Development of system to predict fetal toxicity based on PK/PD evaluation by transplacental transfer and effect of drugs

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In the present study, a novel approach to predict fetal toxicity induced by the use of non-steroidal anti-inflammatory drugs (NSAIDs) in full-term pregnant women was developed using the transplacental pharmacokinetic (TP-PK) parameters obtained from in situ human placental perfusion studies, and the pharmacodynamic (PD) parameters obtained from fetal plasma concentration-response relationship in rats. Using the novel approach, the fetal toxicity of NSAIDs such as ibuprofen was quantitatively predicted and the use of NSAIDs is suggested to be dangerous to full-term pregnant women.