Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Ganapathy, Mohan"'
Autor:
Matthew E. Popkin, Markus Goese, Diane Wilkinson, Stuart Finnie, Talia Flanagan, Cristiana Campa, Alexandra Clinch, Andrew Teasdale, Andrew Lennard, Graham Cook, Ganapathy Mohan, Matthew D. Osborne
Publikováno v:
The AAPS journal. 24(6)
This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9617b640135d2a50a2c74c204f1a33e
https://pubmed.ncbi.nlm.nih.gov/36168002
https://pubmed.ncbi.nlm.nih.gov/36168002
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
Autor:
Mary Oates, Sau L. Lee, Tony Tong, Ganapathy Mohan, Giuseppe Randazzo, Michael P. Thien, Geoffrey K. Wu, Adam C. Fisher, Robert Ju, Richard T Lostritto, Emanuela Lacana, Bruce D. Johnson, Katherine M. Tyner, Stephen W. Hoag, Brian Hasselbalch, Grace McNally, Susan Rosencrance, Anna Schwendeman, Louis Yu, Moheb Nasr, Martin VanTrieste, Tara Gooen Bizjak, Henry A. Havel, Paul Seo, Siva Vaithiyalingam, Barbara Allen, Lawrence X. Yu, Ilgaz Akseli, Thomas F. O’Connor, Gregory E. Amidon, Ramesh Sood, Roger Nosal, Margaret Caulk, Ashley Boam, Janet Woodcock, Paula R Katz, Fionnuala Walsh, Robert Iser, Vinod P. Shah, Scott Furness, Larisa Wu, Russell Wesdyk, G. K. Raju, Joseph Famulare, Mahesh Ramanadham, Arzu Selen, Mehul Mehta, James E. Polli, David Doleski, Diane Zezza, Bernhardt L. Trout
Publikováno v:
The AAPS journal. 18(2)
The October 2015 FDA/PQRI Conference on Advancing Product Quality provided a forum for the exchange of ideas focused on drug product quality between regulatory agencies, the pharmaceutical industry, and academia. Key topics of the 2015 conference wer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a4fa8e10c71dffd445e850573ee75ded
https://pubmed.ncbi.nlm.nih.gov/26860627
https://pubmed.ncbi.nlm.nih.gov/26860627
Autor:
Vincent Antonucci, Zhihong Ge, Ganapathy Mohan, John R. Curran, Dean Ellison, Tao Wang, Jean Wyvratt, Peter J. Skrdla, Thomas Dowling
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 50:794-796
Due to the high method variability (typicallyor = 0.5%, based on a literature survey and internal Merck experience) encountered in the HPLC weight percent (%) assays of various active pharmaceutical ingredients (APIs), it is proposed that the routine
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47bb0c94a48ae92390e81be86ba3cc01
https://doi.org/10.1016/j.jpba.2009.06.027
https://doi.org/10.1016/j.jpba.2009.06.027
Autor:
Ganapathy Mohan
Publikováno v:
Pharmaceutical Stability Testing to Support Global Markets ISBN: 9781441908889
Impurities that are seen in the active pharmaceutical ingredients (API) and the degradants that are seen in the drug products are to be identified and quantified according to regulatory requirements, especially when they are recurring ones and above
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9854d2d5f6b36e236ad78a9c0e65fc85
https://doi.org/10.1007/978-1-4419-0889-6_16
https://doi.org/10.1007/978-1-4419-0889-6_16
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Autor:
Rebecca Frank, Lutz Müller, Larry P. Yotti, Mark D. Smith, Robert J. Mauthe, Jane A. Fagerland, Ganapathy Mohan, Nirdosh Jagota, Chris Beels, Alexander S. Jacks, Joseph J. DeGeorge, Dean Ellison, John MacKinnon, Sheila M. Galloway, Charles Humfrey, Marta M. Andino, Michael R. O’Donovan, Betsy Fritschel, Daniel K. Ness, Alfons G.M. De Knaep, Christopher M. Riley, Ernie Harpur, Gopi Vudathala, David M. De Antonis
Publikováno v:
Regulatory toxicology and pharmacology : RTP. 44(3)
The synthesis of pharmaceutical products frequently involves the use of reactive reagents and the formation of intermediates and by-products. Low levels of some of these may be present in the final drug substance and drug product as impurities. Such
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c2e722b60284f601580faa4280e53224
https://pubmed.ncbi.nlm.nih.gov/16412543
https://pubmed.ncbi.nlm.nih.gov/16412543
Publikováno v:
Asian Journal of Atmospheric Environment (AJAE); Mar2011, Vol. 5 Issue 1, p47-55, 9p