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

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Challenges in study analysis and interpretation 1. Toxicological interpretation 2. Standardised effect sizes (SES) 3. Statistical Analysis Plan & summary statistics and raw analysis outputs 41
1. Toxicological interpretation • EuropaBio Members appreciate that EFSA has commented on the imperfect relationship between statistical significance and toxicological relevance in the final version of the guidance. • However, without feedback from EFSA regarding the flexibility that will be permitted in overall design, some concerns about the prominence of the statistical analysis persist. • EFSA (2011b) recently stated, “Many researchers incorrectly conclude that any statistically significant effect is biologically relevant...” – This gives EuropaBio Members confidence that EFSA considers statistical analysis one tool of many to be used to identify toxicologically-relevant differences. • The scientific training of toxicologists, and their experience in interpreting data, must ultimately determine the relationship between the finding and treatment with the test substance. 42
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 and 40: 4. Should males and females be anal
Page 41: Part 2: Study analysis and interpre
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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