Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Konstantina M. Vanevski"'
The new drug development process is carried out through a sequence of developmental and evaluative steps. The European and US regulatory authorities have established substantial regulatory guidance regarding drug development and the regulatory approv
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::549283046b6bdd4558253dfe15c92f28
https://doi.org/10.1016/b978-0-12-849905-4.00037-x
https://doi.org/10.1016/b978-0-12-849905-4.00037-x
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
Autor:
Ashley Strougo, Solange Corriol-Rohou, Angela Joubert James, Dennis Potempa, Steven J. Kovacs, Raafat Bishai, Christina Bucci-Rechtweg, Jeffrey S. Barrett, Jing Liu, Amy Cheung, Sebastian Haertter, Konstantina M. Vanevski
Publikováno v:
Clinical pharmacology and therapeutics. 103(3)
Extrapolation can be used to address challenges in pediatric drug development. This review describes how these challenges could be addressed by further evolution of quantitative frameworks (i.e., model-based/informed drug discovery and development) a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1675a1866f2329dd40833506348aadba
https://pubmed.ncbi.nlm.nih.gov/29277892
https://pubmed.ncbi.nlm.nih.gov/29277892
Publikováno v:
Blood. 134:4630-4630
Background: Gene therapy for hemophilia A has the potential to reduce the treatment burden for care-providers and patients, by eliminating the need for regular factor VIII (FVIII) prophylaxis through the long-term expression of endogenous FVIII at le
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a5d3a662ecf59507c97ba86fe6ea0f61
https://doi.org/10.1182/blood-2019-125764
https://doi.org/10.1182/blood-2019-125764
Autor:
Michael J. Fossler, Mark Rogge, Konstantina M. Vanevski, S. Aubrey Stoch, Donald Heald, Akintunde Bello, Mark J. Dresser
Publikováno v:
Journal of clinical pharmacology. 55(11)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b3fb3af54ca64ffb1cbc6ca595815f28
https://pubmed.ncbi.nlm.nih.gov/25998173
https://pubmed.ncbi.nlm.nih.gov/25998173
Autor:
Paul S. Albert, Olivia T. Bartlett, Angela Bates, David A. Bluemke, Craig B. Borkowf, John T. Burklow, Susan Lowell Butler, Robert M. Califf, Leighton Chan, James J. Cimino, Melissa C. Colbert, Irene Dankwa-Mullan, Dennis O. Dixon, Ezekiel J. Emanuel, Thomas A. Fleisher, Bradley D. Freeman, Lawrence M. Friedman, William A. Gahl, Elaine K. Gallin, John I. Gallin, Lynn H. Gerber, Bruce Goldstein, Michael M. Gottesman, Christine Grady, P. Suzanne Hart, Clare Hastings, David K. Henderson, Nicholas C. Ide, Laura Lee Johnson, Jillian Kallman Price, Barbara I. Karp, Miriam Kelty, Harvey G. Klein, Bruce R. Korf, Rhonda G. Kost, Patricia A. Kvochak, Laura M. Lee, Juan J.L. Lertora, Nianjun Liu, Songtao Liu, Thomas C. Markello, Margaret A. Matula, Patrick McGarey, Patrick R. Murray, Charles Natanson, Robert B. Nussenblatt, Frederick P. Ognibene, Christopher O. Olopade, Olufunmilayo I. Olopade, Sope Olugbile, Vivian W. Pinn, Karen E. Pitt, Michael A. Proschan, Alan T. Remaley, Denise T. Resnik, Kyu Bak Louis Rhee, Stephen J. Rosenfeld, Pamela A. Shaw, Joanna H. Shih, Amy P.N. Skubitz, Marjorie Speers, Diane C. St. Germain, Catherine M. Stoney, Stephen E. Straus, Junfeng Sun, Nancy S. Sung, Tony Tse, Konstantina M. Vanevski, Alison Wichman, Rebecca J. Williams, Jennifer Yessis, Robert A. Yetter, Deborah A. Zarin, Kathryn C. Zoon
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e8257de7f0fd3693a57182f85c91b6fe
https://doi.org/10.1016/b978-0-12-382167-6.01002-x
https://doi.org/10.1016/b978-0-12-382167-6.01002-x