Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Elizabeth Bielski"'
Autor:
Abhinav Ram Mohan, Qiang Wang, Sneha Dhapare, Elizabeth Bielski, Anubhav Kaviratna, Liangfeng Han, Susan Boc, Bryan Newman
Publikováno v:
Pharmaceutics, Vol 14, Iss 11, p 2495 (2022)
Dry powder inhalers (DPIs) are drug–device combination products where the complexity of the formulation, its interaction with the device, and input from users play important roles in the drug delivery. As the landscape of DPI products advances with
Externí odkaz:
https://doaj.org/article/e71ae98760924dc292af207559588133
Autor:
Jieon Lee, Kairui Feng, Denise S. Conti, Ross Walenga, Michael Wientjes, Hezhen Wang, Bryan Newman, Liangfeng Han, Sneha Dhapare, Elizabeth Bielski, Andrew Babiskin, Fang Wu, Mark Donnelly, Myong‐Jin Kim, Wenlei Jiang, Markham C. Luke, Lanyan Fang, Liang Zhao
Publikováno v:
Clinical Pharmacology & Therapeutics. 112:982-989
Herein, we present the US Food and Drug Administration (FDA) Office of Research and Standards' current thinking, challenges, and opportunities for comparative clinical endpoint bioequivalence (BE) studies of orally inhaled drug products (OIDPs). Give
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c925cfdc9f41d56c03ffa53e6c4684ee
https://doi.org/10.1002/cpt.2553
https://doi.org/10.1002/cpt.2553
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 The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations [1] (Revision 1, April 2018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
Publikováno v:
The AAPS Journal
Demonstrating bioequivalence (BE) of nasal suspension sprays is a challenging task. Analytical tools are required to determine the particle size of the active pharmaceutical ingredient (API) and the structure of a relatively complex formulation. This
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7df8bd04bb66fffb8ae722dc3e87f3a4
https://doi.org/10.1208/s12248-021-00605-w
https://doi.org/10.1208/s12248-021-00605-w