Zobrazeno 1 - 10
of 61
pro vyhledávání: '"Mark, Rogge"'
Autor:
Konstantinos Biliouris, Puneet Gaitonde, Wei Yin, Daniel A. Norris, Yanfeng Wang, Scott Henry, Robert Fey, Ivan Nestorov, Stephan Schmidt, Mark Rogge, Lawrence J. Lesko, Mirjam N. Trame
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 7, Iss 9, Pp 581-592 (2018)
A pharmacokinetic (PK) model was developed for nusinersen, an antisense oligonucleotide (ASO) that is the first approved treatment for spinal muscular atrophy (SMA). The model was built with data from 92 nonhuman primates (NHPs) following intrathecal
Externí odkaz:
https://doaj.org/article/b2b051a9f867456392cdfdba33f08ea2
Publikováno v:
The Journal of Clinical Pharmacology. 62:1468-1471
Autor:
Karthik Venkatakrishnan, Neeraj Gupta, Patrick F. Smith, Tiffany Lin, Neil Lineberry, Tatiana Ishida, Lin Wang, Mark Rogge
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:298-309
Access lag to innovative therapies in Asian populations continues to present a challenge to global health. Recent progressive changes in the global regulatory landscape, including newer guidelines, are enabling simultaneous global drug development an
Autor:
Andy Z X, Zhu, Mark, Rogge
Publikováno v:
Methods in molecular biology (Clifton, N.J.). 2486
Significant advances in analytical technologies have dramatically improved our ability to deconvolute disease biology at molecular, cellular, and tissue levels. Quantitative system pharmacology (QSP) modeling is a computational framework to systemati
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
Autor:
Andy Z. X. Zhu, Mark Rogge
Publikováno v:
Methods in Molecular Biology ISBN: 9781071622643
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::27677b6e27d106cc7081b7a14873fa4e
https://doi.org/10.1007/978-1-0716-2265-0_5
https://doi.org/10.1007/978-1-0716-2265-0_5
Publikováno v:
Journal of clinical pharmacologyReferences. 62(1)
Publikováno v:
Journal of clinical pharmacologyReferences. 62(1)
Autor:
Joanna C. Masters, Ahmed Salem, Mark Rogge, Gina Pastino, Jean-Michel Gries, William A. Clementi, Lorraine M. Rusch, Bruce I. Gaynes, Hartmut Derendorf, Sudhakar M. Pai, Ahmed A. Othman, Parag Kumar, Islam Younis, Douglas S. Greene
Publikováno v:
The Journal of Clinical Pharmacology
Journal of Clinical Pharmacology
Journal of Clinical Pharmacology
Autor:
Mark Rogge, Fei Hua, John M. Burke, Liming Zhang, Chunlin Chen, Raibatak Das, Lucia Wille, Wendy J. Winchester, Jill Wykosky, Majid Vakilynejad, Joshua F. Apgar, Jangir Selimkhanov
Publikováno v:
Journal of Pharmacokinetics and Pharmacodynamics. 46:485-498
We developed a mathematical model of colon physiology driven by serotonin signaling in the enteric nervous system. No such models are currently available to assist drug discovery and development for GI motility disorders. Model parameterization was i