EMA就药物开发中遗传标志物议题向社会征集意见

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http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/07/news_detail_001297.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true

12/07/2011

European Medicines Agency seeks views on genomic markers in medicine development

The European Medicines Agency has released a reflection paper on use of 'genomic markers' in the development and testing of human medicines for public consultation.

The reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection discusses the role that markers in the DNA can play in predicting which patients are likely to benefit from a medicines or experience side effects. The paper also covers their role in understanding how medicines work, selecting patients for inclusion in clinical trials and evaluating treatments.

The paper, prepared by the Committee for Medicinal Products for Human Use's (CHMP's) Pharmacogenomics Working Party, focuses on the experiences gained by the Agency through applications for marketing authorisations and scientific advice.

The paper is open for comments until 25 November 2011.