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Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper.
Mitra, Amitava; Ahmed, Mariam A; Krishna, Rajesh; Sun, Kefeng; Gibbons, Francis D; Campagne, Olivia; Rayad, Noha; Roman, Youssef M; Albusaysi, Salwa; Burian, Maria; Younis, Islam R.
Afiliación
  • Mitra A; Clinical Pharmacology, Kura Oncology, Boston, Massachusetts, USA.
  • Ahmed MA; Quantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
  • Krishna R; Integrated Drug Development, Certara USA, Inc., Princeton, New Jersey, USA.
  • Sun K; Quantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
  • Gibbons FD; Quantitative Solutions, Preclinical and Translational Sciences, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
  • Campagne O; Quantitative Clinical Pharmacology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.
  • Rayad N; Clinical Pharmacology, Modeling and Simulation, Parexel International (MA) Corporation, Mississauga, Ontario, Canada.
  • Roman YM; Department of Pharmacotherapy and Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Virginia, USA.
  • Albusaysi S; Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
  • Burian M; Translational Medicine Neuroscience and Gene Therapy, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
  • Younis IR; Clinical Pharmacology Sciences, Gilead Science, Inc, Foster City, California, USA.
Clin Pharmacol Ther ; 114(3): 515-529, 2023 09.
Article en En | MEDLINE | ID: mdl-37313953
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Terapia Genética Tipo de estudio: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Terapia Genética Tipo de estudio: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Clin Pharmacol Ther Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos