title: When do you need a validated assay?
authors.affiliation: Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Center for Drug Research & Evaluation Research, U.S. Food and Drug Administration, Silver Spring, MD 20993-002, USA. brian.booth@fda.hhs.gov
authors.forename: Brian
authors.initials: B
authors.lastname: Booth
mesh_terms: D015415:Biomarkers / Q000032:analysis; D002166:Camptothecin / Q000031:analogs & derivatives / Q000032:analysis / Q000378:metabolism; D033161:Government Regulation; D006801:Humans; D000077146:Irinotecan; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers; D000077146:Irinotecan; D002166:Camptothecin