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Scientific white paper on concentration-QTc modeling.
Garnett, Christine; Bonate, Peter L; Dang, Qianyu; Ferber, Georg; Huang, Dalong; Liu, Jiang; Mehrotra, Devan; Riley, Steve; Sager, Philip; Tornoe, Christoffer; Wang, Yaning.
Afiliação
  • Garnett C; Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. christine.garnett@fda.hhs.gov.
  • Bonate PL; Astellas Pharma Global Development, Northbrook, IL, USA.
  • Dang Q; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Ferber G; Statistik Georg Ferber GmbH, Riehen, Switzerland.
  • Huang D; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Liu J; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Mehrotra D; Biostatistics, Merck & Co., Inc., Gwynedd, PA, USA.
  • Riley S; Clinical Pharmacology, Pfizer Inc., New York, NY, USA.
  • Sager P; Stanford University, Stanford, CA, USA.
  • Tornoe C; Clinical Reporting, Novo Nordisk A/S, Bagsværd, Denmark.
  • Wang Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
J Pharmacokinet Pharmacodyn ; 45(3): 383-397, 2018 06.
Article em En | MEDLINE | ID: mdl-29209907
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas / Sistema Cardiovascular / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: J Pharmacokinet Pharmacodyn Assunto da revista: FARMACOLOGIA Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas / Sistema Cardiovascular / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Revista: J Pharmacokinet Pharmacodyn Assunto da revista: FARMACOLOGIA Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Estados Unidos