Zobrazeno 1 - 10
of 47
pro vyhledávání: '"Katherine M. Tyner"'
Autor:
James L. Weaver, Grainne A. Tobin, Taylor Ingle, Simona Bancos, David Stevens, Rodney Rouse, Kristina E. Howard, David Goodwin, Alan Knapton, Xiaohong Li, Katherine Shea, Sharron Stewart, Lin Xu, Peter L. Goering, Qin Zhang, Paul C. Howard, Jessie Collins, Saeed Khan, Kidon Sung, Katherine M. Tyner
Publikováno v:
Particle and Fibre Toxicology, Vol 14, Iss 1, Pp 1-14 (2017)
Abstract Background As nanoparticles (NPs) become more prevalent in the pharmaceutical industry, questions have arisen from both industry and regulatory stakeholders about the long term effects of these materials. This study was designed to evaluate
Externí odkaz:
https://doaj.org/article/785283ca27204af9b663b605868fcf5a
Publikováno v:
Pharmaceutical Development and Technology. 26:846-851
Lansoprazole orally disintegrating tablets (ODTs) can be administered orally or through a nasogastric (NG) tube for patients who are unable to swallow. In addition, off-label administration through...
Autor:
Katherine M. Tyner, Charles Wu, Yen-Ming Chan, Jing Li, Rajiv Agarwal, Douglas C. Throckmorton, Su-Lin Lee, Robert Temple, Cassandra Taylor
Publikováno v:
Journal of natural products. 83(2)
The United States FDA has received over 800 botanical investigational new drug applications (IND) and pre-IND meeting requests (PIND) in the years preceding 2018. The current data show that indications for submitted INDs cover nearly every review div
Autor:
Lawrence X. Yu, Adam C. Fisher, Katherine M. Tyner, Sau L. Lee, N. Sarah Arden, Michael Kopcha
Publikováno v:
International Journal of Pharmaceutics. 602:120554
Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of sophisticated drug products and dosage forms. Along with the evolution of medicines, the manufacturing practices for t
Publikováno v:
The AAPS Journal. 19:1359-1376
Iron carbohydrate colloid drug products are intravenously administered to patients with chronic kidney disease for the treatment of iron deficiency anemia. Physicochemical characterization of iron colloids is critical to establish pharmaceutical equi
Autor:
Katherine M. Tyner, Mamta Kapoor, Sau L. Lee, Mei-Ling Chen, Celia N. Cruz, Sheetal R. D’Mello
Publikováno v:
Nature Nanotechnology. 12:523-529
The Center for Drug Evaluation and Research (CDER) within the US Food and Drug Administration (FDA) is tracking the use of nanotechnology in drug products by building and interrogating a technical profile of products containing nanomaterials submitte
Publikováno v:
The AAPS Journal. 19:632-641
Research in the area of liposomes has grown substantially in the past few decades. Liposomes are lipid bilayer structures that can incorporate drug substances to modify the drug's pharmacokinetic profile thereby improving drug delivery. The agency ha
Publikováno v:
The AAPS Journal. 19:26-42
With the great interests in the discovery and development of drug products containing nanoparticles, there is a great demand of quantitative tools for assessing quality, safety, and efficacy of these products. Physiologically based pharmacokinetic (P
Autor:
Vinod P. Shah, Sesha Neervannan, Scott E. McNeil, Daryl C. Drummond, Rachael M. Crist, Jon S. B. de Vlieger, Daan J.A. Crommelin, Katherine M. Tyner, Wenlei Jiang
Publikováno v:
The AAPS Journal. 21
To guide developers of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: "Drug Products, Including Biological Products, that Contain Nanomaterials" in
Publikováno v:
Bioanalysis ISBN: 9783030017736
Applications for new pharmaceuticals in the USA are reviewed by the FDA’s Center for Drug Evaluation and Research (FDA/CDER), which evaluates the safety and efficacy of both drug substances and drug products. The degree of innovation and variety in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5f07d1344a27323e04c260d052ae4023
https://doi.org/10.1007/978-3-030-01775-0_12
https://doi.org/10.1007/978-3-030-01775-0_12