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clinical Pharmacokinetic and Bioequivalence Studies of Two Brands of Cephradine in Healthy Korean Using HPLC Method

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pharmacology & Pharmacy 2018年第7期9卷 279-292页

作者： Hyun-Jin Kim Shin-Hee Kim Semi Kim Jae-Sung Ahn Ju-Seop Kang Department of pharmacology Clinical Pharmacology Laboratory Division of Molecular Therapeutics Development Hanyang Biomedical Research Institute College of Medicine Hanyang University Seoul South Korea

The goal of our research was to compare the pharmacokinetics and evaluate the bioequivalence of two brands of cephradine 500 mg capsules in 24 normal Korean volunteers. The plasma samples were acquired at 13 time points for 8 h after administration. The concentrations of cephradine in human plasma were measured by a high-performance liquid chromatography (HPLC). Isocratic mobile phase which consisted of acetonitrile, methanol, and 20 mM potassium phosphate (15/5/80, v/v/v, pH 3.48) was used to separate the analytical column cosmosil cholester (250 × 4.6 mm, 3 μm). Analytes were detected in ultraviolet (260 nm). The novel analytical method was described as simple sample preparation, a short retention time (less than 6 min) and making it suitable for use in clinical trials. Pharmacokinetic parameters, such as AUC0-t (20.54 vs 18.42 μg·h/mL), AUC0-infinity (21.22 vs 19.14 μg·h/mL), Cmax (12.69 vs 12.81 μg/mL), Tmax (1.22 vs 0.92 h), half-life (1.02 vs 1.13 h), extrapolation (3.22% vs 3.75%), and Ke (0.73 vs 0.69 h–1) were determined for the reference and test drugs in plasma. Pharmacokinetic parameters with a 90% confidence interval were 87% - 95% for AUC0-t and 91% - 115% for Cmax. They were satisfied within the bioequivalence range 80% - 125% of the KFDA guidelines. Therefore, our HPLC method was well applied in a bioequivalence and pharmacokinetic study of two formulations in normal subjects.

关键词： Bioequivalence Cephalosporin Antibiotic Cephradine Korean Volunteers Pharmacokinetics

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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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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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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。

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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)

3D assessment of intervertebral disc degeneration in zebrafish identifies changes in bone density that prime disc disease

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Bone Research 2021年第4期9卷 521-536页

作者： Erika Kague Francesco Turci Elis Newman Yushi Yang Kate Robson Brown Mona S.Aglan Ghada A.Otaify Sarnia A.Temtamy Victor L.Ruiz-Perez Stephen Cross C.Patrick Royall P.Eckhard Witten Chrissy L.Hammond School of Physiology Pharmacology and NeuroscienceBiomedical SciencesUniversity of BristolBristolUK School of Physics HH Wills Physics LaboratoryUniversity of BristolBristolUK Centre for Nanoscience and Quantum Information University of BristolBristolUK Bristol Centre for Functional Nanomaterials University of BristolBristolUK Department of Anthropology and Archaeology University of BristolBristolUK Department of Mechanical Engineering University of BristolBristolUK clinical Genetics Department Human Genetics and Genome Research DivisionCenter of Excellence for Human GeneticsNational Research CentreCairoEgypt lnstituto de Investigaciones Biomedicas de Madridand Ciber de Enfermedades Raras(CIBERER)MadridSpain Wolfson Bioimaging Facility Biomedical SciencesUniversity of BristolBristolUK School of Chemistry University of BristolBristolUK Evolutionary Developmental Biology Department of BiologyGhent UniversityGhentBelgium

Back pain is a common condition with a high social impact and represents a global health *** disc disease(IVDD)is one of the major causes of back pain;no therapeutics are currently available to reverse this *** impact of bone mineral density(BMD)on IVDD has been controversial,with some studies suggesting osteoporosis as causative for IVDD and others suggesting it as protective for *** studies to evaluate the influence of genetic components of BMD in IVDD could highlight opportunities for drug development and *** taking a holistic 3D approach,we established an aging zebrafish model for spontaneous *** BMD in aging,detected by automated computational analysis,is caused by bone deformities at the ***,aged zebrafish spines showed changes in bone morphology,microstructure,mineral heterogeneity,and increased fragility that resembled *** of the discs recapitulated IVDD symptoms found in humans:the intervertebral ligament(equivalent to the annulus fibrosus)showed disorganized collagen fibers and herniation,while the disc center(nucleus pulposus equivalent)showed dehydration and cellular *** manipulated BMD in young zebrafish by mutating sp7 and cathepsin K,leading to low and high BMD,***,we detected IVDD in both groups,demonstrating that low BMD does not protect against IVDD,and we found a strong correlation between high BMD and *** learning was applied to high-resolution synchrotron\iCJ image data to analyze osteocyte 3D lacunar distribution and morphology,revealing a role of sp7 in controlling the osteocyte lacunar 3D *** findings suggest potential avenues through which bone quality can be targeted to identify beneficial therapeutics for IVDD.

关键词： intervertebral degeneration protective