Literature DB >> 31976775

Implementing the EU in vitro diagnostic regulation - a European regulatory perspective on companion diagnostics.

Armin Ritzhaupt1, Ivana Hayes1, Falk Ehmann2.   

Abstract

Keywords:  EMA; In vitro diagnostic regulation; biomarker; companion diagnostics; medicine authorities

Year:  2020        PMID： 31976775     DOI： 10.1080/14737159.2020.1720653

Source DB:  PubMed          Journal:  Expert Rev Mol Diagn        ISSN： 1473-7159            Impact factor:   5.225


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  3 in total

Review 1.  PD-L1 as a biomarker of response to immune-checkpoint inhibitors.

Authors:  Deborah Blythe Doroshow; Sheena Bhalla; Mary Beth Beasley; Lynette M Sholl; Keith M Kerr; Sacha Gnjatic; Ignacio I Wistuba; David L Rimm; Ming Sound Tsao; Fred R Hirsch
Journal:  Nat Rev Clin Oncol       Date:  2021-02-12       Impact factor: 66.675

Review 2.  Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape.

Authors:  Mariya Gromova; Annegret Vaggelas; Gabriele Dallmann; Diane Seimetz
Journal:  Biomark Insights       Date:  2020-12-08

3.  Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe.

Authors:  Denis Horgan; Giuseppe Curigliano; Olaf Rieß; Paul Hofman; Reinhard Büttner; Pierfranco Conte; Tanja Cufer; William M Gallagher; Nadia Georges; Keith Kerr; Frédérique Penault-Llorca; Ken Mastris; Carla Pinto; Jan Van Meerbeeck; Elisabetta Munzone; Marlene Thomas; Sonia Ujupan; Gilad W Vainer; Janna-Lisa Velthaus; Fabrice André
Journal:  J Pers Med       Date:  2022-01-08
  3 in total

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