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| 1 | 对儿科药物开发的非临床安全性评价的考虑显示文摘儿科药物研发是目前药物研发的一个热点,其中非临床安全性评价是儿科药物研发的一个必要和独特的部分。基于化合物类型/适应证(包括'只是儿科/先是儿科'用药)和儿科人群相关的特性,需要及时地制定一个适当的儿科药物非临床研发策略和计划,来支持儿科临床试验和新药上市申请。儿童用药的安全问题是独特的,且与器官系统的发育密切相关,需要根据一个透彻的'缺口'分析,制定一个总的非临床儿科药物研发计划。本文介绍了国外药品监管机构对儿科药物研发的非临床安全性评价指导原则、儿科药物研发过程中的科学咨询、儿科临床研发计划,以及对幼龄动物非临床安全性评价的策略和要求,包括药物安全性在成年和儿科患者中的差异及原因、何种情况下要求进行幼龄动物试验及其时间安排等,以期为国内研发者提供参考。 | 黄芳华 王庆利 Jim Ridings 王英 张云 | 2016 | 中国新药杂志2016，25，18： | 12 |
| 2 | 幼龄动物毒理学研究:试验设计、实施和结果分析显示文摘非临床安全性评价是儿科药物研发的一个必要和独特的部分。儿童用药的安全性问题与成人用药相比具有独特性,不仅与儿童器官系统的发育密切相关,而且儿童药动学特性(吸收、分布、代谢和排泄)的变化常常会导致暴露量和毒性反应不同于成人。目前,人们通过幼龄动物毒理学试验来评估药物在儿童用药的安全性。幼龄动物毒理学试验有许多需要特殊考虑的地方,无标准的试验设计,需要具体问题具体分析来确定相应的试验设计。本文介绍国外对幼龄动物毒理学试验的经验,介绍了不同动物种属之间器官发育的比较,重点阐述了幼龄动物试验设计和实施的特殊关注要点,包括总体试验设计、评价指标的选择、种属选择、剂量选择、动物起始年龄和给药期限、同窝幼仔的分组考虑、一些实施问题试验数据分析与评价等。通过以上国外经验的介绍,期望对国内研发者提供参考。 | 黄芳华 王庆利 JIM Ridings 王英 张云 | 2017 | 中国新药杂志2017，26，2： | 10 |
| 3 | Versatile on-chip light coupling and(de)multiplexing from arbitrary polarizations to controlled waveguide modes using an integrated dielectric metasurface显示文摘Metasurfaces have found broad applicability in free-space optics,while its potential to tailor guided waves remains barely explored.By synergizing the Jones matrix model with generalized Snell’s law under the phase-matching condition,we propose a universal design strategy for versatile on-chip mode-selective coupling with polarization sensitivity,multiple working wavelengths,and high efficiency concurrently.The coupling direction,operation frequency,and excited mode type can be designed at will for arbitrary incident polarizations,outperforming previous technology that only works for specific polarizations and lacks versatile mode controllability.Here,using silicon-nanoantenna-patterned silicon-nitride photonic waveguides,we numerically demonstrate a set of chip-scale optical couplers around 1.55μm,including mode-selective directional couplers with high coupling efficiency over 57%and directivity about 23 d B.Polarization and wavelength demultiplexer scenarios are also proposed with 67%maximum efficiency and an extinction ratio of 20 d B.Moreover,a chip-integrated twisted light generator,coupling free-space linear polarization into an optical vortex carrying 1 h orbital angular momentum(OAM),is also reported to validate the mode-control flexibility.This comprehensive method may motivate compact wavelength/polarization(de)multiplexers,multifunctional mode converters,on-chip OAM generators for photonic integrated circuits,and high-speed optical telecommunications. | YUAN MENG ZHOUTIAN LIU ZHENWEI XIE RIDE WANG TIANCHENG QI FUTAI HU HYUNSEOK KIM QIRONG XIAO XING FU QIANG WU SANG-HOON BAE MALI GONG XIAOCONG YUAN | 2020 | Photonics Research2020，8，4： | 8 |
| 4 | 国外儿科药物研发的监管要求和研发策略显示文摘从历史上看,药物用于儿童时通常没有获得像成人药物一样的安全性和有效性证据。随着人们对全球药品监管有关儿科药物研发互动协调的关注的不断增长,同时对儿童遗传性罕见病也给予了越来越多的支持和关注,尽早和监管机构接触的期望日渐增高。欧盟和美国的法律都强制性要求进行和支持儿科药物研发,同时包括随之而来的经济利益,即延长儿科用药的专利保护。在提交上市许可申请之前,欧盟儿科法规要求制药公司申请人与欧洲药品管理局(EMA)达成儿科研究计划的协议,而目前美国有4个儿科药物研发相关的法律,提出了儿科研究计划的要求。世界卫生组织推出了'量身定制儿童药物'的倡议。对于全球性药物开发项目,明智的做法是尽可能早地寻求欧盟EMA和美国FDA有关儿科药物研发计划的科学建议,并达成协议。 | 黄芳华 王庆利 Jim Ridings Susan Watts 王英 张云 | 2016 | 中国新药杂志2016，25，19： | 5 |
| 5 | Some antecedents and effects of trust in virtual communities显示文摘 | Catherine M Ridings David Gefen Bay Arinze | 2002 | Journal of Strategic Information Systems2002，，3： | 4 |
| 6 | Structure and Composition of Organic Reefs and Carbonate Mud Mounds: Concepts and Categories 显示文摘 | Riding R | 2002 | Earth-Science Reviews2002，58，12： | 1 |
| 7 | Epoxy silicone release coatings UV cure instantly in air显示文摘 | ECKBERG R P RIDING K D GRENOBLE M E | 1989 | Adhesives Age1989，32，4： | 1 |
| 8 | Towards a Model for the Determinants of Occupational Stress among Schoolteachers显示文摘 | M G BORG R J RIDING J M FALZON | 1991 | European Journal of Psychology of Education1991，，6： | 1 |
| 9 | Inhibition of self-incompatible pollen in Papaver rhoeas involves a complex series of cellular events显示文摘 | JORDAN N D RIDE J P RUDD J J | 2000 | Annals of Botany2000，85，： | 1 |
| 10 | Occupational stress in general nurses and midwives显示文摘 | Wheeler H Riding R | 1994 | Brit J Nurs1994，3，10： | 1 |
| 11 | Cloning and expression of a protective antigen from the cattle tick Boophilus microplus显示文摘 | Willadsen P Riding G A McKenna R V | 1989 | Proc Natl Acad Sci USA1989，86，： | 1 |
| 12 | Structure and composition of organic reefs and car-bonate mud mounds:Concepts and categories显示文摘 | Riding R | 2002 | Earth-Sci-ence Reviews2002，58，： | 1 |
| 13 | Psychological Barriers:Lurker and Poster Motivation andBehavior in Online Communities显示文摘 | Ridings | 2006 | Communications of AIS2006，，18： | 1 |
| 14 | Identification of an Archean marine oxygen oasis显示文摘 | RIDING R FRALICK P LIANG L | 2014 | Precambrian Research2014，251，： | 1 |
| 15 | Defaulting on loan guaran- tees: costs and benefits of encouraging earily-stage growth 显示文摘 | Allan L Riding George Haines Jr | 1998 | Frontiers of Entrepreneu~hip Research1998，19，： | 1 |
| 16 | Genetic susceptibility to VTE: a primary care approach显示文摘 | Ridings HD Holt L Cook R | 2009 | JAAPA2009，22，7： | 1 |
| 17 | Virtual community attrac- tion:Why people hang out online显示文摘 | Ridings C M Gefen D | 2004 | Journal of Computer-Mediated Communication2004，10，1： | 1 |
| 18 | Microbial carbonates : The geological record of calcifiedbacterial-algal mats and biofilms显示文摘 | Riding R | 2000 | Sedimentology2000，47，1： | 1 |
| 19 | The self- incompatibility response in Papaver rhoeas is mediated by cytosolic free calcium显示文摘 | Ride J P Reed N | 1993 | Plant J1993，4，： | 1 |
| 20 | Cognitive styles-an overview and integration 显示文摘 | RIDING R J CHEEMA I | 1991 | Education Psychology1991，，11： | 1 |
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