Pharmacology and Pharmacometrics Core

药理学和药理学核心

• 批准号: 10593158
• 负责人: ERIC L NUERMBERGER
• 金额: $ 12.73万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-16 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10593158
• 关键词: Acceleration; Accountability; Adherence; Analytical Chemistry; Award; Biological; Biological Assay; Blood; Cerebrospinal Fluid; Clinical; Clinical Data; Clinical Pharmacology; Clinical Research; Collaborations; Data Analyses; Decision Making; Development; Dose; Drug Evaluation; Drug Interactions; Drug Kinetics; Drug usage; Dryness; Education; Elements; Environment; Environmental Risk Factor; Evaluation; FAIR principles; Fostering; Genetic; Goals; Hair; Human Milk; Human Resources; Individual; Investigational Therapies; Knowledge; Laboratories; Leadership; Link; Maryland; Measures; Mentors; Methods; Modeling; Modernization; Patient Care; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Plasma; Procedures; Regimen; Reporting; Research; Research Design; Research Personnel; Sampling; Scientist; Series; Services; Source; Specimen Handling; Spottings; Structure of parenchyma of lung; Talents; Therapeutic; Therapeutic Research; Training; Treatment outcome; Tuberculosis; Universities; Urine; Validation; Work; Writing; analytical method; assay development; career; clinical care; demographics; design; drug development; early phase clinical trial; experience; good laboratory practice; innovation; interest; meetings; method development; next generation; novel; pharmacokinetics and pharmacodynamics; pharmacometrics; post-market; pre-clinical; preclinical study; sample collection; synergism; therapeutic development; training opportunity; translational study; tuberculosis drugs; tuberculosis treatment

ABSTRACT – JHU TRAC PHARMACOLOGY AND PHARMACOMETRICS CORE (PPC) The Pharmacology and Pharmacometrics Core (PPC) will foster the creation, implementation, and conduct of new tuberculosis (TB) therapeutics research, harnessing existing and new physical and human resources, in the furtherance of: 1) Clinical and translational pharmacology-informed drug evaluation and development; and 2) Education and development of New Investigators (NI) in this field. There is a need for new and better therapeutics for the treatment of TB. Understanding pharmacokinetic-pharmacodynamic (PK/PD) relationships is key to advancing drug development and being able to develop rational therapeutics and successful treatment for all by determining the right drug at the right dose for the right patient. The PPC will provide added value to the JHU TRAC by offering state-of-the-art analytical chemistry support for the development and use of drug assays of biological samples, clinical and translational pharmacology support for design of pre -clinical and clinical studies, and quantitative pharmacology support for analysis, interpretation, and integration of preclinical and/or clinical data to support NI and established investigators studying novel aspects of TB treatment. The PPC is led by Drs. Kelly Dooley (Director, Clinical Pharmacology) and Michelle Rudek (Co-Director, Analytical and Clinical Pharmacology) at JHU, with senior leadership input by Dr. Eric Nuermberger (JHU, Translational Pharmacology) and Dr. Joga Gobburu (Pharmacometrics) at the University of Maryland. This team has several decades of combined experience in pre-clinical and clinical pharmacology. The specific aims of the PPC are to: 1) Provide consultative clinical and translational pharmacology support for JHU TRAC, and assist and mentor investigators in the design and conduct of preclinical and clinical studies focused on TB therapeutics; 2) Provide state-of-the-art, Good Laboratory Practice (GLP)-quality evaluations to quantify drugs (and metabolites) to treat TB in biological samples; and 3) Provide PK and PK/PD data analysis and interpretation to support translational and clinical projects involving TB drugs, and to support decision-making for safe and efficient drug development. The PPC will synergize with the TRAC by providing support and training opportunities for NI/ESI recipients of Developmental Awards involving studies with PK/PD components, and by participating in the weekly TRAC Seminar Series, the TRAC-specific Writing Accountability Groups (WAGs) for NI/ESI, the TRAC K-Club and K2R Club, the annual TB Scientific Meeting and TRAC Data Fair. The PPC investigators look forward to applying their collective expertise to benefit TB clinical care by promoting innovative approaches to TB treatment and accelerating experimental therapeutic agent development.

摘要 – JHU TRAC 药理学和药理学核心 (PPC) 药理学和药理学核心 (PPC) 将促进创建、实施和开展 新的结核病治疗研究，利用现有的和新的物质和人力资源， 促进：1) 临床和转化药理学指导的药物评估和开发；2) 该领域新研究者（NI）的教育和发展需要新的、更好的治疗方法。 了解药代动力学-药效学 (PK/PD) 关系是治疗 TB 的关键。 推进药物开发并能够为所有人开发合理的疗法和成功的治疗 为合适的患者确定合适剂量的合适药物将为 JHU 提供附加价值。 TRAC 为药物检测的开发和使用提供最先进的分析化学支持 生物样本、临床和转化药理学为临床前和临床设计提供支持 研究以及用于分析、解释和整合临床前研究的定量药理学支持 和/或支持 NI 和已建立的研究人员研究结核病治疗新方面的临床数据。 PPC 由 Kelly Dooley 博士（临床药理学主任）和 Michelle Rudek（分析联合主任）领导 约翰霍普金斯大学 (JHU) 的高级领导团队 Eric Nuermberger 博士（约翰霍普金斯大学、转化医学 马里兰大学的 Joga Gobburu 博士（药理学）和 Joga Gobburu 博士（药理学）这个团队有几个。 数十年的临床前和临床药理学综合经验 PPC 的具体目标是： 1) 为JHU TRAC提供咨询性临床和转化药理学支持，并协助和指导 设计和开展以结核病治疗为重点的临床前和临床研究的研究人员；2) 提供 最先进的良好实验室规范 (GLP) 质量评估，以量化治疗药物（和代谢物） 生物样品中的结核病；3) 提供 PK 和 PK/PD 数据分析和解释以支持转化 以及涉及结核病药物的临床项目，并支持安全有效的药物开发决策。 PPC 将与 TRAC 协同作用，为 NI/ESI 接收者提供支持和培训机会 涉及 PK/PD 成分研究以及参加每周 TRAC 的发展奖 研讨会系列、NI/ESI 的 TRAC 特定写作责任小组 (WAG)、TRAC K-Club 和 K2R 俱乐部、年度 TB 科学会议和 TRAC 数据博览会 PPC 调查人员期待着应用他们的成果。 通过促进结核病治疗和治疗的创新方法，集体专业知识有利于结核病临床护理 加速实验性治疗剂的开发。