title: Issues involved in the process of developing a medical food.
abstract: The creation of a medical food with potential health benefits for a particular patient population is a surprisingly complex process. Fortunately, the developmental process for a specific medical food is not as rigorous or as tightly regulated as that of a pharmaceutical agent. However, numerous factors unique to the enteral formulation of a new product come into play, such as physical/chemical compatibility, pH, stability, bioavailability, decay, and even palatability. Additional considerations such as strength of health benefit claims, packaging or presentation, and marketability determine the ultimate commercialization and whether a product ends up being released to the public. A full understanding of the development, substantiation, and commercialization of a medical food is necessary for important physiologic concepts in nutrition therapy to end up as part of the therapeutic regimen at the bedside of the critically ill obese patient.
authors: Department of Surgery, University of Pittsburg, Pittsburg, Pennsylvania, USA. Juan.Ochoa@US.nestle.com
authors: Juan B
authors: JB
authors: Ochoa
authors: Stephen A
authors: SA
authors: McClave
authors: Jose
authors: J
authors: Saavedra
mesh_terms: D001682:Biological Availability; D003132:Commerce; D003257:Consumer Product Safety; D004345:Drug Industry; D004348:Drug Labeling; D004750:Enteral Nutrition / Q000379:methods; D005502:Food / Q000592:standards*; D006801:Humans; D009765:Obesity / Q000178:diet therapy*; D004364:Pharmaceutical Preparations / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations