Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Theresa Mullin"'
Publikováno v:
Research Involvement and Engagement, Vol 4, Iss 1, Pp 1-6 (2018)
Plain English summary People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focu
Externí odkaz:
https://doaj.org/article/07859c65db75468a853d8f11f4443eb7
Autor:
Elisabeth M. Oehrlein, Robyn Bent, Fraser Bocell, Lili Garrard, Laura Lee Johnson, Naomi Knoble, David Reasner, Michelle Tarver, Kevin Weinfurt, Theresa Mullin
Publikováno v:
Value in Health. 26:791-795
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0ff4210be5136721d259bc4761193d92
https://doi.org/10.1016/j.jval.2023.04.006
https://doi.org/10.1016/j.jval.2023.04.006
Autor:
Ségolène Gaillard, Vivian W. L. Tsang, Sharon R. Smith, Pamela Dicks, Joana Claverol, Susan McCune, Begonya Nafria, Charles Thompson, Theresa Mullin, Christine Woods, Leanne L. West, Jennifer Preston, Chester J. Koh
Publikováno v:
Ther Innov Regul Sci
Patient engagement in health care has been an emerging priority in the global effort and move toward the consideration of patients as experts of their own conditions. However, the input of pediatric patients and their families have not been consisten
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf526f757293aa410ff333e63592cbe4
https://doi.org/10.1177/2168479018820875
https://doi.org/10.1177/2168479018820875
Publikováno v:
Clinical Pharmacology & Therapeutics. 105:926-931
Eight years ago, this journal published "The Value and Benefits of the International Conference on Harmonization to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health" to mark the 20th anniversary of the International Counc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::19e1f7641d202828cf9340b922d3c71e
https://doi.org/10.1002/cpt.1289
https://doi.org/10.1002/cpt.1289
Publikováno v:
Clinical Pharmacology & Therapeutics. 105:789-791
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::52df2be744475010ef37baddaf90aa0e
https://doi.org/10.1002/cpt.1290
https://doi.org/10.1002/cpt.1290
Autor:
Joshua L. Barton, Theresa Mullin
Publikováno v:
Pharmaceutical Medicine. 31:7-12
Originally enacted to address the delays in US Food and Drug Administration (FDA) new drug review due to chronic understaffing and outdated systems, the Prescription Drug User Fee Act (PDUFA) of 1992, with its 5-year reauthorization cycle, enabled ra
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6334048cd06f479bac5a8636108b9e11
https://doi.org/10.1007/s40290-016-0170-6
https://doi.org/10.1007/s40290-016-0170-6
Publikováno v:
Clinical Pharmacology & Therapeutics. 100:626-632
This article describes recent developments in licensing and reimbursement policies in the EU, US, and Japan, examines causes of changes and compares differences and projects trends. With respect to licensing, the European Medicines Agency (EMA), US F
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::322594e48092f07b70a5168348b963ca
https://doi.org/10.1002/cpt.505
https://doi.org/10.1002/cpt.505
Publikováno v:
Research Involvement and Engagement
Research Involvement and Engagement, Vol 4, Iss 1, Pp 1-6 (2018)
Research Involvement and Engagement, Vol 4, Iss 1, Pp 1-6 (2018)
Plain English summary People living with a condition are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. In 2012, the U.S. Food and Drug Administration (FDA) established the Patient-Focu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b3246be4f07c4493719c58a2d455b99
https://doi.org/10.1186/s40900-018-0093-3
https://doi.org/10.1186/s40900-018-0093-3
Autor:
Theresa Mullin
This chapter will focus on the operations and contributions of the International Council on Harmonisation (ICH) to support international regulation of drugs and biological products. It begins with background on the establishment and earlier operation
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::75ad39ef55bf89f852cff0f2e1de76e9
https://doi.org/10.1016/b978-0-12-849905-4.00007-1
https://doi.org/10.1016/b978-0-12-849905-4.00007-1
Autor:
Paul S. Albert, Elizabeth A. Bartrum, Karen E. Berliner, Juliana Blome, Enriqueta Bond, Valerie H. Bonham, Craig B. Borkowf, John T. Burklow, Robert M. Califf, Leighton Chan, Sue Cheng, James J. Cimino, Janine Clayton, Patricia S. Coffey, Melissa C. Colbert, Josh A. Duberman, Michelle Feige, Cheryl A. Fisher, Molly M. Flannery, Maryrose Franko, Bradley D. Freeman, Elaine K. Gallin, John I. Gallin, Naomi L. Gerber, Bruce Goldstein, Marjorie J. Good, Michael M. Gottesman, Christine Grady, David K. Henderson, Nicholas C. Ide, Jonathan P. Jarow, Laura Lee Johnson, Barbara I. Karp, Phyllis Klein, Laura M. Lee, Juan J.L. Lertora, Diane M. Maloney, Patrick McGarey, Amy E. McKee, Jon W. McKeeby, Theresa Mullin, Charles Natanson, Lynnette Nieman, Robert B. Nussenblatt, Frederick P. Ognibene, Christopher O. Olopade, Olufunmilayo I. Olopade, Valerie L. Prenger, Jillian K. Price, Michael A. Proschan, Jerry Sachs, Joseph A. Sclafani, Joe V. Selby, Pamela A. Shaw, Kelly S. Sherman, Pamela C. Sieving, Amy P.N. Skubitz, Jean R. Slutsky, Julia Slutsman, Diane C. St Germain, Catherine M. Stoney, Stephen E. Straus, Elyse I. Summers, Junfeng Sun, Michelle Tagle, Tony Tse, Konstantina M. Vanevski, Paul G. Wakim, Gwenyth R. Wallen, Evelyn P. Whitlock, Rebecca J. Williams, Deborah A. Zarin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5cbfd98a0c929e79f2d1fe59daca5ed0
https://doi.org/10.1016/b978-0-12-849905-4.01002-9
https://doi.org/10.1016/b978-0-12-849905-4.01002-9