PHARMACOKINETICS OF UNDERSTUDIED DRUGS USED DURING PREGNANCY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 主要目的： 估计妊娠女性中已经接受药物治疗（在大多数情况下，计划在整个妊娠期间继续接受药物治疗）的药物PK参数，并将其与哺乳期间和未妊娠时的PK数据进行比较（在相同受试者中）。 基本假设是： 妊娠妇女的药物清除率在妊娠期间（妊娠中期/妊娠晚期）发生显著变化，并在产后恢复至基线值。 次要目的： 与（产后）非妊娠女性的PK变异性相比，估计妊娠女性中药物PK参数的个体间变异性。 估计整个妊娠期间的药物-蛋白结合，并将PK与基因型和相关药物代谢酶的表达相关联。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Primary Objective: To estimate drug PK parameters in pregnant women for medication stay are already receiving (and in most cases, plan to continue receiving throughout pregnancy) and to compare them (in the same subjects) with PK data during nursing and in the absence of pregnancy. The underlying hypothesis is that: Drug clearance in pregnant women changes significantly during (the second/third trimesters of) pregnancy and returns to baseline values postpartum. Secondary Objectives: To estimate inter-individual variability of drug PK parameters in pregnant women compared with PK variability in (postpartum) non-pregnant women. To estimate drug-protein binding across pregnancy and to correlate PK with genotype and expression of relevant drug metabolizing enzymes.