Zobrazeno 1 - 10
of 41
pro vyhledávání: '"Bernard A. Olsen"'
Publikováno v:
TrAC Trends in Analytical Chemistry. 101:17-23
Thorough knowledge and control of impurities is an expectation for the registration of pharmaceuticals. Actual and potential impurity investigations are phased during drug development to acquire the appropriate information necessary to ensure drug sa
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::622db5ddc8352b3449379ee6f6ba6bbd
https://doi.org/10.1016/j.trac.2017.10.025
https://doi.org/10.1016/j.trac.2017.10.025
Autor:
Nick Toltl, Steven W. Baertschi, Colette O’Shea, Patrick J. Jansen, Timothy J. Wozniak, Bernard A. Olsen
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 125
An analytical artifact peak appearing to be an impurity was observed intermittently among several laboratories performing HPLC analyses of olanzapine drug substance and formulation samples. The artifact peak was identified as Cu(I) that was formed fr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48d82c6bdc20c6bc65ed6bd2afee7cb6
https://pubmed.ncbi.nlm.nih.gov/27023131
https://pubmed.ncbi.nlm.nih.gov/27023131
Autor:
Hoi-Ming Chi, Kemal Altinkemer, Huff Bret Eugene, Herbert Moskowitz, Okan K. Ersoy, Bernard A. Olsen, Peter F. Gavin
Publikováno v:
Decision Support Systems. 48:69-80
We develop an adaptive Automated Intelligent Manufacturing System (AIMS) for Case 1:to a well-understood-pharmaceutical-process to demonstrate our methodology, Case 2:with clustering, to a not-well-controlled or understood-process for seemingly ident
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::46f6e332f8ad8609ab9c654ae044f231
https://doi.org/10.1016/j.dss.2009.06.010
https://doi.org/10.1016/j.dss.2009.06.010
Publikováno v:
Organic Process Research & Development. 13:285-291
The assessment and control of genotoxic impurities (GTI) in pharmaceutical products has received considerable attention in recent years. Molecular functional groups that render starting materials and synthetic intermediates useful as reactive buildin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::639011f49abb0d2b7b2d236eafde781d
https://doi.org/10.1021/op8002129
https://doi.org/10.1021/op8002129
A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)
Autor:
Peter F. Gavin, Bernard A. Olsen
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 46:431-441
The development of an ion-pairing HPLC method and associated system suitability parameters for the analysis of atomoxetine hydrochloride (LY139603 HCl) using a quality by design approach is described. Potential method conditions were evaluated for th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::845fddbd2041245c270f793371a8661e
https://doi.org/10.1016/j.jpba.2007.10.037
https://doi.org/10.1016/j.jpba.2007.10.037
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 44:906-913
HPLC is a generally accepted method for assay of drug substances. However, recent claims cast doubts on the utility of HPLC assay methods for characterizing quality [S. Görög, J. Pharm. Biomed. Anal. 36 (2005) 931-937]. This study examines the util
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::047b44fcbd32945b438edbf981b751f7
https://doi.org/10.1016/j.jpba.2007.04.023
https://doi.org/10.1016/j.jpba.2007.04.023
Publikováno v:
Advanced Drug Delivery Reviews. 59:12-28
The understanding, identification, quantification and control of impurities in drug substances are essential as new molecular entities are evaluated in clinical development. As chemical processes used to produce drug substances mature from the early
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce0145a7670cdaef4377d63a3ec93406
https://doi.org/10.1016/j.addr.2006.10.005
https://doi.org/10.1016/j.addr.2006.10.005
Publikováno v:
TrAC Trends in Analytical Chemistry. 25:796-805
Advances in HPLC technology have improved capability for drug impurity profiling in terms of faster analysis time, better separations and faster method development. We review developments in monolithic columns, sub-2-μm particle columns operated at
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::87b1e55b5b7469e778c853136ca1decc
https://doi.org/10.1016/j.trac.2006.06.005
https://doi.org/10.1016/j.trac.2006.06.005
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 41:1251-1259
Establishing appropriate impurity specifications for active pharmaceutical ingredient (API) starting materials is an important component of the commercialization and registration of an API. Multiple sources and routes of manufacture of starting mater
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce57dc1bf6e8f6470e9f958ed9dcd3ec
https://doi.org/10.1016/j.jpba.2006.03.013
https://doi.org/10.1016/j.jpba.2006.03.013