Eliminating Bottlenecks for Efficient Bioanalysis: Practices and Applications in Drug Discovery and Development

[1]  O. Flint,et al.  Cannabinoid receptor antagonist-induced striated muscle toxicity and ethylmalonic-adipic aciduria in beagle dogs. , 2012, Toxicological sciences : an official journal of the Society of Toxicology.

[2]  Rainer Bischoff,et al.  Internal standards in the quantitative determination of protein biopharmaceuticals using liquid chromatography coupled to mass spectrometry. , 2012, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[3]  E. Diamandis,et al.  The bottleneck in the cancer biomarker pipeline and protein quantification through mass spectrometry-based approaches: current strategies for candidate verification. , 2010, Clinical chemistry.

[4]  Hong Gao,et al.  LC‐MS Bioanalysis of Drugs in Tissue Samples , 2013 .

[5]  Naidong Weng,et al.  Important considerations for quantitation of small-molecule biomarkers using LC-MS. , 2012, Bioanalysis.

[6]  H. Kato,et al.  Clinical‐scale high‐throughput human plasma proteome analysis: Lung adenocarcinoma , 2005, Proteomics.

[7]  Richard D. LeDuc,et al.  Mapping Intact Protein Isoforms in Discovery Mode Using Top Down Proteomics , 2011, Nature.

[8]  Zheng Ouyang,et al.  Pellet digestion: a simple and efficient sample preparation technique for LC-MS/MS quantification of large therapeutic proteins in plasma. , 2012, Bioanalysis.

[9]  Christopher S. Hughes,et al.  High-throughput cytochrome P450 inhibition assays using laser diode thermal desorption-atmospheric pressure chemical ionization-tandem mass spectrometry. , 2007, Analytical chemistry.

[10]  Allen F. Hirsch,et al.  Good laboratory practice regulations , 1989 .

[11]  C. Hop,et al.  Plasma-pooling methods to increase throughput for in vivo pharmacokinetic screening. , 1998, Journal of pharmaceutical sciences.

[12]  D. Holtzman,et al.  Quantitative analysis of amyloid beta peptides in cerebrospinal fluid of Alzheimer's disease patients by immunoaffinity purification and stable isotope dilution liquid chromatography/negative electrospray ionization tandem mass spectrometry. , 2006, Rapid communications in mass spectrometry : RCM.

[13]  Ronan M. T. Fleming,et al.  A community-driven global reconstruction of human metabolism , 2013, Nature Biotechnology.

[14]  R. A. Thompson,et al.  Use of radiolabeled compounds in drug metabolism and pharmacokinetic studies. , 2012, Chemical research in toxicology.

[15]  E. Ezan,et al.  Immunopurification and mass spectrometric quantification of the active form of a chimeric therapeutic antibody in human serum. , 2008, Analytical chemistry.

[16]  Naidong Weng,et al.  Special FocuS iSSue: HigH-ReSolution MS peRSpective , 2010 .

[17]  Irene van den Broek,et al.  Bioanalytical LC-MS/MS of protein-based biopharmaceuticals. , 2013, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[18]  I. Blair.  Analysis of estrogens in serum and plasma from postmenopausal women: Past present, and future , 2010, Steroids.

[19]  C. T. Viswanathan.  Bringing new technologies into regulatory space. , 2012, Bioanalysis.

[20]  Xianmei Cai,et al.  Sample reduction strategies in discovery bioanalysis. , 2013, Bioanalysis.

[21]  G. Poste.  Bring on the biomarkers , 2011, Nature.

[22]  D. Billheimer,et al.  Mass spectrometric immunoassay and MRM as targeted MS‐based quantitative approaches in biomarker development: Potential applications to cardiovascular disease and diabetes , 2013, Proteomics. Clinical applications.

[23]  Henrik Zetterberg,et al.  A novel Aβ isoform pattern in CSF reflects γ-secretase inhibition in Alzheimer disease , 2010, Alzheimer's Research & Therapy.

[24]  S. Needham,et al.  The advantages of microflow LC-MS/MS compared with conventional HPLC-MS/MS for the analysis of methotrexate from human plasma. , 2013, Bioanalysis.

[25]  D. Kassel.  In Vitro ADME Profiling and Pharmacokinetic Screening in Drug Discovery , 2012 .

[26]  T. Santa,et al.  Derivatization in liquid chromatography for mass spectrometric detection. , 2013, Drug discoveries & therapeutics.

[27]  M. Reily,et al.  Mass Spectrometry for Metabolomics , 2013 .

[28]  W. Schafer,et al.  Evaluation of micro ultra high pressure liquid chromatography for pharmaceutical analysis , 2013 .

[29]  Anders Tunek,et al.  High-throughput screening of drug-brain tissue binding and in silico prediction for assessment of central nervous system drug delivery. , 2007, Journal of medicinal chemistry.

[30]  Thomas Layloff,et al.  Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies , 1992 .

[31]  I. Kola,et al.  Can the pharmaceutical industry reduce attrition rates? , 2004, Nature Reviews Drug Discovery.

[32]  E. De Pauw,et al.  Development of an absolute quantification method targeting growth hormone biomarkers using liquid chromatography coupled to isotope dilution mass spectrometry. , 2007, Journal of chromatography. A.

[33]  Joseph L. Cantone,et al.  Application of quantitative LC–MS surrogate peptide methodology in the analysis of the amyloid beta peptide (Aβ) biosynthetic intermediate protein APP–βCTF , 2009, Journal of Neuroscience Methods.

[34]  D L Massart,et al.  Knowledge-based system for the automated solid-phase extraction of basic drugs from plasma coupled with their liquid chromatographic determination. Application to the biodetermination of beta-receptor blocking agents. , 1994, Journal of chromatography. A.

[35]  E. Ezan,et al.  MS-based approaches for studying the pharmacokinetics of protein drugs. , 2011, Bioanalysis.

[36]  Constantinos Apostolou,et al.  Quantitative determination of donepezil in human plasma by liquid chromatography/tandem mass spectrometry employing an automated liquid-liquid extraction based on 96-well format plates. Application to a bioequivalence study. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[37]  Ian A Blair,et al.  Stable-isotope dilution LC–MS for quantitative biomarker analysis. , 2010, Bioanalysis.

[38]  Bo Liu,et al.  Snapshot PK: a rapid rodent in vivo preclinical screening approach. , 2008, Drug discovery today.

[39]  D. Kassel,et al.  A new ultra‐high throughput method for characterizing combinatorial libraries incorporating a multiple probe autosampler coupled with flow injection mass spectrometry analysis , 1998 .

[40]  Oscar Núñez,et al.  State-of-the-art in fast liquid chromatography-mass spectrometry for bio-analytical applications. , 2013, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[41]  Jing-tao Wu,et al.  Evaluation of surrogate matrices for standard curve preparation in tissue bioanalysis. , 2012, Bioanalysis.

[42]  M. Novotny.  Capillary HPLC: Columns and Related Instrumentation , 1980 .

[43]  John S Janiszewski,et al.  Perspectives on bioanalytical mass spectrometry and automation in drug discovery. , 2008, Current drug metabolism.

[44]  M. Mann,et al.  Universal sample preparation method for proteome analysis , 2009, Nature Methods.

[45]  D. Anagnostopoulos,et al.  Determination of colistin A and colistin B in human plasma by UPLC-ESI high resolution tandem MS: application to a pharmacokinetic study. , 2013, Journal of pharmaceutical and biomedical analysis.

[46]  Daniel B Kassel,et al.  High-throughput mass spectrometric cytochrome P450 inhibition screening. , 2013, Methods in molecular biology.

[47]  W. Humphreys,et al.  Continuous Blood Withdrawal as a Rapid Screening Method for Determining Clearance and Oral Bioavailability in Rats , 1998, Pharmaceutical Research.

[48]  M. Fidock,et al.  Bioanalysis of biomarkers for drug development. , 2012, Bioanalysis.

[49]  R. Süssmuth,et al.  Application of a Rapid and Integrated Analysis System (RIAS) as a High-Throughput Processing Tool for In Vitro ADME Samples by Liquid Chromatography/Tandem Mass Spectrometry , 2011, Journal of biomolecular screening.

[50]  Wilson Z Shou,et al.  Recent development in high-throughput bioanalytical support for in vitro ADMET profiling , 2010, Expert opinion on drug metabolism & toxicology.

[51]  Kjell Johnson,et al.  An efficient approach for the rapid assessment of oral rat exposures for new chemical entities in drug discovery. , 2006, Journal of pharmaceutical sciences.

[52]  David B. Buckley,et al.  Exploring the utility of high-resolution MS with post-acquisition data mining for simultaneous exogenous and endogenous metabolite profiling. , 2013, Bioanalysis.

[53]  Hugues Henry,et al.  Comparison between a high-resolution single-stage Orbitrap and a triple quadrupole mass spectrometer for quantitative analyses of drugs. , 2012, Rapid communications in mass spectrometry : RCM.

[54]  Maria P. Pavlou,et al.  The long journey of cancer biomarkers from the bench to the clinic. , 2013, Clinical chemistry.

[55]  Olga Kavetskaia,et al.  Development and application of a new on-line SPE system combined with LC-MS/MS detection for high throughput direct analysis of pharmaceutical compounds in plasma. , 2005, Journal of chromatography. A.

[56]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007 .

[57]  Darryl B. Hardie,et al.  A quantitative study of the effects of chaotropic agents, surfactants, and solvents on the digestion efficiency of human plasma proteins by trypsin. , 2010, Journal of proteome research.

[58]  Walter A. Korfmacher,et al.  Cassette-accelerated rapid rat screen: a systematic procedure for the dosing and liquid chromatography/atmospheric pressure ionization tandem mass spectrometric analysis of new chemical entities as part of new drug discovery. , 2001, Rapid communications in mass spectrometry : RCM.

[59]  W. M. van der Flier,et al.  Tau and p-tau as CSF biomarkers in dementia: a meta-analysis , 2011, Clinical chemistry and laboratory medicine.

[60]  Michael D. Reily,et al.  LC–MS in Endogenous Metabolite Profiling and Small‐Molecule Biomarker Discovery , 2011 .

[61]  K. Resing,et al.  Comparison of Label-free Methods for Quantifying Human Proteins by Shotgun Proteomics*S , 2005, Molecular & Cellular Proteomics.

[62]  T. Maurer,et al.  Influence of nonspecific brain and plasma binding on CNS exposure: implications for rational drug discovery , 2002, Biopharmaceutics & drug disposition.

[63]  T. Olah,et al.  Increasing high-throughput discovery bioanalysis using automated selected reaction monitoring compound optimization, ultra-high-pressure liquid chromatography, and single-step sample preparation workflows. , 2009, Rapid communications in mass spectrometry : RCM.

[64]  T. Olah,et al.  Full-scan high resolution accurate mass spectrometry (HRMS) in regulated bioanalysis: LC-HRMS for the quantitation of prednisone and prednisolone in human plasma. , 2011, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[65]  Sankha S. Basu,et al.  Rotenone-Mediated Changes in Intracellular Coenzyme A Thioester Levels: Implications for Mitochondrial Dysfunction , 2011, Chemical research in toxicology.

[66]  P. Timmerman,et al.  Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum. , 2010, Bioanalysis.

[67]  R. L. Beardsley,et al.  Accelerating high quality bioanalytical LC/MS/MS assays using fused-core columns. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[68]  R. Süssmuth,et al.  An integrated platform for fully automated high-throughput LC–MS/MS analysis of in vitro metabolic stability assay samples , 2010 .

[69]  Mark Sanders,et al.  Expedient data mining for nontargeted high-resolution LC-MS profiles of biological samples. , 2013, Bioanalysis.

[70]  Y. Sugiyama,et al.  Evaluation of the efficiency of targeting of antitumor drugs: simulation analysis based on pharmacokinetic/pharmacodynamic considerations. , 1996, Journal of drug targeting.

[71]  Naidong Weng,et al.  Capsule review on bioanalytical method transfer: opportunities and challenges for chromatographic methods. , 2011, Bioanalysis.

[72]  Viswanath Devanarayan,et al.  Confirmatory reanalysis of incurred bioanalytical samples , 2007, The AAPS Journal.

[73]  H. Mulla,et al.  Dried Blood Spot Sampling with LC-MS Analysis for Routine Therapeutic Caffeine Monitoring in Neonates , 2012 .

[74]  Ramona C Rodila,et al.  A sample preparation process for LC-MS/MS analysis of total protein drug concentrations in monkey plasma samples with antibody. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[75]  K. Heinig,et al.  An improved LC-MS/MS method for the determination of taspoglutide in plasma and urine using orthogonal HILIC-RP column switching, ultra-performance LC separation and 'wrong-way-round' electrospray ionization. , 2011, Biomedical chromatography : BMC.

[76]  Min Meng,et al.  Method development and validation of six bile acids for regulated bioanalysis: improving selectivity and sensitivity. , 2013, Bioanalysis.

[77]  Steven A Carr,et al.  Protein biomarker discovery and validation: the long and uncertain path to clinical utility , 2006, Nature Biotechnology.

[78]  Shaolian Zhou,et al.  Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods , 2005 .

[79]  Darryl B. Hardie,et al.  Mass spectrometric quantitation of peptides and proteins using Stable Isotope Standards and Capture by Anti-Peptide Antibodies (SISCAPA). , 2004, Journal of proteome research.

[80]  B. Pedersen,et al.  A trauma‐like elevation of plasma cytokines in humans in response to treadmill running , 1998, The Journal of physiology.

[81]  T. Croley,et al.  The Chromatographic Role in High Resolution Mass Spectrometry for Non-Targeted Analysis , 2012, Journal of the American Society for Mass Spectrometry.

[82]  Magnus Knutsson,et al.  Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum. , 2009, Bioanalysis.

[83]  A P Watt,et al.  Higher throughput bioanalysis by automation of a protein precipitation assay using a 96-well format with detection by LC-MS/MS. , 2000, Analytical chemistry.

[84]  Geoff Watts,et al.  UK Biobank opens its data vaults to researchers , 2012, BMJ : British Medical Journal.

[85]  A. Nedderman,et al.  Looking back through the MIST: a perspective of evolving strategies and key focus areas for metabolite safety analysis. , 2010, Bioanalysis.

[86]  Christopher A. James,et al.  Application of automated serial blood sampling and dried blood spot technique with liquid chromatography-tandem mass spectrometry for pharmacokinetic studies in mice. , 2011, Journal of pharmaceutical and biomedical analysis.

[87]  R. Plumb,et al.  High-throughput quantification for a drug mixture in rat plasma-a comparison of Ultra Performance liquid chromatography/tandem mass spectrometry with high-performance liquid chromatography/tandem mass spectrometry. , 2006, Rapid communications in mass spectrometry : RCM.

[88]  Wilson Z Shou,et al.  Recent development in software and automation tools for high-throughput discovery bioanalysis. , 2012, Bioanalysis.

[89]  Gérard Hopfgartner,et al.  Quantification of acetaminophen and two of its metabolites in human plasma by ultra-high performance liquid chromatography-low and high resolution tandem mass spectrometry. , 2012, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[90]  Yuan-Qing Xia,et al.  It is time for a paradigm shift in drug discovery bioanalysis: from SRM to HRMS. , 2011, Journal of mass spectrometry : JMS.

[91]  O. Heudi,et al.  Laser diode thermal desorption-positive mode atmospheric pressure chemical ionization tandem mass spectrometry for the ultra-fast quantification of a pharmaceutical compound in human plasma. , 2011, Journal of pharmaceutical and biomedical analysis.

[92]  N. Penner,et al.  Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how? , 2012, Chemical research in toxicology.

[93]  Y. Li,et al.  A high-speed liquid chromatography/tandem mass spectrometry platform using multiplexed multiple-injection chromatography controlled by single software and its application in discovery ADME screening. , 2013, Rapid communications in mass spectrometry : RCM.

[94]  Hossein Salimi-Moosavi,et al.  General LC-MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies. , 2012, Analytical chemistry.

[95]  Kevin Bateman,et al.  2 Bioanalytical report writing , 2022 .

[96]  Yulia Benitex,et al.  Addressing the need for biomarker liquid chromatography/mass spectrometry assays: a protocol for effective method development for the bioanalysis of endogenous compounds in cerebrospinal fluid. , 2013, Rapid communications in mass spectrometry : RCM.

[97]  Csaba Nemes,et al.  Application of parallel liquid chromatography/mass spectrometry for high throughput microsomal stability screening of compound libraries , 2002, Journal of the American Society for Mass Spectrometry.

[98]  Christoph H Borchers,et al.  Multi-site assessment of the precision and reproducibility of multiple reaction monitoring–based measurements of proteins in plasma , 2009, Nature Biotechnology.

[99]  Mathieu Dubois,et al.  Bioanalysis of recombinant proteins and antibodies by mass spectrometry. , 2009, The Analyst.

[100]  D. Kassel,et al.  A high throughput metabolic stability screening workflow with automated assessment of data quality in pharmaceutical industry. , 2010, Journal of chromatography. A.

[101]  F. Garofolo,et al.  Large molecule bioanalysis using Q-TOF without predigestion and its data processing challenges. , 2012, Bioanalysis.

[102]  L L Needham,et al.  Isotope dilution--mass spectrometric quantification of specific proteins: model application with apolipoprotein A-I. , 1996, Clinical chemistry.

[103]  F. Tse,et al.  Strategies in quantitative LC-MS/MS analysis of unstable small molecules in biological matrices. , 2011, Biomedical chromatography : BMC.

[104]  J. Arora,et al.  8-Oxo-2'-deoxyguanosine as a biomarker of tobacco-smoking-induced oxidative stress. , 2012, Free radical biology & medicine.

[105]  H. Soares,et al.  Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report , 2005, Pharmaceutical Research.

[106]  Xia Yin,et al.  2009 White Paper on recent issues in regulated bioanalysis from the 3rd Calibration and Validation Group Workshop. , 2010, Bioanalysis.

[107]  Hossein Salimi-Moosavi,et al.  Simultaneous Analysis of Multiple Monoclonal Antibody Biotherapeutics by LC-MS/MS Method in Rat Plasma Following Cassette-Dosing , 2012, The AAPS Journal.

[108]  Jiunn H. Lin,et al.  Tissue distribution and pharmacodynamics: a complicated relationship. , 2006, Current drug metabolism.

[109]  S. Goodison,et al.  Urine-based assays for the detection of bladder cancer. , 2009, Biomarkers in medicine.

[110]  Yuan Wang,et al.  Urinary metabonomic study of lung cancer by a fully automatic hyphenated hydrophilic interaction/RPLC-MS system. , 2010, Journal of separation science.

[111]  M. Carroll,et al.  Blood cells from Friedreich ataxia patients harbor frataxin deficiency without a loss of mitochondrial function. , 2011, Mitochondrion.

[112]  Lihua Huang,et al.  Impact of variable domain glycosylation on antibody clearance: an LC/MS characterization. , 2006, Analytical biochemistry.

[113]  J. Schellens,et al.  Enzymatic digestion as a tool for the LC-MS/MS quantification of large peptides in biological matrices: measurement of chymotryptic fragments from the HIV-1 fusion inhibitor enfuvirtide and its metabolite M-20 in human plasma. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[114]  Daniel E Mulvana,et al.  Critical topics in ensuring data quality in bioanalytical LC-MS method development. , 2010, Bioanalysis.

[115]  T. Veenstra,et al.  Cancer biomarker discovery: Opportunities and pitfalls in analytical methods , 2011, Electrophoresis.

[116]  Naidong Weng,et al.  Analysis of polar metabolites by hydrophilic interaction chromatography--MS/MS. , 2011, Bioanalysis.

[117]  Davy Guillarme,et al.  Newer Developments in HPLC Impacting Pharmaceutical Analysis : A Brief Review , 2013 .

[118]  Constantinos Apostolou,et al.  Advantages of automation in plasma sample preparation prior to HPLC/MS/MS quantification: application to the determination of cilazapril and cilazaprilat in a bioequivalence study. , 2011, Journal of AOAC International.

[119]  Sankha S. Basu,et al.  SILEC: a protocol for generating and using isotopically labeled coenzyme A mass spectrometry standards , 2011, Nature Protocols.

[120]  A. Yocum,et al.  Effect of immunoaffinity depletion of human serum during proteomic investigations. , 2005, Journal of proteome research.

[121]  V. P. Miller.  SPE-MS analysis of absorption, distribution, metabolism and excretion assays: a tool to increase throughput and steamline workflow. , 2012, Bioanalysis.

[122]  Guodong Chen,et al.  Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies , 2011, Analytical and Bioanalytical Chemistry.

[123]  David S. Wishart,et al.  HMDB 3.0—The Human Metabolome Database in 2013 , 2012, Nucleic Acids Res..

[124]  Liyu Yang,et al.  Development of methods to monitor ionization modification from dosing vehicles and phospholipids in study samples. , 2011, Bioanalysis.

[125]  Jürgen Cox,et al.  A practical guide to the MaxQuant computational platform for SILAC-based quantitative proteomics , 2009, Nature Protocols.

[126]  Erin Chambers,et al.  Systematic and comprehensive strategy for reducing matrix effects in LC/MS/MS analyses. , 2007, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[127]  Philip Timmerman,et al.  Tiered approach revisited: introducing stage-appropriate or assay-appropriate scientific validation. , 2014, Bioanalysis.

[128]  S. Walker,et al.  Pharmaceutical innovation by the seven UK-owned pharmaceutical companies (1964-1985). , 1988, British journal of clinical pharmacology.

[129]  K. Bateman,et al.  Quantitative-qualitative data acquisition using a benchtop orbitrap mass spectrometer , 2009, Journal of the American Society for Mass Spectrometry.

[130]  Fabio Garofolo,et al.  Large-molecule quantification: sensitivity and selectivity head-to-head comparison of triple quadrupole with Q-TOF. , 2013, Bioanalysis.

[131]  M. Molloy,et al.  Recent progress in selected reaction monitoring MS-driven plasma protein biomarker analysis. , 2009, Bioanalysis.

[132]  S. V. Rahavendran,et al.  Microflow LC‐MS for Quantitative Analysis of Drugs in Support of Microsampling , 2013 .

[133]  Steven W. Taylor,et al.  Simultaneous quantification of davalintide, a novel amylin-mimetic peptide, and its active metabolite in beagle and rat plasma by online SPE and LC-MS/MS. , 2012, Bioanalysis.

[134]  S. Needham,et al.  Micro-LC-MS/MS: the future of bioanalysis. , 2013, Bioanalysis.

[135]  Ian A Blair,et al.  Biochemical Fractionation and Stable Isotope Dilution Liquid Chromatography-mass Spectrometry for Targeted and Microdomain-specific Protein Quantification in Human Postmortem Brain Tissue* , 2012, Molecular & Cellular Proteomics.

[136]  G. Lawson,et al.  Quantitative determination of atenolol in dried blood spot samples by LC-HRMS: a potential method for assessing medication adherence. , 2012, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[137]  M. Berna,et al.  Coupling immunoaffinity techniques with MS for quantitative analysis of low-abundance protein biomarkers , 2007, Expert review of proteomics.

[138]  Phil Jeffrey,et al.  Improving the in Vitro Prediction of in Vivo Central Nervous System Penetration: Integrating Permeability, P-glycoprotein Efflux, and Free Fractions in Blood and Brain , 2006, Journal of Pharmacology and Experimental Therapeutics.

[139]  I. Wilson,et al.  UPLC/MS(E); a new approach for generating molecular fragment information for biomarker structure elucidation. , 2006, Rapid communications in mass spectrometry : RCM.

[140]  Tjerk Bueters,et al.  High-throughput analysis of standardized pharmacokinetic studies in the rat using sample pooling and UPLC-MS/MS. , 2011, Journal of pharmaceutical and biomedical analysis.

[141]  P. Jandera.  Advances in the development of organic polymer monolithic columns and their applications in food analysis--a review. , 2013, Journal of chromatography. A.

[142]  Sami El Deeb,et al.  Monolithic Silica for Fast HPLC: Current Success and Promising Future , 2011 .

[143]  D. Drexler,et al.  Cassette incubation followed by bioanalysis using high-resolution MS for in vitro ADME screening assays. , 2012, Bioanalysis.

[144]  David Higton,et al.  Ask the experts: automation: part I. , 2013, Bioanalysis.

[145]  Yan Xu,et al.  Tissue sample preparation in bioanalytical assays. , 2012, Bioanalysis.

[146]  S. V. Rahavendran,et al.  Discovery pharmacokinetic studies in mice using serial microsampling, dried blood spots and microbore LC-MS/MS. , 2012, Bioanalysis.

[147]  Daniel J Weston,et al.  Conference Report: High-resolution MS in drug discovery and development: current applications and future perspectives. , 2012, Bioanalysis.

[148]  Heather Myler,et al.  Bioanalytical Approaches to Quantify “Total” and “Free” Therapeutic Antibodies and Their Targets: Technical Challenges and PK/PD Applications Over the Course of Drug Development , 2011, The AAPS Journal.

[149]  Prashant S. Kharkar,et al.  Two-dimensional (2D) in silico models for absorption, distribution, metabolism, excretion and toxicity (ADME/T) in drug discovery. , 2010 .

[150]  A. Wu,et al.  Implementation of liquid chromatography/mass spectrometry into the clinical laboratory. , 2013, Clinica chimica acta; international journal of clinical chemistry.

[151]  Edward Wells,et al.  Unique challenges of providing bioanalytical support for biological therapeutic pharmacokinetic programs. , 2011, Bioanalysis.

[152]  T. Pal,et al.  Determination of gemifloxacin in different tissues of rat after oral dosing of gemifloxacin mesylate by LC-MS/MS and its application in drug tissue distribution study. , 2010, Journal of pharmaceutical and biomedical analysis.

[153]  Bill J Smith,et al.  Prediction of Human Pharmacokinetics From Preclinical Information: Comparative Accuracy of Quantitative Prediction Approaches , 2009, Journal of clinical pharmacology.

[154]  Ming Zhu,et al.  Highly specific and sensitive measurements of human and monkey interleukin 21 using sequential protein and tryptic peptide immunoaffinity LC-MS/MS. , 2013, Analytical chemistry.

[155]  D. Fraier,et al.  Ion-suppression effects in liquid chromatography-tandem mass spectrometry due to a formulation agent, a case study in drug discovery bioanalysis. , 2005, Journal of pharmaceutical and biomedical analysis.

[156]  M. Behari,et al.  Ultrastructural Variations in Platelets and Platelet Mitochondria: A Novel Feature in Amyotrophic Lateral Sclerosis , 2011, Ultrastructural pathology.

[157]  Hao Wang,et al.  Validation and application of an LC-MS/MS method for quantitation of three fatty acid ethanolamides as biomarkers for fatty acid hydrolase inhibition in human plasma. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[158]  Paul Workman,et al.  The application of cassette dosing for pharmacokinetic screening in small-molecule cancer drug discovery , 2007, Molecular Cancer Therapeutics.

[159]  A Kaufmann,et al.  Comprehensive comparison of liquid chromatography selectivity as provided by two types of liquid chromatography detectors (high resolution mass spectrometry and tandem mass spectrometry): "where is the crossover point?". , 2010, Analytica chimica acta.

[160]  I. Wilson,et al.  A pragmatic and readily implemented quality control strategy for HPLC-MS and GC-MS-based metabonomic analysis. , 2006, The Analyst.

[161]  P. Timmerman,et al.  Managing scientific, technical and regulatory innovation in regulated bioanalysis: a discussion paper from the European Bioanalysis Forum. , 2013, Bioanalysis.

[162]  Fumin Li,et al.  Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC-MS. , 2011, Bioanalysis.

[163]  C. Cramers,et al.  Microcolumn liquid chromatography: Instrumentation, detection and applications , 1997 .

[164]  Naidong Weng,et al.  Relative quantitation of glycoisoforms of intact apolipoprotein C3 in human plasma by liquid chromatography-high-resolution mass spectrometry. , 2013, Analytical chemistry.

[165]  N. Kelleher,et al.  The emergence of top-down proteomics in clinical research , 2013, Genome Medicine.

[166]  Jie Zhang,et al.  Handbook of LC-MS bioanalysis : best practices, experimental protocols, and regulations , 2013 .

[167]  Eugene Ciccimaro,et al.  Liquid chromatography/mass spectrometry of pre-ionized Girard P derivatives for quantifying estrone and its metabolites in serum from postmenopausal women. , 2011, Rapid communications in mass spectrometry : RCM.

[168]  Kristopher W King,et al.  ASPECTS: an automation-assisted SPE method development system. , 2013, Bioanalysis.

[169]  Xin Zhang,et al.  Analysis of small-molecule drugs in tissue: current practices , 2013 .

[170]  William S. Hancock,et al.  Development of different analysis platforms with LC-MS for pharmacokinetic studies of protein drugs. , 2009, Analytical chemistry.

[171]  K. Blennow,et al.  The application of cerebrospinal fluid biomarkers in early diagnosis of Alzheimer disease. , 2013, The Medical clinics of North America.

[172]  J. Campbell,et al.  Using high-resolution quadrupole TOF technology in DMPK analyses. , 2012, Bioanalysis.

[173]  Ruedi Aebersold,et al.  Challenges and Opportunities in Proteomics Data Analysis* , 2006, Molecular & Cellular Proteomics.

[174]  R. Hargreaves,et al.  Clinical biomarkers in drug discovery and development , 2003, Nature Reviews Drug Discovery.

[175]  Z. Ouyang,et al.  A strategy for liquid chromatography/tandem mass spectrometry based quantitation of pegylated protein drugs in plasma using plasma protein precipitation with water-miscible organic solvents and subsequent trypsin digestion to generate surrogate peptides for detection. , 2011, Rapid communications in mass spectrometry : RCM.

[176]  R. Caprioli,et al.  Matrix-assisted laser desorption ionization imaging mass spectrometry: in situ molecular mapping. , 2013, Biochemistry.

[177]  Peeter Ross,et al.  Direct demonstration of tissue uptake of an inhaled drug: proof-of-principle study using matrix-assisted laser desorption ionization mass spectrometry imaging. , 2011, Analytical chemistry.

[178]  N. Anderson,et al.  Quantification of a proteotypic peptide from protein C inhibitor by liquid chromatography-free SISCAPA-MALDI mass spectrometry: application to identification of recurrence of prostate cancer. , 2013, Clinical chemistry.

[179]  Stacy Ho,et al.  2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS. , 2013, Bioanalysis.

[180]  Naidong Weng,et al.  Bioanalysis of drug in tissue: current status and challenges. , 2012, Bioanalysis.

[181]  Michael D Reily,et al.  Advances in mass spectrometry applied to pharmaceutical metabolomics , 2011, Analytical and bioanalytical chemistry.

[182]  Monica H. Elliott,et al.  Current trends in quantitative proteomics. , 2009, Journal of mass spectrometry : JMS.

[183]  H. Karnes,et al.  Investigation of endogenous blood plasma phospholipids, cholesterol and glycerides that contribute to matrix effects in bioanalysis by liquid chromatography/mass spectrometry. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[184]  R. Nagilla,et al.  Cassette dosing for pharmacokinetic screening in drug discovery: comparison of clearance, volume of distribution, half-life, mean residence time, and oral bioavailability obtained by cassette and discrete dosing in rats. , 2011, Journal of pharmaceutical sciences.

[185]  M. Mann,et al.  Stable isotope labeling by amino acids in cell culture for quantitative proteomics. , 2007, Methods in molecular biology.

[186]  D. DeMets,et al.  Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework , 2001, Clinical pharmacology and therapeutics.

[187]  R. Plumb,et al.  Investigating the human metabolism of acetaminophen using UPLC and exact mass oa-TOF MS. , 2005, Journal of pharmaceutical and biomedical analysis.

[188]  M. Bartolomei,et al.  Bisphenol A Exposure Disrupts Genomic Imprinting in the Mouse , 2013, PLoS genetics.

[189]  Anthony J. DeStefano,et al.  Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations , 2009, The AAPS Journal.

[190]  S. Shiva,et al.  Platelet mitochondrial function: from regulation of thrombosis to biomarker of disease. , 2013, Biochemical Society transactions.

[191]  T. Olah,et al.  Targeted quantitative bioanalysis in plasma using liquid chromatography/high-resolution accurate mass spectrometry: an evaluation of global selectivity as a function of mass resolving power and extraction window, with comparison of centroid and profile modes. , 2011, Rapid communications in mass spectrometry : RCM.

[192]  E. Paramithiotis,et al.  Protein biomarker quantification by mass spectrometry. , 2010, Expert opinion on medical diagnostics.

[193]  Zhongzhou Shen,et al.  Quantitative analysis of PD 0332991 in mouse plasma using automated micro-sample processing and microbore liquid chromatography coupled with tandem mass spectrometry. , 2011, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[194]  Walter A. Korfmacher,et al.  Novel in vivo procedure for rapid pharmacokinetic screening of discovery compounds in rats , 1999 .

[195]  Bernd Thiede,et al.  Isobaric protein and peptide quantification: perspectives and issues , 2010, Expert review of proteomics.

[196]  L. Cohen,et al.  Flexible automated approach for quantitative liquid handling of complex biological samples. , 2007, Analytical chemistry.

[197]  G. Cuda,et al.  Nano LC-MS/MS: a robust setup for proteomic analysis. , 2011, Methods in molecular biology.

[198]  Robert S Plumb,et al.  Comparison of the quantification of a therapeutic protein using nominal and accurate mass MS/MS. , 2012, Bioanalysis.

[199]  Vinod P. Shah,et al.  Bioanalytical Method Validation—A Revisit with a Decade of Progress , 2000, Pharmaceutical Research.

[200]  E. Chernetsova,et al.  Ambient desorption ionization mass spectrometry (DART, DESI) and its bioanalytical applications , 2011 .

[201]  Xinping Fang,et al.  LC-MS/MS approach for quantification of therapeutic proteins in plasma using a protein internal standard and 2D-solid-phase extraction cleanup. , 2007, Analytical chemistry.

[202]  N Leigh Anderson,et al.  High-throughput SISCAPA quantitation of peptides from human plasma digests by ultrafast, liquid chromatography-free mass spectrometry. , 2012, Journal of proteome research.

[203]  V. Weaver,et al.  Analysis of protein expression during oxidative stress in breast epithelial cells using a stable isotope labeled proteome internal standard. , 2005, Journal of proteome research.

[204]  R. Perlis,et al.  Translating biomarkers to clinical practice , 2011, Molecular Psychiatry.

[205]  Jie Zhang,et al.  An automation-assisted generic approach for biological sample preparation and LC-MS/MS method validation. , 2011, Bioanalysis.

[206]  Viswanath Devanarayan,et al.  Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement , 2006, Pharmaceutical Research.

[207]  L. Vereyken,et al.  Comparison of triple quadrupole and high-resolution TOF-MS for quantification of peptides. , 2012, Bioanalysis.

[208]  I. Phillips,et al.  Cytochrome P450 Protocols , 1998, Methods in Molecular Biology.

[209]  Vinod P. Shah,et al.  The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation , 2007, The AAPS Journal.

[210]  Chidambaram T Viswanathan.  Incurred sample reanalysis: a global transformation. , 2011, Bioanalysis.

[211]  Bernhard Kuster,et al.  Quantitative mass spectrometry in proteomics: critical review update from 2007 to the present , 2012, Analytical and Bioanalytical Chemistry.

[212]  T. Maurer,et al.  RELATIONSHIP BETWEEN EXPOSURE AND NONSPECIFIC BINDING OF THIRTY-THREE CENTRAL NERVOUS SYSTEM DRUGS IN MICE , 2005, Drug Metabolism and Disposition.

[213]  B. Warrack,et al.  Normalization strategies for metabonomic analysis of urine samples. , 2009, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[214]  Paul Morgan,et al.  Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. , 2012, Drug discovery today.

[215]  Marian Kelley.  Incurred sample reanalysis: it is just a matter of good scientific practice. , 2011, Bioanalysis.

[216]  Walter A. Korfmacher,et al.  High-resolution mass spectrometry will dramatically change our drug-discovery bioanalysis procedures. , 2011, Bioanalysis.

[217]  S. Mandlekar,et al.  Insight into tissue unbound concentration: utility in drug discovery and development. , 2013, Current drug metabolism.

[218]  Olivier Heudi,et al.  Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry. , 2008, Analytical chemistry.

[219]  Mike West,et al.  Development of a high-speed, multiplexed sample-delivery instrument for LC-MS/MS bioanalysis. , 2012, Bioanalysis.

[220]  G. Siuzdak,et al.  XCMS Online: a web-based platform to process untargeted metabolomic data. , 2012, Analytical chemistry.

[221]  A. Kaufmann,et al.  Evaluation of the interrelationship between mass resolving power and mass error tolerances for targeted bioanalysis using liquid chromatography coupled to high-resolution mass spectrometry. , 2013, Rapid communications in mass spectrometry : RCM.

[222]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007, The AAPS Journal.

[223]  Christopher E. Keefer,et al.  Systematic and pairwise analysis of the effects of aromatic halogenation and trifluoromethyl substitution on human liver microsomal clearance. , 2011, Drug metabolism letters.

[224]  W. Humphreys,et al.  Integrated quantitative and qualitative workflow for in vivo bioanalytical support in drug discovery using hybrid Q-TOF-MS. , 2012, Bioanalysis.

[225]  E. Solon.  Use of radioactive compounds and autoradiography to determine drug tissue distribution. , 2012, Chemical research in toxicology.

[226]  Andrew N Hoofnagle,et al.  Multiple-reaction monitoring-mass spectrometric assays can accurately measure the relative protein abundance in complex mixtures. , 2012, Clinical chemistry.

[227]  S. Grebe,et al.  LC-MS/MS in the Clinical Laboratory - Where to From Here? , 2011, The Clinical biochemist. Reviews.

[228]  Fotini Betsou,et al.  Identification of evidence-based biospecimen quality-control tools: a report of the International Society for Biological and Environmental Repositories (ISBER) Biospecimen Science Working Group. , 2013, The Journal of molecular diagnostics : JMD.

[229]  Birgit Grund,et al.  Analysis of biomarker data: logs, odds ratios, and receiver operating characteristic curves , 2010, Current opinion in HIV and AIDS.

[230]  N. Anderson,et al.  The Human Plasma Proteome , 2002, Molecular & Cellular Proteomics.

[231]  Bertrand Rochat,et al.  The future key role of LC-high-resolution-MS analyses in clinical laboratories: a focus on quantification. , 2012, Bioanalysis.

[232]  Liang Yuan,et al.  Automatic Liquid Handling for Life Science , 2012, Journal of laboratory automation.

[233]  Jeffrey W. Smith,et al.  Mass Spectrometry-Based Label-Free Quantitative Proteomics , 2009, Journal of biomedicine & biotechnology.

[234]  D. Ransohoff,et al.  Sources of bias in specimens for research about molecular markers for cancer. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[235]  Chun Li,et al.  A modern in vivo pharmacokinetic paradigm: combining snapshot, rapid and full PK approaches to optimize and expedite early drug discovery. , 2013, Drug discovery today.

[236]  J Cummings,et al.  Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs , 2010, British Journal of Cancer.

[237]  B. Han,et al.  Identification of clinical biomarkers for pre-analytical quality control of blood samples. , 2013, Biopreservation and biobanking.

[238]  Binodh DeSilva,et al.  Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision , 2011, The AAPS Journal.

[239]  Erin E. Chambers,et al.  Development of a fast method for direct analysis of intact synthetic insulins in human plasma: the large peptide challenge. , 2013, Bioanalysis.

[240]  B. Rochat.  Quantitative/qualitative analysis using LC-HRMS: the fundamental step forward for clinical laboratories and clinical practice. , 2012, Bioanalysis.

[241]  Gérard Hopfgartner,et al.  High-resolution mass spectrometry for integrated qualitative and quantitative analysis of pharmaceuticals in biological matrices , 2012, Analytical and Bioanalytical Chemistry.