a statistical assessment of differences and equivalences between genetically modified and reference plant varieties之间的差异和等价统计评估转基因植物品种和参考.pdfVIP

van der Voet et al. BMC Biotechnology 2011, 11:15 /1472-6750/11/15 METHODOLOGY ARTICLE Open Access A statistical assessment of differences and equivalences between genetically modified and reference plant varieties 1* 2 3 3 Hilko van der Voet , Joe N Perry , Billy Amzal , Claudia Paoletti Abstract Background: Safety assessment of genetically modified organisms is currently often performed by comparative evaluation. However, natural variation of plant characteristics between commercial varieties is usually not considered explicitly in the statistical computations underlying the assessment. Results: Statistical methods are described for the assessment of the difference between a genetically modified (GM) plant variety and a conventional non-GM counterpart, and for the assessment of the equivalence between the GM variety and a group of reference plant varieties which have a history of safe use. It is proposed to present the results of both difference and equivalence testing for all relevant plant characteristics simultaneously in one or a few graphs, as an aid for further interpretation in safety assessment. A procedure is suggested to derive equivalence limits from the observed results for the reference plant varieties using a specific implementation of the linear mixed model. Three different equivalence tests are defined to classify any result in one of four equivalence classes. The performance of the proposed methods is investigated by a simulation study, and the methods are illustrated on compositional data from a field study on maize grain. Conclusions: A clear distinction of practical relevance is shown between difference and equivalence testing. The proposed tests are shown to have appropriate performance characteristics by simulation, a