Zobrazeno 1 - 10
of 22
pro vyhledávání: '"Nina Cauchon"'
Autor:
Michael J. Abernathy, Nina Cauchon, Marquerita Algorri, Twinkle R. Christian, Celeste Frankenfeld Lamm, Christine M.V. Moore
Publikováno v:
Journal of Pharmaceutical Sciences. 111:593-607
The traditional paradigm for pharmaceutical manufacturing is focused primarily upon centralized facilities that enable mass production and distribution. While this system reliably maintains high product quality and reproducibility, its rigidity impos
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e26bf2f13463b6dd9703bc387a8820e1
https://doi.org/10.1016/j.xphs.2021.08.032
https://doi.org/10.1016/j.xphs.2021.08.032
Publikováno v:
Journal of Pharmaceutical Sciences. 109:1427-1438
The process of assembling regulatory documents for submission to multiple global health agencies can present a repetitive cycle of authoring, editing, and data verification, which increases in complexity as changes are made for approved products, par
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::28dcb3fc26559f0e109b637070be16dd
https://doi.org/10.1016/j.xphs.2020.01.020
https://doi.org/10.1016/j.xphs.2020.01.020
Autor:
Xichen Zhang, Eric Weilage, Omari Anson, Minhui Ma, Jeroen M. Bezemer, Scott W. Roberts, Nina Cauchon
Publikováno v:
Organic Process Research & Development. 24:96-100
A discussion on the regulatory chemistry, manufacturing, and control (CMC) strategy and the dialogue and response from global health authorities regarding the proposed impurity/degradant control st...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::cf69d1f891717a1f5aaf4b63b7e6d3fd
https://doi.org/10.1021/acs.oprd.9b00479
https://doi.org/10.1021/acs.oprd.9b00479
Autor:
Michael J. Abernathy, Mike McGorry, Nina Cauchon, Jill Beierle, Sheetal Gaiki, Kathleen Sugrue-Richards, Gang Xue, Pradeep Mady, Andrew Lennard, David Cronin, Kabir Ahluwalia
Publikováno v:
Journal of pharmaceutical sciences. 111(5)
Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. Modernizing regulatory
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::977e6abb52d263c181b1c72b20aea74b
https://pubmed.ncbi.nlm.nih.gov/34610323
https://pubmed.ncbi.nlm.nih.gov/34610323
Autor:
Cheenu Murti, Christine Nylund Kolz, Steve Cole, Ganapathy Mohan, Noreen Curristin, Kim Huynh-Ba, Andrew Lennard, K. Tang, James Bernstein, Nina Cauchon, Scott W. Roberts
Publikováno v:
The AAPS Journal. 23
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceut
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a9a14bae61e3e3382e5484fdb09cc4d3
https://doi.org/10.1208/s12248-021-00618-5
https://doi.org/10.1208/s12248-021-00618-5
Publikováno v:
Journal of pharmaceutical sciences. 108(7)
This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark develop
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ff8c4658dbee7780c9348acedc5b62c6
https://pubmed.ncbi.nlm.nih.gov/30794794
https://pubmed.ncbi.nlm.nih.gov/30794794
Autor:
Zhe J. Tang, Archana Rawat, Vivian K. Robertson, Jiang B. Fang, Nina Cauchon, Tawnya G. Flick, James S. McElvain
Publikováno v:
Molecular Pharmaceutics. 7:1466-1477
Dissolution testing is frequently used to determine the rate and extent at which a drug is released from a dosage form, and it plays many important roles throughout drug product development. However, the traditional dissolution approach often emphasi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::76c8afdeddef6abef93b4817d28f5fd8
https://doi.org/10.1021/mp100125b
https://doi.org/10.1021/mp100125b
Autor:
Nina Cauchon, Bhaskara R. Jasti, Xiaoling Li, Rick Chiu, Peter Zhou, Ping Gao, Saroj Vangani, Cesar Medina, Mary-Anne Del-Barrio
Publikováno v:
Clinical Research and Regulatory Affairs. 26:8-19
A novel in-vitro dissolution system based on the principle of flow-through technique has been designed to evaluate the in-vitro release rate of poorly water-soluble compounds. The flow through appa...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::264414e82199d04a086314482d2de64c
https://doi.org/10.1080/10601330902905887
https://doi.org/10.1080/10601330902905887
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 46:639-644
This paper describes the development and validation of a rapid, direct, and stability-indicating method for analysis of etidronate, a bisphosphonate compound without a UV chromophore. A mixed-mode column was used to separate etidronate from its impur
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3313a513967fa8cb1c66fdfe8bbb96bd
https://doi.org/10.1016/j.jpba.2007.11.041
https://doi.org/10.1016/j.jpba.2007.11.041