Toxicology Mechanisms and Methods
Neonatal animal testing paradigms and theirsuitability for testing infant formula
Edwin G. Flammdoi: 10.3109/15376516.2012.725108
Due to the ever increasing number of substances added to infant formula, and thefact that the majority of data determining the safety of these substances has beenderived from adult animals, a search of the available data was performed todetermine if an appropriate neonatal model could be found that could be used forperforming toxicological safety studies. This exercise utilized three different forms ofmedia. The first informational source is from a publication from the Institute ofMedicine (IOM) of the National Academies. The second form of informational datautilized was from simple YAHOO and Google Scholar searches on the internet. Thethird source of information was from the U.S. Food and Drug Administration (FDA),more specifically, the Center for Drug Evaluation and Review (CDER) preclinicalguidance document. Following the examination of the above informational sources, it became apparent that neonatal rats and pigshave been the most utilized of the neonatal models. Following the evaluation of the papers the experimental paradigm whichappears to be the most appropriate for testing substances new to infant formula, and could be used as a pivotal study was theneonatal pig utilizing the automated feeding device called the Autosow. © 2012 Informa Healthcare USA, Inc. This provisional PDF corresponds to the article as it appeared upon acceptance. Fullyformatted PDF and full text (HTML) versions will be made available soon.
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