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Industry experiences with immune-mediated findings in biotherapeutic nonclinical toxicology studies.
MacLachlan, Timothy K; Kronenberg, Sven; Marshall, Nikki; Andrews, Laura; Berens, Shawn Jay; Brouta, Frederic; Fogal, Birgit; Freebern, Wendy; Herzyk, Danuta; Kamperschroer, Cris; Kiessling, Andrea; Schneidkraut, Marlowe; Maier, Curtis.
Afiliação
  • MacLachlan TK; Department of Preclinical Safety, Novartis Institutes for Biomedical Research, Cambridge, MA, 02139, USA. Electronic address: timothy.maclachlan@novartis.com.
  • Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, 4070, Basel, Switzerland.
  • Marshall N; Non-Clinical Safety, GlaxoSmithKline, 1250 South Collegeville RD, Collegeville, PA, 19426, USA.
  • Andrews L; Abbvie Preclinical Safety, Worcester, MA, USA, 01605.
  • Berens SJ; Investigative Toxicology and Pathology, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
  • Brouta F; UCB Biopharma SRL, Non-Clinical Safety Evaluation, 1420, Braine-l'Alleud, Belgium.
  • Fogal B; Nonclinical Drug Safety, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, 06877, USA.
  • Freebern W; Bristol Myers Squibb, Drug Safety Evaluation, New Brunswick, NJ, 08903, USA.
  • Herzyk D; Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
  • Kamperschroer C; Pfizer Worldwide Research & Development, Groton, CT, USA.
  • Kiessling A; Department of Preclinical Safety, Novartis Institutes for Biomedical Research, Basel, Switzerland.
  • Schneidkraut M; Astellas Discovery Science and Management, 1 Astellas Way, N2.103, Northbrook, IL, 60062, USA.
  • Maier C; Non-Clinical Safety, GlaxoSmithKline, 1250 South Collegeville RD, Collegeville, PA, 19426, USA.
Regul Toxicol Pharmacol ; 119: 104825, 2021 Feb.
Article em En | MEDLINE | ID: mdl-33220389

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Sistema Imunitário Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Sistema Imunitário Idioma: En Ano de publicação: 2021 Tipo de documento: Article