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

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4. Section summary/discussion • The power profile as a whole is very positive for each of the three proposed design scenarios. – Each scenario strikes a reasonable balance between power and ethical considerations. • Findings demonstrate that the power inherent in previous studies of this size (i.e., 10-12 animals per treatment group per gender, in line with OECD TG 408) should in general be similarly adequate. • While power is important, the toxicological relevance of all observed differences are discussed in any case regardless of statistical significance. 39
Part 2: Study analysis and interpretation 40
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 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: 4. Should males and females be anal
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

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

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