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A Novel Approach to Evaluate the Pharmacokinetic Biocomparability of a Monoclonal Antibody Derived from Two Different Cell Lines Using Simultaneous Crossover Design

Autor: Brian Geist, Trina Jiao, Tong-Yuan Yang, Charles E. Pendley, Thomas A. Puchalski, Kenneth M. Goldberg, Thomas S. McIntosh, Hugh M. Davis, Honghui Zhou, Chao Han

Publikováno v: The AAPS Journal. 16:125-128

A parallel study design with a large number of subjects has been a typical path for pharmacokinetic (PK) biocomparability assessment of biotherapeutics with long half-lives and immunogenic propensity, for example, monoclonal antibodies (mAb). A recen

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c35043e8286950b983fab4669f5ffd40
https://doi.org/10.1208/s12248-013-9547-6

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Exploratory Pharmacokinetic/Pharmacodynamic and Tolerability Study of BCMAxCD3 in Cynomolgus Monkeys

Autor: Eric Baldwin, Joyce Ford, Kodandaram Pillarisetti, Dan Weinstock, Kevin Bellew, Suzette Girgis, Trina Jiao, Chidozie Amuzie, Rebecca Grimme Watson, Shoba Shetty

Publikováno v: Blood. 128:5668-5668

JNJ-64007957 is a bispecific antibody that binds to CD3 on T cells, and BCMA on plasma cells, and should induce T cell mediated killing of BCMA expressing malignant plasma cells. The objectives of this study were to characterize the tolerability of J

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::527b4bb9def9ea6f820e1187d19fa9fc
https://doi.org/10.1182/blood.v128.22.5668.5668

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A Phase I Study of CNTO 328, An Anti-Interleukin-6 Monoclonal Antibody in Patients with B-Cell Non-Hodgkin’s Lymphoma, Multiple Myeloma, or Castleman’s Disease

Autor: Mark J. Cornfeld, Peter M. Voorhees, Richard R. Furman, Sundar Jagannath, Jennifer Herring, Trina Jiao, Razelle Kurzrock, Xiang Qin, Frits van Rhee, Hossein Borghaei, Luis Fayad, Sagar Lonial, Lubomir Sokol, Ming Qi

Publikováno v: Blood. 112:1009-1009

Interleukin (IL)-6 is a multifunctional cytokine that serves as a growth factor for B-cell non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and Castleman’s Disease (CD). CNTO 328 is a chimeric monoclonal antibody that binds with both high spec

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0f5240300df789a0a03bafa597bc7f74
https://doi.org/10.1182/blood.v112.11.1009.1009

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CNTO 328, an Anti-Interleukin (IL)-6 Monoclonal Antibody (mAb) - Preliminary Results of Subjects with Castleman’s Disease from a Phase 1 Study in Selected Hematological Malignancies

Autor: Frits Vanrhee, Mohamed H. Zaki, Peter M. Voorhees, Carlos A. Garay, Richard R. Furman, Trina Jiao, Luis Fayad, Razelle Kurzrock, Christine F. Lihou, Hossein Borghaei, Uma Prabhakar, Robert Z. Orlowski

Publikováno v: Blood. 108:2728-2728

Background: IL-6 is a pleiotropic cytokine, the dysregulation of which plays an etiological role in many diseases. Multicentric Castleman’s disease (CD) is a polyclonal lymphoproliferative disorder in which IL-6, overproduced by enlarged lymph node

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::275625102886d3e3b924322cc50df25d
https://doi.org/10.1182/blood.v108.11.2728.2728

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