Issues in clinical trial design from the FDA perspective.
Katz
Russell
R
Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, Office of Drug Evaluation I, Food and Drug Administration, Rockville, Maryland 20852, USA. katzr@cder.fda.gov
D015415:Biomarkers; D002986:Clinical Trials as Topic; D006801:Humans; D012107:Research Design; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers