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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:
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:
Freed, A.1 Anita.Freed@pfizer.com, Colgan, S.1 Stephen.T.Colgan@pfizer.com, Kochling, J.2 Jianmei.Kochling@sanofi.com, Alasandro, M.3 malasandro@orexigen.com
Publikováno v:
AAPS Open. 9/6/2017, Vol. 3 Issue 1, p1-10. 10p.
Autor:
Liberman, Robert Paul, Mueser, Kim T., Wallace, Charles J., Jacobs, Harvey E., Eckman, Thad, Massel, H. Keith
Publikováno v:
Schizophrenia Bulletin; 1986, Vol. 12 Issue 4, p631-647, 17p
Autor:
Fenghe Qiu, Garry Scrivens
Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific