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定量药理学与儿童药物研发和合理用药

中国临床药理学与治疗学 2010年第1期15卷 1-10页

作者：史军 jeffrey s.barrett Daiichi-sankyo Pharma Development Edison The Children's Hospital of Philadelphia Philadelphia

This article provides a comprehensive overview of key issues related to pediatric drug development and rational dosing guidance in pediatrics with an emphasis on how pharmacometrics can improve the efficiency and productivity of pediatric *** pharmacokinetics(PK)and pharmacodynamics(PD)of drugs are often different between adult and pediatric populations which necessitate specific studies in *** aims of this review are to discuss a number of recent methodological developments of modeling and simulation that facilitate the evaluation of drugs in *** focus has been placed on addressing the key issues of PK/PD scaling,sparse sampling,colinearity,covariate evaluation,dose optimization for trial design and label,modeling strategies and validation *** features and potential advantages of Bayesian hierarchical model,physiology-based PK models,and K-PD models are also presented.

关键词：儿童合理用药药物研发定量药理学药理学工作者药物试验弱势群体受试者

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对儿童用药和临床试验的思考

临床儿科杂志 2012年第3期30卷 298-300页

作者：吴荻曹进王晓玲 jeffrey s.barrett Laboratory for Applied PK/PD Division of Clinical Pharmacology ＆ TherapeuticsThe Children's Hospital of Philadelphia Kinetic Modeling and Simulation CoreInstitute for Translational Medicine and TherapeuticsUniversity of Pennsylvania 中国食品药品检定研究院北京100050 首都医科大学附属北京儿童医院北京100045

近年来,有高达79%的儿科药物在没有明确标识或者没有额外获得儿童使用许可的情况下使用[1]。2006年,我国医院对于4亿儿科患者使用的1 103种药品中仅有64种（占5.8%）是按说明书指导使用的[2]。另有数据显示,中国患病儿童占总患病人口的... 详细信息

近年来,有高达79%的儿科药物在没有明确标识或者没有额外获得儿童使用许可的情况下使用[1]。2006年,我国医院对于4亿儿科患者使用的1 103种药品中仅有64种（占5.8%）是按说明书指导使用的[2]。另有数据显示,中国患病儿童占总患病人口的20%左右,但80%以上的已上市药品没有儿童使用标识,90%的药物没有儿童剂型[3]。

关键词：儿童用药临床试验儿科药物上市药品儿科患者数据显示患病儿童说明书

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儿童临床试验设计在药物研发和评估中的应用

中华儿科杂志 2011年第12期49卷 952-956页

作者： Di Wu 申昆玲王晓玲曹进 jeffrey s. barrett Laboratory for Applied PK/PD Division of Clinical Pharmacology ＆ Therapeutics Department of Pediatrics The Children＇s Hospital of Philadelphia Kinetic Modeling and simulation Core Institute of Translational Medicine and Therapeutics University of Pennsylvania Philadelphia PA 19104 USA 首都医科大学附属北京儿童医院中国食品药品检定研究院

儿童具有生长和发育两个特点，其个体发育包括药物代谢酶、转运蛋白、受体和器官的发育。儿童的生长和发育使得药物的吸收、分布、代谢和排泄及药物在儿童的不同发育阶段对发育中器官的药效都存在着与成人显著不同的差异。

关键词：药物研发儿童试验设计个体发育药物代谢酶应用评估临床

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转化型研究中的定量药理学(英文)

转化型研究中的定量药理学(英文)

定量药理学:一个促进药物开发及转换型研究严谨思考的多学科领域

中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： jeffrey s barrett Laboratory for Applied PK/PD Clinical Pharmacology & Therapeutics Division The Children’s Hospital of Philadelphia Pediatrics DepartmentSchool of MedicineUniversity of PennsylvaniaPhiladelphiaPA 19104USA

转化型研究一般是指将基础科学发现应用到治疗或预防疾病或损伤,其价值通常是基于探索或发展可产生有效疗法的可能性。当今的制药工业已发展成为一个从事转化型研究的高度专业化行业, 在美国国立卫生研究院的倡议及激励下,医学科研队伍...

转化型研究一般是指将基础科学发现应用到治疗或预防疾病或损伤,其价值通常是基于探索或发展可产生有效疗法的可能性。当今的制药工业已发展成为一个从事转化型研究的高度专业化行业, 在美国国立卫生研究院的倡议及激励下,医学科研队伍同样接受了这一模式。临床和转化型研究奖的设立可以为能从事此类研究机构所需的多学科环境创造机会。临床和转化型研究奖的一个关键组成部分以及美国国立卫生研究院的工作路线图和美国食品药物管理局的关键路径计划中的一个元素就是通过定量药理学研究桥接基础与临床科学。关国宾夕法尼亚大学/费城儿童医院临床和转化型研究相对突出,两项研究和教育目标均依赖于定量药理学。美国国立卫生研究院所赞助的一项旨在探索神经激肽1受体拮抗用于治疗神经性爱滋病的研究案例, 正是用来说明运用定量药理进行转化型研究的范例。

关键词：

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中国临床药理学与治疗学 2008年第5期13卷 481-493页

作者： jeffrey s barrett Michael J Fossler K.David Cadieu Marc R Gastonguay 沈杰谢海棠孙瑞元 Laboratory for Applied PKPD Clinical Pharmacology & Therapeutics Divisionthe Children's Hospital of PhiladelphiaPediatrics DepartmentSchool of MedicineUniversity of PennsylvaniaPhiladelphiaPA 19104USA Clinical Pharmacokinetics Modeling and SimulationGlaxoSmithKlineKing of PrussiaPennsylvania 19406USA KDC Group Inc.New JerseyNJ 08648USA Metrum Institute ConnecticutUSA 皖南医学院弋矶山医院药物临床评价中心

尽管从事定量药理学研究的科学工作者一再强调将定量分析的原则应用于促进新药研发的决策,定量药理学的发展还是超过了上述领域。普通研究和决策领域总是期望着常规和传统的研究范例发生进步,当与定量药理学相关的领域自身在发展并与其... 详细信息

尽管从事定量药理学研究的科学工作者一再强调将定量分析的原则应用于促进新药研发的决策,定量药理学的发展还是超过了上述领域。普通研究和决策领域总是期望着常规和传统的研究范例发生进步,当与定量药理学相关的领域自身在发展并与其交互作用时,自然便产生对临床药理学的协同作用。创新性和可塑性训练计划和策略均是将来临床研究工作中必不可少的要素。掌握定量药理学领域的知识成为对药理科学家的要求,具有定量药理学背景的人员可望获得更高的薪水。目前定量药理学相关培训计划,教学资料,及学术权威均比较贫乏,学生们可以从企业化、调控性的背景的教师等多种机构的教职员那获得指导,此外也可以通过在线课程,可视化教学进修课程,与他们的导师保持联系。对课程和学位的管理可以采取灵活的态度,这样可在短期内培养更多的定量药理学工作者。

关键词：定量药理学关键路径国立卫生研究院(NIH)路线图教育临床药理学(Pharmacometrics)

Tale of mitochondria and mitochondria-associated ER membrane in patient-derived neuronal models of Wolfram syndrome

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Neural Regeneration Research 2025年第9期20卷 2587-2588页

作者： Laetitia Aubry Timothy barrett sovan sarkar I-sTEM CECSCorbeil-EssonnesFrance UniversitéParis-saclay Universitéd’EvryINSERMI-STEMUMR861Corbeil-EssonnesFrance Institute of Cancer and Genomic sciences Institute of Biomedical ResearchCollege of Medical and Dental SciencesUniversity of BirminghamEdgbastonBirminghamUK Department of Endocrinology Birmingham Women’s and Children’s HospitalSteelhouse LaneBirminghamUK

Mitochondria and mitochondria-associated endoplasmic reticulum membrane in neurodegenerative diseases:Mitochondria generate most of the chemical energy needed to power the biochemical reactions of cells,and thus are often referred to as the"powerhouse"of the ***,this organelle is also involved in a pleth,ora of different cellular functions such as calcium(Ca^(2+))homeostasis,apoptosis,oxidative stress,and several metabolic pathways including oxidative phosphorylation,tricarboxylic acid cycle,andβ-oxidation of fatty acids.

