title: Medical applications of microarray technologies: a regulatory science perspective.
abstract: The potential medical applications of microarrays have generated much excitement, and some skepticism, within the biomedical community. Some researchers have suggested that within the decade microarrays will be routinely used in the selection, assessment, and quality control of the best drugs for pharmaceutical development, as well as for disease diagnosis and for monitoring desired and adverse outcomes of therapeutic interventions. Realizing this potential will be a challenge for the whole scientific community, as breakthroughs that show great promise at the bench often fail to meet the requirements of clinicians and regulatory scientists. The development of a cooperative framework among regulators, product sponsors, and technology experts will be essential for realizing the revolutionary promise that microarrays hold for drug development, regulatory science, medical practice and public health.
authors.affiliation: Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA. petricoin@cber.fda.gov
authors.forename: Emanuel F
authors.initials: EF
authors.lastname: Petricoin
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Hackett
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Lesko
authors.forename: Raj K
authors.initials: RK
authors.lastname: Puri
authors.forename: Steven I
authors.initials: SI
authors.lastname: Gutman
authors.forename: Konstantin
authors.initials: K
authors.lastname: Chumakov
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.forename: David W
authors.initials: DW
authors.lastname: Feigal
authors.forename: Kathryn C
authors.initials: KC
authors.lastname: Zoon
authors.forename: Frank D
authors.initials: FD
authors.lastname: Sistare
mesh_terms: D005544:Forecasting; D005826:Genetics, Medical / Q000639:trends; D023281:Genomics / Q000639:trends; D006801:Humans; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods / Q000639:trends*; D011050:Policy Making; D040901:Proteomics / Q000639:trends; D012106:Research / Q000639:trends; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration