Search Results - "Martin, Steven W"

Clinical Pharmacokinetic Assessment of an Anti-MAdCAM Monoclonal Antibody Therapeutic by LC-MS/MS by Fernández Ocaña, Mireia, James, Ian T, Kabir, Musarat, Grace, Christopher, Yuan, Guojun, Martin, Steven W, Neubert, Hendrik

“…Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been shown to be a viable tool for preclinical pharmacokinetic (PK) analysis of monoclonal…”
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A Dynamic Quantitative Systems Pharmacology Model of Inflammatory Bowel Disease: Part 1 – Model Framework by Rogers, Katharine V., Martin, Steven W., Bhattacharya, Indranil, Singh, Ravi Shankar Prasad, Nayak, Satyaprakash

“…A mechanistic, multistate, mathematical model of inflammatory bowel disease (IBD) was developed by including key biological mechanisms in blood and gut,…”
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A Single‐Dose Placebo‐Controlled Study of AMG 162, a Fully Human Monoclonal Antibody to RANKL, in Postmenopausal Women by Bekker, Pirow J, Holloway, Donna L, Rasmussen, Amy S, Murphy, Robyn, Martin, Steven W, Leese, Philip T, Holmes, Gregory B, Dunstan, Colin R, DePaoli, Alex M

“…The safety and bone antiresorptive effect of a single subcutaneous dose of AMG 162, a human monoclonal antibody to RANKL, was investigated in 49 postmenopausal…”
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Quantitative Prediction of Human Pharmacokinetics for mAbs Exhibiting Target-Mediated Disposition by Singh, Aman P., Krzyzanski, Wojciech, Martin, Steven W., Weber, Gregory, Betts, Alison, Ahmad, Alaa, Abraham, Anson, Zutshi, Anup, Lin, John, Singh, Pratap

“…Prediction of human pharmacokinetics (PK) can be challenging for monoclonal antibodies (mAbs) exhibiting target-mediated drug disposition (TMDD). In this…”
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A Dynamic Quantitative Systems Pharmacology Model of Inflammatory Bowel Disease: Part 2 – Application to Current Therapies in Crohn’s Disease by Rogers, Katharine V., Martin, Steven W., Bhattacharya, Indranil, Singh, Ravi Shankar Prasad, Nayak, Satyaprakash

“…Inflammatory bowel disease (IBD) is a heterogeneic disease with a variety of treatments targeting different mechanisms. A multistate, mechanistic, mathematical…”
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Comparability Considerations and Challenges for Expedited Development Programs for Biological Products by Schrieber, Sarah J., Putnam, Wendy S., Chow, Edwin Chiu Yuen, Cieslak, Jacek, Zhuang, Yanli, Martin, Steven W., Hanson, Paul, Maggio, Frank, Rosado, Leslie A. Rivera

“…Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed…”
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Adoption and Abandonment of Precision Soil Sampling in Cotton Production by Walton, Jonathan C, Lambert, Dayton M, Roberts, Roland K, Larson, James A, English, Burton C, Larkin, Sherry L, Martin, Steven W, Marra, Michele C, Paxton, Kenneth W, Reeves, Jeanne M

“…Adoption of precision agriculture technology has received considerable attention, but abandonment has received little. This paper identifies factors motivating…”
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Lymphatic absorption is the primary contributor to the systemic availability of epoetin Alfa following subcutaneous administration to sheep by McLennan, Danielle N, Porter, Christopher J H, Edwards, Glenn A, Martin, Steven W, Heatherington, Anne C, Charman, Susan A

“…The contribution of the lymphatics to the absorption and systemic availability of recombinant human epoetin alfa (rHuEPO) following s.c. injection was examined…”
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Exposure–response characterization of tofacitinib efficacy in moderate to severe ulcerative colitis: Results from a dose‐ranging phase 2 trial by Mukherjee, Arnab, Hazra, Anasuya, Smith, Mike K., Martin, Steven W., Mould, Diane R., Su, Chinyu, Niezychowski, Wojciech

“…Aims Tofacitinib is an oral, small molecule JAK inhibitor being investigated for ulcerative colitis (UC). In a phase 2 dose‐ranging study, tofacitinib…”
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Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn’s Disease: The OPERA II Study by D’Haens, Geert R, Reinisch, Walter, Lee, Scott D, Tarabar, Dino, Louis, Edouard, Kłopocka, Maria, Klaus, Jochen, Schreiber, Stefan, Il Park, Dong, Hébuterne, Xavier, Nagy, Peter, Cataldi, Fabio, Martin, Steven W, Nayak, Satyaprakash, Banerjee, Anindita, Gorelick, Kenneth J, Sandborn, William J

