Pharmacometrics and Clinical Trial Design Core

摘要（药物计量学和临床试验设计核心） 印第安纳州-俄亥俄州立大学药物计量学和临床试验设计（PCTD）核心 治疗学数据、模型、知识和研究协调中心中的孕产妇和儿科精确度 （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： 孕产妇和儿科治疗学。PCTD还将整合来自知识库和门户核心的数据， 真实的世界证据核心，和其他合作者，以支持药物计量学模型的发展， 孕妇和哺乳期妇女和儿童，以提供药物处置变化的机制性见解， 整个生命周期的反应以及个体间和个体内变异的来源。PCTD的目标是：1） 汇集具有产科和儿科专业知识的药物计量学家和临床药理学家， 有助于数据质量的指导方针，利用尖端的药物计量学和数据科学方法（在 与知识库核心结合），并协助开发和分析产科-儿科数据 临床药理学研究; 2）促进数据的利用，并确定来自 体外、临床前和临床研究，将这些信息整合到基于生理学的综合研究中， 药代动力学-药效学（PBPK-PD）模型，包括母体 妊娠期和产后的生理学，包括哺乳模型，与新生儿的联系，并描述 整个童年的成熟。PBPK-PD模型将纳入个体间和个体内的关键来源 变异性，包括但不限于药物基因组学、肥胖、伴随疾病和残疾，以提供 为孕产妇和儿童健康提供精准治疗信息的平台;以及3）作为国家和国际 通过增强模型信息化药物开发、临床研究设计和个性化 在妊娠和儿科发育的各个阶段，通过实施新的 药理学建模方法。PCTD将与MPRINT中心指导委员会合作， 研究优先事项和里程碑，并与推广，传播和培训核心，以传播 结果，并提供有关应用于孕产妇和儿科治疗的药物计量学方法的教育 research.

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.