Zobrazeno 1 - 10
of 66
pro vyhledávání: '"Michael W, Leach"'
Autor:
Michael W. Leach, Katherine Hammerman
Publikováno v:
Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology ISBN: 9780128210475
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c181d8ac96ac8537561dc598359449be
https://doi.org/10.1016/b978-0-12-821047-5.00024-5
https://doi.org/10.1016/b978-0-12-821047-5.00024-5
Autor:
Basel T. Assaf, Adam D. Aulbach, Virunya Bhat, Brad Bolon, William M. Bracken, Alys E. Bradley, Glenn H. Cantor, Kevin B. Donnelly, Elodie Drevon-Gaillot, Stephen K. Durham, Jeffery A. Engelhardt, Daniela Ennulat, James Fikes, John Reginald Foster, Kathleen Funk, Sibylle Gröters, Magali R. Guffroy, Silvia Guionaud, Katherine Hammerman, Carole Harbison, Claudia Harper, Christopher Hurst, Evan B. Janovitz, Kevin Keane, Stephanie Klein, Rebecca Kohnken, Michael W. Leach, Xiantang Li, René Meisner, Keith Nelson, Thomas Nolte, Arun R. Pandiri, Jonathan A. Phillips, Colin G. Rousseaux, Daniel G. Rudmann, Keegan C. Rudmann, Aaron M. Sargeant, JoAnn C.L. Schuh, A. Eric Schultze, Rani S. Sellers, James A. Swenberg, Eric Tien, John L. Vahle, Lyn M. Wancket, Charles E. Wood
Publikováno v:
Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology ISBN: 9780128210475
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::31409643d62572b0c03a3aa33f1f4680
https://doi.org/10.1016/b978-0-12-821047-5.01002-2
https://doi.org/10.1016/b978-0-12-821047-5.01002-2
Autor:
Hsiao-Tzu Chien, Helen Prior, Laura Andrews, Leon van Aerts, Annick Cauvin, David O. Clarke, Kaushik Datta, Maggie Dempster, Noel Dybdal, Wendy Freebern, Lolke de Haan, Danuta Herzyk, Adam Hey, Thomas Kissner, Sven Kronenberg, Michael W. Leach, Donna Lee, Katrin Schutte, Fiona Sewell, Kevin Trouba, Peter Ulrich, Lucinda Weir, Peter van Meer
Publikováno v:
Regulatory Toxicology and Pharmacology, 138
Contains fulltext : 290916.pdf (Publisher’s version ) (Open Access) To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has show
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a712af51bb6e1da72593e0cdaedcd2e2
http://hdl.handle.net/2066/290916
http://hdl.handle.net/2066/290916
Autor:
Chao Han, Marque Todd, Chunze Li, Frank R. Brennan, Zheng Yang, Sherri Dudal, Wendy J. Bailey, Yingxue Chen, Nagendra V. Chemuturi, Kapil Mayawala, Lise I. Loberg, Antoine Deslandes, Clarke David O, Michael W. Leach, Mark Rogge
Publikováno v:
Clinical Pharmacology & Therapeutics. 109:1395-1416
Various approaches to first-in-human (FIH) starting dose selection for new molecular entities (NMEs) are designed to minimize risk to trial subjects. One approach uses the minimum anticipated biological effect level (MABEL), which is a conservative m
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e9b9ae8f92d0d96e2c0c7071ecc9d48d
https://doi.org/10.1002/cpt.2009
https://doi.org/10.1002/cpt.2009
Autor:
Helen Prior, Laura Andrews, Annick Cauvin, Hsiaotzu Chien, David O. Clarke, Kaushik Datta, Maggie Dempster, Noel Dybdal, Wendy Freebern, Lolke de Haan, Danuta Herzyk, Adam Hey, Thomas Kissner, Sven Kronenberg, Michael W. Leach, Donna Lee, Kirsty Reid, Katrin Schutte, Fiona Sewell, Kevin Trouba, Peter Ulrich, Leon van Aerts, Peter van Meer, Lucinda Weir
Publikováno v:
Regulatory Toxicology and Pharmacology. 138:105339
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4146fe9c04d39dfa50daeca91bc58f4b
https://doi.org/10.1016/j.yrtph.2023.105339
https://doi.org/10.1016/j.yrtph.2023.105339
Autor:
Michael W. Leach
Publikováno v:
Translational Medicine ISBN: 9781003124542
Translational Medicine
Translational Medicine
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::101947a4ab40294761ccdb062dceaff9
https://doi.org/10.1201/9781003124542-23
https://doi.org/10.1201/9781003124542-23
Autor:
Diann Blanset, Maggie Dempster, Renaud Fleurance, Esther Sutter, Michael W. Leach, Timothy K. MacLachlan, Elizabeth Galbreath, Kathleen M. Heinz-Taheny, Laura Andrews, Anna Maria Giusti, Mary Ellen Cosenza, Joy A. Cavagnaro, Shari A. Price
Publikováno v:
Regulatory Toxicology and Pharmacology. 121:104872
Monoclonal antibodies (mAbs) and mAb derivatives have become mainstay pharmaceutical modalites. A critical assessment is to ascertain the specificity of these molecules prior to human clinical trials. The primary technique for determining specificity
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ad0a2670e20ca1eb2780cf9b882a8b8
https://doi.org/10.1016/j.yrtph.2021.104872
https://doi.org/10.1016/j.yrtph.2021.104872
Autor:
Leslie G. Lorello, Jim McNally, Hugh D. Conlon, Michael W. Leach, Carol F. Kirchhoff, Teresa Annette Smolarek, Andrew Saati, Sarah Koob, Mazin Derzi, Ahmed M. Shoieb, Penny Sharpe, Michael W. Bolt, Theodore R. Johnson
Publikováno v:
Advances in Therapy
Introduction PF-06438179, a potential biosimilar to Remicade® (infliximab, Janssen Biotech, Inc.), is a chimeric mouse–human monoclonal antibody targeting human tumor necrosis factor alpha (TNF). Methods Analytical (small subset reported here) and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::af1eb4ef54c3121972985f519b27fd07
https://doi.org/10.1007/s12325-016-0403-9
https://doi.org/10.1007/s12325-016-0403-9
Autor:
Michael W. Leach, Leslie G. Lorello, Gregory L. Finch, Sharon L. Ripp, Ahmed M. Shoieb, Shawn P. O'Neil, Jameel Syed, Zaher A. Radi, Matthew S. Thompson, Mazin Derzi
Publikováno v:
Regulatory Toxicology and Pharmacology. 112:104587
Adalimumab, a recombinant fully human monoclonal antibody targeting tumor necrosis factor (TNF), is approved in the United States and Europe to treat various inflammatory and autoimmune indications. Biosimilars are approved biologics highly similar,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9b782c4c13b3cd4d270d27d6799df466
https://doi.org/10.1016/j.yrtph.2020.104587
https://doi.org/10.1016/j.yrtph.2020.104587
Autor:
Karen E. Rule, Gregory L. Finch, Michael H.I. Shiue, Paul R. Brown, Stephane Thibault, Michael W. Leach, David W. Clarke, Marjorie A. Peraza
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 95
Bevacizumab, a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF), is approved for treatment of metastatic colorectal cancer, nonsquamous non-small-cell lung cancer, metastatic kidney cancer, and glioblastom
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3e5d4b921de4c5e3af29f4ef75215f8
https://pubmed.ncbi.nlm.nih.gov/29574193
https://pubmed.ncbi.nlm.nih.gov/29574193