EMA Seeks Views on Genomic Markers in Medicine Development
The EMA releases a reflection paper on use of 'genomic markers' in the development and testing of human medicines for public consultation.
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 paper is open for comments until 25 November 2011.
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.
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