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- W2078604472 abstract "To determine the sensitivity of male reproductive toxicity endpoints in NHPs we performed a power analysis of routine and triggered endpoints using control data from sexually mature Asian and Mauritian NHPs. The power to detect a 50% change from control was 13-30% for male reproductive organ weights, ∼30% for testicular volume, 6-66% for seminal analyses and 10-78% for male hormones. Overall, male reproductive endpoints have poor power (less than 80%) to detect a 50% change from control with a group size of 3 monkeys. Confidently identifying adverse male reproductive effects with these endpoints would likely require specialized study designs with larger group sizes. Triggering of non-routine endpoints in cases where there is special concern for male reproductive toxicity is unlikely to increase sensitivity to detect adverse effects." @default.
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- W2078604472 date "2013-11-01" @default.
- W2078604472 modified "2023-09-29" @default.
- W2078604472 title "Sensitivity of male reproductive endpoints in nonhuman primate toxicity studies: A statistical power analysis" @default.
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- W2078604472 doi "https://doi.org/10.1016/j.reprotox.2013.06.061" @default.
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