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

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4. Design scenarios considered Three design scenarios were considered: • 1 animal/cage; 3 treatment groups x 12 cages per treatment per gender = 72 animals in total – high <strong>dose</strong>, low <strong>dose</strong>, control • 2 animals/cage; 3 treatment groups x 6 cages per treatment per gender = 72 animals in total – high <strong>dose</strong>, low <strong>dose</strong>, control • 2 animals/cage; 4 treatment groups x 5 cages per treatment per gender = 80 animals in total – GM high incorporation rate, non-GM high incorporation rate, GM low incorporation rate, non-GM low incorporation rate 29
4. Analysis details • For the 3-treatment group designs, power was based on two analysis scenarios: – the comparison of individual treatments, – the comparison between control and mean of high and low <strong>dose</strong>s. • For the 4-treatment group design, power was based on the comparison of treatments (i.e. GM vs non-GM) averaged over incorporation rates, in line with EFSA guidance. • In all cases, cage was regarded as the ExpU. • Males and females were considered separately. • All results assume a two-sided alternative hypothesis. 30
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 27 and 28: 4. Endpoints and effect sizes Endpo
Page 29: 4. Average coefficients of variatio
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 49 and 50: 3. Summary statistics and raw analy
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

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