Výsledky vyhledávání - "Michael, Eschenberg"

Romiplostim promotes platelet recovery in a mouse model of multicycle chemotherapy-induced thrombocytopenia

Autor: Patricia McElroy, Keri Buck, Graham Molineux, Ping Wei, Angus M. Sinclair, Barbra Sasu, Michael Eschenberg

Publikováno v: Experimental Hematology. 43(6):479-487

Chemotherapy-induced thrombocytopenia can lead to chemotherapy treatment delays or dose reductions. The ability of romiplostim, a thrombopoietin (TPO) mimetic, to promote platelet recovery in a mouse model of multicycle chemotherapy/radiation therapy

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e81ff8c5d79e62064d72866d80fa438a

Zobrazit plný text záznamu

In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study

Autor: Theingi M. Thway, Michael Eschenberg, Chris Macaraeg, Mark Ma

Publikováno v: The AAPS Journal. 17:684-690

Formulation changes at later stages of biotherapeutics development require biocomparability (BC) assessment. Using simulation, this study aims to determine the potential effect of bias difference observed between the two formulations after spiking in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::149656ce89a0e3fd63bffa3c71e2c625
https://doi.org/10.1208/s12248-015-9741-9

Zobrazit plný text záznamu

FGF23 neutralization improves chronic kidney disease–associated hyperparathyroidism yet increases mortality

Autor: Nessa Hawkins, Mei-Mei Tsai, Charles Henley, Ching Chen, William G. Richards, Xuechen Xia, Edward Shatzen, Michael Eschenberg, Vivian Bi, Wei Wang, Jennitte Stevens, S. C. Ward, Russell C. Cattley, Xiaodong Li, Thomas J. Wronski, James W. Davis, Victoria Shalhoub, Lisa Renshaw

Publikováno v: Journal of Clinical Investigation. 122:2543-2553

Chronic kidney disease-mineral and bone disorder (CKD-MBD) is associated with secondary hyperparathyroidism (HPT) and serum elevations in the phosphaturic hormone FGF23, which may be maladaptive and lead to increased morbidity and mortality. To deter

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6bc48acdb0029f63226cb4b898ef9be9
https://doi.org/10.1172/jci61405

Zobrazit plný text záznamu

Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision

Autor: Michael Eschenberg, Binodh DeSilva, Theingi M. Thway, Mark Ma, Dominador Calamba, Chris Macaraeg

Publikováno v: The AAPS Journal. 13:291-298

Incurred sample reanalysis (ISR) is recommended by regulatory agencies to demonstrate reproducibility of validated methods and provide confidence that methods used in pharmacokinetic and toxicokinetic assessments give reproducible results. For macrom

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::54ab8a32d379a82a4c6954cef10ed544
https://doi.org/10.1208/s12248-011-9271-z

Zobrazit plný text záznamu

Bioanalytical method requirements and statistical considerations in incurred sample reanalysis for macromolecules

Autor: Laura Brunner, Liana Zhang, Ramak Pourvasei, Mark Ma, Theingi M. Thway, Chris Macaraeg, Michael Eschenberg, Binodh DeSilva, Dominador Calamba

Publikováno v: Bioanalysis. 2:1587-1596

Background: Incurred sample reanalysis (ISR) is the most recent in-study validation parameter that regulatory agencies have mandated to ensure reproducibility of bioanalytical methods supporting pharmacokinetic/toxicokinetic and clinical studies. The

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3cc0f1f8912df3d7b99cd5ee503db33
https://doi.org/10.4155/bio.10.75

Zobrazit plný text záznamu

Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma

Autor: Stephen J. Schuster, Alessandra Cesano, Amy Chadburn, John P. Leonard, Heather Ziccardi, William A. Wegener, Scott Z. Fields, David M. Goldenberg, Urte Gayko, Morton Coleman, Michael W. Schuster, Michelle Ashe, Hans J. Hansen, Richard R. Furman, Jamie C. Ketas, Michael Eschenberg, Eric J. Feldman

Publikováno v: Clinical Cancer Research. 10:5327-5334

Purpose: We conducted a single-center, dose-escalation study evaluating the safety, pharmacokinetics, and efficacy of epratuzumab, an anti-CD22 humanized monoclonal antibody, in patients with aggressive non-Hodgkin’s lymphoma.Experimental Design: E

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2c1da048c873419297fe8219f2bd9aeb
https://doi.org/10.1158/1078-0432.ccr-04-0294

Zobrazit plný text záznamu

Phase I/II Trial of Epratuzumab (Humanized Anti-CD22 Antibody) in Indolent Non-Hodgkin’s Lymphoma

Autor: Hans J. Hansen, Heather Ziccardi, Morton Coleman, Alessandra Cesano, Michael Eschenberg, Scott Ely, Jamie C. Ketas, David M. Goldenberg, Amy Chadburn, William A. Wegener, Richard R. Furman, John P. Leonard, Urte Gayko

Publikováno v: Journal of Clinical Oncology. 21:3051-3059

Purpose: This single-center, dose-escalation study examines the safety, efficacy, and pharmacokinetics of epratuzumab (anti-CD22 humanized monoclonal antibody) in patients with recurrent indolent non-Hodgkin’s lymphoma (NHL).Patients and Methods: P

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::40ab4a5b102caef093b41f8244e593a0
https://doi.org/10.1200/jco.2003.01.082

Zobrazit plný text záznamu

Progressive increases in bone mass and bone strength in an ovariectomized rat model of osteoporosis after 26 weeks of treatment with a sclerostin antibody

Autor: William S. Simonet, Denise Dwyer, Xiaodong Li, Paul J. Kostenuik, Michael S. Ominsky, Michael Eschenberg, Marina Stolina, Chun-Ya Han, Hua Zhu Ke, Qing-Tian Niu, Kelly S Warmington, Franklin J. Asuncion, Mario Grisanti

Publikováno v: Endocrinology. 155(12)

The effects of up to 26 weeks of sclerostin antibody (Scl-Ab) treatment were investigated in ovariectomized (OVX) rats. Two months after surgery, 6-month-old osteopenic OVX rats were treated with vehicle or Scl-Ab (25 mg/kg, sc, one time per week) fo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9595eb6770846b15c99ba605a969241
https://pubmed.ncbi.nlm.nih.gov/25259718

Zobrazit plný text záznamu

Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes

Autor: Binodh DeSilva, Ramak Pourvasei, Edward Lee, Vimal Patel, Kinnari Pandya, Judy Shih, Jean W. Lee, Mark Ma, Chris Macaraeg, Michael Eschenberg

Publikováno v: The AAPS journal. 15(1)

Manufacturing changes during a biological drug product life cycle occur often; one common change is that of the manufacturing site. Comparability studies may be required to ensure that the changes will not affect the pharmacokinetic properties of the

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fb6262c0b50e736e1570a7d1fa349b2f
https://pubmed.ncbi.nlm.nih.gov/23054973

Zobrazit plný text záznamu

Beyond glass transitions: studying the highly viscous and elastic behavior of frozen protein formulations using low temperature rheology and its potential implications on protein stability

Autor: Tian Wu, Priti Baker, Beekman Alice C, M. D. Hale, Michael Eschenberg, Merrill Seymour Goldenberg, Deirdre Murphy Piedmonte, Jian Hua Gu

Publikováno v: Pharmaceutical research. 30(2)

A novel application of oscillatory shear rheology was used to directly monitor global phase behavior of protein formulations in the frozen state and study its correlation with physical instability of frozen protein formulations.Oscillatory rheology w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::596c884c7c28a0de60e13c0694d4e334
https://pubmed.ncbi.nlm.nih.gov/23070601

Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání