Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013

Daniel H Teitelbaum; Peggi Guenter; Donna Griebel; Steven A Abrams; Staffan Bark; Mary Baker; Karyn L Berry; Bruce R Bistrian; J Thomas Brenna; Denis Bonnot; Yvon A Carpentier; Richard J Deckelbaum; Mary Hise; Berthold Koletzko; Jay M Mirtallo; Andrew E Mulberg; Randall C O'Reilly; Jonathan Shaffer; Elke von Kleist; Gary P Zaloga; Thomas R Ziegler

doi:10.1177/0148607114560825

Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013

Daniel H Teitelbaum, Peggi Guenter, Donna Griebel, Steven A Abrams, Staffan Bark, Mary Baker, Karyn L Berry, Bruce R Bistrian, J Thomas Brenna, Denis Bonnot, Yvon A Carpentier, Richard J Deckelbaum, Mary Hise, Berthold Koletzko, Jay M Mirtallo, Andrew E Mulberg, Randall C O'Reilly, Jonathan Shaffer, Elke von Kleist, Gary P ZalogaThomas R Ziegler

Medical Education (L5)

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	768-86
Number of pages	19
Journal	Journal of parenteral and enteral nutrition
Volume	39
Issue number	7
DOIs	https://doi.org/10.1177/0148607114560825
Publication status	Published - Sept 2015

Keywords

Congresses as Topic
Enteral Nutrition
Fat Emulsions, Intravenous
Humans
Parenteral Nutrition
Societies, Medical
United States
United States Food and Drug Administration
Journal Article

Access to Document

10.1177/0148607114560825

Cite this

Teitelbaum, D. H., Guenter, P., Griebel, D., Abrams, S. A., Bark, S., Baker, M., Berry, K. L., Bistrian, B. R., Brenna, J. T., Bonnot, D., Carpentier, Y. A., Deckelbaum, R. J., Hise, M., Koletzko, B., Mirtallo, J. M., Mulberg, A. E., O'Reilly, R. C., Shaffer, J., von Kleist, E., ... Ziegler, T. R. (2015). Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013. Journal of parenteral and enteral nutrition, 39(7), 768-86. https://doi.org/10.1177/0148607114560825

@article{18bd46f167ea4143b61f72a0e4d11e1d,

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.",

keywords = "Congresses as Topic, Enteral Nutrition, Fat Emulsions, Intravenous, Humans, Parenteral Nutrition, Societies, Medical, United States, United States Food and Drug Administration, Journal Article",

author = "Teitelbaum, {Daniel H} and Peggi Guenter and Donna Griebel and Abrams, {Steven A} and Staffan Bark and Mary Baker and Berry, {Karyn L} and Bistrian, {Bruce R} and Brenna, {J Thomas} and Denis Bonnot and Carpentier, {Yvon A} and Deckelbaum, {Richard J} and Mary Hise and Berthold Koletzko and Mirtallo, {Jay M} and Mulberg, {Andrew E} and O'Reilly, {Randall C} and Jonathan Shaffer and {von Kleist}, Elke and Zaloga, {Gary P} and Ziegler, {Thomas R}",

note = "{\textcopyright} 2014 American Society for Parenteral and Enteral Nutrition.",

year = "2015",

month = sep,

doi = "10.1177/0148607114560825",

language = "English",

volume = "39",

pages = "768--86",

journal = "Journal of parenteral and enteral nutrition",

issn = "0148-6071",

publisher = "John Wiley & Sons Ltd",

number = "7",

}

Teitelbaum, DH, Guenter, P, Griebel, D, Abrams, SA, Bark, S, Baker, M, Berry, KL, Bistrian, BR, Brenna, JT, Bonnot, D, Carpentier, YA, Deckelbaum, RJ, Hise, M, Koletzko, B, Mirtallo, JM, Mulberg, AE, O'Reilly, RC, Shaffer, J, von Kleist, E, Zaloga, GP & Ziegler, TR 2015, 'Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013', Journal of parenteral and enteral nutrition, vol. 39, no. 7, pp. 768-86. https://doi.org/10.1177/0148607114560825

TY - JOUR

T1 - Proceedings From FDA/A.S.P.E.N. Public Workshop

T2 - Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013

AU - Teitelbaum, Daniel H

AU - Guenter, Peggi

AU - Griebel, Donna

AU - Abrams, Steven A

AU - Bark, Staffan

AU - Baker, Mary

AU - Berry, Karyn L

AU - Bistrian, Bruce R

AU - Brenna, J Thomas

AU - Bonnot, Denis

AU - Carpentier, Yvon A

AU - Deckelbaum, Richard J

AU - Hise, Mary

AU - Koletzko, Berthold

AU - Mirtallo, Jay M

AU - Mulberg, Andrew E

AU - O'Reilly, Randall C

AU - Shaffer, Jonathan

AU - von Kleist, Elke

AU - Zaloga, Gary P

AU - Ziegler, Thomas R

PY - 2015/9

Y1 - 2015/9

N2 - 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.

AB - 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.

KW - Congresses as Topic

KW - Enteral Nutrition

KW - Fat Emulsions, Intravenous

KW - Humans

KW - Parenteral Nutrition

KW - Societies, Medical

KW - United States

KW - United States Food and Drug Administration

KW - Journal Article

U2 - 10.1177/0148607114560825

DO - 10.1177/0148607114560825

M3 - Article

C2 - 25475623

SN - 0148-6071

VL - 39

SP - 768

EP - 786

JO - Journal of parenteral and enteral nutrition

JF - Journal of parenteral and enteral nutrition

IS - 7

ER -

Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013

Abstract

Keywords

Access to Document

Fingerprint

Cite this