Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Robert J. Timpano"'
Autor:
Lori McCaig, Alexander Abbott, Cherokee Hoaglund-Hyzer, Andrew Lennard, Fenghe Qiu, Jenny Carhart, Mingkun Fu, Robert J. Timpano, Tony Mazzeo, Yelizaveta Babayan, Chad Nolan Wolfe, Dennis Stephens, Elke Debie, Megan McMahon, Sylvine Pischel, Kayla Woodlief, Debra Webb, Yan Wu, Hanlin Li, Chi-wan Chen
Publikováno v:
The AAPS Journal. 23
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::43a0c51e112b56e2b17e7cfd2e7b4b93
https://doi.org/10.1208/s12248-021-00646-1
https://doi.org/10.1208/s12248-021-00646-1
Autor:
Cherokee Hoaglund-Hyzer, Mingkun Fu, Alexander Abbott, Megan McMahon, Sylvine Pischel, Lori McCaig, Chi-wan Chen, Jenny Carhart, Kayla Woodlief, Andrew Lennard, Dennis Stephens, Yan Wu, Debra Webb, Fenghe Qiu, Robert J. Timpano, Hanlin Li, Tony Mazzeo, Elke Debie, Yelizaveta Babayan, Chad Nolan Wolfe
Publikováno v:
The AAPS Journal. 23
In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::731bc556aaab25ec8ed805c05e69f648
https://doi.org/10.1208/s12248-021-00641-6
https://doi.org/10.1208/s12248-021-00641-6
The application and the global regulatory reception to the use of APS approaches for the assignment of storage conditions, packaging configurations, and use periods/expiry for solid oral dosage forms are discussed. Clinical stability programs are des
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6f93a0d15c871a4d17ab39557b18e495
https://doi.org/10.1016/b978-0-12-802786-8.00009-7
https://doi.org/10.1016/b978-0-12-802786-8.00009-7
Autor:
Martyn D. Ticehurst, Paul Gerst, Robert J. Timpano, Bruce C. MacDonald, Julie Lippke, Garry Scrivens, Andrew P. Monahan, Dana Carabillo, Gavin Wood, Kevin Ryan
In order to predict the shelf life of packaged products, it is necessary to know the humidity levels inside the packaging. This chapter provides a comprehensive description of the methods used to simulate the humidity inside packaging, and provides t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8f4c2e4ce75a8fbe6c20bb18619589d1
https://doi.org/10.1016/b978-0-12-802786-8.00005-x
https://doi.org/10.1016/b978-0-12-802786-8.00005-x
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:
Roger Weaver, Robert J. Timpano, Matthew Roberts, Kevin W. Fields, Stephen T. Colgan, Kevin Ryan, Garry Scrivens
Publikováno v:
Journal of Pharmaceutical Innovation. 9:259-271
The International Conference on Harmonization (ICH) has provided practical guidance on the amount and type of stability data needed to support marketing applications (International Conference on Harmonization Guideline Q1A(R2), 2003; International Co
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::dd4aabf13b05cc155c21384158f0a9c4
https://doi.org/10.1007/s12247-014-9198-x
https://doi.org/10.1007/s12247-014-9198-x
Autor:
Barbara Alice Johnson, William B. Arikpo, Michael Bruce Fergione, Timothy W. Graul, Michael Christopher Roy, Bruce C. MacDonald, Kenneth Craig Waterman, Robert J. Timpano
Publikováno v:
Journal of Pharmaceutical Sciences. 97:1499-1507
Significant degradation of the amine-based smoking cessation drug varenicline tartrate in an early development phase osmotic, controlled-release (CR) formulation yields predominantly two products: N-methylvarenicline (NMV) and N-formylvarenicline (NF
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::318aeff24524cada1625015e31e7672c
https://doi.org/10.1002/jps.21119
https://doi.org/10.1002/jps.21119
Autor:
Mary T. am Ende, Rashmi A Gadkari, Anthony J. Carella, Angel L Otano, Timothy W. Graul, Robert J. Timpano, Sara Kristen Moses
Publikováno v:
Pharmaceutical development and technology. 12(4)
In this investigation, the potency distribution of a low-dose drug in a granulation was optimized through a two-part study using statistically designed experiments. The purpose of this investigation was to minimize the segregation potential by improv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cf003d23ecff50e6531da70f788597b3
https://pubmed.ncbi.nlm.nih.gov/17763144
https://pubmed.ncbi.nlm.nih.gov/17763144