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抗体药物的药理学与治疗学研究

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抗体药物的药理学与治疗学研究

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刘昌孝院士组织天津药物研究院、天津医科大学、天津中医药大学、温州医科大学、中国科学院沈阳应用生态研究所、重庆医科大学附属医院和齐鲁制药有限公司药物研究院从事相关研究的科学工作者,经过两年的精心笔耕,顺利完成《抗体药物的药理学与治疗学研究》一书的编著任务。刘昌孝编写的《抗体药物的药理学与治疗学研究》重点从抗体药物所特有的靶向性、免疫原性和临床安全性出发,反映国内外研究进展,为抗体药物的研发提供借鉴。
《抗体药物的药理学与治疗学研究》分为总论和各论上下两篇,共分22章。总论部分7章,主要阐述抗体药物的研发思路与成药性的关键理论和技术;各论部分15章,分别从药物作用特点与作用机制、药理学与毒理学、药动学、药效学、免疫原性、临床耐受性与安全性、药物相互作用及临床应用前景等方面阐述了对不同类别的治疗用抗体药物的基础研究和临床应用的重要进展。
《抗体药物的药理学与治疗学研究》可供从事抗体药物研究的医药类高校及科研院所教师、研究人员及本科以上学生参考使用。
Comments

★“抗体药物经历20多年的发展为新药创新研究奠定了基础,其研究开发仍是目前的热点和国家的需求。近年来国家在生物技术方面给予了越来越多的关注与重视,单抗药物研究已被列入国家‘九五’、‘十五’、‘十一五’及‘十二五’计划和国家重点攻关项目,以及地方政府的重大科技攻关专项,使之研究开发速度和效率大有进步。抗体药物研究体现了多学科交叉的特点,在理论、技术和临床应用方面,其研究具有前沿性和挑战性,对于推动我国抗体药物的发展意义重大。”
——中国工程院院士,中国医学科学院医药生物技术研究所甄永苏

★“刘昌孝院士所领导的新药评价研究中心和释药技术与药代动力学国家重点实验室,近20年来在生物技术新药研究和科学评价中获得突出成绩,积累了丰富的理论和实践知识,完成过100多个生物技术药物的评价研究,特别是在生物技术药物的药理学、药效学、药代动力学、毒代动力学和安全性方面的研究很有特色。”
——中国工程院院士、中国药理学会副理事长杨宝锋

★“本书重点从抗体药物所特有的靶向性、免疫原性和临床安全性出发,反映了国内外研究进展,可为进行抗体药物的研发提供借鉴。结合本人从事的主要研究领域包括基因工程、基因治疗、抗体及核酸药物等生物技术药物的生物学活性、质量标准和安全性评价的研究工作,出版此书符合国家需求。”
——中国食品药品检验研究院副院长王军志
Catalogue

前言

第1章 抗体药物研究发展概述
1.1 引言
1.2 抗体药物的发展历史和发展趋势
1.3 抗体药物发展的前沿科学与关键技术的发展
1.4 抗体药物偶联技术的发展
1.5 单克隆抗体药物应用的局限性
1.6 世界抗体药物快速发展的形势
1.7 我国单克隆抗体药物研发和产业化问题与展望
1.8 抗体药物生物医学评价研究概述
参考文献

第2章 抗体药物的药理学和药效动力学研究
2.1 引言
2.2 药效动力学研究试验设计
2.3 抗体药物的药理学特点
2.4 抗体药物的主要作用机制研究
2.5 抗体药物的耐药性
2.6 抗体药物药效学和实验治疗学研究的实例
参考文献

第3章 治疗性抗体药物的药代动力学和毒代动力学研究
3.1 引言
3.2 抗体药物药代动力学研究的挑战
3.3 抗体药物药代动力学研究的特点和内容
3.4 药代动力学.药效动力学研究
3.5 抗体药物毒动学的研究
3.6 抗体药物的PK研究实例
3.7 讨论与展望:发展机遇与挑战
3.8 结论
参考文献

第4章 抗体一药物偶联物(ADC)药代动力学研究
4.1 引言
4.2 研发的趋势和挑战
4.3 ADC作用原理
4.4 生物分析方法的特殊性
4.5 生物分析方法的建立、筛选和验证
4.6 LC.MS的应用
4.7 PK/PD模型研究和体外实验的应用
4.8 讨论
4.9 结论
参考文献

第5章 抗体药物的药效动力学与药代动力学同步研究
5.1 引言
5.2 :PK/PD模型
5.3 临床前。PK/PD研究
5.4 临床:PK/PD研究
5.5 抗体药物的PK/PD研究
5.6 0期临床的PK/PD研究
参考文献

第6章 抗体药物的临床前毒理学与安全性研究
6.1 引言
6.2 药物非临床研究质量管理规范
6.3 毒性和安全性研究的指导原则
6.4 安全性研究实验设计的基本要点
6.5 靶向性分布单抗的药代动力学研究是设计毒理和安全性研究的基础
6.6 抗体药物安全性研究实例
6.7 新技术、新方法的应用
参考文献

第7章 抗体药物的临床药理学与治疗学研究
7.1 引言
7.2 新药临床试验的核心是转换研究
7.3 临床研究的伦理准则
7.4 药物临床试验质量管理规范
7.5 临床药理学和治疗学研究设计的基本原则
7.6 抗体药物临床药理学
7.7 临床治疗学研究
7.8 单克隆抗体类药物耐药性
7.9 临床药物毒性与药物不良反应
7.10 展望
参考文献

第8章 阿达木单抗
第9章 阿来组单抗
第10章 贝伐单抗
第11章 依法珠单抗
第12章 吉妥单抗
第13章 那他珠单抗
第14章 奥马珠单抗
第15章 帕利珠单抗
第16章 曲妥珠单抗
第17章 西乏昔堕精
第18章 英夫利昔单抗
第19章 莫罗莫那
第20章 法索单抗锝
第21章 利妥昔单抗
第22章 其他治疗用单抗
索引
Introduction

抗体药物引导了生物技术的第二次革新浪潮,抗体药物的研究、开发是当今国际生物医药研究与开发的热点,其研究进展显现了国际抗体药物领域的发展现状和趋势。从基础研究角度来看,治疗用抗体药物的研究体现了新兴交叉学科的特点,其发展与生物医学研究和评价具有前沿性和挑战性。结合国内外的前沿研究和挑战,高度重视抗体药物的生物医学研究相关的药理学和治疗学问题,在理论和应用上具有重要的科学意义和实用价值。
总结30多年的发展,以细胞工程和基因工程为基础的抗体工程技术的发展推动了抗体药物的研发和应用,主要体现在3个方面。一,单克隆抗体研制成功是突破性进展:1975年Kdehler和Milstein用B淋巴细胞杂交瘤技术成功制备了单克隆抗体,这是具有重大意义的突破性进展。单克隆抗体的特异性高和性质均一的特点,可大大降低其在体内与正常组织细胞的交叉反应,为利用抗体治疗疾病带来了希望。已在临床应用或在研制中的抗体药物基本属于单克隆性的抗体药物。第二,基因工程抗体为抗体药物临床应用奠定了重要基础:利用DNA重组技术修饰抗体或制备各种模式的新型抗体。为克服鼠源性抗体在人体可引起人抗鼠抗体(HAMA)反应,以基因工程技术改造鼠源性抗体,从而制备嵌合抗体或人源化抗体,或全人源抗体。抗体人源化不仅为抗体药物的临床应用奠定了重要基础,而且各种模式基因工程抗体的制备推动了具有不同特点的新型抗体药物的发展。第三,抗体,药物偶联物(antibodydrugconjugate,ADC)是新一代抗体药物发展的里程碑:包括抗体及其片段与药物的化学偶联物、基因工程融合蛋白,以及用放射性核素标记的抗体等偶联形式发展该类药物。特别是肿瘤治疗的抗体药物偶联物的研发已被关注,这种兼有抗体的特异性和“弹头”药物的效应功能的药物既显示靶向性又具有对肿瘤靶细胞的强杀伤力。
新近抗体药物的发展围绕以下4方面获得新的进展。一是提高特异性:抗体对特定的抗原具有高度特异性,这是抗体药物突出的基本特征,是抗体药物用于靶向治疗的基础。二是提高多样性:包括靶抗原多样性、抗体结构多样性、作用机制多样性等方面。对于抗体药物偶联物,还具有“弹头”分子多样性,可以利用各式各样的“弹头”分子制备偶联物。三是定向制备:针对特定的靶分子,定向制备抗体药物和抗体药物偶联物,根据需要,选择不同的“弹头”药物分子。四是可以利用不同的分子(模块)进行组装:借助DNA重组技术可以将抗体片段与各种活性蛋白制备融合蛋白,也可以借助化学偶联技术将抗体片段与各种小分子“弹头”物质制成抗体药物偶联物。因此,抗体药物是研究开发新型分子靶向药物的有效途径与丰富资源。
基因组学研究促进了疾病相关基因及疾病相关分子机制研究,推动了分子靶向药物的研发和应用,推动了个体化治疗的发展。从基因(及其衍生物)到分子靶向药物,继而实施个体化治疗,对已经上市的抗体药物进行新适应证的研究,充分发挥抗体药物的临床应用价值,体现了转化医学的基本理念和基本模式及针对特定的、疾病相关的靶分子或通路,研制高度特异性的靶向药物,并用于个体化治疗的发展前景。
抗体药物经历了30多年的发展,虽然单克隆抗体药物已取得很大的成功,但仍然有许多难以克服的问题,如抗体靶抗原的不确定性,以及抗体自身的抗原性等,都是制约抗体药物研发的主要问题。由于人们对很多存在于靶细胞和组织上的靶抗原的确切分布和功能的认识尚待深入,因此产生了很多临床应用的疗效不确定性、耐药性和安全性问题。这类药物的风险,可能与针对同一靶分子不同表位的作用有关,可能会由此介导完全相反的生物学效应。适应证的抗体药物治疗在某些情况下也存在脱靶(off-target)现象,因此加强和突破靶治疗的基础研究显得非常重要。再如,由于生物技术的难点,抗体药物开发的障碍是生产成本过高,需要突破制备成本和质量等抗体药物技术和产业化的瓶颈。抗体药物的研究与开发作为21世纪生物制药领域的重要组成部分,目前面临着市场前景光明与发展瓶颈并存的问题,特别是靶抗原的不确定性和抗体自身的抗原性等,这些抗体药物独特而难以解决的问题的存在,的确给当前的抗体药物发展带来了诸多困难。克服这些困难还有赖于免疫医学的研究与发展。此外,从药理学角度认识抗体药物的作用特点和作用机制,在药代动力学特性上发挥优势、克服不足,提高抗体药物在体内的分布、代谢、药效和毒副反应的一致性,也可以大大降低抗体药物开发的临床风险。本书将围绕上述问题,系统介绍和探讨抗体药物发展的生物医学研究和应用领域的理论与应用成果及存在的问题,为促进我国抗体药物的研发和产业化发展抛砖引玉。
抗体药物研究体现了多学科交叉的特点,在理论、技术和临床应用方面,存在诸多难以克服的问题和研究开发的风险,面对抗体药物发展形势和国内外研究开发的挑战,近年来我国在生物技术方面给予了越来越多的关注和重视,抗体药物研究已被列入国家“九五”、“十五”、“十一五”及“十二五”规划和国家重点攻关项目,以及地方政府的重大科技攻关专项,使其研究开发有所进步,但是由于我国基础研究和关键技术研究与世界差距较大,要成为世界生物药物的大国和强国仍然任重道远。
刘昌孝所领导的新药评价研究中心和释药技术与药代动力学国家重点实验室,在近20年完成过近100项生物技术药物研究开发的药理学、毒理学、药代动力学研究,为发展我国生物技术新药、服务全国创新药物研究开发和评价研究作出过一定的贡献,积累了一定的理论知识和实践经验。为此,希望通过我们研究团队以文字形式表达和总结在生物技术药物研究开发的点点滴滴,形成一个较为系统的理论和应用体系,奉献给社会和同行。

