Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides—Harmonized Terminology and Tactical Recommendations von Shankar, G., Arkin, S., Cocea, L., Devanarayan, V., Kirshner, S., Kromminga, A., Quarmby, V., Richards, S., Schneider, C. K., Subramanyam, M., Swanson, S., Verthelyi, D., Yim, S.

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The intrinsic connectivity distribution: A novel contrast measure reflecting voxel level functional connectivity von Scheinost, D., Benjamin, J., Lacadie, C.M., Vohr, B., Schneider, K.C., Ment, L.R., Papademetris, X., Constable, R.T.

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Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude von Ehmann, F, Papaluca Amati, M, Salmonson, T, Posch, M, Vamvakas, S, Hemmings, R, Eichler, H G, Schneider, C K

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The Etiology and Outcome of Cerebral Ventriculomegaly at Term in Very Low Birth Weight Preterm Infants von Ment, Laura R, Vohr, Betty, Allan, Walter, Westerveld, Michael, Katz, Karol H, Schneider, Karen C, Makuch, Robert W

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Outcome of Children in the Indomethacin Intraventricular Hemorrhage Prevention Trial von Ment, Laura R, Vohr, Betty, Allan, Walter, Westerveld, Michael, Sparrow, Sara S, Schneider, Karen C, Katz, Karol H, Duncan, Charles C, Makuch, Robert W

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Taking immunogenicity assessment of therapeutic proteins to the next level von Büttel, I.C., Chamberlain, P., Chowers, Y., Ehmann, F., Greinacher, A., Jefferis, R., Kramer, D., Kropshofer, H., Lloyd, P., Lubiniecki, A., Krause, R., Mire-Sluis, A., Platts-Mills, T., Ragheb, J.A., Reipert, B.M., Schellekens, H., Seitz, R., Stas, P., Subramanyam, M., Thorpe, R., Trouvin, J.-H., Weise, M., Windisch, J., Schneider, C.K.

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Low-dose indomethacin and prevention of intraventricular hemorrhage : a multicenter randomized trial von MENT, L. R, OH, W, SCHNEIDER, K. C, MAKUCH, R. W, EHRENKRANZ, R. A, PHILIP, A. G. S, VOHR, B, ALLAN, W, DUNCAN, C. C, SCOTT, D. T, TAYLOR, K. J. W, KATZ, K. H

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Regulatory aspects of biosimilars. Myths and facts von Schneider, C K, Weise, M

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Regional Brain Volume Abnormalities and Long-term Cognitive Outcome in Preterm Infants von Peterson, Bradley S, Vohr, Betty, Staib, Lawrence H, Cannistraci, Christopher J, Dolberg, Aaron, Schneider, Karen C, Katz, Karol H, Westerveld, Michael, Sparrow, Sara, Anderson, Adam W, Duncan, Charles C, Makuch, Robert W, Gore, John C, Ment, Laura R

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Establishment of the first International Repository for Transfusion-Relevant Bacteria Reference Strains: ISBT Working Party Transfusion-Transmitted Infectious Diseases (WP-TTID), S... von Störmer, M., Arroyo, A., Brachert, J., Carrero, H., Devine, D., Epstein, J. S., Gabriel, C., Gelber, C., Goodrich, R., Hanschmann, K.-M., Heath, D. G., Jacobs, M. R., Keil, S., de Korte, D., Lambrecht, B., Lee, C.-K., Marcelis, J., Marschner, S., McDonald, C., McGuane, S., McKee, M., Müller, T. H., Muthivhi, T., Pettersson, A., Radziwon, P., Ramirez-Arcos, S., Reesink, H. W., Rojo, J., Rood, I., Schmidt, M., Schneider, C. K., Seifried, E., Sicker, U., Wendel, S., Wood, E. M., Yomtovian, R. A., Montag, T.

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School-Age Outcomes of Very Low Birth Weight Infants in the Indomethacin Intraventricular Hemorrhage Prevention Trial von Vohr, Betty R, Allan, Walter C, Westerveld, Michael, Schneider, Karen C, Katz, Karol H, Makuch, Robert W, Ment, Laura R

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Neurodevelopmental outcome at 36 Months' corrected age of preterm infants in the multicenter indomethacin intraventricular hemorrhage prevention trial von MENT, L. R, VOHR, B, MAKUCH, R. W, OH, W, SCOTT, D. T, ALLAN, W. C, WESTERVELD, M, DUNCAN, C. C, EHRENKRANZ, R. A, KATZ, K. H, SCHNEIDER, K. C

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Clinical trials with advanced therapy medicinal products von Schüssler-Lenz, M, Schneider, C K

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Low-dose indomethacin therapy and extension of intraventricular hemorrhage: A multicenter randomized trial von Ment, Laura R., Oh, William, Ehrenkranz, Richard A., Phillip, Alistair G.S., Vohr, Betty, Allan, Walter, Makuch, Robert W., Taylor, Kenneth J.W., Schneider, Karen C., Katz, Karol H., Scott, David T., Duncan, Charles C.

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After the TGN1412 incident. Principles for assessment of first-in-man trials with monoclonal antibodies by the Paul Ehrlich Institute von Schneider, C K, Kalinke, U

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Neonatal auditory activation detected by functional magnetic resonance imaging von Anderson, Adam W., Marois, Rene, Colson, Eve R., Peterson, Bradley S., Duncan, Charles C., Ehrenkranz, Richard A., Schneider, Karen C., Gore, John C., Ment, Laura R.

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Early-onset intraventricular hemorrhage in preterm neonates: Incidence of neurodevelopmental handicap von Vohr, Betty, Allan, Walter C., Scott, David T., Katz, Karol H., Schneider, Karen C., Makuch, Robert W., Ment, Laura R.

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Problems in microbial safety of advanced therapy medicinal products. Squaring the circle von Montag-Lessing, T, Störmer, M, Schurig, U, Brachert, J, Bubenzer, M, Sicker, U, Beshir, R, Spreitzer, I, Löschner, B, Bache, C, Becker, B, Schneider, C K

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Cerebral Lateralization is Protective in the Very Prematurely Born von Scheinost, Dustin, Lacadie, Cheryl, Vohr, Betty R, Schneider, Karen C, Papademetris, Xenophon, Constable, R Todd, Ment, Laura R

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Alterations in functional connectivity for language in prematurely born adolescents von Schafer, Robin J., Lacadie, Cheryl, Vohr, Betty, Kesler, Shelli R., Katz, Karol H., Schneider, Karen C., Pugh, Kenneth R., Makuch, Robert. W., Reiss, Allan L., Constable, R. Todd, Ment, Laura R.

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