title: Neonatal animal testing paradigms and their suitability for testing infant formula.
abstract: Due to the ever increasing number of substances added to infant formula, and the fact that the majority of data determining the safety of these substances has been derived from adult animals, a search of the available data was performed to determine if an appropriate neonatal model could be found that could be used for performing toxicological safety studies. This exercise utilized three different forms of media. The first informational source is from a publication from the Institute of Medicine (IOM) of the National Academies. The second form of informational data utilized was from simple YAHOO and Google Scholar searches on the internet. The third source of information was from the U.S. Food and Drug Administration (FDA), more specifically, the Center for Drug Evaluation and Review (CDER) preclinical guidance document. Following the examination of the above informational sources, it became apparent that neonatal rats and pigs have been the most utilized of the neonatal models. Following the evaluation of the papers, the experimental paradigm which appears to be the most appropriate for testing substances new to infant formula, and could be used as a pivotal study was the neonatal pig utilizing the automated feeding device called the Autosow.
authors.affiliation: Division of Biotechnology and GRAS Notice Review, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition , U.S. Food and Drug Administration, College Park, MD 20740, USA. Edwin.Flamm@fda.hhs.gov
authors.forename: Edwin G
authors.initials: EG
authors.lastname: Flamm
mesh_terms: D000818:Animals; D000830:Animals, Laboratory; D000831:Animals, Newborn; D004285:Dogs; D005503:Food Additives / Q000633:toxicity*; D059022:Food Safety / Q000379:methods*; D000882:Haplorhini; D006801:Humans; D041943:Infant Formula / Q000737:chemistry* / Q000592:standards; D007227:Infant Nutritional Physiological Phenomena / Q000187:drug effects / Q000502:physiology; D007231:Infant, Newborn; D051379:Mice; D023421:Models, Animal; D051381:Rats; D018570:Risk Assessment; D013552:Swine; D018675:Toxicity Tests / Q000295:instrumentation / Q000379:methods*
chemical_list: D005503:Food Additives