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The Biostatistics work package performs statistical analyses of the results from the rodent feeding studies, reports on the results, and provides recommendations on the statistical methodology for long-term feeding trials.

 

The statistical power attainable for the primary parameters of toxicological interest when using sample sizes as specified in the standard OECD protocols is evaluated in a prospective power analysis.

 

The purpose of the statistical analysis is to derive point and interval estimates of the difference in parameters between the NK603-fed groups and the control group. These estimates are compared to a null hypothesis of equality (classical approach, differences tests) and to null hypotheses specifying a difference equal to external equivalence limits (G-TwYST approach, equivalence tests). Equivalence limits indicate minimum differences of potential toxicological relevance. For setting the equivalence limits use is made of data from non-GM groups in the feeding studies of the GRACE project.

 

 

Paper published describing the statistical approach for equivalence testing in G-TwYST

An open access paper describing the statistical approach for equivalence testing in G-TwYST has now been published in Food and Chemical Toxicology. The method was tested on data from the GRACE project, as described in this paper. We will now progress by applying the method in the statistical analyses of the G-TwYST feeding trials, to be reported first in the statistical reports as project deliverables.

Highlights

  • An equivalence testing method is proposed to assess the safety of regulated products
  • We combine data from a current study with test and control, and historical studies with assumedly safe reference products
  • The method is illustrated with animal feeding studies using genetically modified and reference maize varieties
  • A high statistical power of the equivalence test is the basis for the equivalence criterion
  • Generalized fiducial inference is used to integrate uncertainties from the historical and the current data

 

van der Voet H, Goedhart PW, Schmidt K (2017). Equivalence testing using existing reference data:  an example with genetically modified and conventional crops in animal feeding studies. Food and Chemical Toxicology, 109: 472-485. https://doi.org/10.1016/j.fct.2017.09.044

 

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G-TwYST results published

13 February 2019

This week the paper  "Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats" has been published in Archives of Toxicology. The open source paper is available online at https://doi.org/10.1007/s00204-019-02400-1.

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G-TwYST data available at CADIMA

13 February 2019

G-TwYST has  made accessible the detailed scientific information including raw data via the open access database CADIMA set up by the FP7 project GRACE.

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