Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Sneha Dhapare"'
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
Publikováno v:
Therapeutic Innovation & Regulatory Science
Background In the USA, drug costs associated with the inhaled corticosteroid (ICS) and long acting β agonist (LABA) combination products have been increasing since 2001. In January 2019, the first generic ICS/LABA drug product was approved by the U.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::163e80c7fd1b3ace70b01162eae3db43
http://europepmc.org/articles/PMC8812951
http://europepmc.org/articles/PMC8812951
Excipient Enhanced Growth Aerosol Surfactant Replacement Therapy in an In Vivo Rat Lung Injury Model
Autor:
P. Worth Longest, Michael Hindle, Sahil R Chindal, Michael S. Valentine, Franck J. Kamga Gninzeko, Sneha Dhapare, Amr Hassan, Susan Boc, Dale Farkas, Rebecca L. Heise, Cindy K. Tho, Mohammad A.M. Momin
Publikováno v:
J Aerosol Med Pulm Drug Deliv
Background: In neonatal respiratory distress syndrome, breathing support and surfactant therapy are commonly used to enable the alveoli to expand. Surfactants are typically delivered through liquid instillation. However, liquid instillation does not
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::827e7118d2042547294aaf8fe4acefd8
https://doi.org/10.1089/jamp.2020.1593
https://doi.org/10.1089/jamp.2020.1593
Publikováno v:
Biopharmaceutics & Drug Disposition. 41:32-43
The kinetic clarification of lung disposition for inhaled drugs in humans via pharmacokinetic (PK) modeling aids in their development and regulation for systemic and local delivery, but remains challenging due to its multiplex nature. This study exer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9b12f8a02f99d17baa1bf43e54378068
https://doi.org/10.1002/bdd.2210
https://doi.org/10.1002/bdd.2210
Autor:
Sagar S, Bachhav, Poonam, Sheth, Dennis, Sandell, Mårten, Svensson, Sharvari, Bhagwat, Denise S, Conti, Oluwamurewa, Oguntimein, Sneha, Dhapare, Bhawana, Saluja, Lawrence, Winner, Jürgen B, Bulitta, Guenther, Hochhaus
Publikováno v:
The AAPS Journal. 24
The therapeutic benefits of metered dose inhalers (MDIs) in pulmonary disorders are mainly driven by aerosol performance, which depends on formulation variables (drug and excipients), device design, and patient interactions. The present study provide
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dc30a3b3f9e36e614ba7800318261f0b
https://doi.org/10.1208/s12248-021-00638-1
https://doi.org/10.1208/s12248-021-00638-1
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
Publikováno v:
Pulmonary Pharmacology & Therapeutics. 53:52-60
Emphysema progressively destroys alveolar structures, leading to disability and death, yet remains irreversible and incurable to date. Impaired vascular endothelial growth factor (VEGF) signaling is an emerging pathogenic mechanism, thereby proposing
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4dfc94a66a1855390fdbd1ad211c7007
https://doi.org/10.1016/j.pupt.2018.09.002
https://doi.org/10.1016/j.pupt.2018.09.002
Autor:
Michael Hindle, Rabijit Dutta, Sneha Dhapare, Xiangyin Wei, P. Worth Longest, Benjamin M. Spence
Publikováno v:
Pharm Res
PURPOSE. The objective of this study was to optimize nose-to-lung aerosol delivery in an adult upper airway model using computational fluid dynamics (CFD) simulations in order to guide subsequent human subject aerosol delivery experiments. METHODS. A
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a063b947b4158648321374c3eae62879
https://pubmed.ncbi.nlm.nih.gov/32968848
https://pubmed.ncbi.nlm.nih.gov/32968848