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Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.
Verbaanderd, Ciska; Trullás Jimeno, Ana; Engelbergs, Jörg; Zander, Hilke; Reischl, Ilona; Moreno Oliver, Ana; Vamvakas, Spiros; Vleminckx, Camille; Bouygues, Christelle; Girard, Thomas; Day, Francesca; Frias, Zaide.
Affiliation
  • Verbaanderd C; PhaRA Consulting, Antwerp, Belgium.
  • Trullás Jimeno A; European Medicines Agency, Amsterdam, The Netherlands.
  • Engelbergs J; Paul Ehrlich Institute, Langen, Germany.
  • Zander H; Paul Ehrlich Institute, Langen, Germany.
  • Reischl I; Austrian Agency for Health and Food Safety, Wien, Austria.
  • Moreno Oliver A; Spanish Agency for Medicines and Health Care Products, Madrid, Spain.
  • Vamvakas S; European Medicines Agency, Amsterdam, The Netherlands.
  • Vleminckx C; European Medicines Agency, Amsterdam, The Netherlands.
  • Bouygues C; European Medicines Agency, Amsterdam, The Netherlands.
  • Girard T; European Medicines Agency, Amsterdam, The Netherlands.
  • Day F; European Medicines Agency, Amsterdam, The Netherlands.
  • Frias Z; European Medicines Agency, Amsterdam, The Netherlands.
Clin Pharmacol Ther ; 114(2): 316-324, 2023 08.
Article in En | MEDLINE | ID: mdl-37132507
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Full text: 1 Database: MEDLINE Main subject: Precision Medicine Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Language: En Year: 2023 Type: Article
Fulltext
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Full text: 1 Database: MEDLINE Main subject: Precision Medicine Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Language: En Year: 2023 Type: Article