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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz, Susan; Zhang, Yan; Fischer, Sally; McGuire, Kristina; Sommer, Ulrike; Amaravadi, Lakshmi; Bandukwala, Abbas; Eck, Steven; Garofolo, Fabio; Islam, Rafiqul; Jordan, Gregor; King, Lindsay; Saito, Yoshiro; Sumner, Giane; Terry, Linda; Vitaliti, Alessandra; Wang, Yow-Ming; Grimaldi, Christine; Joyce, Alison; Palmer, Rachel; Andisik, Matthew; Araya, Marcela; Azadeh, Mitra; Baltrukonis, Daniel; Elliott, Rebecca; Haidar, Sam; Kumar, Seema; Mayer, Andrew; Neff, Florian; Palackal, Nisha; Peng, Kun; Abhari, Mohsen Rajabi; Satterwhite, Christina; Savoie, Natasha; Soo, Catherine; Vinter, Stephen; Welink, Jan; Yan, Weili; Maher, Kevin; Lanham, David; Bertholet, Sylvie; Dakappagari, Naveen; Gonneau, Christèle; Green, Cherie; Junker, Fabian; Kar, Sumit; Patti-Diaz, Lisa; Sarikonda, Shyam; McCausland, Megan; Teixeira, Priscila Camillo.
Afiliação
  • Spitz S; Incyte Research Institute, Wilmington, DE, USA.
  • Zhang Y; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • Fischer S; Genentech, South San Francisco, CA, USA.
  • McGuire K; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Sommer U; Novartis, Basel, Switzerland.
  • Amaravadi L; Boston Pharmaceuticals, Cambridge, MA, USA.
  • Bandukwala A; US FDA, Silver Spring, MD, USA.
  • Eck S; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA.
  • Garofolo F; BRI, Vancouver, BC, Canada.
  • Islam R; Celerion, Lincoln, NE, USA.
  • Jordan G; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • King L; Pfizer, Andover, MA, USA.
  • Saito Y; Japan MHLW-NIHS, Tokyo, Japan.
  • Sumner G; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Terry L; GlaxoSmithKline, Stevenage, UK.
  • Vitaliti A; Novartis, Basel, Switzerland.
  • Wang YM; US FDA, Silver Spring, MD, USA.
  • Grimaldi C; Boehringer Ingelheim, Ridgefield, CT, USA.
  • Joyce A; Pfizer, Groveland, MA, USA.
  • Palmer R; Sanofi, Framingham, MA, USA.
  • Andisik M; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Araya M; Pfizer, Medford, MA, USA.
  • Azadeh M; Takeda, Cambridge, MA, USA.
  • Baltrukonis D; Pfizer, Groton, CT, USA.
  • Elliott R; Genentech, South San Francisco, CA, USA.
  • Haidar S; US FDA, Silver Spring, MD, USA.
  • Kumar S; EMD Serono, Andover, MA, USA.
  • Mayer A; GlaxoSmithKline, Collegeville, PA, USA.
  • Neff F; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Palackal N; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Peng K; Genentech, South San Francisco, CA, USA.
  • Abhari MR; US FDA, Silver Spring, MD, USA.
  • Satterwhite C; Charles River, Reno, NV, USA.
  • Savoie N; CFABS, Montreal, QC, Canada.
  • Soo C; Health Canada, Ottawa, ON, Canada.
  • Vinter S; UK MHRA, London, UK.
  • Welink J; EMA, London, UK.
  • Yan W; Genentech, South San Francisco, CA, USA.
  • Maher K; US FDA, Silver Spring, MD, USA.
  • Lanham D; Eurofins Bioanalysis Services, Abingdon, UK.
  • Bertholet S; GSK vaccines, Rockville, MD, USA.
  • Dakappagari N; Navigate, a Novartis Subsidiary, San Diego, CA, USA.
  • Gonneau C; Covance, Meyrin, Switzerland.
  • Green C; Genentech, South San Francisco, CA, USA.
  • Junker F; F. Hoffmann-La Roche, Basel, Switzerland.
  • Kar S; CFABS, Montreal, QC, Canada.
  • Patti-Diaz L; Bristol-Myers Squibb, Mt. Laurel, NJ, USA.
  • Sarikonda S; Navigate, a Novartis Subsidiary, San Diego, CA, USA.
  • McCausland M; Q2 Solutions, Marietta, GA, USA.
  • Teixeira PC; F. Hoffmann-La Roche, Basel, Switzerland.
Bioanalysis ; 13(5): 295-361, 2021 Mar.
Article em En | MEDLINE | ID: mdl-33511867
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Bioensaio / Biotecnologia / Terapia Genética / Relatório de Pesquisa / Terapia Baseada em Transplante de Células e Tecidos Idioma: En 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: Bioensaio / Biotecnologia / Terapia Genética / Relatório de Pesquisa / Terapia Baseada em Transplante de Células e Tecidos Idioma: En Ano de publicação: 2021 Tipo de documento: Article