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An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials.
DeGeorge, Joseph; Robertson, Sarah; Butler, Lynne; Derzi, Mazin; Stoch, S Aubrey; Diaz, Dolores; Hartke, James; Guzzie-Peck, Peggy; Mortimer-Cassen, Elisabeth; Bogdanffy, Matthew; Will, Yvonne; Greene, Nigel.
Afiliación
  • DeGeorge J; Bianca Holdings, Lansdale, Pennsylvania, USA.
  • Robertson S; Vertex Pharmaceuticals, Boston, Massachusetts, USA.
  • Butler L; Pfizer Worldwide Research and Development, Groton, Connecticut, USA.
  • Derzi M; Pfizer Worldwide Research and Development, Groton, Connecticut, USA.
  • Stoch SA; Merck & Co, Inc., Kenilworth, New Jersey, USA.
  • Diaz D; Denali Therapeutics, San Francisco, California, USA.
  • Hartke J; Celgene, Nonclinical Development, San Diego, California, USA.
  • Guzzie-Peck P; Janssen Research and Development, Spring House, Pennsylvania, USA.
  • Mortimer-Cassen E; AstraZeneca, Melbourne, Hertfordshire, UK.
  • Bogdanffy M; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.
  • Will Y; Pfizer Worldwide Research and Development, Groton, Connecticut, USA.
  • Greene N; AstraZeneca, Waltham, Massachusetts, USA.
Clin Pharmacol Ther ; 103(4): 566-569, 2018 04.
Article en En | MEDLINE | ID: mdl-29285748
ABSTRACT
The European Medicines Agency (EMA) in 2017 issued a revised guideline on nonclinical and clinical aspects of first-in-human (FIH) and early clinical trials (CTs). External input was solicited during a draft comment phase, and although some industry suggestions were adopted, others were not. We agree that subject safety is of utmost priority, and believe that minimizing risk must be balanced with efficient and informative study designs to bring new medicines to patients.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Guías como Asunto / Experimentación Humana Terapéutica / Control de Medicamentos y Narcóticos / Industria Farmacéutica / Desarrollo de Medicamentos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Guías como Asunto / Experimentación Humana Terapéutica / Control de Medicamentos y Narcóticos / Industria Farmacéutica / Desarrollo de Medicamentos Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos