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    Optimizing NBE PK/PD assays using the Gyrolab Affinity Software; conveniently within the bioanalyst's existing workflow.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Biotherapeutics Discovery, Boehringer Ingelheim Pharmaceuticals, 900 Ridgebury Road, Ridgefield, CT 06877, USA.
    Aim: The fully automated microfluidics-based Gyrolab is a popular instrument for the bioanalysis of protein therapeutics; requiring minimal sample and reagent volumes. Gyros offers affinity software for determining binding affinity in solution using a high-throughput method and miniaturized reactions.

    Results: Using this affinity software, multiple CTGF-targeting reagents were characterized on the Gyrolab after <100% target coverage was seen in a cynomolgus pharmacokinetic/PD study dosed with anti-CTGF antibodies. Read More

    Examining heat treatment for stabilization of the lipidome.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Department of Chemistry, University of Florida, 214 Leigh Hall, Gainesville, FL 32611, USA.
    Aim: To confidently determine lipid-based biomarkers, it is important to minimize variation introduced during preanalytical steps. We evaluated reducing variation associated with lipid measurements in invertebrate sentinel species using a state-of-the-art heat treatment technique.

    Materials And Methods: Earthworms (Eisenia fetida), house crickets (Acheta domestica) and ghost shrimp (Palaemonetes paludosus) were euthanized either by flash freezing or heat treatment. Read More

    Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    UQ Centre for Clinical Research, The University of Queensland, Brisbane, Australia.
    Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. Read More

    Evaluation of cAMS forC microtracer ADME studies: opportunities to change the current drug development paradigm.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Novartis Pharma AG, Novartis Institutes for Biomedical Research, PK Sciences, Fabrikstrasse 14, CH-4002 Basel, Switzerland.
    Aim: Although regulatory guidances require human metabolism information of drug candidates early in the development process, the human mass balance study (or hADME study), is performed relatively late. hADME studies typically involve the administration of aC-radiolabelled drug where biological samples are measured by conventional scintillation counting analysis. Another approach is the administration of therapeutic doses containing aC-microtracer followed by accelerator mass spectrometry (AMS) analysis, enabling hADME studies completion much earlier. Read More

    The future of LC-MS for pharmaceutical analysis: an interview with Jun Qu.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Department of Pharmaceutical Sciences, School of Pharmacy, University at Buffalo, New York, NY, USA.
    Jun Qu speaks to Sankeetha Nadarajah, Editor of Bioanalysis: Jun Qu is the group leader of the proteomics and pharmaceutical analysis lab of SUNY-Buffalo (NY, USA) and a Professor in the Department of Pharmaceutical Sciences. His research is focused on the study of Clinical and Pharmaceutical Proteomics and Pharmaceutical Analysis using LC-MS-based strategies. His research programs include high-resolution and large-scale expression profiling of pathological proteomes, for the discovery of novel disease/therapeutics biomarkers using gel-free proteomic methods; sensitive identification, localization and quantification of post-translational modifications in tissue proteomes such as these in myocardium, using novel anti-PTM affinity capture and alternating Collision-induced dissociation/Electron transfer dissociation to obtain abundant PTM information; targeted investigation of marker proteins that are of high interests for clinical and pharmaceutical study, using highly sensitive nano-LC/SRM-based methods; and highly sensitive and accurate investigation of the PK of biotherapeutics using LC-MS. Read More

    Incorporating dried blood spot LC-MS/MS analysis for clinical development of a novel oncolytic agent.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Eli Lilly & Company, Lilly Research Laboratories, Lilly Corporate Center Indianapolis, IN 46285, USA.
    Aim: Design and execution of a dried blood spot (DBS-LC-MS/MS) assay for pharmacokinetic analyses in oncology patients.

    Results & Discussion: The methodology was validated to collect and store DBS samples from multiple clinical sites, and analyze blood with diverse hematocrit ranges (25-55) to match the potential patient population. Bridging data comparing DBS and plasma showed high degree of concordance with DBS:plasma ratios of 0. Read More

    Parallel artificial liquid membrane extraction of psychoactive analytes: a novel approach in therapeutic drug monitoring.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Department of Pharmaceutical Chemistry, School of Pharmacy, University of Oslo, Oslo, Norway.
    Aim: Liquid-liquid extraction is widely used in therapeutic drug monitoring of antipsychotics, but difficulties in automation of the technique can result in long operational time. In this paper, parallel artificial liquid membrane extraction was used for extraction of serotonin- and serotonin-norepinephrine reuptake inhibitors from human plasma, and an approach to automate the technique was investigated.

    Results: Eight model analytes were extracted from 125 μl human plasma with recoveries in the range 72-111% (relative standard deviation [RSD] ≤12. Read More

    Novel automated immune turbidimetric assay for routine urinary cystatin-C determinations.
    Bioanalysis 2018 Feb 16. Epub 2018 Feb 16.
    Department of Laboratory Medicine, University of Pécs Medical School, 7624 Pécs, Ifjúság u. 13, Hungary.
    Aim: There is no commercially available urinary cystatin-C (u-CYSC) test in the market. Therefore, we optimized and validated an automated immune turbidimetric test for u-CYSC measurements and investigated u-CYSC concentrations in acute and chronic diseases which might lead to renal tubular disorders.

    Materials & Methods: A particle-enhanced immune turbidimetric assay was adapted and validated on a Cobas 8000/c502 analyzer. Read More

    Coated blade spray: shifting the paradigm of direct sample introduction to MS.
    Bioanalysis 2018 Feb 29;10(4):257-271. Epub 2018 Jan 29.
    Department of Chemistry, University of Waterloo, Waterloo, Ontario N2L 3G1, Canada.
    Coated blade spray (CBS) is a solid-phase microextraction-based technology that can be directly coupled to MS to enable the rapid qualitative and quantitative analysis of complex matrices. The goal of this mini review is to concisely introduce CBS's operational fundamentals and to consider how it correlates/contrasts with existing direct-to-MS technologies suitable for bioanalytical applications. In addition, we provide a fair comparison of CBS to other existing solid-phase microextraction-to-MS approaches, as well as an overview of recent CBS applications/strategies that have been developed to analyze diverse compounds present in biofluids. Read More

    Development and validation of an ELISA to study panitumumab pharmacokinetics.
    Bioanalysis 2018 Feb 18;10(4):205-214. Epub 2018 Jan 18.
    Université François Rabelais de Tours, CNRS UMR 7292 GICC, Tours, France.
    Aim: Panitumumab is a monoclonal antibody directed against EGFR that is approved for the treatment of metastatic colorectal cancer. To investigate its pharmacokinetics and concentration-response relationship, a validated assay is required.

    Results: An ELISA assay was developed and validated according to international recommendations. Read More

    Extended 3D and 4D cumulative plots for evaluation of unmatched incurred sample reanalysis.
    Bioanalysis 2018 Feb 18;10(3):153-162. Epub 2018 Jan 18.
    Faculty of Mathematics & Information Science, Warsaw University of Technology, 75 Koszykowa Street, 00-662 Warsaw, Poland.
    Aim: Incurred sample reanalysis (ISR) helps ensure the reliability of pharmacokinetic studies. An appropriate graph may facilitate the evaluation of an unmatched reanalyses or a failed ISR test.

    Methods: We evaluated different ways of visualizing multidimensional ISR data using an extended cumulative ISR plot. Read More

    Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
    Bioanalysis 2018 Feb 18;10(4):197-204. Epub 2018 Jan 18.
    European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium.
    European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates. Read More

    Emerging technologies for biotherapeutic bioanalysis from a high-throughput and multiplexing perspective: insights from an AAPS emerging technology action program committee.
    Bioanalysis 2018 Feb 18;10(3):181-194. Epub 2018 Jan 18.
    SQI Diagnostics, Inc., Toronto, ON M9W 1A4, Canada.
    This manuscript aims to provide insights and updates on emerging technologies from a throughput and multiplexing perspective and to update readers on changes in previously reported technologies. The technologies discussed range from nascent (ultrasensitive Cira, Intellicyt, Dynaxi and Captsure™) to the more established (Ella and SQIDlite™). For the nascent technologies, there was an emphasis on user interviews and reviews, where available, to help provide an unbiased view to our readers. Read More

    Ultrafast determination of vitamin E using LC-ESI-MS/MS for preclinical development of new nutraceutical formulations.
    Bioanalysis 2018 Feb 15;10(4):215-227. Epub 2018 Jan 15.
    Faculty of Pharmacy, University of Castilla-La Mancha, Albacete, Spain.
    Aim: We proposed a rapid and high quality method to determine α-tocopherol (α-T) in different biopharmaceutical samples using liquid chromatography-diode array detector on-line ESI-MS/MS.

    Materials & Methods: A working standard solution of α-T and internal standard, phenyl-5,7-dimethyl-d6-α-tocopherol, were used for optimization and validation of the method. Levels of α-T in nanoemulsions, serum and plasma samples were evaluated. Read More

    Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects.
    Bioanalysis 2018 Feb 15;10(4):241-255. Epub 2018 Jan 15.
    Exploratory Biomarker Assay, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.
    Aim: GSKA is a compound that was in development in clinical trials. A bioanalysis method to quantify GSKA using volumetric absorptive microsampling (VAMS) was developed and hematocrit (HCT) related assay bias was investigated.

    Methodology: After accurate sampling of 10 μl blood, VAMS tips were air dried approximately 18 h and desorbed by an aqueous solution containing internal standard. Read More

    Quantitation of saxitoxin in human urine using immunocapture extraction and LC-MS.
    Bioanalysis 2018 Feb 15;10(4):229-239. Epub 2018 Jan 15.
    Emergency Response Branch, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control & Prevention, Atlanta, GA, 30341 USA.
    Aim: An immunomagnetic capture protocol for use with LC-MS was developed for the quantitation of saxitoxin (STX) in human urine.

    Materials & Methods: This method uses monoclonal antibodies coupled to magnetic beads. STX was certified reference material grade from National Research Council, Canada. Read More

    Offline derivatization LC-MS/MS method for simultaneous estimation of vanillin and vanillic acid in guinea pig plasma.
    Bioanalysis 2018 Feb 15;10(3):131-142. Epub 2018 Jan 15.
    Pharmaceutical Candidate Optimization, Biocon Bristol-Myers Squibb R&D Center (BBRC), Syngene International Limited, Biocon Park, Plot 2 & 3, Bommasandra IV Phase, Bangalore - 560 099, India.
    Aim: Vanillin used as a positive control substrate of aldehyde oxidase activity gets metabolized to vanillic acid. Low MW and low sensitivity in negative ion mode are challenges with these analytes. Our objective was to develop a simple offline derivatization LC-MS/MS method to address these challenges. Read More

    Principles of vaccine potency assays.
    Bioanalysis 2018 Feb 15;10(3):163-180. Epub 2018 Jan 15.
    Vaccines Analytical Development, Merck & Co., Inc., West Point, PA 19486, USA.
    Compared with biologics, vaccine potency assays represent a special challenge due to their unique compositions, multivalency, long life cycles and global distribution. Historically, vaccines were released using in vivo potency assays requiring immunization of dozens of animals. Modern vaccines use a variety of newer analytical tools including biochemical, cell-based and immunochemical methods to measure potency. Read More

    Pharmacokinetic determination and analysis of nortriptyline based on GC-MS coupled with hollow-fiber drop-to-drop solvent microextraction technique.
    Bioanalysis 2018 Feb 15;10(3):143-152. Epub 2018 Jan 15.
    Department of Chemistry, National Institute of Technology, Raipur, Chhattisgarh, 492010, India.
    Aim: A simple, sensitive and robust technique of hollow-fiber drop-to-drop solvent microextraction coupled with GC-MS has been successfully developed for the detection of antidepressant drug nortriptyline in human blood and urine samples. The recoveries of the drug from the spiked samples are found to be well within the range and appropriate to support the method.

    Results: The LOD for the drug was obtained to be 0. Read More

    A label-free platform for dopamine biosensing.
    Bioanalysis 2018 Jan 15;10(1):11-21. Epub 2017 Dec 15.
    Analytical Biosensors Group, Analytical Chemistry Department, Faculty of Sciences, Aragón Institute of Nanoscience, University of Zaragoza, 50009-Zaragoza, Spain.
    Aim: This work presents a label-free platform for dopamine (DA) monitoring based on the spectroscopic properties of laccase.

    Results: Working in batch mode, DA ranging from 25 to 250 μM, can be determined without the interference of norepinephrine and epinephrine. Laccase immobilized in a polyacrylamide film is the basis of a platform for the label-free determination of DA. Read More

    Immunogenicity of therapeutic protein products: current considerations for anti-drug antibody assay in Japan.
    Bioanalysis 2018 Jan 15;10(2):95-105. Epub 2017 Dec 15.
    National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-9501, Japan.
    Immunogenicity assessment is an important issue for ensuring the safety and efficacy of therapeutic protein products. Although the reliability of the anti-drug antibody (ADA) assay is one of the key points, there are some difficulties in assessing its validity because the analytes are polyclonal antibodies with variable and unknown characteristics. To elucidate the points to consider for the ADA assay, a Japanese research group was established that discusses the issues raised on the immunogenicity assessment. Read More

    Application of matrix-assisted laser desorption/ionization mass spectrometry imaging in combination with LC-MS in pharmacokinetic study of metformin.
    Bioanalysis 2018 Jan 15;10(2):71-81. Epub 2017 Dec 15.
    Department of Analytical Chemistry, University of Chemistry & Technology Prague, Technická 5, 16628, Prague, Czech Republic.
    Aim: To demonstrate and discuss the pros and cons of various conventional and innovative analytical approaches. Methodology & results: Matrix-assisted laser desorption/ionization mass spectrometry imaging (MSI) of tissue sections as well as the extraction of tissue homogenates, blood plasma and dried blood spots coupled with LC-MS were employed to monitor the pharmacokinetics of metformin in mice. The time profile of metformin measured by matrix-assisted laser desorption/ionization MSI correlated well with the results found by LC-MS. Read More

    Assessing a multiplex-targeted proteomics approach for the clinical diagnosis of periodontitis using saliva samples.
    Bioanalysis 2018 Jan 15;10(1):35-45. Epub 2017 Dec 15.
    University of Montpellier, LBPC - IRMB, CHU de Montpellier, 80 rue Augustin Fliche, 34 295 Montpellier, France.
    Aim: The present study focused on the research of new biomarkers based on the liquid chromatography-multiple-reaction monitoring (MRM) proteomic profile in whole saliva of patients with periodontitis compared with periodontal healthy patients.

    Methods: A 30-min multiplexed liquid chromatography-MRM method was used for absolute quantification of 35 plasma biomarkers in saliva from control patients and patients with periodontitis.

    Results: Three proteins namely hemopexin, plasminogen and α-fibrinogen were shown to be clearly related to the presence of periodontitis compared with healthy patients. Read More

    Highly selective and sensitive measurement of active forms of FGF21 using novel immunocapture enrichment with LC-MS/MS.
    Bioanalysis 2018 Jan 14;10(1):23-33. Epub 2017 Dec 14.
    Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Route 206 & Province Line Road, Princeton, NJ 08543, USA.
    Aim: Recombinant FGF21 analogs are under wide ranging investigations as a potential therapeutic agent for Type 2 diabetes, as well as other metabolic disorders. The endogenous FGF21 is often used as a surrogate pharmacodynamic(PD) biomarker to assess drug efficacy and safety. Results & methodology: Immunocapture was performed using a monoclonal antibody which had been generated to bind to specific domain of native FGF21 as the capture reagent. Read More

    Laser desorption/ionization MS imaging of cancer kidney tissue on silver nanoparticle-enhanced target.
    Bioanalysis 2018 Jan 14;10(2):83-94. Epub 2017 Dec 14.
    Faculty of Chemistry, Rzeszów University of Technology, 6 Powstańców Warszawy Ave, 35-959, Rzeszów, Poland.
    Aim: Renal cell carcinoma is a very aggressive and often fatal disease for which there are no specific biomarkers found to date. The purpose of work was to find substances that differentiate the cancerous and healthy tissue by using laser desorption/ionization MS imaging combined with silver nanoparticle-enhanced target.

    Results: Ion images and comparative analysis of spectra revealed differences in intensities for several metabolites, for which their biochemical properties were discussed. Read More

    Detection of biomarkers of acute myocardial infarction by high-throughput suspension array technology in serum sample.
    Bioanalysis 2018 Jan 14;10(1):47-58. Epub 2017 Dec 14.
    School of Public Health, Guangzhou Medical University, Guangzhou, 511436, PR China.
    Aim: In order to assist and support early diagnosis of acute myocardial infarction (AMI), suspension array technology was established for multiplexed, rapid and accurate measurement of AMI biomarkers in serum samples. Methodology & results: It was developed by coating AMI biomarkers on distinguishable microbeads and competing with free biomarkers for complementary antibodies. The limits of detection of three AMI biomarkers were 2. Read More

    Supercritical fluid chromatography: a promising alternative to current bioanalytical techniques.
    Bioanalysis 2018 Jan 13;10(2):107-124. Epub 2017 Dec 13.
    University of Liege, CIRM, Laboratory of Pharmaceutical Analytical Chemistry, 4000 Liège, Belgium.
    During the last years, chemistry was involved in the worldwide effort toward environmental problems leading to the birth of green chemistry. In this context, green analytical tools were developed as modern Supercritical Fluid Chromatography in the field of separative techniques. This chromatographic technique knew resurgence a few years ago, thanks to its high efficiency, fastness and robustness of new generation equipment. Read More

    The application of control charts in regulated bioanalysis for monitoring long-term reproducibility.
    Bioanalysis 2017 Dec;9(24):1955-1965
    Astellas Pharma Europe B.V., Drug Development Research, Bioanalysis-Europe, Sylviusweg 62, 2333 BE Leiden, The Netherlands.
    In regulated bioanalysis, the acceptance of results is batch-wise. When during clinical development derived pharmacokinetic or pharmacodynamic results from different studies will be combined or compared, it is recommendable to monitor the long-term reproducibility of bioanalytical assays. Long-term reproducibility can be evaluated by control charts generated from control samples included in each batch. Read More

    2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
    Bioanalysis 2017 Dec 5;9(24):1967-1996. Epub 2017 Dec 5.
    BioMarin Pharmaceutical, San Rafael, CA, USA.
    The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, 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 LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. Read More

    Ocular bioanalysis: challenges and advancements in recent years for these rare matrices.
    Bioanalysis 2017 Dec 5;9(24):1997-2014. Epub 2017 Dec 5.
    Roche Pharmaceutical Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.
    There are many ocular diseases still presenting unmet medical needs. Therefore, new ophthalmologic drugs are being developed. Bioanalysis of eye compartments (along with plasma and other tissues) is important to determine exposure of the target organ to the drug and to help interpret local pharmacological or toxic effects. Read More

    Determination of olopatadine in human tears by hydrophilic interaction liquid chromatography-MS/MS method.
    Bioanalysis 2017 Dec 5;9(24):1943-1954. Epub 2017 Dec 5.
    Department of Physical Chemistry & Instrumental Methods, University of Belgrade - Faculty of Pharmacy, Vojvode Stepe 450, Belgrade, Serbia.
    Aim: The objective of the study was development of hydrophilic interaction liquid chromatography-ESI/MS/MS method for the determination of olopatadine in tear matrix.

    Materials & Methods: Separation was performed on Acquity BEH amide column (2.1 × 100 mm, 1. Read More

    2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
    Bioanalysis 2017 Dec 5;9(23):1895-1912. Epub 2017 Dec 5.
    Celgene, Summit, NJ, USA.
    The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 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, 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 ligand binding assay (LBA)/LCMS and LBA approaches. Read More

    Quantitative analysis of imetelstat in plasma with LC-MS/MS using solid-phase or hybridization extraction.
    Bioanalysis 2017 Dec 5;9(23):1859-1872. Epub 2017 Dec 5.
    Development Bioanalysis, Janssen Research & Development, 2340 Beerse, Belgium.
    Aim: Imetelstat, a 13-mer oligonucleotide with a lipid tail is being evaluated for treating hematologic myeloid malignancies. This report describes the development of extraction and quantification methods for imetelstat. Methodology & results: Imetelstat was extracted using SPE (rat plasma) or by hybridization using a biotinylated capture probe (human plasma) and was quantified by LC-MS/MS. Read More

    ICP-MS determination of serum aluminum in monkeys subcutaneously administered an alhydrogel-formulated drug candidate.
    Bioanalysis 2017 Dec 24;9(23):1873-1881. Epub 2017 Nov 24.
    Department of PK Sciences, Novartis Institutes for BioMedical Research, East Hanover, NJ 07936, USA.
    Aim: To develop and validate an inductively coupled plasma-mass spectrometry method for quantitative bioanalysis of aluminum (Al) in monkey serum in support of a GLP TOX study with alhydrogel-formulated drug candidate.

    Methods & Results: The method was linear over a dynamic range of 10-1000 ng/ml using a 50-μl sample volume. The intra-/inter-run precision (%CV) of the quality control sample results were ≤7. Read More

    Bioanalytical methods for the detection of antidiabetic drugs: a review.
    Bioanalysis 2017 Dec 24;9(24):2015-2025. Epub 2017 Nov 24.
    Department of Pharmacy, Universidade Federal do Paraná, 632 Lothário Meissner Avenue, 80210-170, Curitiba - PR, Brazil.
    Type 2 diabetes mellitus, a disease which prevalence has been progressively increasing worldwide, is characterized by chronic hyperglycemia resulting from the combination of inappropriate insulin secretion and/or resistance to insulin action. If left uncontrolled, diabetes is associated with complications such as dysfunction and failure of various organs, and even premature death. Along with lifestyle-modification strategies, several classes of oral antidiabetic agents can be employed for glycemic control. Read More

    Microdosing, isotopic labeling, radiotracers and metabolomics: relevance in drug discovery, development and safety.
    Bioanalysis 2017 Dec 24;9(23):1913-1933. Epub 2017 Nov 24.
    Australian Nuclear Science & Technology Organisation, Human Health Theme, New Illawarra Road, Lucas Heights, NSW, 2234, Australia.
    This review discusses the use of stable (C,D) or radioactive isotopes (C,C,F,I,Cu,Ga) incorporated into the molecular structure of new drug entities for the purpose of pharmacokinetic or -dynamic studies. Metabolite in safety testing requires the administration of pharmacologically active doses. In such studies, radiotracers find application mainly in preclinical animal investigations, whereby LC-MS/MS is used to identify metabolite structure and drug-related effects. Read More

    Toward best practices in data processing and analysis for intact biotherapeutics by MS in quantitative bioanalysis.
    Bioanalysis 2017 Dec 24;9(23):1883-1893. Epub 2017 Nov 24.
    Bioanalysis, Immunogenicity & Biomarkers, In vitro/In vivo Translation Platform, R&D Platform Technology & Science, GSK, 709 Swedeland Rd. King of Prussia, PA, 19460, USA.
    Aim: Typically, quantitation of biotherapeutics from biological matrices by LC-MS is based on a surrogate peptide approach to determine molecule concentration. Recent efforts have focused on quantitation of the intact protein molecules or larger mass subunits of monoclonal antibodies. To date, there has been limited guidance for large or intact protein mass quantitation for quantitative bioanalysis. Read More

    2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
    Bioanalysis 2017 Nov 17;9(22):1807-1825. Epub 2017 Nov 17.
    UK MHRA, London, UK.
    The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 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, 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 ligand-binding assay (LBA) approaches. Read More

    Volumetric absorptive microsampling combined with impact-assisted extraction for hematocrit effect free assays.
    Bioanalysis 2017 Nov 17;9(22):1761-1769. Epub 2017 Nov 17.
    Altasciences Clinical Research, 575 Armand-Frappier, Laval, Quebec H7V 4B3, Canada.
    Aim: Volumetric absorptive microsampling (VAMS) is a recent technology available for sampling and analyzing low blood volume. The present work describes the utilization of VAMS for the quantitation of naproxen and ritonavir in human blood using a novel bead-based impact-assisted extraction (IAE) procedure.

    Results: Sampling volume accuracy of the VAMS device was independent of the blood hematocrit (HCT) level, however analyte recovery decreased with increasing HCT when extracted using ultrasonication. Read More

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