Zobrazeno 1 - 10
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pro vyhledávání: '"Lionberger P"'
Akademický článek
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Autor:
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 624-630 (2023)
Abstract On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrat
Externí odkaz:
https://doaj.org/article/7ba25868225a4671a0706b3a2c4392e8
Autor:
Ross L. Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 12, Iss 5, Pp 560-574 (2023)
Abstract In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States. This review summarizes the presentations
Externí odkaz:
https://doaj.org/article/5c0bae85a62f4563a75d8c48d83d86ce
Autor:
Chetan P. Kulkarni, Jia Yang, Megan L. Koleske, Giovanni Lara, Khondoker Alam, Andre Raw, Bhagwant Rege, Liang Zhao, Dongmei Lu, Lei Zhang, Lawrence X. Yu, Robert A. Lionberger, Kathleen M. Giacomini, Deanna L. Kroetz, Sook Wah Yee
Publikováno v:
Pharmaceutics, Vol 16, Iss 5, p 647 (2024)
The presence of mutagenic and carcinogenic N-nitrosamine impurities in medicinal products poses a safety risk. While incorporating antioxidants in formulations is a potential mitigation strategy, concerns arise regarding their interference with drug
Externí odkaz:
https://doaj.org/article/db2f7b3198274994a190b6df5cb02c07
Coursing the mottled mosaic: Generalist predators track pulses in availability of neonatal ungulates
Autor:
Katey S. Huggler, Matthew M. Hayes, Patrick W. Burke, Mark Zornes, Daniel J. Thompson, Patrick Lionberger, Miguel Valdez, Kevin L. Monteith
Publikováno v:
Ecology and Evolution, Vol 13, Iss 7, Pp n/a-n/a (2023)
Abstract The density and distribution of resources shape animal movement and behavior and have direct implications for population dynamics. Resource availability often is “pulsed” in space and time, and individuals should cue in on resource pulse
Externí odkaz:
https://doaj.org/article/4c7404973b29450a9d31433d32dc430d
Autor:
Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yan Wang, Markham Luke, Myong-Jin Kim, Robert Lionberger, Yi Zhang
Publikováno v:
Pharmaceutics, Vol 15, Iss 9, p 2366 (2023)
One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and
Externí odkaz:
https://doaj.org/article/671453aa31f540588579982b4b729154
Autor:
Mitchell J. Brunet, Kevin L. Monteith, Katey S. Huggler, Daniel J. Thompson, Patrick W. Burke, Mark Zornes, Patrick Lionberger, Miguel Valdez, Joseph D. Holbrook
Publikováno v:
Ecosphere, Vol 14, Iss 1, Pp n/a-n/a (2023)
Abstract The alternative prey hypothesis supposes that predators supported by a primary prey species will shift to consume alternative prey during a decrease in primary prey abundance. The hypothesis implies that during declines of one prey species,
Externí odkaz:
https://doaj.org/article/96231345edf243eea1b64927010d0493
Akademický článek
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Autor:
Saeid Raofi, Minori Kinjo, Dajun Sun, Zhichuan Li, Heather Boyce, Karthika Natarajan, Mitchell Frost, Liang Zhao, Markham Luke, Robert Lionberger, Debra Kelsh, Myong‐Jin Kim
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 5, Pp 1977-1987 (2021)
Abstract This study assessed the impact of product particle sizes (fine: 106–500 µm; coarse: 500–1000 µm) on oxycodone pharmacokinetics (PK) following nasal insufflation of milled oxycodone extended‐release (ER) abuse‐deterrent (AD) tablets
Externí odkaz:
https://doaj.org/article/f7d0df0f0a8844c69710608e5b08428c
Akademický článek
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