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An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics.
Besheer, Ahmed; Burton, Lori; Galas, Richard J; Gokhale, Kedar; Goldbach, Pierre; Hu, Qingyan; Mathews, Ligi; Muthurania, Kevin; Narasimhan, Chakravarthy; Singh, Shubhadra N; Stokes, Elaine S E; Weiser, Sarah; Zamiri, Camellia; Zhou, Shuxia.
Afiliação
  • Besheer A; Lonza Drug Product Services, Basel, Switzerland.
  • Burton L; Bristol Myers Squibb, Drug Product Development, One Squibb Drive, New Brunswick, NJ 08903, USA.
  • Galas RJ; Takeda Pharmaceuticals International Co., Drug Product Development, 40 Landsdowne Street, Cambridge, MA 02139, USA.
  • Gokhale K; Janssen Research & Development, Biotherapeutics Drug Product Development, 200 Great Valley Parkway, Malvern, PA 19355, USA.
  • Goldbach P; F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, Basel 4070, Switzerland.
  • Hu Q; Regeneron Pharmaceuticals Inc., Formulation Development, 777 Old Saw Mill River Road, Tarrytown, New York NY 10591 USA.
  • Mathews L; Janssen Research & Development, Biotherapeutics Drug Product Development, 200 Great Valley Parkway, Malvern, PA 19355, USA.
  • Muthurania K; Janssen Research & Development, Biotherapeutics Drug Product Development, 200 Great Valley Parkway, Malvern, PA 19355, USA.
  • Narasimhan C; Merck & Co., Inc. MSD, Biologics and Vaccines Development, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA.
  • Singh SN; GlaxoSmithKline R&D, Biopharmaceutical Product Sciences, Collegeville, PA 19426, USA.
  • Stokes ESE; BioPhorum, The Gridiron Building, 1 Pancras Square, London N1C 4AG UK. Electronic address: elaine@biophorum.com.
  • Weiser S; Pfizer, Inc, BioTherapeutics PharmSci, 1 Burtt Road, Andover MA 01810, USA.
  • Zamiri C; Genentech (A Member of the Roche Group), Pharmaceutical Development, 1 DNA Way, South San Francisco, CA 94080, USA.
  • Zhou S; Takeda Pharmaceuticals International Co., Drug Product Development, 40 Landsdowne Street, Cambridge, MA 02139, USA.
J Pharm Sci ; 110(2): 610-614, 2021 02.
Article em En | MEDLINE | ID: mdl-33127425
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Preparações Farmacêuticas / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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XML
PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Preparações Farmacêuticas / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article