Target-Controlled Infusions: Paths to Approval

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.

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Bibliographic Details
Published inAnesthesia and analgesia Vol. 122; no. 1; pp. 86 - 89
Main Author Dryden, Paul E
Format Journal Article
LanguageEnglish
Published United States International Anesthesia Research Society 01.01.2016
Subjects
Anesthetics, Intravenous - administration & dosage
Anesthetics, Intravenous - adverse effects
Anesthetics, Intravenous - blood
Anesthetics, Intravenous - pharmacokinetics
Consciousness - drug effects
Device Approval
Diffusion of Innovation
Drug Delivery Systems - instrumentation
Drug Dosage Calculations
Drug Monitoring
Equipment Design
Humans
Hypnotics and Sedatives - administration & dosage
Hypnotics and Sedatives - adverse effects
Hypnotics and Sedatives - blood
Hypnotics and Sedatives - pharmacokinetics
Infusions, Intravenous
Models, Biological
Monitoring, Intraoperative
Patient Safety
Risk Assessment
Risk Factors
Software
United States
United States Food and Drug Administration
United States
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More Information
Summary: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.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
ISSN:0003-2999
1526-7598
DOI:10.1213/ANE.0000000000001018