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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita, Uma; Sun, Kefeng; Braun, Manuela; Lembke, Wibke; Mody, Hardik; Kamerud, John; Yang, Tong-Yuan; Braun, Inka V; Fang, Xiaodong; Gao, Wei; Gupta, Swati; Hofer, Magdalena; Liao, Michael Z; Loo, LiNa; McBlane, Fraser; Menochet, Karelle; Stubenrauch, Kay-Gunnar; Upreti, Vijay V; Vigil, Adam; Wiethoff, Christopher M; Xia, Cindy Q; Zhu, Xu; Jawa, Vibha; Chemuturi, Nagendra.
Afiliação
  • Kavita U; Spark Therapeutics, Inc., Philadelphia, Pennsylvania, 19104, USA. uma.kavita@sparktx.com.
  • Sun K; Takeda Development Center Americas Inc., 125 Binney St, Cambridge, Massachusetts, 02142, USA. kefeng.sun@takeda.com.
  • Braun M; Bayer AG, Pharmaceuticals R&D, 13342, Berlin, Germany.
  • Lembke W; Integrated Biologix GmbH, 4051, Basel, Switzerland.
  • Mody H; Genentech Inc., South San Francisco, California, USA.
  • Kamerud J; Pfizer, Andover, Massachusetts, 01810, USA.
  • Yang TY; Janssen R&D LLC., Spring House, Pennsylvania, 19477, USA.
  • Braun IV; Bayer AG, 42113, Wuppertal, Germany.
  • Fang X; Asklepios BioPharmaceutical, Inc., Research Triangle, North Carolina, 27709, USA.
  • Gao W; EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, 01821, USA.
  • Gupta S; AbbVie, 2525 Dupont Drive, Irvine, California, 92612, USA.
  • Hofer M; Spark Therapeutics, Inc., Philadelphia, Pennsylvania, 19104, USA.
  • Liao MZ; Genentech Inc., South San Francisco, California, USA.
  • Loo L; Vertex Pharmaceuticals Boston, Boston, Massachusetts, 02210, USA.
  • McBlane F; Novartis, Basel, Switzerland.
  • Menochet K; UCB Pharma Ltd., SL1 3WE, Slough, UK.
  • Stubenrauch KG; Roche Diagnostics GmbH, 82377, Penzberg, Germany.
  • Upreti VV; Amgen, South San Francisco, California, 94080, USA.
  • Vigil A; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, 06877, USA.
  • Wiethoff CM; Eli Lilly and Company, Indianapolis, Indiana, 46285, USA.
  • Xia CQ; ReNAgade Therapeutics, Cambridge, Massachusetts, 02142, USA.
  • Zhu X; AstraZeneca, Waltham, Massachusetts, 02451, USA.
  • Jawa V; Bristol Myers Squibb, Lawrence Township, New Jersey, 08648, USA.
  • Chemuturi N; Takeda Development Center Americas Inc., 125 Binney St, Cambridge, Massachusetts, 02142, USA.
AAPS J ; 25(5): 78, 2023 07 31.
Article em En | MEDLINE | ID: mdl-37523051
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Terapia Genética / Dependovirus Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Terapia Genética / Dependovirus Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article