Zobrazeno 1 - 10
of 91
pro vyhledávání: '"Robert Lionberger"'
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:
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:
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
Autor:
Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C. Nallani, Chandrahas G. Sahajwalla, Silvia N. Calderon, Rigoberto A. Roca, Kairui Feng, Issam Zineh, Robert Lionberger
Publikováno v:
EClinicalMedicine, Vol 41, Iss , Pp 101135- (2021)
Background: Over the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse. Al
Externí odkaz:
https://doaj.org/article/96bba9afeafa417a89bd446a27aa3786
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 8, Iss 6, Pp 347-351 (2019)
Externí odkaz:
https://doaj.org/article/629729c65a25441dbab66fc85a9341c8
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. 12:624-630
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4e0d67fd17f6ab9325b746cf4471e58a
https://doi.org/10.1002/psp4.12931
https://doi.org/10.1002/psp4.12931
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. 12:560-574
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 and panel
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e424b5c22c189ca33b6ad5f4220ebe03
https://doi.org/10.1002/psp4.12889
https://doi.org/10.1002/psp4.12889
Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades
Publikováno v:
Drug Metab Dispos
Transporters govern the access of molecules to cells or their exit from cells, thereby controlling the overall distribution of drugs to their intracellular site of action. Clinically relevant drug-drug interactions mediated by transporters are of inc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74a30f784522441e995099339f3f58ef
https://doi.org/10.1124/dmd.121.000706
https://doi.org/10.1124/dmd.121.000706
Autor:
Sydney Stern, Jill Coghlan, Vishalakshi Krishnan, Sam G. Raney, Andrew Babiskin, Wenlei Jiang, Robert Lionberger, Xiaoming Xu, Anna Schwendeman, James E. Polli
Publikováno v:
Pharmaceutical Research
Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::149075a2477047275ebb52d562d33333
https://doi.org/10.1007/s11095-021-03149-y
https://doi.org/10.1007/s11095-021-03149-y