Pharmacology and Pharmacometrics Core
药理学和药理学核心
基本信息
- 批准号:10431024
- 负责人:
- 金额:$ 16.43万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AccountabilityAdherenceAnalytical ChemistryAwardBiologicalBiological AssayBloodCerebrospinal FluidClinicalClinical DataClinical PharmacologyClinical ResearchCollaborationsConsultationsData AnalysesDecision MakingDevelopmentDoseDrug EvaluationDrug InteractionsDrug KineticsDrug usageEducationElementsEnvironmentEnvironmental Risk FactorEvaluationFAIR principlesFosteringGeneticGoalsHairHuman MilkHuman ResourcesIndividualInvestigational TherapiesKnowledgeLaboratoriesLeadershipLinkMarketingMarylandMeasuresMentorsMethodsModelingModernizationPatient CarePatient RightsPharmaceutical PreparationsPharmacodynamicsPharmacogenomicsPharmacologyPlasmaProceduresRegimenReportingResearchResearch DesignResearch PersonnelSamplingScientistSeriesServicesSourceSpecimen HandlingSpottingsStructure of parenchyma of lungTalentsTherapeuticTherapeutic Human ExperimentationTimeTraining SupportTreatment outcomeTuberculosisUniversitiesUrineValidationWorkWritinganalytical methodassay developmentbasecareerclinical caredemographicsdesigndrug developmentearly phase clinical trialeducation researchexperiencegood laboratory practiceinnovationinterestmeetingsmethod developmentnext generationnovelpharmacokinetics and pharmacodynamicspharmacometricspre-clinicalpreclinical studysample collectiontherapeutic developmenttraining opportunitytranslational studytuberculosis drugstuberculosis treatment
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kelly E. Dooley其他文献
SEGURANÇA E EFICÁCIA DA TERAPIA ANTIRRETROVIRAL BASEADA EM DOLUTEGRAVIR, NA SEMANA 48, EM ADULTOS COINFECTADOS HIV/TB
- DOI:
10.1016/j.bjid.2018.10.027 - 发表时间:
2018-12-01 - 期刊:
- 影响因子:
- 作者:
Kelly E. Dooley;Richard Kaplan;Noluthando Mwelase;Beatriz Grinsztejn;Eduardo Ticona;Marcus Lacerda;Omar Sued;Elena Belonosova;Mounir Ait‐Khaled;Kostas Angelis;Dannae Brown;Rajendra Singh;Christine Talarico;Allan Tenorio;Michael Keegan;Michael Aboud;Roberto Zajdenverg - 通讯作者:
Roberto Zajdenverg
Development and validation of a time-varying correction factor for QT interval assessment in drug-resistant tuberculosis patients
耐药结核病患者 QT 间期评估的时变校正因子的开发与验证
- DOI:
10.1016/j.ijantimicag.2025.107460 - 发表时间:
2025-04-01 - 期刊:
- 影响因子:4.600
- 作者:
Thanakorn Vongjarudech;Anne-Gaëlle Dosne;Bart Remmerie;Kelly E. Dooley;James C.M. Brust;Gary Maartens;Graeme Meintjes;Mats O. Karlsson;Elin M. Svensson - 通讯作者:
Elin M. Svensson
Risk-stratified treatment for drug-susceptible pulmonary tuberculosis
药物敏感型肺结核的风险分层治疗
- DOI:
10.1038/s41467-024-53273-7 - 发表时间:
2024-10-30 - 期刊:
- 影响因子:15.700
- 作者:
