Candidate biomarkers for the diagnosis and prognosis of drug‐induced liver injury: An international collaborative effort von Church, Rachel J., Kullak‐Ublick, Gerd A., Aubrecht, Jiri, Bonkovsky, Herbert L., Chalasani, Naga, Fontana, Robert J., Goepfert, Jens C., Hackman, Frances, King, Nicholas M. P., Kirby, Simon, Kirby, Patrick, Marcinak, John, Ormarsdottir, Sif, Schomaker, Shelli J., Schuppe‐Koistinen, Ina, Wolenski, Francis, Arber, Nadir, Merz, Michael, Sauer, John‐Michael, Andrade, Raul J., van Bömmel, Florian, Poynard, Thierry, Watkins, Paul B.

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Serum glutamate dehydrogenase activity enables early detection of liver injury in subjects with underlying muscle impairments von Schomaker, Shelli, Potter, David, Warner, Roscoe, Larkindale, Jane, King, Nicholas, Porter, Amy C., Owens, Jane, Tomlinson, Lindsay, Sauer, John-Michael, Johnson, Kent, Aubrecht, Jiri

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Rat Urinary Osteopontin and Neutrophil Gelatinase-Associated Lipocalin Improve Certainty of Detecting Drug-Induced Kidney Injury von Phillips, Jonathan A, Holder, Daniel J, Ennulat, Daniela, Gautier, Jean-Charles, Sauer, John-Michael, Yang, Yi, McDuffie, Eric, Sonee, Manisha, Gu, Yi-Zhong, Troth, Sean P, Lynch, Karen, Hamlin, Diane, Peters, David G, Brees, Dominique, Walker, Elizabeth G

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eTRANSAFE: Building a sustainable framework to share reproducible drug safety knowledge with the public domain [version 1; peer review: 2 approved] von Sarntivijai, Sirarat, Blomberg, Niklas, Lauer, Katharina B., Briggs, Katharine, Steger-Hartmann, Thomas, van der Lei, Johan, Sauer, John-Michael, Liwski, Richard, Mourby, Miranda, Camprubi, Montse

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Current state of cardiac troponin testing in Duchenne muscular dystrophy cardiomyopathy: review and recommendations from the Parent Project Muscular Dystrophy expert panel von Spurney, Christopher F, Ascheim, Deborah, Charnas, Lawrence, Cripe, Linda, Hor, Kan, King, Nicholas, Kinnett, Kathi, McNally, Elizabeth M, Sauer, John-Michael, Sweeney, Lee, Villa, Chet, Markham, Larry W

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A Formulation Strategy for Gamma Secretase Inhibitor ELND006, a BCS Class II Compound: Development of a Nanosuspension Formulation with Improved Oral Bioavailability and Reduced Fo... von Quinn, Kevin, Gullapalli, Rampurna Prasad, Merisko-liversidge, Elaine, Goldbach, Erich, Wong, Angelina, Liversidge, Gary G., Hoffman, Wherly, Sauer, John-michael, Bullock, John, Tonn, George

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Qualification of translational safety biomarkers von Sauer, John-Michael, Porter, Amy C

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Preclinical biomarker qualification von Sauer, John-Michael, Porter, Amy C

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Taxines: a review of the mechanism and toxicity of yew ( Taxus spp.) alkaloids von Wilson, Christina R., Sauer, John-Michael, Hooser, Stephen B.

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The Predictive Safety Testing Consortium and the Coalition Against Major Diseases von Stephenson, Diane, Sauer, John-Michael

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Design and synthesis of a novel, orally active, brain penetrant, tri-substituted thiophene based JNK inhibitor von Bowers, Simeon, Truong, Anh P., Neitz, R. Jeffrey, Neitzel, Martin, Probst, Gary D., Hom, Roy K., Peterson, Brian, Galemmo, Robert A., Konradi, Andrei W., Sham, Hing L., Tóth, Gergley, Pan, Hu, Yao, Nanhua, Artis, Dean R., Brigham, Elizabeth F., Quinn, Kevin P., Sauer, John-Michael, Powell, Kyle, Ruslim, Lany, Ren, Zhao, Bard, Frédérique, Yednock, Ted A., Griswold-Prenner, Irene

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Effect of Potent CYP2D6 Inhibition by Paroxetine on Atomoxetine Pharmacokinetics von Belle, Donna J., Ernest, C. Steven, Sauer, John-Michael, Smith, Brian P., Thomasson, Holly R., Witcher, Jennifer W.

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Design and synthesis of cell potent BACE-1 inhibitors: Structure–activity relationship of P1′ substituents von Sealy, Jennifer M., Truong, Anh P., Tso, Luke, Probst, Gary D., Aquino, Jose, Hom, Roy K., Jagodzinska, Barbara M., Dressen, Darren, Wone, David W.G., Brogley, Louis, John, Varghese, Tung, Jay S., Pleiss, Michael A., Tucker, John A., Konradi, Andrei W., Dappen, Michael S., Toth, Gergely, Pan, Hu, Ruslim, Lany, Miller, Jim, Bova, Michael P., Sinha, Sukanto, Quinn, Kevin P., Sauer, John-Michael

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The regulatory acceptance of translational safety biomarkers von Sauer, John-Michael, Porter, Amy C.

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Net Reclassification Index and Integrated Discrimination Index Are Not Appropriate for Testing Whether a Biomarker Improves Predictive Performance von Burch, Peter M, Glaab, Warren E, Holder, Daniel J, Phillips, Jonathan A, Sauer, John-Michael, Walker, Elizabeth G

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Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions von Porter, Amy C, Aubrecht, Jiri, Birch, Chandler, Braun, Jonathan, Cuff, Carolyn, Dasgupta, Suryasarathi, Gale, Jeremy D, Hinton, Robert, Hoffmann, Steven C, Honig, Gerard, Linggi, Bryan, Schito, Marco, Casteele, Niels Vande, Sauer, John-Michael

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Effect of hepatic impairment on the pharmacokinetics of atomoxetine and its metabolites von Chalon, Stephan A., Desager, Jean‐Pierre, DeSante, Karl A., Frye, Reginald F., Witcher, Jennifer, Long, Amanda J., Sauer, John‐Michael, Golnez, Jean‐Luc, Smith, Brian P., Thomasson, Holly R., Horsmans, Yves

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Perspectives on statistical strategies for the regulatory biomarker qualification process von Hendrix, Suzanne B., Mogg, Robin, Wang, Sue Jane, Chakravarty, Aloka, Romero, Klaus, Dickson, Samuel P., Sauer, John-Michael, McShane, Lisa M.

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The Engineered Antibiotic Peptide PLG0206 Eliminates Biofilms and Is a Potential Treatment for Periprosthetic Joint Infections von Huang, David, Pachuda, Nicholas, Sauer, John Michael, Dobbins, Dessie, Steckbeck, Jonathan

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Clinical pharmacokinetics of atomoxetine von SAUER, John-Michael, RING, Barbara J, WITCHER, Jennifer W

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