Document Detail

Neonatal animal testing paradigms and their suitability for testing infant formula.
MedLine Citation:
PMID:  22924893     Owner:  NLM     Status:  Publisher    
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.
Edwin G Flamm
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-8-28
Journal Detail:
Title:  Toxicology mechanisms and methods     Volume:  -     ISSN:  1537-6524     ISO Abbreviation:  Toxicol. Mech. Methods     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-8-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101134521     Medline TA:  Toxicol Mech Methods     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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.
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