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2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel.
Affiliation
  • Ackermann B; Eli Lilly & Company, Indianapolis, IN, USA.
  • Neubert H; Pfizer, Andover, MA, USA.
  • Hughes N; Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada.
  • Garofolo F; Angelini Pharma, Piazzale della Stazione, snc, 0040 S. Palomba Pomezia (RM), Italy.
  • Abberley L; GlaxoSmithKline, King of Prussia, PA, USA.
  • Alley SC; Seattle Genetics, Bothell, WA, USA.
  • Brown-Augsburger P; Eli Lilly & Company, Indianapolis, IN, USA.
  • Bustard M; Health Canada, Ottawa, ON, Canada.
  • Chen LZ; Boehringer Ingelheim, Ridgefield, CT, USA.
  • Heinrich J; Roche Innovation Center Penzberg, pRED Pharmaceutical Sciences, Germany.
  • Katori N; Japan MHLW-NIHS, Tokyo, Japan.
  • Kaur S; Genentech, South San Francisco, CA, USA.
  • Kirkovsky L; Pfizer, San Diego, CA, USA.
  • Laterza OF; Merck & Co., Inc., Rahway, NJ, USA.
  • Le Blaye O; France ANSM, Saint Denis, France.
  • Lévesque A; inVentiv Health Clinical, Quebec City, QC, Canada.
  • Santos GM; Brazil ANVISA, Brasilia, Brazil.
  • Olah T; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Savoie N; CFABS, Montreal, QC, Canada.
  • Skelly M; US FDA, Silver Spring, MD, USA.
  • Spitz S; MedImmune, Gaithersburg, MD, USA.
  • Szapacs M; GlaxoSmithKline, King of Prussia, PA, USA.
  • Tampal N; US FDA, Silver Spring, MD, USA.
  • Wang J; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Welink J; Dutch MEB, Utrecht, The Netherlands.
  • Wieling J; Antaeus Biopharma, Fochteloo, The Netherlands.
  • Haidar S; US FDA, Silver Spring, MD, USA.
  • Vinter S; UK MHRA, London, UK.
  • Whale E; UK MHRA, London, UK.
  • Witte B; Germany BfArM, Bonn, Germany.
Bioanalysis ; 7(23): 3019-34, 2015 Dec.
Article in En | MEDLINE | ID: mdl-26627049
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Biotechnology / Biomarkers Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2015 Type: Article Affiliation country: United States
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / Biotechnology / Biomarkers Type of study: Guideline Limits: Humans Language: En Journal: Bioanalysis Year: 2015 Type: Article Affiliation country: United States