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.

该赠款提案的总体目的是在 华盛顿大学。药理学单元的主要目标是表征 在怀孕期间具有治疗价值的药物的药代动力学和药效学 临床药理学会因怀孕状态而改变。一般研究重点将是细胞色素P450 酶和膜转运蛋白。该建议描述了可用的环境和资源 华盛顿大学建立成功且富有生产力的产科药理学 研究部门。为了证明我们的研究兴趣和能力以下翻译 提出了将我们在临床和基础科学中融合优势的研究，以评估 以下研究目标。 1。我们的目的是确定CYP2C9和有机阳离子转运蛋白的体内活性（OCT）是否是 使用以下表型标记通过怀孕阶段进行改变：格列本 CYP2C9和OCT的二甲双胍。 I期（人口药代动力学分析）和II期 （药代动力学 /药效学分析）提出了研究妊娠对的影响 上述药物 - 代谢酶和转运蛋白（第二和第三个三个月与3个月 产后时期）。 2。我们的目的是确定胰岛素与格列本卷与格列本伯里德和二甲双胍的功效和安全性 妊娠糖尿病的治疗。提出了III期疗效和安全试验来评估 妊娠糖尿病的影响以及治疗对脓肿，胎儿和婴儿 /儿童发育的影响 mtcomes。