title: Skin biopsies for the measurement of clinical pharmacodynamic biomarkers.
abstract: The integration of biomarkers reporting on drug pharmacodynamics or on a disease state is becoming necessary in the cost-effective design of clinical trials. Transcriptional changes in skin measured using whole-genome arrays have been useful in assessing the disease state in dermatology. Not only are skin biopsies well-tolerated and easy to obtain, but they sample a system in which many complex signaling and developmental networks are active and in which a wide variety of drug targets may be expected to play a role, either directly or indirectly. Recent advances have led to the use of transcriptional profiling of skin for making pharmacodynamic measurements in clinical trials, even for non-dermatological conditions.
authors.affiliation: Department of Molecular Profiling, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Phillips
authors.forename: Alan B
authors.initials: AB
authors.lastname: Sachs
mesh_terms: D000818:Animals; D001706:Biopsy / Q000379:methods / Q000639:trends; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D015195:Drug Design; D020869:Gene Expression Profiling / Q000379:methods / Q000639:trends; D005786:Gene Expression Regulation / Q000187:drug effects*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism*; D010599:Pharmacokinetics; D012867:Skin / Q000378:metabolism* / Q000473:pathology
chemical_list: D004364:Pharmaceutical Preparations