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药理学和药效学核心（PPC） 药理学和药物计量学核心（PPC）将促进创建，实施和进行 新的结核病疗法研究，利用现有的和新的物质和人力资源， 促进：1）临床和转化药理学知情的药物评价和开发;以及2） 教育和发展新的调查员（NI）在这一领域。需要新的更好的治疗方法 用于治疗肺结核。了解药代动力学-药效学（PK/PD）关系是 推进药物开发，并能够为所有人开发合理的治疗方法和成功的治疗方法， 为合适的病人确定合适剂量的合适药物。PPC将为JHU提供附加值 TRAC通过为药物检测的开发和使用提供最先进的分析化学支持 为临床前和临床试验设计提供临床和转化药理学支持 研究和定量药理学支持，用于分析、解释和整合临床前 和/或临床数据来支持NI和研究TB治疗新方面的既定研究者。的 PPC由Kelly Dooley博士（临床药理学总监）和Michelle Rudek博士（分析总监）领导 和临床药理学），由Eric Nuermberger博士（JHU，翻译 药理学）和马里兰州大学的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经验。该方案的具体目标是： 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 研究人员在设计和开展临床前和临床研究的重点是结核病治疗; 2）提供 最先进的药物非临床研究质量管理规范（GLP）-质量评价，以量化药物（和代谢物）治疗 生物样品中的TB;和3）提供PK和PK/PD数据分析和解释，以支持翻译 和涉及结核病药物的临床项目，并支持安全和有效药物开发的决策。 方案支助方案将与核心预算资源调拨目标协同增效，为国家机构/环境支助方案的受援国提供支助和培训机会， 涉及PK/PD部分研究的开发奖，并通过参加每周TRAC 研讨会系列，国家机构/国际教育机构的TRAC具体写作问责小组，TRAC K俱乐部和K2 R 俱乐部，年度结核病科学会议和TRAC数据博览会。PPC研究人员期待着应用他们的 通过推广结核病治疗的创新方法，使结核病临床护理受益的集体专业知识， 加速实验性治疗剂的开发。