Skin biopsies for the measurement of clinical pharmacodynamic biomarkers.
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.
Phillips
Robert L
RL
Department of Molecular Profiling, Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
Sachs
Alan B
AB
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
D004364:Pharmaceutical Preparations