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Kevin D Clark, Cheng Zhang, Jared L Anderson
Biological and pharmaceutical samples represent formidable challenges in sample preparation that hold important consequences for bioanalysis and genotoxic impurity quantification. This Feature will emphasize significant advances toward the development of rapid, sensitive, and selective sample preparation methods.
October 25, 2016: Analytical Chemistry
Imelda Ryona, Jack Henion
Despite many benefits including simple point-of-care sample collection, reduced costs, and simplified shipping and storage, dried blood spot (DBS) techniques have faced adoption resistance such as the hematocrit (Hct) effects and the established preference for bioanalysis of plasma rather than whole blood. One way to potentially circumvent these challenges is to adopt the concept of a dried plasma spot (DPS) technique. One approach to accomplishing this is through an on-card red blood cell (RBC) filtration to generate plasma from whole blood without the need for centrifugation...
October 24, 2016: Analytical Chemistry
Man Wang, Ping Ma, Xiaonan Xi, Lei Liu, Yabin Wen, Kangning Liu, Liang Sun, Yaxin Lu, Zheng Yin
The bioanalysis and especially the sample preparation of nucleoside drugs in complex media, such as human plasma, has been challenging due to the high polarity and high solubility of these drugs in water. Online solid phase extraction (SPE) offers significant advantages, such as automation and timesaving. Thus, several types of SPE columns have been developed for compounds with different polarities. In this study, SPE was applied to overcome the issue of sample pretreatment of nucleoside drugs in human plasma, with the final aim of establishing a robust analytical platform for drugs with similar structures...
December 1, 2016: Talanta
Wei-Wei Zhao, Xiao-Dong Yu, Jing-Juan Xu, Hong-Yuan Chen
Photoelectrochemical (PEC) bioanalysis is a newly developed technique for innovative biomolecular detection. Quantum dots (QDs) with unique photophysical properties are key components in realization of various exquisite PEC bioanalyses. Particularly, significant progress has been made in the QD-based PEC bioanalysis. In this work, we briefly summarize the most recent and important developments in the use of traditional and newly emerging QDs for novel PEC bioanalytical applications. The future prospects in this dynamic field are also highlighted...
October 14, 2016: Nanoscale
Klaus Gjervig Jensen, Anne-Marie Jacobsen, Christoffer Bundgaard, Dorrit Ostergaard Nilausen, Zia Thale, Gamini Chandrasena, Martin Jorgensen
Inclusion of a microdose of (14)C-labeled drug in the first-in-man study of new investigational drugs and subsequent analysis by accelerator mass spectrometry has become an integrated part of drug development at Lundbeck. It has been found to be highly informative with regards to investigations of the routes and rates of excretion of the drug and the human metabolite profiles according to MIST guidance, and also when additional metabolism related issues needed to be addressed. In the first-in-man study with the NCE Lu AF09535, contrary to anticipated, surprisingly low exposure was observed when measuring the parent compound using conventional bioanalysis...
October 13, 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Mohammad Mahdi Moein, Aziza El Beqqali, Mohamed Abdel-Rehim
Bioanalysis is an essential part in drug discovery and development. Bioanalysis is related to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples and it involves several steps from sample collection to sample analysis and data reporting. The first step is sample collection from clinical or preclinical studies; then sending the samples to laboratory for analysis. Second step is sample clean-up (sample preparation) and it is very important step in bioanalysis. In order to reach reliable results, a robust and stable sample preparation method should be applied...
September 20, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Eric Yang, Jan Welink, Stephanie Cape, Eric Woolf, Jens Sydor, Christopher James, Dina Goykhman, Mark Arnold, Neil Addock, Ronald Bauer, Michael Buonarati, Eugene Ciccimaro, Raj Dodda, Christopher Evans, Fabio Garofolo, Nicola Hughes, Rafiq Islam, Corey Nehls, Amanda Wilson, Chad Briscoe, Mark Bustard, Laura Coppola, Stephanie Croft, Dieter Drexler, Luca Ferrari, Daniela Fraier, Rand Jenkins, John Kadavil, Lloyd King, Wenkui Li, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Rachel Sun, Nilufer Tampal, Steve Vinter, Jason Wakelin-Smith, Qin Yue
The 2016 10(th) Workshop on Recent Issues in Bioanalysis (10(th) WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity...
October 7, 2016: Bioanalysis
Patrick Bennett
No abstract text is available yet for this article.
October 5, 2016: Bioanalysis
Xiaowen Xu, Lei Wang, Yongqi Huang, Wushuang Gao, Kan Li, Wei Jiang
A wide range of analytical techniques in bioanalysis rely on surface-based biomolecular detection, which requires the confinement of probes onto heterogeneous surface to react with targets. Probe arrangement on the interface is critical for target recognition and determines assay performance. Much effort has been devoted to screen the optimized probe arrangement according to experimental tests. Such a data-driven posteriori pattern faces low efficiency, ambiguous orientation and possible deviated tested ranges from the best case...
October 4, 2016: Analytical Chemistry
Shirin Hooshfar, Michael G Bartlett
Bioanalytical methods are employed for the quantitative determination of drugs and their metabolites in biological matrices, in all stages of the drug development process. However, because of the highly complex nature of these matrices there is a wide range of potential biological, chemical and physical hazards that can influence the quality of the data produced by these methods. The present review focuses on the evaluation of the most important and frequent errors that may be encountered during bioanalytical method development/validation and analysis of clinical or preclinical samples mainly using chromatography...
October 1, 2016: Biomedical Chromatography: BMC
Ali Mohamadi, Lawrence W Miller
The synthesis, photophysical properties, and kinetic stability of a series of water-soluble, highly emissive Tb(III) and Eu(III) complexes featuring triethylenetetraamine hexaacetic acid (TTHA) and cyclohexyl triethylenetetraamine hexaacetic acid (cyTTHA) chelator scaffolds and carbostyril sensitizers are reported. The unique and modular design of the chelators gives rise to striking quantum yields of emission in aqueous solutions (up to 54%) as well as the characteristic lanthanides' photophysical properties (long excited-state lifetimes, large effective Stokes shifts, and narrow emission peaks)...
October 3, 2016: Bioconjugate Chemistry
Brian Rago, Tracey Clark, Lindsay King, Jenny Zhang, L Nathan Tumey, Fengping Li, Frank Barletta, Cong Wei, Mauricio Leal, Steve Hansel, Xiaogang Han
AIM: Complex nature of bioconjugates require multiple bioanalytical approaches to support PK and absorption, distribution, metabolism and excretion characterization. For antibody-drug conjugate (ADC) bioanalysis both LC-MS and ligand-binding assays (LBAs) are employed. RESULTS: A method consisting of immunocapture extraction of ADC from biomatrices followed by LC-MS analysis of light and heavy chain is described. Drug antibody ratio (DAR) profiles of ADC Tras-mcVC-PF06380101 dosed at 0...
November 2016: Bioanalysis
Suzanne L Parker, Yarmarly C Guerra Valero, Jeffrey Lipman, Jason A Roberts, Steven C Wallis
The reliability of extraction recovery of an analyte in bioanalysis is fundamentally important for downstream analytical testing. For dried format microsamples, if the recovery changes with time the concentration in clinical samples, derived from calibration standards and alongside quality control samples prepared following different drying protocols, may not reflect the true result. The purpose of this paper was therefore to evaluate changes to extraction recovery across time for one analyte, the glycopeptide antibiotic vancomycin, in plasma using two dried microsampling formats, dried plasma spots and volumetric absorptive microsampling...
November 2016: Bioanalysis
Erik C Burns, Jeff Moran, Sheila Breidinger, Stacy Ho, Randy Guthrie, Lakshmi Amaravardi
17th Annual Land O'Lakes Bioanalytical Conference, Madison, WI, USA, 11-14 July 2016 The 17th Annual Land O'Lakes Bioanalytical Conference, titled 'Biomarker Validation, Stability, and Regulatory Concerns', was held on 11-14 July 2016 (Monday through Thursday) in Madison, WI, USA. The Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices...
November 2016: Bioanalysis
Sanja Dragovic, Nico P E Vermeulen, Helga H Gerets, Philip G Hewitt, Magnus Ingelman-Sundberg, B Kevin Park, Satu Juhila, Jan Snoeys, Richard J Weaver
The current test systems employed by pharmaceutical industry are poorly predictive for drug-induced liver injury (DILI). The 'MIP-DILI' project addresses this situation by the development of innovative preclinical test systems which are both mechanism-based and of physiological, pharmacological and pathological relevance to DILI in humans. An iterative, tiered approach with respect to test compounds, test systems, bioanalysis and systems analysis is adopted to evaluate existing models and develop new models that can provide validated test systems with respect to the prediction of specific forms of DILI and further elucidation of mechanisms...
September 22, 2016: Archives of Toxicology
Veronika Pilařová, Mumtaz Sultani, Kristine Skoglund Ask, Lucie Nováková, Stig Pedersen-Bjergaard, Astrid Gjelstad
The new microextraction technique named parallel artificial liquid membrane extraction (PALME) was introduced as an alternative approach to liquid-liquid extraction of charged analytes from aqueous samples. The concept is based on extraction of analytes across a supported liquid membrane sustained in the pores of a thin polymeric membrane, a well-known extraction principle also used in hollow fiber liquid-phase microextraction (HF-LPME). However, the new PALME technique offers a more user-friendly setup in which the supported liquid membrane is incorporated in a 96 well plate system...
September 14, 2016: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Glenn Loos, Ann Van Schepdael, Deirdre Cabooter
Quantitative pharmaceutical analysis is nowadays frequently executed using mass spectrometry. Electrospray ionization coupled to a (hybrid) triple quadrupole mass spectrometer is generally used in combination with solid-phase extraction and liquid chromatography. Furthermore, isotopically labelled standards are often used to correct for ion suppression. The challenges in producing sensitive but reliable quantitative data depend on the instrumentation, sample preparation and hyphenated techniques. In this contribution, different approaches to enhance the ionization efficiencies using modified source geometries and improved ion guidance are provided...
October 28, 2016: Philosophical Transactions. Series A, Mathematical, Physical, and Engineering Sciences
Takahiro Nakamura
Tower Hall Funabori, Tokyo, Japan, 9-10 March 2016 At the 7th Japan Bioanalysis Forum symposium, bioanalytical methods and processes were discussed with authorities after the issuing of bioanalytical method validation guidelines (EMA and Japanese Ministry of Health, Labour and Welfare) and draft guidance (US FDA). Method establishment and bioanalysis of biomarkers were discussed with a focus on scientific validation. Bioanalytical methods for antibody-drug conjugates, the potential of MS imaging and microsampling activity in drug development were introduced...
October 2016: Bioanalysis
Rituraj Dubey, Ravi Bhushan
No abstract text is available yet for this article.
October 2016: Bioanalysis
Inas A Abdallah, Peng Huang, Jing Liu, David Y Lee, Lee-Yuan Liu-Chen, Hazem E Hassan
Levo-tetrahydropalmatine (l-THP) is an alkaloid isolated from Chinese medicinal herbs of the Corydalis and Stephania genera. It has been used in China for more than 40 years mainly as an analgesic with sedative/hypnotic effects. Despite its extensive use, its metabolism has not been quantitatively studied, nor there a sensitive reliable bioanalytical method for its quantification simultaneously with its metabolites. As such, the objective of this study was to develop and validate a sensitive and selective HPLC method for simultaneous quantification of l-THP and its desmethyl metabolites l-corydalmine (l-CD) and l-corypalmine (l-CP) in rat plasma and brain tissues...
September 8, 2016: Biomedical Chromatography: BMC
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