Details
| Original language | English |
|---|---|
| Pages (from-to) | 125-135 |
| Number of pages | 11 |
| Journal | Regulatory Toxicology and Pharmacology |
| Volume | 44 |
| Issue number | 2 |
| Early online date | 18 Nov 2005 |
| Publication status | E-pub ahead of print - 18 Nov 2005 |
Abstract
The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use. Substantial equivalence is established if no meaningful difference from the conventional counterpart was found, leading to the conclusion that the Novel Food is as safe and nutritious as its traditional counterpart. In general, the non-significance of p value is used for the proof of safety. From a statistical perspective, the problems connected with such an approach are demonstrated, namely that quite different component-specific false negative error rates result. As an alternative, the proof of safety is discussed with the inherently related definition of safety thresholds. Moreover, parametric and non-parametric confidence intervals for the difference and the ratio to control (conventional line) are described in detail. Finally, the treatment of multiple components for a global proof of safety is explained.
Keywords
- Bioequivalence, Genetically modified, Novel food, Proof of safety, Statistics, Substantial equivalence
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics(all)
- Toxicology
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In: Regulatory Toxicology and Pharmacology, Vol. 44, No. 2, 18.11.2005, p. 125-135.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Statistical analysis used in the nutritional assessment of novel food using the proof of safety
AU - Hothorn, Ludwig A.
AU - Oberdoerfer, Regina
PY - 2005/11/18
Y1 - 2005/11/18
N2 - The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use. Substantial equivalence is established if no meaningful difference from the conventional counterpart was found, leading to the conclusion that the Novel Food is as safe and nutritious as its traditional counterpart. In general, the non-significance of p value is used for the proof of safety. From a statistical perspective, the problems connected with such an approach are demonstrated, namely that quite different component-specific false negative error rates result. As an alternative, the proof of safety is discussed with the inherently related definition of safety thresholds. Moreover, parametric and non-parametric confidence intervals for the difference and the ratio to control (conventional line) are described in detail. Finally, the treatment of multiple components for a global proof of safety is explained.
AB - The safety assessment of Novel Food, including GM biotechnology-derived crops, starts with the comparison of the Novel Food with a traditional counterpart that is generally accepted as safe based on a history of human food use. Substantial equivalence is established if no meaningful difference from the conventional counterpart was found, leading to the conclusion that the Novel Food is as safe and nutritious as its traditional counterpart. In general, the non-significance of p value is used for the proof of safety. From a statistical perspective, the problems connected with such an approach are demonstrated, namely that quite different component-specific false negative error rates result. As an alternative, the proof of safety is discussed with the inherently related definition of safety thresholds. Moreover, parametric and non-parametric confidence intervals for the difference and the ratio to control (conventional line) are described in detail. Finally, the treatment of multiple components for a global proof of safety is explained.
KW - Bioequivalence
KW - Genetically modified
KW - Novel food
KW - Proof of safety
KW - Statistics
KW - Substantial equivalence
UR - http://www.scopus.com/inward/record.url?scp=32544457857&partnerID=8YFLogxK
U2 - 10.1016/j.yrtph.2005.10.001
DO - 10.1016/j.yrtph.2005.10.001
M3 - Article
C2 - 16298467
AN - SCOPUS:32544457857
VL - 44
SP - 125
EP - 135
JO - Regulatory Toxicology and Pharmacology
JF - Regulatory Toxicology and Pharmacology
SN - 0273-2300
IS - 2
ER -