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Publications from our Bioanalytical and ADME Experts

Collaborative R&D

  • Verplaetse R, and Henion J (2016) Quantitative Determination of Opioids in Whole Blood Using Fully Automated Dried Blood Spot Desorption Coupled to On-line SPE-LC-MS/MS. Drug Testing and Analysis, 8, 30-38.
  • Draher J, Ehling S, Cellar N, Reddy T, Henion J, and Sousou, N (2016) Determination of emerging nitrogenous economic adulterants in milk proteins by high performance liquid chromatography/compact mass spectrometry. RCMS, 30 (11), 1265-1272.
  • Hao C, Sousou N, Eikel D, and Henion J (2015) Thin-Layer Chromatography/Mass Spectrometry Analysis of Sample Mixtures Using a Compact Mass Spectrometer. Am. Lab, May 2015.
  • Verplaetse R , Henion J (2015) Monitoring Opiate Use for Pain Management Using a Fully Automated DBS-SPE-UHPLC-MS/MS Approach, in 63rd American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, St. Louis, MO.
  • Henion J , Oliveira RV, Sturm RM, Abbott R, and Wang P (2014) Micro Sampling of Dried Blood and Plasma Spots with Automated Direct Elution Analysis by LC/MS, in Ghent Symposium on Alternative Sampling Strategies in Toxicology and Therapeutic Drug Monitoring, Ghent, Belgium.
  • Henion J (2015) LC/MS: The Past, Present and Future, in HPLC 2015, Geneva, Switzerland.
  • Sturm RM , Henion J, Abbott R, and Wang P (2015) Novel Membrane Devices and Their Potential Utility in Blood Sample Collection Prior to Analysis of Dried Plasma Spots. Bioanalysis 7(16): 1987-2002.
  • Oliveira RV , Henion J, and Wickremsinhe E (2014) Fully-Automated Approach for Online Dried Blood Spot Extraction and Bioanalysis by Two-Dimensional-Liquid Chromatography Coupled with High-Resolution Quadrupole Time-of-Flight Mass Spectrometry. Anal Chem 86(2): 1246-1253.
  • Oliveira RV , Henion J, and Wickremsinhe ER (2014) Automated Direct Extraction and Analysis of Dried Blood Spots Employing On-Line SPE High-Resolution Accurate Mass Bioanalysis. Bioanalysis 6(15): 2027-2041.
  • Oliveira RV , Henion J, and Wickremsinhe E (2014) Automated High-Capacity On-Line Extraction and Bioanalysis of Dried Blood Spot Samples Using Liquid Chromatography/High-Resolution Accurate Mass Spectrometry Rapid Communications in Mass Spectrometry 28(22): 2415-2426.
  • Sturm RM , Henion J, Abbott R, and Wang P (2014) Dried Plasma Spots Derived From Filtered Whole Blood. Hemato-Compatible? in 62nd American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Baltimore, MD.
  • Henion J , Sturm RM, Abbott R, and Wang P (2014) Recent Developments in Automated Dried Plasma Spot Analysis Using a Novel Membrane Size Exclusion Card, in Mass Spectrometry: Applications to the Clinical Lab, San Diego, CA.
  • Henion J , Oliveira RV, and Chace DH (2013) Microsample Analyses Via DBS: Challenges and Opportunities. Bioanalysis 5(20): 2547-2565.
  • Henion J , Oliveira RV, Li F, Foley T, and Pomponio R (2013) Dried Blood Spots: The Future, in Microsampling in Pharmaceutical Bioanalysis (Zane P and Emmons G eds) pp 48-66, Future Science.
  • Sturm RM , Henion J, Abbott R, and Wang P (2013) HRAM MS Bioanalysis of Micro Samples Employing Membrane-Based Dried Matrix Spots: An Alternative to Cellulose DBS Substrates, in Thermo Scientific Users Meeting at the 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Sturm RM , Henion J, Abbott R, and Wang P (2013) Development of a Molecular Filtration Membrane Substrate as an Alternative for DBS LC/MS Bioanalysis, in 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Oliveira RV , Henion J, and Wickremsinhe E (2013) Direct Automated Analysis of Dried Blood Spots (DBS) by 2D LC-HRMS: Effects of Hematocrit on DBS Results, in 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Shen M , Sun L, Bateman K, and Henion J (2013) Development of Ultrasensitive Nanoscale LC/MS Techniques for Quantification of an HIV-1 Integrase Inhibitor in Human Plasma, in 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Henion J , Sturm RM, Abbott R, and Wang P (2013) HRAM MS Bioanalysis of Micro Samples Employing Membrane-Based Dried Matrix Spots: An Alternative to Cellulose DBS Substrates, in European Bioanalytical Forum (EBF) 6th Open Meeting, Barcelona, Spain.
  • Henion J (2012), Sample Preparation Alternatives for High-Throughput LC/MS Analyses, in American Society of Mass Spectrometry ( ASMS) Asilomar Conference. Pacific Grove, CA.
  • Li Y , Henion J, Abbott R, and Wang P (2012) Semi-Automated Direct Elution of Dried Blood Spots for the Quantitative Determination of Guanfacine in Human Blood. Bioanalysis 4(12): 1445-1456.
  • Li Y , Henion J, Abbott R, and Wang P (2012) The Use of a Membrane Filtration Device to Form Dried Plasma Spots for the Quantitative Determination of Guanfacine in Whole Blood. Rapid Communications in Mass Spectrometry 26(10): 1208-1212.
  • Li Y , Henion J, Abbott R, and Wang P (2011) Dried Blood Spots as a Sampling Technique for the Quantitative Determination of Guanfacine in Clinical Studies. Bioanalysis 3(22): 2501-2514.

Drug Discovery and Development

  • Raub TJ, Wishart GN, Kulanthaivel P, Staton BA, Ajamie RT, Sawada GA, Gelbert LM, Shannon HE, Sanchez-Martinez C, and De Dios A. (2015) Brain exposure of two selective dual CDK4 and CDK6 Inhibitors and the antitumor activity of CDK4 and CDK6 inhibition in combination with temozolomide in an intracranial glioblastoma xenograft. Drug Metab Dispos. 43(9): 1360-71.
  • Takahashi H, Riether D, Bartolozzi A, Bosanac T, Berger V, Binetti R, Broadwater J, Chen Z, Crux R, De Lombaert S, Dave R, Dines JA, Fadra-Khan T, Flegg A, Garrigou M, Hao MH, Huber J, Hutzler JM, Kerr S, Kotey A, Liu W, Lo HY, Loke PL, Mahaney PE, Morwick TM, Napier S, Olague A, Pack E, Padyana AK, Thomson DS, Tye H, Wu L, Zindell RM, Abeywardane A, and Simpson T. (2015) Synthesis, SAR, and series evolution of novel oxadiazole-containing 5-lipoxygenase activating protein inhibitors: discovery of 2-[4-(3-{(r)-1-[4-(2-amino-pyrimidin-5-yl)-phenyl]-1-cyclopropyl-ethyl}-[1,2,4]oxadiazol-5-yl)-pyrazol-1-yl]-N,N-dimethyl-acetamide (BI 665915). J Med Chem. 58(4):1669-90.
  • Pritchard JF, Anderson SR, Breuckner C, Premkumar ND, and Polli JW. (2013) A hitchhiker’s guide to outsourcing ADME studies: the inside of outsourcing. Bioanalysis. 5(4):403-5.
  • Zamek-Gliszczynski MJ, Abraham TL, Alberts JJ, Kulanthaivel P, Jackson KA, Chow KH, McCann DJ, Hu H, Anderson S, Furr NA, Barbuch RJ, and Cassidy KC. (2013) Pharmacokinetics, Metabolism, and Excretion of the GSK-3 Inhibitor Ly2090314 in Rats, Dogs, and Humans: A Case Study in Rapid Clearance by Extensive Metabolism with Low Circulating Metabolite Exposures. Drug Metab Dispos. 41:714-26.
  • Martinez-Perez JA, Iyengar S, Shannon HE, Bleakman D, Alt A, Clawson DK, Arnold BM, Bell MG, Bleisch TJ, Castaño AM, Del Prado M, Dominguez E, Escribano AM, Filla SA, Ho KH, Hudziak KJ, Jones CK, Mateo A, Mathes BM, Mattiuz EL, Ogden AM, Simmons RM, Stack DR, Stratford RE, Winter MA, Wu Z, and Ornstein PL. (2013) GluK1 antagonists from 6-(carboxy)phenyl decahydroisoquinoline derivatives: in vitro profile and in vivo analgesic efficacy. Bioorg Med Chem Lett. 23(23): 6463-66.
  • Wickremsinhe ER, Huang NH, Abdul BG, Knotts K, Ruterbories KJ, and Manro JR. (2013) Preclinical bridging studies: understanding dried blood spot and plasma exposure profiles. Bioanalysis. 5(2): 159-70.
  • Lowe S, Dean R, Ackermann B, Jackson K, Natanegara F, Anderson S, Eckstein J, Yuen E, Ayan-Oshodi M, Ho M, McKinzie D, Perry K, and Svensson K. (2012) Effects of a novel mGlu₂/₃ receptor agonist prodrug, LY2140023 monohydrate, on central monoamine turnover as determined in human and rat cerebrospinal fluid. Psychopharmacology (Berl). 219(4): 959-70.
  • Hughes RO, Rogier DJ, Devraj R, Zheng C, Cao G, Feng H, Xia M, Anand R, Xing L, Glenn J, Zhang K, Covington M, Morton PA, Hutzler JM, Davis JW 2nd, Scherle P, Baribaud F, Bahinski A, Mo ZL, Newton R, Metcalf B, and Xue CB. (2011) Discovery of ((1S,3R)-1-isopropyl-3-((3S,4S)-3-methoxy-tetrahydro-2H-pyran-4-ylamino)cyclopentyl)(4-(5-(trifluoromethyl)pyridazin-3-yl)piperazin-1-yl)methanone, PF-4254196, a CCR2 antagonist with an improved cardiovascular profile. Bioorg Med Chem Lett. 21(9): 2626-30.

Drug-Drug Interactions (DDI)

  • Albaugh D, Fullenwider C, Hutzler JM, and Fisher MB. (2012) Time-Dependent Inhibition and Estimation of CYP3A4 Clinical Pharmacokinetic Drug-Drug Interactions Using Cultured Human Hepatocytes. Drug Metab and Dispos. 40(7): 1336-44.
  • Hutzler JM , Balogh L, Zientek M, Kumar V, and Tracy TS. (2009) Mechanism-Based Inactivation of Cytochrome P450 2C9 by Tienilic Acid and (±)-Suprofen: A Comparison of Kinetics Using Different Probe Substrates. Drug Metab Dispos. 37(1): 59-65.
  • Hutzler JM , Melton RJ, Rumsey JM, Locuson, CW, and Wienkers LC. (2006) Inhibition of Cytochrome P450 3A4 by a Pyrimidineimidazole: Evidence for Complex Heme Interactions. Chem Res Toxicol. 19(12): 1650-59.
  • Hummel MA, Tracy TS, Hutzler JM, Wahlstrom JL, Zhou Y, and Rock DA. (2006) Influence of Fluorescent Probe Size and Cytochrome b5 on Drug-Drug Interactions in CYP2C9. J Biomol Screen. 11(3): 303-9.
  • Hutzler JM , Messing DM, and Wienkers LC. (2005) Predicting Drug-Drug Interactions in Drug Discovery: Where are we now and where are we going? Curr Opin Drug Discov Devel. 8(1): 51-58.
  • Ring BJ, Patterson BE, Mitchell MI, Vandenbranden M, Gillespie J, Bedding AW, Jewell H, Payne CD, Forgue ST, Eckstein J, Wrighton SA, and Phillips DL. (2005) Effect of tadalafil on cytochrome P450 3A4-mediated clearance: studies in vitro and in vivo. Clin Pharmacol Ther. 77(1): 63-75.

