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Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA).
Bercu, Joel P; Masuda-Herrera, Melisa; Johnson, George; Czich, Andreas; Glowienke, Susanne; Kenyon, Michelle; Thomas, Rob; Ponting, David J; White, Angela; Cross, Kevin; Waechter, Fernanda; Rodrigues, Maria Augusta C.
  • Bercu JP; Gilead Sciences, Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA. Electronic address: joel.bercu@gilead.com.
  • Masuda-Herrera M; Gilead Sciences, Nonclinical Safety and Pathobiology (NSP), Foster City, CA, USA.
  • Johnson G; Institute of Life Science, Swansea University Medical School, Singleton Park, Swansea, SA3 5DE, UK.
  • Czich A; Sanofi, R&D Preclinical Safety, D-65926, Frankfurt, Germany.
  • Glowienke S; Novartis AG, NIBR, Klybeckstrasse, CH-4057, Basel, Switzerland.
  • Kenyon M; Pfizer Worldwide Research and Development, Genetic Toxicology, Eastern Point Road, Groton, CT, USA.
  • Thomas R; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK.
  • Ponting DJ; Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK.
  • White A; GlaxoSmithKline R&D, Park Road, Ware, Hertfordshire, SG12 0DP, UK.
  • Cross K; Leadscope Inc. an Instem Company, Columbus, OH, 43215, USA.
  • Waechter F; Aché Laboratórios Farmacêuticos S.A., Rodovia Presidente Dutra, km 222,2, Porto da Igreja, 07034-904, Guarulhos, SP, Brazil.
  • Rodrigues MAC; Brazilian Health Regulatory Agency, ANVISA, Brasilia, Brazil.
Regul Toxicol Pharmacol ; 123: 104926, 2021 Jul.
Article en En | MEDLINE | ID: mdl-33862169

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Dietilnitrosamina / Mutágenos Tipo de estudio: Guideline Límite: Humans Idioma: En Año: 2021 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Dietilnitrosamina / Mutágenos Tipo de estudio: Guideline Límite: Humans Idioma: En Año: 2021 Tipo del documento: Article