA (50-500 ng/ml)...
September 5, 2018: Bioanalysis
Ling Song, Yang Liu, Xueting Yao, Hongzhong Liu, Bo Chen, Xifeng Ma, Huimin Zhou, Chengkon Shih, Ji Jiang, Xijing Chen, Pei Hu, Dongyang Liu
AIM:  Janagliflozin is a novel, orally selective sodium-glucose co-transporter-2 (SGLT2) inhibitor, which showed good efficacy and safety in preclinical study. The objective of this study is to develop and validate the HPLC-MS/MS method to determine janagliflozin in both of human urine and plasma. METHODS:  Janagliflozin was separated on Waters Xbridge Phenyl C18 column and detected on API 4000 tandem mass spectrometer with ESI source in negative mode. RESULTS: This method provided good linearity in the range of 5-5000 ng/ml and 5-1000 ng/ml in plasma and urine...
September 5, 2018: Bioanalysis
Vinita Gupta, Navdeep Kalia, Mahesh Yadav, Amy Noyes, Jeremy Good, Robert Hendricks, Wenfeng Xu
AIM: Cytokine/chemokine levels can reflect the pharmacodynamics of checkpoint inhibitors. The single molecule array (Simoa) HD-1 is a sensitive next-generation immunoassay platform for quantification of low abundance proteins, with potential for cancer immunotherapy mechanism of action studies. RESULTS: The Simoa IL-12p70 reagents, standard curve and test conditions were optimized for improved precision and linearity of dilution in plasma of cancer patients. The assay achieved a lower limit of quantification of 0...
September 5, 2018: Bioanalysis
Akira Wakamatsu, Shoko Ochiai, Eiko Suzuki, Yoshinobu Yokota, Midori Ochiai, Yosuke Kotani, Satomi Sasahara, Keita Nakanaga, Yuki Hashimoto, Satoko Ueno, Nozomu Kato, Satoshi Kawada, Jun Hayakawa, Eiichi Shimada, Shinya Horita, Kazuaki Sakai
It is important to select an appropriate surrogate matrix for preparing calibration standards and quality control samples while quantitatively assaying for endogenous substances, because a blank matrix that does not contain the endogenous substance cannot be derived from the species from which the target study samples are collected. This is because the assay results might be affected, depending on the characteristics of the analyte in the surrogate matrix. Our discussion group that participated in the Japan Bioanalysis Forum discussed the recommended selection strategies, focusing on large and small molecules in ligand binding assays and LC-MS, respectively...
September 5, 2018: Bioanalysis
Mônica Siqueira Ferreira, Cláudio Roberto Marquez, Danieli Almeida Dos Santos, José Jorge Gabbai, Aline Cristina Martho, Amanda Hayashi Yamanouchi Brandão, Kleyton Arlindo Barella, Maria Francesca Riccio, Ana Cláudia Noboli, Pedro Serafim Júnior
AIM: Dexamethasone (Dex) has been used for the treatment of ocular diseases, presenting concentrations up to 150 ng/ml in the biological matrix. Drug sampling has been performed from aqueous humor (AH), which the volume varies from 50 to 200 μl, becoming a challenge for analytical analyses. RESULTS: We developed and validated a direct and sensitive method by LC-MS/MS for Dex measurement in human AH, using water as surrogate matrix to reduce the sample volume applied in some validation assays...
September 5, 2018: Bioanalysis
Mona M Al-Shehri, Manal A El-Gendy, Adel S El-Azab, Mohammed A Hamidaddin, Ibrahim A Darwish
AIM: To support the therapeutic drug monitoring of afatinib (AFT), an ELISA was required. RESULTS: A hapten for AFT was prepared and linked to each of BSA and KLH proteins by diazotization/coupling reaction. A polyclonal antibody recognizing AFT with high affinity (IC50  = 40 ng ml-1 ) was generated and used in the development of a competitive ELISA for quantitation of AFT in plasma samples. The assay limit of detection was 2 ng ml-1 . The assay accuracy and precision were proved...
August 17, 2018: Bioanalysis
Rastislav Monošík, Lars Ove Dragsted
AIM: We tested a large set (n = 181) of wet urine and dried urine samples spotted on regular cosmetic cotton swabs for comparative UHPLC-MSMS analysis of various metabolites across a wide polarity and structural range. Results/methodology: The agreement of measurements between conventional 24 h urines and dried urine spots made from them in situ was evaluated by Passing-Bablok regression and Bland-Altman analysis after creatinine correction. There was full agreement in qualitative results but quantitative analysis revealed underestimation of dried urine spots in some cases...
August 8, 2018: Bioanalysis
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