UW Obstetric-Fetal Pharmacology Research Unit

华盛顿大学产胎儿药理学研究单位

• 批准号: 7354428
• 负责人: MARY F HEBERT
• 金额: $ 1.6万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7354428
• 关键词: Adult; Andro-Diane; Animal Model; Animals; Applications Grants; Area; Basic Science; Biochemical; CYP2C9 gene; Child; Chronic Disease; Clinical; Clinical Data; Clinical Pharmacology; Clinical Trials; Condition; Cytochrome P450; Data; Development; Discipline of obstetrics; Disease; Dose; Drug Kinetics; Drug usage; Elderly; Environment; Enzymes; Exposure to; Fetus; Funding; Gestational Diabetes; Glyburide; Goals; Health Professional; In Vitro; Infant; Insulin; Label; Membrane Transport Proteins; Metformin; Natural History; Numbers; Organ; Organic Cation Transporter; Orphan; Patient currently pregnant; Performance; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenetics; Pharmacology; Pharmacotherapy; Phase; Phenotype; Physicians; Physiological; Population; Postpartum Period; Pre-Clinical Model; Pregnancy; Pregnant Women; Research; Research Infrastructure; Resources; Safety; Scientist; Site; Specialist; Staging; System; Technology; Testing; Therapeutic; Third Pregnancy Trimester; Time; Today; Toxic effect; Training; Translational Research; United States Food and Drug Administration; Universities; Washington; Woman; Work; base; drug efficacy; experience; fetal; in vivo; interest; men; models and simulation; named group; news; nonhuman primate; pharmacokinetic model; placental transfer; research study

The overall objective of this grant proposal is to establish an Obstetric-Fetal Pharmacology Unit at the University of Washington. The major goal of the pharmacology unit will be to characterize the pharmacokinetics and pharmacodynamics of drugs that are of therapeutic value during pregnancy and whose clinical pharmacology is altered by the pregnant state. The general research focus will be cytochrome P450 enzymes and membrane transporters. This proposal describes the available environment and resources at the University of Washington for establishing a successful and productive Obstetric-Fetal Pharmacology Research Unit. As a demonstration of our research interests and capabilities the following translational research studies that integrate our strengths in clinical and basic sciences are proposed to evaluate the following study aims. 1. We aim to determine whether the in vivo activities of CYP2C9 and organic cation transporter (OCT) are altered through stages of pregnancy using the following phenotype markers: glyburide for CYP2C9 and metformin for OCT. Phase I (population pharmacokinetic analysis) and Phase II (pharmacokinetic / pharmacodynamic analysis) studies are proposed to investigate the effects of pregnancy on the aforementioned drug-metabolizing enzymes and transporters (second and third trimesters vs. 3 months postpartum period). 2. We aim to determine the efficacy and safety of insulin vs. glyburide vs. glyburide plus metformin for treatment of gestational diabetes mellitus. A Phase III efficacy and safety trial is proposed to evaluate the effects of gestational diabetes as well as the treatments on matemal, fetal and infant / child developmental mtcomes.

这项拨款提案的总体目标是在哥伦比亚大学建立一个产科-胎儿药理学单位。 华盛顿大学。药理学单元的主要目标是表征 在妊娠期间具有治疗价值的药物的药代动力学和药效学， 临床药理学因妊娠状态而改变。细胞色素P450是研究的重点 酶和膜转运蛋白。本建议书描述了 华盛顿大学建立了一个成功和富有成效的产科-胎儿药理学 研究股。作为我们的研究兴趣和能力的证明，以下翻译 研究，结合我们在临床和基础科学的优势，建议评估 遵循学习目标。 1.我们的目的是确定CYP2C9和有机阳离子转运蛋白（OCT）的体内活性是否 使用以下表型标记物在妊娠各阶段发生改变： CYP 2C9和二甲双胍用于OCT I期（群体药代动力学分析）和II期 （药代动力学/药效学分析）研究旨在研究妊娠对 上述药物代谢酶和转运蛋白（第二和第三个三个月对3个月 产后期）。 2.我们的目的是确定胰岛素与格列本脲与格列本脲加二甲双胍治疗糖尿病的疗效和安全性。 妊娠期糖尿病的治疗建议进行III期疗效和安全性试验， 妊娠期糖尿病及其治疗对母儿和婴幼儿发育的影响 mtcomes。