Enhanced normograms and pregnancy outcome analysis in nonhuman primate developmental toxicity studies

Reproductive Toxicology(2020)

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摘要
•Assess and benchmark pregnancy outcome data; of regulatory ICH driven DART studies.•New concept of separate normograms through statistical analysis.•Enhanced normograms based on data derived enhanced pre- and postnatal developmental studies.•Providing new features such as higher resolution around the late stages of pregnancy.
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关键词
Cynomolgus monkey,Non-human primate,DART,Drug development,Biologic,Biopharmaceutical
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