Pharmacology and Pharmacometrics Core

药理学和药理学核心

• 批准号: 10431024
• 负责人: Kelly E. Dooley
• 金额: $ 16.43万
• 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/10431024
• 关键词: Accountability; Adherence; Analytical Chemistry; Award; Biological; Biological Assay; Blood; Cerebrospinal Fluid; Clinical; Clinical Data; Clinical Pharmacology; Clinical Research; Collaborations; Consultations; Data Analyses; Decision Making; Development; Dose; Drug Evaluation; Drug Interactions; Drug Kinetics; Drug usage; Education; Elements; Environment; Environmental Risk Factor; Evaluation; FAIR principles; Fostering; Genetic; Goals; Hair; Human Milk; Human Resources; Individual; Investigational Therapies; Knowledge; Laboratories; Leadership; Link; Marketing; Maryland; Measures; Mentors; Methods; Modeling; Modernization; Patient Care; Patient Rights; 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 Human Experimentation; Time; Training Support; Treatment outcome; Tuberculosis; Universities; Urine; Validation; Work; Writing; analytical method; assay development; base; career; clinical care; demographics; design; drug development; early phase clinical trial; education research; experience; good laboratory practice; innovation; interest; meetings; method development; next generation; novel; pharmacokinetics and pharmacodynamics; pharmacometrics; pre-clinical; preclinical study; sample collection; 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.

JHU TRAC药理学与药学核心(PPC) 药理学和药物计量学核心(PPC)将促进创建、实施和实施 新的结核病治疗研究，利用现有和新的物质和人力资源，在 促进：1)临床和转化性药理学知情的药物评价和开发；以及2) 这一领域的新调查人员(NI)的教育和发展。需要新的和更好的治疗方法 用于治疗结核病。了解药代动力学-药效学(PK/PD)关系是 推进药物开发，为所有人开发合理的治疗方法和成功的治疗方法 以正确的剂量为正确的患者确定正确的药物。PPC将为JHU提供附加值 为药物分析方法的开发和使用提供最先进的分析化学支持 为临床前和临床设计提供生物样本、临床和翻译药理学支持 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，以支持NI和研究结核病治疗的新方面的现有研究人员。这个 PPC由Kelly Dooley博士(临床药理学主任)和Michelle Rudek博士(分析联席主任)领导 和临床药理学)，高级领导意见由Eric Nuermberger博士(JHU，翻译 Joga Gobburu博士(药理学)和Joga Gobburu博士(药理学)。这个团队有几个 在临床前和临床药理学方面有数十年的综合经验。PPC的具体目标是： 1)为JHU TRAC提供临床和翻译药理学咨询支持，并协助和指导 设计和实施以结核病治疗为重点的临床前和临床研究的调查人员；2)提供 最先进、良好的实验室操作规范(GLP)--对要治疗的药物(和代谢物)进行量化的质量评估 生物样本中的结核；以及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，并支持安全和高效的药物开发决策。 PPC将通过为新感染/ESI接受者提供支持和培训机会，与TRAC协同工作 发展奖，涉及PK/PD成分的研究，并通过参加每周TRAC 研讨会系列，NI/ESI、TRAC K-Club和K2R的TRAC特定写作责任小组(WAG) 俱乐部、一年一度的结核病科学会议和TRAC数据交易会。PPC调查人员期待着应用他们的 通过促进结核病治疗和治疗的创新方法，使结核病临床护理受益的集体专业知识 加快实验性治疗剂的开发。