关键词： oxidative cycle carboxylic

Chemotherapy-induced small extracellular vesicles prime the pre-metastatic niche to accelerate neuroblastoma metastasis

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Genes & Diseases 2024年第4期11卷 65-68页

作者： Carson A.Wills Xiaoming Liu Longgui Chen Yuanjun Zhao Zhenqiu Liu Vladimir s.spiegelman jeffrey sundstrom Hong-Gang Wang Department of Pediatrics Division of Pediatric Hematology and OncologyThe Pennsylvania State University Collegeof MedicinePA 17033USA Department of Ophthalmology The Pennsylvania State University College of MedicinePA 17033USA Department of Public Health sciences The Pennsylvania StateUniversityCollegeofMedicinePA 17033USA

Neuroblastoma is the most common extracranial solid tumor in children,accounting for more than 10%of cancerrelated deaths in this *** standard of care for patients diagnosed with medium-to high-risk neuroblastoma,incl... 详细信息

关键词： neuroblastoma metastatic metastasis

Estradiol increases cortical and trabecular bone accrual and bone strength in an adolescent male-to-female mouse model of gender-affirming hormone therapy

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Bone Research 2024年第1期12卷 95-106页

作者： Tian Nie Varun s.Venkatesh suzanne Golub Kathryn s.stok Haniyeh Hemmatian Reena Desai David J.Handelsman jeffrey D.Zajac Mathis Grossmann Rachel A.Davey Department of Medicine Austin HealthUniversity of MelbourneHeidelbergVIC 3084Australia Department of Biomedical Engineering University of MelbourneParkvilleVIC 3010Australia ANZAC Research Institute University of Sydney and AndrologyConcord Repatriation General HospitalConcordNSW 2137Australia

The effects of gender-affirming hormone therapy on the skeletal integrity and fracture risk in transitioning adolescent trans girls are *** address this knowledge gap,we developed a mouse model to simulate male-to-female transition in human adolescents in whom puberty is first arrested by using gonadotrophin-releasing hormone analogs with subsequent estradiol *** was suppressed by orchidectomy in male mice at 5 weeks of *** 3 weeks post-surgery,male-to-female mice were treated with a high dose of estradiol(~0.85 mg)by intraperitoneal silastic implantation for 12 *** included intact and orchidectomized males at 3 weeks post-surgery,vehicle-treated intact males,intact females and orchidectomized males at 12 weeks *** to male controls,orchidectomized males exhibited decreased peak bone mass accrual and a decreased maximal force the bone could withstand prior to *** treatment in orchidectomized male-to-female mice compared to mice in all control groups was associated with an increased cortical thickness in the mid-diaphysis,while the periosteal circumference increased to a level that was intermediate between intact male and female controls,resulting in increased maximal force and *** trabecular bone,estradiol treatment increased newly formed trabeculae arising from the growth plate as well as mineralizing surface/bone surface and bone formation rate,consistent with the anabolic action of estradiol on osteoblast *** data support the concept that skeletal integrity can be preserved and that long-term fractures may be prevented in trans girls treated with GnRHa and a sufficiently high dose of *** study is needed to identify an optimal dose of estradiol that protects the bone without adverse side effects.

关键词： treatment treatment strength

New insights on the high-corrosion resistance of UHP Mg-Ge alloys tested in a simulated physiological environment

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Journal of Magnesium and Alloys 2024年第3期12卷 1026-1044页

作者： Ting Liu Xingrui Chen jeffrey Venezuela Yuan Wang Zhiming shi Wenyi Chen Matthew Dargusch Centre for Advanced Materials Processing and Manufacturing(AMPAM) School of Mechanical and Mining Engineeringthe University of QueenslandBrisbaneQLD 4072Australia CsIRO Mineral Resources 1 Technology CourtPullenvaleQLD 4069Australia

UHP Mg-Ge alloys was recently found to provide excellent corrosion *** paper provides new insights on the mechanism of improved corrosion resistance of UHP Mg-Ge alloys in Hanks’*** studied UHP Mg-0.5Ge and UHP Mg-1Ge alloys showed superior corrosion resistance compared to UHP Mg and WE43,with the Mg-1Ge exhibiting the best corrosion *** exceptional corrosion resistance of the UHP alloy is attributed to(i)Mg_(2)Ge’s ability to suppress cathodic kinetics,(ii)Ge’s capability to accelerate the formation of a highly passive layer,and the(iii)low amounts of corrosion-accelerating impurities.

关键词： UHP Mg-Ge alloy Cathodic kinetics suppression Biodegradable metals In vitro corrosion Magnesium corrosion.