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Strategies for Setting Patient-Centric Commercial Specifications for Biotherapeutic Products.
Ruesch, Margaret N; Benetti, Luca; Berkay, Eileen; Cirelli, David J; Frantz, Neha; Gastens, Martin H; Kelley, Wayne P; Kretsinger, Juliana; Lewis, Mike; Novick, Shawn; Rellahan, Barbara; Pack, Laura; Stroop, Corné J M; Subashi, Ann; Yin, Ping; Zeng, Ming; Stults, John.
Afiliação
  • Ruesch MN; Worldwide Research, Development and Medical, Pfizer Inc., Andover, MA 01810, USA. Electronic address: margaret.n.ruesch@pfizer.com.
  • Benetti L; Merck & Co., Inc., Kenilworth, NJ, USA.
  • Berkay E; Janssen R&D, LLC, Malvern, PA 19355, USA.
  • Cirelli DJ; Worldwide Research, Development and Medical, Pfizer Inc., Andover, MA 01810, USA.
  • Frantz N; Biogen, Research Triangle Park, NC 27709, USA.
  • Gastens MH; NBE Development, AbbVie Inc., North Chicago, IL 60064, USA.
  • Kelley WP; Pharma Research & Development, GlaxoSmithKline, King of Prussia, PA 19406, USA.
  • Kretsinger J; Bioproduct Analytical Development, Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Lewis M; Janssen R&D, LLC, Malvern, PA 19355, USA.
  • Novick S; BioPhia Consulting, Inc., Lake Forest, IL 60045, USA.
  • Rellahan B; Amgen, Homer Building, Washington, DC 20005, USA.
  • Pack L; Product Quality, Seagen, Bothell, WA 98021, USA.
  • Stroop CJM; Biologics and Vaccines Analytics, MSD, Oss, the Netherlands.
  • Subashi A; Global Product Development, Pfizer Inc., Groton, CT, USA.
  • Yin P; Global Regulatory Affairs, Vertex Pharmaceuticals, Boston, MA 02210, USA.
  • Zeng M; Parenteral Science & Technology, Bristol-Myers Squibb Company, New Brunswick, NJ 08903, USA.
  • Stults J; Genentech, Inc., South San Francisco, CA 94080, USA. Electronic address: stults.john@gene.com.
J Pharm Sci ; 110(2): 771-784, 2021 02.
Article em En | MEDLINE | ID: mdl-33035537
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Assistência Centrada no Paciente / Anticorpos Monoclonais Limite: Humans Idioma: En Revista: J Pharm Sci Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Assistência Centrada no Paciente / Anticorpos Monoclonais Limite: Humans Idioma: En Revista: J Pharm Sci Ano de publicação: 2021 Tipo de documento: Article