title: Target-Controlled Infusions: Paths to Approval.
abstract: Target-controlled infusion of IV anesthetic drugs is approved worldwide with the exception of the United States. The purpose of this special article is to review regulatory pathways that could lead to target-controlled infusion (TCI) clearance or approval in the United States.
authors.affiliation: From ProMedic, Inc., Bonita Springs, Florida.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Dryden
mesh_terms: D018686:Anesthetics, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D003243:Consciousness / Q000187:drug effects*; D018795:Device Approval; D004059:Diffusion of Innovation; D016503:Drug Delivery Systems / Q000295:instrumentation; D054796:Drug Dosage Calculations; D016903:Drug Monitoring; D004867:Equipment Design; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D007262:Infusions, Intravenous; D008954:Models, Biological; D016343:Monitoring, Intraoperative; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives