FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies

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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2015, Vol. 20 ›› Issue (2): 208-212.

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FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies

ZHAO De-heng, XIAO Hui-lai

Center for Drug Evaluation, China Food and Drug Administration,Beijing 100038,China

Received:2013-07-02 Revised:2014-03-14 Online:2015-02-26 Published:2015-03-20

Abstract

Abstract: Pharmacogenomics is currently a hot topic. FDA issued “Guidance for Industry Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling” in 2013. The article introduces its IV Clinical Evaluation of Pharmacogenomics. There is no similar guidance in our country. It is expected to benefit the research and supervision of our country in this respect.

Key words: FDA, guidance, pharmacogenomics, early-phase clinical studies, study design

CLC Number:

R969

ZHAO De-heng, XIAO Hui-lai. FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2015, 20(2): 208-212.

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FDA's recommentdations on pharmacogenomics studies in early-phase clinical studies

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