Drug Discovery and Evaluation

出版者:SPRINGER VERLAG GMBH

作者:Vogel, Gerhard H.

页数:920

出版时间:2006-10

价格:$ 439.57

装帧:精装

isbn号码:9783540256380

具体描述

Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays. Safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails. This "sequential" strategy has been abandoned for several reasons: - Some negative effects on organ function, e.g. ventricular tachy-arrhythmia, were detected too late. On the other hand, negative findings in chronic toxicity studies in animals turned out to be irrelevant for human beings. - New scientific approaches, e.g. combinatorial chemistry, high-throughput screening, in silico models, pharmaco-genomics and pharmaco-proteomics offered new possibilities. - There are several examples which show that the "druggability" of compounds was considerably underestimated when the probability of success of a new project was assessed. The success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. A change of strategy was therefore adopted, involving the following changes: - Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization). - The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group. Easily accessible and the most informative tests now have to be selected. - Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development. Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics. The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs. The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process. In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide. Please note that this publication is available as print only OR online only OR print + online set. Save 75% of the online list price when purchasing the bundle. For more information on the online version please type the publication title into the search box above, then click on the "eReference" version in the results list.

用户评价

坦白说，我对《药物发现与评估》这本书的期待，更多的是在于它能够提供一种宏观的视角。我不仅仅想了解具体的某个药物是如何被研发出来的，更想知道整个药物研发的生态系统是怎样的。它涉及到哪些不同的学科，比如药理学、毒理学、临床医学、化学、生物学等等，这些学科之间是如何协同作用的？还有，药物研发的流程是不是标准化的，有哪些关键的里程碑？比如，临床试验的几个阶段，每个阶段的目标是什么，成功率有多高，失败的原因又是什么？我希望能从中了解到，一个新药的开发周期究竟有多长，成本有多高，以及在这个过程中，有哪些政府机构或国际组织在扮演着监管的角色，确保药物的安全性和有效性。如果它能像一部纪录片一样，为我展现出整个产业的运作模式，那我将会非常满意。

这本书的名字叫《药物发现与评估》，光听名字就让人觉得它充满了科学的严谨和探索的未知。我一直对医学研究和新药的诞生过程非常好奇，尤其是在这个日新月异的时代，仿佛每天都有新的突破在发生。我期望这本书能够为我揭开药物研发神秘的面纱，让我理解从最初的科学设想到最终药品上市，这条漫长而艰辛的道路究竟需要经历哪些环节。我希望能看到关于药物设计原理的介绍，例如如何通过理解疾病的生物学机制来寻找潜在的靶点，以及如何利用化学和生物学知识来设计能够与这些靶点相互作用的分子。同时，我也对药物的评估过程充满兴趣，包括早期在实验室进行的体外和体内试验，如何判断一个化合物是否具有治疗潜力，又如何排除那些可能带来严重副作用的物质。这本书如果能详细讲解这些科学的逻辑和方法，我会觉得物超所值。

我买这本书完全是出于偶然，当时只是在书店里随便翻看，被它的封面设计吸引了。我一直认为，一本好的科普读物，不应该只是枯燥的数据和理论的堆砌，更应该讲述背后的故事，以及那些为了人类健康而默默奉献的科研人员。我希望这本书能够做到这一点，用生动的语言，穿插一些有趣的案例，来介绍药物发现的历史进程。比如，那些伟大的发现是如何偶然产生的，又或者是在无数次的失败中，科学家们是如何坚持下来的。我特别想了解一些经典药物的研发故事，例如青霉素的发现，或者像阿司匹林这样家喻户晓的药物，它们最初是如何被发现并逐渐推广使用的。如果书中能够描绘出科学家们在实验室里通宵达旦的场景，或者他们面对挫折时的心路历程，那将是非常引人入胜的。

我购买《药物发现与评估》这本书，主要是想提升自己在生物医药领域的专业知识，为未来的学习或工作打下基础。我是一名在校学生，对药物研发的具体操作流程和理论基础还比较模糊。我希望这本书能够系统地介绍药物发现的各个阶段，从药物筛选、先导化合物的优化，到临床前研究中的药代动力学、药效学和毒理学评估，再到各个阶段的临床试验设计和数据分析。我更关注的是那些在实际研发过程中至关重要的技术和方法，例如高通量筛选技术、计算机辅助药物设计、生物标记物的应用等等。如果书中能够包含一些相关的案例研究，详细分析某个药物研发的成功或失败之处，并从中提炼出可供借鉴的经验教训，那将对我非常有启发。

我对这本书的兴趣点在于，它是否能够帮助我理解当前药物研发面临的挑战和未来的发展趋势。我知道，很多疾病，比如阿尔茨海默病、癌症，仍然是医学界的难题，而新药的研发也充满困难，投入巨大，但成功率却不高。我想知道，这本书是否会讨论到这些挑战，比如如何克服药物的耐药性问题，如何寻找新的治疗靶点，以及如何利用新技术，比如基因编辑、人工智能等，来加速药物的发现和开发过程。我也很想知道，这本书是否会涉及到一些前沿的药物研发领域，比如靶向治疗、免疫疗法、个性化医疗等等，它们是如何工作的，又将为未来的医学带来怎样的改变。如果它能让我对未来的新药研发有更清晰的认识，那这本书就非常有价值了。