Pharmacometrics and Clinical Trial Design Core

药理学和临床试验设计核心

• 批准号: 10676277
• 负责人: Sara K Quinney
• 金额: $ 83.35万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10676277
• 关键词: Adolescent; Adult; Biological Markers; Child; Childhood; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials Design; Collaborations; Communities; Data; Data Science; Development; Discipline of obstetrics; Disease; Education; Ethics; Goals; Guidelines; In Vitro; Indiana; Individual; Individual Differences; Infant; International; Knowledge; Knowledge Portal; Lactation; Link; Logistics; Longevity; Maternal Physiology; Maternal and Child Health; Methods; Modeling; Needs Assessment; Neonatal; Obesity; Ohio; Paper; Pediatrics; Pharmaceutical Preparations; Pharmacogenomics; Pharmacology; Pharmacology Study; Pharmacotherapy; Physiology; Play; Population; Postpartum Period; Precision therapeutics; Pregnancy; Pregnant Women; Research; Research Design; Research Personnel; Research Priority; Resources; Role; Services; Source; System; Therapeutic; Therapeutic Research; Time; Training; Universities; Woman; Work; data integration; data quality; disability; drug development; drug disposition; individual variation; innovation; insight; knowledgebase; medication administration; neonate; novel; open source; outreach; personalized pharmacotherapy; personalized therapeutic; pharmacodynamic model; pharmacokinetics and pharmacodynamics; pharmacometrics; physiologically based pharmacokinetics; precision medicine; preclinical study; pregnant; repository; response; tool; treatment response

Summary (Pharmacometrics and Clinical Trial Design Core) The Pharmacometrics and Clinical Trial Design (PCTD) Core of the Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center (IU-OSU MPRINT DMKRCC) will provide expertise in pharmacometrics and clinical trial design relating to maternal and pediatric therapeutics. The PCTD will also integrate data from the Knowledgebase and Portal Core, Real World Evidence Core, and other collaborators to support development of pharmacometric models in pregnant and lactating women and children to provide mechanistic insight into changes in drug disposition and response across the lifespan and sources of inter- and intra-individual variability. The Aims of the PCTD will 1) bring together pharmacometricians and clinical pharmacologists with expertise in obstetrics and pediatrics to contribute to guidelines for data quality, utilize cutting-edge pharmacometric and data science methods (in conjunction with Knowledgebase Core), and assist in developing and analyzing data from obstetric-pediatric clinical pharmacology research; 2) Facilitate utilization of data and identification of gaps in knowledge from in vitro, preclinical, and clinical studies by incorporating this information into integrative physiologically based pharmacokinetic-pharmacodynamic (PBPK-PD) models that encompass dynamic changes in maternal physiology across gestation and postpartum, including lactation models, link to neonates, and describe maturation throughout childhood. PBPK-PD models will incorporate critical sources of inter- and intra-individual variability, including but not limited to pharmacogenomics, obesity, concomitant disease, and disability, to provide a platform to inform precision therapy in maternal and child health; and 3) Serve as a national and international resource by enhancing model informed drug development, clinical study design and personalized pharmacotherapy at various stages of pregnancy and pediatric development through implementation of novel pharmacometric modeling approaches. The PCTD will work with the MPRINT Hub Steering Committee to set research priorities and milestones and with the Outreach, Dissemination and Training Core to disseminate results and provide education on pharmacometric approaches applied to maternal and pediatric therapeutic research.

摘要（药物计量学和临床试验设计核心） 印第安纳大学 - 俄亥俄州立大学的药物测量和临床试验设计（PCTD）核心 治疗数据，模型，知识和研究协调中心的母亲和小儿精度 （IU-OSU MPRINT DMKRCC）将提供有关药物计量学和临床试验设计的专业知识 孕产妇和小儿疗法。 PCTD还将整合来自知识库和门户核心的数据， 现实世界的证据核心和其他合作者支持制定药物计量模型 怀孕和哺乳的妇女和儿童，以提供有关药物处置变化和的机械洞察力 寿命和个体内变异性的响应和来源。 PCTD的目的将1） 将具有妇产科专业知识的药剂师和临床药理学家召集在一起 使用尖端的药物计量学和数据科学方法为数据质量指南做出贡献（在 与知识基核的结合），并协助开发和分析产科培养基的数据 临床药理学研究； 2）促进数据的利用和识别知识中的差距 通过将这些信息纳入基于生理的综合性，体外，临床前和临床研究 药代动力学 - 药物动力学（PBPK-PD）模型，包括母体的动态变化 跨妊娠和产后的生理学，包括哺乳模型，与新生儿联系，并描述 整个童年的成熟。 PBPK-PD模型将结合个体间和个体内的关键来源 可变性，包括但不限于药物基因组学，肥胖，伴随疾病和残疾，以提供 一个为孕产妇和儿童健康提供精确疗法的平台； 3）作为国家和国际 通过增强模型知情的药物开发，临床研究设计和个性化资源 通过实施新颖的妊娠和小儿发育的各个阶段的药物治疗 药物测量方法。 PCTD将与MPRINT HUB指导委员会合作 研究优先事项和里程碑，并通过宣传，传播和训练核心进行传播 结果并提供有关适用于孕产妇和小儿治疗的药物计量方法的教育 研究。