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Industrial Perspective on the Benefits Realized From the FDA's Model-Informed Drug Development Paired Meeting Pilot Program.
Galluppi, Gerald R; Brar, Satjit; Caro, Luzelena; Chen, Yuan; Frey, Nicolas; Grimm, Hans Peter; Rudd, Deanne Jackson; Li, Chi-Chung; Magee, Mindy; Mukherjee, Arnab; Nagao, Lee; Purohit, Vivek S; Roy, Amit; Salem, Ahmed Hamed; Sinha, Vikram; Suleiman, Ahmed A; Taskar, Kunal S; Upreti, Vijay V; Weber, Benjamin; Cook, Jack.
Afiliação
  • Galluppi GR; Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.
  • Brar S; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
  • Caro L; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Chen Y; Department of Drug Metabolism and Pharmacokinetics, Genentech Inc., a member of the Roche Group, South San Francisco, California, USA.
  • Frey N; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
  • Grimm HP; Roche Pharma Research and Exploratory Development, Pharmaceutical Science, Roche Innovation Center, Basel, Switzerland.
  • Rudd DJ; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Li CC; Department of Clinical Pharmacology, Genentech, member of the Roche group, South San Francisco, California, USA.
  • Magee M; GlaxoSmithKline, Philadelphia, Pennsylvania, USA.
  • Mukherjee A; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
  • Nagao L; Faegre Drinker Biddle & Reath, LLP, Washington, DC, USA.
  • Purohit VS; Clinical Pharmacology, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
  • Roy A; Bristol Myers, Inc., Woodbury, Connecticut, USA.
  • Salem AH; Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, Illinois, USA.
  • Sinha V; Ain Shams University, Cairo, Egypt.
  • Suleiman AA; Quantitative Pharmacology and Pharmacometrics, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Taskar KS; Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany.
  • Upreti VV; DMPK, IVIVT, GlaxoSmithKline, Ware, UK.
  • Weber B; Clinical Pharmacology Modeling and Simulation, Amgen Inc., South San Francisco, California, USA.
  • Cook J; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Clin Pharmacol Ther ; 110(5): 1172-1175, 2021 11.
Article em En | MEDLINE | ID: mdl-33991429
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Desenho de Fármacos / Aprovação de Drogas / Indústria Farmacêutica Tipo de estudo: Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Desenho de Fármacos / Aprovação de Drogas / Indústria Farmacêutica Tipo de estudo: Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos