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PMid:11856775
doi: 10.1016/j.tox.2007.07.020
Federal regulations (45 CFR 46 Subpart B) provide additional protections for pregnant women and neonates, and IRB review cannot approve protocols that expose infants to unknown developmental risks without compelling scientific justification and robust preclinical safety data
Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, et al
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