Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.
نویسندگان
چکیده
The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements. IVFEs have the ability to deliver critical nutritional substrates to the patient. Recent literature purports that they may also play roles in modulation of immune functionality and pulmonary physiology, but data supporting these potential benefits are limited. While soybean-based IVFEs have comprised the dominant fat in U.S. markets, a number of other novel IVFEs may prove to optimize the care of children and adults in both hospitalized and home settings. The October 2013 U.S. Food and Drug Administration (FDA)/American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Public Workshop brought together scientists, researchers, and clinical experts to present updated clinical perspectives of IVFEs, including historical development, current state of usage throughout the world, and considerations for the regulatory approval of new IVFEs in the United States.
منابع مشابه
A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing.
BACKGROUND Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices invo...
متن کاملEffects of Multiple Infusions of a Fat Emulsion on Blood Coagulation, Liver Function and Urinary Excretion of Steroids in Schizophrenic Patients.
Preface 1 JOHN F. MUELLER AND LT. COL. JOHN E. CANHAM Analysis of Intravenous Fat Emulsions and Components 4 ARTHUR ROSE, NICHOLAS PELICK, F. M. ANGELONI AND M. E. MILLER Characterized Oils for Use in Intravenous Fat Emulsions 16 W. S. SINGLETON Studies on a Transparent and Concentrated Fat Emulsion for Intravenous Use . . 23 E. B. MCQUARRIE AND H. P. ANDERSEN Toxicity Testing of Fat Emulsions....
متن کاملReport From the NEI/FDA Endpoints Workshop on Age-Related Macular Degeneration and Inherited Retinal Diseases.
The Association for Research in Vision (ARVO), together with the Foundation Fighting Blindness (FFB), organized the National Eye Institute (NEI)–Food and Drug Administration (FDA) endpoints workshop on age-related macular degeneration (AMD) and inherited retinal diseases (IRD) on November 9, 2016. The public workshop convened basic researchers, clinicians, and regulatory authorities in an inter...
متن کاملTreatment of quetiapine overdose with intravenous lipid emulsion.
We report the case of a 29-year-old woman who attempted suicide by oral ingestion of potentially fatal doses of multiple drugs including quetiapine. Intravenous lipid emulsion (ILE) was administered at a dose higher than that used in the standard management of toxicity. Rapid improvement was observed in the patient's status, and no additional treatment was required during the period of observat...
متن کاملComparison of temperature responses to intravenous infusions of dextrose and fat emulsions.
A FEBRILE response to intravenous fat emulsion is the most frequent untoward side effect following short-term infusions. Though this side effect is probably not now common or severe enough to limit the clinical usefulness of intravenous fat emulsion, an understanding of its mechanism is important. One hypothesis offered is that the fever is a result of rapid metabolism of the infused fat with t...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- JPEN. Journal of parenteral and enteral nutrition
دوره 39 7 شماره
صفحات -
تاریخ انتشار 2015