Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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3. Statistical Analysis Plan • From the Scientific Opinion document it is unclear whether it is mandatory to provide a separate SAP in addition to the details concerning the proposed statistical analysis that are included in the study protocol. • EuropaBio Members wish to avoid unnecessary duplication, and believe that the level of detail that will be provided in the study protocol should suffice. 47
3. Summary statistics and raw analysis outputs • EuropaBio Members’ understanding is that EFSA wishes to see results presented both in terms of means and p-values, and differences and 95% confidence intervals. • However, some requirements are less clear, and others (e.g., the median) seem to be of questionable value in most cases. • It is the opinion of EuropaBio Members that the following summary statistics would generally be appropriate: – Mean, min, max and SD for each treatment group. – P-values for all fixed effects and specific contrasts. – Point estimate of the difference between GM and non-GM together with 95% confidence interval for the difference. • EuropaBio Members seek confirmation from EFSA as to whether the above list is acceptable. 48
Page 1 and 2: Repeated-d
Page 3 and 4: Existing safety data and the weight
Page 5 and 6: Hazard Identification and multiple
Page 7 and 8: Section summary • EuropaBio Membe
Page 9 and 10: Part 1: Study design and conduct 9
Page 11 and 12: 1. Defining toxicologically relevan
Page 13 and 14: 1. Endpoints and effect sizes Endpo
Page 15 and 16: 1. Toxicological endpoints for powe
Page 17 and 18: 2. Experimental design • EFSA gui
Page 19 and 20: 2. Experimental design (continued)
Page 21 and 22: 2. Section summary/discussion • E
Page 23 and 24: 3. Group or single housing (continu
Page 25 and 26: 3. Section summary/discussion • E
Page 27 and 28: 4. Endpoints and effect sizes Endpo
Page 29 and 30: 4. Average coefficients of variatio
Page 31 and 32: 4. Analysis details • For the 3-t
Page 33 and 34: 4. Results 1 animal/cage, 3 treatme
Page 35 and 36: 4. Results 2 animals/cage, 3 treatm
Page 37 and 38: 4. Provisos for power analyses •
Page 39 and 40: 4. Should males and females be anal
Page 41 and 42: Part 2: Study analysis and interpre
Page 43 and 44: 1. Toxicological interpretation •
Page 45 and 46: 2. Presentation of results on the s
Page 47: 2. Section summary/discussion • E
Page 51 and 52: 3. Section summary/discussion • P
Page 53 and 54: References • EFSA. 2011c. Guidanc
Page 55 and 56: References • WHO. 2003. GEMS/FOOD

Repeated-dose 90-day Oral Toxicity Studies on Whole ... - Europabio

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