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Yami has a consolidation warehouse in China which collects multiple sellers’ packages and combines to one order. Our Yami consolidation warehouse will directly ship the packages to your door. Cross-store free shipping over $69.

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You may return products within 30 days upon receiving the products. Sellers take responsibilities for any wrong shipment or missing items. Packing needs to be unopened for any other than quality issues return. We promise to pack carefully, but because goods are taking long journey to destinations, simple damages to packaging may occur. Any damages not causing internal goods quality problems are not allowed to return. If you open the package and any quality problem is found, please contact customer service within three days after receipt of goods.

Shipping Information

Yami Consolidation Service Shipping Fee $9.99(Free shipping over $69)

Sellers in China will ship their orders within 1-2 business days once the order is placed. Packages are sent to our consolidation warehouse in China and combined there. Our Yami consolidation warehouse will directly ship the packages to you via UPS. The average time for UPS to ship from China to the United States is about 10 working days and it can be traced using the tracking number. Due to the pandemic, the delivery time may be delayed by about 5 days. The package needs to be signed by the guest. If the receipt is not signed, the customer shall bear the risk of loss of the package.

Sold by JD@CHINA

Service Guarantee

Free shipping over 69
Genuine guarantee

Shipping

Yami Consolidated Shipping $9.99(Free shipping over $69)


Seller will ship the orders within 1-2 business days. The logistics time limit is expected to be 7-15 working days. In case of customs clearance, the delivery time will be extended by 3-7 days. The final receipt date is subject to the information of the postal company.

Yami Points information

All items are excluding from any promotion or points events on Yamibuy.com

Return Policy

You may return product within 30 days upon receiving the product. Items returned must be new in it's original packing, including the original invoice for the purchase. Customer return product at their own expense.

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About the brand

Jingdong book

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About the brand

Jingdong book