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Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
Vargas, Hugo M; Rolf, Michael G; Wisialowski, Todd A; Achanzar, William; Bahinski, Anthony; Bass, Alan; Benson, Charles T; Chaudhary, Khuram W; Couvreur, Nicolas; Dota, Corina; Engwall, Michael J; Michael Foley, C; Gallacher, David; Greiter-Wilke, Andrea; Guillon, Jean-Michel; Guth, Brian; Himmel, Herbert M; Hegele-Hartung, Christa; Ito, Maki; Jenkinson, Stephen; Chiba, Katsuyoshi; Lagrutta, Armando; Levesque, Paul; Martel, Eric; Okai, Yoshiko; Peri, Ravikumar; Pointon, Amy; Qu, Yusheng; Teisman, Ard; Traebert, Martin; Yoshinaga, Takashi; Gintant, Gary A; Leishman, Derek J; Valentin, Jean-Pierre.
Afiliação
  • Vargas HM; Translational Safety & Bioanalytical Sciences, Amgen Research, Thousand Oaks, California, USA.
  • Rolf MG; Research & Development, Clinical Pharmacology & Safety Sciences, AstraZeneca, Gothenburg, Sweden.
  • Wisialowski TA; Global Safety Pharmacology, Pfizer Global Research and Development, Groton, Connecticut, USA.
  • Achanzar W; BMS Bristol-Myers Squibb Company, Princeton, New Jersey, USA.
  • Bahinski A; GlaxoSmithKline, Collegeville, Pennsylvania, USA.
  • Bass A; Merck & Co., Inc., Boston, Massachusetts, USA.
  • Benson CT; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Chaudhary KW; GlaxoSmithKline, Collegeville, Pennsylvania, USA.
  • Couvreur N; Safety Pharmacology, Institute de Recherches Servier, Suresnes, France.
  • Dota C; Research & Development, Chief Medical Officer Organization, AstraZeneca, Gothenburg, Sweden.
  • Engwall MJ; Translational Safety & Bioanalytical Sciences, Amgen Research, Thousand Oaks, California, USA.
  • Michael Foley C; Integrative Pharmacology, Abbvie, Inc, North Chicago, Illinois, USA.
  • Gallacher D; Global Safety Pharmacology, Janssen Research & Development, Beerse, Belgium.
  • Greiter-Wilke A; Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Guillon JM; Sanofi R&D, Preclinical Safety, Paris, France.
  • Guth B; Department of Drug Discovery Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
  • Himmel HM; Safety Pharmacology, Bayer AG, Wuppertal, Germany.
  • Hegele-Hartung C; Safety Pharmacology, Bayer AG, Wuppertal, Germany.
  • Ito M; Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
  • Jenkinson S; Global Safety Pharmacology, Pfizer Global Research and Development, San Diego, California, USA.
  • Chiba K; Medicinal Safety Research Laboratories, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
  • Lagrutta A; Merck & Co., Inc., West Point, Pennsylvania, USA.
  • Levesque P; BMS Bristol-Myers Squibb Company, Princeton, New Jersey, USA.
  • Martel E; Department of Drug Discovery Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
  • Okai Y; Takeda Pharmaceutical Company Ltd., Fujisawa, Kanagawa, Japan.
  • Peri R; Takeda Pharmaceutical Company Ltd., Cambridge, Massachusetts, USA.
  • Pointon A; Research & Development, Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, UK.
  • Qu Y; Translational Safety & Bioanalytical Sciences, Amgen Research, Thousand Oaks, California, USA.
  • Teisman A; Global Safety Pharmacology, Janssen Research & Development, Beerse, Belgium.
  • Traebert M; Safety Pharmacology, Novartis Institute of Biomedical Research, Basel, Switzerland.
  • Yoshinaga T; Global Cardiovascular Assessment, Eisai Co., Ltd., Tokyo, Japan.
  • Gintant GA; Integrative Pharmacology, Abbvie, Inc, North Chicago, Illinois, USA.
  • Leishman DJ; Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Valentin JP; UCB Biopharma SPRL, Braine-l'Alleud, Belgium.
Clin Pharmacol Ther ; 109(2): 310-318, 2021 02.
Article em En | MEDLINE | ID: mdl-32866317

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Síndrome do QT Longo / Drogas em Investigação Tipo de estudo: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Síndrome do QT Longo / Drogas em Investigação Tipo de estudo: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos