Zobrazeno 1 - 10
of 24
pro vyhledávání: '"Jeffrey M. Kallemeyn"'
Autor:
Stephen P. Lathrop, Laurie B. Mlinar, Onkar N. Manjrekar, Yong Zhou, Kaid C. Harper, Eric R. Sacia, Molly Higgins, Andrew R. Bogdan, Zhe Wang, Steven M. Richter, Wei Gong, Eric A. Voight, Jeremy Henle, Moiz Diwan, Jeffrey M. Kallemeyn, Jack C. Sharland, Bo Wei, Huw M. L. Davies
Publikováno v:
Organic Process Research & Development. 27:90-104
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a83ea84a6dc011ab6d614bf84d5ca909
https://doi.org/10.1021/acs.oprd.2c00288
https://doi.org/10.1021/acs.oprd.2c00288
Autor:
Jeffrey M. Kallemeyn, John Hartung, Timothy Connolly, Andrew Ickes, Brian Kotecki, Leon Van Haandel, Milad Nazari, Onkar Manjrekar, Shuang Chen
Publikováno v:
Organic Process Research & Development. 26:2947-2956
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::746f5ad4fc0bd564e32398c375327f7a
https://doi.org/10.1021/acs.oprd.2c00245
https://doi.org/10.1021/acs.oprd.2c00245
Autor:
Michael J. Burns, Ian X. Andrews, Jens-Christoph Baumann, Eric L. Elliott, Jared W. Fennell, Jeffrey M. Kallemeyn, Sebastien Lemaire, Natasha S. Murphy, Magali Palacio, Steven A. Raw, Alastair J. Roberts, Nayrton Flávio Moura Rocha, Didier Schils, Rolf Schulte Oestrich, Andrew L. Shannon-Little, Neil Stevenson, Pere Talavera, Andrew Teasdale, Michael W. Urquhart, Fernanda Waechter
Publikováno v:
Organic Process Research & Development.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ec479e4710fc066449fbba59682687dc
https://doi.org/10.1021/acs.oprd.2c00360
https://doi.org/10.1021/acs.oprd.2c00360
Autor:
Jeremy J. Henle, Matthew M. Ravn, Westin H. Morrill, Gang Zhao, Nandkishor K. Nere, Haojuan Wei, John C. Vinci, Chen Ding, Michael G. Fickes, Dennie S. Welch, Timothy B. Towne, Kenneth M. Engstrom, Matthew J. Pelc, Kirill A. Lukin, Jeffrey M. Kallemeyn, Russell D. Cink, James Marren, Shashank Shekhar
Publikováno v:
Organic Process Research & Development. 24:1373-1392
Glecaprevir was identified as a potent hepatitis C virus (HCV) protease inhibitor, and a large-scale synthesis was required to support the late-stage clinical trials and subsequent commercial launc...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::55504cedaa416eb3c106ac91ee56d5fa
https://doi.org/10.1021/acs.oprd.0c00244
https://doi.org/10.1021/acs.oprd.0c00244
Autor:
Russell D. Cink, Jeremy J. Henle, David R. Hill, Jianzhang Mei, Timothy B. Towne, Kirill A. Lukin, Matthew M. Ravn, Steven C. Cullen, Nandkishor K. Nere, Ahmad Y. Sheikh, Richard D. Bishop, Matthew J. Pelc, Shuang Chen, Bradley D. Gates, Jeffrey M. Kallemeyn, Gang Zhao, Chen Ding, José G. Napolitano, M. Robert Leanna
Publikováno v:
Organic Process Research & Development. 24:183-200
Glecaprevir was identified as a potent HCV NS3/4A protease inhibitor, and an enabling synthesis was required to support the preclinical evaluation and subsequent Phase I clinical trials. The enabli...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::204c32c375d134f4abc4b0c8123674bf
https://doi.org/10.1021/acs.oprd.9b00469
https://doi.org/10.1021/acs.oprd.9b00469
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
Publikováno v:
Organic Process Research & Development. 23:2532-2537
The tetrasubstituted pyrrolidine core of ABBV-3221 was synthesized by catalytic, enantioselective cycloaddition. A Cu(I) catalyst system was identified as ideal for further development, which gave ...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9747c77c2fecf9311274662a269f4481
https://doi.org/10.1021/acs.oprd.9b00292
https://doi.org/10.1021/acs.oprd.9b00292
Publikováno v:
Journal of Pharmaceutical Innovation. 14:176-184
A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced or quality by design (QbD) development for the active pharmaceutical ingredient (API) can lead to dif
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2cec0d237496c77ad03492565c57aeee
https://doi.org/10.1007/s12247-018-9363-8
https://doi.org/10.1007/s12247-018-9363-8
Autor:
Phil J. Borman, John Lepore, Sushil K. Srivastava, Nathan D. Ide, John Donaubauer, Steven Tymonko, Matt E. Popkin, Lindsay A. Hobson, Kevin D. Seibert, Timothy Curran, Batool Ahmed Omer, Jeffrey M. Kallemeyn, Looker Adam
Publikováno v:
Journal of Pharmaceutical Innovation. 13:367-372
This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility through differentiated outcomes for elements of API manufacture, such as the control strategy an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::62d076d7d103e30887516e50a28d8f9a
https://doi.org/10.1007/s12247-018-9339-8
https://doi.org/10.1007/s12247-018-9339-8
Publikováno v:
Organic Process Research & Development. 19:1517-1523
The control of mutagenic impurities is of crucial interest to pharmaceutical companies and regulatory agencies alike. One risk-based methodology to assess the likelihood of impurity carryover to drug substance entails evaluation of the physicochemica
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ce11667a8756b1fb45ff8eafa0b23ecd
https://doi.org/10.1021/acs.oprd.5b00257
https://doi.org/10.1021/acs.oprd.5b00257