Výsledky vyhledávání

Autor: Denise Jin, Balaji Agoram, Michael J. Wick, Chris H. Takimoto

Prior to entering clinical testing, a new molecular entity must first undergo a series of rigorous scientific assessments. These include pharmacologic evaluations of safety and efficacy, toxicology testing under carefully controlled conditions, and t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::70ce5e47c1d2cdbb2cdad0edb404dbef
https://doi.org/10.1016/b978-0-12-819869-8.00031-8

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Contributors

Autor: Darrell R. Abernethy, Balaji Agoram, John M. Allen, Mark E. Arnold, Arthur J. Atkinson, Thomas J. Bateman, Kimberly Bergman, Brian Booth, David W. Boulton, Robert A. Branch, Gilbert J. Burckart, Mary Buschmann, Owen Carmichael, Christine Chamberlain, Ligong Chen, Charles E. Daniels, Promi Das, Jana G. Delfino, John N. Van Den Anker, Albert W. Dreisbach, Michael Dyszel, Justin C. Earp, M. Khair ElZarrad, Osatohanmwen J. Enogieru, Elimika Pfuma Fletcher, David M. Foster, Marilynn C. Frederiksen, Aleksandra Galetin, Pamela D. Garzone, Kathleen M. Giacomini, Megan A. Gibbs, Jack A Gilbert, Danijela Gnjidic, Charles T. Gombar, Denis M. Grant, Charles Grudzinskas, Bengt Hamren, Nicholas H.G. Holford, Shiew-Mei Huang, Renee Iacona, Nina Isoherranen, Denise Jin, Bridgette L. Jones, Gregory L. Kearns, Cindy Kortepeter, Elizabeth Kunkoski, S.W. Johnny Lau, Christopher Leptak, Juan J.L. Lertora, Lawrence J. Lesko, Jiang Liu, Qi Liu, Rajanikanth Madabushi, Raymond Miller, Diane R. Mould, Monica Muñoz, Thomas D. Nolin, Robert Joseph Noveck, R. Scott Obach, Michael Pacanowski, Mary F. Paine, Carl C. Peck, Anuradha Ramamoorthy, A. David Rodrigues, Malcolm Rowland, Chandrahas G. Sahajwalla, Martina Dagmar Sahre, Robert N. Schuck, Khushboo Sharma, Tristan Sissung, Catherine S. Stika, Chris H. Takimoto, Helen Tomkinson, Jack Uetrecht, Paolo Vicini, Karen D. Vo, John A. Wagner, Yaning Wang, Yow-Ming C. Wang, Peter G. Wells, Michael J. Wick, Sook Wah Yee, Ophelia Yin, Nathalie K. Zgheib, Lei Zhang, Hao Zhu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::848d2065918d75dffbea67f6015e7476
https://doi.org/10.1016/b978-0-12-819869-8.09990-0

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Model-Based Discovery and Development of Biopharmaceuticals: A Case Study of Mavrilimumab

Autor: Bing Wang, Lorin Roskos, Denise Jin, Paolo Vicini, Chi-Yuan Wu

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology. 7:5-15

Drug development is a lengthy, costly process with low probability of success. Biopharmaceuticals are highly specific molecules, with efficacy and safety closely tied to target biology and pharmacology. The "learning-predicting-confirming" continuum

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0d2010105661c3ee46d74ffa6a2e4e98
https://doi.org/10.1002/psp4.12245

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Population pharmacokinetic and pharmacodynamic modeling of MNRP1685A in cynomolgus monkeys using two-target quasi-steady-state (QSS) model

Autor: Hong Xiang, Denise Jin, Frank-Peter Theil, Amita Joshi, Yan Xin, Lisa A. Damico-Beyer, Shuang Bai

Publikováno v: Journal of Pharmacokinetics and Pharmacodynamics. 39:217-226

MNRP1685A (anti-NRP1) is a fully human IgG1 monoclonal antibody against neuropilin-1 (NRP1), a protein necessary for blood vessel maturation. MNRP1685A binds to free membrane-bound NRP1 (mNRP1) and circulating NRP1 (cNRP1). Total cNRP1 increased in a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9278d5be36f561c42b3faf4b79c85ac4
https://doi.org/10.1007/s10928-012-9244-6

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Population pharmacokinetic analysis from phase I and phase II studies of the humanized monovalent antibody, onartuzumab (MetMAb), in patients with advanced solid tumors

Autor: John Bothos, Lisa A. Damico-Beyer, Surinder Kaur, Amita Joshi, Ihsan Nijem, Shuang Bai, Yan Xin, Stephen Eppler, Denise Jin, Amy C. Peterson, John D. Davis, Premal Patel

Publikováno v: The Journal of Clinical Pharmacology.

Onartuzumab is a unique, humanized, monovalent (one-armed) monoclonal antibody (mAb) against the MET receptor. The intravenous (IV) pharmacokinetics (PK) of onartuzumab were investigated in a phase I study and a phase II study in recurrent non-small

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::8ac6ba28e8ab9ccc6004b4dff272cf3a
https://doi.org/10.1002/jcph.148

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Characterization of the long-term pharmacokinetics of bevacizumab following last dose in patients with resected stage II and III carcinoma of the colon

Autor: Manish Gupta, Jing Li, Denise Jin, Yan Xin, David E. Allison, Jennifer Visich

Publikováno v: Cancer chemotherapy and pharmacology. 71(3)

The study characterizes the long-term pharmacokinetics (PK) following last dose of bevacizumab as adjuvant therapy in patients with resected stage II and III colon carcinoma in a Phase III clinical study (AVF3077s).Patients in AVF3077s received bevac

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::342e08e1aa6794b4bed7682dacda4ee7
https://pubmed.ncbi.nlm.nih.gov/23228985

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A guide to rational dosing of monoclonal antibodies

Autor: Mark J. Dresser, Denise Jin, Dan Lu, Yan Xin, Shuang Bai, Lisa A. Damico-Beyer, Karin Jorga, Manish Gupta, Yi Zhang, David E. Allison, Amita Joshi, Meina Tang, Yanan Zheng

Publikováno v: Clinical pharmacokinetics. 51(2)

Dosing of therapeutic monoclonal antibodies (mAbs) is often based on body size, with the perception that body size-based dosing would reduce inter-subject variability in drug exposure. However, most mAbs are target specific with a relatively large th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a094689ecaab93ea34c19a5745f69383
https://pubmed.ncbi.nlm.nih.gov/22257150

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