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Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts.
De Jong, Wim H; Hoffmann, Sebastian; Lee, Michelle; Kandárová, Helena; Pellevoisin, Christian; Haishima, Yuji; Rollins, Beau; Zdawczyk, Austin; Willoughby, Jamin; Bachelor, Michael; Schatz, Timothy; Skoog, Shelby; Parker, Sherry; Sawyer, Anita; Pescio, Paolo; Fant, Kristina; Kim, Kwang-Mahn; Kwon, Jae Sung; Gehrke, Helge; Hofman-Hüther, Hana; Meloni, Marisa; Julius, Conrad; Briotet, Damien; Letasiova, Silvia; Kato, Reiko; Miyajima, Atsuko; De La Fonteyne, Liset J J; Videau, Christelle; Tornier, Carine; Turley, Audrey P; Christiano, Nicholas; Rollins, Thor S; Coleman, Kelly P.
Afiliación
  • De Jong WH; National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. Electronic address: Wim.de.jong@rivm.nl.
  • Hoffmann S; Seh consulting + services, Paderborn, Germany.
  • Lee M; Nelson Laboratories, Inc., Salt Lake City, UT, USA.
  • Kandárová H; MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia.
  • Pellevoisin C; EPISKIN, Lyon, France.
  • Haishima Y; National Institute of Health Sciences (NIHS), Division of Medical Devices, Tokyo, Japan.
  • Rollins B; Arthrex, Inc., Naples, FL, USA(1).
  • Zdawczyk A; NAMSA, Northwood, OH, USA.
  • Willoughby J; Cyprotex US LCC, Kalamazoo, MI, USA(2).
  • Bachelor M; MatTek Corporation, Ashland, MA, USA.
  • Schatz T; American Preclinical Services LLC, Minneapolis, MN, USA.
  • Skoog S; US Food and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD, USA.
  • Parker S; WuXi AppTec, St Paul, MN, USA.
  • Sawyer A; Becton Dickinson, Research Triangle Park, NC, USA.
  • Pescio P; Eurofins Biolab Srl, Vimodrone, Milan, Italy.
  • Fant K; SP Technical Research Institute of Sweden, Borås, Sweden.
  • Kim KM; Yonsei University, College of Dentistry, Seoul, South Korea.
  • Kwon JS; Yonsei University, College of Dentistry, Seoul, South Korea.
  • Gehrke H; Eurofins Biopharma, Planegg, Munich, Germany.
  • Hofman-Hüther H; Eurofins Biopharma, Planegg, Munich, Germany.
  • Meloni M; VitroScreen, Milan, Italy.
  • Julius C; Envigo CRS GmbH, Rossdorf, Germany.
  • Briotet D; NAMSA, Chasse sur Rhône, France.
  • Letasiova S; MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia.
  • Kato R; National Institute of Health Sciences (NIHS), Division of Medical Devices, Tokyo, Japan.
  • Miyajima A; National Institute of Health Sciences (NIHS), Division of Medical Devices, Tokyo, Japan.
  • De La Fonteyne LJJ; National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
  • Videau C; EPISKIN, Lyon, France.
  • Tornier C; EPISKIN, Lyon, France.
  • Turley AP; Nelson Laboratories, Inc., Salt Lake City, UT, USA.
  • Christiano N; Arthrex, Inc., Naples, FL, USA.
  • Rollins TS; Nelson Laboratories, Inc., Salt Lake City, UT, USA.
  • Coleman KP; Medtronic, plc, Minneapolis, MN, USA.
Toxicol In Vitro ; 50: 439-449, 2018 08.
Article en En | MEDLINE | ID: mdl-29326048
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polímeros / Materiales Biocompatibles / Pruebas de Irritación de la Piel / Epidermis / Irritantes Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: Toxicol In Vitro Asunto de la revista: TOXICOLOGIA Año: 2018 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polímeros / Materiales Biocompatibles / Pruebas de Irritación de la Piel / Epidermis / Irritantes Tipo de estudio: Diagnostic_studies Límite: Humans Idioma: En Revista: Toxicol In Vitro Asunto de la revista: TOXICOLOGIA Año: 2018 Tipo del documento: Article