[Individualized anticancer therapies: which regulatory guidelines?].
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.
Bedairia
Naima
N
Centre des innovations thérapeutiques en oncologie et hématologie, centre hospitalier universitaire Saint-Louis, 1, avenue Claude-Vellefaux, 75010 Paris.
Marty
Michel
M
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
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D005819:Genetic Markers