Zobrazeno 1 - 10
of 21
pro vyhledávání: '"Bing V. Li"'
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:
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
Autor:
Bryan, Newman, Andrew, Babiskin, Elizabeth, Bielski, Susan, Boc, Sneha, Dhapare, Lanyan, Fang, Katharine, Feibus, Anubhav, Kaviratna, Bing V, Li, Markham C, Luke, Tian, Ma, Michael, Spagnola, Ross L, Walenga, Zhong, Wang, Liang, Zhao, Nashwa, El-Gendy, Craig M, Bertha, Mohammed, Abd El-Shafy, Dhaval K, Gaglani
Publikováno v:
Advanced Drug Delivery Reviews. 190:114526
Regulatory science for generic dry powder inhalers (DPIs) in the United States (U.S.) has evolved over the last decade. In 2013, the U.S. Food and Drug Administration (FDA) published the draft product-specific guidance (PSG) for fluticasone propionat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1ea5eea0c6ce8bd102221687121e7ab9
https://doi.org/10.1016/j.addr.2022.114526
https://doi.org/10.1016/j.addr.2022.114526
Autor:
Nashwa, El-Gendy, Craig M, Bertha, Mohammed, Abd El-Shafy, Dhaval K, Gaglani, Andrew, Babiskin, Elizabeth, Bielski, Susan, Boc, Sneha, Dhapare, Lanyan, Fang, Katharine, Feibus, Anubhav, Kaviratna, Bing V, Li, Markham C, Luke, Tian, Ma, Bryan, Newman, Michael, Spagnola, Ross L, Walenga, Liang, Zhao
Publikováno v:
Advanced Drug Delivery Reviews. 189:114519
Regulatory science for generic dry powder inhalation products worldwide has evolved over the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations [1] (Revision 1, April 2018
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3907c75931d410ba46ca169e7fe798ef
https://doi.org/10.1016/j.addr.2022.114519
https://doi.org/10.1016/j.addr.2022.114519
Autor:
Mohammad Absar, Qing Liu, Bhawana Saluja, Bing V. Li, Changning Guo, Robert Lionberger, Dale P. Conner, Badrul A. Chowdhury
Publikováno v:
The AAPS journal. 21(2)
In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed dru
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4bc690a31760a6551bc72d89e7f8cf4d
https://pubmed.ncbi.nlm.nih.gov/30617594
https://pubmed.ncbi.nlm.nih.gov/30617594
Publikováno v:
The AAPS Journal. 17:837-852
This article is part of a series of reports from the “Orlando Inhalation Conference-Approaches in International Regulation” which was held in March 2014, and coorganized by the University of Florida and the International Pharmaceutical Aerosol Co
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::15a87fa252cd3884cc72a4b345d6e76e
https://doi.org/10.1208/s12248-015-9763-3
https://doi.org/10.1208/s12248-015-9763-3
Autor:
Sally Seymour, Robert Lionberger, Wallace P. Adams, Hoainhon N. Caramenico, Dale P. Conner, Badrul A. Chowdhury, Bing V. Li, Susan Limb, John R. Peters, Dongmei Lu, Rohit K. Katial, Sau L. Lee, Lawrence X. Yu, Stephanie Choi
Publikováno v:
The AAPS Journal. 17:546-557
International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities and differences among
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f9b7caac9377fece58384308b0b826e
https://doi.org/10.1208/s12248-015-9733-9
https://doi.org/10.1208/s12248-015-9733-9
Publikováno v:
The AAPS Journal. 15:465-476
Demonstration of equivalence in aerodynamic particle size distribution (APSD) is one key component for establishing bioequivalence of orally inhaled drug products. We previously proposed a modified version of the Chi-square ratio statistic (mCSRS) fo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f14bc2ce64cd74e9728496a8431da844
https://doi.org/10.1208/s12248-013-9453-y
https://doi.org/10.1208/s12248-013-9453-y