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Just Accepted

Toxicology Mechanisms and Methods

Neonatal animal testing paradigms and theirsuitability for testing infant formula

Edwin G. Flammdoi: 10.3109/15376516.2012.725108

Abstract

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.

DISCLAIMER: The ideas and opinions expressed in the journal’s

Just Accepted

articles do not necessarily reflect those of Informa Healthcare (the Publisher), the Edi-tors or the journal. The Publisher does not assume any responsibility for any injury and/or damage to persons or property arising from or related to any use of the ma-terial contained in these articles. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer ofeach drug to be administered to verify the dosages, the method and duration of administration, and contraindications. It is the responsibility of the treating physician orother health care professional, relying on his or her independent experience and knowledge of the patient, to determine drug dosages and the best treatment for thepatient.

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have undergone full scientific review but none of the additional editorial preparation, such as copyediting, typesetting, and proofreading, as havearticles published in the traditional manner. There may, therefore, be errors in

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articles that will be corrected in the final print and final online version of thearticle. Any use of the

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articles is subject to the express understanding that the papers have not yet gone through the full quality control process prior topublication.

T o x i c o l o g y M e c h a n i s m s a n d M e t h o d s D o w n l o a d e d f r o m i n f o r m a h e a l t h c a r e . c o m b y 8 5 . 2 1 0 . 3 9 . 4 9 o n 0 9 / 0 9 / 1 2 F o r p e r s o n a l u s e o n l y .

J U S T A C C E P T E D

ReviewNEONATAL ANIMAL TESTING PARADIGMS AND THEIRSUITABILITY FOR TESTING INFANT FORMULA

Edwin G. Flamm*Division of Biotechnology and GRAS Notice Review, Office of Food Additive SafetyCenter for Food Safety and Applied Nutrition, U.S. Food and Drug Administration

Running title:

Neonatal Animal Testing Paradigms

Keywords:

Autosow, Colostrum, gavage, “pup-in-a-cup”

*The

opinions expressed in this article are the authors’

personal opinions and do notnecessarily reflect those of FDA, DHHS, or the Federal Government.

Corresponding author

Edwin G. FlammDivision of Biotechnology and GRAS Notice Review, Office of Food Additive SafetyCenter for Food Safety and Applied Nutrition, U.S. Food and Drug Administration5100 Paint Branch Parkway, College Park, MD 20740, U.S.A.Email: Edwin.Flamm@fda.hhs.govTel: 240-402-1285

J U S T A C C E P T E D

Neonatal Animal Testing Paradigms

Abstract:

Due to the ever increasing number of substances added to infant formula, and the factthat the majority of data determining the safety of these substances has been derived from adultanimals, a search of the available data was performed to determine if an appropriate neonatalmodel could be found that could be used for performing toxicological safety studies. Thisexercise utilized three different forms of media. The first informational source is from apublication from the Institute of Medicine (IOM) of the National Academies. Thesecond form of informational data utilized was from simple YAHOO and Google Scholarsearches on the internet. The third source of information was from the U.S. Food and DrugAdministration (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 neonatalmodels. Following the evaluation of the papers the experimental paradigm whichappears to be the most appropriate for testing substances new to infant formula, and could beused as a pivotal study was the neonatal pig utilizing the automated feeding device called theAutosow.