“…Abstract Background Patients with Crohn’s disease (CD) experience intestinal inflammation. Ontamalimab (SHP647), a fully human immunoglobulin G2 monoclonal…”
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The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study by Vermeire, Séverine, Ghosh, Subrata, Panes, Julian, Dahlerup, Jens F, Luegering, Andreas, Sirotiakova, Jana, Strauch, Ulrike, Burgess, Gary, Spanton, Jacqueline, Martin, Steven W, Niezychowski, Wojciech

“…Leucocyte migration to gut mucosa, mediated by integrin binding to mucosal addressin cell adhesion molecule (MAdCAM), is a promising target for therapeutic…”
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Clinical dose–response for a broad set of biological products: A model-based meta-analysis by Wu, Joseph, Banerjee, Anindita, Jin, Bo, Menon, Sandeep M, Martin, Steven W, Heatherington, Anne C

“…Characterizing clinical dose–response is a critical step in drug development. Uncertainty in the dose–response model when planning a dose-ranging study can…”
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Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis by Vong, Camille, Martin, Steven W., Deng, Chenhui, Xie, Rujia, Ito, Kaori, Su, Chinyu, Sandborn, William J., Mukherjee, Arnab

“…Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinetics in…”
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Mo1780 Tofacitinib Pharmacokinetics and Durability of Drug Exposure in Moderate to Severe Crohn's Disease Patients in Phase 2 Induction and Maintenance Studies by Mukherjee, Arnab, Deng, Chenhui, Xie, Rujia, Martin, Steven W, Chan, Gary, Moscariello, Michele, Niezychowski, Wojciech, Maller, Eric

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Developing and Pricing Precipitation Insurance by Martin, Steven W., Barnett, Barry J., Coble, Keith H.

“…Production agriculture and agribusiness are exposed to many weather-related risks. Recent years have seen the emergence of an increased interest in…”
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Know Your Variability: Challenges in Mechanistic Modeling of Inflammatory Response in Inflammatory Bowel Disease (IBD) by Rogers, Katharine V., Bhattacharya, Indranil, Martin, Steven W., Nayak, Satyaprakash

“…The development of quantitative systems pharmacology (QSP) models for understanding diseases and therapeutics requires integration of data from multiple…”
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The role of mechanism-based pharmacokinetic–pharmacodynamic (PK–PD) modelling in translational research of biologics by Agoram, Balaji M., Martin, Steven W., van der Graaf, Piet H.

“…Lack of predictability of clinical efficacy and safety is an important problem facing pharmaceutical research today. Translational PK–PD has the ability to…”
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Long-Term Safety, Efficacy and Pharmacokinetics of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) Monoclonal Antibody SHP647 in Crohnʼs Disease: The OPERA II Study: 606 by DʼHaens, Geert R., Reinisch, Walter, Lee, Scott D., Tarabar, Dino, Louis, Edouard, Klopocka, Maria, Klaus, Jochen, Schreiber, Stefan, Park, Dong Il, Hébuterne, Xavier, Cataldi, Fabio, Martin, Steven W., Nayak, Satyaprakash, Banerjee, Anindita, Gorelick, Kenneth J., Sandborn, William J.

“…Introduction: The endothelial adhesion protein mucosal addressin cell adhesion molecule-1 (MAdCAM-1) is a promising novel drug target. The fully human IgG2…”
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Mo1781 Tofacitinib Plasma Concentration Monitoring Is Not Needed for Optimization of Induction Therapy in Moderate to Severe Ulcerative Colitis: Results of Pooled Exposure-Response Analyses of Phase 3 Induction Studies by Mukherjee, Arnab, Tsuchiwata, Shinichi, Deng, Chenhui, Vong, Camille, Xie, Rujia, Martin, Steven W, Yu, Dahong, Woodworth, Deborah A, Niezychowski, Wojciech, Su, Chinyu

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Pharmacokinetics and Exposure-Response of Tofacitinib in a Phase 3 Maintenance Study in Ulcerative Colitis Patients by Mukherjee, Arnab, D'Haens, Geert R, Sandborn, William J, Tsuchiwata, Shinichi, Vong, Camille, Deng, Chenhui, Xie, Rujia, Hazra, Anasuya, Martin, Steven W, Friedman, Gary, Niezychowski, Wojciech, Su, Chinyu

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