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The rat bone marrow micronucleus test: Statistical considerations on historical negative control data.
Igl, Bernd-Wolfgang; Bitsch, Annette; Bringezu, Frank; Chang, Steffi; Dammann, Martina; Frötschl, Roland; Harm, Volker; Kellner, Rupert; Krzykalla, Volker; Lott, Jasmin; Nern, Marlies; Pfuhler, Stefan; Queisser, Nina; Schulz, Markus; Sutter, Andreas; Vaas, Lea; Vonk, Richardus; Zellner, Dietmar; Ziemann, Christina.
Affiliation
  • Igl BW; Bayer AG, Research and Clinical Sciences Statistics, Müllerstr. 178, 13353, Berlin, Germany.
  • Bitsch A; Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Nikolai-Fuchs-Str. 1, 30625, Hannover, Germany.
  • Bringezu F; Merck KGaA, Biopharma and Non-Clinical Safety, Frankfurter Str. 250, 64293 Darmstadt, Germany.
  • Chang S; Envigo CRS GmbH, In den Leppsteinswiesen 19, 64380 Rossdorf, Germany.
  • Dammann M; BASF SE, RB/TC - Z470, Carl-Bosch-Str. 38, 67056 Ludwigshafen am Rhein, Germany.
  • Frötschl R; Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
  • Harm V; Bayer AG, Research and Clinical Sciences Statistics, Müllerstr. 178, 13353, Berlin, Germany.
  • Kellner R; Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Nikolai-Fuchs-Str. 1, 30625, Hannover, Germany.
  • Krzykalla V; Boehringer Ingelheim Pharma GmbH & Co. KG, Biostatistics and Data Sciences Europe, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.
  • Lott J; Boehringer Ingelheim Pharma GmbH & Co. KG, Development NCE NDS, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.
  • Nern M; Bayer AG, Research & Development, Pharmaceuticals, Genetic Toxicology Wuppertal, Aprather Weg 18a, 42096, Wuppertal, Germany.
  • Pfuhler S; Procter & Gamble, 8700 Mason-Montgomery Rd., Cincinnati, 45040, Ohio, USA.
  • Queisser N; Bayer AG, Research & Development, Pharmaceuticals, Genetic Toxicology, 13342, Berlin, Germany.
  • Schulz M; Envigo CRS GmbH, In den Leppsteinswiesen 19, 64380 Rossdorf, Germany.
  • Sutter A; Bayer AG, Research & Development, Pharmaceuticals, Genetic Toxicology, 13342, Berlin, Germany.
  • Vaas L; Bayer AG, Research and Clinical Sciences Statistics, Müllerstr. 178, 13353, Berlin, Germany.
  • Vonk R; Bayer AG, Medical Writing and Statistics Oncology, Müllerstr. 178, 13353, Berlin, Germany.
  • Zellner D; Boehringer Ingelheim Pharma GmbH & Co. KG, Biostatistics and Data Sciences Europe, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.
  • Ziemann C; Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Nikolai-Fuchs-Str. 1, 30625, Hannover, Germany. Electronic address: christina.ziemann@item.fraunhofer.de.
Regul Toxicol Pharmacol ; 102: 13-22, 2019 Mar.
Article in En | MEDLINE | ID: mdl-30572081
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Micronucleus Tests / Control Groups Type of study: Prognostic_studies Limits: Animals Language: En Journal: Regul Toxicol Pharmacol Year: 2019 Document type: Article Affiliation country: Germany Country of publication: Netherlands
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Micronucleus Tests / Control Groups Type of study: Prognostic_studies Limits: Animals Language: En Journal: Regul Toxicol Pharmacol Year: 2019 Document type: Article Affiliation country: Germany Country of publication: Netherlands