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Safe composition levels of transgenic crops assessed via a clinical medicine model

Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop,...

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Autores principales: Herman, Rod A, Scherer, Peter N, Phillips, Amy M, Storer, Nicholas P, Krieger, Mark
Formato: Texto
Lenguaje:English
Publicado: WILEY-VCH Verlag 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2978321/
https://www.ncbi.nlm.nih.gov/pubmed/20084639
http://dx.doi.org/10.1002/biot.200900217
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author Herman, Rod A
Scherer, Peter N
Phillips, Amy M
Storer, Nicholas P
Krieger, Mark
author_facet Herman, Rod A
Scherer, Peter N
Phillips, Amy M
Storer, Nicholas P
Krieger, Mark
author_sort Herman, Rod A
collection PubMed
description Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop, no single variety is considered the standard for safety or nutrition, so the substantial equivalence of transgenic crops is investigated relative to the array of commercial crop varieties with a history of safe consumption. Although used extensively in clinical medicine to compare new generic drugs with brand-name drugs, equivalence limits are shown to be a poor model for comparing transgenic crops with an array of reference crop varieties. We suggest an alternate model, also analogous to that used in clinical medicine, where reference intervals are constructed for a healthy heterogeneous population. Specifically, we advocate the use of distribution-free tolerance intervals calculated across a large amount of publicly available compositional data such as is found in the International Life Sciences Institute Crop Composition Database.
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spelling pubmed-29783212010-11-18 Safe composition levels of transgenic crops assessed via a clinical medicine model Herman, Rod A Scherer, Peter N Phillips, Amy M Storer, Nicholas P Krieger, Mark Biotechnol J Research Article Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. Substantial equivalence has become established as a foundation concept in the safety evaluation of transgenic crops. In the case of a food and feed crop, no single variety is considered the standard for safety or nutrition, so the substantial equivalence of transgenic crops is investigated relative to the array of commercial crop varieties with a history of safe consumption. Although used extensively in clinical medicine to compare new generic drugs with brand-name drugs, equivalence limits are shown to be a poor model for comparing transgenic crops with an array of reference crop varieties. We suggest an alternate model, also analogous to that used in clinical medicine, where reference intervals are constructed for a healthy heterogeneous population. Specifically, we advocate the use of distribution-free tolerance intervals calculated across a large amount of publicly available compositional data such as is found in the International Life Sciences Institute Crop Composition Database. WILEY-VCH Verlag 2010-02 /pmc/articles/PMC2978321/ /pubmed/20084639 http://dx.doi.org/10.1002/biot.200900217 Text en Copyright © 2010 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
spellingShingle Research Article
Herman, Rod A
Scherer, Peter N
Phillips, Amy M
Storer, Nicholas P
Krieger, Mark
Safe composition levels of transgenic crops assessed via a clinical medicine model
title Safe composition levels of transgenic crops assessed via a clinical medicine model
title_full Safe composition levels of transgenic crops assessed via a clinical medicine model
title_fullStr Safe composition levels of transgenic crops assessed via a clinical medicine model
title_full_unstemmed Safe composition levels of transgenic crops assessed via a clinical medicine model
title_short Safe composition levels of transgenic crops assessed via a clinical medicine model
title_sort safe composition levels of transgenic crops assessed via a clinical medicine model
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2978321/
https://www.ncbi.nlm.nih.gov/pubmed/20084639
http://dx.doi.org/10.1002/biot.200900217
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