Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Alex Viehmann"'
Autor:
Jennifer Maguire, Adam Fisher, Djamila Harouaka, Nandini Rakala, Carla Lundi, Marcus Yambot, Alex Viehmann, Neil Stiber, Kevin Gonzalez, Lyle Canida, Lucinda Buhse, Michael Kopcha
Publikováno v:
The AAPS Journal. 25
Between October 2020 and March 2022, FDA’s Center for Drug Evaluation and Research (CDER) completed two pilot programs to assess the quality management maturity (QMM) of drug manufacturing establishments. Mature quality systems promote proactive de
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1b8c1414df106c7a088b7a6f65762e2c
https://doi.org/10.1208/s12248-022-00777-z
https://doi.org/10.1208/s12248-022-00777-z
Autor:
Matt Fellows, Thomas Friedli, Ye Li, Jennifer Maguire, Nandini Rakala, Marten Ritz, Matteo Bernasconi, Mark Seiss, Neil Stiber, Mat Swatek, Alex Viehmann
Publikováno v:
The AAPS journal. 24(6)
Over the past several decades, pharmaceutical manufacturing has become increasingly global and supply chains have become longer, more complex, and fragmented. While pharmaceutical products available to patients and customers typically conform with ap
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::17e8436cd76ccf334a104879de3a8d1a
https://pubmed.ncbi.nlm.nih.gov/36266372
https://pubmed.ncbi.nlm.nih.gov/36266372
Autor:
Erin, Leigh Wood, Akshaya, Tatke, Alex, Viehmann, Melika, Ashtiani, Richard L, Friedman, Michael, Kopcha, Adam C, Fisher
Publikováno v:
International Journal of Pharmaceutics. 625:122119
An international sampling study yielded 69 samples of extended-release prescription pharmaceuticals for legal sale in the U.S. Samples included 29 lots of innovator and 40 lots of generic solid oral extended-release drugs manufactured at 16 different
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b8a7ac6ab1d78c57d60b8679389b3be4
https://doi.org/10.1016/j.ijpharm.2022.122119
https://doi.org/10.1016/j.ijpharm.2022.122119
Autor:
Michael Kopcha, Lucinda F. Buhse, Adam C. Fisher, Janet Woodcock, Richard L. Friedman, Melika Ashtiani, Alex Viehmann
Publikováno v:
JAMA Network Open
Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38244f2a1c382b2db7ac604240e76507
https://doi.org/10.1001/jamanetworkopen.2020.13920
https://doi.org/10.1001/jamanetworkopen.2020.13920