Improving Drug Development for the Critically Ill Child
改善危重儿童的药物开发
基本信息
- 批准号:7544930
- 负责人:
- 金额:$ 13.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2004
- 资助国家:美国
- 起止时间:2004-12-15 至 2010-01-11
- 项目状态:已结题
- 来源:
- 关键词:AccountingAdultAffectBackBest Pharmaceuticals for Children ActBody WaterCaringChildChildhoodClinicalClinical InvestigatorClinical PharmacologyClinical ResearchClinical TrialsClinical Trials DesignCritical IllnessCritically ill childrenDataDevelopmentDiseaseDopamineDoseDrug ExposureDrug InteractionsDrug KineticsDrug effect disorderDrug usageEvaluationFeedbackFoundationsFutureGoalsGrantGuidelinesIntensive CareInvestigationK-Series Research Career ProgramsKnowledgeLabelLaboratory ResearchLifeMentorsMethodologyModelingModernizationMorbidity - disease rateOrganOutcomeOutcome StudyPatientsPentobarbitalPerformancePharmaceutical PreparationsPharmacodynamicsPharmacologic SubstancePharmacologyPlasma ProteinsPopulationProspective StudiesProtocols documentationPublishingRecommendationRelative (related person)ResearchResearch DesignResearch PersonnelRiskSafetySample SizeSimulateSourceSpecimenTechniquesTestingTherapeuticTherapeutic AgentsTimeTissuesToxic effectTrainingTreatment ProtocolsUnited States Food and Drug AdministrationVariantWritingbasecostdesigndrug developmentevidence baseexpectationexperienceimprovedinnovationmodels and simulationmortalitymultidisciplinarypatient orientedpatient safetypharmacodynamic modelprogramsprospectiveresearch clinical testingresponsesimulationskill acquisitionsuccess
项目摘要
DESCRIPTION (provided by applicant): The impact of recent legislative changes focused on improving our knowledge of drugs used in the treatment !of children is slowly being realized, but current studies have not investigated the differences in drug disposition afforded by disease state. This is most notable for critically ill children, in who changes in organ function, total body water, tissue and plasma proteins, can all affect the disposition and action of therapeutic drugs. The long-term research goal of this proposal is to optimize the safety and efficacy of drugs used in the treatment of critically ill children by bridging our gap in knowledge of the clinical pharmacology of drugs frequently used in these patients. We will use sophisticated pharmacokinetic-pharmacodynamic (PK-PD) modeling techniques and clinical trial simulation to streamline the development and performance of clinical studies. Our central hypothesis is that informative clinical trials can be designed more efficiently when well characterized models that account for sources of variation in pharmacokinetics and pharmacodynamics are utilized. We plan to initially construct select models based on published clinical pharmacologic data, and then perform clinical trials simulations for the design of prospective studies of drugs frequently used in the care of critically ill children. Based on the results of our models and trial simulations, we will then carry forward and perform clinical studies of two frequently used drugs (pentobarbital and dopamine) in critically ill children. lastly, we will integrate results from these clinical studies back into our models to allow for pharmacologically more rational dosing in this difficult to study pediatric population. For this mentored training, two complementary approaches will be pursued. The first will be formal coursework covering a range of topics iintegral to the field of clinical pharmacology. The second approach will be through a mentored clinical and laboratory research program. This intensive didactic and mentored training will allow for the development of a future independent pediatric clinical investigator.
描述(由申请人提供):最近的立法变化的影响集中在提高我们对治疗中使用的药物的知识!儿童的药物处置正在慢慢实现,但目前的研究还没有调查疾病状态提供的药物处置差异。这对于重症患儿最为明显,因为他们的器官功能、全身水分、组织和血浆蛋白的变化都会影响治疗药物的处置和作用。这项建议的长远研究目标,是透过填补我们对这些病人常用药物的临床药理学知识的空白,以优化用于治疗危重症儿童的药物的安全性和有效性。我们将使用复杂的药代动力学-药效学(PK-PD)建模技术和临床试验模拟来简化临床研究的开发和执行。我们的中心假设是,信息丰富的临床试验,可以更有效地设计时,充分表征的模型,说明药代动力学和药效学的变异来源被利用。我们计划首先根据已发表的临床药理学数据构建选择模型,然后进行临床试验模拟,用于设计经常用于重症儿童护理的药物的前瞻性研究。根据我们的模型和试验模拟的结果,我们将继续进行两种常用药物(戊巴比妥和多巴胺)在危重儿童中的临床研究。最后,我们将把这些临床研究的结果整合回我们的模型中,以便在这个难以研究的儿科人群中更合理地给药。对于这种辅导培训,将采取两种互补的办法。第一个将是正式的课程作业,涵盖临床药理学领域不可或缺的一系列主题。第二种方法将通过指导临床和实验室研究计划。这种密集的教学和指导培训将允许未来独立的儿科临床研究者的发展。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Population pharmacokinetics of pentobarbital in neonates, infants, and children after open heart surgery.
新生儿、婴儿和儿童心脏直视手术后戊巴比妥的群体药代动力学。
- DOI:10.1016/j.jpeds.2011.04.021
- 发表时间:2011
- 期刊:
- 影响因子:0
- 作者:Zuppa,AthenaF;Nicolson,SusanC;Barrett,JeffreyS;Gastonguay,MarcR
- 通讯作者:Gastonguay,MarcR
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Athena F. Zuppa其他文献
Population pharmacokinetics of ϵ-aminocaproic acid in adolescents undergoing posterior spinal fusion surgery.
接受后路脊柱融合手术的青少年中ε-氨基己酸的群体药代动力学。
- DOI:
10.1093/bja/aeu459 - 发表时间:
2015 - 期刊:
- 影响因子:9.8
- 作者:
P. Stricker;M. Gastonguay;Devika Singh;J. Fiadjoe;Emily M. Sussman;E. Y. Pruitt;T. Goebel;Athena F. Zuppa - 通讯作者:
Athena F. Zuppa
Intraoperative Dexmedetomidine Reduces Postoperative Mechanical Ventilation in Infants After Open Heart Surgery
术中右美托咪定可减少心脏直视手术后婴儿的术后机械通气
- DOI:
- 发表时间:
2015 - 期刊:
- 影响因子:4.1
- 作者:
B. Achuff;Susan C. Nicolson;O. Elci;Athena F. Zuppa - 通讯作者:
Athena F. Zuppa
A natural history study of medical cannabis consumption in pediatric autism in the United States
- DOI:
10.1016/j.rasd.2022.101994 - 发表时间:
2022-08-01 - 期刊:
- 影响因子:
- 作者:
Mary Ann DiLiberto;Athena F. Zuppa;Amanda Cornetta;Walter Faig;Tryce Scully;Amanda Bennett;Meghan Thomas;Elizabeth Ward;Stephen Barr;Benjamin E. Yerys - 通讯作者:
Benjamin E. Yerys
Athena F. Zuppa的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Athena F. Zuppa', 18)}}的其他基金
Collaborative Pediatric Critical Care Research Network - Clinical Site
儿科重症监护协作研究网络 - 临床网站
- 批准号:
10248817 - 财政年份:2021
- 资助金额:
$ 13.25万 - 项目类别:
Collaborative Pediatric Critical Care Research Network - Clinical Site
儿科重症监护协作研究网络 - 临床网站
- 批准号:
10670240 - 财政年份:2021
- 资助金额:
$ 13.25万 - 项目类别:
Collaborative Pediatric Critical Care Research Network - Clinical Site
儿科重症监护协作研究网络 - 临床网站
- 批准号:
10468848 - 财政年份:2021
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
低温对咪达唑仑和吗啡药代动力学的影响
- 批准号:
8339217 - 财政年份:2012
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
低温对咪达唑仑和吗啡药代动力学的影响
- 批准号:
8452088 - 财政年份:2012
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
低温对咪达唑仑和吗啡药代动力学的影响
- 批准号:
8645724 - 财政年份:2012
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Pharmacology on Duration of Ventilation in Patients with Resp Failure
药理学对呼吸衰竭患者通气持续时间的影响
- 批准号:
8096760 - 财政年份:2009
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Pharmacology on Duration of Ventilation in Patients with Resp Failure
药理学对呼吸衰竭患者通气持续时间的影响
- 批准号:
8266354 - 财政年份:2009
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Pharmacology on Duration of Ventilation in Patients with Resp Failure
药理学对呼吸衰竭患者通气持续时间的影响
- 批准号:
7904140 - 财政年份:2009
- 资助金额:
$ 13.25万 - 项目类别:
Impact of Pharmacology on Duration of Ventilation in Patients with Resp Failure
药理学对呼吸衰竭患者通气持续时间的影响
- 批准号:
7764827 - 财政年份:2009
- 资助金额:
$ 13.25万 - 项目类别:
相似海外基金
Co-designing a lifestyle, stop-vaping intervention for ex-smoking, adult vapers (CLOVER study)
为戒烟的成年电子烟使用者共同设计生活方式、戒烟干预措施(CLOVER 研究)
- 批准号:
MR/Z503605/1 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Research Grant
Early Life Antecedents Predicting Adult Daily Affective Reactivity to Stress
早期生活经历预测成人对压力的日常情感反应
- 批准号:
2336167 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Standard Grant
RAPID: Affective Mechanisms of Adjustment in Diverse Emerging Adult Student Communities Before, During, and Beyond the COVID-19 Pandemic
RAPID:COVID-19 大流行之前、期间和之后不同新兴成人学生社区的情感调整机制
- 批准号:
2402691 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Standard Grant
Elucidation of Adult Newt Cells Regulating the ZRS enhancer during Limb Regeneration
阐明成体蝾螈细胞在肢体再生过程中调节 ZRS 增强子
- 批准号:
24K12150 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Migrant Youth and the Sociolegal Construction of Child and Adult Categories
流动青年与儿童和成人类别的社会法律建构
- 批准号:
2341428 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Standard Grant
Understanding how platelets mediate new neuron formation in the adult brain
了解血小板如何介导成人大脑中新神经元的形成
- 批准号:
DE240100561 - 财政年份:2024
- 资助金额:
$ 13.25万 - 项目类别:
Discovery Early Career Researcher Award
Laboratory testing and development of a new adult ankle splint
新型成人踝关节夹板的实验室测试和开发
- 批准号:
10065645 - 财政年份:2023
- 资助金额:
$ 13.25万 - 项目类别:
Collaborative R&D
Usefulness of a question prompt sheet for onco-fertility in adolescent and young adult patients under 25 years old.
问题提示表对于 25 岁以下青少年和年轻成年患者的肿瘤生育力的有用性。
- 批准号:
23K09542 - 财政年份:2023
- 资助金额:
$ 13.25万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Identification of new specific molecules associated with right ventricular dysfunction in adult patients with congenital heart disease
鉴定与成年先天性心脏病患者右心室功能障碍相关的新特异性分子
- 批准号:
23K07552 - 财政年份:2023
- 资助金额:
$ 13.25万 - 项目类别:
Grant-in-Aid for Scientific Research (C)
Issue identifications and model developments in transitional care for patients with adult congenital heart disease.
成人先天性心脏病患者过渡护理的问题识别和模型开发。
- 批准号:
23K07559 - 财政年份:2023
- 资助金额:
$ 13.25万 - 项目类别:
Grant-in-Aid for Scientific Research (C)