Zobrazeno 1 - 10
of 73
pro vyhledávání: '"Steven W. Baertschi"'
Autor:
Steven W. Baertschi, Chloe Wang, Chris Foti, Andreas Kuemmell, Gabriela Araujo, John M. Campbell, Dorina Kotoni, Neal Adams, Stacey Marden, Leonardo R. Allain, Patrick J. Jansen, Todd Zelesky, Juçara Ribeiro Franca, Steven Hostyn, Gregory Rullo, Gregory W. Sluggett, Renan Azevedo, Ana Cláudia O. Santos, Simon R. Hicks
Publikováno v:
Journal of pharmaceutical sciences. 111(2)
Stress testing (also known as forced degradation) of pharmaceutical products has long been recognized as a critical part of the drug development process, providing foundational information related to intrinsic stability characteristics and to the dev
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c11151b38830af969a5013b1688ad2d1
https://pubmed.ncbi.nlm.nih.gov/34111446
https://pubmed.ncbi.nlm.nih.gov/34111446
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
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 149:206-213
Accelerated stability studies of pharmaceutical products are commonly conducted at various combinations of temperature and relative humidity (RH). The RH of the sample environment can be controlled to set points using humidity-controlled stability ch
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::44c628e58b1f831f49fe53db9bb2e01b
https://doi.org/10.1016/j.jpba.2017.10.035
https://doi.org/10.1016/j.jpba.2017.10.035
Autor:
Steven W. Baertschi, Craig A. J. Kemp, Patrick J. Jansen, W. Smith, Karen A. McCune, Douglas E. Dorman
Publikováno v:
Journal of Pharmaceutical Sciences. 105:3256-3268
Stress-testing (forced degradation) studies have been conducted on pemetrexed disodium heptahydrate (1) (LY231514·2Na·7H2O) drug substance in order to identify its likely degradation products and establish its degradation pathways. Solid samples of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b50dec6b739d7fa325d16117866843b
https://doi.org/10.1016/j.xphs.2016.06.029
https://doi.org/10.1016/j.xphs.2016.06.029
Autor:
Leonardo, Allain, Steven W, Baertschi, David, Clapham, Chris, Foti, Wendy M, Lantaff, Robert A, Reed, Allen C, Templeton, Hanne Hjorth, Tønnesen
Publikováno v:
Journal of Pharmaceutical Sciences. 105:1586-1594
The ICH Q1B guidance and additional clarifying manuscripts provide the essential information needed to conduct photostability testing for pharmaceutical drug products in the context of manufacturing, packaging, and storage. As the previous 2 papers i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::df964b1a93143d3d398778e163ae8ca7
https://doi.org/10.1016/j.xphs.2016.02.035
https://doi.org/10.1016/j.xphs.2016.02.035
Publikováno v:
Journal of pharmaceutical sciences. 108(5)
Degradation rates of solid-state drug products generally increase as the drug load decreases. A model for quantifying this effect based on surface area ratios is proposed here. This model relates the degradation rate to an estimate of the proportion
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::00e4f9994f3edae834d7f26fcf462911
https://pubmed.ncbi.nlm.nih.gov/30550816
https://pubmed.ncbi.nlm.nih.gov/30550816
Autor:
Andreas Kaerner, Patrick J. Jansen, Matthew Clemens, Tim A. Smitka, Steven W. Baertschi, Lindsay Maxwell-Backer, Jerry R. Draper, K. Wayne Taylor
Publikováno v:
Journal of pharmaceutical sciences. 108(9)
Prasugrel hydrochloride is the active ingredient in Effient™, a thienopyridine platelet inhibitor. An extensive study of the degradation chemistry of prasugrel hydrochloride (LY640315 hydrochloride) has been carried out on the drug substance (part
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3a888408d554366a2f98bbc09fb6964f
https://pubmed.ncbi.nlm.nih.gov/30981754
https://pubmed.ncbi.nlm.nih.gov/30981754
Autor:
Anjali Agrawal, Stan Altan, Steven W. Baertschi, Chandan Bhugra, Ricardo Borjas, John Campbell, Dana Carabillo, Juan Chen, Lilan H. Chen, Donald Clancy, Elise Clement, Stephen T. Colgan, David Curran, Gena Dalziel, Mayur Dudhedia, Sudharsan Dwaraknath, Anita L. Freed, Paul Gerst, Michael Hawley, Evan M. Hetrick, Cherokee S. Hoaglund Hyzer, Gordon Hutton, Madhuri Jerfy, Satish Kamath, Ammar Khawam, Todd Lewis, Hanlin Li, Julie Lippke, Bruce C. MacDonald, Llurellyn Malcolm, Keith Masse, Tony Mazzeo, Andrew P. Monahan, Ewa Nauka, Rachel Orr, Brian W. Pack, Jeegna Patel-Jones, Jackson D. Pellett, William R. Porter, Fenghe Qiu, Jeffrey C. Roberts, Samantha Rusk, Kevin O. Ryan, Kevin Ryan, Robert Schwabe, Garry Scrivens, Ashish Soman, Jon T. Swanson, Zhixin Jessica Tan, Martyn Ticehurst, Robert J. Timpano, Bryan S. Wicks, Zeena Williams, Chad N. Wolfe, Gavin Wood, Zufan Steven Wu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ddf3d76a1a8cc8978d2bef65c0f977b9
https://doi.org/10.1016/b978-0-12-802786-8.09988-5
https://doi.org/10.1016/b978-0-12-802786-8.09988-5
Autor:
Hanne Hjorth Tønnesen, Steven W. Baertschi, David E. Clapham, Mark H. Kleinman, Robert A. Reed, Chris Foti, Allen C. Templeton, S Kristensen
Publikováno v:
Journal of Pharmaceutical Sciences. 104:2688-2701
The ICH Q1B guidance and additional clarifying manuscripts provide the essential information needed to conduct photostability testing for pharmaceutical drug products in the context of manufacturing, packaging, and storage. As the previous 2 papers i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::404f3c9f50ce0c58096318d2f170b5b2
https://doi.org/10.1002/jps.24396
https://doi.org/10.1002/jps.24396
Autor:
Mark H. Kleinman, David P. Elder, Alan P. McKeown, Steven W. Baertschi, Mark D. Mowery, Andrew Teasdale
Publikováno v:
Organic Process Research & Development. 19:1447-1457
This paper outlines strategies in alignment with ICH M7 for systematically assessing the potential risk posed by mutagenic degradants in active pharmaceutical ingredients (API) and formulated products. A mutagen risk assessment (MRA) process that inv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4651f405fe6af4483f271c29d8b5f63c
https://doi.org/10.1021/acs.oprd.5b00091
https://doi.org/10.1021/acs.oprd.5b00091