Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses
第一作者:
Amberg, Alexander
作者:
Amberg, Alexander [1]
;
Andaya, Roxanne V. [2]
;
Anger, Lennart T. [3]
;
Barber, Chris [4]
;
Beilke, Lisa [5]
;
Bercu, Joel [6]
;
Bower, Dave [7]
;
Brigo, Alessandro [8]
;
Cammerer, Zoryanna [9]
;
Cross, Kevin P. [10]
;
Custer, Laura [11]
;
Dobo, Krista [12]
;
Gerets, Helga [13]
;
Gervais, Veronique [14]
;
Glowienke, Susanne [15]
;
Gomez, Stephen [16]
;
Van Gompel, Jacky [17]
;
Harvey, James [18]
;
Hasselgren, Catrin [19]
;
Honma, Masamitsu [20]
;
Johnson, Candice [21]
;
Jolly, Robert [22]
;
Kemper, Raymond [23]
;
Kenyon, Michelle [24]
;
Kruhlak, Naomi [25]
;
Leavitt, Penny [26]
;
Miller, Scott ;
Muster, Wolfgang ;
Naven, Russell ;
Nicolette, John ;
Parenty, Alexis ;
Powley, Mark ;
Quigley, Donald P. ;
Reddy, M. Vijayaraj ;
Sasaki, Jennifer C. ;
Stavitskaya, Lidiya ;
Teasdale, Andrew ;
Trejo-Martin, Alejandra ;
Weiner, Sandy ;
Welch, Dennie S. ;
White, Angela ;
Wichard, Joerg ;
Woolley, David ;
Myatt, Glenn J.
作者单位:
Leadscope Inc, 1393 Dublin Rd, Columbus, OH 43215 USA
[1]
AstraZeneca, Macclesfield, Cheshire, England
[2]
Novartis Pharma AG, Preclin Safety, CH-4057 Basel, Switzerland
[3]
Genentech Inc, 1 DNA Way, San Francisco, CA 94080 USA
[4]
ForthTox Ltd, POB 13550, Linlithgow EH49 7YU, Scotland
[5]
FDA Ctr Drug Evaluat & Res, Silver Spring, MD USA
[6]
Gilead Sci, 333 Lakeside Dr, Foster City, CA USA
[7]
AbbVie Inc, N Chicago, IL USA
[8]
Janssen Pharmaceut Co Johnson & Johnson, B-2340 Beerse, Belgium
[9]
GlaxoSmithKline, Pk Rd, Ware SG12 0DP, Herts, England
[10]
UCB Biopharma SPRL, Chemin Foriest, B-B1420 Braine L Alleud, Belgium
[11]
Natl Inst Hlth Sci, Tokyo, Japan
[12]
Toxicol Solut Inc, San Diego, CA USA
[13]
Roche Innovat Ctr Basel, Pharmaceut Sci, Roche Pharmaceut Res & Early Dev, Basel, Switzerland
[14]
Servier Grp, Gidy, France
[15]
Takeda, Cambridge, MA USA
[16]
Merck Res Labs, West Point, PA 19486 USA
[17]
Bayer Pharma AG, Invest Toxicol, Muellerstr 178, D-13353 Berlin, Germany
[18]
Eli Lilly & Co, Toxicol Div, Indianapolis, IN USA
[19]
Sanofi, R&D Preclin Safety Frankfurt, Ind Pk Hoechst, D-65926 Frankfurt, Germany
[20]
Consultant Theravance Biopharma US Inc, 901 Gateway Blvd, San Francisco, CA 94080 USA
[21]
Janssen Res & Dev, 1400 McKean Rd, Spring House, PA 19477 USA
[22]
Bristol Myers Squibb, Drug Safety Evaluat, 1 Squibb Dr, New Brunswick, NJ 08903 USA
[23]
Lhasa Ltd, Leeds, W Yorkshire, England
[24]
Pfizer Global Res & Dev, 558 Eastern Point Rd, Groton, CT 06340 USA
[25]
Vertex Pharmaceut Inc, Discovery & Investigat Toxicol, 50 No Ave, Boston, MA USA
[26]
发布时间
2019-11-16
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Regulatory Toxicology and Pharmacology
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