328 related articles for article (PubMed ID: 24634469)
1. Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.
Pignatti F; Ehmann F; Hemmings R; Jonsson B; Nuebling M; Papaluca-Amati M; Posch M; Rasi G
Clin Cancer Res; 2014 Mar; 20(6):1458-68. PubMed ID: 24634469
[TBL] [Abstract][Full Text] [Related]
2. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
Senderowicz AM; Pfaff O
Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
[TBL] [Abstract][Full Text] [Related]
3. FDA perspective on companion diagnostics: an evolving paradigm.
Mansfield EA
Clin Cancer Res; 2014 Mar; 20(6):1453-7. PubMed ID: 24634468
[TBL] [Abstract][Full Text] [Related]
4. Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.
Tazawa Y
Breast Cancer; 2016 Jan; 23(1):19-23. PubMed ID: 25605056
[TBL] [Abstract][Full Text] [Related]
5. The Health Technology Assessment of companion diagnostics: experience of NICE.
Byron SK; Crabb N; George E; Marlow M; Newland A
Clin Cancer Res; 2014 Mar; 20(6):1469-76. PubMed ID: 24634470
[TBL] [Abstract][Full Text] [Related]
6. Biomarker-Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union.
Verbaanderd C; Trullás Jimeno A; Engelbergs J; Zander H; Reischl I; Moreno Oliver A; Vamvakas S; Vleminckx C; Bouygues C; Girard T; Day F; Frias Z
Clin Pharmacol Ther; 2023 Aug; 114(2):316-324. PubMed ID: 37132507
[TBL] [Abstract][Full Text] [Related]
7. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.
Roscoe DM; Hu YF; Philip R
Expert Rev Mol Diagn; 2015; 15(7):869-80. PubMed ID: 26109316
[TBL] [Abstract][Full Text] [Related]
8. US FDA perspective on challenges in co-developing in vitro companion diagnostics and targeted cancer therapeutics.
Philip R; Carrington L; Chan M
Bioanalysis; 2011 Feb; 3(4):383-9. PubMed ID: 21338257
[TBL] [Abstract][Full Text] [Related]
9. The new EU regulation on in vitro diagnostics: potential issues at the interface of medicines and companion diagnostics.
Enzmann H; Meyer R; Broich K
Biomark Med; 2016 Dec; 10(12):1261-1268. PubMed ID: 27661101
[TBL] [Abstract][Full Text] [Related]
10. The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulation.
Pignatti F; Gravanis I; Herold R; Vamvakas S; Jonsson B; Marty M
Clin Cancer Res; 2011 Aug; 17(16):5220-5. PubMed ID: 21844037
[TBL] [Abstract][Full Text] [Related]
11. Risk management frameworks for human health and environmental risks.
Jardine C; Hrudey S; Shortreed J; Craig L; Krewski D; Furgal C; McColl S
J Toxicol Environ Health B Crit Rev; 2003; 6(6):569-720. PubMed ID: 14698953
[TBL] [Abstract][Full Text] [Related]
12. Companion diagnostics: the key to personalized medicine. Foreword.
Jørgensen JT
Expert Rev Mol Diagn; 2015 Feb; 15(2):153-6. PubMed ID: 25597758
[TBL] [Abstract][Full Text] [Related]
13. Regulatory considerations for companion diagnostic devices.
Lee EY; Shen HC
Biomark Med; 2015; 9(1):67-75. PubMed ID: 25605456
[TBL] [Abstract][Full Text] [Related]
14. [A proposal for reforming psychologists' training in France and in the European Union].
Bouchard JP
Encephale; 2009 Feb; 35(1):18-24. PubMed ID: 19250989
[TBL] [Abstract][Full Text] [Related]
15. Procedures and methods of benefit assessments for medicines in Germany.
Bekkering GE; Kleijnen J
Eur J Health Econ; 2008 Nov; 9 Suppl 1():5-29. PubMed ID: 18987905
[TBL] [Abstract][Full Text] [Related]
16. Update on molecular companion diagnostics - a future in personalized medicine beyond Sanger sequencing.
Campbell MR
Expert Rev Mol Diagn; 2020 Jun; 20(6):637-644. PubMed ID: 32167388
[TBL] [Abstract][Full Text] [Related]
17. Influence of companion diagnostics on efficacy and safety of targeted anti-cancer drugs: systematic review and meta-analyses.
Ocana A; Ethier JL; Díez-González L; Corrales-Sánchez V; Srikanthan A; Gascón-Escribano MJ; Templeton AJ; Vera-Badillo F; Seruga B; Niraula S; Pandiella A; Amir E
Oncotarget; 2015 Nov; 6(37):39538-49. PubMed ID: 26446908
[TBL] [Abstract][Full Text] [Related]
18. [Procedures and methods of benefit assessments for medicines in Germany].
Bekkering GE; Kleijnen J
Dtsch Med Wochenschr; 2008 Dec; 133 Suppl 7():S225-46. PubMed ID: 19034813
[TBL] [Abstract][Full Text] [Related]
19. ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European
Vanstapel FJLA; Orth M; Streichert T; Capoluongo ED; Oosterhuis WP; Çubukçu HC; Bernabeu-Andreu FA; Thelen M; Jacobs LHJ; Linko S; Bhattoa HP; Bossuyt PMM; Meško Brguljan P; Boursier G; Cobbaert CM; Neumaier M
Clin Chem Lab Med; 2023 Mar; 61(4):608-626. PubMed ID: 36716120
[TBL] [Abstract][Full Text] [Related]
20. Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.
Fridlyand J; Simon RM; Walrath JC; Roach N; Buller R; Schenkein DP; Flaherty KT; Allen JD; Sigal EV; Scher HI
Nat Rev Drug Discov; 2013 Oct; 12(10):743-55. PubMed ID: 24008432
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]