Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Lois Hinman"'
Autor:
James F. Kelly, Ronald A Salerno, Kevin Carl, Brian B Spear, Lois Hinman, Brian M. Abbott, Courtney Harper, Elizabeth Mansfield, Stephen P. Day, Russell Katz, Robert L. Becker, Michael Pacanowski, William Pignato
Publikováno v:
Pharmacogenomics. 11:1669-1675
At the 5th FDA–Drug Industry Association (DIA) Workshop on ‘Pharmacogenomics in Drug Development and Regulatory Decision Making’, track four focused on the current thinking and issues in the co-development of therapeutic drugs or biologics, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0f66ac66a4084683f4c33122dbdca15e
https://doi.org/10.2217/pgs.10.141
https://doi.org/10.2217/pgs.10.141
Autor:
Ansar Jawaid, Timothy W. Robison, Sandra L Close, Ian Hunt, Sharada Louis Truter, Huixiao Hong, Catherine Cornu-Artis, Michael E. Burczynski, Laurent Essioux, Li Zhang, Peter Morrow, Weida Tong, Federico Goodsaid, Rosane Charlab, Issam Zineh, Shashi Amur, Lois Hinman, Lawrence J. Lesko, James T. Mayne, David Laurie, Kevin Carl, David Jacobson-Kram, Jacky Vonderscher, Jiri Aubrecht, Jennifer Catalano, Ina Schuppe-Koistinen, Marisa Papaluca-Amati, Leming Shi, Albert J. Fornace, Heng-Hong Li, Klaus Lindpaintner, Olivia Spleiss, Agnes Westelinck, John Roth
Publikováno v:
Nature Reviews Drug Discovery. 9:435-445
Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::9e2e34f16439e789f9572e1eb16801aa
https://doi.org/10.1038/nrd3116
https://doi.org/10.1038/nrd3116
Autor:
Brian B Spear, Zenta Tsuchihashi, Lois Hinman, Francis Kalush, Federico Goodsaid, James F. Kelly, Peter F. Bross
Publikováno v:
Pharmacogenomics. 10:127-136
The 4th US FDA/Industry Workshop on Pharmacogenomics in Drug Development and Regulatory Decision Making, was held in MD, USA, on December 10–12, 2007. One of the breakout sessions of the workshop focused on the regulatory issues around codevelopmen
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6fc93b62b0714eaec106c0fde3f8d20e
https://doi.org/10.2217/14622416.10.1.127
https://doi.org/10.2217/14622416.10.1.127
Autor:
D Raunig, James T. Mayne, D Fu, Lawrence J. Lesko, S Furlong, P Sager, Robert A. Dean, Glen Clack, CD Lathia, J Bloom, D Amakye, K Zerba, CA Altar, Lois Hinman, C Girman, J Meyer, D Bounos, S Madani, Viswanath Devanarayan, P Wong, SA Williams
Publikováno v:
Clinical Pharmacology & Therapeutics. 83:368-371
A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative.1 This article describes a systematic framework that was developed by Pharmaceuti
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4bef00dc2512cfd7cfdc2d4746405d09
https://doi.org/10.1038/sj.clpt.6100451
https://doi.org/10.1038/sj.clpt.6100451
Autor:
Dai Wang, Catalina Lopez-Correa, N Grecco, Lois Hinman, Monique A. Franc, Amir Snapir, S P Piccoli, Amelia Wall Warner, Nadine Cohen, Sharada Louis Truter, Agnes Westelinck
Publikováno v:
Clinical pharmacology and therapeutics. 91(6)
Interindividual variation in pharmacodynamic (PD) response to drugs is an ongoing area of research for drugs in clinical development, pre- and postapproval. To characterize how pharmacogenomic (PG) variations can serve as a predictor of differences i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37f92614235714fcf4264451dd2c8987
https://pubmed.ncbi.nlm.nih.gov/22534869
https://pubmed.ncbi.nlm.nih.gov/22534869
Autor:
Federico M, Goodsaid, Shashi, Amur, Jiri, Aubrecht, Michael E, Burczynski, Kevin, Carl, Jennifer, Catalano, Rosane, Charlab, Sandra, Close, Catherine, Cornu-Artis, Laurent, Essioux, Albert J, Fornace, Lois, Hinman, Huixiao, Hong, Ian, Hunt, David, Jacobson-Kram, Ansar, Jawaid, David, Laurie, Lawrence, Lesko, Heng-Hong, Li, Klaus, Lindpaintner, James, Mayne, Peter, Morrow, Marisa, Papaluca-Amati, Timothy W, Robison, John, Roth, Ina, Schuppe-Koistinen, Leming, Shi, Olivia, Spleiss, Weida, Tong, Sharada L, Truter, Jacky, Vonderscher, Agnes, Westelinck, Li, Zhang, Issam, Zineh
Publikováno v:
Nature reviews. Drug discovery. 9(6)
Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::1176c54f6d0619d7051797228170d3a7
https://pubmed.ncbi.nlm.nih.gov/20514070
https://pubmed.ncbi.nlm.nih.gov/20514070