title: Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013.
abstract: 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.
authors.affiliation: C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, Michigan dttlbm@med.umich.edu.
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Teitelbaum
authors.affiliation: American Society for Parenteral and Enteral Nutrition, Silver Spring, Maryland.
authors.forename: Peggi
authors.initials: P
authors.lastname: Guenter
authors.affiliation: Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Donna
authors.initials: D
authors.lastname: Griebel
authors.affiliation: Department of Pediatrics, Sections of Neonatology and USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Abrams
authors.affiliation: Department of Surgery, Karolinska Institute, Stockholm, Sweden, and Department of Surgery, Visby Hospital, Visby, Sweden.
authors.forename: Staffan
authors.initials: S
authors.lastname: Bark
authors.affiliation: Hospira, Inc, Chicago, Illinois.
authors.forename: Mary
authors.initials: M
authors.lastname: Baker
authors.affiliation: Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Karyn L
authors.initials: KL
authors.lastname: Berry
authors.affiliation: Harvard Medical School, Clinical Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Bistrian
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, New York.
authors.forename: J Thomas
authors.initials: JT
authors.lastname: Brenna
authors.affiliation: Scientific Affairs, Business Unit, Parenteral Nutrition & Colloids, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Denis
authors.initials: D
authors.lastname: Bonnot
authors.affiliation: Free University of Brussels (Université Libre de Bruxelles) and Lipid Nutrition Center, Brussels, Belgium.
authors.forename: Yvon A
authors.initials: YA
authors.lastname: Carpentier
authors.affiliation: Department of Pediatrics and Epidemiology, Institute of Human Nutrition, Columbia University Medical Center, New York, New York.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Deckelbaum
authors.affiliation: Baxter Healthcare, Deerfield, Illinois.
authors.forename: Mary
authors.initials: M
authors.lastname: Hise
authors.affiliation: Dr von Hauner Children's Hospital, University of Munich Medical Centre, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Koletzko
authors.affiliation: The Ohio State University, College of Pharmacy, Ohio State University, Columbus, Ohio.
authors.forename: Jay M
authors.initials: JM
authors.lastname: Mirtallo
authors.affiliation: Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Mulberg
authors.affiliation: University of Colorado, Boulder, Colorado.
authors.forename: Randall C
authors.initials: RC
authors.lastname: O'Reilly
authors.affiliation: Intestinal Failure Unit, Salford Royal Hospital, University of Manchester, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Shaffer
authors.affiliation: Hospital Care Division, B. Braun Melsungen AG, Melsungen, Germany.
authors.forename: Elke
authors.initials: E
authors.lastname: von Kleist
authors.affiliation: Baxter Healthcare, Deerfield, Illinois.
authors.forename: Gary P
authors.initials: GP
authors.lastname: Zaloga
authors.affiliation: Division of Endocrinology, Metabolism and Lipids and Emory Center for Clinical and Molecular Nutrition, Emory University Hospital, Atlanta, Georgia.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Ziegler
mesh_terms: D003226:Congresses as Topic; D004750:Enteral Nutrition / Q000379:methods*; D005217:Fat Emulsions, Intravenous / Q000627:therapeutic use*; D006801:Humans; D010288:Parenteral Nutrition / Q000379:methods*; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005217:Fat Emulsions, Intravenous
keywords: fatty acids; lipids; nutrition; research and diseases