Toward a Consensus on Applying Quantitative Liquid Chromatography‐Tandem Mass Spectrometry Proteomics in Translational Pharmacology Research: A White Paper

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  • Bhagwat Prasad
    Department of Pharmaceutics University of Washington Seattle Washington USA
  • Brahim Achour
    Centre for Applied Pharmacokinetic Research University of Manchester Manchester UK
  • Per Artursson
    Department of Pharmacy Uppsala University Uppsala Sweden
  • Cornelis E.C.A. Hop
    Genentech South San Francisco California USA
  • Yurong Lai
    Gilead Sciences Foster City California USA
  • Philip C. Smith
    Eshelman School of Pharmacy University of North Carolina at Chapel Hill Chapel Hill North Carolina USA
  • Jill Barber
    Centre for Applied Pharmacokinetic Research University of Manchester Manchester UK
  • Jacek R. Wisniewski
    Biochemical Proteomics Group Max Planck Institute of Biochemistry Martinsried Germany
  • Daniel Spellman
    Pharmacokinetics Pharmacodynamics & Drug Metabolism Merck & Co., Inc. West Point Pennsylvania USA
  • Yasuo Uchida
    Graduate School of Pharmaceutical Sciences Tohoku University Sendai Japan
  • Michael A. Zientek
    Takeda California San Diego California USA
  • Jashvant D. Unadkat
    Department of Pharmaceutics University of Washington Seattle Washington USA
  • Amin Rostami‐Hodjegan
    Centre for Applied Pharmacokinetic Research University of Manchester Manchester UK

Description

<jats:p>Quantitative translation of information on drug absorption, disposition, receptor engagement, and drug–drug interactions from bench to bedside requires models informed by physiological parameters that link <jats:italic>in vitro</jats:italic> studies to <jats:italic>in vivo</jats:italic> outcomes. To predict <jats:italic>in vivo</jats:italic> outcomes, biochemical data from experimental systems are routinely scaled using protein quantity in these systems and relevant tissues. Although several laboratories have generated useful quantitative proteomic data using state‐of‐the‐art mass spectrometry, no harmonized guidelines exit for sample analysis and data integration to <jats:italic>in vivo</jats:italic> translation practices. To address this gap, a workshop was held on September 27 and 28, 2018, in Cambridge, <jats:styled-content style="fixed-case">MA</jats:styled-content>, with 100 experts attending from academia, the pharmaceutical industry, and regulators. Various aspects of quantitative proteomics and its applications in translational pharmacology were debated. A summary of discussions and best practices identified by this expert panel are presented in this “White Paper” alongside unresolved issues that were outlined for future debates.</jats:p>

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