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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan, Luying; Mora, Johanna; Walravens, Karl; Wagner, Leslie; Hopper, Shirley; Loo, Lina; Bettoun, David; Bond, Sarah; Dessy, Francis; Downing, Sean; Garofolo, Fabio; Gupta, Soumi; Henderson, Neil; Irwin, Chad; Ishii-Watabe, Akiko; Kar, Sumit; Jawa, Vibha; Joseph, Julie; Malvaux, Ludovic; Marshall, Jean-Claude; McDevitt, Jessica; Mohapatra, Susovan; Seitzer, Jessica; Smith, Justin; Solstad, Therese; Sugimoto, Hiroshi; Tounekti, Omar; Wu, Bonnie; Wu, Yuling; Xu, Yuanxin; Xu, Joshua; Yamamoto, Takenori; Yang, Lin; Torri, Albert; Kirshner, Susan; Maxfield, Kimberly; Vasconcelos, Joao Pedras; Abhari, Mohsen Rajabi; Verthelyi, Daniela; Brodsky, Eric; Carrasco-Triguero, Montserrat; Kamerud, John; Andisik, Matthew; Baltrukonis, Daniel; Bivi, Nicoletta; Cludts, Isabelle; Coble, Kelly; Gorovits, Boris; Gunn, George R; Gupta, Swati.
Afiliação
  • Pan L; Takeda, Cambridge, MA, USA.
  • Mora J; Bristol Myers Squibb, Lawrenceville, NJ, USA.
  • Walravens K; GlaxoSmithKline, Rixensart, Belgium.
  • Wagner L; US FDA, Silver Spring, MD, USA.
  • Hopper S; UK MHRA, London, UK.
  • Loo L; Vertex, Boston, MA, USA.
  • Bettoun D; Larimar, Bala-Cynwyd, PA, USA.
  • Bond S; Alnylam, Cambridge, MA, USA.
  • Dessy F; GlaxoSmithKline, Rixensart, Belgium.
  • Downing S; Takeda, Cambridge, MA, USA.
  • Garofolo F; BRI Frontage, Vancouver, BC, Canada.
  • Gupta S; BioMarin, Novato, CA, USA.
  • Henderson N; AstraZeneca, Gothenburg, Sweden.
  • Irwin C; Health Canada, Ottawa, ON, Canada.
  • Ishii-Watabe A; Japan MHLW, Tokyo, Japan.
  • Kar S; WRIB, Montreal, QC, Canada.
  • Jawa V; Bristol Myers Squibb, Lawrenceville, NJ, USA.
  • Joseph J; Health Canada, Ottawa, ON, Canada.
  • Malvaux L; GlaxoSmithKline, Rixensart, Belgium.
  • Marshall JC; Moderna, Mystic, CT, USA.
  • McDevitt J; Bristol Myers Squibb, Lawrenceville, NJ, USA.
  • Mohapatra S; Stoke, Cambridge, MA, USA.
  • Seitzer J; Intellia, Cambridge, MA, USA.
  • Smith J; Pfizer, Groton, CT, USA.
  • Solstad T; Norway NoMA, Oslo, Norway.
  • Sugimoto H; Takeda, Cambridge, MA, USA.
  • Tounekti O; Health Canada, Ottawa, ON, Canada.
  • Wu B; Janssen R&D, Spring House, PA, USA.
  • Wu Y; AstraZeneca, Gaithersburg, MD, USA.
  • Xu Y; Intellia, Cambridge, MA, USA.
  • Xu J; US FDA, Jefferson, AR, USA.
  • Yamamoto T; Japan MHLW, Tokyo, Japan.
  • Yang L; REGENXBIO, Rockville, MD, USA.
  • Torri A; Regeneron, Tarrytown, NY, USA.
  • Kirshner S; US FDA, Silver Spring, MD, USA.
  • Maxfield K; US FDA, Silver Spring, MD, USA.
  • Vasconcelos JP; US FDA, Silver Spring, MD, USA.
  • Abhari MR; US FDA, Silver Spring, MD, USA.
  • Verthelyi D; US FDA, Silver Spring, MD, USA.
  • Brodsky E; US FDA, Silver Spring, MD, USA.
  • Carrasco-Triguero M; Sangamo, Brisbane, CA, USA.
  • Kamerud J; Pfizer, Groton, CT, USA.
  • Andisik M; Regeneron, Tarrytown, NY, USA.
  • Baltrukonis D; Pfizer, Groton, CT, USA.
  • Bivi N; Lilly, Indianapolis, IN, USA.
  • Cludts I; UK MHRA, London, UK.
  • Coble K; Boehringer Ingelheim, Danbury, CT, USA.
  • Gorovits B; Sana Bio, Cambridge, MA, USA.
  • Gunn GR; GSK, Collegeville, PA, USA.
  • Gupta S; AbbVie, Irvine, CA, USA.
Bioanalysis ; 15(14): 773-814, 2023 Jul.
Article em En | MEDLINE | ID: mdl-37526071
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos sob Prescrição Tipo de estudo: Etiology_studies / Guideline / Qualitative_research / Risk_factors_studies Idioma: En Revista: Bioanalysis Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos sob Prescrição Tipo de estudo: Etiology_studies / Guideline / Qualitative_research / Risk_factors_studies Idioma: En Revista: Bioanalysis Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos