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Items: 1 to 20 of 146

1.

Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan.

Shimazawa R, Ikeda M.

J Clin Pharm Ther. 2014 Apr;39(2):210-4. doi: 10.1111/jcpt.12129.

2.
3.

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 15;20(6):1445-52. doi: 10.1158/1078-0432.CCR-13-1761.

4.

Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan.

Shimazawa R, Ikeda M.

J Clin Pharm Ther. 2013 Dec;38(6):468-75. doi: 10.1111/jcpt.12089.

PMID:
23895776
5.

International differences in companion diagnostic approvals: how are we able to manage the differences?

Shimazawa R, Ikeda M.

Expert Rev Mol Diagn. 2015 Feb;15(2):157-9. doi: 10.1586/14737159.2015.969243.

PMID:
25308218
6.

Regulatory issues on breath tests and updates of recent advances on [13C]-breath tests.

Modak AS.

J Breath Res. 2013 Sep;7(3):037103. doi: 10.1088/1752-7155/7/3/037103. Review.

PMID:
23774086
7.

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.

Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E.

Ther Deliv. 2010 Nov;1(5):631-41.

PMID:
22833953
8.

A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics.

Luo D, Smith JA, Meadows NA, Schuh A, Manescu KE, Bure K, Davies B, Horne R, Kope M, DiGiusto DL, Brindley DA.

Front Genet. 2016 Jan 28;6:357. doi: 10.3389/fgene.2015.00357. Erratum in: Front Genet. 2016;7:104.

9.

Clinical and economic challenges facing pharmacogenomics.

Cohen J, Wilson A, Manzolillo K.

Pharmacogenomics J. 2013 Aug;13(4):378-88. doi: 10.1038/tpj.2011.63.

PMID:
22231566
10.

[Discussing the usefulness of companion diagnostics - introductory remarks by chairpersons].

Nobori T, Nomura F.

Rinsho Byori. 2014 Dec;62(12):1263-4. Review. Japanese.

PMID:
25823244
11.

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. doi: 10.1586/14737159.2015.1045490. Review.

PMID:
26109316
12.

Companion diagnostics for targeted cancer drugs - clinical and regulatory aspects.

Olsen D, Jørgensen JT.

Front Oncol. 2014 May 16;4:105. doi: 10.3389/fonc.2014.00105. Review.

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14.

ENVIRONMENTAL SCAN ON PHARMACEUTICALS REQUIRING COMPANION DIAGNOSTICS.

Cowling T, Boucher M.

Int J Technol Assess Health Care. 2016 Jan;32(5):327-336. doi: 10.1017/S0266462316000532.

PMID:
27955717
16.

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

Frueh FW, Amur S, Mummaneni P, Epstein RS, Aubert RE, DeLuca TM, Verbrugge RR, Burckart GJ, Lesko LJ.

Pharmacotherapy. 2008 Aug;28(8):992-8. doi: 10.1592/phco.28.8.992.

PMID:
18657016
17.

Pharmacogenomic biomarkers in drug labels: what do they tell us?

Tutton R.

Pharmacogenomics. 2014 Feb;15(3):297-304. doi: 10.2217/pgs.13.198.

PMID:
24533709
18.

Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.

Shimazawa R, Ikeda M.

Clin Ther. 2012 Oct;34(10):2104-16. doi: 10.1016/j.clinthera.2012.09.004.

PMID:
23036337
19.

(13)C breath tests in personalized medicine: fiction or reality?

Modak AS.

Expert Rev Mol Diagn. 2009 Nov;9(8):805-15. doi: 10.1586/erm.09.58. Review.

PMID:
19895226
20.

Regulatory approval pathways for molecular diagnostic technology.

Liotta LA, Petricoin EF 3rd.

Methods Mol Biol. 2012;823:409-20. doi: 10.1007/978-1-60327-216-2_27.

PMID:
22081361
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