Immunoassay

  • D. Jani, J. Allinson, F. Berisha, K. Cowan, V. Devanarayan, C. Gleason, A. Jeromin, S. Keller, M. Khan, B. Nowatzke, P. Rhyne, and L. Stephen (2016) Recommendations for Use and Fit-for-purpose validation of biomarker multiplex ligand binding assays in drug development. The AAPS Journal. 18(1): 1-14.
  • P. Rhyne, C. Mapelli, O. Wong, F. Berisha, R. Neely (2016) Immunoassay standards and measurement of clinical biomarkers using intra-assay calibration standards. European patent: EP 2534490 B1.
  • Khan MU, Bowsher RR, Cameron M, Devanarayan V, Keller S, King L, Lee J, Morimoto A, Rhyne P, Stephen L, Wu Y, Wyant T, and Lachno DR (2015) Recommendations For Adaptation and Validation Of Commercial Kits For Biomarker Quantification In Drug Development. Bioanalysis 7(2):229-242.
  • Jani D, Allinson J, Berisha F, Cowan KJ, Devanarayan V, Gleason C, Jeromin A, Keller S, Khan MU, Nowatzke B, Rhyne P, and Stephen L (2015) Recommendations for Use And Fit-for-Purpose Validation Of Biomarker Multiplex Ligand Binding Assays in Drug Development. The AAPS Journal. In Press.
  • M Khan, Bowsher R, Cameron M, Devanarayan V, Keller S, King L, Lee J, Morimoto A, Rhyne P, Stephen L, Wu Y, Wyant T, and R Lachno (2015) Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development. Bioanalysis 7(2): 292-242.
  • Stevenson L, Amaravadi L, Myler H, Salazar-Fontana L, Gorovits B, Kirshner S, Xue L, Garofolo F, Alley SC, Thway T, Joyce A, Bansal S, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Dumont I, Fluhler E, Fraser S, Gouty D, Gupta S, Haidar S, Hayes R, Ingelse B, Ishii-Watabe A, Kaur S, King L, Laterza O, Leung S, Levesque A, Ma M, Petit-Frere C, Pillutla R, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wakelin-Smith J, Wilson A, Woolf E, and Yang TY (2014) 2014 White Paper On Recent Issues In Bioanalysis: A Full Immersion In Bioanalysis (Part 3 - LBA and Immunogenicity). Bioanalysis 6(24):3355-3368.
  • Cowan KJ and Rhyne P (2014) Adaptation and Validation of Commercial Kits for Biomarker Quantification in Drug Development; Recommendations and Case Studies. Presented by the AAPS Ligand Binding Assay Focus Group, June 4.
  • C. Albright, R. Dockens, J. Meredith, Jr., R. Olson, R. Slemmon, K. Lentz, J. Wang, R. Denton, G. Pilcher, P. Rhyne, and G. Tong (2013) Pharmacodynamics of Selective Inhibition of γ-Secretase by Avagacestat. Journal of Pharmacology and Experimental Therapeutics. 344:686-695.
  • Nicholson R, Lowes S, Caturla MC, Safavi A, Mamelak D, Islam R, Allinson J, Gouty D, Khan M, Lelacheur R, Shoup R, Martinez S, Dumont I, Zimmer J, Steffen R, Petrilla J, Awaiye K, Sheldon C, Turk D, Fast D, Kamerud J, Dinan A, Lin ZJ, Garofolo W, Tang D, Wright L, Lin J, Yamashita Y, Liu Y, Xu A, Hayes R, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Warren M, Karnik S, Cojocaru L, Reuschel S, Gonzalez P, Fatmi S, Vija J, Rock M, Malone M, Nowatzke W, and Fang X (2012) Conference Report: 6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity For Endogenous Compounds; Biomarkers; Biosimilars. Bioanalysis 4(19):2335-2342.

In Vitro Metabolism and In Vitro-In Vivo Correlation (IVIVC)

  • Hutzler JM , Ring BJ, and Anderson SR. (2015) Low-Turnover Drug Molecules: A Current Challenge for Drug Metabolism Scientists. Drug Metab Dispos. 43: 1917-1928.
  • Hutzler JM , Cerny MA, Yang YS, Asher C, Wong D, Frederick K, and Gilpin, K. (2014) Cynomolgus Monkey as a Surrogate for Human Aldehyde Oxidase Metabolism of the EGFR Inhibitor BIBX1382. Drug Metab Dispos. 42(10): 1751-60.
  • Hutzler JM , Yang YS, Brown C, Heyward S, and Moeller T. (2014) Aldehyde Oxidase Activity in Donor-Matched Fresh and Cryopreserved Human Hepatocytes and Assessment of Variability in 75 Donors. Drug Metab Dispos. 42(6): 1090-97.
  • Hutzler JM , Obach RS, Dalvie D, and Zientek M. (2013) Strategies for a Comprehensive Understanding of Metabolism by Aldehyde Oxidase. Exp Opinin Drug Metab Toxicol. 9(2): 153-68.
  • Baker JA, Wickremsinhe ER, Li CH, Oluyedun OA, Dantzig AH, Hall SD, Qian YW, Ring BJ, Wrighton SA, and Guo Y. (2013) Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase. Drug Metab Dispos. 41(3): 541-45.
  • Hutzler JM , Yang Y-S, Albaugh D, Fullenwider C, Schmenk J, and Fisher MB. (2012) Characterization of Aldehyde Oxidase Enzyme Activity in Cryopreserved Human Hepatocytes. Drug Metab Dispos. 40(2): 267-75.
  • Hutzler JM , Linder CD, Melton RJ, Vincent J, and Daniels JS. (2010) In Vitro-In Vivo Correlation and Translation to the Clinical Outcome for CJ-13,610, a Novel Inhibitor of 5-Lipoxygenase. Drug Metab Dispos. 38(7): 1113-21.
  • Hutzler JM , Renaud N, and Linder C. (2009) Is 1-Aminobenzotriazole an Appropriate In Vitro Tool as a Non-Specific Cytochrome P450 Inactivator? Drug Metab Dispos. 37(1): 10-13.
  • Hieronymus TL , Nanovskaya TN, Deshmukh SV, Vargas R, Hankins GD, and Ahmed MS. (2006) Methadone metabolism by early gestational age placentas. Am J Perinatol. 23(5): 287-94.

LCMS Biologics and Biomarkers

  • Lowes, S, and Ackermann BL (2016) AAPS and US FDA Crystal City VI Workshop on Bioanalytical Method Validation for Biomarkers. Bioanalysis 8(3): 163-167.
  • Jones BR (2016) Challenges in Method Development and Validation of LCMS Biomarker Assays, in The Delaware Valley Drug Metabolism Discussion Group, Langhorne, PA.
  • Jones BR (2016) Robustness of Hybrid LBA/LCMS Assays in a High-Throughput, Regulated Environment, in 10th Annual Workshop on Recent Issues in Bioanalysis, Orlando, FL.
  • Sturm RM (2015) PD Biomarker Measurement by LC/MS/MS - Technological Advancements to Address Sensitivity and Throughput Challenges, in Thermo Scientific Annual MS Users' Meeting, Somerset, NJ.
  • Sturm RM (2015) PD Biomarker Measurement by LC/MS/MS - Technological Advancements to Address Sensitivity and Throughput Challenges, in Thermo Scientific Annual MS Users' Meeting, Cambridge, MA.
  • P. Rhyne (2016) Incorporating clinical biomarkers into clinical trials. Translating Molecular Biomarkers into Clinical Assays – Techniques and Applications. Springer, eBook, in press.
  • Jenkins R, Duggan JX, Aubry AF, Zeng J, Lee JW, Cojocaru L, Dufield D, Garofolo F, Kaur S, Schultz GA, Xu K, Yang Z, Yu J, Zhang YJ, and Vazvaei F (2015) Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics. The AAPS Journal 17(1): 1-16.
  • Sturm RM , Jones BR, Shan L, Buckholz JE, Biondolillo RF, and Mulvana DE (2015) PD Biomarker Measurement by LC/MS/MS – Resolving Sensitivity and Throughput Challenges Using High Resolution Mass Spectrometry, in 16th Annual Land O'Lakes Bioanalytical Conference, Madison, WI.
  • Jones BR (2015) Incorporation of Technological Advancements Into An IA-LC/MS/MS Assay For High Throughput Analysis of a Protein Biomarker, in 21st International Reid Bioanalytical Forum, Guildford, UK.
  • Shan L , Sturm RM, Biondolillo RF, Buckholz JE, Jones BR, Faucette R, and Sexton D (2015) Bottom-Up Quantitative Measurement of an Antibody Therapeutic in Human Plasma by LC-MS/MS Using Formic Acid Digestion, in Clinical and Pharmaceutical Solutions through Analysis, Langhorne, PA.
  • Buckholz JE , Jones BR, Biondolillo RF, Joyce PE, Strong DJ, Cox MC, and Ackermann BL (2015) Accuracy of Endogenous Dilution as a Measure of Biomarker Selectivity: Quantitation of cGMP and cAMP in Human Plasma by LC-MS/MS in Clinical and Pharmaceutical Solutions through Analysis, Langhorne, PA.
  • Jones BR (2015) PD Biomarker Measurement by LC/MS/MS – Technological Advancements to Address Sensitivity and Throughput Challenges, in Clinical and Pharmaceutical Solutions through Analysis, Langhorne, PA.
  • Cox JM, Butler JP, Lutzke BS, Jones BR, Buckholz JE, Biondolillo RF, Talbot JA, Chernet E, Svensson A, and Ackermann BL (2015) A Validated LC/MS/MS Method for Neurotransmitter Metabolite Analysis in Human Cerebrospinal Fluid using Benzoyl Chloride Derivatization. Bioanalysis 7(19): 2461-2475.
  • Jones BR , Buckholz JE, McCardle K, King E, Nouri P, and Zhang J (2014) Quantitation of Cholesterol and 4β Hydroxycholesterol in Human Plasma using Surrogate Matrix and ESI-LC/MS/MS, in CPSA USA 2014, Langhorne, PA.
  • Dufield D, Neubert H, Garofolo F, Kirkovsky L, Stevenson L, Dumont I, Kaur S, Xu K, Alley SC, Szapacs M, Arnold M, Bansal S, Haidar S, Welink J, Le Blaye O, Wakelin-Smith J, Whale E, Ishii-Watabe A, Bustard M, Katori N, Amaravadi L, Aubry AF, Beaver C, Bergeron A, Cai XY, Cojocaru L, DeSilva B, Duggan J, Fluhler E, Gorovits B, Gupta S, Hayes R, Ho S, Ingelse B, King L, Levesque A, Lowes S, Ma M, Musuku A, Myler H, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Swanson S, Torri A, Vazvaei F, Wilson A, Woolf E, Xue L, and Yang TY (2014) 2014 White Paper On Recent Issues In Bioanalysis: A Full Immersion In Bioanalysis (Part 2 - Hybrid LBA/LCMS, ELN & Regulatory Agencies' Input). Bioanalysis 6(23):3237-3249.
  • Sturm RM , Lietz C, and Li L (2014) Improved Isobaric Tandem Mass Tag Quantification by Ion Mobility Mass Spectrometry. Rapid Communications in Mass Spectrometry 28(9): 1051-1060.
  • Schultz, GA (2013) Quantitative Analysis of Biomarkers with the Specificity and Robustness of Liquid Chromatography/Mass Spectrometry (LC/MS) and the Sensitivity of ELISA. Presented as part of the Quintiles’ webinar series, “Better Methods for Novel Biomarkers“, June 27.
  • Jones, BR (2013) LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches. Presented as part of the Quintiles’ webinar series, “Better Methods for Novel Biomarkers“, October 3.
  • Schultz GA (2013) Sample Preparation and Method Development Strategies that Enable Robust and 'High Throughput' LCMS Bioanalysis using Microseparations, in Applied Pharmaceutical Analysis Conference, Boston, MA.
  • Stevenson L, Garofolo F, DeSilva B, Dumont I, Martinez S, Rocci M, Amaravadi L, Brudny-Kloeppel M, Musuku A, Booth B, Dicaire C, Wright L, Mayrand-Provencher L, Losauro M, Gouty D, Arnold M, Bansal S, Dudal S, Dufield D, Duggan J, Evans C, Fluhler E, Fraser S, Gorovits B, Haidar S, Hayes R, Ho S, Houghton R, Islam R, Jenkins R, Katori N, Kaur S, Kelley M, Knutsson M, Lee J, Liu H, Lowes S, Ma M, Mikulskis A, Myler H, Nicholson B, Olah T, Ormsby E, Patel S, Pucci V, Ray C, Schultz G, Shih J, Shoup R, Simon C, Song A, Neto JT, Theobald V, Thway T, Wakelin-Smith J, Wang J, Wang L, Welink J, Whale E, Woolf E, and Xu R (2013) 2013 White Paper On Recent Issues in Bioanalysis: 'Hybrid'--The Best of LBA and LCMS. Bioanalysis 5(23):2903-2918.
  • Jones BR , Schultz GA, Eckstein JA, and Ackermann BL (2012) Surrogate matrix and surrogate analyte approaches for definitive quantitation of endogenous biomolecules. Bioanalysis 4(19):2343-2356.
  • Jones BR , Zhang J, Schultz GA, Eckstein JA, and Ackermann BL (2012) A Direct Comparison of Surrogate Matrix and Surrogate Analyte Approaches to Quantitation of Endogenous Amino Acids in Plasma by LC/MS/MS, in 60th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Vancouver, BC.
  • Milligan PL, Cox JM, Jones BR, Schultz GA, and Ackermann BL (2012) LC/MS/MS Quantitation of L-Glutamic Acid in Human Plasma: A Direct Comparison of the Surrogate Matrix and Surrogate Analyte Approaches, in 60th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Vancouver, BC.
  • Porter KM , Shan L, and Schultz GA (2012) Validation of an Immunoprecipitation and Immunoaffinity LC-MS/MS Assay for Intact Human Insulin, in60th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Vancouver, BC.
  • Schultz GA , and Lowes S (2012) Overview of Regulatory Guidelines and How High Resolution and Mass Accuracy MS Data Fulfill the Requirements, in 60th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Vancouver, BC.
  • Sturm RM , Sheynkman G, Booth B, Smith L, Pedersen J, and Li L (2012) Absolute Quantification of Prion Protein (90-231) Using Stable Isotope-Labeled Chymotryptic Peptide Standards in a LC-MRM AQUA Workflow. Journal of the American Society for Mass Spectrometry 23(9): 1522-1533.
  • Hougton R, Gouty D, Allinson J, Green R, Losauro M, Lowes S, LeLacheur R, Garofolo F, Couerbe P, Bronner S, Struwe P, Schiebl C, Sangster T, Pattison C, Islam R, Garofolo W, Pawula M, Buonarati M, Hayes R, Cameron M, Nicholson R, Harman J, Wieling J, De Boer T, Reuschel S, Cojocaru L, Harter T, Malone M, and Nowatzke W (2012) Recommendations on Biomarker Bioanalytical Method Validation by GCC. Bioanalysis 4(20):2439-2446.
  • Buckholz JE , Jones BR, Bearup KM, Porter KM, Strong DR, and Schultz GA (2011) A Validated Method for the Definitive Quantitation of Hepcidin 25 in Rat Serum by LC-MS/MS, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Jones BR , Bearup KM, Schultz GA, Eckstein JA, and Ackermann BL (2011) Surrogate Analyte Parallelism of Endogenous Amino Acids in Plasma by LC/MS/MS, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Jones BR , Schultz GA, Lowes S, Eckstein JA, Lutzke BS, and Ackermann BL (2011) LC/MS Biomarker Assay Validation Strategies Using Surrogate Matrix and Surrogate Analyte Approaches, in European Bioanalytical Forum (EBF) 4th Open Meeting, Barcelona, Spain.
  • Porter KM , Neubert H, and Schultz GA (2011) Validation of an Immunoprecipitation, Digestion and Immunoaffinity LC-MS/MS Assay for Human β-NGF Biomarker and Implementation in Support of Clinical Trials, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Schultz GA (2011) High Throughput Quantitation of a Protein Biomarker Using Immunoprecipitation, Digestion and Immunoaffinity LC/LC/nanoLC-SRM on a TSQ Vantage, in Thermo Scientific Users Meeting at the 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Schultz GA , Henion J, and Lowes S (2011) High Precision LC-MS/MS Using Nanoelectrospray Ionization Combined with Full-Scan Accurate Mass Spectrometry, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Schultz GA , Jones BR, Cormack KA, and Lowes S (2011) A Model Standard Operating Procedure for Quantitative LC-MS Biomarker Assay Validation, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Greer T, Sturm R, and Li L (2011) Mass Spectrometry Imaging for Drugs and Metabolites. Journal of Proteomics 74(12): 2617-2631.
  • Wickremsinhe ER, Lutzke BS, Jones BR, Schultz GA, Freeman AB, Pratt SE, Bones AM, and Ackermann BL (2010) Quantification of Gemcitabine Incorporation Into Human DNA by LC/MS/MS as a Surrogate Measure for Target Engagement. Anal Chem 82(15): 6576-6583.
  • Jones BR , Schultz GA, Lowes S, Eckstein JA, Lutzke BS, and Ackermann BL (2010) Parallelism and Response Factor Considerations for LC/MS Biomarker Assay Validation Using Surrogate Matrix and Surrogate Analyte Approaches, in 58th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Salt Lake City, UT.
  • Sturm RM , Dowell J, and Li L (2010) Rat Brain Neuropeptidomics: Tissue Collections, Protease Inhibition, Neuropeptide Extraction, and Mass Spectrometric Analysis, in Peptidomics (Soloviev M ed) pp 217-226, Humana Press.
  • Lowes, S, and Ackermann BL (2016) AAPS and US FDA Crystal City VI Workshop on Bioanalytical Method Validation for Biomarkers. Bioanalysis 8(3): 163-167.
  • Jones BR (2016) Challenges in Method Development and Validation of LCMS Biomarker Assays, in The Delaware Valley Drug Metabolism Discussion Group, Langhorne, PA.
  • Jones BR (2016) Robustness of Hybrid LBA/LCMS Assays in a High-Throughput, Regulated Environment, in 10th Annual Workshop on Recent Issues in Bioanalysis, Orlando, FL.
  • Sturm RM (2015) PD Biomarker Measurement by LC/MS/MS - Technological Advancements to Address Sensitivity and Throughput Challenges, in Thermo Scientific Annual MS Users' Meeting, Somerset, NJ.
  • Sturm RM (2015) PD Biomarker Measurement by LC/MS/MS - Technological Advancements to Address Sensitivity and Throughput Challenges, in Thermo Scientific Annual MS Users' Meeting, Cambridge, MA.

Metabolite Identification (Met ID)

  • Waters NJ, Smith SA, Olhava EJ, Duncan KW, Burton RD, O'Neill J, Rodrigue ME, Pollock RM, Moyer MP, and Chesworth R. (2016) Metabolism and disposition of the DOT1L inhibitor, pinometostat (EPZ-5676), in rat, dog and human. Cancer Chemother Pharmacol. 77(1): 43-62.
  • Rioux N, Duncan KW, Lantz RJ, Miao XS, Chan-Penebre E, Moyer MP, Munchhof MJ, Copeland RA, Chesworth R, and Waters NJ. (2015) Species differences in metabolism of EPZ015666, an oxetane-containing protein arginine methyltransferase-5 (PRMT5) inhibitor. Xenobiotica. 31: 1-10.
  • Wickremsinhe E, Bao J, Smith RL, Burton RD, Dow S, and Perkins E. (2013) Preclinical Absorption, Distribution, Metabolism, and Excretion of an Oral Amide Prodrug of Gemcitabine Designed to Deliver Prolonged Systemic Exposure. Pharmaceutics. 5(2), 261-76.
  • Baker JA, Wickremsinhe ER, Li CH, Oluyedun OA, Dantzig AH, Hall SD, Qian YW, Ring BJ, Wrighton SA, and Guo Y. (2013) Pharmacogenomics of gemcitabine metabolism: functional analysis of genetic variants in cytidine deaminase and deoxycytidine kinase. Drug Metab Dispos. 41(3): 541-45.
  • He MM, Ji T, Barbuch RJ, Campanale K, Lantz R, Hadden C, and Wilke A. (2011) The fate of 4-hydroxycarbazole metabolite: metabolism and carcinogenicity assessment of a β-adrenergic receptor modulator containing carbazole structure. Xenobiotica. 41(12): 1108-21.
  • Borel AG, Jones TM, Barbuch RJ, Jackson DA, Kulanthaivel P, Mattiuz E, Klimkowski VJ, Wheeler WJ, and Rener GA. (2011) Metabolism of LY654322, a Growth Hormone Secretagogue, to an Unusual Diimidazopyridine Metabolite. Drug Metab Dispos. 39: 740-49.
  • Anderson S , Knadler MP and Luffer-Atlas D. (2010) Overview of Metabolite Safety Testing from an Industry Perspective. Bioanalysis. 2(7): 1249-61.
  • Miao XS, Zhong C, Wang Y, Savage RE, Yang RY, Kizer D, Volckova E, Ashwell MA, and Chan TCK. (2009) In vitro metabolism of b-lapachone (ARQ 501) in mammalian hepatocytes and cultured human cells. Rapid Commun Mass Spectrom. 23(1): 12-22.
  • Anderson S , Luffer-Atlas D and Knadler MP. (2009) Predicting Circulating Human Metabolites: How Good Are We? Chem Res Toxicol . 22(2): 243–56.
  • Williams ET, Jones KO, Ponsler GD, Lowery SM, Perkins EJ, Wrighton SA, Rutebories KJ, Kazui M, and Farid NA. (2008) The biotransformation of prasugrel, an new thienopyridine prodrug, by the human carboxylesterases 1 and 2. Drug Metab Dispos. 36(7): 1227-32.
  • Hutzler JM , Rock DA, Melton RJ, Rumsey JM, Schnute ME, Thompson DC, and Wienkers LC. (2008) Assessment of the Metabolism and Intrinsic Reactivity of a Novel Catechol Metabolite. Chem Res Toxicol. 21(5): 1125-33.
  • Eckstein JA, Ammerman GM, Reveles JM and Ackermann BL. (2008) Analysis of glutamine, glutamate, pyroglutamate, and GABA in cerebrospinal fluid using ion pairing HPLC with positive electrospray LC/MS/MS. J Neurosci Methods. 171(2): 190-96.
  • Smith RL , Gillespie TA, Rash TJ, Kurihara A, and Farid NA. (2007) Disposition and metabolic fate of prasugrel in mice, rats, and dogs. Xenobiotica. 37(8): 884-901.
  • Farid NA, Smith RL, Gillespie TA, Rash TJ, Blair PE, Kurihara A, and Goldberg MJ. (2007) The disposition of prasugrel, a novel thienopyridine, in humans. Drug Metab Dispos. 35(7): 1096-1104.

Small Molecule Bioanalysis

  • Lowes, S., & Rocci, M. L., Jr. (2017). REGULATED BIOANALYSIS: fundamentals and practice. S.l.: SPRINGER.
  • Lowes S , Hucker R, Jemal M, Marini JC, Rezende VM, Shoup R, Singhal P, Timmerman P, Yoneyama T, Weng N, and Zimmer D (2015) Tiered Approaches To Chromatographic Bioanalytical Method Performance Evaluation: Recommendation For Best Practices and Harmonization From The Global Bioanalysis Consortium Harmonization Team. The AAPS Journal 17(1):17-23.
  • Evans C, Arnold M, Bryan P, Duggan J, James CA, Li W, Lowes S, Matassa L, Olah T, Timmerman P, Wang X, Wickremsinhe E, Williams J, Woolf E, and Zane P (2015) Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations From the IQ Consortium Microsampling Working Group. The AAPS Journal 17(2):292-300.
  • Lusk T , Lauzun J, and Mulvana DE (2015) Getting the Most Out of Your Mass Spectrometer – Multiplexing LC/MS Assays for High Throughput. in63rd American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, St. Louis, MO.
  • Hua W , Lesslie M, Hoffman BT, Binns C, and Mulvana DE (2015) Development of a Sensitive and Fast UHPLC-MS/MS Method for Determination of Clopidogrel, Clopidogrel Acid, and Clopidogrel Active Metabolite H4 in Human Plasma. Bioanalysis. 7(12): 1471-1482.
  • Mulvana DE , Sturm R, Bowen CL, Buckholz JE, Biondolillo RF, McCardle K, Evans CA, and Jones BR (2015) Overcoming Triple Quadrupole Selectivity Challenges by Use of High-Resolution Accurate Mass Spectrometry to Enable Sensitive Quantitation of a Small Molecule Therapeutic in Rabbit Plasma, in 21st International Reid Bioanalytical Forum, Guildford, UK.
  • Ingelse B , Barroso B, Gray N, Jakob-Rodamer V, Kingsley C, Sykora C, Vinck P, Wein M, and White S (2014) European Bioanalysis Forum: Recommendation On Dealing With Hemolyzed and Hyperlipidemic Matrices. Bioanalysis 6(23):3113-3120.
  • Lowes S , LeLacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Zimmer J, Caturla MC, Couerbe P, Awaiye K, Fatmi S, Farmen R, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Zhang T, Pasas-Farmer S, Garofolo W, Moussallie M, Rocci M, Allinson J, Gouty D, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Hayes R, Bouhajib M, Stipancic M, Nicholson R, Nehls C, Warren M, Karnik S, Houghton R, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, and Watson A (2014) Recommendations on Incurred Sample Stability (ISS) by GCC.Bioanalysis 6(18):2385-2390.
  • Rocci M, Lowes S, Shoup R, Garofolo F, Farmen R, Zhang T, Allinson J, Gouty D, Hayes R, Nicholson R, Houghton R, Dumont I, LeLacheur R, Zimmer J, Cruz Caturla M, Couerbe P, Awaiye K, Fatmi S, Sheldon C, Bower J, Fiscella M, Fast D, Cape S, Hulse J, Kamerud J, Pasas-Farmer S, Garofolo W, Moussallie M, Buonarati M, Boudreau N, Pellerin B, Lin J, Xu A, Bouhajib M, Stipancic M, Nehls C, Warren M, Karnik S, Stovold C, Reuschel S, Cojocaru L, Marcelletti J, Fang X, Smith I, and Watson A (2014) 7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing. Bioanalysis 6(20):2713-2720.
  • Fluhler E, Hayes R, Garofolo F, Dumont I, Blaye OL, Arnold M, Bansal S, Verhaeghe T, Wilson A, Stevenson L, Myler H, Bauer R, Bergeron A, Bustard M, Cai XY, Carbone M, Cojocaru L, Desai-Krieger D, Duggan J, Haidar S, Ho S, Ingelse B, Katori N, Levesque A, Lowes S, Ma M, Mettke K, Michon J, Musuku A, Olah T, Patel S, Rose M, Schultz G, Smeraglia J, Spooner N, Stouffer B, Vazvaei F, Wakelin-Smith J, Wang J, Welink J, Whale E, Woolf E, Xue L, and Yang TY (2014) 2014 White Paper On Recent Issues In Bioanalysis: A Full Immersion In Bioanalysis (Part 1--Small Molecules by LCMS).Bioanalysis 6(22):3039-3049.
  • Bower J, Fast D, Garofolo F, Gouty D, Hayes R, Lowes S, Nicholson R, LeLacheur R, Bravo J, Shoup R, Dumont I, Carbone M, Zimmer J, Ortuno J, Caturla MC, Datin J, Lansing T, Fatmi S, Struwe P, Sheldon C, Islam R, Yu M, Hulse J, Kamerud J, Lin J, Doughty J, Kurylak K, Tang D, Buonarati M, Blanchette A, Levesque A, Gagnon-Carignan S, Lin J, Ray G, Liu Y, Khan M, Xu A, El-Sulayman G, DiMarco C, Bouhajib M, Tacey D, Jenkins R, der Strate B, Briscoe C, Karnik S, Rhyne P, Garofolo W, Schultz G, Roberts A, Redrup M, DuBey I, Conliffe P, Pekol T, Hantash J, Cojocaru L, Allen M, Reuschel S, Watson A, Farrell C, Groeber E, Malone M, Nowatzke W, and Fang X (2014) 8th GCC: Consolidated Feedback To US FDA On The 2013 Draft FDA Guidance On Bioanalytical Method Validation. Bioanalysis 6(22):2957-2963.
  • Lusk T (2014) Method Development of a Simultaneous Fast Quantitation of Niacin, Nicotinamide, and Nicotinuric Acid Using HPLC Tandem Mass Spectrometry. in 62nd American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Baltimore, MD.
  • Hua W , Ierardi T, Lesslie M, Hoffman BT, and Mulvana DE (2014) Development and Validation of a HILIC-MS/MS Method for Quantification of Decitabine in Human Plasma by Using Lithium Adduct Detection. J. Chromatogr. B. 969: 117-122.
  • Hua W , Lesslie M, Hoffman BT, and Mulvana DE (2013) Development of a HILIC-MS/MS Method for Quantification of Decitabine in Human Plasma by Using Lithium Adducts, in 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Hua W , Lesslie M, Hoffman BT, and Mulvana DE (2013) Development of a UHPLC-MS/MS Method for Determination of Clopidogrel, Clopidogrel Acid, and Clopidogrel Active Metabolite H4 in Human Plasma, in 61st American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Minneapolis, MN.
  • Honing M, Ingelse B, and Pramanik BN (2013) MS Applications in Support of Medicinal Chemistry Sciences, in Mass Spectrometry for Drug Discovery and Drug Development (Korfmacher WA ed) pp 239-275, John Wiley & Sons, Inc, Hoboken, NJ, USA.
  • Ingelse B (2013) How to Deal with Haemolysed and Hyperlipidemic Samples: An EBF Perspective, in European Bioanalytical Forum (EBF) 6th Open Meeting, Barcelona, Spain.
  • Timmerman P, Henderson N, Smeraglia J, Mulder H, Ingelse B, Brudny-Kloeppel M, and Companjen A (2013) Managing Scientific, Technical and Regulatory Innovation In Regulated Bioanalysis: A Discussion Paper From The European Bioanalysis Forum. Bioanalysis 5(2):139-145.
  • Zeman SL , Lesslie M, Hoffman BT, and Mulvana DE (2012) Non-Specific Binding in Human Urine: An Effective Method Development Experiment for Detection, in 60th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Vancouver, BC.
  • Van Lierop MJ, Alkema W, Laskewitz AJ, Dijkema R, van der Maaden HM, Smit MJ, Plate R, Conti PG, Jans CG, Timmers CM, van Boeckel CA, Lusher SJ, McGuire R, van Schaik RC, de Vlieg J, Smeets RL, Hofstra CL, Boots AM, van Duin M, Ingelse BA, Schoonen WG, Grefhorst A, van Dijk TH, Kuipers F, and Dokter WH (2012) A Novel Non-steroidal Selective Glucocorticoid Receptor Modulator with Full Anti-inflammatory Properties and Improved Therapeutic Index. PloS ONE 7(11):e48385.
  • Boterman M, Doig M, Breda M, Lowes S, Jersey J, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Cruz Caturla M, Couerbe P, Guittard J, Maltas J, Lansing T, Bhatti M, Schiebl C, Struwe P, Sheldon C, Hayes R, Sangster T, Pattison C, Bouchard J, Goodwin L, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Zimmer D, Folguera L, Zimmermann T, Pawula M, Moussallie M, Teixeira Lde S, Rocha T, Tang D, Jardieu P, Truog J, Lin J, Lundberg R, Cox C, Breau A, Bigogno C, Schoutsen D, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Nicholson R, Jenkins R, Lin MH, Karnik S, De Boer T, Houghton R, Green R, DeMaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Malone M, Best S, and Fang X (2012) Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis 4(6):651-660.
  • Lowes S , Jersey J, Shoup R, Garofolo F, Needham S, Couerbe P, Lansing T, Bhatti M, Sheldon C, Hayes R, Islam R, Lin Z, Garofolo W, Moussallie M, Teixeira Lde S, Rocha T, Jardieu P, Truog J, Lin J, Lundberg R, Breau A, Dilger C, Bouhajib M, Levesque A, Gagnon-Carignan S, Jenkins R, Nicholson R, Lin MH, Karnik S, DeMaio W, Smith K, Cojocaru L, Allen M, Fatmi S, Sayyarpour F, Malone M, and Fang X (2012) 4th Global CRO Council For Bioanalysis: Coadministered Drug Stability, EMA/US FDA Guidelines, 483s and Carryover. Bioanalysis 4(7):763-768.
  • DeSilva B, Garofolo F, Rocci M, Martinez S, Dumont I, Landry F, Dicaire C, Szekely-Klepser G, Weiner R, Arnold M, Bansal S, Bateman K, Bauer R, Booth B, Davis S, Dudal S, Gouty D, Grundy J, Haidar S, Hayes R, Jemal M, Kaur S, Kelley M, Knutsson M, Le Blaye O, Lee J, Lowes S, Ma M, Mitsuoka T, Neto JT, Nicholson R, Ormsby E, Sailstad J, Stevenson L, Tang D, Welink J, Viswanathan CT, Wang L, Woolf E, and Yang E (2012) 2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines. Bioanalysis 4(18):2213-2226.
  • Lowes S , Boterman M, Doig M, Breda M, Jersey J, Lelacheur R, Shoup R, Garofolo F, Dumont I, Martinez S, Needham S, Zimmer J, Caturla MC, Couerbe P, Maltas J, Steffen R, Petrilla J, Safavi A, Awaiye K, Bhatti M, Sheldon C, Schiebl C, Struwe P, Turk D, Sangster T, Pattison C, Fast D, Goodwin L, Kamerud J, Dinan A, Mamelak D, Islam R, Segers R, Lin ZJ, Hillier J, Garofolo W, Folguera L, Zimmer D, Zimmermann T, Pawula M, Moussallie M, de Souza Teixeira L, Rocha T, Allinson J, Jardieu P, Tang D, Gouty D, Wright L, Truog J, Lin J, Yamashita Y, Khan M, Liu Y, Xu A, Lundberg R, Cox C, Breau A, Hayes R, Bigogno C, Schoutsen D, Dilger C, Jonker J, Bouhajib M, Levesque A, Gagnon-Carignan S, Harman J, Nicholson R, Jenkins R, Warren M, Lin MH, Karnik S, De Boer T, Houghton R, Green R, Demaio W, Sable R, Smith K, Siethoff C, Cojocaru L, Allen M, Reuschel S, Gonzalez P, Harter T, Fatmi S, Rock M, Vija J, Sayyarpour F, Malone M, Nowatzke W, Best S, and Fang X (2012) Recommendations on Bioanalytical Method Stability Implications of Co-Administered and Co-Formulated Drugs By Global CRO Council for Bioanalysis (GCC). Bioanalysis4(17):2117-2126.
  • Zeman SL , Hoffman BT, and Mulvana DE (2011) Internal Standard Addition: An Evaluation of Different Methodologies and the Impact on Quantitation and IS Precision, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Binns C , Norwood K, Champion K, Hua W, Nattrass C, Green T, Mulvana DE, and Perkins JR (2011) Optimization of a Robust LC/MS/MS Assay for the Quantitation of an Unstable Compound to Support Clinical Studies, in 59th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Denver, CO.
  • Garofolo F, Rocci ML, Jr., Dumont I, Martinez S, Lowes S, Woolf E, van Amsterdam P, Bansal S, Barra AC, Bauer R, Booth BP, Carrasco-Triguero M, DeSilva B, Dunn J, Gallicano K, Gouty D, Ho S, Hucker R, Jemal M, Katori N, Le Blaye O, Lee J, Li W, Michael S, Nehls C, Nicholson R, Ormsby E, Tang D, Viswanathan CT, Weiner R, and Young G (2011) 2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings From Audits and Inspections. Bioanalysis 3(18):2081-2096.
  • Mulvana DE (2010) Critical Topics in Ensuring Data Quality in Bioanalytical LC-MS Method Development. Bioanalysis 2(6): 1051-1072.
  • Hoffman BT , Moore E, and Mulvana DE (2010) Supported Liquid Extraction vs Liquid-Liquid Extraction: Comparing Phospholipid and Analyte Recoveries under Various Extraction Conditions, in 58th American Society of Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, Salt Lake City, UT.
  • Hoffman BT (2010) Evaluation of a New Sample Preparation Approach To Quantitative Bioanalytical LC/MS/MS, in Waters Corporation Bioanalysis World Tour at the Applied Pharmaceutical Analysis (APA/BSAT) meeting, Baltimore, MD.
  • Savoie N, Garofolo F, van Amsterdam P, Booth BP, Fast DM, Lindsay M, Lowes S, Masse R, Mawer L, Ormsby E, Phull R, Rocci ML, Jr., Vallano PT, and Yin X (2010) 2009 White Paper On Recent Issues In Regulated Bioanalysis From The 3rd Calibration and Validation Group Workshop. Bioanalysis2(1):53-68.
  • Timmerman P, Lowes S, Fast DM, and Garofolo F (2010) Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis. Bioanalysis 2(4):683.
  • Van Amsterdam P, Arnold M, Bansal S, Fast D, Garofolo F, Lowes S, Timmerman P, and Woolf E (2010) Building the Global Bioanalysis Consortium - Working Towards a Functional Globally Acceptable and Harmonized Guideline on Bioanalytical Method Validation. Bioanalysis 2(11):1801-1803.
  • Savoie N, Garofolo F, van Amsterdam P, Bansal S, Beaver C, Bedford P, Booth BP, Evans C, Jemal M, Lefebvre M, Lopes de Silva AL, Lowes S, Marini JC, Masse R, Mawer L, Ormsby E, Rocci ML, Jr., Viswanathan C, Wakelin-Smith J, Welink J, White JT, and Woolf E (2010) 2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance. Bioanalysis 2(12):1945-1960.

Book Chapters

  • Zientek M, Kang P, Hutzler JM and Obach, RS (2012) Molybdenum-Containing Hydroxylases. Encyclopedia of Drug Metabolism and Interactions. Volume 1, Chapter 11. John Wiley & Sons Inc. Alexander V. Lyubimov (Ed.).
  • Anderson S , Luffer-Atlas D and Knadler MP. (2012) Predicting Human Biotransformation Pathways. Encyclopedia of Drug Metabolism and Interactions. Volume VI, Chapter 5. John Wiley & Sons, Inc. Alexander V. Lyubimov (Ed.).
  • Hutzler JM and Cerny MA (2012) Bioactivation II: Phase I (Non-Cytochrome P450). Encyclopedia of Drug Metabolism and Interactions. Volume IV, Chapter 3. John Wiley & Sons Inc. Alexander V. Lyubimov (Ed.).
  • Hutzler JM Cook J and Fleishaker JC (2011) Drug-Drug Interactions: Designing Development Programs and Appropriate Product Labeling. Pharmacokinetics in Drug Development: Advances and Applications. Vol. 3. P. Bonate and D.R. Howard (Eds.).

Podium Presentations

  • Hutzler JM , Aldehyde Oxidase and Donor Variability: Is Estimating Human Clearance Possible? Great Lakes Drug Metabolism Discussion Group. Ann Arbor, MI. May 2015.
  • Pritchard JF, Anderson SR, Breuckner C, Premkumar ND, and Polli JW, A hitchhiker’s guide to outsourcing ADME studies. American Association of Pharmaceutical Scientists (AAPS). Chicago, IL. October 2012.
  • Hutzler JM , Challenges to Predicting Clearance of Aldehyde Oxidase Substrates in Humans: Species Differences and Subject Variability. American Chemical Society (ACS). Indianapolis, IN. September 2013.
  • Hutzler JM , Emerging Role of Aldehyde Oxidase Substrates in Drug Metabolism and Drug Discovery. American Chemical Society (ACS) national meeting. Indianapolis, IN. September 2013.
  • Hutzler JM , Assessment of the Stability of Aldehyde Oxidase Activity in Fresh and Cryopreserved Human Hepatocytes. International Society for the Study of Xenobiotics (ISSX). Dallas, TX. October 2012.
  • Hutzler JM , Characterization of Aldehyde Oxidase Activity in Human Cell Systems. Life Technologies Hepatocyte Expert Program. Boston, MA. May 2012.
  • Hutzler JM , Characterization of Aldehyde Oxidase Activity in Cryopreserved Human Hepatocytes and Applications in Drug Discovery. 2011 Hepatocyte Research Association Meeting, approved satellite of the 17th North American Regional ISSX Meeting. Atlanta, GA. October 2011.
  • Hutzler JM , Concepts in Moving from Preclinical In Vitro ADME to Clinical Pharmacokinetics. Short Course for 17th North American Regional ISSX Meeting. Atlanta, GA. October 2011.
  • Hutzler JM , Aldehyde Oxidase Metabolism and Implications in Drug Discovery Efforts. AAPS, New England Regional Discussion Group. Rocky Hill, CT. April 2011.
  • Anderson SR , The Utilization of 3H/14 C in Drug Discovery and Development:
    An ADME Perspective
    . Land O Lakes Conference on Drug Metabolism. Merrimac, WI. September 2010.
  • Anderson SR , PPDM Open Forum Panelist: An Evolution or Revolution in Drug Metabolism: When, Where, Why, What, How? AAPS Annual Meeting. Los Angeles, CA. October 2009.
  • Anderson SR , To Test or Not to Test Round Table: Complicating Factors in Risk Assessment of Drug Metabolites. AAPS Annual Meeting. Los Angeles, CA. October 2009.
  • Anderson SR , The Effect of Losing Multiple Clearance Pathways on Drug Safety and Viability. Great Lakes Drug Metabolism and Disposition Group. Lincolnshire, IL. May 2009.