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

被引：4

作者：

Otsubo, Yasuto ^{[1
]}

Ishiguro, Akihiro ^{[2
]}

Uyama, Yoshiaki ^{[3
,4
]}

机构：

[1] PMDA, Off New Drug 2, Tokyo 1000013, Japan

[2] PMDA, Off New Drug 5, Tokyo 1000013, Japan

[3] PMDA, Off Review Management, Tokyo 1000013, Japan

[4] Chiba Univ, Dept Regulatory Sci Med, Grad Sch Med, Chiba 2608670, Japan

来源：

PHARMACOGENOMICS | 2013年 / 14卷 / 02期

关键词：

biomarker; drug development; international harmonization; personalized medicine; pharmacogenomics; regulatory science; CELL LUNG-CANCER; CLINICAL-TRIALS; BIOMARKER INFORMATION; PREDICTIVE BIOMARKERS; GEFITINIB; JAPANESE; PHARMACOKINETICS/PHARMACODYNAMICS; HLA-A-ASTERISK-3101; POLYMORPHISMS; MUTATIONS;

D O I：

10.2217/PGS.12.194

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

引用

页码：195 / 203

页数：9

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