Obstetric-Fetal Pharmacology Research Units Network

描述（由申请人提供）：德克萨斯大学医学分支（UTMB）有能力作为产科-胎儿药理学研究单位（OPRU）网络的成员积极参与。加里汉金斯，医学博士，作为PI，是负责拟议的临床试验使用降糖药物治疗糖尿病在怀孕期间。他在几项NIH多中心试验中拥有丰富的经验，例如，非整倍体风险的早期和中期评估（FASTER），子宫硫酸镁研究（BEAM）的有益作用和阴道超声环扎试验。Hankins博士通过参与UTMB的区域妇幼保健计划（RMCHP）成功招募和留住了患者。所有RMCHP诊所都遵循由汉金斯博士领导的母胎医学部门制定的协议。每年有12 000多名孕妇在RMCHP诊所系统内接受护理，其中约7 000人在UTMB分娩。药理学/药代动力学（PK）合作研究者Mahmoud S. Ahmed博士在研究中利用人类胎盘和衍生制剂方面拥有超过25年的专业知识。Ahmed博士是胎盘受体、其天然配体和介导反应以及滋养层组织释放hCG机制的实验室先驱研究者。他们研究了体外和体内长期给予阿片类药物对胎盘生理学和母婴结局的影响。利用胎盘小叶的双重灌注，他们证明了外排蛋白和胎盘代谢酶对阿片类药物胎盘转运PK的影响。他们确定胎盘芳香化酶是一种药物代谢酶，并正在研究其多态性。肯尼斯·D Carey，DVM，PhD作为动物模型合作研究者，负责协调将在圣安东尼奥的西南国家灵长类动物研究中心（SNPRC）进行的狒狒研究。将研究正常和糖尿病狒狒群体。Hankins博士是SNPRC的助理研究员，并与灵长类动物研究人员有着广泛的接触。妇产科拥有资金充足的科学家，他们在与RFA相关的领域具有专业知识，包括感染，血管生理学和胎盘功能。临床PK合作研究者Susan Abdel-Rahman，Pharm D.，和韦恩Scarlgrass，MD，PhD，在PK研究方案的开发、获得的数据的评价和PK/PD建模方面拥有超过30年的综合经验。 UTMB的新生儿科、GCRC和其他部门将为该项目提供支持。

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the capability to participate actively as a member of the Obstetric-Fetal Pharmacology Research Units (OPRU) Network. Gary Hankins, MD, as PI, is responsible for the proposed clinical trial on the use of hypoglycemic drugs in the treatment of diabetes during pregnancy. He has extensive experience within several NIH multicenter trials, eg, First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER), Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM), and the Vaginal Ultrasound Cerclage Trial. Dr. Hankins has achieved successful patient recruitment and retention by involvement with UTMB's Regional Maternal & Child Health Program (RMCHP). All RMCHP clinics follow protocols established by the Maternal-Fetal Medicine division, headed by Dr. Hankins. Over 12,000 pregnant women are cared for annually within the RMCHP clinic system, approximately 7,000 of whom deliver at UTMB. The Pharmacology/Pharmacokinetics (PK) Co-Investigator, Mahmoud S. Ahmed, PhD, has over 25 years of expertise in utilizing human placenta and derived preparations in his investigations. Dr. Ahmed is a laboratory-pioneered investigator in placental receptors, their natural ligands and mediated responses, as well as the mechanism of hCG release from trophoblast tissue. They investigated the effects of in vitro and in vivo chronic administration of opiates on placental physiology and maternal-neonatal outcome. Utilizing dual perfusion of placental lobule, they demonstrated the influence of efflux protein and placental metabolic [enzymes on the PK for placental transfer of opiates. They identified placental aromatase as a drug-metabolizing enzyme and are investigating its polymorphism. Kenneth D. Carey, DVM, PhD, as Animal Model Co-Investigator, is responsible for coordinating the baboon studies to be conducted at the Southwest National Primate Research Center (SNPRC) in San Antonio. A population of normal and diabetic baboons will be studied. Dr. Hankins is an adjunct investigator at the SNPRC and has had extensive involvement with the Primate research staff. The Department of Ob/Gyn has well-funded scientists with expertise in areas relevant to this RFA including infection, vascular physiology, and placental functions. Clinical PK Co-Investigators Susan Abdel-Rahman, Pharm D., and Wayne Snodgrass, MD, PhD, have over 30 years of combined experience in the development of protocols for PK studies, evaluation of data obtained, and PK/PD modeling. The Division of Neonatology, the GCRC, and other departments at UTMB will provide support for this project.