(Q38105254)

28 August 2017

title

Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan (English)

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28 August 2017

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Akihiro Ishiguro

1

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28 August 2017

Satomi Yagi

series ordinal

2

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28 August 2017

Yoshiaki Uyama

series ordinal

3

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28 August 2017

publication date

9 May 2013

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Journal of Human Genetics

28 August 2017

published in

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28 August 2017

volume

58

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28 August 2017

issue

6

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28 August 2017

page(s)

313-316

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https://scigraph.springernature.com/pub.10.1038/jhg.2013.36

28 August 2017

exact match

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cites work

Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

The cancer biomarker problem

21 January 2018

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https://api.crossref.org/works/10.1038%2FJHG.2013.36

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Leveling the playing field: bringing development of biomarkers and molecular diagnostics up to the standards for drug development

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Phase III and submission failures: 2007–2010

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Trial watch: Phase II failures: 2008-2010.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Can the pharmaceutical industry reduce attrition rates?

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Methodological quality of pharmacogenetic studies: issues of concern

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Why, when, and how should pharmacogenetics be applied in clinical studies?: current and future approaches to study designs

21 January 2018

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https://api.crossref.org/works/10.1038%2FJHG.2013.36

Clinical trials for predictive medicine

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Personalized medicine using DNA biomarkers: a review

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Erlotinib in previously treated non-small-cell lung cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

21 January 2018

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https://api.crossref.org/works/10.1038%2FJHG.2013.36

Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Rare cancer trial design: lessons from FDA approvals

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects.

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FJHG.2013.36

21 January 2018

Identifiers

DOI

10.1038/JHG.2013.36

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Dimensions Publication ID

28 August 2017

1009121531

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