PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs von Turecek, Peter L., Bossard, Mary J., Schoetens, Freddy, Ivens, Inge A.

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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies von Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

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PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development von Ivens, Inge A., Achanzar, William, Baumann, Andreas, Brändli-Baiocco, Annamaria, Cavagnaro, Joy, Dempster, Maggie, Depelchin, B. Olympe, Irizarry Rovira, Armando R., Dill-Morton, Laura, Lane, Joan H., Reipert, Birgit M., Salcedo, Theodora, Schweighardt, Becky, Tsuruda, Laurie S., Turecek, Peter L., Sims, Jennifer

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Nonclinical Safety Assessment of a Long-Acting Recombinant PEGylated Factor Eight (BAY 94-9027) With a 60 kDa PEG von Ivens, Inge A., Banczyk, David, Gutberlet, Katrin, Jackman, Shawna, Vauléon, Stéphanie, Frisk, Anna-Lena

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BAY 94–9027, a PEGylated Recombinant Human FVIII, Shows Less Immunogenicity Compared to Un-PEGylated Recombinant FVIII von Ivens, Inge A, Zierz, Ruprecht, Haaning, Jesper, McDonald, Thomas

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Results of the prospective multicenter SoLKiD cohort study indicate bio-psycho-social outcome risks to kidney donors 12 months after donation von Suwelack, Barbara, Berger, Klaus, Wolters, Heiner, Gerß, Joachim W.O., Bormann, Eike, Wörmann, Viktorya, Burgmer, Markus, Koch, Martina, Kröncke, Sylvia, Weimer, Rolf, Rainer, Lucy, Sommerer, Claudia, Zeier, Martin, Budde, Klemens, Halleck, Fabian, Ivens, Katrin, Hansen, Anita, Reinke, Petra, Pascher, Andreas, Mühlfeld, Anja, Floege, Jürgen, Wahba, Roger, Vitinius, Frank, Kribben, Andreas, Eisenberger, Ute, Hugo, Christian, Quick, Carmen, Nitschke, Martin, Derad, Inge, Rath, Thomas, Mönch, Christian, Schiffer, Mario, Güler, Faikal, Krüger, Bernd, Bönnighoff, Roderich, Hauser, Ingeborg, Platschek, Steffen, Lopau, Kai, Pein, Ulrich, Weigand, Karl, Feldkamp, Thorsten, Kunzendorf, Ulrich

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Targeted Inhibition of Activated Protein C Anticoagulant Activity By Monoclonal Antibody HAPC1573 for Treatment of Hemophilia von Zhao, Xiao-Yan, Yegneswaran, Subramanian, Bauzon, Maxine, Sim, Derek, Patel, Chandra, Schneider, Doug, McLean, Kirk, Zhu, Ying, Jiang, Xiaoqiao, Evans, Vince, Gu, Jian-Ming, Ivens, Inge, Xu, Jun, Bringmann, Peter Wolfgang, Kauser, Katalin, Esmon, Charles

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Invited Review: Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations von Vahle, John L, Finch, Gregory L, Heidel, Shawn M, Hovland, David N, Ivens, Inge, Parker, Suezanne, Ponce, Rafael A, Sachs, Clifford, Steigerwalt, Ronald, Short, Brian, Todd, Marque D

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Carcinogenicity Assessments of Biotechnology-Derived Pharmaceuticals: A Review of Approved Molecules and Best Practice Recommendations von Vahle, John L., Finch, Gregory L., Heidel, Shawn M., Hovland, David N., Ivens, Inge, Parker, Suezanne, Ponce, Rafael A., Sachs, Clifford, Steigerwalt, Ronald, Short, Brian, Todd, Marque D.

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HUMAN GENE THERAPY METHODS FOR HEMOPHILIA A von Shah, Anita, Schmidt, Nicole, Vanevski, Konstantina, Ivens, Inge

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