Vincent K. Chang;Marjorie Z. Imperial;Patrick P. J. Phillips;Gustavo E. Velásquez;Payam Nahid;Andrew Vernon;Ekaterina V. Kurbatova;Susan Swindells;Richard E. Chaisson;Susan E. Dorman;John L. Johnson;Marc Weiner;Amina Jindani;Thomas Harrison;Erin E. Sizemore;William Whitworth;Wendy Carr;Kia E. Bryant;Deron Burton;Kelly E. Dooley;Melissa Engle;Pheona Nsubuga;Andreas H. Diacon;Nguyen Viet Nhung;Rodney Dawson;Radojka M. Savic - 通讯作者:
Radojka M. Savic
Development and validation of a liquid chromatography-tandem mass spectrometry assay for the simultaneous analysis of isoniazid and pyrazinamide in cerebrospinal fluid
- DOI:
10.1016/j.jpba.2024.116613 - 发表时间:
2025-03-15 - 期刊:
- 影响因子:
- 作者:
Sydwell Poulo Maputla;Anton Joubert;Sandra Castel;Marthinus van der Merwe;Edda Zangenberg;Sean Wasserman;Kelly E. Dooley;Lubbe Wiesner - 通讯作者:
Lubbe Wiesner
Tuberculosis Preventive Treatment in High TB-Burden Settings: A State-of-the-Art Review
- DOI:
10.1007/s40265-024-02131-3 - 发表时间:
2024-12-28 - 期刊:
- 影响因子:14.400
- 作者:
Violet Chihota;Makaita Gombe;Amita Gupta;Nicole Salazar-Austin;Tess Ryckman;Christopher J. Hoffmann;Sylvia LaCourse;Jyoti S. Mathad;Vidya Mave;Kelly E. Dooley;Richard E. Chaisson;Gavin Churchyard - 通讯作者:
Gavin Churchyard
Kelly E. Dooley的其他文献
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{{ truncateString('Kelly E. Dooley', 18)}}的其他基金
Investigating Multiple PK and PD Relationships for TB-HIV (IMPPRove TB-HIV)
调查 TB-HIV 的多重 PK 和 PD 关系 (IMPPRove TB-HIV)
- 批准号:
10882249 - 财政年份:2023
- 资助金额:
$ 16.43万 - 项目类别:
Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa
在南非夸祖鲁纳塔尔省,第二代 InSTI 用于治疗接受利福平治疗的结核病合并感染患者的 HIV-1
- 批准号:
10459435 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa
在南非夸祖鲁纳塔尔省,第二代 InSTI 用于治疗接受利福平治疗的结核病合并感染患者的 HIV-1
- 批准号:
10829561 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Mentoring Investigators in HIV and Tuberculosis Therapeutics Research
指导艾滋病毒和结核病治疗研究的研究人员
- 批准号:
9926650 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Mentoring Investigators in HIV and Tuberculosis Therapeutics Research
指导艾滋病毒和结核病治疗研究的研究人员
- 批准号:
10729712 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa
在南非夸祖鲁纳塔尔省,第二代 InSTI 用于治疗接受利福平治疗的结核病合并感染患者的 HIV-1
- 批准号:
10677030 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Mentoring Investigators in HIV and Tuberculosis Therapeutics Research
指导艾滋病毒和结核病治疗研究的研究人员
- 批准号:
10335264 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa
在南非夸祖鲁纳塔尔省,第二代 InSTI 用于治疗接受利福平治疗的结核病合并感染患者的 HIV-1
- 批准号:
10840501 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Second Generation InSTIs for the Treatment of HIV-1 in patients with TB co-infection on Rifampicin-based Treatment in KwaZulu Natal, South Africa
在南非夸祖鲁纳塔尔省,第二代 InSTI 用于治疗接受利福平治疗的结核病合并感染患者的 HIV-1
- 批准号:
10226892 - 财政年份:2020
- 资助金额:
$ 16.43万 - 项目类别:
Ph2a Study: Rifampin, Merrem, Augmentin for Tuberculosis IND 129159; 12/31/2015
Ph2a 研究:利福平、Merrem、Augmentin 治疗结核病 IND 129159;
- 批准号:
10014610 - 财政年份:2017
- 资助金额:
$ 16.43万 - 项目类别:
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