Zobrazeno 1 - 10
of 43
pro vyhledávání: '"Gregory W. Sluggett"'
Autor:
Alon Grinberg Dana, Haoyang Wu, Gregory W. Sluggett, Todd Zelesky, Geoffrey P. F. Wood, Jason Mustakis, Duminda S. Ranasinghe, William H. Green, Frank C. Pickard
Publikováno v:
Molecular Pharmaceutics. 18:3037-3049
Stress testing of active pharmaceutical ingredients (API) is an important tool used to gauge chemical stability and identify potential degradation products. While different flavors of API stress testing systems have been used in experimental investig
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::20b9bd8634d72c0995f41b155960c232
https://doi.org/10.1021/acs.molpharmaceut.1c00261
https://doi.org/10.1021/acs.molpharmaceut.1c00261
Autor:
Eric L. Elliott, Rodney L. Parsons, Christopher J. Borths, Jeffrey C. Roberts, Timothy T. Kramer, John Donaubauer, Jared Evans, Michael Urquhart, Heewon Lee, Ping Zhuang, Ke Wang, Mark D. Argentine, Andrew Teasdale, Gregory W. Sluggett
Publikováno v:
Organic Process Research & Development. 25:831-837
ICH M7 provides several risk-based control options to manage mutagenic and potentially mutagenic impurities (MI and PMIs) in the manufacture of pharmaceuticals. A Working Group in the International...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::dca48a49d72f650c4dacef79f44cd5e5
https://doi.org/10.1021/acs.oprd.0c00517
https://doi.org/10.1021/acs.oprd.0c00517
Autor:
Haoyang Wu, Alon Grinberg Dana, Duminda S. Ranasinghe, Frank C. Pickard, Geoffrey P. F. Wood, Todd Zelesky, Gregory W. Sluggett, Jason Mustakis, William H. Green
Publikováno v:
Molecular pharmaceutics. 19(5)
Gauging the chemical stability of active pharmaceutical ingredients (APIs) is critical at various stages of pharmaceutical development to identify potential risks from drug degradation and ensure the quality and safety of the drug product. Stress tes
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0faa7781488456a748c3134c01210a29
https://pubmed.ncbi.nlm.nih.gov/35435696
https://pubmed.ncbi.nlm.nih.gov/35435696
Autor:
Jens-Christoph Baumann, Nathan D. Ide, Neil G. Stevenson, Didier Schils, Pere Talavera, Jared W. Fennell, Lucie E. Lovelle, David P. Elder, Vincent Antonucci, Michael J. Burns, Dirk Lauwers, Andrew Teasdale, Michael Urquhart, Tetsuji Itoh, Dennie S. Welch, Roland Brown, Rolf Schulte Oestrich, Susanne A. Stalford, Jeffrey M. Kallemeyn, Robert Molzahn, Varie David Lee, Elizabeth M. Covey-Crump, Gregory W. Sluggett, Fabrice Gallou, Guido Jordine, Martin A. Ott, Eric L. Elliott, Looker Adam
Publikováno v:
Organic Process Research & Development. 23:2470-2481
The ICH M7 guidance provides a series of flexible control options for the control of (potentially) mutagenic impurities (PMIs) that fully align with key risk-based principles. This includes option ...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b378783186bda28493ceedee7c3f59bf
https://doi.org/10.1021/acs.oprd.9b00358
https://doi.org/10.1021/acs.oprd.9b00358
Autor:
Gregory W. Sluggett, Frank C. Pickard, Alon Grinberg Dana, Haoyang Wu, William H. Green, Jason Mustakis, Todd Zelesky, Geoffrey P. F. Wood, Duminda S. Ranasinghe
While different flavors of API stress testing systems have been used in experimental investigations for decades, the detailed kinetics of such systems as well as the chemical composition of prominent reactive species, specifically reactive oxygen spe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a77f56cd39ad36f5685e6c49136f174
https://doi.org/10.26434/chemrxiv.14368193
https://doi.org/10.26434/chemrxiv.14368193
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:
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:
Margaret S. Landis, Geoffrey P. F. Wood, Klimentina Pencheva, Adrian L. V. Davis, Johannes Khinast, Michael Brunsteiner, Garry Scrivens, Amrit Paudel, Gregory W. Sluggett, Heidrun Gruber-Woelfler, Corinna Gressl
Publikováno v:
Molecular pharmaceutics. 14(12)
Understanding properties and mechanisms that govern drug degradation in the solid state is of high importance to ensure drug stability and safety of solid dosage forms. In this study, we attempt to understand drug-excipient interactions in the solid
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b52c68b3bab5f148649debf547a3ec3a
https://pubmed.ncbi.nlm.nih.gov/29058913
https://pubmed.ncbi.nlm.nih.gov/29058913
Autor:
Maria M. O’Sullivan, Eric M. Cordi, Jon Blunt, Gregory W. Sluggett, Ciaran Byrne, John A. Ragan, Brian G. Conway, Corey L. Stanchina, Sandra Mullane, Esmort Chisowa, Stuart Taylor, Janice E. Sieser, Denis Lynch, Leo Joseph Letendre, Marcella Whelan, Holly Strohmeyer, Robert A. Singer, Paul Bowles, Kyle R. Leeman
Publikováno v:
Organic Process Research & Development. 18:26-35
This is the first in a series of three papers describing the identification and development of a commercial synthesis of filibuvir (1). This contribution describes development of an Evans aldol reaction to control the tertiary alcohol stereocenter, a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1e980e41e3c1612b4046300761480666
https://doi.org/10.1021/op4002356
https://doi.org/10.1021/op4002356
Autor:
Stuart Taylor, Gregory W. Sluggett, Brian G. Conway, Leo Joseph Letendre, Robert A. Singer, Nicola Mawby, Kevin Meldrum, Jon Blunt, Zhihui Peng, Kyle R. Leeman, John A. Ragan, Holly Strohmeyer, Eric M. Cordi, Li-Jen Ping, Janice E. Sieser, Roberto Colon-Cruz, Brian C. Vanderplas
Publikováno v:
Organic Process Research & Development. 18:36-44
This paper describes an improved sequence for the conversion of an oxazolidinone (3) to a β-keto lactone (5). The primary drivers behind this change were the modest and variable yields observed in the intramolecular cyclization to generate the β-ke
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::249802ea1a0efa9c951d4e02f1bee3a6
https://doi.org/10.1021/op400236r
https://doi.org/10.1021/op400236r