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Concordance of 3 alternative teratogenicity assays with results from corresponding in vivo embryo-fetal development studies: Final report from the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) DruSafe working group 2.
McNerney, M; Potter, D; Augustine-Rauch, K; Barrow, P; Beyer, B; Brannen, K; Engel, S; Enright, B P; Nowland, W S; Powles-Glover, N; Powlin, S; Schneidkraut, M J; Stanislaus, D; Turner, K; Graziano, M.
Affiliation
  • McNerney M; Nonclinical Research and Development, Bristol Myers Squibb, New Brunswick, NJ, USA.
  • Potter D; Drug Safety R&D, Pfizer Inc., Cambridge, MA, USA.
  • Augustine-Rauch K; Nonclinical Research and Development, Bristol Myers Squibb, Lawrenceville, NJ, USA.
  • Barrow P; Pharmaceutical Sciences, Roche Pharma Research and Early Development, Basel, Switzerland.
  • Beyer B; Preclinical Safety, Sanofi U.S. Inc., Bridgewater, NJ, USA.
  • Brannen K; Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, PA, USA.
  • Engel S; Drug Safety R&D, Pfizer Inc., Groton, CT, USA.
  • Enright BP; Preclinical Safety, Abbvie Inc., North Chicago, IL, USA.
  • Nowland WS; Drug Safety R&D, Pfizer Inc., Groton, CT, USA.
  • Powles-Glover N; Clinical Pharmacology and Safety Sciences, AstraZeneca, Cambridge, UK.
  • Powlin S; Drug Safety Research and Evaluation, Takeda Pharmaceutical International Co, Cambridge, MA, USA.
  • Schneidkraut MJ; Drug Safety Research Laboratories - US, Astellas, Northbrook, IL, USA.
  • Stanislaus D; Nonclinical Safety, GlaxoSmithKline, Collegeville, PA, USA.
  • Turner K; Nonclinical Safety, Janssen R&D LLC, Spring House, PA, USA.
  • Graziano M; Nonclinical Research and Development, Bristol Myers Squibb, New Brunswick, NJ, USA. Electronic address: michael.graziano1@organon.com.
Regul Toxicol Pharmacol ; 124: 104984, 2021 Aug.
Article in En | MEDLINE | ID: mdl-34216694
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Teratogens / Teratogenesis / Animal Testing Alternatives Type of study: Prognostic_studies / Risk_factors_studies Limits: Animals Language: En Journal: Regul Toxicol Pharmacol Year: 2021 Document type: Article Affiliation country: United States
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Teratogens / Teratogenesis / Animal Testing Alternatives Type of study: Prognostic_studies / Risk_factors_studies Limits: Animals Language: En Journal: Regul Toxicol Pharmacol Year: 2021 Document type: Article Affiliation country: United States