Clinical trial design for intravenous fat emulsion products

0

“The development of intravenous fat emulsion (IVFE) is the culmination of physiological, biochemical, nutritional, and medical scientific advancements” Teitelbaum et al (2014).

Reference:

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., Zaloga, G.P. and Ziegler, T.R. (2014) Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013. Journal of Parenteral & Enteral Nutrition. December 4th. [epub ahead of print].

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.

Thank you to our partners for supporting IVTEAM

Share.

Comments are closed.

Free Email Updates
Join 5.5K IVTEAM members. Subscribe now and be the first to receive all the latest free updates from IVTEAM!
100% Privacy. We don't spam.