title: [Individualized anticancer therapies: which regulatory guidelines?].
abstract: 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.
authors.affiliation: Centre des innovations thérapeutiques en oncologie et hématologie, centre hospitalier universitaire Saint-Louis, 1, avenue Claude-Vellefaux, 75010 Paris.
authors.forename: Naima
authors.initials: N
authors.lastname: Bedairia
authors.forename: Michel
authors.initials: M
authors.lastname: Marty
mesh_terms: D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000378:metabolism; D002986:Clinical Trials as Topic; D005819:Genetic Markers; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D017410:Practice Guidelines as Topic
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D005819:Genetic Markers