Pharmacometrics and Clinical Trial Design Core

药理学和临床试验设计核心

• 批准号: 10487579
• 负责人: Sara K Quinney
• 金额: $ 83.28万
• 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/10487579
• 关键词: Adolescent; Adult; Biological Markers; Child; Childhood; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials Design; Collaborations; Communities; Data; Data Analyses; 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; Neonatal; Obesity; Ohio; Paper; Pediatrics; Pharmaceutical Preparations; Pharmacodynamics; 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 Human Experimentation; Time; Training; Universities; Woman; Work; data integration; data quality; disability; drug development; drug disposition; individual variation; innovation; insight; knowledgebase; neonate; novel; open source; outreach; personalized pharmacotherapy; personalized therapeutic; 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计量学和临床试验设计(PCTD)核心 治疗数据、模型、知识和研究协调中心的母儿精确度 (IU-OSU MPRINT DMKRCC)将提供与以下相关的药物计量学和临床试验设计方面的专业知识 母婴治疗学。PCTD还将整合来自知识库和门户核心的数据， 真实世界证据核心和其他合作者支持开发药物计量模型 为孕妇和哺乳期妇女和儿童提供对药物处置和药物处置变化的机械性洞察 在生命周期内的反应，以及个体间和个体内变异的来源。PCTD的目标将是1) 汇集具有产科和儿科专业知识的药物计量师和临床药剂师 促进数据质量指南，利用尖端的药物计量学和数据科学方法(in 与Knowledgebase Core合作)，并协助开发和分析来自产科-儿科的数据 临床药理学研究；2)促进数据的利用和识别来自 通过将这些信息整合到综合生理学基础上进行的体外、临床前和临床研究 包含孕妇体内动态变化的药代动力学-药效学(PBPK-PD)模型 孕期和产后的生理学，包括哺乳模式，与新生儿的联系，并描述 在整个童年时期都成熟了。PBPK-PD模型将纳入个体间和个体内部的关键来源 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 为妇幼保健领域的精准治疗提供信息的平台；以及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的资源 孕期不同阶段的药物治疗和儿科发展通过实施新的 药物计量学建模方法。PCTD将与MPRINT中心指导委员会合作，制定 研究优先事项和里程碑，并与外联、传播和培训核心一起传播 结果并提供有关应用于母儿治疗的药物计量学方法的教育 研究。