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Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development.
Manner, David H; Battioui, Chakib; Hantel, Stefan; Beasley, B Nhi; Wei, Lee-Jen; Geiger, Mary Jane; Turner, J Rick; Abt, Markus.
Afiliação
  • Manner DH; Eli Lilly and Company, Lilly Corporate Center Drop Code 2240, Indianapolis, IN. Electronic address: mannerdh@lilly.com.
  • Battioui C; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: Battioui_chakib@lilly.com.
  • Hantel S; Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, Biberach, Germany. Electronic address: stefan.hantel@boehringer-igelheim.com.
  • Beasley BN; Food and Drug Administration, Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products, 10903 New Hampshire Ave, WO 22 - 4169, Silver Spring, MD. Electronic address: nhi.beasley@fda.hhs.gov.
  • Wei LJ; Department of Biostatistics, Harvard University, 677 Huntington Ave, Boston, MA. Electronic address: wei@hsph.harvard.edu.
  • Geiger MJ; VP & Therapeutic Area Lead - Cardiovascular, Drug Development Services, ICON plc, 2100 Pennbrook Parkway, North Wales, PA. Electronic address: maryjane.geiger@iconplc.com.
  • Turner JR; Adjunct Professor of Pharmacy Practice, Campbell University College of Pharmacy & Health Sciences, P.O. Box 1090, 180 Main Street, Buies Creek, NC. Electronic address: j.rick.turner123@outlook.com.
  • Abt M; F. Hoffmann-La Roche AG, Grenzacherstrasse 124, CH-4070, Basel, Switzerland. Electronic address: Markus.abt.ma1@roche.com.
Am Heart J ; 215: 178-186, 2019 09.
Article em En | MEDLINE | ID: mdl-31349109

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Diabetes Mellitus Tipo 2 / Desenvolvimento de Medicamentos / Hipoglicemiantes Tipo de estudo: Etiology_studies / Prognostic_studies Limite: Humans Idioma: En Revista: Am Heart J Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Diabetes Mellitus Tipo 2 / Desenvolvimento de Medicamentos / Hipoglicemiantes Tipo de estudo: Etiology_studies / Prognostic_studies Limite: Humans Idioma: En Revista: Am Heart J Ano de publicação: 2019 Tipo de documento: Article