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Scientific and Regulatory Policy Committee Points to Consider: Histopathologic Evaluation in Safety Assessment Studies for PEGylated Pharmaceutical Products.
Irizarry Rovira, Armando R; Bennet, Bindu M; Bolon, Brad; Braendli-Baiocco, Annamaria; Chandra, Sundeep; Fleurance, Renaud; Garman, Robert; Hutto, David; Lane, Joan; Romeike, Annette; Sargeant, Aaron; Zimmerman, Bevin.
Affiliation
  • Irizarry Rovira AR; 1 Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Bennet BM; 2 Janssen Pharmaceuticals, Spring House, Pennsylvania, USA.
  • Bolon B; 3 GEMpath Inc., Longmont, Colorado, USA.
  • Braendli-Baiocco A; 4 Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
  • Chandra S; 5 BioMarin Pharmaceutical Inc., San Rafael, California, USA.
  • Fleurance R; 6 UCB Biopharma, Braine-l'Alleud, Belgium.
  • Garman R; 7 Consultants in Veterinary Pathology, Murrysville, Pennsylvania, USA.
  • Hutto D; 8 Shire Pharmaceuticals, Cambridge, Massachusetts, USA.
  • Lane J; 9 Biogen Inc., Cambridge, Massachusetts, USA.
  • Romeike A; 10 Covance Inc., Rueil-Malmaison, France.
  • Sargeant A; 11 Charles River Laboratories, Spencerville, Ohio, USA.
  • Zimmerman B; 12 Charles River Laboratories, Ashland, Ohio, USA.
Toxicol Pathol ; 46(6): 616-635, 2018 08.
Article in En | MEDLINE | ID: mdl-30092727
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Policy Making / Polyethylene Glycols / Vacuoles / Pharmaceutical Preparations / Consumer Product Safety / Drug Evaluation, Preclinical / Drug-Related Side Effects and Adverse Reactions Type of study: Etiology_studies / Evaluation_studies / Prognostic_studies Limits: Animals Language: En Journal: Toxicol Pathol Year: 2018 Type: Article Affiliation country: United States
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Policy Making / Polyethylene Glycols / Vacuoles / Pharmaceutical Preparations / Consumer Product Safety / Drug Evaluation, Preclinical / Drug-Related Side Effects and Adverse Reactions Type of study: Etiology_studies / Evaluation_studies / Prognostic_studies Limits: Animals Language: En Journal: Toxicol Pathol Year: 2018 Type: Article Affiliation country: United States