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FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Ackley, David; Birkebak, Joanne; Blumel, Jorg; Bourcier, Todd; de Zafra, Christina; Goodwin, Andrew; Halpern, Wendy; Herzyk, Danuta; Kronenberg, Sven; Mauthe, Robert; Shenton, Jacintha; Shuey, Dana; Wange, Ronald L.
Affiliation
  • Ackley D; Eli Lilly and Co. Inc., Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • Birkebak J; Gilead Sciences Inc., 333 Lakeside Dr, Foster City, CA, 94404, USA. Electronic address: joanne.birkebak@gilead.com.
  • Blumel J; Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
  • Bourcier T; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • de Zafra C; Seagen, 21823 30th Drive SE, Bothell, WA, 98021, USA.
  • Goodwin A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
  • Halpern W; Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
  • Herzyk D; Merck & Co., Inc., West Point, PA, USA.
  • Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
  • Mauthe R; Pfizer Inc., 445 Eastern Point Road, Groton, CT, 06340, USA.
  • Shenton J; Amgen Inc., Translational Safety & Bioanalytical Sciences, Thousand Oaks, CA, USA.
  • Shuey D; Incyte Corporation, 1801 Augustine Cut-off, Wilmington, DE, USA.
  • Wange RL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
Regul Toxicol Pharmacol ; 138: 105327, 2023 Feb.
Article in En | MEDLINE | ID: mdl-36586472
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Primates / COVID-19 Type of study: Guideline Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Regul Toxicol Pharmacol Year: 2023 Document type: Article Affiliation country: United States Country of publication: Netherlands
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Primates / COVID-19 Type of study: Guideline Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Regul Toxicol Pharmacol Year: 2023 Document type: Article Affiliation country: United States Country of publication: Netherlands