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Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Leach, Michael W; Clarke, David O; Dudal, Sherri; Han, Chao; Li, Chunze; Yang, Zheng; Brennan, Frank R; Bailey, Wendy J; Chen, Yingxue; Deslandes, Antoine; Loberg, Lise I; Mayawala, Kapil; Rogge, Mark C; Todd, Marque; Chemuturi, Nagendra V.
Afiliación
  • Leach MW; Drug Safety Research and Development, Pfizer, Inc., Cambridge, Massachusetts, USA.
  • Clarke DO; Nonclinical Safety Assessment, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
  • Dudal S; DMPK Project Leads and Translational M&S, Pharmaceutical Sciences, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
  • Han C; Biologics Development Sciences, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA.
  • Li C; Department of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA.
  • Yang Z; Metabolism and Pharmacokinetics, Bristol-Myers Squibb Co., Princeton, New Jersey, USA.
  • Brennan FR; Non-Clinical Safety, UCB Pharma, Slough, UK.
  • Bailey WJ; Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, Pennsylvania, USA.
  • Chen Y; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Boston, Massachusetts, USA.
  • Deslandes A; Translational Medicine & Early Development, Sanofi R&D, Centre de Recherche Vitry-sur-Seine 13, Vitry-sur-Seine Cedex, France.
  • Loberg LI; Preclinical Safety, AbbVie, North Chicago, Illinois, USA.
  • Mayawala K; Quantitative Pharmacology and Pharmacometrics, PPDM, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Rogge MC; Quantitative and Translational Science, Takeda Pharmaceuticals, Cambridge, Massachusetts, USA.
  • Todd M; Drug Safety Research and Development, Pfizer, Inc., San Diego, California, USA.
  • Chemuturi NV; Pharmacokinetic Sciences, Novartis Institute of BioMedical Research, Inc., Cambridge, Massachusetts, USA.
Clin Pharmacol Ther ; 109(6): 1395-1415, 2021 06.
Article en En | MEDLINE | ID: mdl-32757299
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Ensayos Clínicos como Asunto / Desarrollo de Medicamentos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Ensayos Clínicos como Asunto / Desarrollo de Medicamentos Tipo de estudio: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos