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2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Welink, Jan; Yang, Eric; Hughes, Nicola; Rago, Brian; Woolf, Eric; Sydor, Jens; Coppola, Laura; Ackermann, Brad; Li, Wenkui; Alley, Stephen C; Arnold, Mark; Berger, Isabella; Briscoe, Chad; Buonarati, Michael; Bustard, Mark; Cancilla, Mark; Cho, Seongeun Julia; Duggan, Jeff; Fraier, Daniela; Garofolo, Fabio; Green, Rachel; Haidar, Sam; Hittle, Lucinda; Ishii-Watabe, Akiko; Islam, Rafiq; Jenkins, Rand; Jones, Barry; Kadavil, John; Kassim, Sean; Kavetska, Olga; Blaye, Olivier Le; Lee, Anita; Liu, Hanlan; Mehl, John; Lima Santos, Gustavo Mendes; Musuku, Adrien; Ramanathan, Ragu; Saito, Yoshiro; Savoie, Natasha; Summerfield, Scott; Surapaneni, Sekhar; Szapacs, Matthew; Tampal, Nilufer; Verhaeghe, Tom; Vinter, Stephen; Whale, Emma.
Afiliación
  • Welink J; EU EMA, London, UK.
  • Yang E; GlaxoSmithKline, King of Prussia, PA, USA.
  • Hughes N; Biopharma Services, Toronto, ON, Canada.
  • Rago B; Pfizer, Groton, CT, USA.
  • Woolf E; Merck Research Labs, West Point, PA, USA.
  • Sydor J; AbbVie Inc., North Chicago, IL, USA.
  • Coppola L; Apotex, Toronto, ON, Canada.
  • Ackermann B; Eli Lilly & Company, Indianapolis, IN, USA.
  • Li W; Novartis, East Hanover, NJ, USA.
  • Alley SC; Seattle Genetics, Bothell, WA, USA.
  • Arnold M; Covance, West Trenton, NJ, USA.
  • Berger I; Austria AGES, Wien, Austria.
  • Briscoe C; PRA Health Sciences, Overland Park, KS, USA.
  • Buonarati M; Intertek, San Diego, CA, USA.
  • Bustard M; Health Canada, Ottawa, ON, Canada.
  • Cancilla M; Merck Research Labs, West Point, PA, USA.
  • Cho SJ; US FDA, Silver Spring, MD, USA.
  • Duggan J; IXD Bioanalytics, Southbury, CT, USA (previously Boehringer-Ingelheim, Ridgefield, CT, USA).
  • Fraier D; F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Garofolo F; Angelini Pharma, Pomezia, RM, Italy.
  • Green R; LGC, Cambridge, UK.
  • Haidar S; US FDA, Silver Spring, MD, USA.
  • Hittle L; Merck & Co., Rahway, NJ, USA.
  • Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan.
  • Islam R; Celerion, Lincoln, NE, USA.
  • Jenkins R; PPD, Richmond, VA, USA.
  • Jones B; Q2 Solutions, Ithaca, NY, USA.
  • Kadavil J; US FDA, Silver Spring, MD, USA.
  • Kassim S; US FDA, Silver Spring, MD, USA.
  • Kavetska O; Pfizer, Groton, CT, USA.
  • Blaye OL; France ANSM, Saint Denis, France.
  • Lee A; Merck & Co., Rahway, NJ, USA.
  • Liu H; Catabasis, Cambridge, MA, USA.
  • Mehl J; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Lima Santos GM; Brazil Anvisa, Brasilia, Brazil.
  • Musuku A; Pharmascience, Montreal, QC, Canada.
  • Ramanathan R; Pfizer, Groton, CT, USA.
  • Saito Y; Japan MHLW-NIHS, Tokyo, Japan.
  • Savoie N; CFABS, Montreal, QC, Canada.
  • Summerfield S; GlaxoSmithKline, Ware, UK.
  • Surapaneni S; Celgene, Summit, NJ, USA.
  • Szapacs M; GlaxoSmithKline, King of Prussia, PA, USA.
  • Tampal N; US FDA, Silver Spring, MD, USA.
  • Verhaeghe T; Janssen Research & Development, Beerse, Belgium.
  • Vinter S; UK MHRA, London, UK.
  • Whale E; UK MHRA, London, UK.
Bioanalysis ; 9(22): 1807-1825, 2017 Nov.
Article en En | MEDLINE | ID: mdl-29148835
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Péptidos / Espectrometría de Masas / Biomarcadores / Cromatografía Líquida de Alta Presión / Bibliotecas de Moléculas Pequeñas Tipo de estudio: Guideline Idioma: En Revista: Bioanalysis Año: 2017 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Péptidos / Espectrometría de Masas / Biomarcadores / Cromatografía Líquida de Alta Presión / Bibliotecas de Moléculas Pequeñas Tipo de estudio: Guideline Idioma: En Revista: Bioanalysis Año: 2017 Tipo del documento: Article País de afiliación: Reino Unido