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Bulletin du Cancer

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Individualized anticancer therapies: which regulatory guidelines? Volume 95, issue 10, octobre 2008

Authors
Centre des innovations thérapeutiques en oncologie et hématologie, centre hospitalier universitaire Saint-Louis, 1, avenue Claude-Vellefaux, 75010 Paris

In this review, we will summarize the guidelines on the evaluation of anticancer medicinal products in man and definitions for genomic biomarkers (FDA validated), pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.